[Federal Register Volume 59, Number 216 (Wednesday, November 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27222]


[[Page Unknown]]

[Federal Register: November 9, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0363]

 

ExogenTM, Inc.; Premarket Approval of Sonic Accelerated 
Fracture Healing System (SAFHS)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by ExogenTM, Inc., West Caldwell, NJ, 
for premarket approval, under the Federal Food, Drug, and Cosmetic Act 
(the act), of the Sonic Accelerated Fracture Healing System 
(SAFHS). After reviewing the recommendation of the Orthopedic 
and Rehabilitation Devices Panel, FDA's Center for Devices and 
Radiological Health (CDRH) notified the applicant, by letter of 
September 13, 1994, of the approval of the application.

DATES: Petitions for administrative review by December 9, 1994.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Marie A. Schroeder, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-1296.

SUPPLEMENTARY INFORMATION: On July 18, 1990, Interpore Therasonics, 
Inc., West Caldwell, NJ 07006, submitted to CDRH an application for 
premarket approval of the SAFHS. Subsequently, the ownership 
was transferred to ExogenTM, Inc., West Caldwell, NJ 07006. The 
Sonic Accelerated Fracture Healing System (SAFHS) is 
indicated for acceleration of the time to a healed fracture for fresh, 
closed, distal radius (Colles') fractures, and fresh, closed or Grade I 
open tibial diaphysis fractures in skeletally mature individuals when 
these fractures are orthopedically managed by closed reduction and cast 
immobilization. The SAFHS emits a low intensity pulsed 
ultrasound collimated beam. Ultrasound coupling gel is used on the skin 
surface at the fracture location where the signal is to be applied.
    On November 22, 1991, the Orthopedic and Rehabilitation Devices 
Panel, an FDA advisory panel, reviewed the application. The original 
indication in the premarket approval application (PMA) stated that the 
device was to be used to accelerate the time to heal for all fresh 
cancellous and cortical bone fractures. The panel concluded that the 
safety of the device had been established and that the supporting 
preclinical studies had shown an effect of the device on bone healing. 
However, the panel members questioned extending the indications to all 
cortical and cancellous fresh fractures because the data presented in 
the PMA was limited to fresh closed, Grade I tibia diaphyseal fractures 
and fresh Colles' fractures. Therefore, the panel recommended that the 
PMA be found not approvable for the indication stated in the PMA. There 
were two votes for approval with conditions and three votes for not 
approvable. The panel discussed a very limited indication for the 
device to restrict its application to fresh tibia and fresh Colles' 
fractures. However, they could not reach a consensus on whether the 
sponsor had demonstrated effectiveness for the device for both fracture 
types. Nevertheless, it was the panel's opinion that the effectiveness 
already seen in some areas could eventually be applicable to others if 
further data were to be obtained from the study already accomplished. 
They also suggested that data obtained from a new study could be used 
to verify the device's performance in the PMA study. The panel 
recommended that several conditions be satisfied to place the PMA in 
approvable form. The conditions included a modification to the 
indication statement to restrict the device's use to the treatment of 
fresh, closed, distal radius (Colles') fractures and fresh, closed or 
Grade I open tibial diaphyseal fractures in skeletally mature 
individuals when these fractures are orthopedically managed by closed 
reduction and cast immobilization. The applicant amended the PMA to 
limit the use of the device to this indication. In addition, the panel 
suggested that the applicant expand the data base to provide additional 
supportive information. They stated that approval could be granted if 
the new data were found acceptable by FDA after appropriate review. At 
the request of FDA, the applicant submitted the results of a long-term 
followup study of all patients classified as healed at the time the PMA 
was presented before the panel, and a protocol for a 2-year post 
approval study to assess the performance of the device as it is 
marketed for the approved indications. Based on the data submitted in 
the PMA and the long-term followup study, CDRH determined that the data 
provide reasonable assurance that the device is safe and effective for 
the indications as specified in the labeling.
    On September 13, 1994, CDRH approved the application by a letter to 
the applicant from the Director of the Office of Device Evaluation, 
CDRH.
    A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

Opportunity for Administrative Review

    Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any 
interested person to petition, under section 515(g) of the act, for 
administrative review of CDRH's decision to approve this application. A 
petitioner may request either a formal hearing under part 12 (21 CFR 
part 12) of FDA's administrative practices and procedures regulations 
or a review of the application and
CDRH's action by an independent advisory committee of experts. A 
petition is to be in the form of a petition for reconsideration under 
Sec. 10.33(b) (21 CFR 10.33(b)). A petitioner shall identify the form 
of review requested (hearing or independent advisory committee) and 
shall submit with the petition supporting data and information showing 
that there is a genuine and substantial issue of material fact for 
resolution through administrative review. After reviewing the petition, 
FDA will decide whether to grant or deny the petition and will publish 
a notice of its decision in the Federal Register. If FDA grants the 
petition, the notice will state the issue to be reviewed, the form of 
review to be used, the persons who may participate in the review, the 
time and place where the review will occur, and other details.
    Petitioners may, at any time on or before December 9, 1994, file 
with the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: October 27, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-27222; Filed 11-8-94; 8:45 am]
BILLING CODE 4160-01-F