(105 days)
The SCULPTURE is designed for use in fragmentation, emulsification and aspiration of soft ussue in the following Surgical Specialties: plastic and reconstructive surgery, general surgery
Not Found
This appears to be a 510(k) clearance letter from the FDA for a device called "Sculpture." The letter confirms that SMEI, Inc. can market the device because it has been determined to be substantially equivalent to devices marketed prior to May 28, 1976.
However, the provided text does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. This document is a regulatory approval letter, not a clinical study report.
Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need access to the actual 510(k) submission document or a clinical study report for the Sculpture device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SMEI, Inc. ර්/o Mr. James E. Lenick FDA Counsel to SMEI 5201 Kingston Pike, Suite 6-148 Knoxville, Tennessee 37919
K971609 Re: Trade Name: Sculpture Regulatory Class: Unclassified Product Code: LFL Dated: July 29, 1997 Received: August 5, 1997
AUG 1 4 1997
Dear Mr. Lenick:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
L Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of of
10(k) Number (if known). ___________________________________________________________________________________________________________________________________________________ Device Name __________________________________________________________________________________________________________________________________________________________________
Indications For Use
The SCULPTURE is designed for use in fragmentation, emulsification and aspiration of soft ussue in the following Surgical Specialties
plastic and reconstructive surgery general surgery
(I'LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) (
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off)Division of General Restorative Devices | |
|---|---|
| 510(k) Number | K971609 |
| (Division Sign-Off)Division of General Restorative Devices | |
|---|---|
| 510(k) Number |
| Prescription Use(Per 21 CFR 801 109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
N/A