(223 days)
The UAS is designed for use in the fragmentation, emilsification and aspiration of soft tissue in the following surgical specialties: Neurosurgery, Gastrointestinal and affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Gynecology, Orthopedic Surgery.
Not Found
This document is an FDA 510(k) clearance letter for the UAS Ultrasonic Aspirator System, dated December 9, 1997. It explicitly states that the device is determined to be "substantially equivalent" to predicate devices marketed before May 28, 1976.
Based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The letter is a regulatory approval document confirming substantial equivalence, not a detailed technical report of a clinical study or performance evaluation. The typical information requested in your prompt (e.g., acceptance criteria, test set details, ground truth, MRMC studies) is usually found in the 510(k) submission itself or related study reports, which are not part of this clearance letter.
Therefore, I cannot populate the table or answer the specific questions about studies, sample sizes, or ground truth based solely on the provided text. The letter only indicates the device is cleared for marketing based on substantial equivalence, and lists the intended uses.
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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, suggesting a sense of community and collaboration.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Brenda Hunt Ouality Assurance/Regulatory Affairs Wells Johnson Company 8000 S. Kolb Road-85706 P.O. Box 18230 Tucson, Arizona 85731-8230
DEC - 9 1997
Re: K971580
Trade Name: UAS Ultrasonic Aspirator System Regulatory Class: II Product Code: LFL Dated: October 28, 1997 Received: November 5, 1997
Dear Ms. Hunt:
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 (OS) 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
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Page 2 - Ms. Hunt
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.
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,
t.c. Olles
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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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Brenda Hunt Ouality Assurance/Regulatory Affairs Wells Johnson Company 8000 S. Kolb Road-85706 P.O. Box 18230 Tucson, Arizona 85731-8230
DEC - 9 1997
Re: K971580
Trade Name: UAS Ultrasonic Aspirator System Regulatory Class: II Product Code: LFL Dated: October 28, 1997 Received: November 5, 1997
Dear Ms. Hunt:
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 (OS) 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
{3}------------------------------------------------
Page 2 - Ms. Hunt
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.
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,
t.c. Olles
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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510(k) Number (if known): K971580
Device Name: UAS ULTRASONIC ASPIRATOR SYSTEM
Indications For Use:
The UAS is designed for use in the fragmentation, emilsification
and is a Ine ons is debigned 200
- 米 Neurosurgery
- Gastrointestinal and affiliated Organ Surgery ★
- Urological Surgery *
- Plastic and Reconstructive Surgery ★
- General Surgery ★
- Gynecology *
- Orthopedic Surgery. ★
(PLEASE 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 | K971580 |
Prescription Use (Per 21 CFR 801.1199)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
/ 300/ HUGO
N/A