(44 days)
For surgical reconstruction of the sound conduction chain between the stapes and the ear drum, where the stapes is intact and mobile, by replacement of the missing ossicles with a partial implant.
S&T Partial Ossicular Replacement Prosthesis
This document is a 510(k) premarket notification for a medical device (S&T Partial Ossicular Replacement Prosthesis), indicating FDA clearance for marketing. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The information requested in the prompt (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically found in clinical study reports, scientific publications, or detailed sections of a premarket application. This specific FDA letter and its linked "Statement of Indications for Use" only confirm that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
Therefore, I cannot fulfill your request based on the provided text. The document does not contain the necessary details to describe the acceptance criteria and the study that proves the device meets them.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 1999
Mr. Charles Grote Manager of Quality Assurance and Regulatory Affairs Micromedics, Inc. 1285 Corporate Center Drive #150 Eagan, MN 55121
Re: K993234
Device: S&T Partial Ossicular Replacement Prosthesis Dated: September 24, 1999 Received: September 27, 1999 Regulatory Class: II Product Code: 77 ETB
Dear Mr. Grote:
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 vour 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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Page 2 -- Mr. Charles Grote
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) 594-4613. 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,
A. Roepl. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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MICROMEDICS, INC. 510(K) Premarket Notification
510(K) Number: Notknown at this time K993234
Device Name: S&T Partial Ossicular Replacement Prosthesis
STATEMENT OF INDICATIONS FOR USE
For surgical reconstruction of the sound conduction chain between the stapes and the ear drum, where the stapes is intact and mobile, by replacement of the missing ossicles with a partial implant.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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Audit Oll
(Division Sign-Off)
Division of Ophthalmic Devices
"19/99
Division of Ophthalmic Devices
510(k) Number K993234
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 874.3450 Partial ossicular replacement prosthesis.
(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.