(71 days)
Histological biopsy of the uterine mucosal lining or sample extraction of uterine menstrual content.
Endometrial Sampler
This document is a 510(k) clearance letter from the FDA for an "Endometrial Sampler" device (K990387). It states that the device is substantially equivalent to a legally marketed predicate device. This type of clearance typically relies on demonstrating equivalence to an existing device rather than conducting new clinical studies with defined acceptance criteria and performance metrics.
Therefore, the specific information requested about acceptance criteria and a study proving the device meets them (such as AI performance, expert ground truth, sample sizes, etc.) is not applicable to this document.
For the vast majority of 510(k) clearances, the manufacturer demonstrates that their new device is as safe and effective as a legally marketed predicate device. This often involves:
- Bench testing: To ensure the device meets engineering specifications.
- Performance testing: To show it functions as intended, often in comparison to the predicate.
- Biocompatibility testing: If applicable, to ensure materials are safe for human contact.
- Sterilization validation: If the device is sterile.
- Software validation: If the device contains software.
These tests are designed to show equivalence, not necessarily to meet new, standalone acceptance criteria with performance metrics like accuracy, sensitivity, or specificity in the way one might evaluate an AI-powered diagnostic device.
In summary, none of the requested information (table of acceptance criteria, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) is present or relevant to this 510(k) clearance document for an Endometrial Sampler.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 1999
Mr. Fanish Engineer President U.A. Medical Products, Inc. 9303-G2 Monroe Road Charlotte, NC 28270
Re: K990387
Endometrial Sampler Dated: February 1, 1999 Received: February 8, 1999 Regulatory Class: II 21 CFR 884.1175/Procode: 85 HHK
Dear Mr. Engineer:
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 legally marketed predicate 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 requlatory 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.
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/dsma/dsmamain.html".
Sincerely yours,
APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section #4
Indications for Use
| 510 (k) Number: | K990387 (to be assigned) |
|---|---|
| ----------------- | -------------------------- |
Device Name: Endometrial Sampler
Intended Use: Histological biopsy of the uterine mucosal lining or sample extraction of uterine menstrual content.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per CFR 801.109)
OR
Over-the-counter Use
David A. Segura
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 19038 510(k) Number
Page 5 of 15
§ 884.1175 Endometrial suction curette and accessories.
(a)
Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.(b)
Classification. Class II (performance standards).