(71 days)
Not Found
Not Found
No
The summary describes a physical device for sample collection and lacks any mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as an "Endometrial Sampler" intended for "Histological biopsy of the uterine mucosal lining or sample extraction of uterine menstrual content," which are diagnostic procedures, not therapeutic ones.
Yes
The device is used for histological biopsy, which involves the removal of tissue for microscopic examination to establish a diagnosis.
No
The device description clearly states "Endometrial Sampler," which is a physical instrument used for tissue collection, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Histological biopsy of the uterine mucosal lining or sample extraction of uterine menstrual content." This describes a procedure to obtain a sample from the body, not a test performed on a sample in vitro (outside the body) to diagnose a condition.
- Device Description: "Endometrial Sampler" further supports that this is a device for collecting a sample, not for performing a diagnostic test on that sample.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing a sample (blood, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing diagnostic information based on sample analysis
This device appears to be a surgical or procedural device used to obtain a sample for subsequent diagnostic testing (which might be an IVD test, but the sampler itself is not).
N/A
Intended Use / Indications for Use
Histological biopsy of the uterine mucosal lining or sample extraction of uterine menstrual content.
Product codes
85 HHK
Device Description
Endometrial Sampler
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
uterine mucosal lining, uterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized symbol that resembles a bird or a human figure in profile, composed of three curved lines.
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
1
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
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