(330 days)
The Casmed UK Single/Double Lumen Oocyte Collection Needle Set and Single/Double Lumen Needle are assisted reproduction needles indicated for use and intended for aspiration and flushing of gametes/oocytes from the body.
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I am sorry, but the provided text only contains a letter from the FDA regarding a 510(k) premarket notification for Oocyte Aspiration Needles and an "Indications for Use Form." This document confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria (as outlined in your request) is not present in the provided text. The document does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for the training set was established.
This FDA letter is a regulatory approval document and not a scientific study report.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 2000
Ms. Debbie Castle CASMED UK Castle House 39 Nork Way Banstead Surrey SM7 1PB ENGLAND
Re: K991271
Oocvte Aspiration Needles Dated: February 8, 2000 Received: February 14, 2000 Requlatory Class: II 21 CFR 884.6100/Procode: 85 MQE
Dear Ms. Castle:
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 26, 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 equivation 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 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 predication 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) 594-4591. Additionally, for question 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" (21CFR 807.97). Other general information on your resonsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Indications for Use Form
Page____of___
510(k) Number (if known): __
Device Name:
Indications For Use:
Casmed UK Single Lumen Oocyte Collection Needle Set Casmed UK Double Lumen Oocyte Collection Needle Set Casmed UK Single Lumen Needle Casmed UK Double Lumen Needle
The Casmed UK Single/Double Lumen Oocyte Collection Needle Set and Single/Double Lumen Needle are assisted reproduction needles indicated for use and intended for aspiration and flushing of gametes/oocytes from the body.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 1 (
Concurrence of CDRH/Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K991271 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | ------------------------------------------------- | ---- | ---------------------- |
(Per 21 CFR 801/109)(Optional Format 1-2-96)
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).