(173 days)
Insemination Catheters are used for transferring spermatozoa into the uterine cavity.
Not Found
This is a 510(k) premarket notification for a medical device (Morton IUI Catheter) and does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria. The provided document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
The letter acknowledges the submission and allows the device to be marketed, subject to general controls. It does not include:
- Acceptance criteria table or device performance reports.
- Details on sample sizes, data provenance, or ground truth establishment.
- Information on expert qualifications, adjudication methods, or MRMC studies.
- Standalone algorithm performance or training set specifics.
The document is primarily an administrative communication regarding market authorization based on substantial equivalence, not a summary of performance studies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring three wavy lines emanating from a central point, representing health and well-being. The text is arranged around the perimeter of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" clearly visible.
NOV 2 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Constance W. Sturgeon President Fertility Technology Resources, Inc. 4343 Shallowford Road Suite D-4 MARIETTA GA 30062
Re: K041470
Trade/Device Name: Morton IUI Catheter Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted reproduction catheters
Regulatory Class: II Product Code: 85 MOF Dated: September 23, 2004 Received: September 24, 2004
Dear Ms. Sturgeon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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), that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment A
Indications for Use
| 510(k): Number | K041470 |
|---|---|
| Device Name: | Morton IUI Catheters |
| Intended Use: | Insemination Catheters are used for transferring spermatozoa intothe uterine cavity. |
Prescription Use __ X (Per CFR 801.109) AND/OR
Over-the-counter use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 041470 510(k) Number __
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).