(39 days)
The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures utilizing washed spermatozoa.
The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures and for transcervical GIFT as an introducer.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for several Intrauterine Insemination (IUI) and GIFT catheters manufactured by Gynétics Medical Products N.V.
Based on the provided text, there is no information about acceptance criteria or a study proving that the device meets those criteria.
The document primarily focuses on:
- Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This is a regulatory determination, not an assessment of performance against pre-defined acceptance criteria from a study described in this document.
- Regulatory Information: It details the regulation numbers, product codes, regulatory class, and general controls provisions of the Act that apply to the device.
- Marketing Authorization: It states that the letter allows the applicant to begin marketing their device.
- Indications for Use: It lists the intended uses for three specific devices:
- IUI #4220: For intra uterine artificial insemination procedures utilizing washed spermatozoa.
- Smooze #4225: For intra uterine artificial insemination procedures utilizing washed spermatozoa.
- Seminor #4502: For intra uterine artificial insemination procedures and for transcervical GIFT as an introducer.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. This type of information would typically be detailed in the 510(k) submission itself, not in the FDA's decision letter.
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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 contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2001
Gynétics Medical Products N.V. % Ms. Grace Holland Regulatory Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606
Re: K013501
Trade/Device Name: Intrauterine Insemination and GIFT Catheters, IUI #4220, Smooze #4225, Seminor #4502 Regulation Number: 21 CFR 884.5250 Regulation Name: Cervical cap Product Code: 85 MFD Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted reproduction catheter Product Code: 85 MQF Regulatory Class: II Dated: October 19, 2001 Received: October 22, 2001
Dear Ms. Holland:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surved in the enalebals) 75 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 r ou may, dicrorere, mains of the Act include requirements for annual registration, listing of general controls proficions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 nroduct 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothleation. The I Dri inding of succianter 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 IT you desire specific acries as one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions 11 (301-4639. Also, please note the regulation entitled, "Misbranding Office of Compinance at (2017 2 ation" (21 CFR Part 807.97). Other general information on by receive to premainer nearly be obtained from the Division of Small Maulfacturers, your its polisional and Consumer 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,
Nancy C. Hodgin
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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Page_1_of_1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Intra-Uterine Insemination Cannula, IUI # 4220
Indications For Use:
The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures utilizing washed spermatozoa.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K013501 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) | |
|---|---|---|---|
| --------------------------------------- | ----------------------------------------------------------- | ---- | ----------------------------------------------- |
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Page 1 of 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:___Intra-Uterine Insemination Cannula, Smooze IUI # 4225
Indications For Use:
The Intra-Uterine Insemination Cannula is to be used for intra uterine The intra-Olenno insomination a utilizing washed spermatozoa.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive and Radiological Devices 50 i 510(k) Number V Over-The-Counter Use OR Prescription Use (Optional Format 1-2-96) (Per 21 CFR 801.109)
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Page_1_of_1___
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: _ Intra-Uterine Insemination Cannula, Seminor 4502
Indications For Use:
The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures and for transcervical GIFT as an introducer.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Nancy Bigelow |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K013501 |
| Prescription Use (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|---|
| --------------------------------------- | -------------------------------------------- | ---- | ----------------------------------------------- |
§ 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).