IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B

K013501 · Gynetics Medical Products NV · MQF · Nov 30, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K013501
• Device Name: IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
• Applicant: Gynetics Medical Products NV
• Product Code: MQF · Obstetrics/Gynecology
• Decision Date: Nov 30, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6110
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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.

Device Story

Intra-Uterine Insemination (IUI) and GIFT catheters (IUI #4220, Smooze #4225, Seminor #4502) are medical devices used by clinicians to facilitate reproductive procedures. The catheters serve as conduits for the delivery of washed spermatozoa into the uterus for artificial insemination or as introducers for transcervical GIFT. These devices are used in clinical settings by healthcare professionals. By providing a controlled pathway for gamete delivery, the catheters assist in reproductive medicine, potentially improving the success of fertility treatments.

Technological Characteristics

Catheter-based devices for reproductive procedures. Specific materials and dimensions are not detailed in the provided documentation.

Indications for Use

Indicated for patients undergoing intra-uterine artificial insemination procedures using washed spermatozoa, and for transcervical Gamete Intrafallopian Transfer (GIFT) procedures as an introducer.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Submission Summary (Full Text)

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

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 [phone] or [phone] 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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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) | <div> <img alt="Check Mark" src="check_mark.png"/> </div> | 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) | <div style="display:inline-block;">✓</div> | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---------------------------------------|--------------------------------------------|----|-----------------------------------------------|
|---------------------------------------|--------------------------------------------|----|-----------------------------------------------|