TOM CAT F.L., TOM CAT S.L.

K972245 · A & A Medical, Inc. · MFD · Aug 6, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K972245
• Device Name: TOM CAT F.L., TOM CAT S.L.
• Applicant: A & A Medical, Inc.
• Product Code: MFD · Obstetrics/Gynecology
• Decision Date: Aug 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TomCat allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes, which may increase the pregnancy rate in couples with unexplained infertility

Device Story

TomCat IUI catheter; 3.5 French diameter; 5.5 inch length; proximal expansion for syringe tip attachment. Material: Class VI Grade propylene. Used by clinicians to perform intrauterine insemination; device bypasses cervix to deliver sperm directly to uterine cavity and fallopian tubes. Intended to increase pregnancy rates in couples with unexplained infertility.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and design characteristics.

Technological Characteristics

3.5 French catheter, 5.5 inches long. Material: Class VI Grade propylene. Proximal expansion for syringe interface. Manual operation. Non-powered, non-electronic, non-implantable.

Indications for Use

Indicated for couples with unexplained infertility to facilitate intrauterine insemination by bypassing the cervix to deliver sperm to the uterine cavity and fallopian tubes.

Regulatory Classification

Identification

A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.

Predicate Devices

• Makler Insemination Device (Sefi-Medical Instruments)
• CSI Insemination Instrument and Sheath (Rocket of London)
• Oligospermis Cup (The Milex Products Inc)
• Cervical Cap (The Lamberts (Deleton) Limited)
• Seminor (Promedex Inc, K905764)
• Uni-Sem (Unimar Inc, K910317)
• Jansen-Anderson Insemination Set (Cook Ob/Gyn, K914150)
• Lifetek IUI Catheter (Lifetek Medical Inc, K921518)
• Insemi-Cath (Cook Ob/Gyn, K870551)
• Select IUI (Select Medical Systems Inc, K954099)
• Insemi-cath II (Cook Ob/Gyn, K954398)
• Genxcatheter (Gnx Intl. Inc, K963031)
• Wallace Artificial Insemination catheter- 8CM/18CM (Marlow Surgical Technologies Inc, K964848)
• Intrauterine Insemination Catheter (Conceptus Inc, K932993)
• Insemi-Cath Insemination catheter (Cook Ob/Gyn, K931630)
• Edwards-Wallace Bourne-Hall (Marlow Surgical, K910577)
• Intrauterine Insemination and Sonohysterography catheter (Ackrad Laboratories, K970492)
• Resubmitted Artificial Insemination Instrument set (Laboratoire ccd, K884696)
• Shepard Intrauterine Insemination catheter (Cook Ob/Gyn, K890301)
• Minispace IUI Catheter (Pharmacia Inc, K902171)

Submission Summary (Full Text)

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K 912245

00 - 0

## 510(k) Summary As Required by 21 section 807.92 ( c )

A & A Medical, Inc. 1-Submitter Name: 4100 Nine McFarland Drive, suite B 2-Address: Alpharetta, GA 30004 (770) 343- 8400

3-Phone:

(770) 343- 8985 4-Fax: 5-Contact Person: Adib Khoury

6-Date summary prepared: June 9th, 1997

7-Device Trade or Proprietary Name: TomCat

8-Device Common or usual name: IUI catheter

Intrauterine insemination cannula 9-Device Classification Name:

10-Substantial Equivalency is claimed against the following devices:

1-Makler Insemination Device from Sefi-Medical Instruments

2-CSI Insemination Instrument and Sheath from Rocket of London

3-Oligospermis Cup from The Milex Products Inc

4-Cervical Cap from The Lamberts (Deleton) Limited

5-Seminor from Promedex Inc

6-Uni-Sem ( TM ) from Unimar Inc

7-Jansen-Anderson Insemination Set from Cook Ob/Gyn

8-Lifetek IUI Catheter from Lifetek Medical Inc

9-Insemi-Cath from Cook ()b/Gyn

10-Select IUI from Select Medical Systems Inc

11-Insemi-cath II from Cook Ob/Gyn

12-Genxcatheter from Gnx Intl. Inc

13-Wallace Artificial Insemination catheter- 8CM/18C M from Marlow Surgical Technologies Inc

14-Intrauterine Insemination Catheter from Conceptus Inc

15-Insemi-Cath Insemination catheter from Cook Ob/ Gyn

16-Edwards-Wallace Bourne-Hall from Marlow Surgical

- 17-Intrauterine Insemination and Sonohysterography catheter from Ackrad Laboratories
- 18-Resubmitted Artificial Insemination Instrument set from Laboratoire ccd c/o Washington Regulatory Service
- 19-Shepard Intrauterine Insemination catheter from Cook Ob/Gyn
- 20-Minispace ( TM ) IUI Catheter from Pharmacia Inc

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#### 11-Description of the Device:

The TomCat IUI catheter is a 3 ½ french catheter with a length of 5 ½ ". This catheter expands in size in the proximal area to accommodate a syringe tip. It is made out of propylene of class VI Grade.

#### 12-Intended use of the device:

The TomCat allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes, which may increase the pregnancy rate in couples with unexplained infertility

#### 13-Safety and Effectiveness of the device:

TomCat is safe and effective as other predicate devices cited above. This is better expressed in the tabulated comparison ( Paragraph 14 below )

#### 14-Summary comparing technological characteristics with other predicate devices:

Please find below a tabulated comparison supporting that TomCat is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached

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P.S. Abbreviations used below: E=Equivalent, S=Similar, N/A= Not Applicable, DES=Description available, N/I=No Information available, 510(k)Summary available, 510(k)=510(k) available

| | | | TECHNOLOGICAL CHARACTERISTICS | | | | | | | | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------|---------------------------|--------------|-------------------------------|-------------------|--------|-----------|-------------|-----------|------------------|-------------------|-----------------|------------------|---------------|------------------------------|----------------------------------------------|------------|---------------|-------------------|----------------|------------------|-----|
| | FDA file reference number | | Indications for use | Target population | Design | Materials | Performance | Sterility | Biocompatibility | Mechanical Safety | Chemical safety | Anatomical sites | Human factors | Energy used and/or delivered | Compatibility wl environment & other devices | Where used | Standards met | Electrical safety | Thermal Safety | Radiation safety | |
| 1-Sefi-Medical Instruments | N/I | DES &AD COPY | E | E | S | S | E | S | S | N/A | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A |
| Makler Insemination Device<br>2-The Rocket of London<br>CSI Insemination Instrument<br>and Sheath | N/I | DES | E | E | S | S | E | S | S | N/A | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A |
| 3-The Milex Products, Inc.<br>Oligospermis Cup | N/I | DES | E | E | S | S | E | S | S | N/A | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A |
| 4-The Lamberts (Deleton)<br>Limited Cervical Cap | N/I | DES | E | E | S | S | E | S | S | N/A | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A |
| 5-Promedex, Inc SEMINOR | K905764 | N/I | E | E | E | E | E | E | S | N/A | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A |
| 6-Unimar, Inc. UNI-SEM(TM) | K910317 | N/I | E | E | E | E | E | E | S | N/A | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A |
| 7-Cook Ob/Gyn JANSEN-ANDERSON<br>INSEMINATION SET | K914150 | 510K | E | E | E | E | E | E | S | N/A | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A |
| 8-Lifetek Medical, Inc.<br> | K921518 | N/I | E | E | E | E | E | E | S | N/A | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A |
| | | | | | | | | | | | | | | | | | | | | | |
| 9-Cook Ob/Gyn INSEMI-CATH | k870551 | 510k | E | E | S | S | E | S | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A | N/A |
| 10-Select Medical systems, Inc | k954099 | 510k cum | E | E | E | E | E | E | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A | N/A |
| SELECT IUI | | | | | | | | | | | | | | | | | | | | | |
| 11-Cook Ob/Gyn INSEMI-CATH II | k954398 | 510k cum | E | E | S | S | E | S | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A | N/A |
| 12-Gnx Intl., Inc GENXCATHETER | k963031 | N/A | E | E | E | E | E | E | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A | N/A |
| 13-Marlow Surgical Technologies, Inc | k964848 | N/A | E | E | E | E | E | E | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A | N/A |
| WALLACE ARTIFICIAL INSEMINATION<br>CATHETER-8CM/18C | | | | | | | | | | | | | | | | | | | | | |
| 14-Conceptus, Inc. INTRAUTERINE<br>INSEMINATION CATHETER | k932993 | 510k cum | E | E | E | E | E | S | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A | N/A |
| 15-Cook Ob/Gyn INSEMI-CATH<br>INSEMINATION CATHETER | k931630 | 510k | E | E | E | E | E | S | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A | N/A |
| 16-Marlow Surgical - EDWARDS-<br>WALLACE BOURNE-HALL | k910577 | 510k | E | E | E | E | E | S | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A | N/A |
| 17-Ackrad Laboratories INTRAUTERINE<br>INSEMINATION AND SONOHYSTERO-<br>GRAPHY CATHETER | k970492 | N/A | S | E | S | S | E | S | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A | N/A |
| 18-Laboratoire ccd c/o Washington<br>Regulatory Service RESUBMITTED<br>ARTIFICIAL INSEMINATION INSTRU-<br>MENT SET | k884696 | N/A | E | E | E | E | E | E | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A | N/A |
| 19-Cook Ob/Gyn SHEPARD INTRA-<br>UTERINE INSEMINATION CATHETER | k890301 | N/A | E | E | S | S | E | S | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A | N/A |
| 20-Pharmacia, Inc. MINISPACE(TM)<br>IUI CATHETER | k902171 | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |

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### Table- Cont'd

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#### ATTACHMENT I

# 510(k) "Substantial Equivalence" Decision-Making Process (Overview)

Image /page/4/Figure/4 description: This image is a flowchart that describes the process of determining if a new device is substantially equivalent to a marketed device. The flowchart starts with the question "New Device is Compared to Marketed Device?" and proceeds through a series of questions about the device's intended use, technological characteristics, and performance information. The flowchart ends with a determination of "Substantially Equivalent" or a requirement for more information.

A more Detailed version is also available in pdf version or found directly below.

End of Summary

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Image /page/5/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human face in profile, with three overlapping heads. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 1997

Mr. Adib Khoury President A & A Medical, Inc. 4100 Nine McFarland Drive, Suite B Alpharetta, Georgia 30004

Re: K972245

ToraCat Intrauterine Insemination Catheter ... Dated: June 11, 1997 Received: June 16, 1997 Regulatory class: unclassified Product code: 85 MFD

Dear Mr. Khoury:

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 interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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. Issting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 requirement, 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 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 vitry diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.ida.gov/odrh/dsmamain.html".

Sincerely vours.

William Yin

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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