MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER

K972823 · A & A Medical, Inc. · MFD · Oct 10, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K972823
• Device Name: MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
• Applicant: A & A Medical, Inc.
• Product Code: MFD · Obstetrics/Gynecology
• Decision Date: Oct 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mini Embryon 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

Mini-Embryon is a 5Fr intrauterine insemination (IUI) catheter; 18 cm length; 1.6 mm OD; 1.0 mm ID. Features 5 cm distal segment with double side eyes and rounded tip for smooth entry; 11 cm marked shaft for handling; proximal Luer Lock for syringe connection. Supplied in Soft and Hard versions. Used by clinicians in a clinical setting to bypass the cervix, delivering sperm to the uterine cavity and fallopian tubes to increase pregnancy rates in couples with unexplained infertility. Device is a passive mechanical instrument; no electronic or software components.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Material: Clear polyethylene. Dimensions: 5Fr (1.6 mm OD, 1.0 mm ID), 18 cm length. Design: 5 cm distal segment with double side eyes and rounded tip; 11 cm marked shaft; proximal Luer Lock. Energy: None (passive mechanical device). Sterilization: Not specified.

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. Not intended for assisted reproduction procedures.

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

• Seminor (K905764)
• Lifetek IUI Catheter (K921518)
• Select IUI (K954099)
• Intrauterine Insemination Catheter (K932993)
• Edwards-Wallace Bourne-Hall (K910577)
• Resubmitted Artificial Insemination Instrument set (K884696)

Submission Summary (Full Text)

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OCT 1 0 1997 .81073

# 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: [phone]-Fax: 5-Contact Person: Adib Khoury 6-Date summary prepared: July 28th, 1997 7-Device Trade or Proprietary Name: Mini-Embryon Intra Uterine Insemination Catheter 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-Seminor from Promedex Inc 2-Lifetek IUI Catheter from Lifetek Medical Inc 3-Select IUI from Select Medical Systems Inc 4-Intrauterine Insemination Catheter from Conceptus Inc 5-Edwards-Wallace Bourne-Hall from Marlow Surgical 6-Resubmitted Artificial Insemination Instrument set from Laboratoire ccd c/o Washington Regulatory Service

### 11-Description of the Device:

The Mini Embryon IUI is a 5Fr Intrauterine Inseminator made of clear polyethylene, 18 cm in length, with an OD of 1.6 mm and an ID of 1.0 mm. A 5 cm distal segment with double side eyes and a rounded tip insures a very smooth entry with minimal disturbance to the endometrial bed. This is complemented with 11 cm of marked catheter shaft with 7 Fr in diameter for better and more secure handling. A proximal Luer Lock allows for connection with a syringe. It is to be supplied in two versions, Soft & Hard.

### 12-Intended use of the device:

The Mini Embryon 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

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K972823
.PL93

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

Mini Embryon 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 Mini Embryon is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached

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 | ATTACHMENTS INSIDE NOTIFICATION | Indications for use | Target population | Design | Materials | Performance | Sterility | Biocompatibility | Mechanical Safety | Chemical safety | Anatomical sites | Human factors | Energy used and/or delivered<br>Compatibility w/ environment & other devices | Where used | Standards met | Electrical safety | Thermal Safety | Radiation safety |
| 1-Promedex, Inc SEMINOR | k905764 | N/A | E | E | E | E | E | S | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A |
| 2-Lifetek Medical, Inc.<br>LIFETEK IUI CATHETER | k921518 | N/A | E | E | E | E | E | S | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A |
| 3-Select Medical systems, Inc<br>SELECT IUI | k954099 | 510k sum | E | E | E | E | E | S | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A |
| 4-Conceptus, Inc. INTRAUTERINE<br>INSEMINATION CATHETER | k932993 | 510k sum | E | E | E | E | E | S | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A |
| 5-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 |
| 6-Laboratoire ccd c/o Washington<br>Regulatory Service RESUBMITTED<br>ARTIFICIAL INSEMINATION INSTRUMENT SET | k884696 | N/A | E | E | E | E | E | S | S | N/A | N/A | E | E | N/A | S | E | E | N/A | N/A | N/A |

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Image /page/2/Figure/2 description: This image is a flowchart outlining the 510(k) "Substantial Equivalence" Decision-Making Process. The flowchart starts with the question, "New Device is Compared to Marketed Device?" and proceeds through a series of questions with "yes" or "no" answers that lead to different outcomes. The final outcome is a determination of "Substantially Equivalent" or a need 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/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is positioned above the text "DEPARTMENT OF HEALTH & ...", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 10 1997

Mr. Adib Khoury President A&A Medical, Inc. 4100 Nine McFarland Drive, Suite B Alpharetta, Georgia 30004-3386

Re: K972823

Mini-Embryon Intrauterine Insemination Catheter Dated: September 3, 1997 Received: September 4, 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 the enclosure) to 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). 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 (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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion 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.fda.gov/cdrh/dsmamain.html".

Sincerely yours

W.Liau Yu

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

Enclosure

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<972823 510(k) Number (if known):

Device Name: MINI EMBRYON INTRAVERINE INSOMINATION CATHETER

Indications For Use:

The Mini Embryon Intrauterine Insemination catheter allows the sperm to bypass the The Mini Embryon Intrautenine Insemmation catherer and works.
cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes.

This catheter is not intended for assisted reproduction procedures

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBORD)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Q. Satting/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)