WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM

K964848 · Marlow Surgical Technologies, Inc. · MFD · Jan 16, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K964848
• Device Name: WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM
• Applicant: Marlow Surgical Technologies, Inc.
• Product Code: MFD · Obstetrics/Gynecology
• Decision Date: Jan 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.

Device Story

Sterile, single-use catheter; used for intrauterine insemination (IUI). Features finely smoothed tip and constant internal lumen to minimize trauma and prevent embryo damage. Operated by physicians to introduce washed spermatozoa into uterine cavity. Device design focuses on atraumatic insertion.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Polypropylene, fluorethylenepropylene, polyurethane. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Design: Catheter with smoothed tip and constant internal lumen.

Indications for Use

Indicated for the introduction of washed spermatozoa into the uterine cavity. Contraindicated for intrafallopian tube 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

• Edwards-Wallace Catheters (Marlow Surgical Technologies, Inc.)

Submission Summary (Full Text)

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510(k)

K964848

JAN 16 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS WALLACE ARTIFICIAL INSEMINATION CATHETERS

The Summary of Safety and Effectiveness on Artificial Insemination Catheters reflects data available and resented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.

## Intended Use

The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.

## Indications

The ability of the Family of Wallace Artificial Insemination Catheter to meet its intended function includes the finely smoothed tip and constant internal lumen to prevent embryo damage and ensure atraumatic technique.

## Contraindications

The Wallace Artificial Insemination Catheters are not intended for intrafallopian tube procedures.

## Caution

Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

## Substantial Equivalency Information

The Wallace Artificial Insemination Catheter are similar to the Edwards-Wallace Catheters currently offered by Marlow Surgical Technologies, Inc.

| | Edwards-Wallace Catheters | AIC Catheters |
| --- | --- | --- |
| Materials | Polypropylene | Polypropylene |
| | Fluorethylenepropylene | Fluorethylenepropylene |
| | Polyurethane | Polyurethane |
| Sterilization | EO | EO |
| | SAL 10^{-6} | SAL 10^{-6} |

The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Wallace Artificial Insemination Catheter are comparable to that of the other catheters.

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