`THE INSEMINATOR' (PROPOSED)

K984306 · Wallach Surgical Devices, Inc. · MFD · Mar 1, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K984306
• Device Name: `THE INSEMINATOR' (PROPOSED)
• Applicant: Wallach Surgical Devices, Inc.
• Product Code: MFD · Obstetrics/Gynecology
• Decision Date: Mar 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 'Inseminator' is used for intrauterine artificial insemination procedures utilizing washed spermatozoa or semen. The 'Inseminator' is not intended for intrafallopian tube or in vitro fertilization (IVF) procedures.

Device Story

The Inseminator is a malleable intrauterine catheter used by physicians to perform artificial insemination. The device features a fine, smoothed tip and a flared proximal end. During the procedure, the physician inserts the catheter into the uterine cavity and introduces washed sperm or semen via a syringe attached to the proximal luer. The device facilitates the delivery of sperm directly into the uterus to assist in conception for infertile couples. It is a single-use, sterile instrument.

Clinical Evidence

No clinical data included. Substantial equivalence is based on design and performance characteristics.

Technological Characteristics

Malleable catheter constructed of polypropylene. Features a fine, smoothed tip and a proximal luer for syringe attachment. Sterilized via Ethylene Oxide (EtO) to a Sterility Assurance Level (SAL) of 10^-6.

Indications for Use

Indicated for intrauterine artificial insemination procedures using washed spermatozoa or semen in infertile couples. Contraindicated for intrafallopian tube or in vitro fertilization (IVF) 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

• TomCat Intrauterine Insemination Catheter (K972245)
• Mini-Embryon Intrauterine Insemination Catheter (K972823)
• Insemi-Cath (K931630)
• Wallace Artificial Insemination Catheter (K964848)
• Uni-Sem™ Intrauterine Cannula for Artificial Insemination (K910317)

Submission Summary (Full Text)

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MARCH 1, 1999

K9843db

510(k) Premarket Notification Submittal 'The Inseminator' by Wallach Surgical Devices, Inc., SUMMARY CERTIFICATION page of SECTION 2

November 30, 1998 - Page 2 of 3

# 510(k) SUMMARY Safety and Effectiveness Information

| Sponsor: | Wallach Surgical Devices, Inc.<br>235 Edison Road<br>Orange, CT 06477 |
|----------------------|-------------------------------------------------------------------------------------------------------|
| Registration #: | 1219739 |
| Contact: | Michael Malis |
| Phone: | 203-799-2000 x114 |
| Fax: | 203-799-2002 |
| Trade Name: | 'The Inseminator' |
| Device Generic Name: | IUI Catheter |
| Classification Name: | Cannula, Intrauterine Insemination Device |
| Classification: | According to Section 513 of FDA, the device classification is<br>Class II, under Product Code 85 MFD. |

# Predicate Devices to which we are claiming substantial equivalence:

- TomCat Intrauterine Insemination Catheter (K972245), A & A Medical. 1.
- Mini-Embryon Intrauterine Insemination Catheter (K972823), A & A Medical. 2.
- Insemi-Cath (K931630), Cook OB/GYN. 3.
- 4. Wallace Artificial Insemination Catheter (K964848), Marlow Surgical Technologies.
- Uni-Sem™ Intrauterine Cannula for Artificial Insemination (K910317), Unimar / ર. CooperSurgical.

## Product Description:

The malleable catheter of Wallach's 'Inseminator' includes the fine, smoothed tip, with a flared proximal end. Insemination fluid (washed sperm) is introduced into the uterine cavity using a syringe attached to the proximal luer.

#### Indications for Use:

For use during intrauterine artificial insemination procedures utilizing washed spermatozoa or semen.

# Contraindications:

The 'Inseminator' is not intended for intrafallopian tube or in vitro fertilization (IVF) procedures.

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### Safety and Performance:

Substantial equivalence for this device is based solely on design and performance characteristics; no performance or safety data is included in this premarket notification. The materials, performance specifications and essential design characteristics of the Wallach's Insemination Catheter are equivalent to those of the predicate devices.

| | Wallach Surgical<br>'Inseminator'<br>K<br>[this 510(k)] | A & A Medical<br>Mini-Embryon<br>K972823 &<br>TomCat IUI<br>K972245 | Cook OB/GYN<br>Insemi-Cath<br>K931630 | Marlow Surgical<br>Wallace Artificial<br>Insemination<br>Catheter, K964848 | Unimar /<br>Cooper<br>Uni-Sem™<br>IUI<br>K910317 |
|-------------------|---------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------|
| Materials | polypropylene | equivalent | similar | similar | similar |
| Sterilization | EtO - SAL 10-6 | equivalent | similar | equivalent | similar |
| Design | Equivalent | equivalent | equivalent | equivalent | equivalent |
| Target Population | Infertile Couples | equivalent | equivalent | equivalent | equivalent |
| Where Used | By a Physician | equivalent | equivalent | equivalent | equivalent |

# SURSTANTIAL EQUIVALENCE CHART

# Conclusion:

Based on the indications for use, technological characteristics and comparison to currently marketed devices, the Wallach Insemination Catheter has been shown to be safe and effective for its intended use.

InsemSummary.doc

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ದಿರಿದ್ದರೆ MAR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael Malis General Manager WALLACH Surgical Devices, Inc. 235 Edison Road Orange, CT 06477

Re: K984306

WALLACH Surgical's "Inseminator" (intrauterine artificial insemination catheter) Dated: November 30, 1998 Received: December 2, 1998 Regulatory Class: II Unclassified/Procode: 85 MFD

Dear Mr. Malis:

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 legally marketed predicate 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. 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 (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 requlation (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/dsma/dsmamain.html".

Sincerely vours.

J.R. 10-21-48

Capt. Daniel G. Schultz, M.D. Acting 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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SECTION 7 Page 1 of 1

510(k) Number (if known): K984306

Wallach Surgical's 'Inseminator' Device Name:

Indications For Use:

17

The 'Inseminator' is used for intrauterine artificial insemination procedures utilizing washed spermatozoa or semen.

The 'Inseminator' is not intended for intrafallopian tube or in vitro fertilization (IVF) ~ procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801.109)

ﺎ ﺗﻜﺮﻳﻢ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96). --

vision Sign-Off)

Division of Reproductive, Abdominal, ENT,
nd Radiological Devices

510(k) Number K984306