INSEMINATION CATHETER, MODEL 320301

K021438 · Labotect Labor-Technik Gottingen · MFD · Jul 16, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K021438
• Device Name: INSEMINATION CATHETER, MODEL 320301
• Applicant: Labotect Labor-Technik Gottingen
• Product Code: MFD · Obstetrics/Gynecology
• Decision Date: Jul 16, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The catheter is used for intrauterine insemination.

Device Story

The Labotect Insemination Catheter is a medical device designed for the transfer of sperm into the uterine cavity. The device features a well-rounded tip and two distal side ports to facilitate fluid delivery. A syringe is attached to the proximal luer to introduce insemination fluid. The catheter is intended for use by clinicians in a medical setting. By providing a controlled delivery mechanism for sperm, the device assists in intrauterine insemination procedures, supporting fertility treatment goals.

Clinical Evidence

No clinical trial data provided. Evidence consists of bench testing, including Mouse Embryo Assay (MEA) with blastocyst hatching >80%, Bacterial Endotoxin Assay (<0.25 EU/ml), and biocompatibility testing (cytotoxicity, sensitization, irritation) per ISO 10993. Post-marketing surveillance data from 10 years of EU usage is cited as supporting safety.

Technological Characteristics

Material: Polypropylene. Design: Catheter with well-rounded tip and two distal side ports; proximal luer connection. Sterilization: Gamma radiation (ANSI/AAMI/ISO 11137 and EN 556, SAL 10^-6). Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for intrauterine insemination in patients requiring 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

• Edwards-Wallace Bourne-Hall (K910577)
• Embryon Intra-uterine Insemination Catheters (K980061)
• Mini-Embryon Intra Uterine Insemination Catheter (K972823)
• MedWorks Insemination Catheter (K982628)
• Jansen-Anderson Insemination Set (K914150)

Submission Summary (Full Text)

{0}------------------------------------------------

K021438
Page 1 of 2

# Labotect Insemination Catheter 320301: abbreviated 510(k)submission

JUL 1 6 2002

# Summary of Safety and Effectiveness

## Submitted By:

Angelika Albrecht c/o Labotect GmbH Willi-Eichler-Str. 25 37079 Göttingen Germany Telephone number: 01149 551 505010 Fax number: 01149 551 5050111

Date 2002-05-01

Device:

Trade Name: Proposed Classification Name: Insemination Catheter Assisted Reproduction Catheters Class II 85 MQF

#### Predicate Devices:

Edwards-Wallace Bourne-Hall (k910577) Marlow-Surgical

Embryon Intra-uterine Insemination Catheters (k980061) Rocket Medical

Mini-Embryon Intra Uterine Insemination Catheter (k972823) A&A Medical, Inc.

MedWorks Insemination Catheter (k982628) MedWorks Corp.

Jansen-Anderson Insemination Set (k914150) Cook OB/Gyn

#### Device description and intended use:

The Insemination Catheters are used for transferring sperms into the uterine cavity. They have a well rounded tip and two distal side ports. The insemination fluid is introduced using a syringe attached to the proximal luer. The material used in these devices is Polypropylene. Biocompatibility is assured according to ISO 10993.

{1}------------------------------------------------

KO2/438
Page 2 of 2

### Special Controls:

These insemination catheters are manufactured and marketed according to special controls of 21CFR Sec. 884.6110.

- > Mouse Embryo Assay batch tested: Two-Cell-MEA, blastocyst hatching >80%
- > Endotoxin batch tested: Bacterial Endotoxin Assay, Endotoxin Value < 0.25 EU/ml
- Sterilization Validation: Gamma sterilization validated according to A ANSI/AAMI/ISO 11137 and EN 556, SAL 10°
- A Design specifications were made to meet the requirements for insemination catheters
- > The Labelling meets the requirements of 21 CFR Part 801 and Part 884. special controls
- A Biocompatibility was tested according to Blue Book memorandum #G95-1 entitled " Use of International Standard ISO 10993. Biological Evaluation of Medical Devices Part-1: Evaluation and Testing." The devices are tested on cytotoxicity, sensitization and irritation or intracoutaneous reactivity using GLP methods.
- > Clinical application is evaluated using a "Post-Marketing-Surveillance-System" to collect and analyse data from clinical application. These Insemination Catheters are marketed for more than 10 years in the EU without any adverse events.

## Substantial Equivalence:

The Insemination Catheters are substantially equivalent to the predicate devices with respect to the indications for use, design and performance specifications.

#### Conclusion:

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

等意義的意義。因為有人權為在國家的意義的意義。因為為國國家會在在有意義的意義

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

THE PRODUCTION CONSTITUTION

Food and Drug Administration 9200 Corporate Boulevard

Rockville MD 20850

# JUL 1 6 2002

Ms. Angelika Albrecht Quality Manager Labotect GmbH Labor-Technik-Göttingen Willi-Eichler-StraBe 25 D-37079 Göttingen GERMANY

Re: K021438 Trade/Device Name: Insemination Catheter, Model 320301 Regulation Number: None Regulatory Class: Unclassified Product Code: 85 MFD Dated: June 19, 2002 Received: July 5, 2002

Dear Ms. Albrecht:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (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 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 (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 product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 510(k) preinarket 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), please contact the Office of Compliance at 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance 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. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

| 510(k) Number (if known): | K021438 |
|---------------------------|-----------------------|
| Device Name: | Insemination Catheter |

Indications For Use:

2744,55

The catheter is used for intrauterine insemination.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-The-Counter Use |
|----------------------|---|----|----------------------|
| (Per 21 CFR 801.109) | | | (Optional Form) |

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021438510(k) Number _

nal Format 1-2-96)