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.

AI/ML Overview

Here's an analysis of the provided text regarding the Labotect Insemination Catheter 320301.

It's important to note that this document describes a traditional medical device (catheter) and not an AI/ML-driven device. Therefore, many of the questions related to AI performance, ground truth, training sets, and expert consensus for AI will not be directly applicable. The details provided are for a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, which focuses on design, material, and manufacturing standards, not algorithmic performance.

Acceptance Criteria and Device Performance

Since this is not an AI/ML device, the "acceptance criteria" are related to manufacturing standards, biocompatibility, and functional aspects for an insemination catheter. The device performance is tied to meeting these specific criteria for safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biocompatibility	Tested according to ISO 10993 (cytotoxicity, sensitization, irritation/intracutaneous reactivity)	"Biocompatibility is assured according to ISO 10993." (implicitly passed all tests as per Blue Book memorandum #G95-1)
Sterilization Validation	Gamma sterilization validated according to ANSI/AAMI/ISO 11137 and EN 556, SAL 10⁻⁶	Fully validated.
Mouse Embryo Assay (MEA)	Two-Cell-MEA, blastocyst hatching >80%	"Mouse Embryo Assay batch tested: Two-Cell-MEA, blastocyst hatching >80%" (Indicates routine batch testing to meet this spec.)
Endotoxin (Bacterial)	Bacterial Endotoxin Assay, Endotoxin Value < 0.25 EU/ml	"Endotoxin batch tested: Bacterial Endotoxin Assay, Endotoxin Value < 0.25 EU/ml" (Indicates routine batch testing to meet this spec.)
Design Specifications	Made to meet the requirements for insemination catheters	"A Design specifications were made to meet the requirements for insemination catheters" (Implies design meets functional and safety requirements for intended use, though specific performance metrics beyond the above aren't detailed in the summary.)
Labeling	Meets requirements of 21 CFR Part 801 and Part 884	"The Labelling meets the requirements of 21 CFR Part 801 and Part 884. special controls"
Clinical Application	Post-Marketing-Surveillance-System to collect and analyze data from clinical application. No adverse events for 10+ years in EU.	"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."

Information Not Applicable to This Device (Traditional Medical Device)

The following points are specifically designed for AI/ML device evaluations. Since the Labotect Insemination Catheter is a traditional, non-AI medical device, these questions are not directly relevant:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable: This device is a physical catheter. "Test set" refers to data for algorithm evaluation. The performance here is primarily based on meeting manufacturing and biological safety standards (e.g., sterilization, biocompatibility, MEA, endotoxin). The clinical "performance" is inferred from its long history of safe use in the EU.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: There is no "ground truth" in the AI/ML sense. The performance is assessed against established biological and engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: No adjudicated "test set" for an algorithm.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: There is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable: For this device, "ground truth" would equate to established physical, chemical, and biological safety standards (e.g., ISO 10993 for biocompatibility, specific blastocyst hatching rates for MEA, endotoxin limits). Clinical "outcomes data" is referenced indirectly via the "Post-Marketing-Surveillance-System" and 10+ years of safe use in the EU, indicating no adverse outcomes over that period.

8. The sample size for the training set

Not Applicable: There is no algorithm to train.

9. How the ground truth for the training set was established

Not Applicable: There is no algorithm to train.

Summary for the Labotect Insemination Catheter:

The Labotect Insemination Catheter's acceptance criteria and proven performance revolve around its physical properties, manufacturing processes, and biological safety. The "study" proving it meets acceptance criteria consists of:

Laboratory testing: Demonstrating compliance with specific standards for biocompatibility (ISO 10993), sterilization (ANSI/AAMI/ISO 11137 and EN 556), Mouse Embryo Assay (>80% blastocyst hatching), and Endotoxin levels (< 0.25 EU/ml).
Design review: Ensuring the device's design meets functional requirements for insemination catheters.
Labeling compliance: Adherence to regulatory requirements (21 CFR Part 801 and Part 884).
Post-Market Surveillance: Relying on over 10 years of marketing in the EU without adverse events, supported by a system to collect and analyze clinical application data, which serves as a long-term clinical safety validation.

The FDA granted 510(k) clearance based on "substantial equivalence" to predicate devices, meaning it has similar indications for use, technological characteristics, and performance specifications that are deemed safe and effective.

Summary

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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:

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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.

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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.

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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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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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)

Regulation Number and Section

§ 884.5250 Cervical cap.

(a)
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.(b)
Classification. Class II (performance standards).