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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.

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K Number

K003056

Device Name

OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218

Manufacturer

LABOTECT LABOR-TECHNIK GOTTINGEN

Date Cleared

2000-12-13

(73 days)

Product Code