(224 days)
The Cervical Mucous Aspiration Catheter is used for cervical mucous aspiration for the evaluation of infertility.
The Cervical Mucous Aspiration Catheter is used for cervical mucous aspiration for the evaluation of infertility. The Cervical Mucous Aspiration Catheter will be made from TFE and nylon. TFE is widely known and accepted in the medical field, therefore, biocompatibility is assured. Biocompatibility testing has been performed on the nylon and the results show a reasonable assurance of safety and effectiveness.
The provided document, K960263, is a 510(k) Premarket Notification for a cervical mucous aspiration catheter from Cook OB/GYN, submitted in 1996. This document is a summary of safety and effectiveness, and its primary purpose is to demonstrate substantial equivalence to predicate devices, not to present a comprehensive study proving performance against defined acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria, specific study details, ground truth establishment, expert involvement, and reader studies is not available within this 510(k) summary.
Here's a breakdown of what information can and cannot be extracted from the provided text according to your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. The document focuses on demonstrating substantial equivalence to predicate devices based on indications for use, design, and materials, rather than setting specific performance metrics like aspiration volume, success rate, or pain levels for the new device. | Not specified in terms of quantitative performance. The document states "biocompatibility is assured" for TFE and "results show a reasonable assurance of safety and effectiveness" for biocompatibility testing on nylon. It also asserts substantial equivalence to predicate devices in "indications for use and design." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable / Not mentioned. This document does not describe a clinical study with a test set to evaluate device performance against specific criteria.
- Data Provenance: Not applicable / Not mentioned. The document references biocompatibility testing but does not provide details of a clinical study or its data origin.
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)
- Number of Experts: Not applicable / Not mentioned.
- Qualifications of Experts: Not applicable / Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable / Not mentioned.
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
- MRMC Study: No. This device is a physical medical instrument (catheter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable / Not mentioned. The document primarily relies on demonstration of substantial equivalence to existing devices. For the biocompatibility testing mentioned, the "ground truth" would likely be laboratory standards for material safety, but the specifics are not detailed.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable / Not mentioned. This document describes a medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable / Not mentioned. As above, this is not an AI/ML device.
Summary based on the provided document:
The 510(k) Premarket Notification for the Cook OB/GYN Cervical Mucous Aspiration Catheter aims to demonstrate substantial equivalence to predicate devices. It relies on similarities in indications for use, design, materials (TFE and nylon), manufacturing process controls, and quality assurance programs. Biocompatibility testing for nylon is mentioned, with results showing "reasonable assurance of safety and effectiveness." However, this document does not contain information about specific performance acceptance criteria or a detailed study designed to prove the device meets such criteria through clinical trials, expert reviews, or data-driven performance metrics typically associated with modern device evaluations. The focus is on regulatory equivalence based on existing devices.
§ 884.1050 Endocervical aspirator.
(a)
Identification. An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.(b)
Classification. Class II (performance standards).