PEDI VAGINAL ASPIRATOR by COOK UROLOGICAL, INC.

The Pedi Vaginal Aspirator is used to aspirate vaginal secretions to evaluate female pediatric patients with vaginitis and/or possible sexual abuse. This device will be made from polyurethane and polyethylene.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the K9549D3 Pedi Vaginal Aspirator, identifying the absence of information related to typical AI/software device acceptance criteria and study details.

The provided 510(k) summary describes a physical medical device, specifically a Pedi Vaginal Aspirator, and not a software or AI-driven diagnostic device. Therefore, the questions related to acceptance criteria, study methodologies, ground truth, and reader performance typically associated with AI/software devices are not applicable to this submission.

The 510(k) process for such a device focuses on demonstrating substantial equivalence to a predicate device, primarily in terms of:

Indications for Use: The purpose for which the device is intended.
Technological Characteristics: The materials, design, and operating principles of the device.
Safety and Effectiveness: Assurances that the new device is as safe and effective as the predicate.

Given this context, I cannot extract the requested information as it does not exist within the provided text. The submission relies on a comparison to the Bard® Rubber Utility Catheter, Radiopaque, to establish substantial equivalence, implying that its safety and effectiveness are derived from the predicate's established history.

Here's a breakdown of why each numbered point cannot be addressed:

A table of acceptance criteria and the reported device performance: Not applicable. For physical devices, performance often relates to material biocompatibility, sterility, functionality (e.g., aspiration capability), and physical integrity, which are typically addressed through bench testing and manufacturing controls, not performance metrics like sensitivity/specificity against a ground truth.
Sample sized used for the test set and the data provenance: Not applicable. There's no "test set" in the sense of patient data for diagnostic performance evaluation. Testing would involve engineering and biocompatibility evaluations.
Number of experts used to establish the ground truth... and qualifications: Not applicable. There's no diagnostic ground truth to establish for a physical aspirator.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for diagnostic interpretation, not for a physical aspirator.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical device, not an algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. There is no algorithm to train.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided 510(k):

The 510(k) for the Pedi Vaginal Aspirator demonstrates substantial equivalence by:**

Indications for Use: Stating it is "substantially equivalent to predicate devices in terms of indications for use." The indication is "to aspirate vaginal secretions to evaluate female pediatric patients with vaginitis and/or possible sexual abuse."
Technological Characteristics: Made from "polyurethane and polyethylene," similar to existing devices.
Manufacturing and Quality: Emphasizing manufacturing according to "specified process controls and a Quality Assurance Program" and undergoing "packaging and sterilization procedures similar to devices currently marketed and distributed by Cook OB/GYN."
Predicate Device: Bard® Rubber Utility Catheter, Radiopaque.

The 510(k) relies on the established safety and effectiveness of the predicate device and sound manufacturing practices, rather than clinical study data demonstrating diagnostic performance, to meet the substantial equivalence requirements.

Summary

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K9549D3

APR 2 9 1996

510(k) Premarket Notification Pedi Vaginal Aspirator Cook OB/GYN

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS I.

Submitted By:

Tammy Bacon Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-6500 October 24, 1995

Device

Trade Name: Proposed Classification Name: Pedi Vaginal Aspirator Catheter, Pediatric, General & Plastic Surgery

Predicate Devices:

The Pedi Vaginal Aspirator is substantially equivalent to predicate devices in terms of indications for use. Predicate devices include the Bard® Rubber Utility Catheter, Radiopaque manufactured by Bard.

Device Description:

Substantial Equivalence:

The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook OB/GYN. Being similar with respect to indications for use and physical construction to predicate device meets the requirements for section 510(k) substantial equivalence.

Regulation Number and Section

§ 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).