PEDI VAGINAL ASPIRATOR

K954903 · Cook Urological, Inc. · HFC · Apr 29, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K954903
• Device Name: PEDI VAGINAL ASPIRATOR
• Applicant: Cook Urological, Inc.
• Product Code: HFC · Obstetrics/Gynecology
• Decision Date: Apr 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1050
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Pedi Vaginal Aspirator is used to aspirate vaginal secretions to evaluate female pediatric patients with vaginitis and/or possible sexual abuse.

Device Story

Device: Pedi Vaginal Aspirator; used for aspiration of vaginal secretions. Input: vaginal secretions. Output: collected sample for clinical evaluation. Usage: clinical setting; operated by healthcare professionals. Benefit: facilitates diagnostic evaluation of pediatric patients presenting with vaginitis or suspected sexual abuse.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: polyurethane and polyethylene. Form factor: catheter. Sterilization: standard procedures consistent with existing marketed devices.

Indications for Use

Indicated for female pediatric patients requiring aspiration of vaginal secretions for evaluation of vaginitis or suspected sexual abuse.

Regulatory Classification

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.

Predicate Devices

• Bard® Rubber Utility Catheter, Radiopaque (Bard)

Submission Summary (Full Text)

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K95 4903

APR 29 1996

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

## I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### Submitted By:

Tammy Bacon
Cook OB/GYN
1100 West Morgan Street
Spencer, Indiana 47460
[phone]
October 24, 1995

### Device

Trade Name: Pedi Vaginal Aspirator
Proposed Classification Name: 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:

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.

### 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 devices, this device meets the requirements for section 510(k) substantial equivalence.