← Product Code [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ) · K960880

# MILL-ROSE BLIND MICROBIOLOGY BRUSH (K960880)

_Mill-Rose Laboratory · EOQ · Apr 29, 1996 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K960880

## Device Facts

- **Applicant:** Mill-Rose Laboratory
- **Product Code:** [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ.md)
- **Decision Date:** Apr 29, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4680
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Intended Use

The device is intended to allow blind, non-directed, protected specimen brush sampling of the lower respiratory tract secretions or to perform surveillance cultures or to diagnose pneumonia in patients receiving mechanical ventilation.

## Device Story

Sterile, flexible polymeric inner sheath within outer sheath; twisted wire brush inside inner sheath; outer sheath occluded with polyethylene glycol wax plug. Operation: device inserted into lower respiratory tract; inner sheath advanced; wax plug expelled; brush advanced to collect non-contaminated specimen. Used in clinical settings for respiratory sampling; operated by physicians or trained clinicians. Output: collected biological specimen for microbiological analysis. Benefit: provides protected, non-contaminated lower respiratory tract samples for diagnostic purposes.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Flexible polymeric inner sheath; outer sheath; twisted wire brush; polyethylene glycol wax plug. Sterile. Design combines features of predicate devices.

## Regulatory Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

## Predicate Devices

- Mill-Rose Laboratories, Inc., Microbiology Brush ([K820771](/device/K820771.md))
- Ballard Medical Products, BAL Cath ([K923487](/device/K923487.md))

## Submission Summary (Full Text)

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K960788C

# 510(k) Summary:

1.) Submitter: Mill-Rose Laboratories, Inc.
7310 Corporate Blvd.
Mentor, OH 44060
(216)255-7995
APR 29 1996

2). Contact Person: Alan C. Poje

3.) Summary Preparation Date: February 29, 1996

4.) Classification Name: Not Known

5.) Common Name: Blind Protected Specimen Brush

6.) Proprietary Name: Mill-Rose Blind Microbiology Brush

7.) Substantially Equivalent Device:
K820771 - Mill-Rose Laboratories, Inc., Microbiology Brush
K923487 - Ballard Medical Products, BAL Cath®

8.) Description of Subject Device:
The subject device is sterile and consists of a flexible polymeric inner sheath which is contained within an outer sheath. Within the inner sheath is a twisted wire brush. The outer sheath is occluded with a polyethylene glycol wax plug. Upon use, the inner sheath is advanced, the plug expelled and the brush advanced to provide a sterile, non-contaminated specimen brush.

9.) Intended Use:
The device is intended to allow blind, non-directed, protected specimen brush sampling of the lower respiratory tract secretions or to perform surveillance cultures or to diagnose pneumonia in patients receiving mechanical ventilation.

10.) Technological Characteristics:
The subject device combines technological characteristics of both predicate devices. It is composed of the same type of materials and is of a similar design.

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I believe, to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.

We would appreciate your earliest attention to this submission. Please contact me if you have any questions.

Sincerely,

![img-0.jpeg](img-0.jpeg)

Alan C. Poje
Director of Regulatory Affairs

ACP/ap

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K960880](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K960880)

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