MILL-ROSE BLIND MICROBIOLOGY BRUSH
Device Facts
| Record ID | K960880 |
|---|---|
| Device Name | MILL-ROSE BLIND MICROBIOLOGY BRUSH |
| Applicant | Mill-Rose Laboratory |
| Product Code | EOQ · Ear, Nose, Throat |
| Decision Date | Apr 29, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
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.
Indications for Use
Indicated for patients receiving mechanical ventilation requiring lower respiratory tract secretion sampling, surveillance cultures, or pneumonia diagnosis.
Regulatory Classification
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)
- Ballard Medical Products, BAL Cath (K923487)
Related Devices
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- K190293 — Single Use Cytology Brush BC-205D · Olympus Medical Systems Corp. · Aug 2, 2019
- K171607 — Bronchi and Gastrointestinal Cytology Brush · Wilson-Cook Medical Inc./Cook Endoscopy · Jul 31, 2017
- K974642 — COMBICATH CATHETER · Plastimed Laboratoire Pharmaceutique · Mar 13, 1998
- K022446 — MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C · Aomori Olympus Co., Ltd. · Mar 28, 2003
