(56 days)
No
The device description and intended use focus on a mechanical brush for specimen collection, with no mention of AI/ML terms or functionalities.
No
The device is described as a specimen sampling tool, used to collect secretions for diagnostic purposes, rather than to treat a condition.
Yes
The "Intended Use / Indications for Use" states the device is intended "to diagnose pneumonia in patients receiving mechanical ventilation," which is a diagnostic purpose.
No
The device description clearly outlines physical components like sheaths, a wire brush, and a wax plug, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to collect a specimen (lower respiratory tract secretions) for the purpose of diagnosis (diagnose pneumonia, surveillance cultures). It does not perform the diagnostic test itself.
- Device Description: The device is a tool for specimen collection. It doesn't contain reagents, assays, or any components that would analyze the specimen to provide a diagnostic result.
- Lack of Diagnostic Function: The description focuses on the mechanism for obtaining a sterile, non-contaminated sample. There is no mention of any analytical process performed by the device.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to obtain the specimen, which is then likely sent to a laboratory for in vitro testing.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower respiratory tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
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.(b)
Classification. Class II.
0
K9607880
510(k) Summary:
-
Mill-Rose Laboratories, Inc. 1.) Submitter: 7310 Corporate Blvd. Mentor, OH 44060 (216)255-7995
APR 2 9 1996 -
Alan C. Poie 2). Contact Person:
-
3.) Summary Preparation Date: February 29, 1996
-
4.) Classification Name: Not Known
-
Blind Protected Specimen Brush 5.) Common Name:
-
Mill-Rose Blind Microbiology Brush 6.) Proprietary Name:
-
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.
1
l 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,
il
J/a
Aran C. Poje Director of Regulatory Affairs
ACP/ap