(56 days)
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.
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.
The provided text is a 510(k) summary for a medical device submitted in 1996. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information in a table or answer the specific questions about device performance studies, sample sizes, ground truth establishment, or expert involvement.
The 510(k) summary typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results with specific acceptance criteria that would be found in a modern clinical validation study. In 1996, the requirements for 510(k) submissions might have been different, and the information contained in this summary does not include the type of detailed performance data and study design requested in your prompt.
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K9607880
510(k) Summary:
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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:
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3.) Summary Preparation Date: February 29, 1996
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4.) Classification Name: Not Known
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Blind Protected Specimen Brush 5.) Common Name:
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Mill-Rose Blind Microbiology Brush 6.) Proprietary Name:
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7.) Substantially Equivalent Device: K820771 - Mill-Rose Laboratories, Inc., Microbiology Brush
K923487 - Ballard Medical Products, BAL Cath®
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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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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
§ 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.