(99 days)
No
The summary describes a disposable kit for tracheostomy care, listing components and procedures. There is no mention of AI, ML, image processing, or any computational analysis of data.
No.
The device is a tray of components for cleaning and care, not a device that directly treats or prevents a disease.
No
Explanation: The device is a 'Tracheostomy Care Tray' intended for the care and cleaning of tracheostomy tubes and insertion sites, which are maintenance and hygiene procedures, not diagnostic ones.
No
The device description clearly states it is a "disposable device" and provides "components necessary for the care and cleaning of tracheostomy tubes," indicating it is a physical kit with hardware components, not software.
Based on the provided information, the MedCare Tracheostomy Care Tray is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "administration of tracheostomy care," which involves cleaning and maintaining a tracheostomy tube and the surrounding area. This is a procedure performed on the patient's body, not on a sample taken from the body.
- Device Description: The description details components for "care and cleaning of tracheostomy tubes and their insertion sites," including wound care, suctioning, and tube cleaning/replacement. These are all external or procedural actions.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The MedCare Tracheostomy Care Tray does not fit this description.
N/A
Intended Use / Indications for Use
The MedCare Tracheostomy Care Tray is a single patient, single use, disposable device which is intended to be used for the administration of tracheostomy care.
Product codes
Unknown
Device Description
The Medcare Tracheostomy Care Tray is intended to provide the components necessary for the care and cleaning of tracheostomy tubes and their insertion sites. The procedure of tracheostomy care includes wound care of the stoma, oral/nasal/pharyngeal/tracheal suctioning, and tracheostomy tube or inner cannula cleaning or inner cannula replacement (in the case of a disposable inner cannula (D.I.C.) system). The kits are provided sterile, disposable, and for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Unknown, K961167
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
JL - 2 1998
(D) 510(k) Summary:
This summary is submitted in conformance with the format described in the 21 CFR Part 807.92 interim rule dated April 28, 1992.
- (1) Submitted By:
MedCare Medical Group, Inc. 234 Old Homestead Highway E. Swanzey, NH 03446
Contact Person:
Craig J. Bell Director of Research and Development (603)352-3230
- (2) Name of Device:
Tracheostomy Care Tray
Classification Name:
Unknown
-
Identification of Predicate Devices: (3)
Tracheostomy Care Trays -
Busse Hospital Disposables (a) Hauppauge, NY 11788
-
(b) Concord/Portex Keene, NH 03431
1
(4) Description of Device Subject to Premarket Notification:
The Medcare Tracheostomy Care Tray is intended to provide the components necessary for the care and cleaning of tracheostomy tubes and their insertion sites. The procedure of tracheostomy care includes wound care of the stoma, oral/nasal/pharyngeal/tracheal suctioning, and tracheostomy tube or inner cannula cleaning or inner cannula replacement (in the case of a disposable inner cannula (D.I.C.) system). The kits are provided sterile, disposable, and for single patient use.
(ર) Intended Use of the Device:
The MedCare Tracheostomy Care Tray is a single patient, single use, disposable device which is intended to be used for the administration of tracheostomy care.
(6) Technological Characteristics
The MedCare Tracheostomy Care Tray is similar to the predicate devices in that all of the devices provide a variety of components for the administration of tracheostomy care. All the devices provide flexibility in componentry selection for kit customization,which provides the maximum convenience for the customer.