MEDCARE TRACHEOSTOMY CARE TRAY

K961167 · Medcare Medical Group, Inc. · LRQ · Jul 2, 1996 · SU

Device Facts

• Record ID: K961167
• Device Name: MEDCARE TRACHEOSTOMY CARE TRAY
• Applicant: Medcare Medical Group, Inc.
• Product Code: LRQ · SU
• Decision Date: Jul 2, 1996
• Decision: SESK
• Submission Type: Traditional
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Medicare Tracheostomy Care Tray is a single patient, single use, disposable device which is intended to be used for the administration of tracheostomy care.

Device Story

Tracheostomy Care Tray provides essential components for tracheostomy tube maintenance and stoma site care; includes supplies for wound cleaning, suctioning, and cannula replacement. Sterile, single-use, disposable kit; used in clinical settings by healthcare providers. Facilitates standardized care procedures; ensures availability of necessary tools for hygiene and site maintenance; supports patient safety by reducing infection risk through single-use components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Sterile, single-use, disposable kit containing various components for tracheostomy care. Materials and design are functionally identical to predicate tracheostomy care trays. No energy source or software components.

Indications for Use

Indicated for patients requiring tracheostomy care, including stoma wound care, suctioning (oral, nasal, pharyngeal, tracheal), and cleaning or replacement of tracheostomy tubes or inner cannulas.

Regulatory Classification

Identification

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Predicate Devices

• Busse Hospital Disposables Tracheostomy Care Trays
• Concord/Portex Tracheostomy Care Trays

Submission Summary (Full Text)

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K961167

JUL 2 1996

## (I) 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
[phone]

### (2) Name of Device:

Tracheostomy Care Tray

**Classification Name:**

Unknown

### (3) Identification of Predicate Devices:

Tracheostomy Care Trays

(a) Busse Hospital Disposables
Hauppauge, NY 11788

(b) Concord/Portex
Keene, NH 03431

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(4) **Description of Device Subject to Premarket Notification:**

The Medicare 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.

(5) **Intended Use of the Device:**

The Medicare 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 Medicare 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.