MEDCARE REGIONAL ANETHESIA KIT

K961075 · Medcare Medical Group, Inc. · CAZ · Sep 6, 1996 · Anesthesiology

Device Facts

• Record ID: K961075
• Device Name: MEDCARE REGIONAL ANETHESIA KIT
• Applicant: Medcare Medical Group, Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Sep 6, 1996
• Decision: SEKD
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MedCare Regional Anesthesia Kit is a single patient, single use, disposable device which is intended to be used for the administration of regional anesthesia.

Device Story

Disposable, single-use kit for regional anesthesia administration; contains various components tailored to specific procedure types (spinal, epidural-caudal, nerve block). Used by clinicians in clinical settings to facilitate anesthesia delivery. Kit customization allows selection of components based on customer requirements and procedure needs. Benefits include convenience and sterility of pre-packaged components for regional anesthesia delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable, single-use kit. Components vary by procedure type (spinal, epidural-caudal, nerve block). No electronic, software, or energy-based components.

Indications for Use

Indicated for administration of regional anesthesia in patients requiring spinal, epidural-caudal, or nerve block procedures.

Regulatory Classification

Identification

An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

Predicate Devices

• Kendall HealthCare Products Company Regional Anesthesia Kits (Spinal, Epidural/Caudal, Nerve Block)

Submission Summary (Full Text)

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K961075

SEP - 6 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:

Regional Anesthesia Kit

**Classification Name:**

Anesthesia Conduction Kit

### (3) Identification of Predicate Devices:

Regional Anesthesia Kits:
1. Spinal
2. Epidural/Caudal
3. Nerve Block

### (a) Kendall HealthCare Products Company
Mansfield, MA 02048

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

The MedCare Medical Group Regional Anesthesia Kit is a disposable, single patient, single use device for the administration of regional anesthesia. The componentry within the kit will vary depending on the customers requirements and the type of regional anesthesia procedure being performed; spinal, epidural-caudal, or nerve block.

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

The MedCare Regional Anesthesia Kit is a single patient, single use, disposable device which is intended to be used for the administration of regional anesthesia.

(6) **Technological Characteristics**

The MedCare Regional Anesthesia Kit is similar to the predicate devices in that all of the devices provide a variety of components for the administration of regional anesthesia. All the devices provide flexibility in componentry selection for customization to the user and the particular type of regional anesthesia being performed; spinal, epidural-caudal, or nerve block.