VITAL PAK

K955417 · Vital Signs, Inc. · DXG · Mar 8, 1996 · Cardiovascular

Device Facts

• Record ID: K955417
• Device Name: VITAL PAK
• Applicant: Vital Signs, Inc.
• Product Code: DXG · Cardiovascular
• Decision Date: Mar 8, 1996
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 870.1435
• Device Class: Class 2

Intended Use

The Vital Pak is a customizable, convenience packaged group of sterile and non-sterile disposable devices. The devices are used during the set-up and performance of anesthesia procedures (e.g., general anesthesia, cardiac anesthetic procedures, etc.) and may, depending on the institutions protocol, be used during the transport to and recovery from the same anesthetic procedure. The Vital Pak is designed to conveniently package together those devices, chosen by each institution, that are legally marketed, and typically and repeatedly used by the anesthesia clinicians.

Device Story

Vital Pak is a customizable convenience kit containing sterile and non-sterile disposable devices; used by anesthesia clinicians during anesthesia procedures (general, cardiac); facilitates setup, transport, and recovery. Device functions as a packaging system for legally marketed, pre-existing medical devices; does not alter individual device function or intended use. Benefits include clinical convenience and standardized procedural preparation.

Clinical Evidence

No clinical data; bench testing only. Substantial equivalence is based on the predicate status of the individual components and the previously cleared General Anesthesia System.

Technological Characteristics

Customizable kit of sterile and non-sterile disposable medical devices. No specific materials, energy sources, or software algorithms described; device is a convenience packaging system for existing, legally marketed components.

Indications for Use

Indicated for use by anesthesia clinicians during the set-up, performance, transport, and recovery phases of anesthesia procedures, including general and cardiac anesthesia.

Regulatory Classification

Identification

A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

Predicate Devices

• General Anesthesia System (GAS) (K945455)

Submission Summary (Full Text)

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2-29-1996 4:47PM FROM QC LAB 201+7907587 P. 6
ATTACHMENT 2

K G H S 4 1 7
MAR - 8 1996

510(k) Summary
VITAL PAK
Prepared February 29, 1996

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and Sec. 807.92(c).

1. Submitter's Name and Address:
Vital Signs, Inc.
20 Campus Road
Totowa, NJ 07512

2. Contact Person:
Ms. Whitney Törning
Telephone: [phone], Extension 392
Fax: [phone]

3. Name of Device:
Classification Name: Accessory to Monitor, Cardiac Output, Thermal Anesthesia Kit
Common Name: Anesthesia Kit
Proprietary Name: Vital Pak

4. Classification:
C.F.R. Section: 21 CFR 870.1435
Panel: Cardiovascular
Product Code: 74KFN
Device Class: Class II

5. Performance Standards:
No performance standard(s) applicable to this device have been promulgated under Section 514 of the Food, Drug and Cosmetic Act.

6. Device Description and Indicated Use:
The Vital Pak is an expansion of the currently marketed General Anesthesia System (GAS). It is, like the GAS, a customizable, convenience packaged group of sterile and non-sterile disposable devices. The devices are used during the set-up and performance of anesthesia procedures (e.g., general anesthesia, cardiac anesthetic procedures, etc.) and may, depending on the institutions protocol, be used during the transport to and recovery from the same anesthetic procedure. The Vital Pak is designed to conveniently package together those devices, chosen by each institution, that are legally marketed, and typically and repeatedly used by the anesthesia clinicians.

20 Campus Road, Totowa, N.J. 07512 • 1-800-932-0760 • N.J. 201-790-1330 • Telex: 881786 (Vital Signs UD) • Fax: [phone]

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7. Substantial Equivalence:

The Vital Pak is an expansion of the General Anesthesia System (GAS). The GAS was described in the 510(k) K945455 and received FDA clearance on December 23, 1994. Since, the addition of legally marketed devices to the GAS does not either change the intended use of the kit, nor does it affect the safety or efficacy of the kit, the Vital Pak is substantially equivalent to the GAS.

The Vital Pak is "convenience packaging" of devices legally marketed and commercially available. The packaging of this convenience kit does not alter the intended use of any of its individual devices. The Vital Pak is as safe and effective as the devices included. Therefore, the Vital Pak is also substantially equivalent to the devices included in it.

[END OF SUMMARY]

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