EMERGENCY RELIEF KIT SYSTEM

K964029 · Baxter Healthcare Corp · LRR · Mar 17, 1997 · SU

Device Facts

• Record ID: K964029
• Device Name: EMERGENCY RELIEF KIT SYSTEM
• Applicant: Baxter Healthcare Corp
• Product Code: LRR · SU
• Decision Date: Mar 17, 1997
• Decision: SEKD
• Submission Type: Traditional
• Device Class: Class N
• Attributes: Therapeutic

Indications for Use

The Baxter Emergency Relief™ System consists of color-coded mini first aid kits. Each kit is intended to be used as a basic first aid treatment for various emergency situations, while seeking further professional medical assistance.

Device Story

Baxter Emergency Relief™ System is a collection of color-coded mini first aid kits containing various finished-good medical components. System serves as a centralized housing unit for first aid supplies. Used in emergency situations to provide basic treatment while awaiting professional medical assistance. Components include gauze dressings, eye pads, vinyl gloves, adhesive tape, scissors, sterile saline, metal extremity splints, cold packs, bandage strips, topical antiseptic ointment, and alcohol swabs. Device is intended for general use in emergency settings.

Clinical Evidence

No clinical data. Testing of the system was deemed not applicable as all regulated devices have an established regulatory path and are obtained in finished good form.

Technological Characteristics

System consists of a collection of pre-packaged, finished-good first aid components. No specific materials, energy sources, or software algorithms are utilized; the device is a kit of existing, regulated medical supplies.

Indications for Use

Indicated for basic first aid treatment of various emergency situations in patients requiring immediate care while seeking further professional medical assistance.

Regulatory Classification

Identification

Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - 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

• Vinyl Gloves (K952786)

Submission Summary (Full Text)

{0}

MAR 04 '97 10:04AM QARA SURGICAL

Baxter

Surgical Group

Baxter Healthcare Corporation

1500 Waukegan Road, Bldg. K

McGaw Park, Illinois 60085

USA

P.5/7

708.473.1500

FAX: [phone]

MAR 17 1997

K964089

# SUMMARY OF SAFETY AND EFFECTIVENESS

## Appendix E

Manufacturer:
Baxter Healthcare Corporation
Surgical Group
Thermal
808 Highway 24 West
Moberly, Missouri 65270

Regulatory Affairs Contact:
Maryalice Smith
Surgical Group
1500 Waukegan Road Bldg. K
McGaw Park, Illinois 60085

Telephone:
[phone]

Date Summary Prepared:
September 20, 1996

Product Trade Name:
Baxter Emergency Relief™ Kit System

Classification:
Class I [21CFR not listed]
Product Code 79LRR

Predicate Device:
Each component within the Emergency Relief System is a finished good with an established regulatory path when applicable. The devices which fall within this category include the following:

1. Gauze Dressing
Class I Exempt
21CFR 878.4450

2. Oval Eye Pad
Class I Exempt
21CFR 878.4440

3. Vinyl Gloves
Class I
21CFR 880.6250
Baxter K952786
Bulk Non-Sterile

4. Adhesive Tape
Class I Exempt
21CFR 880.5240

{1}

MAR 04 '97 10:04AM QARA SURGICAL
K964029
P.6/7

## Predicate Device:

| 5. | Scissors | Class I Exempt
21CFR 878.4800 |
| --- | --- | --- |
| 6. | Sterile Saline
For Eye Irrigation | Over-The-Counter
21CFR 349.20 |
| 7. | Metal Extremity
Splint | Class I Exempt
21CFR 378.3910 |
| 8. | Cold Pack | Preamendment
Baxter Thermal |
| 9. | Bandage Strips | Class I Exempt
21CFR 880.5240 |
| 10. | Topical Antiseptic
Ointment | Over-The-Counter
21CFR 333.110(a) |
| 11. | Alcohol Swab | Over-The-Counter
21CFR 333 460(b)(2)
Tenative Final
Monograph for
Health Care
Antiseptic Drug
Products; Proposed
Rule. |

## Description:

The Baxter Emergency Relief™ System is designed as one large unit which houses various first aid kits. Each mini kit contains various individual components traditionally used for first aid treatment. Each individual component is a finished good with an established regulatory path where applicable. All components are purchased as finished goods and packaged in the appropriate mini kit, including direction for use inserts. All direction for use inserts correspond to the instruction manual accompanying the system.

## Intended Use:

The Baxter Emergency Relief™ System consists of color-coded mini first aid kits. Each kit is intended to be used as a basic first aid treatment for various emergency situations, while seeking further professional medical assistance.

62

{2}

MAR 04 '97 10:04AM QARA SURGICAL
K964029 P.7/7

## Substantial Equivalence:

The Emergency Relief™ Kit System substantial equivalency is established by each device component contained within the mini kits in that:
- intended use is the same

## Summary of Testing:

Testing of the system was deemed not applicable as all regulated devices has an established regulatory path and is obtained in finished good form

63