(161 days)
The Baxter Emergency Relief TM 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.
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.
The provided text does not contain information about the acceptance criteria or a study that proves a device meets specific acceptance criteria. The document is a summary of safety and effectiveness for the Baxter Emergency Relief™ Kit System, detailing its components, classification, intended use, and substantial equivalence to predicate devices. It explicitly states: "Testing of the system was deemed not applicable as all regulated devices has an established regulatory path and is obtained in finished good form." This indicates that no specific performance study was conducted for the overall kit system as its components are already approved finished goods.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
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: 04AM QARA SURGICAL
Baxter
Surgical Group
Baxter Healthcare Corporati 1500 Waukeean Road, Bldg w Park, Illinois 60085
708.473.1500
FAX: 708.785.2460
MAR 1 7 1997
Image /page/0/Picture/6 description: The image shows a series of bold, black numbers and letters. The characters appear to be handwritten or in a stylized font. The characters are 'K964089'.
SUMMARY OF SAFETY AND EFFEC 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:
Date Summary Prepared:
Product Trade Name:
Classification:
Predicate Device:
(847) 785-3322
September 20, 1996
Baxter Emergency Relief ™ Kit System
Class I [21CFR not listed} Product Code 79LRR
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 Exempt21CFR 878.4450 |
|---|---|---|
| 2. | Oval Eye Pad | Class I Exempt21CFR 878.4440 |
| 3. | Vinyl Gloves | Class I21CFR 880.6250Baxter K952786Bulk Non-Sterile |
| 4. | Adhesive Tape | Class I Exempt21CFR 880.5240 |
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10:04AM QARA SURGICAL MAR 04 '97
Predicate Device:
K96 4029 P.6/7
| 5. | Scissors | Class I Exempt21CFR 878.4800 |
|---|---|---|
| 6. | Sterile SalineFor Eye Irrigation | Over-The-Counter21CFR 349.20 |
| 7. | Metal ExtremitySplint | Class I Exempt21CFR 378.3910 |
| 8. | Cold Pack | PreamendmentBaxter Thermal |
| 9. | Bandage Strips | Class I Exempt21CFR 880.5240 |
| 10. | Topical AntisepticOintment | Over-The-Counter21CFR 333.110(a) |
| 11. | Alcohol Swab | Over-The-Counter21CFR333 460(b)(2)Tentative FinalMonograph forHealth CareAntiseptic DrugProducts; ProposedRule |
Description:
Intended Use:
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.
The Baxter Emergency Relief ™ System is designed as one large unit which houses
The Baxter Emergency Relief TM 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.
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| Substantial Equivalence: | The Emergency Relief ™ Kit Systemsubstantial equivalency is established by eachdevice component contained within the minikits in that:- intended use is the same |
|---|---|
| Summary of Testing: | Testing of the system was deemed notapplicable as all regulated devices has anestablished regulatory path and is obtained infinished good form |
:
N/A