(161 days)
Not Found
No
The summary describes a collection of basic first aid supplies and explicitly states that all components are finished goods with established regulatory paths. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is described as a system of "color-coded mini first aid kits" used for "basic first aid treatment." This indicates it is a collection of general first aid supplies, not a device used to treat or alleviate a disease or condition in a therapeutic manner.
No
The device is a system of first aid kits intended for basic treatment during emergencies, not for diagnosing conditions.
No
The device description clearly states it is a system of physical first aid kits containing various individual components, which are hardware.
Based on the provided information, the Baxter Emergency Relief TM System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as "basic first aid treatment for various emergency situations." This involves direct application to the body for wound care, bandaging, etc., which are not in vitro diagnostic procedures.
- Device Description: The description mentions "various individual components traditionally used for first aid treatment." These components are things like bandages, gauze, gloves, etc., which are used externally or topically, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Baxter Emergency Relief TM System does not fit this description.
N/A
Intended Use / Indications for Use
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.
Product codes
79LRR
Device Description
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 TM System is designed as one large unit which houses various first aid kits
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Testing of the system was deemed not applicable as all regulated devices has an established regulatory path and is obtained in finished good form
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
: 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 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
10:04AM QARA SURGICAL MAR 04 '97
Predicate Device:
K96 4029 P.6/7
| 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)
Tentative Final
Monograph for
Health Care
Antiseptic Drug
Products; Proposed
Rule |
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.
2
.
.
| 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 |
: