(82 days)
No
The summary describes a sterile gauze sponge made of cotton, with no mention of software, algorithms, or any technology related to AI or ML.
No
This device, gauze sponges, is used for absorption and wound care, which are supportive functions and do not directly treat a disease or condition.
No
The device, DeGasa Sterile USP Gauze Sponges, is described as sterile gauze used in a hospital setting. Its intended use is for situations where sterile gauze is required, which points to a treatment or care role rather than diagnosis. Diagnostic devices are typically used to identify diseases or conditions.
No
The device description clearly states it is a physical product made of cotton (gauze sponges), not software.
Based on the provided information, the DeGasa Sterile USP Gauze Sponges are not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for absorbing fluids and protecting wounds in a hospital setting. This is a direct application to the body or for wound care, not for examining specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description details the physical composition and form of the gauze, which is a medical device used for wound care and absorption. It doesn't describe a device designed to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic information about a patient's health status
Gauze sponges are considered general medical devices used for wound management and absorption, not for diagnostic testing.
N/A
Intended Use / Indications for Use
DeGasa Sterile USP Gauze Sponges are used in a hospital setting where sterile gauze is required. The instructions for use by physicians using gauze sponges are exactly the same as the instructions for use found on present labeling for similar products currently on the market.
Product codes
Not Found
Device Description
DeGasa USP Gauze are sterile gauze sponges that are made with 100 % cotton, and are in the form of plain woven cloth conforming to the specifications of USP type VII.
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
hospital setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
| JUL 29 1996 | 510(K) SUMMARY
(as required by 807.92(c)) | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| | K961773 | |
| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)
40178 U.S. 19 North
Tarpon Springs, FL 34689 | |
| | Phone:
Fax: | 813-942-3908
813-942-3828 |
| Contact Person: | Patrick J. Lamb | |
| Date of Summary: | May 6, 1996 | |
| Trade Name: | Protec Sterile Gauze Sponge | |
| Classification Name: | Gauze Sponge | |
| Predicate Device: | Keilei International K895086 | |
| Device Description/ | DeGasa USP Gauze are sterile gauze sponges that
are made with 100 % cotton, and are in the form of
plain woven cloth conforming to the specifications of
USP type VII. | |
| Comparison: | Protec | Keilei |
| | Threads per 2.54 cm Warp
Threads per 2.54 cm Filling
Avg. count per 6.45 sq. cm
Weight: g per sq. meter | Same
Same
Same
Same |
| Intended Use: | DeGasa Sterile USP Gauze Sponges are used in a
hospital setting where sterile gauze is required. The
instructions for use by physicians using gauze
sponges are exactly the same as the instructions for
use found on present labeling for similar products
currently on the market. | |