(72 days)
Not Found
No
The device description and intended use are for standard gauze sponges, and there is no mention of AI, ML, or image processing.
No.
The device description indicates it is a gauze sponge, used for physical functions like absorbing fluids and protecting wounds, rather than treating a disease or condition therapeutically.
No
The device description states its intended use is for controlling bleeding, absorbing body fluids, and protecting wounds, which are therapeutic and protective functions, not diagnostic ones.
No
The device description clearly states it is composed of USP Type VII gauze, indicating a physical, hardware-based medical device. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Control bleeding, absorb body fluids, and protect wounds from contamination." This describes a device used directly on or in the body for therapeutic or protective purposes, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical product (gauze sponges) made of a specific material (USP Type VII gauze) and available in different sizes and plies. This aligns with a medical device used externally or internally for wound care and fluid absorption.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
Therefore, the Surgicade™ Non-Sterile Gauze Sponges are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Control bleeding, absorb body fluids, and protect wounds from contamination.
Product codes
Not Found
Device Description
Surgicade™ Non-Sterile Gauze Sponges are composed of USP Type VII gauze, ourgical on the each Spire Care Spirity and Compose of Carrype of Suble
available in thicknesses of 8 ply (2" x 2", 4" x 4", 4" x 8"), 12 ply (2" x 2",
3" x 3", 4" x 4", 4"
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
Not Found
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
K962972
Oct. 11, 1996
510 (k) SUMMARY
ADMINISTRATIVE -
Submitter: Accunex Canada, Inc. 202-2117 West 5th Avenue Vancouver, B.C. Canada V6J 1P8 604-736-4219
Contact Person: Mr. Xianping Huang
Date of Preparation: July 30, 1996
DEVICE NAME ll.
Proprietary Name: Surgicade™ Non-Sterile Gauze Sponges Common Name: Wound Dressing Classification Name: Gauze Sponge
PREDICATE DEVICES ==============================================================================================================================================================================
Non-Sterile Gauze Sponges (Team Mfg., Inc.); K922055. Lorrex Cover Sponges, Non-Sterile (Lorrex Health Products); K942070
IV. DEVICE DESCRIPTION
Surgicade™ Non-Sterile Gauze Sponges are composed of USP Type VII gauze, ourgical on the each Spire Care Spirity and Compose of Carrype of Suble
available in thicknesses of 8 ply (2" x 2", 4" x 4", 4" x 8"), 12 ply (2" x 2",
3" x 3", 4" x 4", 4"
v. INTENDED USE
Control bleeding, absorb body fluids, and protect wounds from contamination.
VI. COMPARISON TO PREDICATE DEVICES
Surgicade™ Non-Sterile Gauze Sponges are similar or identical in composition, function and intended use to legally marketed gauze sponges, such as Non-Sterile Gauze Sponges (Team Mfg., Inc.) and Lorrex Cover Sponges, Non-Sterile (Lorrex Health Products). All such devices are composed of absorbent gauze in various thicknesses and sizes, and have the same intended use.
Accordingly, Accunex Canada Inc. has concluded that the Surgicade™ Non-Sterile Gauze Sponges are safe and effective for their intended use and perform at least as well as legally marketed predicate devices, such as the Team Non-Sterile Gauze Sponges and I orrex Non-Sterile Cover Sponges.
Image /page/0/Picture/17 description: The image shows the number 10 in a stylized font. The number 1 is bold and upright, while the number 0 is slightly tilted and has a decorative flourish extending upwards and to the right. Above the number 0, there is a signature or some other form of handwritten mark.