(63 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology. The intended use and user descriptions are for standard medical procedures and personnel.
No.
The intended use describes procedures like wound dressing, debridement, cleaning, prepping, and scrubbing, which are general medical procedures and do not inherently classify the device as therapeutic. It removes substances rather than treating a disease or condition.
No
The intended uses listed (wound dressing, debridement, cleaning, prepping, and scrubbing) are therapeutic or procedural actions, not diagnostic ones. Diagnostic devices are used to identify or determine the nature of a disease or condition.
Unknown
The provided text only includes the Intended Use/Indications for Use and Intended User/Care Setting sections. It lacks a Device Description, which is crucial for determining if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (wound dressing, debridement, cleaning, prepping, and scrubbing) are all procedures performed directly on or with a patient's body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens.
- User Roles: While lab technicians are listed as users, their role in these procedures would likely be related to preparing materials or assisting with the procedures, not performing in vitro diagnostic tests.
The description points to a device used for direct patient care procedures, not for laboratory analysis of specimens.
N/A
Intended Use / Indications for Use
THIS PRODUCT IS INTENDED TO BE USED BY:
- SURGEONS
• NURSES
• LAB TECHNICIANS
• I. V. TEAM
FOR THE FOLLOWING PROCEDURES:
• WOUND DRESSING
• DEBRIDEMENT
• CLEANING
• PREPPING AND SCRUBBING
Product codes
EFQ
Device Description
Not Found
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
SURGEONS
NURSES
LAB TECHNICIANS
I. V. TEAM
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and a human profile in the center.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 1999
Mr. Richard S. Wang President Symtex Healthcare Corporation 783 Pinefalls Avenue Walnut, California 91789
Re: K991215
Trade Name: Symtex Gauze Pads and Symtex Gauze Sponges Regulatory Class: Unclassified Product Code: EFQ Dated: April 5, 1999 Received: April 9, 1999
Dear Mr. Wang:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Richard S. Wang
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Jun, 07 1999 10:27AM P2
Image /page/2/Picture/3 description: The image shows a series of numbers and letters written in a bold, calligraphic style. The sequence appears to be 'K991215'. The characters are thick and have a brush-stroke appearance, giving them a dynamic and artistic feel. The overall impression is one of handwritten text with a distinct and expressive style.
Page 1 of 1
510(k) Number (if known): K991215
Device Name: Symtex Gauze Pads (I's) and Symtex Gauze Spon,
sterile (2'5)
Indications For Use:
THIS PRODUCT IS INTENDED TO BE USED BY:
- SURGEONS
• NURSES
• LAB TECHNICIANS
• I. V. TEAM
FOR THE FOLLOWING PROCEDURES:
• WOUND DRESSING
• DEBRIDEMENT
• CLEANING
• PREPPING AND SCRUBBING
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K991215 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |