SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S

• K Number: K991215
• Device Name: SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
• Manufacturer: SYMTEX HEALTHCARE CORP.
• Date Cleared: 1999-06-11 ( 63 days)
• Product Code: EFQ
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended 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

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification acceptance letter for a medical device called "Symtex Gauze Pads and Symtex Gauze Sponges." It states that the FDA has determined the device is substantially equivalent to devices marketed prior to May 28, 1976.

Based on the provided text, there is no information available regarding acceptance criteria or the study that proves the device meets those criteria. This document is solely an FDA clearance letter, not a study report or a detailed device submission.

Here's why the requested information cannot be extracted:

• Type of Device: The device is "Gauze Pads and Gauze Sponges." These are typically low-risk, well-established medical devices (Class I or II, often exempt from extensive clinical trials). The FDA's substantial equivalence determination for such devices often relies on comparison to existing, legally marketed predicate devices, rather than new performance studies with specific acceptance criteria.
• Nature of Document: This is a regulatory clearance letter, which confirms the device's clearance for marketing. It summarizes the FDA's decision but does not include the detailed technical or clinical data that would have been part of the 510(k) submission itself.
• Lack of Performance Data: The letter simply states "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." It does not mention any specific performance metrics, clinical outcomes, or study results.

Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone studies, or ground truth establishment, as this information is not present in the provided document.

Summary

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)
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Regulation Number and Section

N/A