(187 days)
No
The device description and performance studies focus on the material properties and biocompatibility of a treated gauze dressing, with no mention of AI or ML technologies.
No.
The device is a wound dressing, which is not considered a therapeutic device in the sense of actively treating a disease or condition with a medical effect beyond providing protection and absorption for wounds. Its primary function is as a dressing for draining wounds.
No
The device description indicates it is a wound dressing, and the intended use is as a primary or secondary dressing for draining wounds. It does not mention any function for diagnosing conditions.
No
The device description clearly states it is a sterile, single-use wound dressing consisting of gauze, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a wound dressing for light to moderate draining wounds. This is a topical application for wound management, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a gauze dressing treated with an antimicrobial agent. This aligns with a wound care product, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVDs are designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is applied in vivo (on the body) for wound treatment.
N/A
Intended Use / Indications for Use
The Kendall Kerlix AMD Antimicrobial Gauze Dressing is intended for OTC use. It is used as a primary dressing for exuding wounds, burns, as a cover for surgical wounds, and to secure and prevent movement of primary dressings.
Product codes
FRO
Device Description
The Kendall Kerlix AMD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of gauze treated with polyhexamethylene biguanide hydrochloride, and is available in both sponge and roll form.
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 (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 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
SEP 1 2 2007
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510(k) Summary
In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
Tyco Healthcare 15 Hampshire St. Mansfield, MA 02048 Date Prepared:
1. Contact Person:
Paul W. Evans Director, Regulatory Affairs (508) 261-8203
-
- Name of Medical Device:
Classification Name: Dressing Common or Usual Name: Kendall Kerlix AMD Antimicrobial Gauze Dressing (OTC)
- Name of Medical Device:
-
- Identification of Legally Marketed Device:
The Kendall Kerlix AMD Antimicrobial Gauze Dressing for OTC use is substantially equivalent in intended use, function, and composition to Kendall's AMD Antimicrobial Gauze Dression (Res) cleared by FDA under 510(k) No. K990530. The primary purpose of this 510(k) is to allow OTC retail marketing of this dressing. Labeling of the OTC product has been augmented to included added directions for use for a non-professional retail population.
- Identification of Legally Marketed Device:
-
- Device Description:
The Kendall Kerlix AMD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of gauze treated with polyhexamethylene biguanide hydrochloride, and is available in both sponge and roll form.
- Device Description:
-
- Device Intended Use:
The Kendall Kerlix AMD Antimicrobial Gauze Dressing is intended for OTC use. It is used as a primary dressing for exuding wounds, burns, as a cover for surgical wounds, and to secure and prevent movement of primary dressings.
- Device Intended Use:
1
KC70653
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6. Product Comparison
The Kendall Kerlix AMD Antimicrobial Gauze Dressing is equivalent to the referenced predicate device in that it is intended to be used as a wound covering, it contains an ingredient that enhances the bacterial barrier function of the dressing, and it has a broad spectrum of antimicrobial activity.
7. Nonclinical Testing
Biocompatibility testing of the predicate Kendall Kerlix AMD Antimicrobial Gauze Dressing has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part l , with the FDA modified matrix presented in memorandum G95-1. The dressing subject to this submission is identical to the predicate device with the exception of OTC labeling.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2007
Tyco Healthcarc % The Kendall Company Mr. Paul W. Evans Director, Regulatory Affairs 15 Hampshire Street Mansfield, Massachusetts 02048
Rc: K070653
Trade/Device Name: Kendall Antimicrobial Drain Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 12, 2007 Received: June 14, 2007
Dear Mr. Evans:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Paul W. Evans
This letter will allow you to begin marketing your device as described in your Section 510(k) promarket notification. The FDA finding of substantial equivalence of your device to a legally marketed prodicate 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark N. Melkerson
Director
$0^{50}$ D.R
$a/12/07$
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):__K070653
Device Name: Kendall Antimicrobial Drain Dressing
Indications For Use: Over the counter use as a primary or secondary dressing for light to moderate draining wounds.
| Prescription Use
(Part 21 CFR 801 Subpart D) | ✓ | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) | |
| ------------------------------------------------- | ----------------- | -------- | ------------------------------------------------ | --------------- |
|---|
(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, and Neurological Devices
| 510(k) Number: | K020653 Page 1 of |
|---|---|
| ---------------- | ------------------- |