(187 days)
Over the counter use as a primary or secondary dressing for light to moderate draining wounds.
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.
The provided text describes a 510(k) premarket notification for a medical device called the "Kendall Kerlix AMD Antimicrobial Gauze Dressing (OTC)". This notification focuses on substantial equivalency to a previously cleared device, rather than providing a detailed study proving performance against pre-defined acceptance criteria in the way one might expect for a novel AI/software medical device.
Therefore, many of the requested sections regarding a study proving acceptance criteria cannot be directly extracted from the provided text. The submission relies on the established performance and safety of the predicate device.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The submission does not define specific quantitative "acceptance criteria" in the traditional sense of a performance study for a novel device. Instead, the core "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in submission) |
|---|---|
| Intended Use Equivalence: | The Kendall Kerlix AMD Antimicrobial Gauze Dressing (OTC) is identical in intended use to the predicate device, with the primary purpose of this 510(k) being to allow OTC retail marketing. The specific OTC indications for use are: "Over the counter use as a primary or secondary dressing for light to moderate draining wounds." |
| Function Equivalence: | The device 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. |
| Composition Equivalence: | 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. This composition is the same as the predicate. |
| Biocompatibility & Safety: | 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 1, 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. |
| Performance (Antimicrobial activity): | The predicate device (and thus the new device due to identical composition) has a broad spectrum of antimicrobial activity and enhances the bacterial barrier function of the dressing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on substantial equivalence to a predicate device. There is no new clinical performance study for this specific device described in the provided text. The biocompatibility testing mentioned refers to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This information is not provided because there was no new clinical performance study with a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm/AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device through its prior clearance and the testing it underwent (e.g., biocompatibility consistent with ISO 10993-1).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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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:
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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.
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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.
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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
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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 |
|---|---|
| ---------------- | ------------------- |
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