(182 days)
The Ultec Pro Ag+ Hydrocolloid Dressings are indicated for use on venous stasis ulcers, pressure ulcers, arterial ulcers, diabetic ulcers, donor sites, lacerations, post surgical incisions, and other dry to lightly exudating symptoms.
The proposed Kendall ULTEC PRO Ag+ Hydrocolloid Dressing is a sterile, single use, highly flexible wound dressing designed for use on dry to lightly exudating wounds. ULTEC PRO Ag+ Hydrocolloid Dressing was designed to create and maintain a moist wound environment that is optimal for wound healing. The alginate formulation of ULTEC PRO Ag+ releases anti-microbial silver and absorbs wound exudates. The release of anti-microbial silver enhances the barrier properties of the hydrocolloid by reducing bacterial growth on the dressing. The proposed wound dressing consists of 65 % acrylic hot melt pressure sensitive adhesive, 25 % sodium alginate, and 10 % inorganic polymer containing silver.
The provided text is a 510(k) summary for the Kendall ULTEC PRO Ag+ Hydrocolloid Dressing. It describes the device, its intended use, and a comparison to legally marketed predicate devices. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria, nor does it provide details about device performance metrics, sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case studies.
The "Nonclinical Testing" section mentions: "Biocompatibility testing of the proposed device 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." This indicates that biocompatibility was evaluated against a standard, but it doesn't provide specific performance numbers, acceptance criteria, or a detailed study description as requested in your prompt.
Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text.
Here's what I can extract and state based on the given information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Meet requirements of ISO 10993-1 and FDA modified matrix (G95-1) | Demonstrated to meet the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1. |
| Other performance criteria (e.g., wound healing efficacy, antimicrobial effectiveness, exudate absorption rates, wear time, etc.) | Not provided in the document. |
2. Sample size used for the test set and the data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. The information relates to a medical device's regulatory submission, not an AI or diagnostic study requiring expert ground truth for image analysis.
4. Adjudication method for the test set: Not applicable/provided.
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 document describes a hydrocolloid wound dressing, not an AI-assisted diagnostic tool or system that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For biocompatibility, the ground truth is adherence to the specified ISO standard and FDA guidance. For other performance aspects (e.g., wound healing), no specific ground truth or study details are provided.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device; there is no mention of a "training set."
9. How the ground truth for the training set was established: Not applicable.
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EXHIBIT # 14
APR 2 9 2004
510(k) Summary
KO33453
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:
Kendall, a Division of Tyco Healthcare 15 Hampshire Street Mansfield, MA 02048 Date Prepared: October 23. 2003
-
- Contact Person
Gail Christie Manager, Regulatory Affairs (508) 261-8440
- Contact Person
-
- Name of Medical Device
Classification Name: Proprietary Name:
- Name of Medical Device
Hydrocolloid Dressing ULTEC PRO Ag+ Hydrocolloid Dressing
3. Identification of Legally Marketed Device
The proposed device, Kendall ULTEC PRO Ag+ Hydrocolloid Dressing is substantially equivalent in intended use, function and composition to the Kendall ULTEC PRO Hydrocolloid Dressing (K943636), Arglaes Antimicrobial Film Dressing (K990810), and Contreet Hydrocolloid Dressing with silver (K013525).
4. Device Description
The proposed Kendall ULTEC PRO Ag+ Hydrocolloid Dressing is a sterile, single use, highly flexible wound dressing designed for use on dry to lightly exudating wounds. ULTEC PRO Ag+ Hydrocolloid Dressing was designed to create and maintain a moist wound environment that is optimal for wound healing.
The alginate formulation of ULTEC PRO Ag+ releases anti-microbial silver and absorbs wound exudates. The release of anti-microbial silver enhances the barrier properties of the hydrocolloid by reducing bacterial growth on the dressing.
The proposed wound dressing consists of 65 % acrylic hot melt pressure sensitive adhesive, 25 % sodium alginate, and 10 % inorganic polymer containing silver.
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page 2 of 2
5. Device Intended Use
ULTEC PRO Ag+ Hydrocolloid Dressings are intended for use on venous stasis ulcers, pressure ulcers, arterial ulcers, diabetic ulcers, donor sites, lacerations, post surgical incisions, and other external wounds presenting dry to lightly exuding symptoms.
్. Product Comparison
The proposed device has the same technological characteristics as the predicate devices. Both the proposed device and the Contreet Hydrocolloid Dressing with silver consist of a hydrocolloid base with added silver.
Both the proposed ULTEC PRO Aq+ Hydrocolloid Dressing and the Arglaes Dressing utilize a silver based antimicrobial agent that is formulated from ionic silver encapsulated in a water soluble polymer structure. The silver polymer matrix used in the Arglaes product contains the same elemental components as those used in the proposed device. The silver polymer used in these devices is obtained from the same manufacturer.
Both the predicate device, UTEC PRO Hydrocolloid Dressing and the proposed ULTEC PRO Ag+ Hydrocolloid Dressing contain adhesive and alginate.
7. Nonclinical Testing
Biocompatibility testing of the proposed device 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like shapes above a wavy line, possibly representing water.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2004
Ms. Gail Christic Manager, Scientific Services/Regulatory Affairs Tyco Healthcare/Kendall 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K033453
Trade/Device Name: Kendall Ultec Pro Ag+ Hydrocolloid Dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 10, 2004 Received: February 13, 2004
Dear Ms. Christie:
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); labcling (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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Gail Christie
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and w you'll colling of substantial equivalence of your device to a legally prematication " 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 If you desire of Compliance at (301) 594-4659. 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 other general mirrhmational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Fal Celia M. Witten, Ph.D., M.D. 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 Statement
510(k) Number (if known):
Device Name: Kendall Ultec Pro Ag+ Hydrocolloid Dressing
Indications for Use:
The Ultec Pro Ag+ Hydrocolloid Dressings are indicated for use on venous stasis ulcers, pressure ulcers, arterial ulcers, diabetic ulcers, donor sites, lacerations, post surgical incisions, and other dry to lightly exudating symptoms.
Prescription Use
Use
(Per 21 CFR 801.109)
OR
Over-The-Counter
Please Do Not Write Below This Line – Continue On Another Page If Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
KO33453 510(k) Number.
N/A