(346 days)
The Contreet Hydrocolloid Dressing is indicated for use in the management of low to highly exudating leg ulcers, skin tears and pressure sores. The dressing can also be used for 2nd degree burns, 200 degree partial thickness burns, donor sites, post operative wounds and skin abrasions.
Contreet Hydrocolloid Dressing is an antibacterial hydrocolloid dressing with silver providing an optimal moist wound healing environment. Contreet Hydrocolloid Dressing has demonstrated in-vitro antibacterial activity in certain strains known to be detrimental to wound healing. Contreet Hydrocolloid Dressing is a waterproof dressing with a semi-permiable film backing.
The provided text is a 510(k) summary for the Contreet Hydrocolloid Dressing, seeking substantial equivalence to existing devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical trial or algorithm validation study would.
Instead, the summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "study" mentioned is an in-vitro antibacterial activity study, which is not a clinical study on human subjects with acceptance criteria typically associated with device performance against specific clinical outcomes.
Therefore, many of the requested fields cannot be directly answered from the information provided.
Here's an attempt to extract relevant details and note what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative clinical criteria for device functionality. The acceptance is based on demonstrating substantial equivalence to predicate devices. | In-vitro antibacterial activity: Demonstrated activity against "certain strains known to be detrimental to wound healing." (No specific strains or quantitative reduction provided). |
| Similarity in Intended Use with predicate devices (Comfeel Plus Ulcer Dressing, Acticoat 7 Dressing, Arglaes-AB Antimicrobial Barrier Film and Island Dressings). | Contreet Hydrocolloid Dressing is indicated for: low to moderately exudating wounds, leg ulcers, pressure sores, partial-thickness burns, donor sites, postoperative wounds, skin abrasions, colonized wounds (to support healing/reduce odor), and where infection risk exists/suspected, or with physician's discretion for infected wounds. Also suitable under compression bandaging for low to moderately exudating venous leg ulcers. |
| Similarity in Technological Characteristics with predicate devices. | Based on Comfeel Plus Ulcer Dressing (hydrocolloid dressing) with the additional incorporation of silver for antimicrobial properties. Shares antimicrobial silver with Acticoat 7 and Arglaes-AB. |
2. Sample size used for the test set and the data provenance:
- Not applicable for a clinical test set. The provided document describes an in-vitro antibacterial activity study.
- The sample size and data provenance for the in-vitro study are not specified in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for the in-vitro study would be established by laboratory methods measuring bacterial reduction, not expert consensus on clinical cases.
4. Adjudication method for the test set:
- Not applicable. This applies to expert reviews of clinical data, which is not 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:
- No. This type of study is completely irrelevant to a hydrocolloid dressing. This is a medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This refers to AI algorithm performance and is not applicable to a hydrocolloid dressing.
7. The type of ground truth used:
- For the in-vitro antibacterial activity "study," the ground truth would be laboratory measurements of bacterial growth/reduction in a controlled environment.
- For the overall substantial equivalence determination, the "ground truth" is adherence to existing regulatory requirements and comparison to validated predicate devices.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device and the type of evaluation described.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of what the document implies about "proof":
The "proof" for the Contreet Hydrocolloid Dressing meeting its purpose (and being cleared by the FDA) is primarily based on:
- Substantial Equivalence: Demonstrated similarity in intended use and technological characteristics to legally marketed predicate devices (Comfeel Plus Ulcer Dressing, Acticoat 7 Dressing, and Arglaes-AB Antimicrobial Barrier Film and Island Dressings).
- In-vitro testing: Evidence of antibacterial activity against "certain strains known to be detrimental to wound healing." This in-vitro data supports the claim of antibacterial properties due to the incorporated silver but does not constitute a clinical study with acceptance criteria for wound healing outcomes in humans.
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Contreet Hydrocolloid Dressing
510(k) Summary
OCT 0 4 2002
Contreet Hydrocollold Dressing
Submitters name, address, phone and fax numbers
Coloplast Corporation 1955 West Oak Circle Marietta, GA 30062-2249 USA Phone: 770-281-8400 Fax: 770-345-8960
Contact person at Coloplast Corp
Elizabeth Boots Vice President Quality Assurance 1940 Commerce Drive PO Box 8300 North Mankato, MN 56002-8300 USA
Date 510(k) prepared
July 3, 2001
Name of the medical device
Trade name Contreet Hydrocolloid Dressing Common name Topical wound dressing Dressing, wound and burn, occlusive (21CFR878.4020) Classification name
Legally marketed device to which substantial equivalence is claimed
Acticoat 7 Dressing (K001519) ARGLAES-AB Antimicrobial Barrier Film and Island Dressings (K990810) Comfeel Plus Ulcer Dressing (K941263)
Description of the device
Contreet Hydrocolloid Dressing is an antibacterial hydrocolloid dressing with silver providing an optimal moist wound healing environment.
Contreet Hydrocolloid Dressing has demonstrated in-vitro antibacterial activity in certain strains known to be detrimental to wound healing.
Contreet Hydrocolloid Dressing is a waterproof dressing with a semi-permiable film backing.
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Intended use of the device
Contreet Hydrocolloid Dressing provides barrier protection against bacteria commonly encountered in wound ulcers.
Contreet Hydrocolloid Dressing is indicated for treatment of low to moderately exudating wounds.
Contreet Hydrocolloid Dressing is indicated for use for leg ulcers and pressure sores and may also be used for partial-thickness burns, donor sites, postoperative wounds and skin abrasions.
Contreet Hydrocolloid Dressing can be used on colonized wounds to support the wound healing and/or to reduce the odor from the wound.
Contreet Hydrocolloid Dressing can be used where the risk of infection is suspected or exists.
Contreet Hydrocolloid Dressing can be used on patients with wound infection at the discretion of the physician.
Contreet Hydrocolloid Dressing is suitable for use under compression bandaging on low to moderately exudating venous leg ulcers.
Summary of technological characteristics of subject device compared to predicate
Contreet Hydrocolloid Dressing compared to Comfeel Plus Ulcer Dressing: Cornfeel is a hydrocolloid dressing and is the product that Contreet Hydrocolloid Dressing is based on. The only difference is that Contreet Hydrocollaid Dressing has silver incorporated into it. The indications for use that apply to Comfeel also apply to Contreet Hydrocolloid Dressing.
Contreet Hydrocolloid Dressing compared to Acticoat 7 Dressing and Arglaes-AB Antimicrobial Barrier Film and Island Dressings: All three dressings contain silver, which acts as an antimicrobial.
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them that could represent hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 4 2002
Ms. Betty Boots Vice President, Quality Assurance Coloplast Corporation 1940 Commerce Drive N. Mankato, Minnesota 56003
Re: K013525
Trade/Device Name: Contreet Hydrocolloid Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: July 8, 2002 Received: July 8, 2002
Dear Ms. Boots:
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 - Ms. Betty Boots
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
Hypt Plurdu
Celia M. Witten, Ph.D., M.D.
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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Statement of indications for use
013525
Device Name: Contreet Hydrocolloid Dressing
Indications for Use:
The Contreet Hydrocolloid Dressing is indicated for use in the management of low to highly exudating leg ulcers, skin tears and pressure sores. The dressing can also be used for 2nd degree burns, 200 degree partial thickness burns, donor sites, post operative wounds and skin abrasions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Stypk Rhodes
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013525
N/A