(346 days)
Not Found
No
The summary describes a hydrocolloid dressing with antibacterial properties, focusing on its physical characteristics and in-vitro activity. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes.
The device is a dressing used in the management of various wounds and burns, including leg ulcers, pressure sores, and surgical wounds, which are conditions that require therapeutic intervention for healing. The mention of "antibacterial activity" also points to a therapeutic function.
No
The Contreet Hydrocolloid Dressing is a therapeutic dressing used for wound management, not for diagnosing medical conditions. Its purpose is to provide a healing environment and antibacterial activity, not to identify or characterize disease.
No
The device description clearly identifies the device as a physical hydrocolloid dressing with silver, which is a hardware component.
Based on the provided information, the Contreet Hydrocolloid Dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of various types of wounds on the body (leg ulcers, skin tears, burns, etc.). This is a therapeutic use, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the dressing and its antibacterial activity in vitro (in a lab setting), but this is a characteristic of the device itself, not a test performed on a patient sample to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing patient samples (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Contreet Hydrocolloid Dressing is a wound care product applied directly to the body for healing purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MGQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg ulcers, skin tears, pressure sores, donor sites, post operative wounds, skin abrasions
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Comfeel Plus Ulcer Dressing (K941263), Acticoat 7 Dressing (K001519), ARGLAES-AB Antimicrobial Barrier Film and Island Dressings (K990810)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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.
1
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.
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 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.
3
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
4
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