(194 days)
Not Found
No
The description focuses on the physical properties and antibacterial activity of a wound dressing, with no mention of AI or ML technologies.
Yes
The device, Contreet Foam Dressing, is indicated for various wound management purposes (e.g., leg ulcers, pressure sores, burns), which are conditions typically treated to restore health or alleviate symptoms, fitting the definition of a therapeutic device.
No
This device is a wound dressing designed for management and healing, not for diagnosing conditions.
No
The device description clearly describes a physical wound dressing with a foam pad, silver as an active component, and a film backing, indicating it is a hardware medical device.
Based on the provided information, the Contreet Foam device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body to analyze these samples.
- Contreet Foam's Function: The description clearly states that Contreet Foam is a wound dressing. Its function is to be applied directly to a wound on the body to manage exudate and provide an antibacterial barrier. It does not analyze samples taken from the body.
- Intended Use: The intended use is for managing various types of wounds, which is a direct application to the body, not an in vitro test.
- Device Description: The description focuses on the physical properties of the dressing (foam, silver, adhesive/non-adhesive, film backing) and its antibacterial activity in vitro (meaning tested in a lab setting, not on a patient sample for diagnosis).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic information, or any of the typical components or processes associated with IVD devices.
Therefore, the Contreet Foam is a wound care device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Contreet Foam is an effective barrier to bacterial penetration in wounds.
Contreet Foam is indicated for exuding wounds, preferably for the management of wounds with moderately to high amounts of exudates.
Contreet Foam is indicated for partial and full thickness wounds, leg ulcers and pressure sores. The dressing can also be used for 20d degree burns, donor sites, postoperative wounds and skin abrasions.
Contreet Foam Non-Adhesive dressing is additionally indicated for diabetic foot ulcers.
Contreet Foam can also support reduction of the odor caused by microorganisms from the wound.
Contreet Foam can be used on patients with wound infection at the discretion of the physician.
Contreet Foam is suitable for use where compression bandaging is indicated.
The Contreet Foam is indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions. Contreet Foam Non-adhesive is additionally indicated for diabetic foot ulcers.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Contreet Foam Dressing is a wound dressing with silver as the active component. The dressing provides an optimal moist wound healing environment, combining an effective antibacterial barrier activity with exudates management.
Contreet Foam Non-adhesive is suitable for use on fragile skin due to the absence of adhesive. The film backing is waterproof and semi permeable.
Contreet Foam Adhesive has a hydrocolloid adhesive border and a central absorbent foam pad containing silver. The film backing is waterproof and semi permeable.
The dressing demonstrates in-vitro antibacterial activity for up to 7 days in certain strains known to be detrimental to wound healing such as Pseudomonas aeruginosa, Staphylococcus aureus, B-haemolytic Streptococcus, MRSA and VRE.*
*The list of bacteria that Contreet Foam has demonstrated in-vitro antibacterial activity towards is as follows: Acinetobacter, C. albicans, C. perfringens, E. cloacae, E. faecalis, E. faecium, E. coli, hemolytic Streptococcus Gr.A, MRSA (Methicillin resistant S. aureus), anaerobic Peptostreptococcus , P. mirabilis, P. vulgaris, P. aeruginosa, S. aureus. Coaqulase negative Staphylococcus, S. epidermidis. VREF (Vancomvcin resistant E. faecium).
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): 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.
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 Foam Dressing K022416 January 21, 2003
510(k) Summary
Contreet Foam Dressing
FEB 0 3 2003
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 Phone: 507-386-4362 Fax: 507-345-3291
Date 510(k) prepared
June 14, 2002
Name of the medical device
Trade name Contreet Foam Dressing, Adhesive and non-adhesive Common name Topical wound dressing Classification name Dressing, wound and burn, occlusive (21CFR878.4020)
Legally marketed device to which substantial equivalence is claimed
Biatain Foam Adhesive Dressing (K983173) Biatain Foam Non-adhesive Dressing (K983163) Acticoat Moisture Control Dressing (K010447)
Description of the device
Contreet Foam Dressing is a wound dressing with silver as the active component. The dressing provides an optimal moist wound healing environment, combining an effective antibacterial barrier activity with exudates management.
Contreet Foam Non-adhesive is suitable for use on fragile skin due to the absence of adhesive. The film backing is waterproof and semi permeable.
1
Contreet Foam Dressing K022416 January 21, 2003
Contreet Foam Adhesive has a hydrocolloid adhesive border and a central absorbent foam pad containing silver. The film backing is waterproof and semi permeable.
The dressing demonstrates in-vitro antibacterial activity for up to 7 days in certain strains known to be detrimental to wound healing such as Pseudomonas aeruginosa, Staphylococcus aureus, B-haemolytic Streptococcus, MRSA and VRE.*
*The list of bacteria that Contreet Foam has demonstrated in-vitro antibacterial activity towards is as follows: Acinetobacter, C. albicans, C. perfringens, E. cloacae, E. faecalis, E. faecium, E. coli, hemolytic Streptococcus Gr.A, MRSA (Methicillin resistant S. aureus), anaerobic Peptostreptococcus , P. mirabilis, P. vulgaris, P. aeruginosa, S. aureus. Coaqulase negative Staphylococcus, S. epidermidis. VREF (Vancomvcin resistant E. faecium).
Intended use of the device
Contreet Foam is an effective barrier to bacterial penetration in wounds.
Contreet Foam is indicated for exuding wounds, preferably for the management of wounds with moderately to high amounts of exudates.
Contreet Foam is indicated for partial and full thickness wounds, leg ulcers and pressure sores. The dressing can also be used for 20d degree burns, donor sites, postoperative wounds and skin abrasions.
Contreet Foam Non-Adhesive dressing is additionally indicated for diabetic foot ulcers.
Contreet Foam can also support reduction of the odor caused by microorganisms from the wound.
Contreet Foam can be used on patients with wound infection at the discretion of the physician.
Contreet Foam is suitable for use where compression bandaging is indicated.
Summary of technological characteristics of subject device compared to predicate
Contreet Foam compared to Biatain Foam Dressings: Biatain Foam Dressings are PUfoam dressings and are the products that Contreet Foam is based on. The only difference is that Contreet Foam has silver incorporated into it. The indications for use that apply to Biatain also apply to Contreet Foam.
Contreet Foam compared to Acticoat Moisture Control Dressing: Both dressings contain silver, which acts as an antimicrobial barrier.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, represented by three curved lines that suggest a head and shoulders. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 3 2003
Coloplast Corporation Elizabeth Boots Vice President, Ouality Assurance 1940 Commerce Drive P. O. Box 8300 North Mankato, Minnesota 56002-8300
Re: K022416
Trade/Device Name: Contreet Foam Adhesive/Non-Adhesive Regulation Number: Unclassified Regulation Name: Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 11, 2002 Received: November 18, 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
3
Page 2 - Ms. Elizabeth Boots
(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. 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), please contact the Office of Compliance at (301) 594-4659. 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
fol 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
510(k) Number (if known):
Device Name:
Contreet Foam Adhesive Contreet Foam Non-Adhesive
Indications for Use:
The Contreet Foam is indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions. Contreet Foam Nonadhesive is additionally indicated for diabetic foot ulcers.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use_ (Per 21 CFR 801.109
Over-The-Counter Use
(Optional Format 1-2-96)
Muriam C. Provost
al, Restorative
Contreet Foam