(157 days)
Not Found
No
The document describes a wound dressing with antibacterial properties and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is a wound dressing designed to support wound healing, maintain a moist environment, and provide antibacterial activity for various types of ulcers and burns. These functions are therapeutic as they are directly involved in treating or mitigating a disease or injury.
No.
The device description and intended use indicate that this device is a wound dressing designed to support wound healing, primarily through absorption, maintaining a moist environment, and antibacterial activity. It is not described as being used to diagnose a condition.
No
The device description clearly indicates it is a physical foam dressing with an active component (ionic silver), not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a wound dressing applied directly to the body to manage wounds and provide antibacterial activity. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a foam dressing with ionic silver for wound management and antibacterial activity. This aligns with a therapeutic device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition based on such analysis. IVDs are designed to provide diagnostic information.
- Performance Studies: The performance studies focus on antibacterial efficacy, odor reduction, and exudate absorption, all related to the therapeutic function of a wound dressing.
Therefore, the Contreet Foam Cavity Dressing is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Contreet Foam Cavity Dressing is indicated for deep, moderately to highly exuding stage II, III and IV pressure ulcers, leg ulcers, diabetic foot ulcers and burns with significant loss of tissue.
Contreet Foam Cavity Dressing maintains a moist wound environment that supports wound healing on wounds that are colonized or wounds where the risk of infection exists.
Contreet Foam Cavity dressings contain an antibacterial ingredient. The dressings demonstrate in-vitro antibacterial activity for up to 7 days. Contreet Foam Cavity Dressing is effective against certain bacterial strains known to be detrimental to wound healing.
Contreet Foam Cavity Dressing can be used on patients with wound infection at the discretion of a physician.
Product codes
FRO
Device Description
Contreet Foam Cavity Dressing is a highly absorbent foam cavity dressing with ionic silver as the active component in the dressing. The cavity dressing is suitable for exuding, deep wounds and is perforated to ensure flexible handling. The cavity dressing provides an optimal moist wound healing environment. combining an effective antibacterial activity in the dressing with exudates management.
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
Non-clinical performance data included:
- Contreet Foam Cavity Dressing performs as well as Contreet Foam with regard to antibacterial efficacy in certain bacteria.
- Contreet Foam Cavity Dressing performs as well as Contreet Foam with regard to support reduction of the odor caused by microorganisms in the wound.
- Contreet Foam Cavity Dressing is similar at absorbing exudate as Acticoat Moisture Control Dressing.
- Contreet Foam Cavity Dressing is made up of the same materials as Contreet Foam dressing which has been demonstrated to be safe to use through relevant toxicological tests.
Key Metrics
Not Found
Predicate Device(s)
Contreet Foam (K022416), Antibacterial Alginate Dressing (K024298), Absorbent Antimicrobial Wound Dressing (K013814), Silverlon Mound Packing Strips (K984210)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Page 1 of 4
510(k) Summary
Contreet Foam Cavity Dressing
- Submitters name, address, phone and fax numbers 1 .
- Contact person at Coloplast Corporation 2.
- Date that the 510 (k) summary was prepared 3.
- Name of the medical device (trade, common and classification name) 4.
- Legally marketed device to which substantial equivalence is claimed న్
- Description of the device 6.
- Intended use of the device 7.
- Summary of technological characteristics of subject device compared to predicate 8. device
- Non-clinical performance data 9.
-
- Conclusion
| 1. Submitters name, address, phone and fax numbers |
|---|
| Coloplast Corp |
| 1955 West Oak Circle |
| Marietta, GA 30062 - 2249 |
| U.S.A. |
| Tel.: (770) 281 8400 |
| Fax: (770) 281 8500 |
| 2. Contact person at Coloplast Corp |
|---|
| Elizabeth Boots |
| BA, MT |
| Quality Assurance Vice President |
| Coloplast Corp, Skin Care Division |
| 1940 Commerce Drive |
| P.O. Box 8300 |
| N. Mankato, MN 56003 - 8300 U.S.A. |
| Tel.: (507) 386 - 4362 |
| Fax: (507) 345 - 3291 |
Date that the 510 (k) summary was prepared November 14, 2003
1
| 4. Name of the medical device (trade, common and classification name) | |
|---|---|
| Trade name | Contreet Foam Cavity Dressing with silver |
| Common Name | Topical wound dressing with active ingredient |
| Classification name | Unclassified |
5. Legally marketed device to which substantial equivalence is claimed -5,464
Contreet Foam (K022416)
Antibacterial Alginate Dressing (K024298)
Absorbent Antimicrobial Wound Dressing (K013814)
Silverlon Mound Packing Strips (K984210)
6. Description of the device
Contreet Foam Cavity Dressing is a highly absorbent foam cavity dressing with ionic silver as the active component in the dressing. The cavity dressing is suitable for exuding, deep wounds and is perforated to ensure flexible handling. The cavity dressing provides an optimal moist wound healing environment. combining an effective antibacterial activity in the dressing with exudates management.
7. Intended use of the device
Contreet Foam Cavity Dressing is indicated for deep, moderately to highly exuding stage II, III and IV pressure ulcers, leg ulcers, diabetic foot ulcers and burns with significant loss of tissue.
Contreet Foam Cavity Dressing maintains a moist wound environment that supports wound healing on wounds that are colonized or wounds where the risk of infection exists.
Contreet Foam Cavity dressings contain an antibacterial ingredient. The dressings demonstrate in-vitro antibacterial activity for up to 7 days. Contreet Foam Cavity Dressing is effective against certain bacterial strains known to be detrimental to wound healing.
Contreet Foam Cavity Dressing can be used on patients with wound infection at the discretion of a physician.
2
863 נרכא
- Summary of technological characteristics of subject device compared to predicate device
Contreet Foam Cavity Dressing compared to Contreet Foam Dressings: Contreet Foam Dressings are PU-foam dressings and are the products that Contreet Foam Cavity Dressing is based on. The only difference is that Contreet Foam Cavity Dressing is indicated for deep cavity wounds.
Contreet Foam Cavity Dressing compared to Antibacterial Alginate Dressing (K024298). Absorbent Antimicrobial Wound Dressing (K013814), and Silverlon™Wound Packing Strips (K984210):
They are all indicated for deep wounds, handle exudate, they contain silver and therefore act as an antibacterial dressing.
9. Non-clinical performance data
Contreet Foam Cavity Dressing performs as well as Contreet Foam with regard to antibacterial efficacy in certain bacteria.
Contreet Foam Cavity Dressing performs as well as Contreet Foam with regard to support reduction of the odor caused by microorganisms in the wound.
Contreet Foam Cavity Dressing is similar at absorbing exudate as Acticoat Moisture Control Dressing.
Contreet Foam Cavity Dressing is made up of the same materials as Contreet Foam dressing which has been demonstrated to be safe to use through relevant toxicological tests.
3
Image /page/3/Picture/1 description: The image shows the Coloplast logo, which consists of a circle divided horizontally with the top half having horizontal lines and the bottom half being solid black. To the right of the circle is the word "Coloplast" in a bold, sans-serif font. Below the logo, there is handwritten text that says "4 of 4".
- Conclusion Contreet Foam Cavity Dressing is similar in function and intended use compared to the
predicate devices. Contreet Foam Cavity Dressing has been demonstrated to be substantially equivalent to the predicate devices with regard to safety and effectiveness through relevant tests. Therefore Contreet Foam Cavity Dressing is considered to be substantially equivalent to the predicate devices for all purposes.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
MAY 1 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Boots Vice President, Quality Assurance Coloplast Corporation 1940 Commerce Drive N. Mankato, Minnesota 56003
Re: K033869
Trade/Device Name: Contreet Foam Cavity Dressing with Silver Regulatory Class: Unclassified Product Code: FRO Dated: March 5, 2004 Received: March 8, 2004
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.
5
Page 2 - Ms. Elizabeth Boots
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and will your to begal finding of substantial equivalence of your device to a legally premailed 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 If you acon o specific as a moliance 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 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,
Miriam C. Provost
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
6
Indications for Use
510(k) Number (if known): K033869
Device Name: Contreet Foam Cavity Dressing with Silver
Indications For Use:
Contreet Foam Cavity Dressing with Silver dressings are indicated for deep wounds with moderate to high amounts of exudate.
Contreet Foam Cavity Dressing with Silver is indicated for stage II, III and IV pressure ulcers, leg ulcers, diabetic foot ulcers and first or second degree burns with significant loss of tissue.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________