(187 days)
Not Found
Not Found
No
The summary describes a wound dressing with antimicrobial properties and provides performance data from in-vitro and animal testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is indicated for managing various wounds and dermatological disorders, which are medical conditions that require treatment to restore health or improve function.
No
Explanation: The device is described as a wound dressing with antimicrobial properties. Its intended use is for the management of various types of wounds, not for diagnosing conditions. The performance studies focus on its antimicrobial activity, not its ability to detect or diagnose diseases.
No
The device description clearly states it is a hydrophilic polyurethane foam dressing, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing for managing various types of wounds. This is a topical application for treating the body directly, not for testing samples taken from the body.
- Device Description: The description details a wound dressing made of foam with an antimicrobial agent. This aligns with a medical device used for wound care, not an in vitro diagnostic test.
- Performance Studies: The performance studies focus on the antimicrobial activity of the dressing against various organisms in vitro and in animal models. While these studies are conducted in vitro (in a lab setting), they are evaluating the performance of the dressing itself, not a diagnostic test that analyzes a patient sample.
- Lack of IVD Characteristics: There is no mention of analyzing patient samples (blood, urine, tissue, etc.), detecting specific biomarkers, or providing diagnostic information about a patient's condition.
In summary, the COPA AMD dressing is a medical device intended for wound management, not an in vitro diagnostic device used for testing patient samples to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 18 and 200 degree burns, dermatologic disorders, other wounds, inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.
Product codes
FRO
Device Description
COPA AMD is a hydrophilic polyurethane foam that is impregnated with Polyhexamethylene Biguanide Hydrochloride (PHMB), an antimicrobial agent that protects the dressing from bacterial penetration and colonization.
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)
Performance data submitted in support of this 510k included in-vitro and animal testing.
Broad spectrum activity was demonstrated against 6 organisms including gram positive, gram negative, and fungal types. Total kill was achieved for 7 consecutive days, with a daily challenge of >6 log of each organism:
- P. aeruginosa
- E. coli
- C. albicans
- S. epidermidis
- S. aureus
- E. faecalis
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The COPA AMD antimicrobial wound dressing is substantially equivalent to the existing COPA (Curafoam) polyurethane foam wound dressings in intended use, materials, physical characteristics, and performance characteristics. The modification attribut, the predicate device is the addition of PHMB antimicrobial agent to prevent bacterial penetration and colonization of the dressing.
Substantial equivalence is also claimed to Kerlix AMD and Excilon AMD, absorbent wound dressings which contain PHBM antimicrobial agent to prevent bacrial penetration and colonization of the dressing.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 ・ (508) 261-8000
510(k) Premarket Notification COPA AMD Antimicrobial Wound Dressing
K071371
page 1 of 2
Section B - 510(K) Summary
| Date Summary
| Was Prepared: | May 11, 2007 | |
|---|---|---|
| Submitter's | ||
| Information: | Kendall | |
| a Division of Tyco Healthcare Group LP | ||
| 15 Hampshire Street | ||
| Mansfield, MA 02048 | ||
| Phone: 508-261-8000 | ||
| Fax: 508-261-6644 | ||
| Contact: | James Welsh | |
| VP, Regulatory Affairs | ||
| Kendall | ||
| a Division of Tyco Healthcare Group LP | ||
| Telephone: 508-261-8532 | ||
| Fax: 508-261-8461 | NOV 1 9 2007 | |
| Device Trade | ||
| Name: | COPA AMD Antimicrobial Wound Dressing | |
| Device Common | ||
| Name: | Wound Dressing, Antimicrobial |
Classification Panel: General and Plastic Surgery
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
The COPA AMD antimicrobial wound dressing is substantially equivalent to the existing COPA (Curafoam) polyurethane foam wound dressings in intended use, materials, physical characteristics, and performance characteristics. The modification attribut, the predicate device is the addition of PHMB antimicrobial agent to prevent bacterial penetration and colonization of the dressing.
Substantial equivalence is also claimed to Kerlix AMD and Excilon AMD, absorbent wound dressings which contain PHBM antimicrobial agent to prevent bacrial penetration and colonization of the dressing.
1
510(k) Premarket Notification COPA AMD Antimicrobial Wound Dressing
Section B - 510(K) Summary
Device Description:
COPA AMD is a hydrophilic polyurethane foam that is impregnated with Polyhexamethylene Biguanide Hydrochloride (PHMB), an antimicrobial agent that protects the dressing from bacterial penetration and colonization.
Intended Use:
COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 18 and 200 degree burns, dermatologic disorders, other wounds, inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.
Performance Data: Performance data submitted in support of this 510k included in-vitro and animal testing.
Broad spectrum activity was demonstrated against 6 organisms including gram positive, gram negative, and fungal types. Total kill was achieved for 7 consecutive days, with a daily challenge of >6 log of each organism:
- . P. aeruginosa
- . E. coli
- C. albicans .
- � S. epidermidis
- S. aureus .
- . E. faecalis
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2007
Tyco Healthcare LLP % Mr. James Welsh VP. Regulatory Affairs 15 Hampshire Street Mansfield. Massachusetts 02048
Re: K071371
Trade/Device Name: COPA AMD antimicrobial wound dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 2, 2007 Received: November 7, 2007
Dear Mr. Welsh:
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 - Mr. James Welsh
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 (240) 276-0115. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely v
for
Mark N. Melkerson
Dep D.R
1965
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) number: K071371
Device Name:
COPA AMD antimicrobial wound dressing
Indications for Use:
COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 200 degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Please Do Not Write Below This Line - Continue On Another Page If Needed
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | 407137 |
| Page |
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