(187 days)
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.
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.
The provided text from the 510(k) Premarket Notification for the COPA AMD Antimicrobial Wound Dressing describes performance data related to its antimicrobial properties. The information pertains to the device's ability to prevent bacterial penetration and colonization.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Broad-spectrum antimicrobial activity against specified organisms | Demonstrated broad-spectrum activity against 6 organisms (gram-positive, gram-negative, and fungal types). |
| Effectiveness over time against bacterial challenge | Total kill was achieved for 7 consecutive days, with a daily challenge of >6 log of each organism. |
| Target organisms | P. aeruginosa, E. coli, C. albicans, S. epidermidis, S. aureus, E. faecalis. |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated in terms of the number of unique dressings or tests. The tests were performed in-vitro and an animal testing was also mentioned.
- Data provenance: The tests were described as "in-vitro and animal testing," indicating laboratory and possibly animal model experiments. The country of origin for these tests is not specified, but the submission is to the US FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance data is based on laboratory (in-vitro) and animal testing, which typically relies on established microbiological and scientific protocols rather than expert consensus on subjective observations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is relevant for studies involving human interpretation (e.g., image reading), not for laboratory or animal testing results.
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
Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical wound dressing and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth was established through microbiological assays (quantifying bacterial kill) for the in-vitro tests and likely biological endpoints related to infection or wound healing for the animal testing.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The "testing" referred to is for device performance, not algorithm training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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 SummaryWas Prepared: | May 11, 2007 | |
|---|---|---|
| Submitter'sInformation: | Kendalla Division of Tyco Healthcare Group LP15 Hampshire StreetMansfield, MA 02048Phone: 508-261-8000Fax: 508-261-6644 | |
| Contact: | James WelshVP, Regulatory AffairsKendalla Division of Tyco Healthcare Group LPTelephone: 508-261-8532Fax: 508-261-8461 | NOV 1 9 2007 |
| Device TradeName: | COPA AMD Antimicrobial Wound Dressing | |
| Device CommonName: | 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.
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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
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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.
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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
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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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