(198 days)
COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 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.
Here's an analysis of the provided text to extract the requested information regarding the device's acceptance criteria and studies:
Assessment: The provided document is a 510(k) Premarket Notification for the COPA AMD Antimicrobial Wound Dressing, specifically for a change in sterilization method from ETO to Gamma irradiation. It is primarily concerned with demonstrating substantial equivalence to a legally marketed predicate device, not with establishing novel performance characteristics through extensive clinical studies. Therefore, many of the typical performance study details for a new device are not present.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to existing COPA AMD antimicrobial wound dressings in: | The COPA AMD antimicrobial wound dressing is substantially equivalent to the existing COPA AMD antimicrobial wound dressings in intended use, materials, physical characteristics, and performance characteristics. |
| - Intended Use | Met |
| - Materials | Met |
| - Physical Characteristics | Met |
| - Performance Characteristics | Met |
| Change in sterilization method from ETO to Gamma irradiation | Not explicitly stated as "met" with specific criteria, but the 510(k) was cleared, implying the change was deemed acceptable and did not alter equivalence. The "Performance Data" section mentions "in-vitro testing" but doesn't detail specific acceptance criteria for this change. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses "in-vitro testing" to support the change in sterilization method. It does not provide details on:
- Sample size for a test set: No specific sample sizes for in-vitro tests are mentioned.
- Data provenance: No country of origin is specified for the in-vitro data.
- Retrospective or prospective: This is not applicable as it's in-vitro testing and not a human study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this 510(k) submission. The submission focuses on demonstrating substantial equivalence through in-vitro testing related to a sterilization change, not on diagnostic performance where expert-established ground truth would be required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no mention of a human-read test set or expert adjudication.
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
This is not applicable. The device is an antimicrobial wound dressing, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "in-vitro testing" mentioned, the ground truth would typically be established by standardized laboratory methods and analytical results, not by expert consensus, pathology, or outcomes data in the context of a clinical study. The document does not specify the exact nature of this "ground truth" but implies it's related to material properties, sterility, or antimicrobial effectiveness after gamma irradiation.
8. The sample size for the training set
This is not applicable. The device is a physical wound dressing and does not involve AI algorithms that require training sets.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the word "KENDALL" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is centered and takes up most of the frame. The font is simple and easy to read.
1
KENDALL 15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 • 5009 261-80
Special 510(k) Premarket Notification COPA AMD Antimicrobial Wound Dressing
Section B – 510(K) Summary
| Date Summary Was Prepared: | August 8, 2008 |
|---|---|
| ---------------------------- | ---------------- |
| Submitter's Information: | Kendalla Division of Tyco Healthcare Group LP15 Hampshire StreetMansfield, MA 02048Phone: 508-261-8000Fax: 508-261-6644 | FEB 2 6 2009 |
|---|---|---|
| Contact: | James WelshVP, Regulatory AffairsKendalla Division of Tyco Healthcare Group LPTelephone: 508-261-8532Fax: 508-261-8461 | |
| 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 AMD antimicrobial wound dressings in intended use, materials, physical characteristics, and performance characteristics. The modification attributed to the predicate device is a change in sterilization method from ETO to Gamma irradiation
K08 2296
page 1 of 2
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads "K082296", and the text at the bottom reads "page 2 of 2". The handwriting is in black ink and appears to be cursive.
15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 · (508) 261-8000
Special 510(k) Premarket Notification COPA AMD Antimicrobial Wound Dressing
Section B -- 510(K) Summary (continued)
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:
Kem
COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 1st 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 testing.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of an eagle.
Public Health Service ·
Covidien LP, Formerly Registered as Tyco Healthcare % Mr. James Welsh Vice President, Regulatory Affairs 15 Hampshire Street Mansfield, Massachusetts 02048
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K082296
Trade/Device Name: COPA AMD antimicrobial wound dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 12, 2009 Received: February 13, 2009
FEB 2 6 2009
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 yours,
L. Arjona. fo
Mark N. Melkerson 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:
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, lacerations, 1*-and-200degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.
Prescription Use (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)
Daniel Krone 2/26/2004
(Division Size-Oils Division of General, Restorative, and Neurological Devices
510(k) Number K062296
N/A