K08 2296
Not Found
No
The summary describes a wound dressing with an antimicrobial agent and does not mention any AI/ML capabilities or related terms.
No.
The device is a wound dressing designed to protect against bacterial penetration and colonization, not to therapeutically treat a condition or disease.
No
The device is a wound dressing designed for the management and protection of wounds, not for diagnosis. Its purpose is therapeutic (antimicrobial protection for the dressing) rather than diagnostic.
No
The device description clearly states it is a hydrophilic polyurethane foam dressing, which is a physical hardware component, 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 with antimicrobial properties. This aligns with a medical device used for wound care, not an IVD used for diagnostic testing.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample (blood, urine, tissue, etc.), or provide information about a patient's health status based on in vitro testing.
- Performance Studies: The performance data mentioned is "in-vitro testing," but this likely refers to testing the antimicrobial properties of the dressing itself (e.g., its ability to inhibit bacterial growth on the dressing), not diagnostic testing on patient samples.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
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, 1st 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 testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K08 2296
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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: | Kendall
a Division of Tyco Healthcare Group LP
15 Hampshire Street
Mansfield, MA 02048
Phone: 508-261-8000
Fax: 508-261-6644 | FEB 2 6 2009 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | James Welsh
VP, Regulatory Affairs
Kendall
a Division of Tyco Healthcare Group LP
Telephone: 508-261-8532
Fax: 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