(252 days)
Not Found
No
The device description and performance studies focus on the material composition and physical properties of a wound dressing, with no mention of AI or ML technologies.
Yes
The device is a dressing indicated for the management of various types of wounds, which is a therapeutic function.
No
The device is a wound dressing designed to manage wounds by absorbing and transferring moisture, and maintaining a moist environment. It does not provide information about a patient's health status or diagnose a condition.
No
The device description clearly states it is a physical wound dressing made of collagen and sodium alginate, 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 states that ColActive® Transfer is for the "management of full and partial thickness wounds." This describes a therapeutic or wound care application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a "pliable, absorbent, perforated, and biocompatible dressing" that absorbs and transfers moisture from wounds. This is consistent with a wound dressing, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies mentioned are bench tests related to the physical properties and stability of the dressing (heat stability, crosslinking, fluid absorption), which are relevant to a wound care product, not a diagnostic device.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. ColActive® Transfer's function is to manage wounds directly, not to diagnose anything.
N/A
Intended Use / Indications for Use
ColActive® Transfer is indicated for management of full and partial thickness wounds including: pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, second degree burns, donor and graft sites, abrasions, dehisced surgical wounds, traumatic wounds healing by secondary intention.
ColActive® Transfer, is indicated for management of full and partial thickness wounds including pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, second degree burns, donor and graft sites, abrasions, dehisced surgical wounds, traumatic wounds healing by secondary intention.
Product codes
KGN
Device Description
ColActive® Transfer is a modification to the existing ColActive® Collagen Wound Dressing previously cleared under K050177 on 27th April 2005. ColActive® Transfer is composed of the same base matrix material; collagen and sodium alginate and is made from substantially an equivalent manufacturing process as the predicate. The new product, ColActive® Transfer is a pliable, absorbent, perforated, and biocompatible dressing. ColActive® Transfer dressings absorb and transfer moisture such as wound fluid and maintains a moist environment at the wound surface. The dressings can be cut to fit specific wounds and can be layered for the management of deep wounds. ColActive® Transfer dressings contain multiple holes that are evenly distributed across the surface area in order to facilitate the movement of excess exudates through the dressing and away from the wound. The new product will be supplied sterile packaged in a single use heat sealed medical grade foil pouch. The single use primaries will be packed, with a product insert, into cartons for distribution.
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)
ColActive® Transfer performance testing, includes bench testing such as heat stability. crosslinking, fluid/water absorption, as well as visual testing (Defect Free surface and even dressing thickness) which confirmed that ColActive® Transfer is substantially equivalent to the predicate devices with regard to materials, intended use and technological characteristics, pursuant to section 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
covalon
Covalon Technologies Inc. A Unique Medical Technologies Company
ISO 13485:2003 CERTIFIED
405 Britannia Road East, Suite 106 Mississauga, Ontario Canada L4Z 3E6 telephone 905.568.8400 facsimile 905.568.5200 www.covalon.com
Special 510(k) Summary of Safety and Effectiveness
1. Sponsor information
Covalon Technologies Inc. 405 Britannia Road East. Suite #106 Mississauga, Ontario, Canada L4Z 3E6
AUG 16 2013
Contact person:
Phone number: Fax number Date of Summary Kim Crooks Vice President of Operations 1-905-568-8400 Ext 265 1-905-568-5200 06 Aug 2013
2. Device name and classification
ColActive® Transfer Proprietary name: Collagen Wound Dressing Common Name: Device Classification: Unclassified General and Plastic Surgery Classification Panel: Product Code: KGN
3. Predicate devices
| Manufacturer | Device | 510(k) number |
|---|---|---|
| Covalon Technologies | ColActive® Collagen Wound Dressing | K050177 |
| Molnlycke Health Care, | ||
| US, LLC | Mepilex ® Transfer Ag | K123892 |
4. Indications for use
ColActive® Transfer is indicated for management of full and partial thickness wounds including: pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, second degree burns, donor and graft sites, abrasions, dehisced surgical wounds, traumatic wounds healing by secondary intention.
P.S
1
Image /page/1/Picture/0 description: The image shows the word "covaton" in bold black letters with a dotted line going vertically through the middle of the word. Below the word is the text "5. Device Description" in bold black letters. The number 5 is included to indicate that this is the fifth item in a list.
ColActive® Transfer is a modification to the existing ColActive® Collagen Wound Dressing previously cleared under K050177 on 27th April 2005. ColActive® Transfer is composed of the same base matrix material; collagen and sodium alginate and is made from substantially an equivalent manufacturing process as the predicate. The new product, ColActive® Transfer is a pliable, absorbent, perforated, and biocompatible dressing. ColActive® Transfer dressings absorb and transfer moisture such as wound fluid and maintains a moist environment at the wound surface. The dressings can be cut to fit specific wounds and can be layered for the management of deep wounds. ColActive® Transfer dressings contain multiple holes that are evenly distributed across the surface area in order to facilitate the movement of excess exudates through the dressing and away from the wound. The new product will be supplied sterile packaged in a single use heat sealed medical grade foil pouch. The single use primaries will be packed, with a product insert, into cartons for distribution.
6. Technological Characteristics:
ColActive® Transfer is a pliable and absorbent dressing that controls wound moisture levels through fluid absorption and transfer.
The predicate and the proposed devices have the same intended use and basic fundamental scientific technology. The only modifications to the predicate device consist of increased amounts of absorbing components (collagen and alginate) as well as flattening and perforating after lyophilization. These modifications confer additional absorption capacity, while facilitating passage of excess fluid to secondary dressings, if required. The modifications do not affect the safety but improve the effectiveness of the device.
ColActive® Transfer will be manufactured according to the product specifications and under good manufacturing practices to ensure the device is safe and effective for its intended use.
7. Performance Data
ColActive® Transfer performance testing, includes bench testing such as heat stability. crosslinking, fluid/water absorption, as well as visual testing (Defect Free surface and even dressing thickness) which confirmed that ColActive® Transfer is substantially equivalent to the predicate devices with regard to materials, intended use and technological characteristics, pursuant to section 510(k).
8. Substantial equivalence
ColActive® Transfer has the following similarities to ColActive® Collagen Wound Dressing which previously received 510(k) concurrence under K050177 on 27th April 2005:
- . has the same indicated use,
Page 2 of 3
2
Image /page/2/Picture/0 description: The image shows the word "covalon" in a bold, sans-serif font. A vertical line of dots is placed in the middle of the word, between the letters "o" and "a". The dots are arranged in a grid pattern, with three rows and three columns.
Special 510(k) Summary of Safety and Effectiveness
- use the same operating principle, .
- incorporate the same basic dressing design, .
- . incorporate the same materials, and
- . are packaged and sterilized using the same materials and processes.
In summary, the modified device, ColActive® Transfer has the same fundamental scientific technology and the same intended use as the predicate device ColActive® The changes that were made improve the fluid handling capability of the dressing and do not affect the safety of the device. Therefore, the modified device ColActive® Transfer is substantially equivalent to its predicate ColActive®.
Covalon Technologies Inc. A Unique Medical Technologies Company
ISO 13485:2003 CERTIFIED
405 Britannia Road East, Suite 106 Mississauga, Ontario Canada L4Z 3E6 telephone 905.568.8400 facsimile 905.568.5200 www.covalon.com
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized representation of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Ticalth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Kim Cooks Vice President of Operations Covalon Technologies Incorporated 405 Britannia Road East, Suite 106 Mississauga, Ontario Canada L.4Z 3E6
Re: K123756 Trade/Device Name: ColActive® Transfer Regulatory Class: Unclassified
Product Code: KGN Dated: July 18, 2013 Received: July 25, 2013
Dear Ms. Cooks:
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. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de receited daily 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.
August 16, 2013
4
Page 2 - Kim Cooks
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K123756
Device Name: ColActive® Transfer
Indications for Use:
ColActive® Transfer, is indicated for management of full and partial thickness wounds including pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular etiologies, venous ulcers, second degree burns, donor and graft sites, abrasions, dehisced surgical wounds, traumatic wounds healing by secondary intention.
Prescription Use X (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)
Jiyoung Dang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123756