(189 days)
Not Found
No
The device description and performance studies focus on the material composition and physical properties of the wound dressing, with no mention of AI or ML technologies.
Yes
The device is indicated for the management of various types of wounds, indicating its therapeutic purpose in healing and managing medical conditions.
No
The device description indicates that ColActive Ag™ is a wound care dressing used for treatment and management of wounds, not for diagnosing conditions.
No
The device description clearly states it is a physical wound dressing composed of collagen, sodium alginate, and silver chloride, provided in sheet or rope form. It is a tangible, physical product, 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 the device is a wound dressing for managing various types of wounds. This is a topical application for treating a physical condition, not for performing tests on samples taken from the body to diagnose or monitor a disease.
- Device Description: The description details the composition and function of a wound dressing, which is applied directly to the wound. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of diagnostic tests, assays, or laboratory procedures.
Therefore, ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is a medical device, but it falls under the category of wound care products, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is indicated for the management of full and partial thickness wounds including:
- Pressure ulcers
- Diabetic ulcers
- Ulcers caused by mixed vascular etiologies
- Venous ulcers
- First and Second degree burns
- Donor and graft sites
- Abrasions
- Dehisced surgical wounds
- Traumatic wounds healing by secondary intention
Product codes
FRO
Device Description
ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is an advanced wound care dressing composed of collagen, sodium alginate and silver chloride provided in a sterile sheet or rope form. ColActive Ag™ Collagen with Silver, Antimicrobial Dressings are pliable, absorbent dressings that absorb moisture such as wound fluid forming a gel, thus maintaining a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization. The dressings act as an effective barrier to bacterial and fungal penetration. The silver content is intended to prevent colonization of the dressing. The dressings can be cut to fit specific wounds and are able to be layered for the management of deep wounds.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043296, FIBRACOL PLUS Collagen Wound Dressing with Alginate, Vitaphore Silver Foam Wound Dressing, Acticoat Silver Coated Dressing
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
JUN 6 - 2005 510 (k) Notification ColActive Ag™ Collagen with Silver, Antimicrobial Dressing Covalon Technologies, Inc.
510 (k) Summary
-
November 15, 2004 1. Date Prepared:
ﻛﺮﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ -
Covalon Technologies Inc. 2. Submitter 586 Spadina Avenue Toronto M5S 2H2 Ontario, CANADA Tel: (416) 944.3496 Fax: (416) 944.8520
| Submission
Correspondent: | Paul L. Guilbaud
Vice President and Director Wound & Tissue
Repair
Covalon Technologies Inc.
14510 Kandi Court
Largo, Florida 33774
Tel: (727) 595.8184
Fax: (727) 517.7005
Email: pquilbaud@covalon.com |
| ------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
-
Proprietary Name: ColActive Ag™ Collagen with Silver, Antimicrobial 4. Dressing
Common Name: Wound Dressing -
- Requiatory Class: MPG
6. Statement of Substantial Equivalence:
ColActive Ag™ Collagen with Silver, Antimicrobial Dressings are substantially equivalent in materials of construction and intended use and identical in function to FIBRACOL PLUS Collagen Wound Dressing with Alginate manufactured by Johnson & Johnson Medical, Vitaphore Silver Foam Wound Dressing manufactured by Vitaphore Corporation and Acticoat Silver Coated Dressing manufactured by Westaim Biomedical, Inc.
7. Indications For Use:
ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is indicated for the management of full and partial thickness wounds including:
1
510 (k) Notification 910 (K) Notinoddon'
ColActive Ag™ Collagen with Silver, Antimicrobial Dressing Covalon Technologies, Inc.
- Pressure ulcers ●
- Diabetic ulcers ●
- Ulcers caused by mixed vascular etiologies ●
- Venous ulcers ●
- First and Second degree burns .
- Donor and graft sites .
- Abrasions .
- Dehisced surgical wounds .
- Traumatic wounds healing by secondary intention .
Description: 8.
ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is an advanced wound care dressing composed of collagen, sodium alginate and silver chloride provided in a sterile sheet or rope form. ColActive Ag™ Collagen with Silver, Antimicrobial Dressings are pliable, absorbent dressings that absorb moisture such as wound fluid forming a gel, thus maintaining a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization. The dressings act as an effective barrier to bacterial and fungal penetration. The silver content is intended to prevent colonization of the dressing. The dressings can be cut to fit specific wounds and are able to be layered for the management of deep wounds."
Biocompatibility: 9.
ColActive Ag™ Collagen with Silver, Antimicrobial Dressings have been demonstrated to be safe wound dressings. To support the biocompatibility of these products, safety tests were conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices.
When all test results from tests conducted on ColActive Ag™ Collagen with Silver, Antimicrobial Dressings are taken into consideration as a whole, ColActive Ag™ Collagen with Silver, Antimicrobial Dressings have been demonstrated to be safe topical wound dressings in accordance with ISO 10993-1.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN € - 2005
Mr. Paul L. Guilbaud Vice President and Director of Wound and Tissue Repair Covalon Technologies Incorporated 14510 Kandi Court Largo, Florida 33774
Re: K043296
Trade/Device Name: ColActive Ag™ Collagen with Silver, Antimicrobial Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 20, 2005 Received: May 23, 2005
Dear Mr. Guilbaud:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becaller by (a) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to trgans) in the Medical Device Amendments, or to conninered phorts to May 20, 1978, as eccordance with the provisions of the Federal Food, DNA A de rices mat nave been require approval of a premarket approval application (PMA). and Costiete Her (110. (110.) that be novice, subject to the general controls provisions of the Act. The r ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provider ing 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 n may be subject to stan as Execural 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 I lease be devilsed that i Drivisantes vour device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I edetar station and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic form in the quiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Mr. Paul L. Guilbaud
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter water notification. The FDA finding of substantial equivalence of your device to a legally premative nedicate 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 If you desire specific arrivaliance 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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
510 (k) Number:
KO43796 Covalon Technologies, Inc.
Device Name: ColActive Ag™ Collagen with Silver, Antimicrobial Dressing
Indications for Use:
ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is indicated for the management of full and partial thickness including:
- Pressure ulcers .
- Diabetic ulcers .
- Ulcers caused by mixed vascular etiologies ◆
- Venous ulcers ●
- First and Second degree burns ●
- Donor and graft sites .
- Abrasions & lacerations ●
- Dehisced surgical wounds .
- . Traumatic wounds healing by secondary intention
Prescription Use
(Per 21 CFR 801.109) √
OR Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| of Gener 1, Restorative | |
|---|---|
| Neurological Devices | |
| 25 | |
| K043296 |