(91 days)
ColActive™ Collagen Wound 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
- Second degree burns
- Donor and graft sites
- Abrasions
- Dehisced surgical wounds
- Traumatic wounds healing by secondary intention
ColActive™ Collagen Wound Dressing is an advanced wound care dressing composed of collagen and sodium alginate provided in a sterile sheet or rope form. Collagen Wound 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 can be cut to fit specific wounds and are able to be layered for the management of deep wounds.
The provided text is a 510(k) Notification for the ColActive™ Collagen Wound Dressing. This document is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission generally does not include clinical studies with acceptance criteria and detailed performance data in the same way a PMA (Premarket Approval) submission would.
In this context, the "study that proves the device meets the acceptance criteria" refers to the demonstration of "substantial equivalence" to a predicate device, as required for 510(k) clearance. The acceptance criteria are implicit in the FDA's requirements for substantial equivalence, which primarily revolve around demonstrating similar materials, intended use, and functioning compared to an already approved device, along with biocompatibility.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance/Evidence from Submission |
|---|---|
| Biocompatibility (Safety): Device materials are safe for patient contact. | ColActive™ Collagen Wound Dressings have been demonstrated to be safe wound dressings. Safety tests were conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices. All test results demonstrated the dressings to be safe topical wound dressings in accordance with ISO 10993-1. |
| Substantial Equivalence in Materials, Intended Use, and Function: The device is as safe and effective as a legally marketed predicate device. | ColActive™ Collagen Wound Dressings are "substantially equivalent in materials of construction and intended use and identical in function" to FIBRACOL PLUS Collagen Wound Dressing with Alginate (Johnson & Johnson Medical) and SkinTemp Kollagen Wound Management Material (Biocore Medical Technologies). The Indications for Use are listed and align with typical wound care dressings. The description of the device (collagen and sodium alginate, pliable, absorbent, forms a gel, maintains moist environment) supports its functional equivalence. |
| Performance (related to intended use, e.g., absorbency, wound healing support): While not explicitly quantified with numerical targets, the device's functional description implies performance consistent with predicate devices. | The dressing "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." This describes the expected mechanism of action and performance for a wound dressing of this type. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not contain information about a "test set" in the context of clinical performance data or a specific dataset used for evaluation related to efficacy or diagnostic accuracy. The "tests" mentioned are biocompatibility tests (ISO 10993).
- Sample Size for Biocompatibility: Not specified in the document. Biocompatibility testing typically involves in vitro and/or in vivo studies on materials, not human-patient "test sets" for performance evaluation in the same way clinical trials do.
- Data Provenance: Not applicable for clinical trial data. For biocompatibility, the tests were conducted according to ISO 10993-1, an international standard.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable to this 510(k) submission. There is no mention of a "test set" requiring expert ground truth for performance evaluation (e.g., image interpretation, disease diagnosis). The submission focuses on substantial equivalence based on material composition, intended use, function, and biocompatibility.
4. Adjudication Method for the Test Set
This information is not applicable as there is no specific "test set" or clinical performance study described that would require an adjudication method.
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 a physical wound dressing, not an AI or diagnostic imaging device that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical wound dressing and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on:
- Predicate Device Characteristics: The established safety and effectiveness of the identified predicate devices (FIBRACOL PLUS Collagen Wound Dressing with Alginate and SkinTemp Kollagen Wound Management Material) served as the primary "ground truth" for substantial equivalence.
- Biocompatibility Standards: ISO 10993-1 outlines the scientific principles and methods for evaluating the biological safety of medical devices, which acts as a "ground truth" for material safety.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of machine learning or clinical trials described for this wound dressing.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set mentioned.
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510 (k) Notification, ColActive™ Collagen Wound Dressing Covalon Technologies, Inc.
K050177 1/2
510 (k) Summary
- January 24, 2005 1. Date Prepared:
- Covalon Technologies Inc. 2. Submitter 405 Britannia Road East, Suite 106 Mississauga, L4Z 3E6 Ontario, CANADA Tel: (416) 944.3496 Fax: (416) 944.8520
Paul L. Guilbaud Submission Vice President and Director Wound & Tissue Correspondent: Repair
14510 Kandi Court Largo, Florida 33774 Tel: (727) 595.8184 Fax: (727) 517 7005 Email: pguilbaud@covalon.com
-
Proprietary Name: ColActive™ Collagen Wound Dressing 4.
Common Name: Wound Dressing -
ક. Requiatory Class: FRO
Statement of Substantial Equivalence: 6.
ColActive™ Collagen Wound 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 and SkinTemp Kollagen Wound Management Material manufactured by Biocore Medical Technologies.
7. Indications For Use:
ColActive™ Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including:
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510 (k) Notification, ColActive™ Collagen Wound Dressing Covalon Technologies, Inc.
KOTO17
2/2
- 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 .
8. Description:
ColActive™ Collagen Wound Dressing is an advanced wound care dressing composed of collagen and sodium alginate provided in a sterile sheet or rope form. Collagen Wound 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 can be cut to fit specific wounds and are able to be layered for the management of deep wounds.
9. Biocompatibility:
ColActive™ Collagen Wound 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™ Collagen Wound Dressings are taken into consideration as a whole, ColActive™ Collagen Wound 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 logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a row. The profiles are connected and appear to be emerging from a single form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2007
Mr. Paul L. Guilbaud Vice President Wound and Tissue Repair Covalon Technologies, Inc. 14510 Kandi Court Largo, Florida 33774
K050177 Re:
Trade Name: ColActive™ Collagen Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: March 29, 2005 Received: March 31, 2005
Dear Mr. Guilbaud:
This letter corrects our substantially equivalent letter of April 27, 2005.
We have reviewed your Section 510(k) premarket notification of intent to market the We have reviewed your Section > Po(t); prematic come is substantially equivalent to May 28 device relefenced above and have decemined use assures on or to May 28, 1976, legally marketed predicate device managements or to devices that have been the enactment date of the Medical Device Thirefections of the Federal Food, Drug, and Cosmetic Act
reclassified in accordance with the provisions of the Federal (DMA) - You m reclassified in accordance with the provisions of a proval (PMA). You may, therefore,
(Act) that do not require approval of a premarket approval (PMA). Ast The general (Act) that do not require approval or a provisions of the Act. The general market the device, subject to the general on programments for annual registration, listing of controls provisions of the Act metading requirement.
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 If your device is classified (see above) into cation (spior regulations affecting your
(PMA), it may be subject to additional controls . Time . The 21, 2017 . In (PMA), it may be subject to additional connects of the 21, Parts 800 to 898. In the Federal device can be louind in the Code of Pederal Hegations).
addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Mr. Paul L. Guilbaud
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 mean that I Dr Hab made a well Federal statutes and regulations administered by other requirements of the Free and on anyone with all the Act's requirements, including, but not I coderal agonolos: You may some (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 manufacturing practice require, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section This leter will anow you to comment DA finding of substantial equivalence of your device 510(K) premarket nothreation "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), If you dobile specific at the Office of Compliance at (240) 276-0115. Also, please note the presse contact the other by reference to premarket notification" (21CFR Part 16 guildion onlines, which other general information on your responsibilities under the Act 807.27). Tourinal of Small Manufacturers, International and Consumer Assistance at its troll the Driber (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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KOK0177
510 (k) Notification, ColActive™ Collagen Wound Dressing Covalon Technologies, Inc.
Page 1 of 1
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT
| 510 (k) Number: | k 050177 |
|---|---|
| Covalon Technologies, Inc. |
ColActive™ Collagen Wound Dressing Device Name:
Indications for Use:
ColActive™ Collagen Wound 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 .
- Second degree burns .
- Donor and graft sites .
- Abrasions ●
- Dehisced surgical wounds .
- Traumatic wounds healing by secondary intention .
Prescription Use V (Per 21 CFR 801.109) OR Over-the-Counter Use
Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
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Koso177
N/A