K Number
K030921
Device Name
COLLAGEN TOPICAL WOUND DRESSING
Date Cleared
2003-05-15

(52 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Collagen Topical Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding. Collagen Topical Wound Dressing may be used for the management of exudating wounds such as: - Pressure ulccrs - . V cnous stasis ulcers - Diabetic ulcers . - Acute wounds, for cxample trauma and surgical wounds ● - Partial-thickness burns
Device Description
The Collagen Topical Wound Dressing is a white to off-white, absorbent, microfibrillar particulate collagen matrix intended for topical use. The product is supplied sterile and for single use only.
More Information

Not Found

No
The device description and performance studies focus on the material properties and biological effects of a collagen matrix, with no mention of AI or ML technologies.

Yes
The Collagen Topical Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding, which are therapeutic actions.

No

The document states that the Collagen Topical Wound Dressing is indicated for the "management of moderately to heavily exudating wounds and to control minor bleeding," and is described as an "absorbent, microfibrillar particulate collagen matrix intended for topical use." These descriptions indicate a therapeutic purpose (wound management and bleeding control) rather than a diagnostic one (identifying a disease or condition).

No

The device description clearly states it is a "particulate collagen matrix," which is a physical material, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the management of wounds and controlling minor bleeding. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description: The description details a topical wound dressing, which is applied directly to the wound. This is consistent with a therapeutic device, not an IVD which would typically involve analyzing a biological sample.
  • Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.

Therefore, the Collagen Topical Wound Dressing is a therapeutic medical device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

Collagen Topical Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.
Collagen Topical Wound Dressing may be used for the management of cxudating wounds such as:

  • Pressure ulccrs
  • . V cnous stasis ulcers
  • Diabetic ulcers .
  • Acute wounds, for cxample trauma and surgical wounds ●
  • Partial-thickness burns

Product codes

KGN

Device Description

The Collagen Topical Wound Dressing is a white to off-white, absorbent, microfibrillar particulate collagen matrix intended for topical use. The product is supplied sterile and for single use only.

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

The results of the in vitro product characterization studies and biocompatibility studies show that the Collagen Topical Wound Dressing is safe and substantially equivalent to its predicate devices.

Key Metrics

Not Found

Predicate Device(s)

K910944, K012990, K990086, K955506, K925548

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

0

MAY 1 5 2003

KOJO9ZI

510(k) Summary

| Applicant Name and Address: | Collagen Matrix, Inc.
509 Commerce Street
Franklin Lakes, New Jersey 07417 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC
Director, Clinical, Regulatory, and Quality Assurance
Tel: (201) 405-1477
Fax: (201) 405-1355 |
| Date of Summary: | March 21, 2003 |
| Device Common Name: | Collagen Topical Wound Dressing |
| Device Trade Name: | To be determined |
| Device Classification Name: | Bandage, Liquid
Class I
880.5090
KMF |
| Predicate Device(s): | Medifil® Kollagen Particles, K910944
Collatek® Powder, K012990
HeliDerm™ Collagen Wound Dressing, K990086
hyCurc® Advanced Collagen Wound Care, K955506
FIBRACOL™ Collagen-Alginate Dressing, K925548 |

Description of the Device

The Collagen Topical Wound Dressing is a white to off-white, absorbent, microfibrillar particulate collagen matrix intended for topical use. The product is supplied sterile and for single use only.

Indications for Use

Collagen Topical Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.

Collagen Topical Wound Dressing may be used for the management of cxudating wounds such as:

  • Pressure ulccrs
  • . V cnous stasis ulcers
  • Diabetic ulcers .

1

  • Acute wounds, for cxample trauma and surgical wounds ●
  • Partial-thickness burns

Summary/Comparison of Technical Characteristics

Collagen Topical Wound Dressing and its predicates have similar technological characteristics. In particular, the Collagen Topical Wound Dressing and its predicates are similar with respect to intended use, material, form, size, etc.

Safety

Collagen Topical Wound Dressing has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all applicable ISO 10993-1 testing for the biological evaluation of medical devices.

Conclusion

The results of the in vitro product characterization studies and biocompatibility studies show that the Collagen Topical Wound Dressing is safe and substantially equivalent to its predicate devices.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

MAY 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Peggy Hansen, RAC Director, Clinical, Regulatory, and Ouality Assurance Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K030921

Trade/Device Name: Collagen Topical Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: March 21, 2003 Received: March 24, 2003

Dear Ms. Hansen:

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. Iisting 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 - Ms. Peggy Hansen, RAC

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 Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):- " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
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Device Name:

Indications for Use:

Collagen Topical Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.

Collagen Topical Wound Dressing may be used for the management of exudating wounds such as:

  • Pressure ulcers .
  • Venous stasis ulcers .
  • Diabetic ulcers .
  • Acute wounds, for example trauma and surgical wounds
  • Partial-thickness burns .

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030921

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)