MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING

K040211 · Collagen Matrix, Inc. · KGN · Feb 27, 2004 · SU

Device Facts

• Record ID: K040211
• Device Name: MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
• Applicant: Collagen Matrix, Inc.
• Product Code: KGN · SU
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

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

Device Story

Absorbent, porous, sponge-like collagen matrix; applied topically to wounds. Functions as physical dressing to manage exudate and control minor bleeding. Used in clinical settings; applied by healthcare professionals. Provides moist wound environment; facilitates management of various ulcer types and acute wounds. Single-use, sterile device.

Clinical Evidence

Bench testing only. Device evaluated via in vitro product characterization and biocompatibility studies per ISO 10993-1 standards. No clinical trial data presented.

Technological Characteristics

Collagen-based matrix; porous, sponge-like form factor. Sterile, single-use. Biocompatibility verified per ISO 10993-1.

Indications for Use

Indicated for management of moderately to heavily exudating wounds and control of minor bleeding in patients with pressure ulcers, venous stasis ulcers, diabetic ulcers, acute wounds (trauma/surgical), and partial-thickness burns.

Predicate Devices

• Collagen Topical Wound Dressing (K030921)

Submission Summary (Full Text)

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FEB 27 2004

K040211

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## 510(k) Summary of Safety and Effectiveness

| Applicant Name and Address: | Collagen Matrix, Inc.<br>509 Commerce Street<br>Franklin Lakes, New Jersey 07417 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC<br>Director, Clinical, Regulatory, and Quality Assurance<br>Tel: [phone]<br>Fax: [phone] |
| Date of Summary: | January 29, 2004 |
| Device Common Name: | Collagen Topical Wound Dressing |
| Device Trade Name: | To be determined |
| Device Classification Name: | Dressing, Wound, Collagen<br>Unclassified<br>KGN |
| Predicate Device(s): | Collagen Topical Wound Dressing, K030921<br>(Original Device) |

### Description of the Device

Collagen Topical Wound Dressing is a white to off-white, absorbent, porous, sponge-like 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 exudating wounds such as:

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

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# Summary/Comparison of Technical Characteristics

Collagen Topical Wound Dressing has the same fundamental scientific technology and intended use as the predicate device. In particular, the Collagen Topical Wound Dressing and its predicate are the same with respect to intended use, material, source, sterilization, 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 device.

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FEB 27 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040211

Trade/Device Name: Collagen Topical Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: January 29, 2004 Received: January 30, 2004

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, 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.

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#### 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 [phone]. 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N. Milhem

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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04 0211

# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Collagen Topical Wound Dressing

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 .

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


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

| 510(k) Number | K040211 |
|---------------|---------|
|---------------|---------|

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