COLLASORB COLLAGEN WOUND DRESSING

K091338 · Hartmann-Conco, Inc. · KGN · Aug 26, 2009 · SU

Device Facts

• Record ID: K091338
• Device Name: COLLASORB COLLAGEN WOUND DRESSING
• Applicant: Hartmann-Conco, Inc.
• Product Code: KGN · SU
• Decision Date: Aug 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

CollaSorb™ 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

Device Story

CollaSorb is a sterile, single-use wound dressing composed of native collagen and calcium-alginate. Designed for management of full and partial thickness wounds; dressing absorbs wound fluid to form a soft, conformable moist gel sheet at the wound surface. Maintains moist wound environment; provides wet stability and elasticity for application to deep wounds. Used in clinical settings for wound management; applied by healthcare providers. Benefits include moisture management and conformability to wound beds.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993-1. Non-pyrogenic status confirmed via rabbit pyrogen test.

Technological Characteristics

Composition: Native collagen and calcium-alginate. Form factor: Pliable, absorbent dressing sheets. Sterilization: Gamma radiation. Biocompatibility: ISO 10993-1 compliant. Biodegradable: Yes.

Indications for Use

Indicated for management of full and partial thickness wounds, including pressure, diabetic, venous, and mixed vascular ulcers, second degree burns, donor/graft sites, abrasions, dehisced surgical wounds, and traumatic wounds healing by secondary intention.

Predicate Devices

• ColActive Collagen Wound Dressing (K050177)

Submission Summary (Full Text)

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K091538

## 510(k) Summary 807.92(c)

HARTMANN-CONCO Inc.

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# SPONSOR

Company Name:

807.92(a)(1)

| Company Address: | 481 Lakeshore Parkway<br>Rock Hill, SC 29730 |
|------------------|----------------------------------------------|
|------------------|----------------------------------------------|

AUG 2 6 2009

510(k) #

K050177

| Telephone: | 803-325-7600 |
|------------|--------------|
| Fax: | 803-325-7606 |

Scott Cost Contact Person:

Summary Preparation Date: March 2, 2009

### DEVICE NAME

Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:

807.92(a)(2) CollaSorbTM Collagen Wound Dressing Collagen Wound Dressing Dressing, Wound, Collagen Unclassified KGN Unclassified

#### PREDICATE DEVICE

### 807.92(a)(3)

Legally Marketed Equivalent Device Product Company Colactive Collagen Wound Dressing Covalon Technologies, Inc.

## DEVICE DESCRIPTION

### 807.92(a)(4)

CollaSorb™ wound dressing is a wound care product composed of a native collagen and calcium-alginate, which comes as a sterile, non-pyrogenic product for single use in a single pouch package.

CollaSorb 10 wound dressings are pliable, absorbent dressings that absorb moisture such as wound fluid by forming a soft, conformable moist gel sheet at the wound surface and thus maintaining a moist environment. Due to its excellent wet stability and elasticity the CollaSorb 100 wound dressing can easily be applied and fitted to the wounds and is also for the management of deep wounds.

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# 1091338

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807.92(a)(5)

## DEVICE INTENDED USE

CollaSorb™ 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 .

| | COMPARISON OF TECHNICAL CHARACTERISTICS | 807.92(a)(6) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | CollaSorbTM | ColActiveTM |
| Indications for use | - Pressure ulcers<br>- Venous ulcers<br>- Diabetic ulcers<br>- Ulcers caused by mixed vascular<br>etiologies<br>- Second degree burns<br>- Donor and graft sites<br>- Abrasions<br>- Dehisced surgical wounds<br>- Traumatic wounds healing by<br>secondary intention | - Pressure ulcers<br>- Venous ulcers<br>- Diabetic ulcers<br>- Ulcers caused by mixed vascular<br>etiologies<br>- Second degree burns<br>- Donor and graft sites<br>- Abrasions<br>- Dehisced surgical wounds<br>- Traumatic wounds healing by<br>secondary intention |
| Material | Collagen / Calcium-Alginate | Collagen / Sodium-Alginate |
| Biodegradable | Yes | Yes |
| Biocompatibility | In accordance with ISO 10993-1 | In accordance with ISO 10993-1 |
| Non-Pyrogenic | Yes (rabbit pyrogen test) | - |
| Sterile | Yes - gamma radiation | Yes - gamma radiation |
| Size | 2 in x 2 in (5 cm x 5 cm = $25 cm^2$ )<br>4 in x 4 in (10 cm x 10 cm = $100 cm^2$ ) | 2 in x 2 in (5 cm x 5 cm = $25 cm^2$ )<br>4 in x 4 in (10 cm x 10 cm = $100 cm^2$ ) |

# CONSULTAT, CULADA CIDINDICTI CO

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

## AUG 2 6 2009

Hartman-Conco Inc. % Smith Associates Mr. E.J. Smith 1468 Harwell Avenue Crofton, Maryland 21114

Re: K091338

Trade/Device Name: CollaSorb Collagen Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: August 3, 2009 Received: August 5, 2009

Dear Mr. Smith:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. E.J. Smith

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

y yours,

. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K0913358

## Indications for Use

510(k) Number (if known):

Device Name: CollaSorb Collagen Wound Dressing

Indications for Use:

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CollaSorb™ 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 X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krane for MKM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K091338