LTM WOUND DRESSING

K082103 · Lifecell Corp. · KGN · Oct 8, 2008 · SU

Device Facts

• Record ID: K082103
• Device Name: LTM WOUND DRESSING
• Applicant: Lifecell Corp.
• Product Code: KGN · SU
• Decision Date: Oct 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

The LTM Wound Dressing is intended for the management of wounds including: - Partial and full thickness wounds; - - Pressure ulcers; - - Venous ulcers: - - Diabetic ulcers; - - Chronic vascular ulcers; - - Tunneled/undermined wounds; - - Surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, ﺘﻌ wound dehiscence); - Trauma wounds (abrasions, lacerations, second-degree burns and skin tears); + - Draining wounds - - And other bleeding surface wounds. The LTM Wound Dressing provides an environment that supports wound healing and control of minor bleeding. The device is intended for single patient, one time use only.

Device Story

LTM Wound Dressing is a processed porcine dermal matrix sheet; provides wound healing environment; controls minor bleeding. Used for various wound types including ulcers, surgical, and trauma wounds. Single-patient, one-time use. Device is identical to LTM Surgical Mesh (K070560).

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (biocompatibility, viral inactivation, biomechanical) performed on the identical predicate device, LTM Surgical Mesh (K070560).

Technological Characteristics

Processed porcine dermal matrix; terminally sterilized sheet; provided in geometric configurations and thickness; packaged in double pouch. Identical to LTM Surgical Mesh (K070560).

Indications for Use

Indicated for management of partial/full thickness wounds, pressure/venous/diabetic/chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites, grafts, post-Moh's/laser/podiatric surgery, dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, and bleeding surface wounds.

Predicate Devices

• Pegasus Biologics, Inc. - Unite Biomatrix (K071425)
• LifeCell Corporation - LTM Surgical Mesh (K070560)

Submission Summary (Full Text)

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082103 1/3

# OCT 0 8 2008

#### 510(K) SUMMARY III.

# LifeCell Corporation's LTM Wound Dressing

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

LifeCell Corporation One Millennium Way Branchburg, NJ 08876

Phone: [phone] Facsimile: [phone]

Contact Person: Manal Morcos

Date Prepared: July 24, 2008

### Names of Device and Name/Address of Sponsor:

LTM Wound Dressing LifeCell Corporation One Millennium Way Branchburg, NJ 08876

# Common or Usual Name

Collagen Wound Dressing

### Classification Name

Dressing, Wound, Collagen

### Classification:

Unclassified

#### Product Code:

KGN

## Predicate Devices:

Pegasus Biologics, Inc. - Unite Biomatrix (K071425) LifeCell Corporation - LTM Surgical Mesh (K070560)

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# Intended Use / Indications for Use

The LTM Wound Dressing is intended for the management of wounds including:

- Partial and full thickness wounds; -
- Pressure ulcers; -
- Venous ulcers: -
- Diabetic ulcers; -
- Chronic vascular ulcers; -
- Tunneled/undermined wounds; -
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, ﺘﻌ wound dehiscence);
- Trauma wounds (abrasions, lacerations, second-degree burns and skin tears); +
- Draining wounds -
- And other bleeding surface wounds.

The LTM Wound Dressing provides an environment that supports wound healing and control of minor bleeding.

The device is intended for single patient, one time use only.

# Technological Characteristics

The LTM Wound Dressing device is identical in materials and construction to the Company's rno DTM Wound Droomigical Mesh (K070560). Like the LTM Surgical Mesh, LTM Wound Dressing consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thickness, and packaged in a double pouch configuration.

# Performance Data

LifeCell's LTM Wound Dressing is technologically identical to the cleared LTM Surgical Mesh (K070560). The LTM Surgical Mesh has undergone extensive biocompatibility testing, animal (1007030). The tivation testing, and biomechanical testing. The data indicates that the device is biocompatible and that the manufacturing process is capable of inactivating any viral components that may come with the starting material. In all instances, the LTM Surgical Mesh functioned as intended and the performance observed was as expected. As LTM Wound Dressing is the exact same device technologically as the LTM Surgical Mesh, the Company submits that testing conducted on the LTM Surgical Mesh is equally applicable to the LTM Wound Dressing.

#### Substantial Equivalence

The LifeCell LTM Wound Dressing is as safe and as effective as the legally marketed predicate devices, Pegasus Biologics, Inc.'s Unite Biomatrix (K071425), and LifeCell Corporation's LTM Surgical Mesh (K070560). The LifeCell LTM Wound Dressing has the same intended uses and the same or similar indications, technological characteristics, and principles of operation as its predicate devices. Performance data demonstrates that LifeCell's LTM Wound

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Dressing is as safe and effective as the predicate device. Thus, LifeCell's LTM Wound Dressing is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 8 2008

LifeCell Corporation % Manal Morcos Manager, Regulatory Affairs One Millenium Way Branchburg, New Jersey 08876

Re: K082103

Trade/Device Name: LTM Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: July 24, 2008 Received: July 25, 2008

Dear Manal Morcos:

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 - Manal Morcos

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark M. Mulhern

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

Enclosure

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#### INDICATIONS FOR USE STATEMENT II.

11082103 510(k) Number (if known):_

Device Name: LTM Wound Dressing

Indications for Use:

The LTM Wound Dressing is intended for the management of wounds including:

- Partial and full thickness wounds; -
- Pressure ulcers; -
- Venous ulcers; -
- Diabetic ulcers; -
- Chronic vascular ulcers; -
- Tunneled/undermined wounds; -
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence);
- Trauma wounds (abrasions, lacerations, second-degree burns and skin tears); ・
- Draining wounds -
- And other bleeding surface wounds.

The LTM Wound Dressing provides an environment that supports wound healing and control of minor bleeding.

The device is intended for single patient, one time use only.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A Millican

(Division Sign-Of estorative.

510(k) Number K082103

LifaCell LTM Wound Dressing 510(k) Page 12 of 68