X-CELL WOUND DRESSING

K974251 · Xylos Corporation · MGQ · Jun 22, 1998 · SU

Device Facts

• Record ID: K974251
• Device Name: X-CELL WOUND DRESSING
• Applicant: Xylos Corporation
• Product Code: MGQ · SU
• Decision Date: Jun 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

X-Cell™, a hydrogel wound dressing is a device intended to cover a wound or burn on a patient's skin to absorb wound exudate, and protect against abrasion, friction, dessication, or external contamination. The moist environment has a cooling effect that may reduce pain.

Device Story

X-Cell™ is a hydrogel wound dressing designed to cover wounds or burns. It functions by absorbing wound exudate and providing a protective barrier against abrasion, friction, desiccation, and external contamination. The hydrogel material maintains a moist environment, which provides a cooling effect to help reduce patient pain. The device is intended for use in clinical or home settings for the management of various skin lesions and wounds. It is not indicated for use on third-degree burns, nor is it intended to act as artificial skin or a treatment/cure for wounds. The dressing is applied topically to the wound site by a healthcare provider or patient.

Clinical Evidence

Bench testing only; biocompatibility testing performed to demonstrate safety for the intended purpose.

Technological Characteristics

Hydrogel wound dressing; physical barrier for exudate absorption and protection; non-implantable; sterile.

Indications for Use

Indicated for management of partial to full thickness wounds (arterial, venous, pressure, diabetic ulcers), first and second degree burns, post-operative surgical wounds, donor sites, and dermal lesions (cuts, abrasions). Contraindicated for third degree burns.

Predicate Devices

• NU-GEL hydrogel wound dressing (Johnson & Johnson)
• Aquacel wound dressing (ConvaTec)

Submission Summary (Full Text)

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JUN 22 1998

The same of the stage of the same of the same and and and and the

L974251

X-Celli™ Wound Dressing : Revised EXHIBIT III-1 : Summary of safety and effectiveness information

# EXHIBIT III-1 : X-CELL HYDROGEL WOUND DRESSING

#### 510 (K) SUMMARY

Submitted By : Eric Flam, Ph.D. NTL Associates, Inc. East Brunswick, NJ 08816 [phone] May 29, 1998

Device Name :XYLOS : X-CELL WOUND DRESSING

- (a) Intended Use
X-Cell™, a hydrogel wound dressing is a device intended to cover a wound or burn on a patient's skin to absorb wound exudate, and protect against abrasion, friction, dessication, or external contamination. The moist environment has a cooling effect that may reduce pain.

- (b) Biocompatibility
The results of the biocompatibility tests show the device to be safe for its intended purpose.

- (c) Substantial Equivalence
The X-Cell™ hydrogel wound dressing is substantially equivalent to the NU-GEL hydrogel wound dressing (from Johnson & Johnson) and the Aquacel wound dressing (from ConvaTec) predicate devices.

P 22

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 22 1998

XYLOS Corporation ·c/o Eric Flam, Ph.D. NTL Associates, Inc. 29 Ainsworth Avenue East Burnswick, New Jersey 08816

K974251 Re: Trade Name: X-Cell™ Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: March 30, 1998 Received: April 1, 1998

Dear Dr. Flam:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitations:

- l. This device may not be labeled for use on third degree burns.
- 2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
- 3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for 4. any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). 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.

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If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone],or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

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

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# X-CcllTM Wound Dressing : Revised APPENDAX IV-A

Page_1 l of

510{k} Number {lf known):_ K974251

Device Name: Xylos X-Cell™ wound dressing

Indiaalions For Use:

### Prescription

X-Cell™ wound dressing may be used for the management of:

- Partlal to Full thickness wounds (arterial, venous, pressure and diabetic ulcers); .
- First and Second degree burns (severe sunbum, etc.); .
- Post-operative surgical wounds; .
- Donor sites; .
- Dermal Lesions (cuts, abrasions, exc.) .

## (PLEASE OO NOT WRITE BELOW THIS UNE-CONTINUE ON ANOTHER PAGE IF NEEDED!

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K974251 |

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)