KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)

K973507 · Kendall Healthcare Products Co. Div.Of Tyco Health · FRO · Dec 15, 1997 · SU

Device Facts

• Record ID: K973507
• Device Name: KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
• Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
• Product Code: FRO · SU
• Decision Date: Dec 15, 1997
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Kendall Xeroform Petrolatum Wound Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate where mild medication and deodorization are desired.

Device Story

Sterile, single-use, non-adherent wound dressing; consists of absorbent gauze impregnated with Xeroform in a petrolatum blend. Applied by clinicians as a primary contact layer for various wound types to provide mild medication and deodorization. Functions as a physical barrier; does not accelerate healing or epithelization. Available in multiple sizes and roll formats. Packaged in metalized chevron pouches.

Clinical Evidence

No clinical data. Biocompatibility testing performed per ISO 10993, Part 1, and FDA memorandum G95-1.

Technological Characteristics

Absorbent gauze impregnated with Xeroform in a petrolatum blend. Sterile, single-use. Available in various dimensions (e.g., 4" x 3yd, 2" x 2"). Biocompatibility testing conducted per ISO 10993-1.

Indications for Use

Indicated for patients with lacerations, skin graft recipient sites, newly sutured wounds, abrasions, minor or partial thickness burns, and surgical wounds with light exudate. Not indicated for third-degree burns.

Predicate Devices

• Sherwood Medical Xeroform Petrolatum Dressing

Submission Summary (Full Text)

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# 171350 /

## EXHIBIT #7

DEC 1 5 1997

### 510(k) Summary

## Kendall Xeroform Petrolatum Wound Dressing

In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:

Kendall Healthcare Products Company 15 Hampshire Street Mansfield, MA 02048 September 3, 1997 Date Prepared:

#### 1. Contact Person

David A. Olson Manager Regulatory Affairs [phone]

#### 2. Name of Medical Device

Classification Name: Common or Usual Name: Unclassified Xeroform Petrolatum Wound Dressing

#### Identification of Legally Marketed Device ന്

The proposed Kendal! Xeroform Petrolatum Wound Dressing is substantially equivalent in intended use and composition to the Sherwood Medical Xeroform Petrolatum Dressing which was in commercial distribution before May 28, 1976.

#### ধ: Device Description

The proposed Kendall Xeroform Petrolatum Wound Dressing is a sterile, singleuse, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend. It is packaged in metalized chevron pouches and is available in 4" x 3yd roll, 1" x 8", 5" x 9", 2" x 2" and 4" x 4" sizes.

#### ട. Device Intended Use

The Kendall Xeroform Petrolatum Wound Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate where mild medication and deodorization are desired.

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#### 6. Product Comparison

The Kendall Xeroform Petrolatum Wound Dressing is equivalent to the referenced predicate device in that they are fabricated from similar materials, have a similar function and equivalent indications for use.

#### 7. Nonclinical Testing

Biocompatibility testing of the Kendall Xeroform Petrolatum Wound Dressing has demonstrated that it contains no bioactive components. Testing performed on the product was based upon guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.

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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" arranged around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 1997

Mr. David A. Olson Manager, Regulatory Affairs Kendall Healthcare Products Company 15 Hampshisre Street Mansfield, Massachusetts 02048

Re: K973507 Kendall Xeroform Petrolatum Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 15, 1997 Received: September 16, 1997

Dear Mr. Olson:

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 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- 1. This device may not be labeled for use on third degree burns.
- 2. This device may not be labeled as having any acceleratimg 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.
- 4. This device may not be labeled as a treatment or a cure for 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

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Page 2 - Mr. David A. Olson

registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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 (CFR), Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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 301-443-6597 or at its internet address http://www.fda.gov/cdrh/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

Enclosure

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K973507

510(k) Number (if known):

Device Name: Kendall Xeroform Petrolatum Dressing

Indications For Use:

It is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate where mild medication and deodorization are desired.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K973507 |

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | _________________ |
|--------------------------|-------------------|
| (Optional Format 1-2-96) | |

(Optional Format 1-2-96)