KENDALL CURITY PETROLATUM GAUZE

K973511 · Kendall Healthcare Products Co. Div.Of Tyco Health · FRO · Dec 16, 1997 · SU

Device Facts

• Record ID: K973511
• Device Name: KENDALL CURITY PETROLATUM GAUZE
• Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
• Product Code: FRO · SU
• Decision Date: Dec 16, 1997
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Kendall Curity Petrolatum Gauze Dressing is intended for use as a primary contact layer in dressing wounds such as minor burns, skin grafts, skin donor sites, as an initial layer in surgical dressings, as protective layer for injured body sites, as a seal around tubes and drains leading from the body.

Device Story

Sterile, single-use, non-adherent dressing; absorbent gauze impregnated with white petrolatum. Used as primary contact layer for wounds, surgical sites, or around tubes/drains. Applied by clinicians in clinical settings. Provides protective barrier; prevents adherence to wound bed. Does not accelerate healing; not for third-degree burns or long-term/permanent use.

Clinical Evidence

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

Technological Characteristics

Absorbent gauze impregnated with white petrolatum. Sterile, single-use. Available in various dimensions. No bioactive components.

Indications for Use

Indicated for use as a primary contact layer for minor burns, skin grafts, skin donor sites, surgical dressings, protective covering for injured sites, and as a seal around tubes and drains. Contraindicated for third-degree burns.

Predicate Devices

• Sherwood Medical Vaseline Petrolatum Gauze Dressing

Submission Summary (Full Text)

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K97 3511

### EXHIBIT #6

## 510(k) Summary

DEC 1 6 1997 Kendall Curity Petrolatum Gauze 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 12, 1997 Date Prepared:

#### 1. Contact Person

David A. Olson Manager Regulatory Affairs [phone]

#### 2. Name of Medical Device

Classification Name: Common or Usual Name: Proprietary Trade Name:

Unclassified Petrolatum Gauze Dressing Curity Petrolatum Gauze Dressing

#### 3. Identification of Legally Marketed Device

The proposed Kendall Curity Petrolatum Gauze Dressing is substantially equivalent in intended use and composition to the Sherwood Medical Vaseline Petrolatum Gauze Dressing which was in commercial distribution before May 28, 1976.

#### 4. Device Description

The proposed Kendall Curity Petrolatum Gauze Dressing is a sterile, single-use, non-adherent dressing consisting of absorbent gauze impregnated with white petrolatum. It is packaged in metalized chevron pouches and is available in ½" x 72", 1" x 36", 3" x 9", 3" x 18", 3" x 36", 6" x 36" and 1" x 8" sizes.

#### ട്. Device Intended Use

The Kendall Curity Petrolatum Gauze Dressing is intended for use as a primary contact layer in dressing wounds such as minor burns, skin grafts, skin donor sites, as an initial layer in surgical dressings, as protective layer for injured body sites, as a seal around tubes and drains leading from the body.

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### 6. Product Comparison

The Kendall Curity Petrolatum Gauze 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 Curity Petrolatum Gauze 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

DEC I 6 1997

Re: K973511 Kendall Curity Petrolatum Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 16, 1997 Received: September 17, 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:

- This device may not be labeled for use on third degree burns. 1.
- 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.
- 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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K973511

# 510(k) Number (if known):

Device Name: KENDALL CURITY PETROLATUM GAUZE DRESSING

Indications For Use:

. .

It is intended for use as a primary layer in dressing wounds such as minor burns, skin grafts, skin donor sites, as an initial layer in surgical dressings, as protective layer for injured body sites, as a seal around tubes and drains leading from the body.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------------------------------------------------|
| (D Sior off | |
| Dive al festa evices | |
| 510(k) Number | C973511 |
| Prescription Use<br>(Per 21 CFR 801.109) | <span style="text-decoration: overline;">X</span> |
| | OR Over-The-Counter Use ______ |
| | (Optional Format 1-2-96) |