KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING

K973509 · Kendall Healthcare Products Co. Div.Of Tyco Health · KMF · Dec 4, 1997 · General Hospital

Device Facts

• Record ID: K973509
• Device Name: KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
• Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
• Product Code: KMF · General Hospital
• Decision Date: Dec 4, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Like predicate devices, the Kendall CURASORB® Zn+Mg Alginate Wound Dressings are external wound dressings designed to help protect the wound, provide a moist environment for wound healing, and absorb wound exudate. CURASORB® Zn+Mg Dressings are indicated for use on wounds which present moderate to heavy wound exudate such as dermal ulcers, traumatic wounds, donor sites and seconddegree burns.

Device Story

CURASORB® Zn+Mg Alginate Wound Dressing is a sterile, single-use, nonwoven, absorptive dressing composed of calcium, sodium, zinc, and magnesium alginate fibers. Used in clinical or home settings for wound management. Upon contact with wound exudate, fibers transform into a firm gel/fiber mat, providing a moist healing environment and cushioning the wound. Available in various pad sizes and packing ropes. Healthcare providers apply the dressing to the wound surface to manage exudate; the device does not accelerate healing or act as synthetic skin.

Clinical Evidence

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

Technological Characteristics

Nonwoven, absorptive dressing composed of calcium, sodium, zinc, and magnesium alginate fibers. Sterile, single-use. Available in various pad dimensions and packing rope lengths. Biocompatibility tested per ISO 10993 Part I.

Indications for Use

Indicated for management of moderate to heavy exudating wounds, including dermal ulcers (venous stasis, pressure, arterial, diabetic), traumatic wounds (lacerations, punctures, abrasions, incisions), donor sites, and second-degree burns. Contraindicated for third-degree burns.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• Kendall CURASORB® Calcium Alginate Dressing
• Kendall CURASORB® Zn Alginate Wound Dressing

Submission Summary (Full Text)

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K973509

### Exhibit 9

DEC - 4 1997

## 510(k) Summary

In accordance with section 513(i)(3) of the SMDA and as described 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 Date: September 4, 1997

#### Contact Person 1.

Jan L. Efflandt, Regulatory Affairs Telephone: [phone]

- 2. Name of Device

| Classification Name: | Unclassified |
|-----------------------|-------------------------------------------------|
| Common or Usual Name: | Calcium Zinc and Magnesium Alginate<br>Dressing |
| Proprietary Name: | CURASORB® Zn+Mg Alginate Wound<br>Dressing |

#### 3. Statement of Substantial Equivalence

The Kendall CURASORB® Zn+Mg Alginate Wound Dressing is substantially equivalent in composition, form, function and intended use to the commercially available Kendall CURASORB® Calcium Alginate Dressing and Kendall CURASORB® Zn Alginate Wound Dressing.

#### Device Description 4.

The Kendall CURASORB® Zn+Mg Alginate Wound Dressings are sterile, single-use, nonwoven, absorptive dressings. The off-white alginate fibers are composed of calcium, sodium, zinc and magnesium. As the dressing absorbs wound exudate it converts to a firm gel/fiber mat. This gel cushions the wound and forms a moist environment at the wound interface. The product is available in 2" x 2", 4" x 4", and 4" x 8" , 6" x 10", 12" x 24" pads, as well as 12", 24" and 36" long wound packing rope.

#### ട്. Device Intended Use

Like predicate devices, the Kendall CURASORB® Zn+Mg Alginate Wound Dressings are external wound dressings designed to help protect the wound, provide a moist environment for wound healing, and absorb wound exudate. CURASORB® Zn+Mg Dressings are indicated for use on wounds which present moderate to heavy wound exudate

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such as dermal ulcers, traumatic wounds, donor sites and seconddegree burns.

#### Product Comparison .

The Kendall CURASORB® Zn+Mg Alginate Wound Dressings are equivalent to the referenced predicate devices 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 CURASORB® Zn+Mg Alginate 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 I, with the FDA modified matrix presented in memorandum G95-1.

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & IAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, depicted in a minimalist, flowing design. The seal appears to be a formal emblem, possibly representing a government agency or organization related to health and services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4 1997

Ms. Jan L. Efflandt 'Regulatory Affairs Administrator Kendall Healthcare Products Company 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K973509 Kendall CURASORB® Zn+Mg Alginate Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: September 15, 1997 Received: September 16, 1997

Dear Ms. Efflandt:

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 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 - Ms. Jan L. Efflandt

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,

[signature]

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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510(k) Number (if known):

973509

Device Name: CURASORB Zn+Mg Alginate Wound Dressing

Indications For Use:

The proposed device is for use in the management of wounds which present moderate to heavy wound exudate such as dermal ulcers (i.e., venous stasis, pressure, arterial, diabetic); traumatic wounds (i.e., lacerations, punctures, abrasions or incisions); donor sites; and second-degree burns.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------|----------|
| Division of General Restorative | |
| 510(k) Number | IC973509 |

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align: center;">X</div> | OR | Over-The-Counter Use |
|------------------------------------------|------------------------------------------|----|----------------------|
|------------------------------------------|------------------------------------------|----|----------------------|

(Optional Format 1-2-96)