ALGISITE M

K983210 · Smith & Nephew, Inc. · KMF · Dec 10, 1998 · General Hospital

Device Facts

• Record ID: K983210
• Device Name: ALGISITE M
• Applicant: Smith & Nephew, Inc.
• Product Code: KMF · General Hospital
• Decision Date: Dec 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

For OTC applications, Algisite M may be used for the management of minor conditions such as: Lacerations Abrasions Skin Tears Minor Burns Under the care of a healthcare professional, Algisite M may be used for the management of full and partial thickness wounds including: Leg Ulcers Pressure Ulcers Diabetic Foot Ulcers Surgical Wounds

Device Story

Algisite M is a calcium alginate wound dressing. It functions as a topical dressing for wound management; it is applied directly to the wound site by a patient (OTC) or healthcare professional. The dressing interacts with the wound environment to manage exudate. It is used in clinical or home settings. The device does not accelerate healing, nor is it a permanent dressing or artificial skin. It provides a physical barrier for wound protection.

Clinical Evidence

No clinical trials were performed. Evidence consists of bench testing for biocompatibility: agar-overlay cytotoxicity (mouse L929 cells), skin irritation (rabbit, BS 5736 Part 8), sensitization (guinea pig, Magnusson & Kligman), acute systemic toxicity (mouse, BS 5736 Part 3), and haemolysis (US National Formulary XIV, result 4.45%).

Technological Characteristics

Calcium alginate dressing. Sterilized via gamma irradiation to SAL 10^-6 per EN 552 and ISO 11137. Biocompatible materials; non-cytotoxic, non-irritant, non-sensitizing, and non-haemolytic.

Indications for Use

Indicated for management of minor wounds (lacerations, abrasions, skin tears, minor burns) for OTC use, and full/partial thickness wounds (leg, pressure, diabetic foot, surgical ulcers) under professional care. 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

• ALGOSTERIL Alginate Dressing
• KALTOSTAT Wound Dressing (K940407)
• Sorbsan Topical Wound Dressing (K914575)

Submission Summary (Full Text)

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DEC 1 0 1998

ણ પ્ર ﺔ ﻳﺘ

# 510(k) Summary

# Algisite M - Calcium Alginate Dressing

Preparation Date: September 8, 1998

Submitter: Jim G. Irvin Address: Smith & Nephew Inc. Wound Management Division 11775 Starkey Road Largo, FL 33773-4727 Phone: [phone] Fax: [phone]

#### Registration Official / Contact Person:

Jim Irvin, Vice President Quality Assurance and Regulatory Affairs Smith & Nephew, Inc. Wound Management Division

Manufacturer Identification/Establishment Registration Number

Smith & Nephew Inc. Wound Management Division 11775 Starkey Road Largo, FL 33773-4727 Phone [phone] Fax [phone]

Establishment Registration Number: 1017593

Classification:

Trade Name: Algisite M - Calcium Alginate Dressing

Common Name: Calcium Alginate Dressing

Classification Name: Class I Wound and Burns Dressing

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## Substantially Equivalent Products:

| Product | Distributor/Manufacturer |
|-------------------------------------|------------------------------------------------------------------------------------------|
| ALGOSTERIL ®<br>Alginate Dressing | For Johnson & Johnson Medical Inc. by Les Laboratoires Brothier S.A.<br>Nanterre, France |
| KALTOSTAT ®<br>Wound Dressing | Calgon Vestal Laboratories<br>St. Louis, MS (K940407) |
| Sorbsan ™ Topical<br>Wound Dressing | For Dow B. Hickman, Inc. By Steriseal Limited<br>Worcestershire, England (K914575) |

### Device Description

Algisite M - Calcium Alginate Dressing

## Technological Characteristics:

The Algisite M - Calcium Alginate Dressing is technologically the same as the substantially equivalent products:

> ALGOSTERIL ® Alginate Dressing KALTOSTAT ® Wound Dressing Sorbsan ™ Topical Wound Dressing

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#### Bio Compatibility

#### Cytotoxicity

An agar - overlay cytotoxicity test, utilizing a culture of mouse L929 cells, was conducted on the test article, Algisite M, in order to determine the potential for in vitro cytotxicity. After incubating at 37°C for 24 hours, the cell cultures were inspected for evidence of cytolysis.

The sample of Algisite M and the negative control were non-toxic and the positive control toxic to L929 cells under the conditions of the test.

#### British Standard 5736 Part 8 Assessment of Skin Irritation

The test article, Algisite M, was evaluated according to British Standard 5736 "Evaluation of medical devices for biological hazards: Part 8 Method of test for skin irritation of solid medical devices". The test is designed to assess the irritation potential of the test material by its direct contact with rabbit skin for five consecutive days.

Under conditions of this study, Algisite M, is considered non-irritant following 5day repeated application to rabbit skin.

#### Magnusson & Kligman Maximization Study in the Guinea Pig

This study was performed according to Safepharm Standards Protocol Number GM 09/83/85D and was designed to assess the contact sensitization potential of Algisite M.

The test material produced a 0% (0/20) sensitization rate and was classified as a non-sensitizer to guinea pig skin.

#### Acute Systemic Toxicity of Saline Extracts of Calcium Alginate in The Mouse

The test article, Algisite M, was evaluated according to British Standard 5736 "Evaluation of medical devices for biological hazards: Part 3 Method of test for systemic toxicity; assessment of acute toxicity of extracts from medical devices". The results of the study will provide information on the acute toxic effects attributable to leachable inherent or extraneous substances of value in predicting the suitability of the test article for its intended use.

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A saline extract of calcium alginate passed the prescribed acute systemic toxicity test in the mouse.

#### Haemolysis

The test article, Algisite M, was evaluated using the U.S. National Formulay XIV method.

The haemolysis value of Algisite M was found to be 4.45% by the above Blood compatibility haemolysis test. As the haemolysis value is less than 5% the sample is considered to be non-haemolytic.

### Sterilization

Algisite M - Calcium Alginate Dressing is gamma irradiated to achieve a sterility assurance level of at 106 or better in a validated process according to EN 552 "Sterilization of medical devices - validation and routine control of sterilization by irradiation", and ISO 11137 "Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization."

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1998

Mr.Jim Irvin Vice President, Quality Assurance and Regulatory Affairs Smith and Nephew, Incorporated Wound Management Division 11775 Starkey Road Largo, Florida 33773-4727

K983210 Re:

Trade Name: Algisite M - Calcium Alginate Dressing Regulatory Class: Unclassifed Product Code: KMF Dated: September 8, 1998 Received: September 14, 1998

Dear Mr. Irvin:

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.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. 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 registration, listing of devices, good manufacturing practices, 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 (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,

A

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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WED 08:54 FAX

TACHMENT NO. 3 (Revised Indications)

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510(k) Number (if known):

Algisite M - Calcium Alginate dressing Device Name:

Indications for Use:

For OTC applications, Algisite M may be used for the management of minor conditions such as:

- 女 Lacerations
- * Abrasions
- す Skin Tears
- キ Minor Burns

Under the care of a healthcare professional, Algisite M may be used for the management of full and partial thickness wounds including:

Leg Ulcers Pressure Ulcers Diabetic Foot Ulcers Surgical Wounds

(PLEASE DO NOT WRITE BELOW THIS LINE-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 | K983210 |

Prescription Use ______ OR Over-The-Counter Use X

(Per 21 CFR 801.109)

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(Optional Format 1-2-96)