AL-GEN CALCIUM ALGINATE DRESSING

K982234 · Innovative Technologies , Ltd. · KMF · Sep 8, 1998 · General Hospital

Device Facts

• Record ID: K982234
• Device Name: AL-GEN CALCIUM ALGINATE DRESSING
• Applicant: Innovative Technologies , Ltd.
• Product Code: KMF · General Hospital
• Decision Date: Sep 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Innovative Technologies Calcium Alginate dressings are intended for use under the guidance of a health care professional on partial and full thickness wounds with moderate to heavy exudate, eg: Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds Donor sites Post-operative wounds Trauma wounds Dermal lesions And for OTC use on wounds such as, abrasions, lacerations, minor cuts and grazes, minor scalds and burns. They are also intended to help control minor bleeding.

Device Story

Al-Gen Calcium Alginate Wound Dressing is a nonwoven, sterile, primary wound dressing composed of 100% pharmaceutical-grade calcium alginate derived from seaweed. Upon contact with wound exudate, the fibers transform into a gelatinous mass, creating a moist wound environment. The dressing is applied directly to the wound site by healthcare professionals or patients (for OTC indications). It functions through physical absorption of exudate and by providing a physical barrier to assist in minor bleeding control. The device is intended for use as part of a dermal wound management protocol. It does not accelerate healing, nor is it intended for use on third-degree burns or as a permanent skin substitute.

Clinical Evidence

Bench testing only. Biocompatibility data was leveraged from the predicate device (K953781). No clinical data provided.

Technological Characteristics

Nonwoven dressing; 100% pharmaceutical grade calcium alginate fibers; sterile; absorbent; conformable; transforms into gel upon exudate contact.

Indications for Use

Indicated for patients with partial and full thickness wounds with moderate to heavy exudate (pressure, venous, diabetic, trauma, post-op, donor sites, dermal lesions) under professional guidance; also indicated for OTC use on minor abrasions, lacerations, cuts, grazes, scalds, and burns, and for control of minor bleeding.

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

• K953781

Reference Devices

• Tegagon HC
• HI alginate dressings

Submission Summary (Full Text)

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SEP 8 1998

K98 2234

# Summary of Safety and Effectiveness for Innovative Technologies Calclum Alginate Dressing

Manufacturer:

Requiatory Affairs Contact:

Telephone:

Date Summary Prepared:

Device Trade Name:

Common or Usual Name:

Classification:

Description:

Intended Use:

Substantial Equivalence:

Testing Summary:

Innovative Technologies, I imitad Road Three, Winsford Industrial Estate Cheshire CW7 3PD, United Kingdom

Chris Oakes, Manager

44 1606 863 500

June 18, 1998

Al-Gen Calcium Alginate Wound Dressings.

Alginate Wound Dressings

Wound Dressings, currently unclassified by FDA.

These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterlle, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist wound environment. Use of any dressing, including Tegagon HC and HI alginate dressings, should be part of a well delined protocol for dermal wound managoment,

Innovative Technologies Calcium Alginate dressings are intended for use under the supervison of health care professionals on moderate to heavy exudate wounds. They may be used for pressure ulcers, anorial ulcers, venous ulcers, diabetic ulcers, donor sites, trauma wounds, and other dermal lesions. For OTC use on abrasions, lacerations, minor cuts and grazes, minut scalds and minut burns. They also are intended to help control minor bleeding via the adsorbtive properties of the dressing or by the physical application of the

If at any time you are unsure of the above conditions or type of wound consult a health care professional.

dressing to the wound.

Substantial equivalence was provided in 510(k) K953781

Riocompatibility test results presented in 510(k) K953781 remains current, no changes to raw materials or components which would require the submission of new toxicity data.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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SEP 8 1098

Mr. Christopher J. Oakes Regulatory Affairs Manager Innovative Technologies Group, Limited Road Three, Winsford Industrial Estate Winsford. Cheshire CW7 3PD United Kingdom

Re: K982234

> Trade Name: Al- Gen Calcium Alginate Dressing Regulatory Class: Unclassified Product Code: KMF Dated: June 19, 1998 Received: June 25, 1998

Dear Mr. Oakes:

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

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## Page 2 - Mr. Christopher J. Oakes

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,

f

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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Page 1 of 1

1982234 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device name: Innovative Technologies Calcium Alginate Dressings

Indications For Use:

Innovative Technologies Calcium Alginate dressings are intended for use under the guidance of a health care professional on partial and full thickness wounds with moderate to heavy exudate, eg:

Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds Donor sites Post-operative wounds Trauma wounds Dermal lesions

And for OTC use on wounds such as, abrasions, lacerations, minor cuts and grazes, minor scalds and burns.

They are also intended to help control minor bleeding.

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|-----------------------------------------------------|---|
| OR Over The Counter Use<br>(Optional Format 1-2-96) | X |

(Sign-Off)
of General Restorative Devices

| 510(k) Number | K982234 |
|---------------|---------|
|---------------|---------|