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 Description

Algisite M - Calcium Alginate Dressing

AI/ML Overview

The provided text describes a 510(k) summary for the Algisite M - Calcium Alginate Dressing. It focuses on demonstrating the substantial equivalence of Algisite M to predicate devices through technological characteristics and biocompatibility testing. There is no information in the document about a study that assesses device performance against specific acceptance criteria in the context of clinical efficacy or diagnostic accuracy. Instead, the studies presented are primarily for biocompatibility and sterility.

Therefore, many of the requested sections regarding clinical performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be answered from the provided document.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for clinical performance or a direct comparison of device performance against such criteria. The reported performance is related to biocompatibility and sterility.

Acceptance Criteria (for Biocompatibility)	Reported Device Performance (Algisite M)
Cytotoxicity: Non-toxic in vitro	Non-toxic to L929 cells
Skin Irritation: Non-irritant	Non-irritant following 5-day repeated application to rabbit skin
Sensitization: Non-sensitizer	0% sensitization rate in guinea pigs (classified as non-sensitizer)
Acute Systemic Toxicity: No acute toxic effects attributable to leachable substances	Passed prescribed acute systemic toxicity test in the mouse
Haemolysis: Haemolysis value < 5% (non-haemolytic)	Haemolysis value of 4.45% (considered non-haemolytic)
Sterility Assurance Level (SAL): 10$^{-6}$ or better	Achieved a sterility assurance level of 10$^{-6}$ or better via gamma irradiation

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cytotoxicity: Mouse L929 cells (in vitro).
Skin Irritation: Rabbit skin (animal model).
Sensitization: 20 guinea pigs (animal model).
Acute Systemic Toxicity: Mouse (animal model).
Haemolysis: In vitro test using blood.
Sterilization: Not applicable for a "test set" in the sense of clinical data. This refers to the product itself and its manufacturing process.

The data provenance is from laboratory/animal studies, not human clinical data. No country of origin for the studies is explicitly stated, though "British Standard" and "U.S. National Formulary" are mentioned, implying international standards were followed. These are prospective laboratory and animal studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for these biocompatibility tests is established by standardized laboratory assay results and observations (e.g., cell viability, skin reactions, animal responses, hemolysis percentages). No human expert consensus for interpreting device performance in a clinical context is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical endpoints or image interpretation where human expert disagreement needs to be resolved. The studies described are laboratory-based and follow standardized protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was performed or described. This document pertains to a medical dressing and its biocompatibility, not an AI-assisted diagnostic or interpretative device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the biocompatibility studies is based on established biological and chemical indicators as defined by the respective standards and protocols (e.g., cell viability, absence of skin irritation, absence of systemic toxicity, specific hemolysis percentages).

8. The sample size for the training set

Not applicable. There is no training set in the context of this device. The product undergoes manufacturing processes and quality control, not machine learning model training.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned.

Summary

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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: (813) 392-1261 Fax: (813) 399-3468

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 (813) 392-1261 Fax (813) 399-3468

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 ®Alginate Dressing	For Johnson & Johnson Medical Inc. by Les Laboratoires Brothier S.A.Nanterre, France
KALTOSTAT ®Wound Dressing	Calgon Vestal LaboratoriesSt. Louis, MS (K940407)
Sorbsan ™ TopicalWound Dressing	For Dow B. Hickman, Inc. By Steriseal LimitedWorcestershire, 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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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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.
1. 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 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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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)

Regulation Number and Section

§ 880.5090 Liquid bandage.

(a)
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.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.