The Comfeel® Seasorb Dressing is indicated for use (under the guidance of a health care professional) in management of moderate to heavily exudating wounds, partial and full thickness wounds, including leg ulcers and pressure sores.

Device Description

The revised Comfeel® Seasorb Dressing consists of an absorbent calcium sodium alginate/sodium carboxymethy/ceilulose xerogel cast onto a high density polyethylene net. The dressing is supplied in three sizes: 4 x 6 cm (3705), and 10 x 10 cm (3710) and 15 x 15 cm (3715). The dressings are packaged in individual pouches and sterilized by ethylene oxlde.

AI/ML Overview

Here's an analysis of the provided text regarding the Comfeel® Seasorb Dressing, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category/Metric	Acceptance Criterion (for NEW device)	Reported Device Performance (NEW device)
Biocompatibility	Non-irritating	Shown no accumulative irritation effects
	Non-sensitizing	No evidence of delayed hypersensitivity
	Non-cytotoxic	Non-cytotoxic (cytotoxicity grade ≤ 2)
Physical Performance	Improved softness (compared to K953497)	Improved softness
	Improved absorption capacity (compared to K953497)	Improved absorption capacity
Sterility	Sterile	Sterile (by ethylene oxide)
Packaging Integrity	Maintained sterility and protection	Polyester pouches laminated with peelable polyethylene prior to sterilization

Note: This submission primarily focuses on demonstrating substantial equivalence to a predicate device (K953497). The acceptance criteria are largely inferred from the statement that the modified device "has been tested and shown" to meet certain safety and performance characteristics, and that its performance has been "improved" compared to the predicate. There are no explicit numerical acceptance criteria stated for these tests in the provided text.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not explicitly state the sample sizes used for any of the tests. It simply mentions that the device "has been tested."

Regarding data provenance:

The information provided is a 510(k) summary, which typically summarizes the results of various tests. It does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of biocompatibility and physical performance tests for a medical device, these would typically be conducted prospectively in a controlled laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a ground truth for testing, nor does it refer to any clinical studies where expert consensus would be required. The tests mentioned (biocompatibility, softness, absorption) are laboratory-based performance tests, not clinical evaluations requiring expert interpretation of outcomes.

4. Adjudication Method for the Test Set

As there's no mention of a clinical study or expert-adjudicated data, an adjudication method is not applicable or not specified in this document. The assessment for the reported performance metrics (biocompatibility, physical properties) would have been based on established laboratory protocols and measurements, not subjective expert agreement.

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 MRMC study was performed. This device is a topical wound dressing, not an imaging or diagnostic device that would typically involve human readers or AI assistance in interpretation. Therefore, there's no information on an effect size for human readers improving with or without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done. This device is a passive wound dressing and does not involve any algorithms or AI components.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is based on:

Established laboratory standards and methods: For biocompatibility (irritation, sensitization, cytotoxicity), the "ground truth" would be determined by the results of standardized assays that demonstrate compliance with predefined safety thresholds.
Physical measurement techniques: For properties like softness and absorption capacity, the "ground truth" would be derived from quantifiable physical measurements following specific testing protocols.

There is no mention of pathology, outcomes data, or expert consensus in establishing the ground truth for these specific performance metrics.

8. The Sample Size for the Training Set

Not Applicable. This device does not use machine learning or AI, and therefore, there is no training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set, there is no ground truth established for it.

Summary

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DEC 310 1998

510(k) Summary Comfeel® Seasorb Dressing

Coloplast Corporation 1955 West Oak Circle Marietta. Georgia 30062-2249 Date: 10/05/98

1. Contact Person

Ms. Sydney Lilly. (770) 281-8260

2. Name of the Medical Device

Proposed Classification name:	Hydrophylic Wound and BurnDressing
Common/usual name:	Topical Wound Dressing
Proprietary name:	Comfeel® Seasorb Dressing

3. Device Classification

The Comfeel® Seasorb Dressing has been classified by the FDA under the proposed heading of Hydrophylic Wound and Burn Dressing as an unclassified device.

4. Statement of Substantial Equivalence

The revised Comfeel® Seasorb Dressing is equivalent to the original Comfeel® Alginate (Seasorb) Dressing, manufactured by Coloplast A/S and approved for market under 510(k) K953497, but with minor alterations.

5. Intended Use

The revised Comfeel® Seasorb Dressing is indicated (under the guidance of a health care professional) for use in management of moderate to heavily exudating wounds, partial and full thickness wounds, including leg ulcers and pressure sores.

6. Description of Device

K 983519

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K983519

510(k) Summary Comfeel® Seasorb Dressing Page 2 of 3

The revised Comfeel® Seasorb Dressing is a modification of Comfeel® alginate (seasorb) dressing (K953497) which consists of 100% alginate. Through adjustment of the formula to 30% carboxymethylcullulose sodium and 70% alginate, the performance of the dressing has been improved measured on softness and absorption capacity.

The revised Comfeel® Seasorb Dressing has been tested and shown no accumulative irritation effects, no evidence of delayed hypersensitivity and is non-cytotoxic (cytotoxicity grade ≤ 2).

A comparison Matrix for the revised Comfeel® Alginate Dressing versus the original Comfeel® Alginate Dressing (K953497) is presented in Section 6.

7. Predicate Device

	Comfeel® Seasorb Dressing	Comfeel® Alginate (Seasorb)Dressing
Statement ofIdenty	Seasorb Dressing is a sterileWound Dressing	Comfeel® Alginate (Seasorb) Dressingis a sterile Wound dressing
Device description	The Seasorb Dressing is a highlyabsorbent wound dressingconsisting of an calcium sodiumalginate/sodiumcarboxymethylcellulose Xerogelcast into a high densitypolyethylene net.	The Comfeel® Alginate (Seasorb)Dressing is a highly absorbent materialcomposed of a Xerogel of calciumsodium alginate cast into a high densitypolyethylene net.
Sizes	4x6 cm, 10x10 cm, 15x15 cm	4x6 cm, 10x10 cm, 15x15 cm
Use (single,reusabledisposable)	Single	Single
Intended use	For management of moderate toheavily exudating Stage I-IVwounds, partial and full thicknesswounds, including leg ulcers,pressure sores and burns etc.	For management of (under theguidance of a health care professional)moderate to heavily exudating wounds,including leg ulcers and pressuresores, etc.

Comfeel®: Alginate (Seasorb) Dressing (Colopiast, Inc. K953497)

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K983519

510(k) Summary Comfeel® Seasorb Dressing Page 2 of 3

	Comfeel® Seasorb Dressing	Comfeel® Alginate (Seasorb)Dressing
Precautions	May be used on patients withsystemic infections when theinfectious conditions are undermedical control.	Wounds which are solely or mainlycaused by arterial insufficiency orcomplicated diabetic wounds (primarilylower leg and foot) should be inspectedby a physician or nurse regularly.
	Seasorb Dressing must beremoved prior to radiationtreatment of long duration (X-rays,ultrasonic treatment, diathermyand micro waves).	A physician should be consulted beforeusing this product on wounds with ahigh risk of infection, or on lesionscaused by syphilis, tuberculosis,leprosy or cancer.
	Not recommended for use on drywounds.	Comfeel®Seasorb (Seasorb) Dressingmust be removed prior to the followingtreatments: radiation, X-rays, ultrasonictreatment, diathermy and micro waves.
	Do not use on patients with knownhypersensitivity to any of theingredients.	Wounds with signs of clinical infection,fever and local symptoms such as painerythema (redness) or pus should havea bacterial swab examination. Use ofthis product may be continued at thediscretion of a physician. Currentsystemic antibiotic treatment may begiven if indicated.
		Not recommended for use on drywounds or third degree burns.
		Do not use on patients with knownhypersensitivity to any of theingredients.
Sterilization	Sterile	Sterile
Packaging	Polyester pouches laminatedwith peelable polyethylene priorto sterilization	Polyester pouches laminated withpeelable polyethylene prior tosterilization

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, depicted in black and white.

DEC 30 1998

M. Sidney Lilly Coloplast Corporation 1955 West Oak Circle Marietta, Georgia 30062

Re: K983519 Trade Name: Comfeel Seasorb Dressing Regulatory Class: Unclassified Product Code: KMF Dated: October 5, 1998 Received: October 8, 1998

Dear Ms. Lilly:

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). 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.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or 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.

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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Ms. M. Sidney Lilly

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,

Mark N Melburn

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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DEC. -18' 98(FRI) 13:51

P. 002

510(k) Number (if known): K983519

Device Name: Comfeel® Seasorb Dressing

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark n Millenn

(Division Sign of General Res 510(k) Number

Prescription Use(Per 21 CFR 801.109
OR Over-The-Counter Use	X

(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.