HeliDerm™ Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds, and to control minor bleeding. HeliDerm™ may be used for the management of exudating wounds such as: PRESSURE ULCERS, VENOUS STASIS ULCERS, DIABETIC ULCERS, ACUTE WOUNDS, for example trauma and surgical wounds, PARTIAL-THICKNESS BURNS.

Device Description

HeliDerm™ Collagen Wound Dressing is a white, absorbent collagen in microfibrillar form for the management of moderately to heavily exudating wounds, and the control of minor bleeding. It provides a physiologically favorable environment that encourages wound healing. When interacting with the wound fluid, it immediately begins to absorb the exudate which may impair tissue regeneration. HeliDerm™ is made from natural materials that contain the proteins that constitute the major building blocks of normal skin and connective tissue. HeliDerm™ protects the wound bed and delicate new tissue. In normal healing wounds, collagen is produced in large quantities by fibroblasts that are recruited to the injured site during the proliferation phase of healing. Collagen and collagen materials may augment fibroblast recruitment and endogenoous collagen production which may encourage and enhance this phase for chronic wounds. The intended use is comparable to absorbent gauze, medical fibers powdered sponges and absorbent heads in that its primary function is to absorb wound exudate. HeliDerm™ is purified bovine flexor tendon collagen. HeliDerm™ can absorb greater than 10 ml of wound exudate and will absorb wound fluids, bacteria, protein products and other microscopic debris that may retard the healing process. In addition, HeliDerm™, being comprised of microfibrillar collagen, is an excellent hemostatic agent which can be used to control minor bleeding. HeliDerm™ is supplied sterile, nonpyrogenic, and for single use in a single blister package.

AI/ML Overview

The provided text describes the 510(k) Premarket Notification for the HeliDerm™ Collagen Wound Dressing. This document is a regulatory submission for a medical device seeking to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than establishing de novo acceptance criteria through a clinical study.

Therefore, the concept of "acceptance criteria" in the context of this document refers to demonstrating that the new device is as safe and effective as selected predicate devices. The "study" isn't a traditional clinical trial with specific performance metrics and statistical significance, but rather a comparison of technological characteristics and safety data to established predicates.

Here's a breakdown based on the information provided, and where information is not present (which is typical for a 510(k) summary relying on substantial equivalence):

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implied to be the characteristics of the predicate devices. The "reported device performance" is the HeliDerm™'s matching or similar characteristics.

Feature / Acceptance Criteria (from Predicate Device)	HeliDerm™ Collagen Wound Dressing Performance
Primary Function: Absorb wound exudate	HeliDerm™'s primary function is to absorb wound exudate.
Composition: Collagen (Type I/Bovine Flexor Tendon)	Comprised of Type I collagen from purified bovine flexor tendon.
Indications for Use:
- Management of moderately to heavily exudating wounds	Indicated for management of moderately to heavily exudating wounds.
- Control of minor bleeding	Indicated for control of minor bleeding.
- Specific wound types (Pressure, Venous Stasis, Diabetic, Acute, Partial-thickness burns)	May be used for Pressure Ulcers, Venous Stasis Ulcers, Diabetic Ulcers, Acute Wounds, Partial-Thickness Burns.
Biocompatibility:	Non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing.
Sterility:	Sterile (Ethylene Oxide).
Non-pyrogenic:	Yes.
Biodegradable:	Yes.
Storage Conditions:	Room temperature.
Absorption Capacity (Implied)	Can absorb greater than 10 ml of wound exudate. (Note: A specific comparative criterion from predicates isn't given, but this is a stated capability of HeliDerm™.)

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not applicable in the context of a clinical performance study with "test set" and "training set" as understood for AI/ML device approval.
Data Provenance: The biocompatibility studies cited are likely internal to Integra LifeSciences Corporation or conducted by contract research organizations on their behalf. The source material for the device (purified bovine flexor tendon collagen) is a key aspect. The context is a regulatory submission, not a new clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to a 510(k) submission for this type of device. There isn't a "ground truth" established by experts in the sense of image interpretation or diagnostic accuracy for this wound dressing. The "ground truth" for proving substantial equivalence relies on established properties of the materials and the predicate devices.

4. Adjudication method for the test set

Not applicable. No "test set adjudication" as would be seen in an AI/ML diagnostic effectiveness study.

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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted or required.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate devices based on regulatory clearances and historical use, combined with standard biocompatibility testing for the new device material.

Biocompatibility Studies: These studies (Cytotoxicity, Primary Skin Irritation, Pyrogenicity, Sensitization/Maximization, Subcutaneous Implant, Systemic Toxicity, Hemolysis, Intracutaneous Toxicity) serve as the "ground truth" for the safety of the material. They confirm the material's interaction with biological systems is acceptable.
Substantial Equivalence to Predicates: The core "ground truth" is that the functional claims, material properties, and intended use of HeliDerm™ are comparable to devices already deemed safe and effective by the FDA.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/ML device.

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

Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" presented in this K990086 document is a substantial equivalence comparison. The Integra LifeSciences Corporation submitted data demonstrating that the HeliDerm™ Collagen Wound Dressing is as safe and effective as several predicate devices already on the market.

The key elements of this "proof" included:

Comparison Table (Table 2): A direct comparison of technological characteristics between HeliDerm™ and its identified predicates (hycure®, KALTOSTAT™, VitaChoice®, Chronicure™, Fibracol™) across various features such as indications for use, materials, collagen source, biodegradability, biocompatibility, sterility, and storage conditions. This table highlights the similarities.
Biocompatibility Studies: A series of standard biological tests were performed on the HeliDerm™ to demonstrate its safety (non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing). These studies provide direct evidence of the new device's safety profile, aligning with expectations for such a device.
Manufacturing Compliance: The device's manufacturing process complies with FDA regulations and European standards for animal tissue sourcing and viral inactivation.
Historical Context: The submission emphasizes that HeliDerm™ is part of a family of collagen products from Integra LifeSciences with a 17-year history of safety and effectiveness, leveraging the established understanding of collagen's role in wound healing and hemostasis.

The FDA's decision (MAR 3 1 1999 letter) indicates that they reviewed this information and determined the device to be substantially equivalent to legally marketed predicate devices, with specific limitations on labeling claims to prevent misrepresentation beyond what was demonstrated by equivalence. This determination effectively means the device meets the acceptance criteria for market clearance by demonstrating parity with existing safe and effective products.

Summary

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03/18/99 17:10 FAX 609 799 3297

Integra LifeSciences Corporation

8 1

INTEGRA LIFESCIENCES

K990086

នាយមក (ប្រហូតក្រ

Confidential K990086

	K990086
510(k) Premarket Notification
HeliDerm™ Collagen Wound Dressing

	HeliDerm™ Collagen Wound Dressing
	SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter's name and address:
	Integra LifeSciences Corporation
	105 Morgan Lane
	Plainsboro, NJ 08536
Contact person and telephone number:
	Judith E. O'Grady
	Senior Vice President, Regulatory Affairs, Quality Assurance and Clinical Research
	(609) 275-0500
Date Summary was prepared:
	January 8, 1999
Name of the device:
Proprietary Name:	HeliDerm™ Collagen Wound Dressing
Common Name:	Topical Wound Dressing
Classification Name:	Dressing, Class I, 21CFR 878.4060
Substantial Equivalence:
	HeliDerm™ is substantially equivalent in function, form and intended use to other
	commercially available non-interactive wound and burn dressings including:
	hycure manufactured for Southwest Technologies, Inc.
	Fibracol manufactured by Johnson & Johnson Medical, Inc.
	KALTOSTAT® WOUND PACKING manufactured for Convatec, a Bristol-Myers Squibb
	Company
	Chronicure manufactured by ABS LifeSciences an Integra LifeSciences Company
	VitaChoice manufactured by Vitaphore Corporation an Integra LifeSciences Company
Device Description:
	HeliDerm™ Collagen Wound Dressing is a white, absorbent collagen in microfibrillar form
	for the management of moderately to heavily exudating wounds, and the control of minor
	bleeding. It provides a physiologically favorable environment that encourages wound healing.
	When interacting with the wound fluid, it immediately begins to absorb the exudate which
	may impair tissue regeneration. HeliDerm™ is made from natural materials that contain the
	proteins that constitute the major building blocks of normal skin and connective tissue.
	HeliDerm™ protects the wound bed and delicate new tissue. In normal healing wounds,
	collagen is produced in large quantities by fibroblasts that are recruited to the injured site
	during the proliferation phase of healing. Collagen and collagen materials may augment
	fibroblast recruitment and endogenoous collagen production which may encourage and
	enhance this phase for chronic wounds. The intended use is comparable to absorbent gauze,
	medical fibers powdered sponges and absorbent heads in that its primary function is to

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K990086 Confidential Integra LifeSciences Corporation 510(k) Premarket Notification HeliDerm™ Collagen Wound Dressing absorb wound exudate. HeliDerm™ is purified bovine flexor tendon collagen. HeliDerm™ is absorb wound exadate. TenDenii - is parinod boilDerm™ can absorb greater than 10 ml of -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------wo upprod and will absorb wound fluids, bacteria, protein products and other microscopic debris that may retard the healing process. In addition, HeliDerm™, being comprised of microfibrillar collagen, is an excellent hemostatic agent which can be used to control minor bleeding. HeliDerm™ is supplied sterile, nonpyrogenic, and for single use in a single blister package. Statement of intended use: HeliDerm™ Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds, and to control minor bleeding. HeliDerm™ may be used for the management of exudating wounds such as: , 11/2 10/2 11/24 11:15 1 PRESSURE ULCERS . VENOUS STASIS ULCERS . DIABETIC ULCERS . ACUTE WOUNDS, for example trauma and surgical wounds . PARTIAL-THICKNESS BURNS . Comparison of technological characteristics to predicate devices: A table comparing characteristics of HeliDerm™ Collagen Wound Dressing and the predicate devices is provided in Table 2. Safety 2 11年 # 91 130 1 Biocompatibility studies have demonstrated HeliDerm™ to be: non-cytotoxic, nonpyrogenic, non-irritating, and non-sensitizing. The following studies were conducted: Cytotoxicity Primary Skin Irritation Pvrogenicity Sensitization/Maximization Subcutaneous Implant 2:43 Systemic toxicity Hemolysis Intracutaneous Toxicity The HeliDerm™ manufacturing process complies with the United States Food and Drug 一十一年第五十十八

Conclusion

HeliDerm™ Collagen Wound Dressing is a member of a family of collagen products manufactured by Integra LifeSciences Corporation with an extensive and established seventeen-year history of safety and effectiveness. Collagen has a primary role in all phases of wound healing, making it an effective agent for managing the treatment of wounds. [] = [ Having the natural property of platelet binding, collagen is optimal for hemostasis. HeliDerm™, being comprised of Type I collagen and having been designed to absorb fluids will aid in the management of exudating wounds and control minor bleeding.

Administration and European Standards for animal tissue sourcing and viral inactivation.

HeliDerm™ Collagen Wound Dressing is substantially equivalent to the predicate devices 1 1 11 11 1991 . delineated in this submission and the requirements for a Premarket Notification 510(k) as defined in CFR 21, Part 807.

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Confidential

Inte :Sciences Corporation 510(k) rremarket Notification HeliDerm™ Collagen Wound Dressing

11 में में मुक्ति में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में

小小

Feature	HeliDerm™Collagen WoundDressing	hycure®Advanced CollagenWoundcare	KALTOSTAT™WOUNDPACKINGCalcium-SodiumAlginate Fiber	VitaChoice®Wound Dressing	Chronicure™Absorptive WoundDressing	Fibracol™Collagen-AlginateDressing
Manufacturer	Integra LifeSciencesCorporation	SouthwestTechnologies, Inc.	Convatec, a Bristol-Myers SquibbCompany	Vitaphore Corp., anIntegra LifeSciencesCompany	ABS LifeSciences,Inc., an IntegraLifeSciences Co.	Johnson & JohnsonMedical, Inc.
Indicationsfor Use	Used in themanagement ofmoderately to heavilyexudating wounds andthe control of minorbleeding	Used for themanagement ofchronic and acutewounds, and skinulcers	Used as an externalwound dressingdesigned to absorbexudate, controlminor bleeding andprotect the woundfrom contamination.	Used in themanagement ofdermal ulcers andchronic wounds.	Used as an aid in themanagement ofchronic wounds andulcers of the skin.	Used as an aid in themanagement of chronicwounds and ulcers ofthe skin.
Materials	Type I Collagen	96% Type ICollagen	Calcium-sodiumalginate	Collagen	Collagen	Collagen/CalciumAlginate
CollagenSource	Bovine FlexorTendon	Bovine FlexorTendon	Not applicable	Bovine FlexorTendon	Avian	Bovine hide
Biodegradable	Yes	Yes	Yes	Yes	Yes	Yes
Bio-compatibility	Yes - Animal Studies	Yes - AnimalStudies	Yes	Yes-Animal Studies	Yes - AnimalStudies	Yes - Animal Studies
Non-Pyrogenic	Yes	Yes	Not claimed	Yes	Not Claimed	Not Claimed
Sterile	Yes - Ethylene Oxide	Yes	Yes	Yes	Yes - γ radiation	Yes - γ radiation
Sizes	0.5 gram, 1.0 gram	1.0 gram	Not listed	Not manufacturedpresently	1 gram individualpackets and 30 grambottles	2 x 2 inches x 3 mm to10 x 10 inches x 3 mm
StorageConditions	Room temperature	Room temperature	Cool, dry place	Room temperature	Room temperature.	None stated

Substantial Equivalence Comparison Chart Table 2:

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SKRYTOSIĄŻKA LITERACKA
95297

INTEGRA
LIFE
SCIENCES

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines extending from the bottom profile, resembling a river or stream.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 1999

Ms. Judith E. O'Grady, RN, MSN Senior Vice President Regulatory Affairs, Quality Assurance and Clinical Research Integra LifeSciences Corporation 105 Morgan Lane Plainsboro, New Jersey 08536

Re: K990086

Trade Name: HeliDerm™ Collagen Wound Dressing Regulatory Class: Unclassifed Product Code: FRO Dated: January 8, 1999 Received: January 11, 1999

Dear Ms. O'Grady:

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.
1. This device may not be labeled as having any accelerating effect on the rate of 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.

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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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年: 第1回

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:韩剧

Confidential K990086

Integra LifeSciences Corporation 510(k) Premarket Notification HeliDerm™ Collagen Wound Dressing

INDICATIONS FOR USE

Indications

510(k) Number:

Device Name: HeliDerm™ Collagen Wound Dressing

Indications for Use:

HeliDerm™ Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds, and to control minor bleeding.

HeliDerm™ may be used for the management of exudating wounds such as:

PRESSURE ULCERS .
VENOUS STASIS ULCERS .
DIABETIC ULCERS .
ACUTE WOUNDS, for example trauma and surgical wounds ●
PARTIAL-THICKNESS BURNS .

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	Over-the-Counter Use ______
(Per 21 CFR 801.109

	cochl (Division Sign Off) Division General Restorative Device 510(k) Number K990086
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Regulation Number and Section

N/A