← Product Code KGN · K990086
# HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM (K990086)
_Integra Lifesciences Corp. · KGN · Mar 31, 1999 · SU · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K990086
## Device Facts
- **Applicant:** Integra Lifesciences Corp.
- **Product Code:** KGN
- **Decision Date:** Mar 31, 1999
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic
## 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: PRESSURE ULCERS . VENOUS STASIS ULCERS . DIABETIC ULCERS . ACUTE WOUNDS, for example trauma and surgical wounds . PARTIAL-THICKNESS BURNS .
## Device Story
HeliDerm™ is a sterile, single-use, microfibrillar collagen wound dressing derived from bovine flexor tendon. It functions as a topical dressing to absorb wound exudate and provide a hemostatic agent for minor bleeding. The device is applied to the wound bed by a clinician or patient; it interacts with wound fluid to absorb exudate and debris. By providing a collagen-rich environment, it supports the wound healing process. It is used in clinical or home settings for various wound types. The device is non-interactive and does not claim to accelerate healing or act as artificial skin.
## Clinical Evidence
No clinical trials were conducted. Safety and effectiveness are supported by bench testing and biocompatibility studies, including cytotoxicity, primary skin irritation, pyrogenicity, sensitization/maximization, subcutaneous implant, systemic toxicity, hemolysis, and intracutaneous toxicity. The device is manufactured in compliance with FDA and European standards for animal tissue sourcing and viral inactivation.
## Technological Characteristics
Microfibrillar Type I collagen derived from bovine flexor tendon. Sterile, nonpyrogenic, single-use. Absorbs >10 ml of fluid. Biocompatible per animal studies. Sterilized via ethylene oxide. Form factor: 0.5g or 1.0g units. Storage: room temperature.
## Predicate Devices
- hycure (Southwest Technologies, Inc.)
- Fibracol (Johnson & Johnson Medical, Inc.)
- KALTOSTAT® WOUND PACKING (Convatec)
- Chronicure (ABS LifeSciences)
- VitaChoice (Vitaphore Corporation)
## Submission Summary (Full Text)
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>
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03/18/99 17:10 FAX 609 799 3297
Integra LifeSciences Corporation
99
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 Wound
Dressing | hycure®
Advanced Collagen
Woundcare | KALTOSTAT™
WOUND
PACKING
Calcium-Sodium
Alginate Fiber | VitaChoice®
Wound Dressing | Chronicure™
Absorptive Wound
Dressing | Fibracol™
Collagen-Alginate
Dressing |
|------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Manufacturer | Integra LifeSciences
Corporation | Southwest
Technologies, Inc. | Convatec, a Bristol-
Myers Squibb
Company | Vitaphore Corp., an
Integra LifeSciences
Company | ABS LifeSciences,
Inc., an Integra
LifeSciences Co. | Johnson & Johnson
Medical, Inc. |
| Indications
for Use | Used in the
management of
moderately to heavily
exudating wounds and
the control of minor
bleeding | Used for the
management of
chronic and acute
wounds, and skin
ulcers | Used as an external
wound dressing
designed to absorb
exudate, control
minor bleeding and
protect the wound
from contamination. | Used in the
management of
dermal ulcers and
chronic wounds. | Used as an aid in the
management of
chronic wounds and
ulcers of the skin. | Used as an aid in the
management of chronic
wounds and ulcers of
the skin. |
| Materials | Type I Collagen | 96% Type I
Collagen | Calcium-sodium
alginate | Collagen | Collagen | Collagen/Calcium
Alginate |
| Collagen
Source | Bovine Flexor
Tendon | Bovine Flexor
Tendon | Not applicable | Bovine Flexor
Tendon | Avian | Bovine hide |
| Biodegradable | Yes | Yes | Yes | Yes | Yes | Yes |
| Bio-
compatibility | Yes - Animal Studies | Yes - Animal
Studies | Yes | Yes-Animal Studies | Yes - Animal
Studies | 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 manufactured
presently | 1 gram individual
packets and 30 gram
bottles | 2 x 2 inches x 3 mm to
10 x 10 inches x 3 mm |
| Storage
Conditions | Room temperature | Room temperature | Cool, dry place | Room temperature | Room temperature. | None stated |
#### Substantial Equivalence Comparison Chart Table 2:
800/8000 டும் வருறிப்பட 이트 프로그램 199 1842 13 107 10 411 appe . ### : 的! -
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.
- 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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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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ייחוץ גייעוץ מועדות חוקות לנוע
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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**Source:** [https://fda.innolitics.com/device/K990086](https://fda.innolitics.com/device/K990086)
**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).
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