← Product Code KGN · K040314

# HEALICOLL (K040314)

_Encoll Corp. · KGN · Aug 12, 2004 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K040314

## Device Facts

- **Applicant:** Encoll Corp.
- **Product Code:** KGN
- **Decision Date:** Aug 12, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Intended Use

Helicoll is intended for the topical wound management that includes: Partial and full-thickness wounds. Pressure ulcers. Venous ulcers. Chronic vascular ulcers. Diabetic ulcers. Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)

## Device Story

Helicoll is a sterile, Type-1 collagen sheet derived from reconstituted collagen, processed to remove lipids, elastin, and immunogenic proteins. It functions as a semi-occlusive, self-adhering dressing that maintains a moist microenvironment at the wound surface. Designed for one-time use, it is applied topically by clinicians to manage various wound types. The device acts as a physical barrier and wound contact layer to support healing. It is supplied as a ready-to-use sheet.

## Clinical Evidence

Bench testing only. Biocompatibility and safety evaluated via in vitro hemolysis, cytotoxicity (agarose overlay), intracutaneous toxicity, dermal sensitization, muscle implantation (1 and 13 weeks), acute systemic toxicity, USP pyrogenicity, mutagenicity (AMES), acute oral toxicity, systemic antigenicity, skin irritation, LAL chromogenic assay, and heavy metal analysis. All tests passed.

## Technological Characteristics

Type-1 collagen sheet; semi-occlusive; self-adhering; pre-sterilized. Purified via papain enzymatic treatment and reducing/delipidation agents. No electronic components or software.

## Predicate Devices

- SkinTemp Kollagen Particles ([K913023](/device/K913023.md))
- ModifiI Kollagen Particles ([K910944](/device/K910944.md))
- Collatek Powder ([K012990](/device/K012990.md))
- HeliDerm Collagen Wound Dressing ([K990086](/device/K990086.md))
- hy Curce Advanced Collagen Wound Care ([K983506](/device/K983506.md))
- Fibracol 11 Collagen-Alginate Dressing ([K925548](/device/K925548.md))
- Fibracol Plus 14 Collagen-Alginate Dressing ([K982597](/device/K982597.md))
- Collagen Dressing ([K030721](/device/K030721.md))
- SIS Wound Dressing II ([K993948](/device/K993948.md))

## Submission Summary (Full Text)

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040314 August 5, 2004 Section C-2

| AUG 1 2 2004                | 510(k) SUMMARY                                         |
|-----------------------------|--------------------------------------------------------|
| Applicant Name and Address: | ENCOLL Corp.<br>4576 Enterprise St., Fremont, CA-94538 |
| Contact Person:             | S. Gunasekaran, PhD                                    |
| Date of Summary:            | 1-10-2004                                              |
| Device Common Name:         | Dressing, wound, Collagen                              |
| Device Trade Name:          | HELICOLL                                               |
| Device Classification Name: | Collagen Wound Dressing<br>Unclassified                |

KGN Product Code:

#### Substantial Equivalence Statement:

Helicoll is a collagen wound dressing device similar to predicate collagen-based devices that are previously approved by the agency and allowed for marketing towards the management of wounds.

Such predicate devices gre listed below: SkinTemp@ Kollagen Particles, K913023 ModifiI® Kollagen Particles, K910944 Collatek® Powder, KO12990 HeliDermTM Collagen Wound Dressing, K990086 hy Curce Advanced Collagen Wound Care, USS506 Fibracol 11 Collagen-Alginate Dressing, K925548 Fibracol Plus 14 Collagen-Alginate Dressing, K982597 CollagenDressing, K03721 SIS Wound Dressing II, by Cook Biotech, K993948

The proposed device is another collagen wound dressing that is quite similar with respect to the indications for use, the major material and the physical construction to the above devices in terms of the substantial equivalency under the 510(k) regulations.

#### Description of the Device

Helicoll is a translucent, off-white, semi-occlusive, self-adhering and ready to use pre-sterilized Type-1 Collagen Sheet for Second-degree Burn, Chronic Ulcers and other topical Wound Managements. Helicoll is flexible with moderate tackiness.

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Page 2 of 3

Helicoll is a reconstituted collagen sheet free of contaminants like lipids, elastin and other

immunogenic proteins (refer to the US Patents below:)

1. 6,548,077(2003) Titled: Purifying type I collagen using two papain treatments and reducing and delipidation agents.

2. 6, 127, 143(2000) Titled: Preparation of purified and biocompatible collagen using two protectytic enzyme treatments and a reducing agent

3. 5,814,328(1998) Titled: Preparation of collagen using papain and a reducing agent.

Helicoll maintains a physiologically moist microenvironment at the wound surface. This device is intended for one time use only.

### Indications or the Intended Uses of the Device:

Helicoll is intended for the topical wound management that includes:

- Partial and full-thickness wounds. ●
- Pressure ulcers. .
- Venous ulcers. .
- Chronic vascular ulcers. .
- . Diabetic ulcers.
- Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) .
- Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, . podiatric, wound dehiscence

#### Summary Comparison of Technical Characteristics

Collagen Topical Wound Dressing and its predicates have similar technological

characteristics. In particular, the Collagen Topical Wound Dressing and its predicates are similar with respect to intended use, material, form, shape, etc.

#### Safety and Efficacy

Collagen Topical Wound Dressing has been evaluated by the following tests to monitor its safety and biocompatibility.

- 1) In vitro Hemolysis (Rabbit RBCs)
- 2) Cytotoxicity Agarose Overlay

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August 5, 200-

Section C-4

3) Intracutaneous Toxicity (Rabbits)

- 4) Dermal Sensitization Maximization (Guinea Pigs)
- Muscle Implantation (Rabbits I week) ર)
- Acute Systemic Toxicity (Mice) 6)
- 7) USP Pyrogenicity (Rabbits)
- 8) Mutagenecity (AMES) Test
- 9) Muscle Implantation (Rabbits 13 weeks)
- 10) Embryonic Cytotoxicity

#### Additional tests conducted are:

Acute Oral Toxicity (Mice)

Systemic Antigenecity (Guinea Pigs)

Skin irritation (Rabbits)

LAL Chromogenic Assay

Heavy Metal analysis

(Please find the detailed protocol and the results in the Appendix of the original submission)

Helicoll has passed all applicable testing for the biological evaluation of medical devices.

#### Conclusion

The results of the in vitro product characterization studies and biocompatibility studies indicate that Helicoll, the Collagen Topical Wound Dressing, is safe and substantially equivalent to its predicate devices.

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Image /page/3/Picture/1 description: The image is a seal or logo. It features a circular border with text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle or bird with three wing-like shapes extending upwards and to the right. The bird is black, and the background is white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 2 2004

Subramanian Gunasekaran, Ph.D. President Encoll Corporation 5686 Geranium Court Newark. California 94560

Re: K040314 Trade/Device Name: Helicoll Regulatory Class: Unclassified Product Code: KGN Dated: June 28, 2004 Received: June 29, 2004

Dear Dr. Gunasekaran:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass suated in the encreations of the enactment date of the Medical Device Amendments, or to conninered pror to they 20, 2018 11:12) in accordance with the provisions of the Federal Food, Drug, devices that have been recuire in asse approval of a premarket approval application (PMA). and Costiere For () for () for ( first the device, subject to the general controls provisions of the Act. The r ou may, merelore, manies of the Act include requirements for annual registration, listing of general obnavil profice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de rice is elabilitional controls. Existing major regulations affecting your device can may or subject to back as a saccrations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease be admised that I D. Broom that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any I cachi statution and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qualify of every of Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2 - Subramanian Gunasekaran, Ph.D

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in yourse finding of substantial equivalence of your device to a legally prematic. The 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), please it you active of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other goteral international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K 040314 HELICOLL Device Name:

### Indications For Use:

The Healicoll Topical Collagen Wound Dressing is intended for the topical wound management that includes:

- Partial and full-thickness wounds. .
- Pressure ulcers. .
- Venous ulcers. .
- Chronic vascular ulcers. .
- Diabetic ulcers. .
- Trauma wounds (abrasions, lacerations, second-degree burns, skin tears), .
- Surgical wounds (donor sites/grafts, post-Mohs' surgery, .

post-laser surgery, podiatric, wound dehiscence)

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

uriam C-Provost
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

e of Device Evaluation (ODE) Concurren

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