(185 days)
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)
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. Helicoll is a reconstituted collagen sheet free of contaminants like lipids, elastin and other immunogenic proteins. Helicoll maintains a physiologically moist microenvironment at the wound surface. This device is intended for one time use only.
The provided text describes the 510(k) summary for a collagen wound dressing called HELICOLL. It focuses on demonstrating substantial equivalence to predicate devices and detailing safety and biocompatibility testing. It does not contain information about formal acceptance criteria for device performance (like accuracy, sensitivity, or specificity) or a study proving the device meets such criteria in a clinical context.
The document discusses:
- Safety and Efficacy: Evaluated through a series of in vitro and in vivo biocompatibility tests, listed in the "Safety and Efficacy" section (pages 2-3).
- Conclusion: The results of "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."
Therefore, I cannot populate the table or answer most of the questions as the required information (performance acceptance criteria, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC study, standalone performance, type of ground truth for performance, how ground truth for training was established) is not present in the provided text. The document focuses on regulatory approval based on safety and biocompatibility for a collagen wound dressing, not on a clinical performance study with defined performance metrics.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All applicable testing for biological evaluation of medical devices passed | Helicoll passed all applicable testing for the biological evaluation of medical devices. |
| (Specific performance metrics like sensitivity, specificity, accuracy, etc., are not provided in the document, as this is a biocompatibility and substantial equivalence summary, not a clinical performance study with such metrics.) | (No data provided for clinical performance.) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable/Not provided. The "tests" mentioned are biocompatibility studies (e.g., In vitro Hemolysis, Cytotoxicity, Intracutaneous Toxicity, Dermal Sensitization, Muscle Implantation, Acute Systemic Toxicity, USP Pyrogenicity, Mutagenicity, Embryonic Cytotoxicity, Acute Oral Toxicity, Systemic Antigenicity, Skin Irritation, LAL Chromogenic Assay, Heavy Metal analysis). These use animal models (Rabbit, Guinea Pigs, Mice) and in vitro methods, not human clinical test sets with data provenance in the way a diagnostic or AI device would.
- Data Provenance: The studies are described as conducted using standard biological evaluation methods (e.g., Rabbit RBCs for hemolysis, rabbits for intracutaneous toxicity, guinea pigs for dermal sensitization, mice for acute systemic toxicity). The specific labs or countries are not mentioned beyond "ENCOLL Corp." as the applicant. These are lab/animal studies, not clinical data from countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. Ground truth in the context of clinical performance (e.g., disease presence) is not relevant for these biocompatibility tests. The "ground truth" for these tests is the observed biological response according to established protocols.
4. Adjudication method for the test set
- Not applicable/Not provided. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data, which is not the nature of the biocompatibility tests described.
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. This is a collagen wound dressing, not a diagnostic or AI-assisted device, so an MRMC study comparing human readers with/without AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a medical device (wound dressing), not an algorithm or AI. Standalone performance is not applicable.
7. The type of ground truth used
- For the biocompatibility tests, the "ground truth" is based on the biological responses observed in the in vitro and animal models, interpreted against established safety standards for medical device materials. This is not clinical expert consensus, pathology, or outcomes data in the usual sense.
8. The sample size for the training set
- Not applicable/Not provided. There is no concept of "training set" for a physical medical device undergoing biocompatibility testing.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
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Page 1 of 3
040314 August 5, 2004 Section C-2
| AUG 1 2 2004 | 510(k) SUMMARY |
|---|---|
| Applicant Name and Address: | ENCOLL Corp.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 DressingUnclassified |
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:)
-
6,548,077(2003) Titled: Purifying type I collagen using two papain treatments and reducing and delipidation agents.
-
6, 127, 143(2000) Titled: Preparation of purified and biocompatible collagen using two protectytic enzyme treatments and a reducing agent
-
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.
-
- In vitro Hemolysis (Rabbit RBCs)
-
- Cytotoxicity Agarose Overlay
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Page 3 of 3
August 5, 200-
Section C-4
- Intracutaneous Toxicity (Rabbits)
-
- Dermal Sensitization Maximization (Guinea Pigs)
- Muscle Implantation (Rabbits I week) ર)
- Acute Systemic Toxicity (Mice) 6)
-
- USP Pyrogenicity (Rabbits)
-
- Mutagenecity (AMES) Test
-
- Muscle Implantation (Rabbits 13 weeks)
-
- 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
{5}------------------------------------------------
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
N/A