(185 days)
Not Found
No
The device description and performance studies focus on the material properties and biological evaluation of a collagen wound dressing, with no mention of AI or ML.
Yes
The device, "Healicoll Topical Collagen Wound Dressing," is intended for the management of various types of wounds, including chronic ulcers and burns, which are conditions that require therapeutic intervention for healing.
No
The device description and intended use clearly state that it is a topical wound dressing for management of various types of wounds, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "translucent, off-white, semi-occlusive, self-adhering and ready to use pre-sterilized Type-1 Collagen Sheet," which is a physical material, not software. The performance studies also focus on the biological evaluation of this material.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "topical wound management." This involves applying the dressing directly to a wound on the body.
- Device Description: The description details a "translucent, off-white, semi-occlusive, self-adhering and ready to use pre-sterilized Type-1 Collagen Sheet." This is a physical dressing applied externally.
- Lack of In Vitro Testing for Diagnosis: The performance studies listed are primarily biocompatibility and safety tests related to how the material interacts with the body. There are no tests described that involve analyzing samples (like blood, urine, or tissue) outside the body to diagnose a condition or disease.
- Anatomical Site: The anatomical site is "Topical wound management," which is on the surface of the body. IVDs typically analyze samples taken from within the body or from bodily fluids.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description. It is a therapeutic device applied directly to a wound.
N/A
Intended Use / Indications for 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
Product codes
KGN
Device Description
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 (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 3) Intracutaneous Toxicity (Rabbits) - 4) Dermal Sensitization Maximization (Guinea Pigs) - Muscle Implantation (Rabbits I week) - Acute Systemic Toxicity (Mice) - 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K913023, K910944, KO12990, K990086, USS506, K925548, K982597, K03721, K993948
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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 Dressing |
| 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.
1
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
2
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.
3
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.
4
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