(49 days)
Collatek Sheet may be used in the management of:
- Partial and full thickness wounds
- Pressure (stage 1-1V) and venous ulcers
- Ulcers caused by mixed vascular etiologies
- Venous stasis and diabetic ulcers
- 1st and 2nd degree burns
- Cuts, abrasions and surgical wounds
Collatek® Shect is a stcrile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. Collatek® Sheet is packaged as a sclfadhering island dressing which is able to conform to most wound sites. Collatek® Sheet consist of a hydrocolloid sheet with a clear adherent medical tape backing on one side and a peel-off silica-coated paper on the other. It is to be used manage full and partial thickness wounds with light exudate.
The provided 510(k) summary for the "Collatek® Sheet" wound dressing primarily focuses on establishing substantial equivalence to predicate devices through comparisons of design, function, materials, and intended use. It does not describe a study that involves acceptance criteria and device performance in the way typically expected for a detailed clinical or performance study report.
Instead, the submission states:
"Bench testing was performed to verify that the performance characteristics of Collatek® Sheet are comparable to the currently marketed predicate device. Collatek® Sheet is designed to absorb light amounts of exudates while forming a protective gelatinous barrier. The collagen helps to protects the wound bed and newly formed granulation tissue by formation of an occlusive gelatinous barrier that is conducive to wound healing."
And regarding safety:
"Biocompatibility texting has confirmed that Collatek(s) Sheet meets requirement as stated in the FDA Blue Book Memorandum G95-J and in ISO10993. Biocompatibility tests were performed by North American Science Associates, Inc. (NAmSA) in accordance with GLP. Biocompatibility data has shown that Collatek® Sheet is safe for use as a medical device for wound care management and is substantially equivalent to the commercially available predicate devices (Cutinova® hydro and DuoDerm® CGF)."
Given the information provided, I cannot populate the table or answer most of your specific questions related to acceptance criteria and a study proving its performance against those criteria, as the document details a substantial equivalence claim based on comparison to existing devices and bench testing/biocompatibility rather than a direct performance study with defined acceptance criteria and clinical outcomes.
Here's what can be inferred or explicitly stated based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Performance | Comparability to predicate device performance characteristics | "Bench testing was performed to verify that the performance characteristics of Collatek® Sheet are comparable to the currently marketed predicate device." |
| Design to absorb light amounts of exudates | "Collatek® Sheet is designed to absorb light amounts of exudates..." | |
| Design to form a protective gelatinous barrier | "...while forming a protective gelatinous barrier." | |
| Collagen to protect wound bed and granulation tissue | "The collagen helps to protects the wound bed and newly formed granulation tissue by formation of an occlusive gelatinous barrier that is conducive to wound healing." | |
| Biocompatibility | Meets requirements of FDA Blue Book Memorandum G95-J and ISO10993 | "Biocompatibility texting has confirmed that Collatek(s) Sheet meets requirement as stated in the FDA Blue Book Memorandum G95-J and in ISO10993." |
| Sterility | Sterilized to an SAL value of 10-6 | "Collatek®Sheet will be stcrilized to an SAL value of 10-6" |
| Sterilization process validated per ANSI/AAMI/ISO1137 | "The sterilization process will be validated using ANSI/AAMI/ISO1137 guidelines." | |
| Substantial Equivalence | Equivalence in design, function, materials, and intended use to predicate devices. | "Collatek® Sheet is equivalent in design, function, materials and intended use and is therefore substantially equivalent to the commercially available predicate devices: (Cutinova® hydro and DuoDcrm® CGF)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Provided: The document mentions "bench testing" and "Biocompatibility tests" but does not specify sample sizes for these tests or the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Information Not Applicable/Provided: This type of information is typically relevant for studies involving human judgment (e.g., image interpretation, clinical assessment). The described "bench testing" and "biocompatibility testing" are laboratory evaluations, not dependent on expert ground truth in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Applicable/Provided: Adjudication methods are typically used in clinical trials or studies where human assessment is involved. This is not described for the bench or biocompatibility testing mentioned.
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, an MRMC comparative effectiveness study was not done. This type of study is not mentioned or implied in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Not Applicable/Provided: The device is a wound dressing, not an algorithm or AI. Standalone performance as an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For bench testing: The "ground truth" would be established by validated test methods and physical/chemical properties, measured against established standards or predicate device performance.
- For biocompatibility testing: The "ground truth" is adherence to specific ISO standards (ISO10993) and FDA guidelines (FDA Blue Book Memorandum G95-J), assessed through specific laboratory assays (e.g., cytotoxicity, sensitization, irritation).
- No clinical ground truth (expert consensus, pathology, outcomes data) derived from patient studies is described in this 510(k) summary.
8. The sample size for the training set
- Information Not Applicable/Provided: The device is a physical wound dressing, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Information Not Applicable/Provided: As above, this is not relevant for this type of device.
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OCT 2 5 2001
BioCore Medical Technologies, Inc.
State-of-the-Art Biomaterials Technologists
Phone: 888-565-5243 301-622-6818 301-625-6819 Fax:
11800 Tech Road: Suite #240 Silver Spring, Maryland 20904 U.S.A.
510(k) Summary
"This summary of 510(k) safety and ctfectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92'
"The assigned 510(k) number is: K012995
Submitter's Name and Address:
BioCore Medical Technologics, Inc. 11800 Tech Rd. Suite 240 Silver Spring, MD 20904
Contact Person, Telephone and Fax Number:
Ajay Kumar, VP of Operations Phone: (301) 625-6818 Fax: (301) 625-6819
Date the Summary was Prepared:
September 19. 2001
Device Names:
Proprictary Namc: Collatck® Sheet Model number: XXXXXXXXXX Common Name: hydrocolloid wound sheet Classification Name: occlusive, wound and burn dressing
Predicate Device:
Trade name: Company :
Cutinova@ hydro Beirsderf , Inc.
Trade name: Company:
DuoDerm® Extra Thin Convatec™, A Bristol-Mycrs Squibb Co.
Kollagen™
BioCore Medical Technologies, Inc. Collatek Sheet
Traditional 510(k)
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Device Description:
Collatek® Shect is a stcrile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. Collatek® Sheet is packaged as a sclfadhering island dressing which is able to conform to most wound sites. Collatek® Sheet consist of a hydrocolloid sheet with a clear adherent medical tape backing on one side and a peel-off silica-coated paper on the other. It is to be used manage full and partial thickness wounds with light exudate.
Basis for Substantial Equivalence:
I. Indications for Use
Collatek® Sheet will be used to manage full thickness and partial thickness wounds with light exudate. Collatek® Sheet is intended for use on these types of wounds: pressure ulcers (stages I-IV), venous ulcers, ulccrs caused by mixed vascular etiologies, diabetic ulcers, first and sceond degree burns, donor sites and other bleeding or secreting dermal lesions/injuries.
Collatek® Sheet's intended use is analogous to the commercially available predicate devices (Cutinova@ hydro and DuoDerni(®) CGF).
2. Instructions for Use
Collatek@ Sheet's manner of application is similar to other wound care products. First, cleanse and dry the wound the wound. Second, apply medication to wound us indicated. Third, apply Collatek@ Sheet to the wound surface, smooth and secure the self-adhesive border. Lastly, change dressing as needed in accordance with labeling instructions.
Collatek® Sheet's indications for use are similar to those of commercially available prodicate devices (Cutinova@) hydro and DuoDerm@ CGI)).
3. Technological Characteristics
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Collatek® Sheet is a hydrocolloid wound dressing. Collatek@ Sheet protects the wound bed and newly formed granulation tissuc by formation of an occlusive gelatinous barrier
Collateke Sheet is packaged as a low moisture hydrocolloid product, this gives Collatek@ Sheet the advantage of being able to absorb liquid exudate and the flexibility to conform to most wound sites. Collatek® Sheet is designed for use on a lightly exudating wound with simple or complex wound irregularities.
Collatek® Sheet is comparable in design and function to the commercially available predicate devices (Cutinova@ hydro and DuoDerm@ CGF).
4. Materials
Collatek(s) Shoct's main constituents are: gelatin, glycerin and collagen, pectin and guar gum. .Collatek@ Shect's collagen is a fibrous, Type I bovine collagen. The constituents of Collatek® Sheet are similar to the constituents of the commercially available predicate devices (Cutinova@) hydro and DuoDerm@ CGF).
S. Performance
Bench testing was performed to verify that the performance characteristics of Collatek@ Sheet are comparable to the currently marketed predicate device. Collatek(@ Sheet is designed to absorb light amounts of exudates while forming a protective gelatinous barrier. The collagen helps to protects the wound bed and newly formed granulation tissue by formation of an occlusive gelatinous barrier that is conducive to wound healing.
6. Safety
Biocompatibility texting has confirmed that Collatek(s) Sheet meets requirement as stated in the FDA Blue Book Memorandum G95-J and in ISO10993. Biocompatibility tests were performed by North American Science Associates, Inc. (NAmSA) in accordance with GLP. Biocompatibility data has shown that Collatek® Sheet is safe for
Li-3
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use as a medical device for wound care management and is substantially equivalent to the commercially available predicate devices (Cutinova® hydro and DuoDerm® CGF).
7. Sterility and Packaging
Collatek® Sheet will be packaged in a single use, disposable silica-coated polyethylene pouch. The package and its contents will be sterilized using electron beam radiation. Collatek@Sheet will be stcrilized to an SAL value of 10th, The sterilization process will be validated using ANSI/AAMI/ISO1137 guidelines.
Conclusion
Collatek@ Sheet is equivalent in design, function, materials and intended use and is therefore substantially equivalent to the commercially available predicate devices: (Cutinova@ hydro and DuoDcrm® CGF). We therefore submit that Collatek® Shect is substantially cquivalent to the prodicates hyCURE® sheet and DuoDerm® CGT.
Table I-2.1 provides a side-by-side comparison for a basis of substantial equivalence for Collatck® Sheet.
Traditional 510(k)
13-4
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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Public Health Service
OCT 2 5 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ajay Kumar Vice President of Operations BioCore Medical Technologies, Inc. 11800 Tech Road Suite #240 Silver Springs, Maryland 20904
Re: K012995 Trade Name: Collatek® Sheet Regulatory Class: Unclassified Product Code: MGP Dated: September 6, 2001 Received: September 6, 2001
Dear Mr. Kumar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Ajay Kumar
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,
Susan Walker, MD
Image /page/5/Picture/5 description: The image contains a single, stylized letter 'l' in a cursive font. The letter is black and appears to be hand-drawn or digitally rendered with a calligraphic style. The background is plain white, which makes the letter stand out prominently.
Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K012995
Device Name: Collatck Sheet
Indications for Use:
Collatek Sheet may be used in the management of:
- Partial and full thickness wounds 등
- Pressure (stage 1-1V) and venous ulcers .
- 내 Ulcors caused by mixed vascular etiologics
- Venous stasis and diabetic ulcers .
- Ist and 2nd degree burns l
- Cuts, abrasions and surgical wounds li
Contraindications:
Collatek Sheet should not be used on persons sensitive to bovine products.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE. IF NEEDED) ·
Concurrence of CDRH, Ollice of Device Evaluation (ODE)
Signature of
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012995
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Usc (Optional Format 1-2-96)
BioCore Medical Technologies, Inc. Collatek Sheet
Traditional 510(k)
D-1
N/A