(49 days)
Collatek Foam may be used in the management of:
- Partial and full thickness wounds
- Pressure (stage I-IV) and venous ulcers
- Ulcers caused by mixed vascular etiologies
- Venous stasis and diabetic ulcers
- 1st and 2nd degree burns
- Cuts, abrasions and surgical wounds
Collatekto Fourn is a sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. It is to be used to manage full and partial thickness wounds with moderate to heavy exudate. Collatek® Foam is composed of two scparate layers: a collagen matrix layer and a medical grade foam layer. Collatek Foam's collagen matrix layer is made from insoluble fibrous type I bovinc collagen derived from cowhide. Collatek@ Foam's foam layer is a medical grade polyurothane fourn. Collatek® Foam will be initially available in a 4"x 4" size pad, additional sizes may be introduced at a later time.
This 510(k) summary for the Collatek® Foam wound dressing does not describe a study involving performance acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, it focuses on demonstrating substantial equivalence to predicate devices. Therefore, the device does not have explicit acceptance criteria or a study "proving" it meets those criteria in the traditional sense of a performance study.
Here's a breakdown based on the information provided, highlighting what is not applicable in this context:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated, inferred from substantial equivalence) | Reported Device Performance (as presented for substantial equivalence) |
|---|---|
| Indications for Use: Comparable to predicate devices for managing full and partial thickness wounds with moderate to heavy exudate, including pressure ulcers (stages I-IV), venous ulcers, mixed vascular etiologies, diabetic ulcers, first and second-degree burns, donor sites, and other dermal lesions/injuries. | Collatek® Foam's indications for use are "comparable" to VigiFOAM® and SkinTemp®. |
| Instructions for Use: Similar wound dressing procedure to predicate devices. | Collatek® Foam's instructions for use are "similar" to VigiFOAM® and SkinTemp®. |
| Technological Characteristics: Similar design (two layers: collagen matrix and medical grade foam) and fluid handling properties (collagen absorption, foam evaporation) to predicate devices. | Collatek® Foam is "similar in design" to VigiFOAM® and SkinTemp®, with a collagen wound-contacting surface and a polyurethane foam backing. |
| Materials: Constituents are the same as predicate devices (Type I bovine collagen from cowhide, medical grade polyurethane foam). | "The constituents of Collatek® are the same as the constituents of the commercially available predicate devices (VigiFOAM® and SkinTemp®)." |
| Safety (Biocompatibility): Meets or exceeds all biocompatibility testing requirements per FDA Blue Book Memorandum G95-1 and ISO 10993. | Biocompatibility testing confirmed Collatek® "meets or exceeds" all requirements, performed by NAMSA in accordance with GLP. Data shown in section K (not provided in this excerpt). |
| Sterility and Packaging: Packaged in single-use, disposable Tyvek® pouch, sterilized to a SAL index of 10^-6 (implied by "1000" in the text which is likely a typo for 10^-6 or a specific SAL definition within their context), validated per ANSI/AAMI/ISO 11137-1994. | Sterilized using electron beam to SAL index of "1000" (likely a typo for 10^-6), validated per ANSI/AAMI/ISO 11137-1994. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission does not describe a "test set" in the context of a clinical performance study with patient samples. The evidence relies on direct comparison to predicate devices and biocompatibility testing. The biocompatibility tests were likely performed on material samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No test set with ground truth established by experts is described for performance evaluation.
4. Adjudication method for the test set
- Not Applicable. No test set with ground truth adjudication is 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
- Not Applicable. This is a wound dressing, not an AI-assisted diagnostic or imaging device, so MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (wound dressing), not an algorithm or AI system.
7. The type of ground truth used
- Not Applicable. For the performance as a wound dressing, the "ground truth" for substantial equivalence is based on the established safety and effectiveness profile of the predicate devices, material properties, and proven biocompatibility and sterility. There isn't an "expert consensus," "pathology," or "outcomes data" specifically collected for this device's performance in a clinical study to establish a ground truth.
8. The sample size for the training set
- Not Applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI or machine learning device requiring a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" or evidence provided is a demonstration of substantial equivalence to legally marketed predicate devices (VigiFOAM® and SkinTemp®) for the same intended use. This is common for 510(k) clearances, especially for devices where the technology is well-understood and similar alternatives exist.
The key elements used to "prove" substantial equivalence are:
- Comparison to Predicate Devices: A side-by-side comparison (Table 1-2.1.2 is mentioned but not provided in the excerpt) showing similarity in:
- Indications for Use
- Instructions for Use
- Technological Characteristics (design, fluid handling)
- Materials (constituents)
- Biocompatibility Testing: Performed by North American Science Associates, Inc. (NAMSA) in accordance with Good Laboratory Practices (GLP), demonstrating the device meets or exceeds FDA Blue Book Memorandum G95-1 and ISO 10993 requirements. This addresses safety.
- Sterility Validation: Confirmation that the sterilization process (electron beam) achieves a Sterility Assurance Level (SAL) of 10^-6 (implied) in accordance with ANSI/AAMI/ISO 11137-1994. This addresses sterility.
Essentially, the company is arguing that because their device is fundamentally the same as already cleared devices, and it passes standard safety and sterility tests, it is equally safe and effective.
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OCT 2 5 2001
BioCore Medical Technologies, Inc.
State-of-the-Art Biomaterials Technologists
Phone: 888-565-5243 301-625-6818 Fax: 301-625-6819
11800 Tech Road: Suite #240 Silver Spring, Maryland 20904 U.S.A.
510(k) Summary
"This summary of 510(k) safety and cffcctiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92"
"The assigned 510(k) number is: K012997
Submitter's Name and Address:
BioCore Medical Technologies, Inc. 11800 Toch 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:
Predicate Device:
Proprietary Name: Collatek® Foam Common Name: collagen/foam wound dressing Classification Name: occlusive, wound and burn dressing
Marketed name: Marketing Company: C.R. Bard, Inc. 510(k) Trade name: 510(k) Company :
VigiFOAM@ Hydrasorb™M Avitar Technologies Inc.
Trade name: Company:
SkinTemp(0) BioCore Medical Technologies, Inc.
Kollagen™
BioCore Medical Technologies, Inc. Collatek Foam
Traditional 510(k)
际--
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Device Description:
Collatekto Fourn is a sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. It is to be used to manage full and partial thickness wounds with moderate to heavy exudate.
Collatek® Foam is composed of two scparate layers: a collagen matrix layer and a medical grade foam layer. Collatek� Foam's collagen matrix layer is made from insoluble fibrous type I bovinc collagen derived from cowhide. Collatek@ Foam's foam layer is a medical grade polyurothane fourn. Collatek® Foam will be initially available in a 4"x 4" size pad, additional sizes may be introduced at a later time.
Basis for Substantial Equivalence:
J. Indications for Use
Collatek® Foam will be used to manage full and partial thickness wounds with moderate to heavy exudate. Collatek® Foam is intended for use on these types of wounds: pressure ulcers (stages I-IV), venous ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, first and second degree burns, donor sites and other bleeding or secreting dermal lesions/injuries.
Collatek® Foam is comparable in indications for use as the commercially available predicate device (Vigil'OAM@, SkinTomp(0).
2. Instructions for Use
Collatek® Foam's manner of wound dressing is intended to be similar to that of other wound care dressings. First, cleanse the wound. Second, apply medication to the wound as indicated. Third, apply Collatck® Foam to the wound surface. Tastly, Cover with absorbent non-stick dressing and change dressing as needed in accordance with labeling instructions.
Collatek®) Foum is comparable in instructions for use as the commercially available predicate devices (VigiliOAM(@ and SkinTemp(B).
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3. Technological Characteristics
Collatek® Foum is composed of two separated layers bonded together to form a single wound care pad. Collatek@ Foam's wound-contacting surface is a fibrous type I collagen layer. Collagen protects the wound bed and newly formed granulation tissue by formation of an occlusive gelatinous barrier
Collatekty Foam's absorbent backing layer is a medical grade polyurelhane foam, Collatek@ Foam's collagen laycr can absorb many times its weight in liquid while the outer foam layer aids in liquid evaporation; this gives Collatek® Foam excellent fluid handling properties.
Collatek® Foam is similar in design as compared to the commercially available predicate devices (VigiFOAM® and SkinTemp(0).
4. Materials
The material used for Collatek® Foam's collagen matrix includes fibrous Type I bovine collagen derived from cowhide. The material used for Collatek® Foam's foam layer is a medical grade polyurethanc foam.
The constituents of Collatek® are the same as the constituents of the commercially available predicate devices (Vigil-OAM(0) and SkinTemp®).
5. Safetv
Biocompatibility testing has confirmed that Collatek® meets or exceeds all biocompatibility testing requirement as stated in the FDA Blue Book Memorandum G95-I and in ISO 10993. Biocompatibility tests were performed by North American Science Associates, Inc. (NAmSA) in accordance with GIJP. Biocompatibility data has shown that Collatek(s) is safe for use as a medical device for wound care management, the biocompatibility results are shown in section K.
6. Sterility and Packaging
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Collatek@ Foam will be packaged in a single use, disposuble Tyvek® pouch. Collatek® Foam will be sterilized using an clectron beam to irradiate the Tyvek® pouch and its contents. Collatek® Foam will be sterilized to a SAL index of 1000. The sterility of Collatek® Foam will be ensured by validation in accordance with ANSI/AAMI/ISO 11137-1994.
Conclusion
With respect to design, function, matcrials and intended use, Collatek Foam dressing is similar in properties and characteristics with the commercially available predicate devices: VigiliOAM (C.R. Bard, Inc.) and SkinTemp (BioCore Medical Technologies. Inc.). We therefore submit that Collatek foam dressing is substantially equivalent to VigiliOAM and SkinTemp. Table 1-2.1.2 provides a side-by-side comparison for a basis of substantial equivalence for Collatek Foam.
Traditional 510(k)
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Image /page/4/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 symbol that resembles an abstract caduceus or a bird-like figure with three curved lines.
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 Spring, Maryland 20904
Re: K012997
Trade Name: Collatek Foam Regulatory Class: Unclassified Product Code: MGP 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 (QS) 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) I mis lotter with are no a reading of substantial equivalence of your device to a legally promated predicated 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 shows a black and white abstract drawing. The drawing appears to be a signature or some type of symbol. The symbol is made up of curved lines and sharp angles.
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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Page I of I
510(k) Number (if known): K012997
Device Name: Collatek Foum
Indications for Use:
Collatek Foam may be used in the management of:
- . Partial and full thickness wounds
- 트 Pressure (stage I-IV) and venous ulcers
- 을 Ulcers caused by mixed vascular etiologies
- Venous stasis and diabctic ulccrs 트
- 트 Ist and 2nd degree burns
- は Cuts, abrasions and surgical wounds
Contraindications:
Collatek Foam should not be used on persons sensitive to hovine products.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
(Optional Periksa P-76)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
BioCore Medical Technologies, Inc. Collatek Foam
Traditional 510(k)
510(k) Number
N/A