(48 days)
Collatek Powder 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
Collatek® Powder is a sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. It is to be used to fill in full and partial thickness wounds with moderate to heavy exudate. Collatek® Powder is able to conform to any wound site. Collatek® Powder is a hydrophilic, hydrocolloid wound-powder with a collagen base. Collatek® Powder's collagen is an insoluble fibrous type 1 bovine collagen derived from cowhide. Collatek® Powder will be available in a 1 gram size packet, additional sizes may be introduced at a later time.
The provided document does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria using metrics like sensitivity, specificity, or accuracy. This submission is for a Traditional 510(k) for a wound dressing, which typically relies on demonstrating substantial equivalence to a predicate device based on design, function, materials, and intended use, rather than a performance study against quantitative acceptance criteria for diagnostic or AI-based devices.
Instead, the document focuses on demonstrating that the Collatek® Powder is substantially equivalent to existing predicate devices (hyCURE® Powder, Comfeel® Powder, and Medifil® II Particles) by comparing:
- Indications for Use: Collatek® Powder's indications are comparable to the predicate devices.
- Instructions for Use: The manner of use is similar to other wound care products and predicate devices.
- Technological Characteristics: Collatek® Powder is analogous in design to the predicate devices, being a hydrocolloid wound dressing designed for moderate to high exudating wounds.
- Materials: The material (fibrous Type I bovine collagen) is the same as some predicate devices.
- Safety: Biocompatibility testing confirmed compliance with FDA Blue Book Memorandum G95-1 and ISO 10993. (Results are reported to be in Appendix K, which is not provided).
- Sterility and Packaging: Sterilization methods and packaging are described, with validation in accordance with ANSI/AAMI/ISO 11137-1994.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and performance study details as they are typically associated with AI/diagnostic device submissions. The information requested (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets) is not relevant or present in this type of 510(k) submission for a wound dressing.
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OCT 2 4 2001
BioCore Medical Technologies, Inc.
State-of-the-Art Biomaterials Technologists
Phone: 888-565-5243 301-625-6818 301-625-6816 Fax:
11800 Tech Road; Suite #240 Silver Spring, Maryland 20904 U.S.A.
1/3
510(k) Summary
"This summary of 510(k) safety and effectivencss information is bcing submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92"
"The assigned 510(k) number is: K012990
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:
Collatek® Powder Proprietary Name: Common Name: hydrocolloid wound powder Classification Name: wound and burn dressing
Predicate Device:
Trade name: Company:
hyCURE® Powder 1 lymed Group Corporation
Tradc name: Company:
Comfect® Powdcr Coloplast Group, Ltd.
Trade name: Company:
Modifil® Particles
Bjolle Medical Technologies. Inc
Kolled
BioCore Medical Technologics, Inc. Collatek Powder
Traditional 510(k)
િ- ।
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Device Description:
Collatek® Powder is a sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. It is to be used to fill in full and partial thickness wounds with moderate to heavy exudate. Collatek® Powder is able to conform to any wound ડાંદિ.
Collatek® Powder is a hydrophilic, hydrocolloid wound-powder with a collagen base. Collatek® Powder's collagen is an insoluble fibrous type 1 bovinc collagen derived from cowhide. Collatek® Powder will be available in a 1 gram size packet, additional sizes may be introduced at a later time
Basis for Substantial Equivalence:
1. Indications for Use
Collatek® Powder will be used to manage full thickness and partial thickness wounds with moderate to heavy exudate. Collatek® Powder is intended for use on: pressure ulcers (stages 1-1V), venous ulcers, ulcers caused by mixed vascular etiologies. diabetic ulcers, first and sccond degree burns, donor sites and other bleeding or secreting dermal injuries.
Collatek® Powder's indications for use are comparable to the commercially available prodicate devices (hyCURE® Powder, Comfeel® Powder and Medifil® II Particles).
2. Instructions for Use
Collatek® Powder's manner of use is similar to other wound care products. Ifirst, cleanse the wound. Second, apply medication to wound as indicated. Third, apply Collatek® Powder to the wound surface. Lastly, Cover with absorbent dressing and change dressing as needed in accordance with labeling instructions.
Collatek® Powder's instructions for use are comparable to the commercially available predicate devices (hyCURE@ Powder, Comfeel® Powder and Medifil(6) II Particles).
3. Technological Characteristics
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Collatek® Powder is a hydrocolloid wound dressing prepared from librous type I bovinc collagen. Collagen protects the wound bed and newly formed granulation tissue by formation of a protective covering that is conducive to wound healing.
Collatek® Powder is designed to be a dry particulate product, this gives Collatek® Powder the advantage of being able to absorb many times its own weight in liquid exudate and the ability to conform to any wound site. For this reason, Collatck® Powder is designed for use on moderate to high exudating wounds with simple and complex wound irregularities.
Collatek® Powder is analogous in design as the commercially available predicate devices (hyCURE® Powder, Comfeel® Powder and Mcdifil® Particles).
4. Materials
The material used for Collatek® Powder consists of fibrous Type I bovine collagen. Collagen is also the material use in manufacture of hyCure and Medifil Particles. Thercforc, Collatek is similar to predicate devices in terms of materials used.
5 Sufely
Biocompatibility testing has confirmed that Collatek® Powder meets requirements as stated in FDA's Bluc Book Mcmorandum G95-1 and ISO 10993. Results are given in Appendix K.
6. Sterility and Packaging
Collatok(0) Powder will be packaged as a single use, disposable foil packet. The package and its contents will be sterilized using electron beam radiation. Collatek® Powder will be sterilized to a SAL index of 100. The sterility of Collatck® Powder will be ensured by validation in accordance with ANSI/AAMI/ISO 11137-1994.
Conclusion
Collatek® Powder is equivalent in design, function, materials and intended use and is therefore substantially equivalent to the commercially available predicate devices: hyCURE® Powder (Hymed Group Corporation), Comfeel® Powder (Coloplast Group, Ltd.) and Medifil® II Particles (BioCorc Medical Technologies, Inc.). We therefore submit that Collatek(@ Powder is substantially cquivalent to hyCURE® Powder, Comfeel® Powdcr and Mcdifil(@ II Particles.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol depicts a stylized human figure with three faces in profile, one behind the other, suggesting a sense of community and support. The overall design is simple and conveys a sense of unity and care.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2007
Mr. Ajay Kumar Vice President of Operations BioCore medical Technologies, Inc. 11800 Tech Road Suite #240 Silver Spring, Maryland 20904
K012990 Re: Trade Name: Collatek Powder Regulatory Class: Unclassified Product Code: KGN Received: September 6, 2001
Dear Mr. Kumar:
This letter corrects our substantially equivalent letter of October 24, 2001.
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 (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 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.
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Page 2 - Mr. Ajay Kumar
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.
This letter will allow you to continue 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), please contact the Office of Compliance at (240) 276-0115. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number (if known): K012990
Device Name: Collatek Powder
Indications for Usc:
Collatek Powder may be used in the management of:
- Partial and full thickness wounds 트
- Pressure (stage I-IV) and venous ulcers 일
- Ulcers caused by mixed vascular etiologies 트
- Venous stasis and diabctic ulccrs 트
- Ist and 2nd degree burns 해
- Cuts, abrasions and surgical wounds
Contraindications:
Collatek powder 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, Office of Device Evaluation (ODE)
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(Division Sim-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012980
X Prescription Use (Pcr 21 CFR 801.109)
ું જ
Over-The-Counter-Use (Optional Format 1-2-96)
BioCore Medical Technologies, Inc. Collatek Powder
Traditional 510(k)
N/A