CollaDental barrier is intended for use in oral surgical procedures including use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; filling of bone defects after roots resection, cystectomy, removal of retained teeth; guided bone regeneration in dental implant associated bony dehiscence defects and guided tissue regeneration procedures in bony dehiscence defects around teeth.

Device Description

CollaDental Barrier is a nonfriable, resorbable membrane made of purified type I collagen derived from pig skin using standardized controlled manufacturing process. The collagen is obtained from veterinary certified pigs and purified to avoid its antigenicity. The manufacturing process complies with the standards for virus inactivation. The CollaDental Barrier has been tested for purity using standard purity testing procedures, sterlized by gamma irradiation and for single use only. It is flexible and conforms to the contours of the defect site. When moistened with water, saline, serum or blood, the device is flexible and conforms to the contours of the defect site.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called CollaDental Barrier. This submission focuses on establishing substantial equivalence to already approved predicate devices, rather than presenting a de novo study with acceptance criteria and performance data in the typical sense of an AI/algorithm-based device.

Therefore, many of the requested criteria for an AI or algorithm study (like sample size for test sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission because the device is a physical product (a resorbable collagen membrane for dental use) and not an AI or algorithm.

The core of this 510(k) is demonstrating that the CollaDental Barrier is as safe and effective as existing, legally marketed devices, primarily through comparison of:

Intended use: Identical or very similar to predicates.
Technological characteristics: Similar materials (purified type I collagen from pig skin), manufacturing process (purified, gamma irradiated), and physical properties (flexible, conforms to defects).
Biocompatibility: Demonstrated through standard ISO 10993 Part 1 testing.

Here's an analysis based on the provided document, highlighting what is (and isn't) present:

Device Name: CollaDental Barrier

Device Type: Resorbable collagen membrane (physical medical device, not an AI/algorithm)

1. Table of Acceptance Criteria and Reported Device Performance

This type of specific table with quantitative metrics (e.g., accuracy, sensitivity, specificity) is not applicable here because this is a 510(k) for a physical medical device, not an AI algorithm. The "acceptance criteria" for a 510(k) revolve around establishing substantial equivalence, primarily by demonstrating similar intended use, technological characteristics, and safety/performance profiles to predicate devices through biocompatibility testing and material characterization, rather than an AI performance study.

What is reported as "performance" for a physical device like this:

Biocompatibility: "CollaDental Barrier has been demonstrated to be safe. To support the biocompatibility of this product, safety tests were conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices. All test results from tests conducted on CollaDental Barrier are taken together as a whole, CollaDental Barrier have been demonstrated to be a safe device in accordance with ISO 10993-1." (Section 9)
Physical Properties: "It is flexible and conforms to the contours of the defect site. When moistened with water, saline, serum or blood, the device is flexible and conforms to the contours of the defect site." (Section 6)
Material: "nonfriable, resorbable membrane made of purified type I collagen derived from pig skin" (Section 6)
Sterilization: "sterilized by gamma irradiation" (Section 6)

2. Sample Size Used for the Test Set and Data Provenance

Not applicable for an AI test set. The regulatory pathway is not for an AI.
For the biocompatibility testing (ISO 10993-1), the document doesn't specify the sample size of materials or animals/cells used in those tests, nor the exact provenance of that data, only that the tests were conducted.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth in the context of expert consensus for AI model validation is not relevant for this physical device's 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of an AI algorithm requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, not applicable. This type of study is for evaluating human-AI interaction in diagnostic/interpretive tasks, which is not relevant for a physical dental membrane.

6. If a Standalone (Algorithm Only) Performance Was Done

No, not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

Ground truth concept is different for a physical medical device. For a physical device like CollaDental Barrier, "ground truth" would be established through:
- Biocompatibility Standards: Adherence to ISO 10993-1, which involves standardized biological tests (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation). The "truth" is whether the material elicits a satisfactory biological response.
- Material Characterization: Chemical composition, physical properties (e.g., tensile strength, degradation rate), and sterility testing, validated against established scientific methods and specifications.
- Clinical Literature/Predicate Device Performance: The "truth" of its intended use and general performance largely derives from the known safety and efficacy of the predicate collagen membranes.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set" or AI ground truth establishment for this device.

Summary of the "Study" and "Acceptance" for this 510(k) Submission:

The "study" conducted for CollaDental Barrier (K100695) is primarily a demonstration of substantial equivalence to existing predicate devices (BioMend Extend absorbable collagen membrane (K992216) and BIO-GIDE® (K042197)).

The "acceptance" is based on the FDA's regulatory determination that:

The device's intended use is substantially equivalent: "augmented around implants placed in immediate extraction sockets, delayed extraction sockets; filling of bone defects after roots resection, cystectomy, removal of retained teeth; guided bone regeneration in dental implant associated bony dehiscence defects and guided tissue regeneration procedures in bony dehiscence defects around teeth."
Its technological characteristics are substantially equivalent (purified Type I collagen from pig skin, non-friable, resorbable, gamma sterilized, flexible, conforms to defects).
Its safety has been demonstrated through standard biocompatibility testing according to ISO 10993 Part 1. This is the primary "proof" of the device's safety profile against established biological criteria.

The FDA's letter (K100695) confirms this determination, stating, "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... You may, therefore, market the device."

In essence, this 510(k) relies on a comparison to well-understood and already approved predicate devices, supported by standard material and biocompatibility testing, rather than a de novo clinical trial or an AI performance study with the specified metrics.

Summary

{0}------------------------------------------------

K100695

COLLAMATRIX Co. Ltd.

510(k) summarv

JAN 0 3 2013

Summary information

1. Date Prepared

March 3, 2010

2. Submitter name and address

Collamatrix Inc.

1F, No.50-1, Keyan Road, Jhunan Science Park Miaoli County, 350, Taiwan

3. Contact person

Name:	Dennis J. N. Seah
Tel:	+ 886 2 7711 3299
Fax:	+ 886 2 7711 3599

4. Device names

Propriety name: CollaDental Barrier Common name: Collagen dental matrix Classification name: Dressing, Wound

ર. Device classification

Regulatory class:	Barrier, Animal Source, Intraoral, Class II
Product code:	NPL

Device description 6.

Page 1 of 3 I F, No. 50-1, Keyan Road, Jhunan Science Park, Miaoli Country, 350, Taiwan Tel: +886 2 7711 3299 Fax: +886 2 7711 3599

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K100695
2 of 3

COLLAMATRIX Co. Ltd.

Barrier-has-been-tested for-purity-using standard-purity-testing procedures, sterlized-by gamma irradiation and for single use only. It is flexible and conforms to the contours of the defect site. When moistened with water, saline, serum or blood, the device is flexible and conforms to the contours of the defect site. CollaDental Barrier has not been tested on persons less than 18 years of age.

7. Intended use

CollaDental Barrier is intended for use in oral surgical procedures including use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; filling of bone defects after roots resection, cystectorny, removal of retained teeth; guided bone regeneration in dental implant associated bony dehiscence defects and guided tissue regeneration procedures in bony dehiscence defects around teeth.

8. Statement of Substantial equivalence

CollaDental Barrier is a device similar to predicate devices that are previously approved by the agency. CollaDental Barrier is substantially equivalent in indications and design principles to predicate devices, BioMend Extend absorbable collagen membrane (K992216) and BIO-GIDE® (K042197), each of which has been determined by FDA to be substantially equivalent to preamendment devices. CollaDental Barrier has the following similarities to the predicate devices in terms of indication for use, technological characteristics, material use and the process for sterilization. In summary, CollaDental Barrier is substantially equivalent to the predicate devices under the 510(k) regulations.

9. Biocompatibility

. '

CollaDental Barrier has been demonstrated to be safe. To support the biocompatibility of this product, safety tests were conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices.

All test results from tests conducted on CollaDental Barrier are taken together as a whole, CollaDental Barrier have been demonstrated to be a safe device in accordance with ISO 10993-1.

IF, No. 50-1, Keyan Road, Jhunan Science Park, Miaoli Country, 350, Taiwan Tel: +886 2 7711 3299 Fax: +886 2 7711 3599

Page 2 of 3

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K100695
3073

COLLAMATRIX Co. Ltd.

10 - Conclusion

. ·

CollaDental Barrier is essentially equivalent in indication for use, technological characteristics and material to the commercially available predicate device, and therefore meets the requirements as defined in 21 CFR § 807.

1F, No. 50-1, Keyan Road, Jhunan Science Park, Miaoli Country, 350, Taiwan Page 3 of 3 Tel: +886 2 7711 3299 Fax: +886 2 7711 3599

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare. The caduceus features a staff with a snake winding around it, representing healing and medicine.

-Public Health Service -

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

January 3, 2013

Mr. Dennis J.N. Seah Collamatrix, Incorporated 26F No. 105, Section 2 Dunhua South Road, DA-AN Distric Taipei, China 106

Re: K100695

Trade/Device Name: CollaDental Barrier Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: January 5, 2011 Received: December 14, 2012

Dear Mr. Seah:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

{4}------------------------------------------------

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

2013.01.03 Susan Runner DDS, MA 08:32:49 -05'00'

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Statement of indications for use

510(K) Number (if known): K100695

Device Name: CollaDental Barrier

Indications for Use:

Prescription Use ನ್ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

2012.12.31 Susan Runner DDS, MA 10:48:45 -05'00' ·

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K100695

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.