(1029 days)
Not Found
No
The device description and intended use focus on a resorbable collagen membrane for oral surgical procedures. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is a resorbable membrane intended for use in oral surgical procedures to aid in bone and tissue regeneration, which aligns with the definition of a therapeutic device that treats or prevents disease/injury.
No
The device is a resorbable membrane for oral surgical procedures, not a tool for diagnosis. Its intended use and description focus on aiding bone and tissue regeneration, not identifying diseases or conditions.
No
The device description clearly states it is a physical, resorbable membrane made of purified type I collagen. It is a tangible product used in oral surgical procedures, not a software application.
Based on the provided information, the CollaDental Barrier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used during oral surgical procedures to aid in tissue regeneration and bone repair. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a resorbable membrane made of collagen, designed to be implanted. This aligns with a medical device used for surgical intervention, not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze blood, tissue, or other biological samples to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The CollaDental Barrier does not fit this description.
N/A
Intended Use / Indications for 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, 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.
Product codes
NPL
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, sterilized 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
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)
Biocompatibility tests were conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices. All test results demonstrated the device to be safe.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
"
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
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
1
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
2
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
3
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
5
Statement of indications for use
510(K) Number (if known): K100695
Device Name: CollaDental Barrier
Indications for 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, 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.
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