(191 days)
Not Found
No
The device description and performance studies focus on the material properties and delivery mechanism of a bone mineral product, with no mention of AI or ML.
No
The device, a porous bone mineral matrix for dental surgery, is used for augmentation or reconstructive treatment and filling defects, which are therapeutic interventions rather than diagnostic or imaging functions.
No
The device is a bone mineral material and delivery applicator used in dental surgical procedures for augmentation and reconstruction, not for diagnosing conditions.
No
The device description clearly states it is a "porous bone mineral matrix consisting predominantly of calcium phosphate, pre-loaded into a delivery applicator." This describes a physical material and a delivery mechanism, not software. The performance studies also focus on biocompatibility, sterilization, and bench testing of the applicator, which are all related to hardware and materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in dental surgery for procedures like bone augmentation and filling defects. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a bone mineral matrix for implantation, not a reagent or instrument used to analyze biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on biocompatibility, sterilization, and functional performance in a surgical context, not on diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic/reconstructive device used directly in a surgical procedure.
N/A
Intended Use / Indications for Use
Porcine Anorganic Bone Mineral in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge ●
- o Filling of infrabony periodontal defects
- Filling of defects after root resection, apicoectomy, and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge o
- Elevation of maxillary sinus floor .
- Filling of periodontal defects in conjunction with products intended for Guided . Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- o Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
Product codes (comma separated list FDA assigned to the subject device)
NPM
Device Description
Porcine Anorganic Bone Mineral in Delivery Applicator is a porous bone mineral matrix consisting predominantly of calcium phosphate, pre-loaded into a delivery applicator. Porcine Anorganic Bone Mineral in Delivery Applicator is produced by removal of the organic components from porcine bone. Porcine Anorganic Bone Mineral in Delivery Applicator is sterilized by gamma irradiation. The product is non-pyrogenic and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental
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)
To demonstrate substantial equivalence, the following non-clinical performance testing on the subject device was performed:
- Biocompatibility of Sterile Finished Device: cytotoxicity, irritation, and sensitization ●
- . Biocompatibility of Delivery Applicator: cytotoxicity, physicochemical attributes of a polymeric material, containers - plastics, physicochemical tests USP
- Biocompatibility of Anorganic Porcine Bone Mineral (previously submitted in the company's own predicate device premarket notification and applicable to the subject device): cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, pyrogenicity, implantation, subacute/subchronic toxicity
- Sterilization validation was performed in accordance with ISO 11137-1 Sterilization of . health care products - Radiation
- Bench testing of delivery applicator functionality and customer assessment.
- Animal performance testing of the Anorganic Porcine Bone Mineral in an intraoral defect . in a canine model (previously submitted in the company's own predicate device premarket notification and applicable to the subject device).
The results of the in vitro product characterization studies, functionality testing, animal performance testing and biocompatibility studies show that the Porcine Anorganic Bone Mineral in Delivery Applicator is substantially equivalent to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2017
Collagen Matrix, Inc. Peggy Hansen Senior Vice President, Quality And Regulatory Affairs 15 Thornton Road Oakland. New Jersey 07436
Re: K162158
Trade/Device Name: Porcine Anorganic Bone Mineral In Delivery Applicator Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: January 13, 2017 Received: January 17, 2017
Dear Peggy Hansen:
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.
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name: Porcine Anorganic Bone Mineral in Delivery Applicator
Indications for Use:
Porcine Anorganic Bone Mineral in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge ●
- o Filling of infrabony periodontal defects
- Filling of defects after root resection, apicoectomy, and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge o
- Elevation of maxillary sinus floor .
- Filling of periodontal defects in conjunction with products intended for Guided . Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- o Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
X -Prescription Use (Part 21 CFR 801.109)
AND/OR
Over-The-Counter Use
Page 1 of 1
3
K162158
510(k) SUMMARY
Applicant Information
| Applicant Name:
Owner Operator No.: | Collagen Matrix, Inc.
9043463 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Address: | 15 Thornton Road
Oakland, New Jersey 07436 |
| Telephone:
Fax: | (201) 405-1477
(201) 405-1355 |
| Contact Person: | Peggy Hansen
Senior VP, Quality and Regulatory Affairs
201-405-1477
phansen@collagenmatrix.com |
| cc: | Danielle Lindner
Senior Regulatory Affairs Associate II
201-405-1477
dlindner@collagenmatrix.com |
| Date Prepared: | February 8, 2017 |
| Name of Device | |
| Trade Name: | Porcine Anorganic Bone Mineral in Delivery Applicator |
| Common Name: | Bone Grafting Material |
| Classification Name: | Bone Grafting Material, Animal Source
21 CFR 872.3930
NPM
Class II
Dental |
Legally Marketed Devices to Which Substantial Equivalence is Claimed
Predicate Device(s) Porcine Anorganic Bone Mineral K140714
4
Description of the Device
Porcine Anorganic Bone Mineral in Delivery Applicator is a porous bone mineral matrix consisting predominantly of calcium phosphate, pre-loaded into a delivery applicator. Porcine Anorganic Bone Mineral in Delivery Applicator is produced by removal of the organic components from porcine bone. Porcine Anorganic Bone Mineral in Delivery Applicator is sterilized by gamma irradiation. The product is non-pyrogenic and for single use only.
Indications for Use
Porcine Anorganic Bone Mineral in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge -
- Filling of infrabony periodontal defects -
- -Filling of defects after root resection, apicoectomy, and cystectomy
- -Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor -
- Filling of periodontal defects in conjunction with products intended for Guided Tissue -Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone -Regeneration
Summary/Comparison of Technical Characteristics
The delivery applicator has been designed to deliver the porcine anorganic bone mineral granules to the intended treatment area that may be more difficult to reach. The only modifications that were made are (i) additional sizes offered to the user in a pre-loaded applicator and (ii) new packaging configuration. The key device characteristics, environment for use, performance specifications, principals of operation, mechanism of action and technological characteristics remain unchanged. The addition of the delivery applicator does not affect the product performance of the bone grafting material, and therefore does not affect substantial equivalence when comparing the subject device to its predicate device. The table below summarizes the comparison of technical characteristics.
5
| Feature | Porcine Anorganic Bone Mineral
In Delivery Applicator
(this submission) | Porcine Anorganic Bone Mineral
(K140714) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Intended for use in dental surgery. The
products may be used in surgical
procedures such as:
• Augmentation or reconstructive
treatment of alveolar ridge
• Filling of infrabony periodontal
defects
• Filling of defects after root resection,
apicoectomy, and cystectomy
• Filling of extraction sockets to
enhance preservation of the alveolar
ridge
• Elevation of maxillary sinus floor
• Filling of periodontal defects in
conjunction with products intended
for Guided Tissue Regeneration
(GTR) and Guided Bone
Regeneration (GBR)
• Filling of peri-implant defects in
conjunction with products intended
for Guided Bone Regeneration. | Intended for use in dental surgery.
The products may be used in surgical
procedures such as:
• Augmentation or reconstructive
treatment of alveolar ridge
• Filling of infrabony periodontal
defects
• Filling of defects after root resection,
apicoectomy, and cystectomy
• Filling of extraction sockets to
enhance preservation of the alveolar
ridge
• Elevation of maxillary sinus floor
• Filling of periodontal defects in
conjunction with products intended
for Guided Tissue Regeneration
(GTR) and Guided Bone
Regeneration (GBR)
• Filling of peri-implant defects in
conjunction with products intended
for Guided Bone Regeneration. |
| Material Source | Porcine Bone | Porcine Bone |
| Material
Composition | Calcium phosphate | Calcium phosphate |
| Mineral Structure | Carbonate apatite | Carbonate apatite |
| Form | Granules | Granules |
| Color | White to off-white | White to off-white |
| Physical
Appearance | Porous, irregular-shaped particles | Porous, irregular-shaped particles |
| Product Sizes | 0.25 and 0.5 cc | 0.25 cc, 0.5 cc, 1.0 cc, 2.0 cc, and 4.0 cc |
| Particle Size
Range | 0.25 - 1 mm | 0.25 – 1 mm and 1 - 2 mm |
| pH | $7.3 \pm 0.1$ | $7.3 \pm 0.1$ |
| Resorption Profile | Gradual resorption | Gradual resorption |
| Unit package | Pre-loaded into plastic delivery
applicator | Plastic jar |
| Feature | Porcine Anorganic Bone Mineral
In Delivery Applicator
(this submission) | Porcine Anorganic Bone Mineral
(K140714) |
| Sterility | Sterile, SAL 10-6
Gamma irradiation
ISO 11137 | Sterile, SAL 10-6
Gamma irradiation
ISO 11137 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Single Use/ Reuse | Single use only | Single use only |
6
Non-Clinical Performance Testing
To demonstrate substantial equivalence, the following non-clinical performance testing on the subject device was performed:
- Biocompatibility of Sterile Finished Device: cytotoxicity, irritation, and sensitization ●
- . Biocompatibility of Delivery Applicator: cytotoxicity, physicochemical attributes of a polymeric material, containers - plastics, physicochemical tests USP
- Biocompatibility of Anorganic Porcine Bone Mineral (previously submitted in the company's own predicate device premarket notification and applicable to the subject device): cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, pyrogenicity, implantation, subacute/subchronic toxicity
- Sterilization validation was performed in accordance with ISO 11137-1 Sterilization of . health care products - Radiation
- Bench testing of delivery applicator functionality and customer assessment.
- Animal performance testing of the Anorganic Porcine Bone Mineral in an intraoral defect . in a canine model (previously submitted in the company's own predicate device premarket notification and applicable to the subject device).
Conclusion
The results of the in vitro product characterization studies, functionality testing, animal performance testing and biocompatibility studies show that the Porcine Anorganic Bone Mineral in Delivery Applicator is substantially equivalent to its predicate device.