(134 days)
No
The device is a bone mineral material and delivery applicator, with no mention of software, algorithms, or any AI/ML related terms or functionalities. The performance studies focus on biocompatibility, sterilization, and mechanical functionality.
Yes
The device is described as an anorganic bone mineral used in various dental surgical procedures to augment, reconstruct, or fill defects, which directly contributes to the repair and healing of tissues, aligning with the definition of a therapeutic device.
No
This device is a bone mineral material and delivery applicator used in surgical procedures to augment, reconstruct, or fill bone defects. It is a therapeutic/restorative device, not one that identifies or analyzes medical conditions.
No
The device description clearly states it is a porous bone mineral matrix preloaded into a delivery applicator, which are physical components, not software.
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 augmentation, filling defects, and sinus floor elevation. These are surgical procedures performed directly on the patient's body.
- Device Description: The device is described as a porous bone mineral matrix preloaded into a delivery applicator for placement in a defect site. This is a material intended to be implanted or placed within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples from the body.
The device is a surgical implant/material used to aid in bone regeneration and repair within the oral cavity.
N/A
Intended Use / Indications for Use
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 conjuncts 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.
Product codes (comma separated list FDA assigned to the subject device)
NPM
Device Description
Anorganic Bone Mineral in Delivery Applicator are porous bone mineral matrices consisting of calcium phosphate derived from bovine bone without the addition of bovine type I collagen, preloaded into a delivery applicator for ease of placement in the defect site. The anorganic bone mineral component is produced by removal of the organic components from bovine bone. Anorganic Bone Mineral in Delivery Applicator is sterilized by gamma irradiation. The products are 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
alveolar ridge, infrabony periodontal defects, defects after root resection, apicoectomy, and cystectomy, extraction sockets, maxillary sinus floor, periodontal defects, peri-implant defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental surgery
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 Bone Mineral (previously submitted in the company's own predicate device premarket notification and applicable to the subject device): cytotoxicity, sensitization, irritation, 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 Bone Mineral derived from porcine bone tissue (K140714) in an intraoral defect in a canine model and the Anorganic Bone Mineral with and without Collagen (K043034) in a rabbit femoral condyle defect model.
Key Results: The results of the in vitro product characterization studies, functionality testing, animal performance testing, and biocompatibility studies show that the 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.
Anorganic Bone Mineral (K043034), Anorganic Bone Mineral with Collagen (K043034), Anorganic Bone Mineral with Collagen Blocks (K043034)
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.
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three lines forming its body and head. The seal also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle.
Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2017
Collagen Matrix, Inc. Danielle Lindner Senior Regulatory Affairs Associate II 15 Thornton Road Oakland, New Jersey 07436
Re: K170541
Trade/Device Name: 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: February 21, 2017 Received: February 23, 2017
Dear Danielle Lindner:
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 mav 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
1
the quality systems (OS) 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 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.
Mary S. Runner -A
Lori Wiggins 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) K170541
Device Name
Anorganic Bone Mineral in Delivery Applicator
Indications for Use (Describe)
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 conjuncts 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.
| Type of Use (Select one or both, as applicable) |
|---|
| Experimental Use (Applicable to STEs Only) - Project or Pilot |
| Routine Use (Applicable to STEs Only) - Production |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY K170541
Applicant Information
| Applicant Name: | Collagen Matrix, Inc. |
|---|---|
| Owner Operator No.: | 9043463 |
| Address: | 15 Thornton Road |
| Oakland, New Jersey 07436 | |
| Telephone: | (201) 405-1477 |
| Fax: | (201) 405-1355 |
| Contact Person: | Danielle Lindner |
| Senior Regulatory Affairs Associate II | |
| (201) 405 -1477 | |
| dlindner@collagenmatrix.com | |
| cc: | Peggy Hansen |
| Senior VP, Quality and Regulatory Affairs | |
| (201) 405 -1477 | |
| phansen@collagenmatrix.com | |
| Date Prepared: | February 21, 2017 |
Name of Device
| Trade Name: | 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) Anorganic Bone Mineral (K043034) Anorganic Bone Mineral with Collagen (K043034) Anorganic Bone Mineral with Collagen Blocks (K043034)
4
| Reference Predicates: | Porcine Anorganic Bone Mineral in Delivery Applicator
K162158
21 CFR 872.3930
Bone Grafting Material
Class II
NPM |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| | Geistlich Bio-Oss Pen®
K120601
21 CFR 872.3930
Bone Grafting Material
Class II
NPM |
Description of the Device
Anorganic Bone Mineral in Delivery Applicator are porous bone mineral matrices consisting of calcium phosphate derived from bovine bone without the addition of bovine type I collagen, preloaded into a delivery applicator for ease of placement in the defect site. The anorganic bone mineral component is produced by removal of the organic components from bovine bone. Anorganic Bone Mineral in Delivery Applicator is sterilized by gamma irradiation. The products are non-pyrogenic and for single use only.
Indications for Use
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.
5
Page 3 of 3
Summary/Comparison of Technical Characteristics
The delivery applicator has been designed to deliver the anorganic bone mineral products to the intended treatment area that may be more difficult to reach. The significant 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.
| Feature | Anorganic Bone Mineral in Delivery
Applicator (Subject Device) | Anorganic Bone Mineral with or
without Collagen (K043034) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | - 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
- Elevation of maxillary sinus floor
- Filling of periodontal and peri-implant
defects in conjunction with products
intended for GTR and GBR | - 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
- Elevation of maxillary sinus floor
- Filling of periodontal and peri-implant
defects in conjunction with products
intended for GTR and GBR |
| Material | Anorganic Bone Mineral | Anorganic Bone Mineral with or without
Purified Type I Collagen |
| Source | Bovine bone (anorganic bone mineral) | Bovine bone (anorganic bone mineral)
with or without bovine tendon (collagen) |
| Composition | Granules: 100% anorganic bone mineral | Granules: 100% anorganic bone mineral
Granules with Collagen:
90% anorganic bone mineral & 10%
collagen |
| Sizes | 0.25 cc, 0.5 cc, 0.75 cc, 1.0 cc | 0.25 g, 0.5 g, 1.0 g, 2.0 g |
| Particle Size Range | 0.25 - 1.0 mm | 0.25 - 1.0 mm (small particle size)
1.0 - 2.0 mm (large particle size) |
| Biocompatibility | Biocompatible | Biocompatible |
| Packaging | Plastic delivery applicator in a single
blister tray with Tyvek lid | Glass vial with plastic screw cap in a
single blister with Tyvek lid |
| Plunger Force | 8.18 ± 3.8 N | Not applicable |
6
| Feature | Anorganic Bone Mineral in Delivery
Applicator (Subject Device) | Anorganic Bone Mineral with or
without Collagen (K043034) |
|--------------|-------------------------------------------------------------------|--------------------------------------------------------------|
| Sterility | Gamma irradiation
SAL 10-6 | Gamma irradiation
SAL 10-6 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Single Use | Single Use Only | Single Use Only |
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 Bone Mineral (previously submitted in the company's own predicate device premarket notification and applicable to the subject device): cytotoxicity, sensitization, irritation, 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 Bone Mineral derived from porcine bone . tissue (K140714) in an intraoral defect in a canine model and the Anorganic Bone Mineral with and without Collagen (K043034) in a rabbit femoral condyle defect model.
Conclusion
The results of the in vitro product characterization studies, functionality testing, animal performance testing, and biocompatibility studies show that the Anorganic Bone Mineral in Delivery Applicator is substantially equivalent to its predicate device.