(209 days)
No
The device description and performance studies focus on the material properties and delivery mechanism of a bone graft substitute, with no mention of AI or ML.
Yes
The device, an Anorganic Bone Mineral with Collagen, is intended for use in dental surgery to augment, reconstruct, and fill various defects in bone tissue. These applications are therapeutic in nature, aiming to treat or alleviate a disease or injury (e.g., bone loss, periodontal defects) and promote healing.
No.
The device is a bone mineral matrix with collagen intended for use in dental surgical procedures to augment or reconstruct bone, fill defects, or preserve alveolar ridge, rather than to diagnose medical conditions or diseases.
No
The device is a physical bone mineral matrix with collagen, pre-loaded into a delivery applicator. The description details the material composition and physical form, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as being for use in dental surgery for various bone grafting and augmentation procedures. This involves direct application to the patient's body during a surgical procedure.
- Device Description: The device is a bone mineral matrix with collagen pre-loaded into a delivery applicator. This is a material intended to be implanted or placed within the body to facilitate bone regeneration.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The device described is a medical device used in a surgical setting, specifically for bone grafting and augmentation in dental procedures. It is not designed to diagnose conditions based on in vitro testing of biological samples.
N/A
Intended Use / Indications for Use
Anorganic Bone Mineral with Collagen 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 with Collagen in Delivery Applicator are porous bone mineral matrices consisting of calcium phosphate derived from bovine bone with the addition of bovine type I collagen, pre-loaded 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. The type I collagen component is derived from bovine Achilles tendon. Anorganic Bone Mineral with Collagen 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 and 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 . physicochemical (material/chemical) characterization testing of non-aged and 36 month real time aged delivery applicators with extraction conditions and methods in accordance with ISO 10993-12 and ISO 10993-18.
- Biocompatibility of Anorganic Bone Mineral and Purified Type I Collagen (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 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.
- Animal performance testing of the Purified Type I Collagen derived from bovine Achilles ● tendon in a rat subcutaneous implantation study.
The results of the in vitro product characterization studies, functionality testing, animal performance testing, and biocompatibility studies show that the Anorganic Bone Mineral with Collagen 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.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the next line.
October 30, 2017
Collagen Matrix, Inc. Danielle Lindner Senior Regulatory Affairs Associate II 15 Thornton Road Oakland, New Jersey 07436
Re: K171008
Trade/Device Name: Anorganic Bone Mineral with Collagen in Delivery Applicator Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: September 26, 2017 Received: September 28, 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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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 -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
Anorganic Bone Mineral with Collagen in Delivery Applicator
Indications for Use (Describe)
Anorganic Bone Mineral with Collagen 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) | ||||
|---|---|---|---|---|
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
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: | Peggy Hansen |
| Senior VP, Quality and Regulatory Affairs | |
| (201) 405 -1477 | |
| phansen@collagenmatrix.com | |
| Date Prepared: | September 25, 2017 |
Name of Device
| Trade Name: | Anorganic Bone Mineral with Collagen 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 |
|---|---|
| Anorganic Bone Mineral with Collagen | |
| Anorganic Bone Mineral with Collagen Blocks |
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 with Collagen in Delivery Applicator are porous bone mineral matrices consisting of calcium phosphate derived from bovine bone with the addition of bovine type I collagen, pre-loaded 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. The type I collagen component is derived from bovine Achilles tendon. Anorganic Bone Mineral with Collagen in Delivery Applicator is sterilized by gamma irradiation. The products are non-pyrogenic and for single use only.
Indications for Use
Anorganic Bone Mineral with Collagen 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
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 with Collagen
in Delivery Applicator (Subject Device) | Anorganic Bone Mineral with 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 with Purified Type
I Collagen | Anorganic Bone Mineral with Purified Type
I Collagen |
| Source | Bovine bone (anorganic bone mineral) with
bovine tendon (collagen) | Bovine bone (anorganic bone mineral) with
bovine tendon (collagen) |
| Form: | Preformed Plug & Moldable Plug | Block |
| Sizes | 0.25 cc, 0.5 cc, 1.0 cc | 0.25 g, 0.5 g, 1.0 g, 2.0 g |
| Biocompatibility | Biocompatible for the cleared indications
for use | Biocompatible for the cleared indications
for use |
| 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 | 4.5 N ± 1.3 N (preformed plug)
4.1 N ± 1.1 N (moldable plug) | Not applicable |
| Sterility | Gamma irradiation, SAL 10⁻⁶ | Gamma irradiation, SAL 10⁻⁶ |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Single Use | Single Use Only | Single Use Only |
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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 . physicochemical (material/chemical) characterization testing of non-aged and 36 month real time aged delivery applicators with extraction conditions and methods in accordance with ISO 10993-12 and ISO 10993-18.
- Biocompatibility of Anorganic Bone Mineral and Purified Type I Collagen (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 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.
- Animal performance testing of the Purified Type I Collagen derived from bovine Achilles ● tendon in a rat subcutaneous implantation study.
Conclusion
The results of the in vitro product characterization studies, functionality testing, animal performance testing, and biocompatibility studies show that the Anorganic Bone Mineral with Collagen in Delivery Applicator is substantially equivalent to its predicate device.