(67 days)
No
The device description and performance studies focus on the material properties and biological performance of a bone graft material, with no mention of AI or ML.
Yes
The device is used for reconstructive treatment and filling of defects in various anatomical sites, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is described as an osteoconductive bone mineral with collagen composite for bone grafting, used for augmentation, reconstruction, and filling of various bone and periodontal defects. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical bone mineral and collagen composite in block form, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures for bone grafting and tissue regeneration within the body. This involves direct interaction with the patient's tissues.
- Device Description: The device is a bone mineral and collagen composite intended for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
Porcine Mineral Collagen Composite Moldable is indicated for:
- · 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
Porcine Mineral Collagen Composite Moldable is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal, oral and maxillofacial surgery. The device is composed of 90% anorqanic bone mineral granules derived from porcine cancellous bone and 10% collagen from porcine Achilles tendon in a composite matrix. The product is supplied sterile, non-pyrogenic and for single use only.
Porcine Mineral Collagen Composite Moldable is provided in a block form and is available in three sizes, 0.5cc, 1.0cc, and 2.0cc.
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, peri-implant defects.
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)
In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device to its predicate devices.
Biocompatibility Testing: A series of in vitro and in vivo biocompatibility testing was performed to assess the safety of the subject device. Testing was determined in accordance with ISO 10993-1 and FDA Guidance on Use of International Standard ISO 10993-1. Tests included Cytotoxicity (L929 MEM Elution Test, ISO 10993-5), Genotoxicity (Mouse Lymphoma Assay, ISO 10993-3; Ames Assay), Sensitization (Guinea Pig Maximization, ISO 10993-10), Irritation Intracutaneous Reactivity (ISO Intracutaneous Reactivity in Rabbits, ISO 10993-10), Acute Systemic Toxicity (Acute Systemic Toxicity in Mice, ISO 10993-3), Pyrogenicity (USP (151) Rabbit Pyrogen Study; USP Bacterial Endotoxin Test), Implantation (Implantation in Canine Intrabony Defect Model, ISO 10993-6), and Subacute / Subchronic / Chronic Toxicity (Implantation in Canine Intrabony Defect Model, ISO 10993-11).
Bench Testing: In vitro product characterization testing was performed to evaluate material properties, biological properties, chemical and physical properties. Testing of the anorganic bone mineral component was conducted in accordance with ASTM F1581. Tests included Mineral Content, Size, Calcium to Phosphate Ratio (mineral only), Scanning Electron Micrograph (SEM), X-Ray Diffraction, IR Spectroscopy, Density, pH, Absorbency, and Pyrogenicity.
Animal Testing: The performance of the device in a canine one-wall intrabony defect model was compared to the performance of the reference device, Bio-Oss Collagen. Radiographic, Micro CT, Histology and Histomorphometry analyses were conducted following implantation at 4, 8, and 13 weeks for the subject device, reference device and sham negative control. Key results: The results demonstrate performance substantially equivalent to the reference device Bio-Oss Collagen when used as intended.
Clinical Studies: Clinical performance data was not required to determine substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Biocompatibility Test Results:
Cytotoxicity: Non-cytotoxic
Genotoxicity: No evidence of causing increase in the mean mutant frequency of the L5178Y/TK+/- cell line either in the presence or absence of metabolic inactivation. The test article was not mutagenic. Non-mutagenic to Salmonella typhimurium and to Escherichia coli strain WP2uvra.
Sensitization: No evidence of causing delayed dermal contact sensitization in the guinea pig.
Irritation Intracutaneous Reactivity: No evidence of irritation or toxicity.
Acute Systemic Toxicity: No mortality or evidence of systemic toxicity.
Pyrogenicity: Non-pyrogenic.
Implantation: Minimum tissue reaction up to 13 weeks of implantation and no adverse tissue reaction to the host.
Subacute / Subchronic / Chronic Toxicity: Minimum tissue reaction up to 13 weeks of implantation and no adverse tissue reaction to the host.
Bench Test Results:
Mineral Content: Mineral content similar to predicate device.
Size: Volumes similar to predicate device.
Calcium to Phosphate Ratio (mineral only): Ratio similar to predicate device.
Scanning Electron Micrograph (SEM): Morphologies similar to reference device.
X-Ray Diffraction: Similar diffraction patterns to reference device.
IR Spectroscopy: Similar functional groups to reference device.
Density: Appropriate density for sufficient porosity.
pH: pH similar to predicate device.
Absorbency: Absorbency similar to predicate device.
Pyrogenicity: Non-pyrogenic.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 11, 2020,
Collagen Matrix, Inc. Gloria Zuclich Director, Regulatory Affairs 15 Thornton Road Oakland, New Jersey 07436
Re: K201859
Trade/Device Name: Porcine Mineral Collagen Composite Moldable Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: July 1, 2020 Received: July 6, 2020
Dear Gloria Zuclich:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201859
Device Name
Porcine Mineral Collagen Composite Moldable
Indications for Use (Describe)
Porcine Mineral Collagen Composite Moldable is indicated for:
- · 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) |
|---|
| Reproduction Use (Part 31 CFR 301, Subpart C) One-Time Screening Use (31 CFR 301, Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
| 1. | Applicant Information | |
|---|---|---|
| Applicant Name: | ||
| Address: | ||
| Telephone: | ||
| Fax: | Collagen Matrix, Inc. | |
| 15 Thornton Road | ||
| Oakland, New Jersey 07436 | ||
| (201) 405-1477 | ||
| (201) 405-1355 | ||
| Contact Person: | Gloria Zuclich | |
| Director of Regulatory Affairs | ||
| gzuclich@collagenmatrix.com | ||
| Date Prepared: | September 08, 2020 | |
| 2. | Name of the Device | |
| Device Trade Name: | Porcine Mineral Collagen Composite Moldable | |
| Device Common Name(s): | Bone Grafting Material | |
| Device Classification Name: | Bone Grafting Material, Animal Source | |
| 872.3930 | ||
| NPM | ||
| Class II | ||
| 3. | Legally Marketed Devices to Which Substantial Equivalence is Claimed | |
| Primary Predicate Device: | Porcine Anorganic Bone Mineral | |
| Collagen Matrix, Inc. | ||
| K140714 | ||
| Reference Device(s): | Bio-Oss® Collagen | |
| Geistlich-Pharma AG | ||
| K033815 | ||
| Collagen Dental Membrane - Porcine Type I | ||
| Collagen | ||
| Collagen Matrix, Inc. | ||
| K110600 | ||
| Collagen Dental Wound Dressings | ||
| Collagen Matrix, Inc. | ||
| K122115 |
4. Description of the Device
Porcine Mineral Collagen Composite Moldable is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal, oral and maxillofacial surgery. The device is
4
composed of 90% anorqanic bone mineral granules derived from porcine cancellous bone and 10% collagen from porcine Achilles tendon in a composite matrix. The product is supplied sterile, non-pyrogenic and for single use only.
Porcine Mineral Collagen Composite Moldable is provided in a block form and is available in three sizes, 0.5cc, 1.0cc, and 2.0cc.
5. Intended Use
Porcine Mineral Collagen Composite Moldable is indicated for:
- . 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.
6. Summary/Comparison of Technical Characteristics
The subject device and the predicate device have the same indications for use.
The subject device has substantially equivalent technological characteristics as the cited legally marketed predicate device. Differences include the physical form, material composition and product range volumes. Differences in the physical form and material composition have been determined to be minor and are substantiated when compared to that of the cited reference devices. The difference in product range volume offered for the subject device falls within the range supplied for the primary predicate device.
| Feature | Porcine Mineral Collagen
Composite Moldable
(This Submission) | Porcine Anorganic Bone
Mineral
(K140714) | Bio-Oss® Collagen
(K033815) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 to enhance
preservation of the
alveolar ridge Elevation of maxillary
sinus floor Filling of periodontal | 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 | Augmentation or
reconstructive treatment
of alveolar ridge Filling of 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 |
5
| defects in conjunction | defects in conjunction | defects in conjunction | |
|---|---|---|---|
| with products intended | with products intended | with products intended | |
| for Guided Tissue | for Guided Tissue | for Guided Tissue | |
| Regeneration (GTR) and | Regeneration (GTR) and | Regeneration (GTR) and | |
| Guided Bone | Guided Bone | Guided Bone | |
| Regeneration (GBR) | Regeneration (GBR) | Regeneration (GBR). | |
| Filling of peri-implant defects | |||
| in conjunction with products | |||
| intended for Guided Bone | |||
| Regeneration (GBR) | Filling of peri-implant defects | ||
| in conjunction with products | |||
| intended for Guided Bone | |||
| Regeneration (GBR) | Filing of peri-implant defects | ||
| in conjunction with products | |||
| intended for Guided Bone | |||
| Regeneration (GBR) | |||
| Physical Form | Block Shaped | Granules | Block Shaped |
| Color | White to off-white | White to off-white | White to off-white |
| Material | |||
| Composition | • Anorganic (porcine) bone | ||
| mineral | • Anorganic (porcine) bone | ||
| mineral | • Anorganic (bovine) bone | ||
| mineral | |||
| • Purified (porcine) collagen | • Purified (porcine) collagen | ||
| Product Range | |||
| (volume) | 0.5 cc to 2.0 cc | 0.5 cc to 4.0 cc | 0.2 cc to 1.2 cc |
| Biocompatible | Biocompatible | Biocompatible | |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 |
| Sterile, SAL 10-6 | Sterile, SAL 10-6 | Sterile, SAL 10-6 | |
| Sterility | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| ISO 11137 | ISO 11137 | ||
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic |
| Single Use/ | |||
| Reuse | Single use only | Single use only | Single use only |
7. Performance Data
In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device to its predicate devices. The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing
A series of in vitro and in vivo biocompatibility testing was performed to assess the safety of the subject device. Testing was determined in accordance with ISO 10993-1 and FDA Guidance on Use of International Standard ISO 10993-1 for the biological evaluation of medical devices within a risk management process. The biocompatibility testing performed is summarized in the table below.
| Test | Test Method | Results |
|---|---|---|
| Cytotoxicity | L929 MEM Elution Test, ISO | |
| 10993-5 | Non-cytotoxic | |
| Genotoxicity | Mouse Lymphoma Assay, ISO | |
| 10993-3 | No evidence of causing increase | |
| in the mean mutant frequency of | ||
| the L5178Y/TK+/- cell line either in | ||
| the presence or absence of | ||
| metabolic inactivation. The test | ||
| article was not mutagenic | ||
| Ames Assay | Non-mutagenic to Salmonella | |
| typhimurium and to Escherichia |
6
| Test | Test Method | Results |
|---|---|---|
| coli strain WP2uvra | ||
| Sensitization | Guinea Pig Maximization, | |
| ISO 10993-10 | No evidence of causing delayed | |
| dermal contact sensitization in the | ||
| guinea pig | ||
| Irritation Intracutaneous | ||
| Reactivity | ISO Intracutaneous Reactivity | |
| in Rabbits, ISO 10993-10 | No evidence of irritation or toxicity | |
| Acute Systemic | ||
| Toxicity | Acute Systemic Toxicity in | |
| Mice, ISO 10993-3 | No mortality or evidence of | |
| systemic toxicity | ||
| Pyrogenicity | USP (151) Rabbit Pyrogen | |
| Study | ||
| USP Bacterial Endotoxin | ||
| Test | Non-pyrogenic | |
| Implantation | Implantation in Canine | |
| Intrabony Defect Model, ISO | ||
| 10993-6 | Minimum tissue reaction up to 13 | |
| weeks of implantation and no | ||
| adverse tissue reaction to the host | ||
| Subacute / Subchronic / | ||
| Chronic Toxicity | Implantation in Canine | |
| Intrabony Defect Model, ISO | ||
| 10993-11 | Minimum tissue reaction up to 13 | |
| weeks of implantation and no | ||
| adverse tissue reaction to the host |
Bench Testing
In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate devices. A series of bench tests were conducted to evaluate material properties, biological properties, chemical and physical properties as indicated. Testing of the anorganic bone mineral component was conducted in accordance with ASTM F1581 Standard Specifications for Composition of Anorganic Bone for Surgical Implants.
| Test | Results |
|---|---|
| Mineral Content | Mineral content similar to predicate device |
| Size | Volumes similar to predicate device |
| Calcium to Phosphate | |
| Ratio (mineral only) | Ratio similar to predicate device |
| Scanning Electron | |
| Micrograph (SEM) | Morphologies similar to reference device |
| X-Ray Diffraction | Similar diffraction patterns to reference device |
| IR Spectroscopy | Similar functional groups to reference device |
| Density | Appropriate density for sufficient porosity |
| pH | pH similar to predicate device |
| Absorbency | Absorbency similar to predicate device |
| Pyrogenicity | Non-pyrogenic |
7
Animal Testing
The performance of the device in a canine one-wall intrabony defect model was compared to the performance of the reference device. Bio-Oss Collagen. Radiographic, Micro CT, Histology and Histomorphometry analyses were conducted following implantation at 4, 8, and 13 weeks for the subiect device, reference device and sham negative control. The results demonstrate performance substantially equivalent to the reference device Bio-Oss Collagen when used as intended.
Animal Tissue Management
Animal tissues are managed in accordance with the following standards and quidance documents:
- ISO 22442-1 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical . Devices - Part 1: Analysis and Risk Management
- . ISO 22442-2 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 2: Controls on Sourcing, Collection, and Handling
- ISO 22442-3 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical . Devices – Part 3: Validation of the Elimination and/or Inactivation of Viruses and Transmissible Agents
- Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro . Diagnostic Devices) Guidance for Industry and Food and Drug Administration Staff, CDRH, FDA, March 15, 2019
- FDA Guidance for Industry Q5A Viral Safety Evaluation of Biotechnology Products . Derived from Cell Lines of Human or Animal Origin, CDER, September 1998
Sterilization
Sterilization validation was performed in accordance with ISO 11137-1 Sterilization of health care products - Radiation.
Shelf Life and Stability
Product and packaging stability was determined using real-time aging data. Performance testing of packaging system was tested in accordance with ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems.
Viral Inactivation
Viral inactivation studies were performed in accordance with ISO 22442-3 to ensure the viral safety of the product.
Clinical Studies
Clinical performance data was not required to determine substantial equivalence.
8. Conclusions Drawn from Non-clinical Studies
The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate devices.