PORCINE ANORGANIC BONE MINERAL

K140714 · Collagen Matrix, Inc. · NPM · Jul 16, 2014 · Dental

Device Facts

• Record ID: K140714
• Device Name: PORCINE ANORGANIC BONE MINERAL
• Applicant: Collagen Matrix, Inc.
• Product Code: NPM · Dental
• Decision Date: Jul 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Porcine Anorganic Bone Mineral 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, apicoectorny, and cystectorny - 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

Device Story

Porcine Anorganic Bone Mineral; porous, granular bone graft material derived from porcine bone via removal of organic components. Used in dental surgeries by clinicians to support new bone formation/ingrowth when autogenous bone is insufficient or contraindicated. Supplied sterile, non-pyrogenic, single-use. Implanted at surgical site; provides osteoconductive scaffold. Benefits patient by facilitating bone regeneration in defects or augmentation sites. Evaluated via bench testing (physicochemical properties, resorption profile) and animal efficacy studies (dog dental intrabony defect, rabbit femoral condyle).

Clinical Evidence

No human clinical data. Evidence based on bench testing (material characterization, physicochemical properties, resorption profile) and two animal efficacy studies (dog dental intrabony defect model and rabbit femoral condyle defect model). Biocompatibility testing performed per ISO 10993 standards (genotoxicity, cytotoxicity, systemic toxicity, local effects). Viral inactivation studies conducted per ISO 22442.

Technological Characteristics

Granular bone graft material; composition: calcium phosphate (carbonate apatite); particle size: 0.25–1 mm and 1–2 mm; pH: 6–9.5. Meets ASTM F1581 standards. Biocompatible, porous structure. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for dental surgery patients requiring bone grafting for alveolar ridge augmentation, infrabony periodontal defects, root resection/apicoectomy/cystectomy defects, extraction socket preservation, maxillary sinus floor elevation, or peri-implant defects, often in conjunction with GTR/GBR products.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OsteoGuide™ Anorganic Bone Mineral (K043034)
• Bio-Oss® Granules (K952617)

Submission Summary (Full Text)

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# JUL 16 2014

## 510(k) SUMMARY

| 1. | Applicant Information | |
|----|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Applicant Name:<br>Address: | Collagen Matrix, Inc.<br>15 Thornton Road<br>Oakland, New Jersey 07436 |
| | Telephone:<br>Fax:<br>Contact Person: | [phone]<br>[phone]<br>Peggy Hansen, RAC<br>VP, Clinical, Regulatory, QA, and Marketing |
| | Date Prepared: | June 16, 2014 |
| 2. | Name of the Device | |
| | Device Trade Name:<br>Device Common Name:<br>Device Classification Name: | Porcine Anorganic Bone, Mineral<br>Bone Grafting Material<br>Bone Grafting Material, Animal Source<br>21 CFR 872.3930<br>Product Code NPM<br>Device Class II |
| 3. | Legally Marketed Devices to Which Substantial Equivalence is Claimed | |
| | Predicate Device(s): | OsteoGuide™ Anorganic Bone Mineral<br>K043034 |
| | | Bio-Oss® Granules<br>K952617 |

## 4. Description of the Device

Porcine Anorganic Bone Mineral is a porous bone graft material consisting predominantly of calcium phosphate supplied in granular form for use in dental surgeries. The anorganic bone mineral is produced by removal of the organic components from porcine bone. The composition of Porcine Anorganic Bone Mineral meets the requirements of ASTM F1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. The anorganic bone mineral matrix is biocompatible, having interconnecting macro- and microscopic porous structure that supports the formation and ingrowth of new bone at the implantation site. The use of Porcine Anorganic Bone Mineral may be considered when autogenous bone is not indicated, or insufficient in quantity to fulfill the needs of the proposed surgical procedure.

The granular product is supplied sterile, non-pyrogenic, and for single use only.

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#### ર. Intended Use

Porcine Anorganic Bone Mineral 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 l
- Filling of defects after root resection, apicoectorny, and cystectorny -
- 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)
- l Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration

#### 6. Summary of Technical Characteristics

Porcine Anorganic Bone Mineral has been determined to be substantially equivalent to the predicate devices having similar technological characteristics as follows:

| Appearance: | White to off-white granules |
|-----------------------|---------------------------------|
| Mineral Structure: | Carbonate Apatite |
| Material Composition: | Calcium Phosphate |
| Particle Size: | 0.25 – 1 mm and 1 – 2 mm |
| pH: | 6 - 9.5 |
| Nitrogen Content: | Meets Specification (ASTM 1581) |

The final composition of the anorganic bone mineral for both devices consists of a calcium phosphate mineral in a carbonate apatite that is produced by removal of organic components from the bone tissue structure.

#### 7. Discussion of Non-clinical Testing

The substantial equivalence of Porcine Anorganic Bone Mineral and its predicates was demonstrated based on in vitro characterization studies, biocompatibility studies, and animal efficacy studies.

Non-clinical testing was performed in accordance with FDA recognized consensus standards and FDA quidelines as follows:

FDA Guidance Document entitled, "Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices," issued on April 28, 2005

ASTM F1581, Standard specifications for composition of anorganic bone for surgical implants.

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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

ISO 10993-3:2009 Biological Evaluation of Medical Devices- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in vitro cytotoxicity

ISO 10993-6:2009 Biological Evaluation of Medical Devices- Part 6: Test for local effects after implantation

ISO 10993-10:2009 Biological Evaluation of Medical Devices- Part 10 Test for local effects after implantation

ISO 10993-11:2009 Biological Evaluation of Medical devices – Part 11 Tests for systemic toxicity

#### Non-clinical Testing Conducted

Material characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate devices. A series of bench tests were conducted to verify the design characteristics such as material composition. structure, physic-chemical properties and resorption profile as compared to the predicate devices.

A series of in vitro and in vivo biocompatibility testing was performed to assess safety of the Porcine Anorganic Bone Mineral as an implantable material.

Two separate animal efficacy studies were conducted to evaluate the device as compared to its predicate device; one in a dog dental intrabony defect model and the other in a rabbit femoral condyle defect model.

Viral inactivation studies were performed to ensure the viral safety of the product.

#### 8. Conclusion of Non-clinical Studies

The results of the material characterization and biocompatibility testing, as well as animal efficacy studies show that Porcine Anorganic Bone Mineral is substantially equivalent to the identified predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human figures or shapes that are interconnected. The text is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## July 16, 2014

Collagen Matrix, Incorporated Ms. Peggy Hansen, RAC Vice President, Clinical, Regulatory, QA and Marketing 15 Thornton Road Oakland, New Jersey 07436

Re: K140714

Trade/Device Name: Porcine Anorganic Bone Mineral Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: June 16, 2014 Received: June 17, 2014

Dear Ms. 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.

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Page 2 - Ms. Hansen

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 device-related 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (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/ReportalProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Digitally signed
by Richard C.
Chapman -S
Date: 2014.07.16
08:15:10 -04'00'
for

Erin 1. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K140714 510(k) Number (if known): __

Device Name: _ Porcine Anorganic Bone Mineral

Indications for Use:

Porcine Anorganic Bone Mineral 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, apicoectorny, and cystectorny ●
- 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Sheena A. Green -S 2014.07.15 08:21:02 -04'00'

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