Porcine Anorganic Bone Mineral in Delivery Applicator

K162158 · Collagen Matrix, Inc. · NPM · Feb 9, 2017 · Dental

Device Facts

• Record ID: K162158
• Device Name: Porcine Anorganic Bone Mineral in Delivery Applicator
• Applicant: Collagen Matrix, Inc.
• Product Code: NPM · Dental
• Decision Date: Feb 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Device consists of porous porcine-derived anorganic bone mineral (calcium phosphate/carbonate apatite) pre-loaded into a plastic delivery applicator. Used in dental surgery by clinicians to deliver bone graft material to difficult-to-reach treatment sites. Applicator facilitates precise placement of granules into defects (e.g., extraction sockets, periodontal defects, sinus floor). Device is single-use, sterile, and non-pyrogenic. Clinical benefit includes enhanced bone regeneration and defect filling in dental procedures. No electronic or software components; purely mechanical delivery system.

Clinical Evidence

No clinical data. Evidence consists of bench testing (functionality, customer assessment), biocompatibility testing (cytotoxicity, irritation, sensitization, USP <661> for plastics), and sterilization validation (ISO 11137-1). Animal performance data for the bone mineral component was previously submitted under K140714.

Technological Characteristics

Material: Porcine-derived anorganic bone mineral (calcium phosphate, carbonate apatite). Form: Granules (0.25-1 mm). Delivery: Plastic applicator. Sterilization: Gamma irradiation (ISO 11137). Biocompatibility: USP <661> for plastics. pH: 7.3 ± 0.1. Resorption: Gradual.

Indications for Use

Indicated for dental surgery patients requiring alveolar ridge augmentation/reconstruction, filling of infrabony periodontal defects, filling of defects post-root resection/apicoectomy/cystectomy, extraction socket preservation, maxillary sinus floor elevation, or filling of periodontal/peri-implant defects in conjunction with GTR/GBR procedures.

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

• Porcine Anorganic Bone Mineral (K140714)

Submission Summary (Full Text)

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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.

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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 [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" (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 [phone] or [phone] 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

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## 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

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### K162158

# 510(k) SUMMARY

#### Applicant Information

| Applicant Name:<br>Owner Operator No.: | Collagen Matrix, Inc.<br>9043463 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Address: | 15 Thornton Road<br>Oakland, New Jersey 07436 |
| Telephone:<br>Fax: | [phone]<br>[phone] |
| Contact Person: | Peggy Hansen<br>Senior VP, Quality and Regulatory Affairs<br>201-405-1477<br>[e-mail] |
| cc: | Danielle Lindner<br>Senior Regulatory Affairs Associate II<br>201-405-1477<br>[e-mail] |
| 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<br>21 CFR 872.3930<br>NPM<br>Class II<br>Dental |

#### Legally Marketed Devices to Which Substantial Equivalence is Claimed

Predicate Device(s) Porcine Anorganic Bone Mineral K140714

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#### 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.

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| Feature | Porcine Anorganic Bone Mineral<br>In Delivery Applicator<br>(this submission) | Porcine Anorganic Bone Mineral<br>(K140714) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Intended for use in dental surgery. The<br>products may be used in surgical<br>procedures such as:<br>• Augmentation or reconstructive<br>treatment of alveolar ridge<br>• Filling of infrabony periodontal<br>defects<br>• Filling of defects after root resection,<br>apicoectomy, and cystectomy<br>• Filling of extraction sockets to<br>enhance preservation of the alveolar<br>ridge<br>• Elevation of maxillary sinus floor<br>• Filling of periodontal defects in<br>conjunction with products intended<br>for Guided Tissue Regeneration<br>(GTR) and Guided Bone<br>Regeneration (GBR)<br>• Filling of peri-implant defects in<br>conjunction with products intended<br>for Guided Bone Regeneration. | Intended for use in dental surgery.<br>The products may be used in surgical<br>procedures such as:<br>• Augmentation or reconstructive<br>treatment of alveolar ridge<br>• Filling of infrabony periodontal<br>defects<br>• Filling of defects after root resection,<br>apicoectomy, and cystectomy<br>• Filling of extraction sockets to<br>enhance preservation of the alveolar<br>ridge<br>• Elevation of maxillary sinus floor<br>• Filling of periodontal defects in<br>conjunction with products intended<br>for Guided Tissue Regeneration<br>(GTR) and Guided Bone<br>Regeneration (GBR)<br>• Filling of peri-implant defects in<br>conjunction with products intended<br>for Guided Bone Regeneration. |
| Material Source | Porcine Bone | Porcine Bone |
| Material<br>Composition | Calcium phosphate | Calcium phosphate |
| Mineral Structure | Carbonate apatite | Carbonate apatite |
| Form | Granules | Granules |
| Color | White to off-white | White to off-white |
| Physical<br>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<br>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<br>applicator | Plastic jar |
| Feature | Porcine Anorganic Bone Mineral<br>In Delivery Applicator<br>(this submission) | Porcine Anorganic Bone Mineral<br>(K140714) |
| Sterility | Sterile, SAL 10-6<br>Gamma irradiation<br>ISO 11137 | Sterile, SAL 10-6<br>Gamma irradiation<br>ISO 11137 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Single Use/ Reuse | 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 <661>
- 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.