Anorganic Bone Mineral in Delivery Applicator

K170541 · Collagen Matrix, Inc. · NPM · Jul 7, 2017 · Dental

Device Facts

• Record ID: K170541
• Device Name: Anorganic Bone Mineral in Delivery Applicator
• Applicant: Collagen Matrix, Inc.
• Product Code: NPM · Dental
• Decision Date: Jul 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Porous bovine-derived calcium phosphate bone mineral matrix; preloaded into plastic delivery applicator. Used in dental surgery by clinicians to fill bone defects or augment alveolar ridges. Applicator facilitates placement in difficult-to-reach sites; plunger force 8.18 ± 3.8 N. Single-use; gamma-sterilized. Provides scaffold for bone regeneration; does not actively participate in healing beyond structural support. Clinician manually dispenses material into defect site; aids in bone preservation and reconstruction.

Clinical Evidence

No clinical data. Evidence includes biocompatibility testing (cytotoxicity, irritation, sensitization), USP <661> physicochemical testing for plastics, and sterilization validation per ISO 11137-1. Animal performance testing conducted in canine intraoral defect models and rabbit femoral condyle defect models to confirm bone mineral efficacy.

Technological Characteristics

Bovine-derived anorganic bone mineral (calcium phosphate). Granule size 0.25-1.0 mm. Delivery applicator: plastic, single-use, plunger force 8.18 ± 3.8 N. Sterilization: Gamma irradiation (SAL 10^-6). Biocompatibility per ISO 10993. Packaging: blister tray with Tyvek lid.

Indications for Use

Indicated for dental surgery patients requiring alveolar ridge augmentation, filling of infrabony periodontal defects, root resection/apicoectomy/cystectomy defect filling, 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

• Anorganic Bone Mineral (K043034)
• Anorganic Bone Mineral with Collagen (K043034)
• Anorganic Bone Mineral with Collagen Blocks (K043034)

Reference Devices

• Porcine Anorganic Bone Mineral in Delivery Applicator (K162158)
• Geistlich Bio-Oss Pen (K120601)

Submission Summary (Full Text)

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### 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

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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 [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.

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

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# 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) |
|-------------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Experimental Use (Applicable to STEs Only) - Project or Pilot</label> |
| <label><input type="checkbox"/> Routine Use (Applicable to STEs Only) - Production</label> |

|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 K170541

# Applicant Information

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

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| Reference Predicates: | Porcine Anorganic Bone Mineral in Delivery Applicator<br>K162158<br>21 CFR 872.3930<br>Bone Grafting Material<br>Class II<br>NPM |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| | Geistlich Bio-Oss Pen®<br>K120601<br>21 CFR 872.3930<br>Bone Grafting Material<br>Class II<br>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.

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# 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<br>Applicator (Subject Device) | Anorganic Bone Mineral with or<br>without Collagen (K043034) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | - Augmentation or reconstructive<br>treatment of alveolar ridge<br>- Filling of infrabony periodontal defects<br>- Filling of defects after root resection,<br>apicoectomy, and cystectomy<br>- Filling of extraction sockets<br>- Elevation of maxillary sinus floor<br>- Filling of periodontal and peri-implant<br>defects in conjunction with products<br>intended for GTR and GBR | - Augmentation or reconstructive<br>treatment of alveolar ridge<br>- Filling of infrabony periodontal defects<br>- Filling of defects after root resection,<br>apicoectomy, and cystectomy<br>- Filling of extraction sockets<br>- Elevation of maxillary sinus floor<br>- Filling of periodontal and peri-implant<br>defects in conjunction with products<br>intended for GTR and GBR |
| Material | Anorganic Bone Mineral | Anorganic Bone Mineral with or without<br>Purified Type I Collagen |
| Source | Bovine bone (anorganic bone mineral) | Bovine bone (anorganic bone mineral)<br>with or without bovine tendon (collagen) |
| Composition | Granules: 100% anorganic bone mineral | Granules: 100% anorganic bone mineral<br>Granules with Collagen:<br>90% anorganic bone mineral & 10%<br>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)<br>1.0 - 2.0 mm (large particle size) |
| Biocompatibility | Biocompatible | Biocompatible |
| Packaging | Plastic delivery applicator in a single<br>blister tray with Tyvek lid | Glass vial with plastic screw cap in a<br>single blister with Tyvek lid |
| Plunger Force | 8.18 ± 3.8 N | Not applicable |

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| Feature | Anorganic Bone Mineral in Delivery<br>Applicator (Subject Device) | Anorganic Bone Mineral with or<br>without Collagen (K043034) |
|--------------|-------------------------------------------------------------------|--------------------------------------------------------------|
| Sterility | Gamma irradiation<br>SAL 10-6 | Gamma irradiation<br>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 <661>
- 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.