OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS

K043034 · Collagen Matrix, Inc. · NPM · Aug 4, 2005 · Dental

Device Facts

• Record ID: K043034
• Device Name: OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS
• Applicant: Collagen Matrix, Inc.
• Product Code: NPM · Dental
• Decision Date: Aug 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OsteoGuide Anorganic Bone Mineral Products are 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 periodontal defects Filling of defects after root resection, apicocectomy, 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

OsteoGuide products are natural, porous bone mineral matrices derived from bovine bone; organic components removed. OsteoGuide Collagen and Blocks variants incorporate purified fibrillar type I collagen. Supplied as sterile, single-use granules or blocks. Used by dental surgeons in clinical settings for bone grafting procedures; provides scaffold for bone regeneration. Acts as osteoconductive material; physically and chemically comparable to human bone mineral. Enhances structural support in dental defects; facilitates healing in conjunction with GTR/GBR membranes.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established via in vitro product characterization and in vitro/in vivo biocompatibility studies.

Technological Characteristics

Natural bovine-derived anorganic bone mineral matrix; optional addition of purified fibrillar type I collagen. Composition meets ASTM F1581-99. Supplied as granules or blocks. Sterile, non-pyrogenic, single-use. Osteoconductive scaffold.

Indications for Use

Indicated for dental surgery patients requiring bone grafting for alveolar ridge augmentation, periodontal defect filling, root resection/apicocectomy/cystectomy defect filling, extraction socket preservation, maxillary sinus floor elevation, or peri-implant defect filling 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

• Bio-Oss®, Bio-Oss® Blocks, Bio-Oss® Collagen (K033815)
• Bio-Oss® Granules (K952617)
• Bio-Oss® Blocks (K970569)
• Bio-Oss® Collagen (K974399)

Submission Summary (Full Text)

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- AUG 4 2005
K043034

#### 510(k) Summary of Safety and Effectiveness

| Applicant Name and Address: Collagen Matrix, Inc. | 509 Commerce Street<br>Franklin Lakes, New Jersey 07417 |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC<br>Director, Clinical, Regulatory, and Quality Assurance<br>Tel: [phone]<br>Fax: [phone] |
| Date of Summary: | February 17, 2005 |
| Device Common Name: | Bone Grafting Material |
| Device Trade Name: | OsteoGuide™ Anorganic Bone Mineral<br>OsteoGuide Collagen™ Anorganic Bone Mineral with<br>Collagen<br>OsteoGuide Blocks™ Anorganic Bone Mineral with<br>Collagen Blocks |
| Device Classification Name: | Bone Grafting Material<br>Unclassified<br>NPM |
| Predicate Device(s): | Bio-Oss®, Bio-Oss® Blocks, Bio-Oss® Collagen, K033815<br>Bio-Oss® Granules, K952617<br>Bio-Oss® Blocks, K970569<br>Bio-Oss® Collagen, K974399 |

#### Description of the Device

"OsteoGuide™ Anorganic Bone Mineral," "OsteoGuide Collagen™ Anorganic Bone Mineral with Collagen,"and "OsteoGuide Blocks™ Anorganic Bone Mineral with Collagen Blocks" are natural, porous bone mineral matrices with and without collagen. The anorganic bone mineral is produced by removal of all organic components from bovine bone. Due to its natural structure, the anorganic bone mineral component of the OsteoGuide products is physically and chemically comparable to the mineralized matrix of human bone. The composition of OsteoGuide Anorganic Bone Mineral meets the requirements of ASTM F1581-99 Standard Specification for Composition of Anorganic bone for Surgical Implants. OsteoGuide Collagen and OsteoGuide Blocks are product extensions that include highly purified fibrillar type I collagen mixed in with the anorganic bone mineral. The product is supplied in granules or blocks, and it is sterile, non-pyrogenic, and for single use only.

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#### Intended Use

OsteoGuide Anorganic Bone Mineral Products are 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 periodontal defects
- Filling of defects after root resection, apicocectomy, 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

OsteoGuide Anorganic Bone Mineral Products and their predicates have the same technological characteristics. In particular, the OsteoGuide Anorganic Bone Mineral Products and their predicates are the same with respect to intended use, material, material characterization, form, and sizes.

#### Safety

OsteoGuide Anorganic Bone Mineral Products have been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.

#### Effectiveness

The characteristics of the OsteoGuide Anorganic Bone Mineral Products meet the design requirements for an effective bone grafting material.

#### Conclusion

The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, show that the OsteoGuide Anorganic Bone Mineral Products are safe and substantially equivalent to Bio-Oss Granules, Bio-Oss Collagen, and Bio-Oss Blocks.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 - 2005

Ms. Peggy Hansen Director, RAC Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K043034

Trade/Device Name: Osteoguide Anorganic Bone Mineral Products Regulation Number: 21 CFR 872.3930 Regulation Name: Tricalcium phosphate granules for dental bone repair Regulatory Class: II Product Code: NPM Dated: July 21, 2005 Received: July 22, 2005

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# <043034

## Indications for Use

| 510(k) Number (if known): | |
|---------------------------|------------------------------------------------------------------|
| Device Name: | OsteoGuide™ Anorganic Bone Mineral |
| | OsteoGuide Collagen™ Anorganic Bone Mineral with Collagen |
| | OsteoGuide Blocks™ Anorganic Bone Mineral with Collagen - Blocks |

Indications for Use:

Natural Mineral Bone Graft Substitutes are 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 periodontal defects
- Filling of defects after root resection, apicocectomy, 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

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)

Siva Russo

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K043034

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