CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3

K030682 · Bioform, Inc. · LYC · Jun 27, 2003 · Dental

Device Facts

• Record ID: K030682
• Device Name: CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3
• Applicant: Bioform, Inc.
• Product Code: LYC · Dental
• Decision Date: Jun 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: - Periodontal Defects - Ridge Augmentation - Extraction Sites - Craniofacial Augmentation - Cystic Defects

Device Story

Calcium Hydroxylapatite Implant is a sterile, non-pyrogenic, cohesive paste consisting of calcium hydroxylapatite particles suspended in a gel of glycerin, water, and sodium carboxymethylcellulose. The device is supplied in a syringe for direct, controlled deposition into dental or oral/maxillofacial defects. The gel binder facilitates placement and prevents particle migration; it is resorbed post-operatively, leaving the non-resorbable calcium hydroxylapatite particles to serve as an osteoconductive scaffold for bone infiltration. The device is used by clinicians in dental or oral/maxillofacial settings. By providing a ready-to-use, pre-mixed paste, the device eliminates the need for intraoperative mixing with blood or saline, reducing contamination risk and improving procedural convenience for the physician.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the history of use of the components in medical devices, preclinical testing, and the established biological mechanism of action (osteoconductive scaffold for tissue ingrowth) shared with predicate devices.

Technological Characteristics

Paste containing calcium hydroxylapatite particles (ASTM F1185) and a binder (glycerin, water, sodium carboxymethylcellulose). Resorbable binder provides controlled porosity for bone ingrowth; non-resorbable particles provide osteoconductive scaffold. Delivered via syringe. Sterile, non-pyrogenic.

Indications for Use

Indicated for filling or augmenting dental intraosseous and oral/maxillofacial defects, including periodontal defects, ridge augmentation, extraction sites, craniofacial augmentation, and cystic defects.

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

• Calcitite (K882682)
• Osteograf AR Alveolar Ridge Hydroxylapatite 18-40 (K852742)
• HA-2000 (K852765)
• Perioglas-BioGlass Bone Graft Particulate (K992416)
• Novabone-Bioglass Bone Graft Particulate (K000149)
• Biogran Bioactive Glass Synthetic Bone Graft Material (K952922)
• PermaMesh Hydroxylapatite Matrix (K921468)
• Osteograf/AR+ Permaridge Hydroxylapatite, 18-40 (K862061)
• HAPSET Hydroxylapatite Bone Graft Plaster (K910432)
• Coaptite Laryngeal Augmentation System (K013243)
• Coaptite Tissue Marker (K012955)

Submission Summary (Full Text)

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## JUN 2 7 2003

Calcium Hydroxylapatite Implant 510(k) Premarket Notification Submission

KOZOLOSA

June 25, 2003

### SECTION 4

# 510(k) Summary of Safety and Effectiveness

#### Manufacturer and Submitter Information: 4.1

BioForm Inc. 4133 Courtney Road, #10 Franksville, WI 53126 Telephone: [phone] Contact: William G. Hubbard Summary Preparation Date: June 25, 2003

| 4.2 | Device Trade Name: | Calcium Hydroxylapatite Implant |
|-----|------------------------|---------------------------------------------------------------------------------------------|
| | Common Name: | Synthetic Bone Graft Material |
| | Classification Name: | Bone Filling and Augmentation Material |
| | Device Class: | Unclassified |
| | Product Code: | LYC |
| | Medical Specialty: | Dental (DE) |
| | Performance Standards: | No applicable mandatory performance standards or<br>special controls exist for this device. |

#### Substantial Equivalent Predicate Device: 4.3

The following are the predicate devices that are substantially equivalent to the Calcium Hydroxylapatite Implant:

| K882682 | Calcitite<br>Calcitek, Inc., 4125-B Sorrento Valley Boulevard, San<br>Diego, CA 92121 |
|---------|------------------------------------------------------------------------------------------------------------------------------|
| K852742 | Osteograf AR Alveolar Ridge Hydroxylapatite 18-40<br>Coors Biomedical Company, 12860 West Cedar Drive,<br>Lakewood, CO 80228 |
| K852765 | HA-2000<br>Orthomatrix, Inc., 6968 Sierra Court, Dublin CA 94568 |
| K992416 | Perioglas-BioGlass Bone Graft Particulate<br>U.S. Biomaterials Corp., One Progress Boulevard, Alachua,<br>FL 32615 |
| K000149 | Novabone-Bioglass Bone Graft Particulate<br>U.S. Biomaterials Corp., One Progress Boulevard, Alachua,<br>FL 32615 |
| K952922 | Biogran Bioactive Glass Synthetic Bone Graft Material |

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### June 25, 2003

| | Orthovita Co., 212 Carnegie Center Drive, Suite 206, |
|---------|----------------------------------------------------------|
| | Princeton, NJ 08540 |
| K921468 | PermaMesh Hydroxylapatite Matrix |
| | CeraMed Corp., 12860 West Cedar Drive, Lakewood, |
| | CO 80228 |
| K862061 | Osteograf/AR+ Permaridge Hydroxylapatite, 18-40 |
| | Coors Biomedical Co., 12860 West Cedar Drive, Suite 210, |
| | Lakewood, CO 80228 |
| K910432 | HAPSET Hydroxylapatite Bone Graft Plaster |
| | Lifecore Biomedical, Inc., 1050 Connecticut Avenue, N.W. |
| | Washington Square, Suite 1100, Washington, D.C. 20036 |

Calcium Hydroxylapatite Craniofacial Implants are identical to Coaptite® Laryngeal Augmentation System (K013243) and Coaptite® Tissue Marker (K012955) manufactured by BioForm Inc. The Calcium Hydroxylapatite Implant is substantially equivalent to the predicate devices sited above.

#### Device Description: 4.4

Calcium Hydroxylapatite Implant is a sterile, non-pyrogenic, flexible, semi-solid, cohesive paste containing calcium hydroxylapatite particles. Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects. Calcium Hydroxylapatite Implant contains calcium hydroxylapatite particles in a pasty gel of glycerin, water and sodium carboxymethylcellulose that acts as a binder for the particles. The calcium hydroxylapatite meets ASTM F1185. The gel ingredients are pharmacoutical grade excipients and are listed as GRAS materials.

#### 4.5 Intended Use:

Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including:

- Periodontal Defects 0
- Ridge Augmentation
- Extraction Sites ●
- Craniofacial Augmentation .
- Cystic Defects .

#### 4.6 Technological Characteristics:

Calcium Hydroxylapatite Implant (CaHA Implant) is a paste of calcium hydroxylapatite (calcium phosphate) particles and a binder. The binder is resorbable and acts to hold the particles together. The resorption of the binder provides the controlled porosity for bono ingrowth. These 'porcs' are the interconnected pathways around and between the calcium hydroxylapatite particles that are non-absorbable. The calcium hydroxylapatite particles provide

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June 25, 2003

an osteoconductive scaffold for bone infiltration. The CaHA Implant functions as an osteoconductive scaffold for bone infiltration, the same mechanism of action as the predicate devices. The premixed and ready to use characteristic facilitates the delivery of CaHA Implant by allowing direct and controlled deposition using the syringe. This may be enhanced for implantation in difficult to access locations by the placing of a needle on the syringe. In addition, the binder serves to reduce or prevent migration during the application and in the post-operative healing period prior to incorporation of the particles by tissue ingrowth.

The Calcium Hydroxylapatite Implant (CaHA Implant) is substantially equivalent in composition and intended use to the predicate devices. The CaHA Implant and the predicate devices are all intended to fill and/or augment dental intraosseous and oral/maxillofacial defects. All of the predicate devices and the CaHA Implant are composites of resorbable (binder) and non-resorbable (calcium phosphate particles) components. The predicate devices use sterile water, saline, the patient's own blood or absorbable sutures to bind the particles together to facilitate delivery of the particles and minimize migration of the particles from the implant site. These other binding agents are resorbed within weeks or months depending upon the used and how it is prepared. All of these are also substantially equivalent in their mechanism of action as they provide a calcium phosphate particle that provides an osteoconductive scaffold for bone infiltration. The bone infiltration provides the final form of the implant.

The principal component of the Calcium Hydroxylapatite Implant, calcium hydroxylapatite is identical to the calcium hydroxylapatite used in most of the predicates and is very similar to the calcium phosphate glasses used in the rest of the predicate devices. All of these meet the same biocompatibility requirements. It is substantially equivalent in terms of biocompatibility and biological mechanism of action in that all of these products utilize tissue ingrowth to support and sustain augmentation.

In terms of risk versus benefit, BioForm believes that the CaHA Implant has obvious advantages compared to the predicate devices. The CAHA implant is provided as a sterile and ready to use paste that is more convenient for the physician, minimizes the potential for contamination during the mixing processes required by other devices, eliminates the risk and pain associated with drawing blood and is more convenient to place. The CaHA Implant also is convenient to use because the amount of filling or augmentation can be easily controlled through direct application.

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June 25, 2003

#### 4.7 Conclusion:

In summary, Calcium Hydroxylapatite Implant is substantially equivalent to the cited predicate devices and, in some instances, identical to certain predicate devices. All have the same intended use designed to fill and/or augment dental intraosseous and oral/maxillofacial defects. The components used in the Calcium Hydroxylapatite Implant and the predicate devices are biocompatible, based on the history use in many medical devices as well as from preclinical testing and clinical experience. All function as composites that utilize a resorbable binder and a non-resorbable calcium phosphate particulate. The binder facilitates placement and the particles function as an osteoconductive matrix. All reach their final form after tissue infiltration. The Calcium Hydroxylapatite Implant is substantially equivalent in intended use, technical characteristics and are as safe as the predicate devices cited.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2003

Mr. William G. Hubbard BioForm Incorporated 4133 Courtney Road, #10 Franksville, Wisconsin 53126

Re: K030682

Trade/Device Name: Calcium Hydroxylapatite Implant Regulation Number: None Regulation Name: Bone Filling and Augmentation Material Regulatory Class: Unclassified Product Code: LYC Dated: June 9, 2003 Received: June 10, 2003

Dear Mr. Hubbard:

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 -- Mr. Hubbard

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 (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.

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/dsma/dsmamain.html

Sincerely yours.

Susan Quinn

Susan Runner, DDS, MA Interim 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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March 4, 2003 Revised June 9, 2003

### SECTION 2

# Indications for Use/Intended Use Statement

510(k) Number (if known): K030682

Device Name: Calcium Hydroxylapatite Implant

Indications for Use:

BioForm's Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including:

- · Periodontal Defects
- · Ridge Augmentation
- · Extraction Sites
- · Craniofacial Augmentation
- · Cystic Defects

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-the-Counter Use or (Per 21 CFR 801.109)

Optional Format 1-2-96

Ka Muluy for RSR

General Hospital,

Number K030682

510(k) Number