PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE

K040278 · Novabone Products, LLC · LYC · Mar 1, 2004 · Dental

Device Facts

• Record ID: K040278
• Device Name: PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE
• Applicant: Novabone Products, LLC
• Product Code: LYC · Dental
• Decision Date: Mar 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of PerioGlas is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include: - Periodontal/Infrabony defects - Ridge Augmentation (sinusotomy, osteotomy, cystectomy) - Extraction sites (ridge maintenance/augmentation, implant preparation/placement) - Sinus lifts - Cystic cavities - Cranio-facial augmentation For larger defects, a mixture of PerioGlas® with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

Device Story

PerioGlas is a synthetic, absorbable, osteoconductive bone graft substitute composed of calcium phospho-silicate bioactive glass (Bioglass) in particulate form (90-710 um). Supplied sterile in PET-G cups or pre-filled syringes. At point-of-care, clinician mixes particulates with sterile water, saline, patient blood/marrow, or autograft/allograft to create a moldable paste. Applied by clinicians to bony voids or gaps in oral, dental, and craniofacial sites. Acts as a scaffold for bone growth; functions as a bone graft extender. Benefits include filling defects and facilitating bone regeneration in surgical/dental procedures.

Clinical Evidence

Bench testing only. Clinical performance was previously evaluated in K992416. No new clinical data provided for this submission.

Technological Characteristics

Material: Calcium phospho-silicate bioactive glass (Bioglass). Form: Particulate (90-710 um). Energy: None. Packaging: Tyvek-sealed PET-G cup or filled syringe. Sterilization: Gamma irradiation. Connectivity: None.

Indications for Use

Indicated for patients requiring bone void filling or augmentation in oral, dental intraosseous, and craniofacial defects, including periodontal/infrabony defects, alveolar ridge augmentation, dental extraction sites, sinus lifts, 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

• PerioGlas - Synthetic Bone Graft Particulate (K992416, K962492, K930115)
• NovaBone (K000149)

Submission Summary (Full Text)

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MAR - 1 2004

Image /page/0/Picture/1 description: The image shows the logo for NOVABONE synthetic bone graft products. Above the logo is the text "K040 278" in a handwritten style. The NOVABONE logo is in bold, black letters, with a stylized sun-like image in the middle of the word. Below the logo, the words "SYNTHETIC BONE GRAFT PRODUCTS" are printed in smaller, sans-serif font.

02/03/04

# 510(k) Summary PerioGlas - Bioglass Bone Graft Particulate

### Submitter Information: 1.

| Name: | NovaBone Products, LLC |
|-------------------|-------------------------------|
| Address: | 13709 Progress Boulevard, #33 |
| Alachua, FL 32615 | |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact: | David M. Gaisser |

## Name of Device: 2.

| Trade Name: | PerioGlas – Bioglass Bone Graft Particulate |
|----------------------|------------------------------------------------------------------------------|
| Common Name: | Osteoconductive Bone Void Filler<br>Synthetic Resorbable Bone Graft Material |
| Classification Name: | Endosseous Implant for Bone Filling and/or Augmentation |

## Legally Marketed Predicate Device: 3.

| Predicate: | PerioGlas - Synthetic Bone Graft Particulate |
|------------|-----------------------------------------------------|
| | [K992416, K962492, K930115] |
| | (Also named as NovaBone per Special 510(k) K000149) |

## Device Description 4.

PerioGlas is a synthetic absorbable osteoconductive bone graft substitute Formosed of a calcium phospho-silicate bioactive glass, Bioglass . The device is in a particulate form of a size range 90-710 um. The device is intended for dental intraosscous, oral, and cranio-/maxillofacial bony defects. It is supplied sterile, packaged either in a Tyvek-sealed PET-G cup or in a filled syringe within a second sterile barrier package. The device packages are protected by an outer shrink-wrapped cardboard box. At time of use, the device is mixed with sterile water, saline, the patient's own blood or marrow, or with autogenous or allograft bone to form a wet sandy paste that is applied to the defect.

### Intended Use 5.

PerioGlas - Bioglass Bone Graft Particulate is indicated to be packed into bony voids or gaps to fill and/or augment oral, dental intraosseous, and craniofacial defects. These defects may include: periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge

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510(k) Premarket Notification NovaBone Products, LLC PerioGlas - Bioglass Frone Graft Particulate

> maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. PerioGlas may be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either as a bone graft extender.

### Technological Characteristics 6.

The technological characteristics of the proposed device and the unmodified PerioGlas device are identical. The in vivo and clinical performance of this device was previously evaluated in K992416. Packaging and labeling verification testing resulting from FMEA risk analysis was completed following design control.

#### Complications 7.

The modifications made to the PerioGlas device do not result in a change in complications associated with the use of the device. Possible complications are the same as to be expected of autogenous bone grafting procedures. These may include: superficial wound infection, deep wound infection, deep wound infection with osteomyelitis, delayed union, loss of reduction, failure of fusion, loss of bone graft, graft protrusion and / or dislodgement, and general complications that may arise from anesthesia and / or surgery. Complications specific to oral/dental use are those as may be typically observed for similar bone grafting procedures and may include: tooth sensitivity, gingival recession, flap sloughing, resorption or ankylosis of the treated root, abscess formation

#### 8. Conclusion

The modifications made to the PerioGlas device do not result in a change in technological characteristics of the device. PerioGlas devices continue to be safe and effective as non-structural osteoconductive bone void fillers for oral and cranio-/maxillofacial defects following modifications to include filled syringe packaging and gamma irradiation sterilization.

01.1

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

MAR = 1 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David M. Gaisser Director, Operation NovaBone Products, LLC 13709 Progress Boulevard, #33 Alachua, Florida 32615

Re: K040278

Trade/Device Name: PerioGlas- Bone Graft Particulate Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LYC Dated: February 3, 2004 Received: February 1, 2004

Dear Mr. Gaisser:

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. Falk

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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph. D.

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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K040278

Confidential

510(k) Premarket Notification NovaBone Products, LLC PerioGlas - Bioglass Bone Graft Particutate

## STATEMENT OF INDICATIONS FOR USE

| 510(k) Number (if known): | K040278 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

Indications For Use:

The intended use of PerioGlas is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include:

- · Periodontal/Infrabony defects
- · Ridge Augmentation (sinusotomy, osteotomy, cystectomy)
- · Extraction · maintenance/augmentation, implant preparation/ sites (ridge placement)
- Sinus lifts
- · Cystic cavities
- · Cranio-facial augmentation

For larger defects, a mixture of PerioGlas® with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Super Rums

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

510(k) Number .

ﮐﺎ Prescription Use

OR (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________