K Number
K070055
Device Name
BONALIVE GRANULES AND BONALIVE PLATES
Manufacturer
Date Cleared
2007-06-25

(172 days)

Product Code
Regulation Number
872.3930
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BonAlive™ Granules are sterile medical devices consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct periodontal or bony defects. BonAlive™ Granules are indicated for use in the craniomaxillofacial area including jaws.
Device Description
BonAlive™ products are sterile medical devices made of S53P4 bioactive glass. Bioactive glasses are characterised by their ability to attach firmly to living tissue. Other properties include being able to bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. Bone bonding is a physico-chemical process leading to continuity between an implant and bone matrix. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue. The composition of this synthetic, osteoconductive material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P2O5 4%. BonAlive™ products are supplied as granules are bone grafting materials intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. BonAlive™ granules are sterilized in hot dry air. The granules are available as different granule and unit sizes.
More Information

Not Found

No
The description focuses on the material properties and intended use of a bioactive glass bone grafting material, with no mention of AI or ML.

No
The device is described as a bone grafting material intended to fill, augment, or reconstruct bony defects, which is a structural and supportive function rather than directly treating a disease or condition.

No

The provided text states that BonAlive™ Granules are "bone grafting materials intended to fill, augment, or reconstruct periodontal or bony defects." This describes a therapeutic, rather than a diagnostic, function.

No

The device description clearly states it is made of bioactive glass granules, which is a physical material, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that BonAlive™ Granules are "bone grafting materials that are intended to fill, augment or reconstruct periodontal or bony defects." This describes a device used in vivo (within the body) for structural support and tissue regeneration.
  • Device Description: The description details the material composition and how it interacts with bone tissue in vivo to promote bonding and new bone formation.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze biological samples. BonAlive™ Granules are implanted directly into the body.

N/A

Intended Use / Indications for Use

BonAlive™ Granules are sterile medical devices consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct periodontal or bony defects. BonAlive™ Granules are indicated for use in the craniomaxillofacial area including jaws.

Product codes (comma separated list FDA assigned to the subject device)

LYC

Device Description

BonAlive™ products are sterile medical devices made of S53P4 bioactive glass. Bioactive glasses are characterised by their ability to attach firmly to living tissue. Other properties include being able to bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. Bone bonding is a physico-chemical process leading to continuity between an implant and bone matrix. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue. The composition of this synthetic, osteoconductive material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P2O5 4%.

BonAlive™ products are supplied as granules are bone grafting materials intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. BonAlive™ granules are sterilized in hot dry air. The granules are available as different granule and unit sizes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

craniomaxillofacial area including jaws, periodontal or bony defects of the oral and maxillofacial region.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K053387

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 872.3930 Bone grafting material.

(a)
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.(b)
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.

0

K070055

Vivoxid Ltd. Turku, Finland

  1. 510(k) Summary

Submitter: Vivoxid Ltd. Turku, Finland

Contact Information: Constance G. Bundy C. G. Bundy Associates, Inc. 6470 Riverview Terrace Fridley, MN 55432

Submission Date: December 29, 2006

Device Name and Classification: BonAlive™ Granules Bone Grafting Material, Product Code: LYC Class II per 872.3930

Equivalent Device Identification: NovaBone Perioglas®, NovaBone-C/M®, K053387

Device Description: BonAlive™ products are sterile medical devices made of S53P4 bioactive glass. Bioactive glasses are characterised by their ability to attach firmly to living tissue. Other properties include being able to bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. Bone bonding is a physico-chemical process leading to continuity between an implant and bone matrix. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue. The composition of this synthetic, osteoconductive material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P2O5 4%.

BonAlive™ products are supplied as granules are bone grafting materials intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. BonAlive™ granules are sterilized in hot dry air. The granules are available as different granule and unit sizes.

Intended Use: BonAlive™ granules consist of bioactive glass, a bone grafting material that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillo facial region.

JUN 2 5 2007

1

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2007

Vivoxid Limited C/O Ms. Constance G. Bundy C.G. Bundy Associates, Incorporated 6470 Riverview Terrace Fridley, Minnesota 55432

Re: K070055

Trade/Device Name: BonAlive™ Granules Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: June 15, 2007 Received: June 19, 2007

Dear Ms. Bundy:

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.

2

Page 2 - Ms. Bundy

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suste Y. Michaid md.

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

3

K070055

4. Indications for Use

510(k) Number (if known): K070055

Device Name: BonAlive™ Granules

Indications for Use:

BonAlive™ Granules are sterile medical devices consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct periodontal or bony defects. BonAlive™ Granules are indicated for use in the craniomaxillofacial area including jaws.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

Susan Penner

Sion Sign-Off) Chision of Anesthesiology, General Hospital, Infaction Control, Dental Devices

510(K) Number: K070055