The intended use of NovaBone Dental Putty 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 NovaBone Dental Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

Device Description

NovaBone Dental Putty is an osteoconductive, bone void filler device. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects and is supplied sterile. It is composed of a calcium-phosphorussodium-silicate particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. The mixed device is supplied sterile, packaged either in a PET-G tray or in a disposable plastic syringe or cartridge. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles are slowly absorbed and replaced by new bone tissue during the healing process. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects. It is supplied sterile.

AI/ML Overview

This document is a 510(k) premarket notification for a device modification, specifically a packaging change, for NovaBone Dental Putty. It does not contain information about acceptance criteria or specific studies proving device performance beyond establishing substantial equivalence to predicate devices. The majority of the document explicitly states that no changes to the device formulation or function have been made and that it does not result in a change in technological characteristics of the device. Therefore, the device relies on the previous clearances of its predicate devices to demonstrate safety and effectiveness.

As such, the information required cannot be fully extracted from the provided text. However, I can explain why certain sections are not applicable or cannot be found based on the provided text.

1. A table of acceptance criteria and the reported device performance

This information is not available in the provided document. This document is a "Special 510(k): Device Modification Summary" focusing on a packaging change. It explicitly states: "The NovaBone Dental Putty device of this submission is identical in composition to the NovaBone Dental Putty predicate devices; no changes to the device formulation or function have been made." Therefore, new acceptance criteria and performance data for the device itself are not presented, as its performance is assumed to be equivalent to the predicate devices. Acceptance criteria would typically be established during the initial clearance of a device, not for a minor modification like a packaging change.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided document. Since no new studies are presented to demonstrate device performance (due to the nature of the modification being only a packaging change), there is no test set or related data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided document. As mentioned, there is no new test set requiring ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided document. There is no test set, thus no adjudication method is relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not available in the provided document. The NovaBone Dental Putty is a synthetic bone graft material, not an AI or imaging diagnostic device. Therefore, MRMC studies or AI involvement are not relevant to this product.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable and not available in the provided document. As stated above, this is not an AI or algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available in the provided document. There is no new study or data presented that would require established ground truth. The device relies on the existing safety and efficacy data of its predicate devices.

8. The sample size for the training set

This information is not applicable and not available in the provided document. There is no AI model or algorithm being trained for this device.

9. How the ground truth for the training set was established

This information is not applicable and not available in the provided document. There is no AI model or algorithm being trained for this device.

Summary based on the document:

The provided document describes a "Special 510(k)" submission for a modification to an already legally marketed device, NovaBone Dental Putty. The modification consists solely of a new packaging format (a filled-cartridge) to augment existing configurations.

The document explicitly states:

"The NovaBone Dental Putty device of this submission is identical in composition to the NovaBone Dental Putty predicate devices; no changes to the device formulation or function have been made."
"This device modification does not result in a change in technological characteristics of the device."
"NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects."

Therefore, this 510(k) submission relies on the concept of substantial equivalence to its predicate devices (NovaBone Dental Putty – Bioactive Synthetic Graft [K091484] and [K063549]) to demonstrate its safety and effectiveness. It does not present new studies, acceptance criteria, or performance data because the device itself has not changed technologically. The FDA's letter (K100671) confirms this by stating that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

To find information on acceptance criteria and performance studies for the NovaBone Dental Putty, one would need to review the original 510(k) submissions for the predicate devices (K091484 and K063549), as those would contain the initial safety and efficacy data that established the device's original clearance.

Summary

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MAR 3 0 2010

Image /page/0/Picture/1 description: The image shows the logo for NOVABONE, a company that drives innovation in osteobiologics. The logo is in black and white, with the company name in large, bold letters. Below the name is the company's slogan, "DRIVING INNOVATION IN OSTEOBIOLOGICS." The logo is simple and modern, and it conveys the company's focus on innovation and technology.

Special 510(k): Device Modification Summary NovaBone Dental Putty - Bioactive Synthetic Bone Graft

03/04/10

1. Submitter Information:

Name:	NovaBone Products, LLC
Address:	13631 Progress Boulevard, Suite 600Alachua, FL 32615
Telephone:	(386) 462-7660
Facsimile:	(386) 418-1636
Contact:	David M. Gaisser

2. Name of Device:

Trade Name:	NovaBone Dental Putty - Bioactive Synthetic Bone Graft
Common Name:	Osteoconductive Bone Void FillerSynthetic Resorbable Bone Graft Material
Regulation Number:	21 CFR 872.3930
Regulation Name:	Bone Grafting Material, Synthetic

Legally Marketed Predicate Device: 3.

Predicate #1:	NovaBone Dental Putty – Bioactive Synthetic Graft[K091484]
Predicate #2:	NovaBone Dental Putty – Bioactive Synthetic Graft[K063549]

Device Description 4.

ડ. Intended Use

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· 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 NovaBone Dental Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

Technological Characteristics 6.

The technological characteristics of the NovaBone Dental Putty device are similar to those of the predicates. The device and the predicates are designed as osteoconductive space-filling devices to be gently packed into defect sites and used as non-structural scaffolds for the body's natural healing and bone regeneration process. The device indications are unchanged from those of the predicate devices. The device is intended to be used alone, or in combination with autogenous or allograft bone.

The NovaBone Dental Putty device of this submission is identical in composition to the NovaBone Dental Putty predicate devices; no changes to the device formulation or function have been made. The primary component of NovaBone Dental Putty is a calcium phospho-silicate particulate, a synthetic material that is both biocompatible and osteoconductive. The NovaBone Dental Putty includes a synthetic binder as an inert carrier for ease of handling and delivery, forming a premixed cohesive material. The binder is biocompatible and is absorbed after implantation, opening space between the bioactive glass particles for cell infiltration and bone formation. The bioactive glass particulate remains for a longer post-implantation period, acting as a scaffold for bone ingrowth. This particulate is absorbed and replaced by new bone tissue.

The filled-cartridge package format as described in this submission is a product line extension, increasing the device package format availability. The new packaging aids in device placement, permitting a different mode of application distinct from that of the previously cleared predicates packaged in tray-in-pouch [K063549] and syringe-in-pouch [K091484] formats. The cartridge packaging system itself is similar to the Class I devices as defined in premarket applications K882551 (cartridge) and K832662/K915147 (cartridge syringe applicator).

7. Conclusion

The NovaBone Dental Putty device modification subject to this submission is to include a filled-cartridge package format to augment the current package configurations. This device modification does not result in a change in

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technological characteristics of the device. NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. David M. Gaisser Vice President NovaBone Products, LLC 13631 Progress Boulevard, Suite 600 Alachua, Florida 32615

MAR 3 0 2010

Re: K100671

Trade/Device Name: NovaBone Dental Putty-Bioactive Synthetic Bone Graft Regulation Number: 21CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: March 4, 2010 Received: March 9, 2010

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. 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 may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Gaisser '

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Confidential

K100671

STATEMENT OF INDICATIONS FOR US

510(k) Number (if known):

Device Name: NovaBone Dental Putty - Bioactive Synthetic Bone Graft

Indications For Use:

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

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

Prescription Use XX

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

RSBetz DDS for Dr. K.P. Mulug

Division Sign-Off) Division of Anesthesiology, General Hospital infection Control. Dental Devices

:10(k) Number: K100671

Regulation Number and Section

§ 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.