Vitoss® Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bioactive Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Device Description

Vitoss Bioactive Foam is a resorbable, osteoconductive implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.

AI/ML Overview

This submission describes a bone graft substitute (Vitoss Bioactive Foam), not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML device evaluation (like sample size for test sets, expert qualifications, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, technological characteristics, and performance data from in vitro studies.

Here's an attempt to address the relevant points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Safety and Effectiveness substantially equivalent to predicates	"Vitoss Bioactive Foam is as safe and effective as its predicates." "The minor differences between Vitoss Bioactive Foam and its predicate devices raise no new issues of safety or effectiveness." "Performance data demonstrate that Vitoss Bioactive Foam is as safe and effective as its predicate devices."
Osteoconductivity	"Vitoss Bioactive Foam is a resorbable, osteoconductive implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone."
Osteostimulatory properties (in vitro)	"Vitoss Bioactive Foam is osteostimulatory based on in-vitro studies in which calcium phosphate growth was induced on the surface of the Vitoss Bioactive Foam after exposure to simulated body fluid. The Vitoss Bioactive Foam strips had widespread calcium phosphate formation by 3 days. This phenomenon was not observed in control samples in which there was no bioactive glass component."
Function as intended	"Performance testing was conducted to ensure that Vitoss Bioactive Foam met its design requirements and performed in a manner substantially similar to the predicate devices. In all instances, Vitoss Bioactive Foam functioned as intended."
Resorption and replacement with bone	"Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process." (This is part of the Intended Use, implying it's an expected outcome, but direct performance data on the rate/extent of human resorption is not provided in this summary. It's likely inferred from the predicate devices and the material's properties.)
Suitable for intended use as a bone void filler	"Vitoss Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure... for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis)." (This is the indication for use, supported by the other performance data and substantial equivalence argument.)

2. Sample size used for the test set and the data provenance

Not Applicable (N/A) for an AI/ML device.
The "performance testing" mentioned refers to in vitro studies. No specific sample sizes for these in vitro tests (e.g., number of strips, number of simulated body fluid trials) are provided in this summary.
The data provenance is from in vitro studies, not human clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A for an AI/ML device.
Ground truth for material properties (e.g., calcium phosphate formation) would be established by standard laboratory analytical methods, not human expert consensus in the context of clinical images.

4. Adjudication method for the test set

N/A for an AI/ML device.

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

N/A. This is not an AI-assisted diagnostic device.

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

N/A. This is not an AI algorithm.

7. The type of ground truth used

The ground truth for the in vitro performance data (osteostimulatory properties) was based on laboratory measurements/observations of calcium phosphate formation in a simulated body fluid, as observed by standard analytical techniques.

8. The sample size for the training set

N/A for an AI/ML device.

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

N/A for an AI/ML device.

Summary

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K672/84

510(k) SUMMARY

SEP 1 8 2007

VITOSS® BIOACTIVE FOAM BONE GRAFT SUBSTITUTE

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355

Phone: (610) 640-1775

Facsimile: (610) 640-1714

Contact Person: Gina M. Nagvajara, Ph.D. V.P., Regulatory Affairs

Date Prepared: August 3, 2007

Common or Usual Name - Vitoss® Bone Graft Substitute- Bioactive Foam Strip, Vitoss® BA Bone Graft Substitute- Bioactive Foam Strip, Bone Graft Substitute

Classification Name - Bone Void Filler

Product Code -MQV

Predicate Devices

Orthovita, Inc. - Vitoss Scaffold Foam Bone Graft Substitute (K032288)
NovaBone – NovaBone Bioactive Synthetic Graft (K052494)
NovaBone -NovaBone Putty Bioactive Synthetic Graft (K060728)
Nanotherapeutics - Origen DBM with Bioactive Glass (K062459)

Intended Use / Indications for Use

Vitoss® Bioactive Foam Bone Graft Substitute is labeled with the following Intended Use statement:

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Vitoss Bioactive Foam Bone Graft Substitute is intended for use as a bone void v thoss Dioactive I vann that are not intrinsic to the stability of the bony structure. ffiter for volus of gaps that area for use in the treatment of surgically created v tross Droactive Fount is marcants created from traumatic injury to the bone. osseous derects of own should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Technological Characteristics

Vitoss Bioactive Foam is a resorbable, osteoconductive implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.

Performance Data

Performance testing was conducted to ensure that Vitoss Bioactive Foam met its design r orrormative sond performed in a manner substantially similar to the predicate devices. In all instances, Vitoss Bioactive Foam functioned as intended.

Vitoss Bioactive Foam is osteostimulatory based on in-vitro studies in which calcium phosphate growth was induced on the surface of the Vitoss Bioactive Foam after exposure to simulated body fluid. The Vitoss Bioactive Foam strips had widespread calcium phosphate formation by 3 days. This phenomenon was not observed in control samples in which there was no bioactive glass component. The osteostimulatory nature of Vitoss Bioactive Foam has not been correlated to human clinical experience.

Substantial Equivalence

Vitoss Bioactive Foam is as safe and effective as its predicates. Vitoss Bioactive Foam has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor differences between Vitoss Bioactive Foam and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that Vitoss Bioactive Foam is as safe and effective as its predicate devices. Thus, Vitoss Bioactive Foam is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Orthovita, Inc. % Gina M. Nagvajara, Ph.D. V.P., Regulatory Affairs 45 Great Valley Parkway Malvern, PA 19355

SEP 1 8 2007

Re: K072184

Trade/Device Name: Vitoss® Bone Graft Substitute-Bioactive Foam Strip, Vitoss® BA Bone Graft Substitute- Bioactive Foam Strip, Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: August 3, 2007 Received: August 6, 2007

Dear Dr. Nagvajara:

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. Ilisting 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.

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

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Page 2 - Dr. Gina M. Nagvajara

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) 276-0120 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

Soubave Pucum

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Vitoss Bioactive Foam 510(k) Notification Orthovita, Inc.

510(k) Number (if known):

Device Name: Vitoss® Bioactive Foam Bone Graft Substitute

INDICATIONS FOR USE:

Vitoss Bioactive Foam Bone Graft Substitute is labeled with the following Intended Use statement:

Vitoss Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bioactive Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

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

Barbara Bonell

Page 1 of 1

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K072184

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.