Vitoss Scaffold Foam Bone Graft Material 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 Scaffold Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss Scaffold Foam Bone Graft Material 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 Scaffold Foam is a porous calcium phosphate resorbable material admixed with Type I bovine collagen for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 um to 1000 um (1 mm). The implant is provided sterile in both cylinder and strip forms. Vitoss Scaffold Foam may be mixed with autogenous blood or bone marrow.

Vitoss Scaffold Foam guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Scaffold Foam is placed in direct contact with viable host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

AI/ML Overview

The Vitoss® Scaffold Foam Bone Graft Material is intended as a bone void filler. The device's performance was established through non-clinical performance data, specifically pre-clinical animal studies, which demonstrated that the device supports bone growth and is resorbed concurrently with bone ingrowth and remodeling.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criteria	New Device: Vitoss® Scaffold Foam Bone Graft Material	Predicate Device: Vitoss® Scaffold Synthetic Cancellous Bone Void Filler	Predicate Device: Healos® Bone Graft Material
Intended Use	Bone Void Filler	Bone Void Filler	Bone Void Filler
Target Population	Individuals with bony defects resulting from surgery or trauma	Individuals with bony defects resulting from surgery or trauma	Individuals with bony defects resulting from surgery or trauma
Anatomical Locations	Bony voids or gaps of the skeletal system (extremities, spine, pelvis)	Bony voids or gaps of the skeletal system (extremities, spine, pelvis)	Bony voids or gaps of the skeletal system (extremities, spine, pelvis)
Labeling	Substantially equivalent to Vitoss® Scaffold Synthetic, with additional collagen-related contraindications/adverse events from Healos®	-	-
Chemical Composition	Calcium salt with Type I bovine collagen	Calcium salt	Calcium salt with Type I bovine collagen
Mineral Phase(s)	β-Tricalcium phosphate (Ca₃(PO₄)₂)	β-Tricalcium phosphate (Ca₃(PO₄)₂)	Hydroxyapatite (Ca₁₀(PO₄)₆(OH)₂)
Physical Structure	Trabecular structure similar to cancellous bone	Trabecular structure similar to cancellous bone	Three-dimensional, open-cell matrix
Pore Size (range)	1-1000 μm	1-1000 μm	4-200 μm
Osteoconductivity	Osteoconductive	Osteoconductive	Osteoconductive
Mechanical Strength	Does not impart mechanical strength to surgical site	Does not impart mechanical strength to surgical site	Does not impart mechanical strength to surgical site
Sterility	Sterilized by gamma irradiation, single use only	Sterilized by gamma irradiation, single use only	Sterilized by e-beam, single use only
Biocompatibility	Established	Established	Established
Dosage Form(s)	Cylinders (Blocks), Strips	Blocks, Morsels	Strips, Pads
Non-clinical Performance	Supports bone growth into metaphyseal defect, resorbed concurrently with bone ingrowth and remodeling	-	-

2. Sample Size for Test Set and Data Provenance

The provided information does not specify a distinct "test set" in the context of human clinical trials. The performance data is derived from "pre-clinical animal data." Therefore, details regarding sample size, country of origin, or retrospective/prospective nature for human test sets are not applicable to the submitted information.

3. Number of Experts and Qualifications for Ground Truth

Given that the performance data relies on pre-clinical animal studies, there's no mention of human experts establishing ground truth for a test set in the traditional sense of a clinical study. The interpretation of animal study results would be conducted by researchers and possibly veterinarians specializing in bone biology and histology. Their specific number and qualifications are not detailed.

4. Adjudication Method

Not applicable, as the performance evaluation is based on animal study results, not human reader assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted or reported in the provided documentation. The comparison is made against predicate devices based on material properties, intended use, and non-clinical animal data.

6. Standalone Performance (Algorithm Only)

The device is a physical bone graft material, not a software algorithm. Therefore, "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable.

7. Type of Ground Truth Used

The ground truth for demonstrating the device's performance was established through histological and observational outcomes from pre-clinical animal studies. These studies assessed bone growth, resorption of the scaffold, and remodeling within metaphyseal defects.

8. Sample Size for Training Set

The concept of a "training set" typically applies to machine learning algorithms. As this is a medical device, the studies performed are for validation, not training an AI model. Therefore, a "training set" sample size is not applicable in this context. The animal data serves as the primary evidence for safety and effectiveness.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set in the context of an AI algorithm. The performance was established through the aforementioned pre-clinical animal studies, with their histological and observational findings serving as the evidence.

Summary

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510(k) Summary Vitoss® Scaffold Foam Bone Graft Material

Submitted by	Address	Telephone	Contact Person
Orthovita, Inc.	45 Great Valley ParkwayMalvern, PA 19355	(610) 640-1775	Gina M. Nagvajara, Ph.D.Director of Research andIntellectual Property
	Subject Device		Predicate Devices
Trade Name	Vitoss® Scaffold FoamBone Graft Material		Vitoss® Scaffold SyntheticCancellous Bone Void Filler;Healos® Bone Graft Material
Common Name	Bone Void Filler		Bone Void Filler
Classification Name	Filler, Calcium SulfatePreformed Pellets		Filler, Calcium SulfatePreformed Pellets

Device Description:

DEC 1 9 2003

Intended Use:

Vitoss Scaffold Foam Bone Graft Material is intended to be used for filling bony voids or gaps of the skelctal 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.

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Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. The text includes 'FO32288' on the top line, followed by 'aofa' on the second line. The handwriting is somewhat stylized, with some characters slightly distorted or overlapping, giving it a unique and informal appearance.

510(k) Summary Vitoss Foam Orthovita, Inc.

Comparison to Predicate:

	NEW DEVICE:VITOSS SCAFFOLDFOAM	PREDICATE:VITOSS SCAFFOLDSYNTHETIC	PREDICATE:HEALOS BONEGRAFT MATERIAL
Intended Use	Bone Void Filler	Bone Void Filler	Bone Void Filler
Target Population	Individuals with bonydefects resulting fromsurgery or trauma	Individuals with bonydefects resulting fromsurgery or trauma	Individuals with bonydefects resulting fromsurgery or trauma
Anatomical Locations	Bony voids or gaps ofthe skeletal system, i.e.,the extremities, spineand pelvis	Bony voids or gaps ofthe skeletal system, i.e.,the extremities, spineand pelvis	Bony voids or gaps ofthe skeletal system, i.e.,the extremities, spineand pelvis
Labeling	Vitoss Scaffold Foam's product label contains the same intended use,contraindications, warnings, precautions, and adverse events as for the VitossScaffold Synthetic Cancellous Bone Void Filler with the addition of collagenrelated contraindications and adverse events from the Healos Bone GraftMaterial product label; wording is not identical but is substantially equivalent
Materials
ChemicalComposition	Calcium salt with TypeI bovine collagen	Calcium salt	Calcium salt with Type Ibovine collagen
Mineral Phase(s)	$β$ -Tricalcium phosphate$Ca_3(PO_4)_2$	$β$ -Tricalcium phosphate$Ca_3(PO_4)_2$	Hydroxyapatite$Ca_{10}(PO_4)_6(OH)_2$
Design
PhysicalStructure	Trabecular structuresimilar to cancellousbone	Trabecular structuresimilar to cancellousbone	Three dimensional,open-cell matrix
Pore Size (range)	1-1000 μm	1-1000 μm	4-200 μm
Performance
Osteoconductivity	Osteoconductive	Osteoconductive	Osteoconductive
MechanicalStrength	Does not impartmechanical strength tosurgical site	Does not impartmechanical strength tosurgical site	Does not impartmechanical strength tosurgical site
Sterility	Sterilized by gammairradiation, single useonly	Sterilized by gammairradiation, single useonly	Sterilized by e-beam,single use only
Biocompatibility	Established	Established	Established
Dosage Form(s)	Cylinders (Blocks),Strips	Blocks, Morsels	Strips, Pads

Non-clinical Performance Data:

Pre-clinical animal data demonstrate that Vitoss Scaffold Foam supports bone growth into a metaphyseal defect. These data show that Vitoss Scaffold Foam is resorbed concurrently with bone ingrowth and remodeling. These results, in conjunction with in-vitro data, demonstrate that Vitoss Scaffold Foam is as safe and as effective as the predicate devices, Vitoss Scaffold Synthetic Cancellous Bone Void Filler and Healos Bonc Graft Material.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Gina M. Nagvajara, Ph.D. Director of Research and Intellectual Property Orthovita, Inc. 45 Great Valley Parkway Malvern, Pennsylvania 19355

Re: K032288

K032206 Regulation Number: 21 CFR 888.3045 Regulation Name: Bone void filler Regulatory Class: II Product Code: MQV Dated: December 1, 2003 Received: December 2, 2003

Dear Dr. Nagvajara:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the Medical Device Amendments, or to commerce province to may 20, 1978, the excordance with the provisions of the Federal Food. Ding, devices that have tocer rechassined in avere approval of a premarket approval application (PMA). and Cosmette Act (11ct) market the device, subject to the general controls provisions of the Act. The 1 the may, therefore, thans of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is enabilional controls. Existing major regulations affecting your device can may be sunyeet to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the councements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean I has be advised that I Dr o waters at your device complics with other requirements of the Act that 1177 hab intatutes and regulations administered by other Federal agencies. You must of any i-cutcal statutes and regaraments, including, but not limited to: registration and listing (21 Comply with an the Hot 3 requirements)); good manufacturing practice requirements as set Of It fart 6077, abounting (21 CFR Part 820); and if applicable, the electronic Routh m the quants (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Lewis Ward

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter with and wyourse FDA finding of substantial equivalence of your device to a legally premance notification 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 in you attire office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millican

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

STATEMENT

510(k) Number (If Known): K032288

Device Name: Vitoss® Scaffold Foam Bone Graft Material

Indications For Use:

Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N Milker

Division of General, Restorative
and Neurological Devices

K032288

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.