Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorte BVF™ Lite™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ Lite™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ Lite™ is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process.

Device Description

Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler. Vivorté BVF™ Lite™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ Lite™ may be manually applied to the bony defect or applied to the defect through a cannula. Vivorté BVF™ Lite™ isothermally hardens in vivo to form a carbonated apatite (hydroxyapatite). Vivorté BVF™ Lite™ has a compressive and bending strength that is greater than that of human cancellous bone. The carbonated apatite (hydroxyapatite), which closely resembles the mineral phase of bone, provides an osteoconductive scaffold for bone healing. The device is gradually resorbed and remodeled by the body as new bone formation occurs during the healing process. Vivorté BVF™ Lite™ is provided in various kit sizes corresponding to the amount of bone void filler produced when the components of the kit are mixed together.

AI/ML Overview

The provided text describes a 510(k) submission for the Vivorté BVF™ Lite™ bone void filler, asserting its substantial equivalence to a predicate device, Synthes® Norian® SRS® Bone Void Filler. The basis for this determination is non-clinical testing, as explicitly stated that no clinical testing was performed or required. Therefore, the acceptance criteria and the study proving the device meets them are solely based on these non-clinical evaluations.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria as numerical thresholds but rather states that the device is "substantially equivalent" to the predicate device in various aspects. The reported performance is therefore framed in terms of similarity to the predicate.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Vivorté BVF™ Lite™)
Material Composition	Composed of synthetic calcium phosphate materials that are "virtually identical" to the predicate. Primarily composed of hydroxyapatite when fully hardened.
Preparation and Hardening Process	Intraoperatively prepared by mixing similar components to produce a self-hardening calcium phosphate bone void filler. Isothermally hardens in vivo to form carbonated apatite (hydroxyapatite).
Resorption and Remodeling Characteristics	Resorbed and remodeled by the body as new bone formation occurs during the healing process, similar to the predicate. Gradually resorbable.
Mixing, Handling/Working, and Setting Times	Comparable to the predicate device.
Chemical, Physical, and Mechanical Characteristics	Similar to the predicate device's when fully hardened (primarily hydroxyapatite). Compressive and bending strength greater than human cancellous bone. Osteoconductive scaffold for bone healing.
Biocompatibility and Toxicity	Meets ISO 10993, ASTM, and USP standards for permanent implants, as demonstrated by testing.
Animal Testing Performance	Demonstrated substantial equivalency to the predicate device in animal testing. (Specific outcomes not detailed, but implied to be comparable to predicate's known performance)
Intended Use and Indications for Use	Similar to the predicate device, for filling bony voids or defects of the skeletal system (extremities, pelvis) that may be surgically created or osseous defects from traumatic injury, only for bony voids or defects not intrinsic to the stability of the bony structure.
Sterility and Prescription Use	Provided packaged sterile and intended as prescription use only single use devices, consistent with the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated for any of the non-clinical tests (chemical, physical, mechanical, biocompatibility, animal testing). The nature of these tests often involves specific numbers of samples per test type (e.g., a certain number of specimens for mechanical strength tests, a certain number of animals for animal studies), but these numbers are not detailed in the summary.
Data Provenance: The data provenance is internal to Vivorté, Inc. or its contracted laboratories that performed the non-clinical tests. The document does not specify the country of origin for the data, but since the submission is to the U.S. FDA, it is presumed to be conducted under U.S. or internationally recognized standards for and applicable to the U.S. market. All testing described is non-clinical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is not applicable as the submission relies solely on non-clinical testing for substantial equivalence, not on human expert evaluation of clinical data or images. Ground truth, in this context, would be established by validated laboratory assays, animal observations, and engineering measurements, not by expert consensus on patient data.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. There was no clinical test set requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between Vivorté BVF™ Lite™ and the predicate device" and "No clinical tests were conducted or submitted in support of substantial equivalency." Therefore, there is no effect size of how much human readers improve with AI vs without AI assistance to report, as there was no clinical study involving human readers or AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. Vivorté BVF™ Lite™ is a physical medical device (bone void filler), not an algorithm or AI software, so standalone performance in the context of AI is irrelevant.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing would be derived from:

Reference Standards/Validated Methods: For chemical composition, physical properties (e.g., density, porosity), and mechanical properties (e.g., compressive strength, bending strength), performance is measured against established scientific and engineering reference standards and/or the known properties of the predicate device.
Biocompatibility Benchmarks: For biocompatibility and toxicity, the ground truth is established by adherence to recognized international standards (ISO 10993) and national standards (ASTM, USP).
Animal Study Observations: For animal testing, the ground truth would be based on histological examination, imaging, and gross observations of bone formation, resorption, and overall tissue response in a controlled biological environment, compared to either (or both) untreated controls or the predicate device.

8. The Sample Size for the Training Set

This question is not applicable. As a physical medical device and not an AI/ML algorithm, there is no "training set" in the computational sense. The "knowledge base" for developing the device would stem from scientific literature, material science research, and established medical device development practices.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8.

Summary

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510(k) Summary

510(k) SPONSOR: Vivorté, Inc. 1044 E. Chestnut Street Louisville, KY 40204 Contact: Robert Burden Email: rburden@vivorte.com Telephone: (502) 693 - 2432 FAX: (502) 714 - 7235

AUG 1 2 2013

TRADE NAME: Vivorté BVFTM Lite™

COMMON NAME: Calcium phosphate bone void filler; bone void filler

Product	Regulation andDescription	ProductCode	Device	DeviceClass
Vivorté BVFT™ Lite™	21 CFR 888.3045 -Resorbable calcium saltbone void filler device	MQV	Filler, bone void,calcium compound	II

PREDICATE DEVICES: Synthes® Norian® SRS® Bone Void Filler (K011897)

DEVICE DESCRIPTION:

INTENDED USE AND INDICATIONS FOR USE:

Vivorté BVF™ Lite™ is a moldable, self-setting, gradually resorbable, calcium phosphate bone void filler. Vivorté BVF™ Lite™ is indicated for use to fill bony voids or defects of the skeletal system (i.e., extremities, pelvis) that may be surgically created or osseous defects created from traumatic injury to the bone and only for bony voids or defects that are not intrinsic to the stability of the bony structure. Vivorté BVF™ Lite™ may be manually applied to the bony

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BASIS FOR SUBSTANTIAL EQUIVALENCE:

Vivorté BVF™ Lite™ is chemically and physically substantially equivalent to the Synthes® Norian® SRS® Bone Void Filler. Both the Vivorté BVF™ Lite™ and the Synthes® Norian® SRS® Bone Void Filler are composed of synthetic calcium phosphate materials that are virtually identical. Both the Vivorté BVFTM Lite™ and the Synthes® Norian® SRS® Bone Void Filler devices are intraoperatively prepared by mixing similar components together to produce selfhardening calcium phosphate bone void fillers that, when implanted in a bony defect, are resorbed and remodeled by the body as new bone formation occurs during the healing process. Both devices have comparable mixing, handling/working, and setting times; and both of these devices, when fully hardened, are composed primarily of hydroxyapatite that have similar chemical, physical, and mechanical characteristics and properties. The indications for use of the Vivorté BVF™ Lite™ and the Synthes® Norian® SRS® Bone Void Filler are similar.

The Vivorté BVF™ Lite™ and Synthes® predicate device are provided packaged sterile and are intended as prescription use only single use devices.

Non-Clinical Testing .

The following testing was performed to demonstrate substantial equivalency of Vivorté BVFTM Lite™ to the predicate devices.

Chemical, physical and mechanical testing .
t Biocompatibility and toxicity (ISO 10993; ASTM; USP) for permanent implants
. Animal testing

Clinical Testing

Clinical testing was not necessary to determine substantial equivalence between Vivorté BVF™ Lite™ and the predicate device.

CONCLUSIONS

The nonclinical tests (i.e. chemical, physical, mechanical, biocompatibility, and animal tests) conducted demonstrate that Vivorté BVFTM Lite™ device is substantially equivalent to the cited predicate device and that the Vivorté BVF™ Lite™ device is therefore as safe, as effective, and performs as well as or better than the predicate device. No clinical tests were conducted or submitted in support of substantial equivalency.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body or wings.

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

August 12, 2013

Vivorté, Incorporated % Peoples & Associates Mr. Stephen J. Peoples 5010 Lodge Pole Lane Fort Wayne, Indiana 46814

Re: K131133

Trade/Device Name: Vivorté BVF™ Lite™ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: June 26, 2013 Received: July 1, 2013

Dear Mr. Peoples:

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.

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

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Page 2 – Mr. Stephen J. Peoples

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Erin | Keith

For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K131133

Device Name: Vivorté BVFTM Lite™

Indications for Use:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131133

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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.