BonVie+ is an implant intended to fill bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. BonVie+ resorbs and is replaced with bone during the healing process.

Device Description

BonVie+ is an osteo-conductive bone void filler. It is supplied sterile in a kit comprised of 1] a pack containing polymers and Ca-salt in powdered form, 2] ampoules containing a biocompatible solution (acetone) for mixing and granulation, and 3] a silicone mat containing cavities of various sizes to form granules of various sizes. The powder formulation comprises hydroxyapatite (HA), calcium carbonate (CaCO3), and calcium chloride (CaCl2) particles with degradable polymers poly(caprolactone) (PCL), poly(ethylene qlycol) (PEG), and poly(lactide-co-dlycolide) (PLGA). The biocompatible solution used for mixing is acetone. Once mixed and granulated, the HA and CaCO3 particles are dispersed throughout the entire structure of the device. Upon implantation, the HA and CaCO3 particles resorb over time. The polymer-based binding matrix also resorb with time. When BonVie+ is placed in direct contact with viable bone and the surrounding biologic fluid environment, porous regions form in the filler material and are infiltrated with bone tissue. Bone formation occurs in apposition to the HA and CaCO3 surface and within the pores of the device resorbs, bone grows into the space previously occupied by the filler material.

AI/ML Overview

This document is a 510(k) summary for a medical device called BonVie+, a resorbable calcium salt bone void filler. The information provided outlines the device, its intended use, and a summary of non-clinical tests to demonstrate substantial equivalence to a predicate device, EP Granules™ BVF.

Based on the provided text, the device itself (BonVie+) is a bone void filler and not an AI/Software device. Therefore, the acceptance criteria and study information typically associated with AI/ML-based medical devices (like those involving test sets, training sets, expert ground truth, MRMC studies, etc.) are not present in this document.

The document describes the device's physical and chemical properties, manufacturing, and preclinical testing to show equivalence to a predicate. It does not mention any AI or software components that would require the kind of performance evaluation requested (e.g., diagnostic accuracy metrics like sensitivity, specificity, AUC).

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as the provided text does not describe a study involving an AI/Machine Learning component.

To directly answer your prompt based on the provided text:

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

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for an AI/Software device. The FDA's acceptance is based on "substantial equivalence" to a predicate device, demonstrated through non-clinical tests.
Reported Device Performance:
- In-vitro Degradation and Surface Characterizations of BonVie+
- X-ray Diffraction (XRD) of BonVie+
- Residual Solution in BonVie+ granules
- Usability Testing
- Compression testing
- Sterilization and packaging validation
- Biocompatibility testing in accordance with ISO 10993
- Pyrogenicity testing/endotoxin monitoring.
- Note: Specific numerical results or statistical outcomes from these tests are not provided in this summary. The summary only lists the types of tests performed to support substantial equivalence.

2. Sample sizes used for the test set and the data provenance:

Not applicable as this is not a study of an AI/Software device performance on a test set of data. The tests listed are for material properties and device safety.

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

Not applicable as no "test set" or "ground truth" (in the context of AI/Software performance) is mentioned for this medical device.

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

Not applicable.

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:

No MRMC study was mentioned. This device does not appear to involve human readers or AI assistance in interpretation.

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

Not applicable.

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

Not applicable. The "ground truth" for this device's acceptance is its compliance with material properties, sterility, biocompatibility, and mechanical performance demonstrated through standard testing, not diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set:

Not applicable.

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

Not applicable.

In summary, the provided FDA 510(k) letter and summary describe a traditional medical device (bone void filler) and its non-clinical testing for substantial equivalence, not an AI/ML-driven device. Therefore, the specific criteria and study methodologies you've asked about, which are pertinent to AI/ML device evaluations, are not present in this document.

Summary

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February 26, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Elute Inc. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103

Re: K250346

Trade/Device Name: BonVie+ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MOV Dated: February 6, 2025 Received: February 6, 2025

Dear Janice Hogan:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely, JESSE MUIR - MUIR - MUIR - MUIR - S
MUIR - MUIR - MUIR - MUIR - S

S S -05'00'

Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)	K250346
Device Name	BonVie+
Indications for Use (Describe)	BonVie+ is an implant intended to fill bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. BonVie+ resorbs and is replaced with bone during the healing process.
Type of Use (Select one or both, as applicable)	☒ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)	☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K250346

510(K) SUMMARY

Elute, Inc.'s BonVie+

Submitter:

Elute, Inc. 417 Wakara Way, Suite 3510 Salt Lake City, UT 84108

Contact Person: Dr. Ashok Khandkar, CEO

Phone: (801) 696-4716

Email: ak@elutinc.com

Correspondent:

Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia PA 19103

Contact Person: Janice M. Hogan

Phone: (267) 675-4611

Email: janice.hogan@hoganlovells.com

Date Prepared: February 6, 2025

Name of Device:

BonVie+

Common or Usual Name: Resorbable calcium salt bone void filler device

Classification Name: Filler, Bone Void, Calcium Compound

Regulation Number: 888.3045

Product Code: MQV

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Predicate Information:

Predicate Device: EP Granules™ BVF

Predicate Applicant: Elute, Inc.

Predicate 510(k) Number: K180853

Predicate Manufacturer: Elute, Inc. 417 Wakara Way, Suite 3510 Salt Lake City, UT 84108

Predicate Produce Code: MQV

Device Description:

BonVie+ is an osteo-conductive bone void filler. It is supplied sterile in a kit comprised of 1] a pack containing polymers and Ca-salt in powdered form, 2] ampoules containing a biocompatible solution (acetone) for mixing and granulation, and 3] a silicone mat containing cavities of various sizes to form granules of various sizes. The powder formulation comprises hydroxyapatite (HA), calcium carbonate (CaCO3), and calcium chloride (CaCl2) particles with degradable polymers poly(caprolactone) (PCL), poly(ethylene qlycol) (PEG), and poly(lactide-co-dlycolide) (PLGA). The biocompatible solution used for mixing is acetone. Once mixed and granulated, the HA and CaCO3 particles are dispersed throughout the entire structure of the device. Upon implantation, the HA and CaCO3 particles resorb over time. The polymer-based binding matrix also resorbs with time. When BonVie+ is placed in direct contact with viable bone and the surrounding biologic fluid environment, porous regions form in the filler material and are infiltrated with bone tissue. Bone formation occurs in apposition to the HA and CaCO3 surface and within the pores of the device resorbs, bone grows into the space previously occupied by the filler material.

Intended Use / Indications for Use:

Indications for Use Comparison:

The indications for use are the same as the predicate device.

Technological Comparison:

The subject and predicate device have the same chemical composition. They are manufactured. While the predicate was provided in preformed granules, the subject device is provided as a powder and solution that can be used, in addition with the provided silicone mat, to fabricate bone

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void filler granules of the desired shape and size. As the available shapes and sizes are equivalent to the predicate device, this does not raise different types of questions.

Non-Clinical and/or Clinical Tests Summary & Conclusions:

· In-vitro Degradation and Surface Characterizations of BonVie+
· X-ray Diffraction (XRD) of BonVie+
· Residual Solution in BonVie+ granules
Usability Testing
· Compression testing
Sterilization and packaging validation
· Biocompatibility testing in accordance with ISO 10993
· Pyrogenicity testing/endotoxin monitoring.

Conclusion

BonVie+ is substantially equivalent to its predicate device.

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.