Uni-FuZe-C Bone Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., 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. Uni-FuZe-C Bone Strip resorbs and is replaced with bone during process.

Device Description

Zavation Medical's Uni-FuZe-C Bone Strip is a bioactive osteoconductive, resorbable, biocompatible bone graft substitute in strip form. The product is composed of a matrix of purified bovine collagen per ASTM F2212, beta tricalcium phosphate (Beta-TCP per ASTM F1088), and Bioglass 45S5 per ASTM F1538.

AI/ML Overview

The provided text describes the 510(k) summary for Zavation Uni-FuZe-C Bone Strip (K221726) and focuses on demonstrating its substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a study directly proving the device meets those criteria in a typical AI/software context.

However, based on the information provided, we can infer performance criteria related to the device's biological and physical characteristics and how they were evaluated.

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

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from regulatory requirements and testing)	Reported Device Performance (Summary of results)
Biocompatibility	Acceptable biological safety profiles (per ISO 10993-1:2018 and FDA Guidance)	Demonstrated acceptable biological safety profiles (Material-Mediated Pyrogenicity, Cytotoxicity, Irritation, Systemic reaction, Implantation tests).
Material Composition	Meeting specific ASTM standards for constituents	Bioactive glass, collagen, and ß-TCP constituents tested and/or certified to meet ASTM F2212, ASTM F1538, and ASTM F1088 requirements.
Biological Performance (In-vivo)	Normal osteoconductive healing response; absence of adverse inflammatory reactions; substantially equivalent performance to predicate.	Macro observations showed healthy tissue absent of adverse inflammatory reactions. Radiographic and microCT analyses indicated no adverse reactions and a normal progression in healing. Histopathology showed normal osteoconductive healing response. Demonstrated substantially equivalent in vivo performance to the primary predicate device across all endpoints.
Bioactivity	Precipitation of apatite during in-vitro assessment (per ISO 23317)	Determined to be bioactive per ISO 23317, with bioactive glass granules precipitating apatite in SBF.
Packaging Integrity	Meeting acceptance criteria for seal strength and integrity	Packaging seal strength and integrity validated via peel strength (ASTM F88/F88M) and bubble emission (ASTM F2096); acceptance criteria were met.
Shipping & Handling	Meeting acceptance criteria for shipping and handling validation	Shipping and handling validations performed per ASTM D7386; acceptance criteria were met.
Shelf Life	Validated for the specified duration	Shelf life validated for one-year.
Sterilization	Meeting specified SAL and endotoxin levels	Sterilization validated to SAL of 10° using VDmax method per ANSI/AAMI/ISO 11137-2: 2013/(R)2019 with 25 kGy minimum dose. LAL testing showed < 20 EU.

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

Sample Size: The document does not explicitly state a numerical sample size for the animal study. It mentions an "established rabbit functional femoral critical cancellous bone defect model." This suggests multiple rabbits were used, but the exact number is not provided.
Data Provenance: The animal study was a prospective study conducted to compare the subject device (Uni-FuZe-C Bone Strip) with the primary predicate device (MasterGraft Putty). The country of origin for the study is not specified but is likely associated with the manufacturer or a contracted research organization.

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

The document does not provide details on the number or qualifications of experts involved in establishing ground truth for the animal study. Clinical judgment from veterinary pathologists or radiologists would typically be involved in interpreting the radiographic, micro-CT, and histological analyses, but this is not explicitly stated.

4. Adjudication method for the test set

The document does not describe an adjudication method for the animal study results. It simply states that "Biological performance was measured using radiographic images, micro-CT, and histological analyses" and that assessments were performed. This implies direct interpretation rather than a consensus-based adjudication process among multiple readers, which is more common in human clinical trials or AI performance evaluations involving subjective assessments.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The study described is an animal model for biological performance, not a human reader study comparing AI assistance.

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

This question is not applicable. The device is a physical medical implant (bone strip), not an AI algorithm or software. Therefore, there is no "standalone" algorithm-only performance to assess.

7. The type of ground truth used

For the animal study:

Direct Observation/Measurement: Macro observations of implant sites.
Imaging Data: Radiographic images and micro-CT analyses, interpreted for signs of healing and adverse reactions.
Histopathology: Microscopic examination of tissue samples from the implant sites.

For material properties:

Standardized Testing Protocols: ASTM standards for material composition (F2212, F1538, F1088) and ISO standards for bioactivity (ISO 23317).
Laboratory Testing: For packaging, shipping, shelf life, and sterilization.

8. The sample size for the training set

This question is not applicable. The device is a physical medical implant, not an AI model requiring a training set.

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

This question is not applicable for the same reason as above (no training set for a physical implant device).

Summary

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January 18, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zavation Medical Products, LLC % Robert A. Poggie, Ph.D. President BioVera, Inc. 65 Promenade Saint Louis Notre-Dame-de-L'lle-Perrot, QC J7W3J6 Canada

Re: K221726

Trade/Device Name: Uni-FuZe-C Bone Strip Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: June 10, 2022 Received: June 14, 2022

Dear Dr. Poggie:

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. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).

Sincerely.

Sara S. Thompson -S

For

Laura C. Rose, 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

510(k) Number (if known) K221726

Device Name Uni-FuZe-C Bone Strip

Indications for Use (Describe)

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)

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510(k) SUMMARY for Zavation Uni-FuZe-C Bone Strip – K221726

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of Zavation Uni-FuZe-C Bone Strip.

A. SUBMITTERS INFORMATION

Submitter Name:	BioVera, Inc.
Submitter Address:	65 Promenade Saint-Louis, Notre-Dame-de-L'Ile-PerrotQuébec, J7W 3J6, CANADA
Contact Person:	Robert A. Poggie, PhD
Phone & Fax Number:	514-901-0796
Date of Submission:	January 5, 2023

B. DEVICE IDENTIFICATION & MANUFACTURER

Manufacturer Name:	Zavation Medical Products, LLC
Manufacturer Address:	3670 Flowood Drive,Flowood, MS 39232 USA
Registration Number:	3008583793
Contact Name:	Elke Carter
Title:	Regulatory Manager
Device Trade Name:	Uni-FuZe-C Bone Strip
Device Common Name:	Bone Void Filler
Classification Name:	Filler, bone void, calcium compound
Classification Code:	MQV
Classification Panel:	Orthopedic
Regulation Number:	21 CFR sections 888.3045
C1. PRIMARY PREDICATE DEVICE
K051386	Medtronic Sofamor Danek USA, MasterGraft Putty
C2. PREDICATE DEVICES
K082166	Medtronic Sofamor Danek USA, MasterGraft Strip
K201781	Zavation Medical Products Uni-FuZe-P Bone Putty

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D. DEVICE DESCRIPTION

E. INDICATIONS FOR USE

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

F. TECHNOLOGICAL CHARACTERISTICS

Zavation Medical's Uni-FuZe-C Bone Strip is a bioactive, osteoconductive, resorbable, biocompatible bone graft substitute in strip form. The product is composed of a matrix of purified bovine collagen per ASTM F2212, beta tricalcium phosphate (Beta-TCP per ASTM F1088), and Bioglass 45S5 per ASTM F1538. The Uni-FuZe-C Bone Strip can be applied directly to the defect site with whole blood hydration. The table below compares characteristics of the subject and predicate devices.

	Subject DeviceZavation Uni-FuZe-CBone Strip	Primary PredicateK051386, MedtronicMasterGraft Putty	Predicate DeviceK082166, MedtronicMasterGraft Strip	Predicate DeviceK201781, ZavationUni-FuZe-P Bone Putty
RegulatoryClass, Code	888.3045, MQV	888.3045, MQV	888.3045, MQV	888.3045, MQV
Materials	Beta-TCP, ASTM F1088Type I bovine collagen,ASTM F2212Bioglass 45S5, ASTMF1538	Biphasic ceramic thatis15% HA & 85% beta TCPType I bovine collagen	Biphasic ceramic of 15%HA & 85% beta TCPType I bovine collagen	Beta-TCP, ASTM F1088Type I bovine collagen,ASTM F2212Bioglass 45S5, ASTMF1538Polyethylene glycol (PEG)
Physical form	Strip	Putty	Strip	Putty
Dosage	3, 5, 6, 10, 13, 20 cc	NA	5, 10, 20 cc	2.5, 5.0, 10.0 cc
Resorbable	Yes	Yes	Yes	Yes
Porosity	Highly porous	Highly porous	Highly porous	Highly porous
Sterile, singleuse	Yes	Yes	Yes	Yes

The subject Uni-FuZe-C Bone Strip and predicate devices are comprised of similar materials (collagen, HA/TCP, bioglass), resorb quickly, similar in size, and can be gently manipulated into bone-voids. Mastergraft putty, the primary predicate device, was used as the control product in the functional animal model for the subject device; the study results support substantial equivalence. The Uni-FuZe-C Bone Strip has similar clinical indications for use as the primary predicate MasterGraft Putty and the same indications as the predicate Uni-FuZe-P Bone Putty.

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G. PERFORMANCE DATA

Assessment of biocompatibility of the Uni-FuZe-C Bone Strip was performed according to ISO 10993-1:2018 and biological effects were considered per the FDA Guidance, "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Material-Mediated Pyrogenicity, Cytotoxicity, Irritation, Systemic reaction, and Implantation tests demonstrated acceptable biological safety profiles.

Assessment of biocompatibility through implantation was performed per ISO 10993-6 at time points of 4 and 13 weeks. Bone healing and biological response were evaluated using an established rabbit functional femoral critical cancellous bone defect model at time points of 1 day and 6 and 12 weeks following implantation for the subject device Uni-FuZe-C Bone Strip and the primary predicate device MasterGraft Putty. Biological performance was measured using radiographic images, micro-CT, and histological analyses. The macro observations of the implant sites demonstrated healthy tissue absent of adverse inflammatory reactions for Uni-FuZe-C Bone Strip. Radiographic and microCT analyses indicated no adverse reactions and a normal progression in healing over time. Histopathology assessment showed normal osteoconductive healing response. The study confirmed the biocompatibility and normal osteoconductive healing response associated with the Uni-FuZe-C and demonstrated substantially equivalent in vivo performance to the primary predicate device across all endpoints.

The 45S5 bioglass, collagen, and ß-TCP constituents of the subject device were tested and / or certified as meeting the requirements of ASTM F2212 for Type I bovine collagen, ASTM F1538 for Bioglass 45S5, and ASTM F1088 for the β-TCP.

The subject device was determined to be bioactive per the requirements of ISO 23317. The bioactive glass granules in the Uni-FuZe-C strip precipitated apatite during the in-vitro assessment, while immersed in simulated body fluid per the definition in ISO 23317.

Packaging seal strength and integrity was validated via peel strength (per ASTM F88/F88M) and bubble emission (per ASTM F2096); acceptance criteria were met. Shipping and handling validations was performed per ASTM D7386; acceptance criteria were met. Shelf life was validated for one-year.

Sterilization was validated to SAL of 10° using method VDmax per ANSI/AAMI/ISO 11137-2: 2013/(R)2019 (VDmax25) with 25 kGy minimum dose. Limulus Amebocyte Lysate (LAL) testing demonstrated the maximum dose for one surgery has less than 20 endotoxin units (< 20 EU).

H. CONCLUSIONS

Uni-FuZe-C Bone Strip has similar indications for use, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between Uni-FuZe-C Bone Strip and the predicate devices do not raise new issues of safety or effectiveness. The performance data demonstrate that Uni-FuZe-C Bone Strip is substantially equivalent to the predicate devices.

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.