(218 days)
There are no Reference Devices listed in the provided text.
No
The device description and performance studies focus on the material composition and biological response of a bone graft substitute, with no mention of AI or ML technologies.
Yes
The device is intended to fill bone voids and is resorbed and replaced with bone, indicating a therapeutic action to treat a condition.
No
This device is a bone strip implant intended to fill bony voids, not to diagnose a condition.
No
The device description clearly states it is a physical bone graft substitute in strip form, composed of collagen, beta tricalcium phosphate, and Bioglass. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The device is a bone graft substitute made of collagen, beta tricalcium phosphate, and Bioglass. These are materials used for tissue repair and regeneration, not for analyzing samples from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on biocompatibility, bone healing, and in vivo performance as a bone graft, not on diagnostic accuracy or analytical performance.
In summary, the Uni-FuZe-C Bone Strip is a medical device intended for surgical implantation to aid in bone repair, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
MQV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic images, micro-CT
Anatomical Site
Skeletal system (i.e., extremities and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
January 18, 2023
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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
1
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
2
Indications for Use
510(k) Number (if known) K221726
Device Name Uni-FuZe-C Bone Strip
Indications for Use (Describe)
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.
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-Perrot |
| Québec, 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
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.
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 Device
Zavation Uni-FuZe-C
Bone Strip | Primary Predicate
K051386, Medtronic
MasterGraft Putty | Predicate Device
K082166, Medtronic
MasterGraft Strip | Predicate Device
K201781, Zavation
Uni-FuZe-P Bone Putty |
|---------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Regulatory
Class, Code | 888.3045, MQV | 888.3045, MQV | 888.3045, MQV | 888.3045, MQV |
| Materials | Beta-TCP, ASTM F1088
Type I bovine collagen,
ASTM F2212
Bioglass 45S5, ASTM
F1538 | Biphasic ceramic that
is15% HA & 85% beta TCP
Type I bovine collagen | Biphasic ceramic of 15%
HA & 85% beta TCP
Type I bovine collagen | Beta-TCP, ASTM F1088
Type I bovine collagen,
ASTM F2212
Bioglass 45S5, ASTM
F1538
Polyethylene 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, single
use | 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 (