FIBERGRAFT® Aeridyan™ Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® Aeridyan™ Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT® Aeridyan™ Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine. FIBERGRAFT® Aeridyan™ Matrix must be hydrated with saline or blood for pelvis and extremity applications.

Device Description

FIBERGRAFT® Aeridyan™ Matrix product is composed of 4585 bioactive glass (M-45 granules), boron bioactive glass (MS-B microspheres/Borospheres™) and bovine type I collagen. After hydration with saline, blood or bone marrow aspirate (BMA), the Aeridyan™ Matrix can be applied directly to the defect site or molded into the desired shape and gently packed into the defect site as a non-setting putty. In posterolateral spine fusion applications, the product is intended to be hydrated with bone marrow aspirate (BMA) and mixed with autograft in a recommended 1:1 ratio. In pelvis and extremity applications, the product must be hydrated with saline or blood.

AI/ML Overview

This document describes the Prosidyan, Inc.'s FIBERGRAFT® Aeridyan™ Matrix Bone Graft Substitute. The acceptance criteria described in the document are based on demonstrating substantial equivalence to predicate devices, focusing on physical and chemical properties, functional performance in animal studies, and biocompatibility.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Assumed based on evidence)	Reported Device Performance
Physical and Chemical Properties	In vitro functionality and bioactivity	Confirmed in vitro functionality and bioactivity. (Note: in vitro bioactivity results have not been correlated to clinical performance).
Biocompatibility	Meet ISO 10993 standards. Similar composition and intended use to clinically used bioactive glass materials.	Demonstrated by ISO 10993 testing. Composed of the same bioactive glass material and used for the same type and duration of patient as predicates.
Sterility	Sterile product	Sterile. (Mentioned in comparative table)
Packaging & Stability	Acceptable packaging, shelf life, and real-time aging.	Packaging evaluations, shelf life testing, and real-time aging testing performed with passing results.
Endotoxin Content	Meet endotoxin limits of established guidelines.	Bacterial endotoxin testing (LAL method) showed the device meets endotoxin limits.
Functional Performance (Posterolateral Spine Study)	Substantially equivalent performance to predicate devices and positive controls in critical sized cancellous bone in a rabbit posterolateral spine fusion model, evaluated by radiographic, histomorphometric, and biomechanical data. No new types of safety or effectiveness concerns.	The animal study demonstrated that FIBERGRAFT® Aeridyan Matrix performs substantially equivalently to the FIBERGRAFT® BG Matrix predicate device and positive controls, with no new safety or effectiveness concerns, through 26 weeks of follow-up.
Functional Performance (Extremities and Pelvis Study)	Substantially equivalent performance to predicate and reference devices in critical-sized defects in a rabbit femoral condyle model, evaluated by radiographic, histological, and histomorphometric data. No adverse impact on performance from minor technological differences.	The animal study demonstrated that FIBERGRAFT® Aeridyan Matrix performs substantially equivalently to the BG Matrix predicate and NovaBone MacroFORM reference devices, with no adverse impact on performance from minor technological differences, through 26 weeks of follow-up.
Overall Substantial Equivalence	Same intended use, similar indications, technological characteristics, and principles of operation as predicate/reference devices. Minor technological differences do not raise new safety or effectiveness issues.	Performance testing demonstrated that the device functions as intended and meets the requirements of Class II bone void fillers compared to predicate and reference devices. Minor technological differences do not raise new issues of safety or effectiveness, thus establishing substantial equivalence.

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

Test Set 1 (Posterolateral Spine Study):
- Sample Size: 71 skeletally mature rabbits.
- Data Provenance: Prospective animal study (rabbit model), likely conducted in a research facility (country not specified).
Test Set 2 (Femoral Condyle Defect Study):
- Sample Size: 44 skeletally mature rabbits.
- Data Provenance: Prospective animal study (rabbit model), likely conducted in a research facility (country not specified).
Other tests (Biocompatibility, physical/chemical, etc.): Sample sizes for these in vitro tests are not specified but would typically follow ISO standards. Data provenance is implied to be laboratory testing.

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

The document does not mention the use of human experts to establish ground truth for the animal studies. The evaluation relied on objective measures:

Radiographic data
Histomorphometric data
Biomechanical data (for posterolateral spine study)
Histological data (for femoral condyle study)

4. Adjudication Method for the Test Set

Not applicable, as ground truth was established by objective measurements in animal models (radiographic, histomorphometric, biomechanical, histological data), not through expert review or consensus.

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 conducted. The studies described are animal studies comparing the device's performance to predicate devices and positive controls through objective biological and physical measurements, not human reader performance with or without AI assistance.

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

This question is not applicable to the device described. The FIBERGRAFT® Aeridyan™ Matrix is a physical bone graft substitute, not an algorithmic or AI-based device. Therefore, the concept of "standalone algorithm performance" doesn't apply.

7. The Type of Ground Truth Used

The ground truth used in the animal studies was objective biological and physical measurements:

Radiographic data: Imaging evidence of bone healing and fusion.
Histomorphometric data: Quantitative analysis of tissue morphology, including bone formation, graft resorption, and new bone growth.
Biomechanical data: Measurement of the mechanical strength of the fused/healed bone (for the spine study).
Histological data: Microscopic examination of tissue structures (for the femoral condyle study).

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical bone graft substitute, not a machine learning model that requires a training set.

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

This question is not applicable, as there is no training set for this type of device.

Summary

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August 23, 2022

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional, and they are likely used to identify the organizations on official documents and websites.

Prosidyan, Inc % Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103

Re: K213803

Trade/Device Name: FIBERGRAFT® Aeridyan™ Matrix Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 19, 2022 Received: July 19, 2022

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 (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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement on last page

510(k) Number (if known) K213803

Device Name

FIBERGRAFT® Aeridyan™ Matrix Bone Graft Substitute

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act(PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conductor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

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510(k) SUMMARY

Prosidyan, Inc.'s FIBERGRAFT® Aeridyan™ Matrix - Bone Graft Substitute

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Prosidyan, Inc. 41 Spring Street #107 New Providence, NJ 07974 Phone: (908) 517-3666 Facsimile: (908) 396-1151 Contact Person: Gina M. Nagvajara, PhD

Date Prepared: July 19, 2022

Name of Device and Name

FIBERGRAFT® Aeridyan™ Matrix Bone Graft Substitute

Common or Usual Name

Filler, Bone Void, Calcium Compound Classification Name/CFR Regulation/Product Code Resorbable Calcium Salt Bone Void Filler, 21 CFR 888.3045, product code MQV

Predicate Device

· Prosidyan Inc, FIBERGRAFT BG Matrix (K180080)

Reference Devices

· NovaBone Products LLC, NovaBone MacroFORM (K140946)
Prosidyan, Inc., FIBERGRAFT® AERIDYAN Matrix (K182670)

Intended Use / Indications for Use

Device Description

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The FIBERGRAFT® AERIDY AN Matrix product was previously cleared in K182670. There have been no technological changes to the device since this last clearance - the formulation, raw materials and critical raw material suppliers remain the same. The intent of this submission is to expand the indication in the pelvis and extremities based on completion of an additional functional animal study.

Technological Characteristics

The FIBERGRAFT Aeridyan Matrix is of the same composition as the previously cleared FIBERGRAFT Aeridyan Matrix in K182670; and also similar in composition to the previously cleared FIBERGRAFT BG Matrix (K180080). All products are resorbable, osteoconductive, bioactive bone void filler devices that are composed of bioactive glass and bovine collagen. The comparison among the devices is shown in the table below.

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	Prosidyan's FIBERGRAFT®Aeridyan ™ Matrix(Subject Device)	Prosidyan's FIBERGRAFT® BGMatrix (K180080)(Predicate Device)	NovaBone MacroFORM (K140946)(Reference Device)	Prosidyan's FIBERGRAFT®AERIDYAN Matrix (K182670)(Reference Device)		Prosidyan's FIBERGRAFT®Aeridyan ™ Matrix(Subject Device)	Prosidyan's FIBERGRAFT® BGMatrix (K180080)(Predicate Device)	NovaBone MacroFORM (K140946)(Reference Device)	Prosidyan's FIBERGRAFT®AERIDYAN Matrix (K182670)(Reference Device)
Intended Use	Bone void filler for orthopedicapplications	Bone void filler for orthopedicapplications	Bone void filler for orthopedicapplications	Bone void filler for orthopedicapplications	Primary Component	45S5 Bioactive Glass, Boronbioactive glass	45S5 Bioactive Glass	45S5 Bioactive Glass	45S5 Bioactive Glass, Boronbioactive glass
Indications for Use	FIBERGRAFT® Aeridyan ™ Matrix- Bone Graft Substitute is indicatedonly for bony voids or gaps that arenot intrinsic to the stability of thebony structure. FIBERGRAFT®Aeridyan™ Matrix is indicated tobe gently packed into bony voidsor gaps of the skeletal system (i.e.,the posterolateral spine,extremities and pelvis). Thesedefects may be surgically createdosseous defects or osseousdefects created from traumaticinjury to the bone. The productprovides a bone void filler thatresorbs and is replaced with boneduring the healing process.FIBERGRAFT® Aeridyan ™ Matrixmust be used with autogenousbone marrow aspirate andautograft in posterolateral spine.FIBERGRAFT® Aeridyan ™ Matrixmust be hydrated with saline orblood for pelvis and extremityapplications.	FIBERGRAFT® BG Matrix - BoneGraft Substitute is indicated onlyfor bony voids or gaps that are notintrinsic to the stability of the bonystructure. FIBERGRAFT® BGMatrix is indicated to be gentlypacked into bony voids or gaps ofthe skeletal system (i.e.,posterolateral spine, extremitiesand pelvis). These defects may besurgically created osseous defectsor osseous defects created fromtraumatic injury to the bone. Theproduct provides a bone void fillerthat resorbs and is replaced withbone during the healing process.FIBERGRAFT® BG Matrix mustbe used with autogenous bonemarrow aspirate and autograft inposterolateral spine.	NovaBone MacroFORMgraft devices are indicated only forbony voids or gaps that are notintrinsic to the stability of the bonystructure. NovaBone MacroFORMis indicated to be gently packedinto bony voids or gaps of theskeletal system (i.e. theextremities and pelvis). Thesedefects may be surgically createdosseous defects or osseousdefects created from traumaticinjury to the bone. NovaBoneMacroFORM must be hydratedwith autogenous bone marrowprior to implantation. The productprovides a bone void filler thatresorbs and is replaced with boneduring the healing process.	AERIDYANFIBERGRAFT®Matrix - Bone Graft Substitute isindicated only for bony voids orgaps that are not intrinsic to thestability of the bony structure.FIBERGRAFT®AERIDYANMatrix is indicated to be gentlypacked into bony voids or gaps ofthe skeletal system (i.e.,posterolateral spine). Thesedefects may be surgically createdosseous defects or osseousdefects created from traumaticinjury to the bone. The productprovides a bone void filler thatresorbs and is replaced with boneduring the healing process.FIBERGRAFT® AERIDYANMatrix must be used withautogenous bone marrow aspirateand autograft in posterolateralspine.	Collagencomposition	Type I Collagen from bovine	Type I Collagen from bovine	Type I Collagen from bovine	Type I Collagen from bovine
Target Population	Individuals with surgically createdosseous defects or osseousdefects due to traumatic injury tobone.	Individuals with surgically createdosseous defects or osseousdefects due to traumatic injury tobone.	Individuals with surgically createdosseous defects or osseousdefects due to traumatic injury tobone.	Individuals with surgically createdosseous defects or osseousdefects due to traumatic injury tobone.	Osteoconductive	Yes	Yes	Yes	Yes
AnatomicalPlacement	Posterolateral spine, Extremitiesand Pelvis	Posterolateral spine, Extremitiesand Pelvis	Extremities and Pelvis	Posterolateral spine	Bioactive	Yes	Yes	Yes	Yes
Resorbs	Yes	Yes	Yes	Yes
Sterility	Sterile	Sterile	Sterile	Sterile
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Biocompatible
Packaging	Thermo-form tray	Thermo-form tray	Thermo-form tray and sealed cups	Thermo-form tray

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K213803

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Performance Data

The performance of the FIBERGRAFT® Aeridyan Matrix has been established by undertaking physical and chemical property evaluation studies, functional performance animal studies and biocompatibility tests. The physical and chemical property studies confirmed the in vitro functionality and bioactivity of the Aeridyan Matrix. The in vitro bioactivity test results have not been correlated to clinical performance. The biocompatibility of the FIBERGRAFT® Aeridyan Matrix has been demonstrated by ISO 10993 testing and the long history of clinical use of the bioactive glass material for the same intended use. In addition, the Aeridyan Matrix is composed of the same bioactive glass material and the same type and duration of patient as the predicates. Packaging evaluations, shelf life testing and real time aging testing were performed with passing results. Bacterial endotoxin testing was performed using the limulus amebocyte lysate (LAL) method and showed that the device meets the endotoxin limits of established guidelines.

The FIBERGRAFT® Aeridyan Matrix product was evaluated in a rabbit posterolateral spine fusion study to support device performance for its indications for use in the FIBERGRAFT® Aeridyan Matrix product was compared to the FIBERGRAFT® BG Matrix predicate device as well as controls. The animal study evaluated device performance in critical sized cancellous bone in the posterolateral spine of 71 skeletally mature rabbits. The performance was evaluated using radiographic, histomorphometric, and biomechanical data. Testing of the FIBERGRAFT® Aeridyan Matrix in the rabbit model is representative of the indications for use and range of anatomical sites proposed for the subject device. The results of the study through 26 weeks of follow-up demonstrated that the FIBERGRAFT® Aeridyan Matrix device performs substantially equivalently to the predicate device and positive control, and any minor technological differences between the device groups do not raise new types of safety or effectiveness concerns.

The FIBERGRAFT® Aeridyan Matrix product has also been evaluated in a rabbit femoral condyle defect study in skeletally mature rabbits to further support device performance for use in extremities and pelvis applications. The FIBERGRAFT® Aeridyan Matrix product was compared to the BG Matrix and NovaBone MacroFORM predicate and reference devices. The animal study evaluated device performance in critical sized defects in the distal femur of 44 skeletally mature rabbits. The performance was evaluated using radiographic, histological, and histomorphometric data. Testing of the FIBERGRAFT® Aeridyan Matrix in the rabbit model is representative of the indications for use and range of anatomical sites proposed for the subject device. The results of the study through 26 weeks of follow up demonstrated that the FIBERGRAFT® Aeridyan Matrix device performs substantially equivalently to the predicate and reference devices, and any minor technological differences between the device groups do not adversely impact performance.

Therefore, performance testing demonstrated that the FIBERGRAFT® Aeridyan Matrix device functions as intended and meets the requirements of class II bone void fillers as compared to the predicate device and reference devices.

Substantial Equivalence

As demonstrated in performance testing, the FIBERGRAFT® Aeridyan Matrix has the same intended use and similar indications, technological characteristics, and principles of operation as the predicate and reference devices. The minor technological differences between Aeridyan Matrix and its predicate device do not raise any new issues of safety or effectiveness. The data demonstrated that Aeridyan Matrix is substantially equivalent to the predicate device.

Conclusion

FIBERGRAFT® Aeridyan Matrix is an osteoconductive, resorbable bone graft substitute composed of bioactive glass, mixed with type I collagen. The FIBERGRAFT® Aeridyan Matrix is substantially equivalent to its predicate and reference devices for its intended use as a synthetic bone void filler. Performance

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testing, including in vivo data, demonstrated that the device functions as intended, supporting substantial equivalence.

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.