These INION BIORESTORE™ implants are bone graft substitutes indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. INION BIORESTORE™ is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine 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.

Device Description

Inion BioRestore™ is a biodegradable bone graft substitute made of bioactive, biodegradable glass. Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect. Based on pre-clinical testing, most of the material degrades in vivo in six months. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and non-pyrogenic.

With this modification, additional packaging sizes and packaging configurations are introduced for the Inion BioRestore™ morsels.

AI/ML Overview

This document is a 510(k) premarket notification for the Inion BioRestore device. The information provided primarily focuses on the regulatory aspects, device description, and verification testing related to packaging modifications for an existing bone graft substitute. As such, the document does not contain the typical acceptance criteria and a study design for a software or AI-based medical device.

Therefore, many of the requested details, such as those related to AI algorithm performance, human reader studies, or training/test set ground truth establishment for an AI device, are not applicable to this submission.

However, I can extract the information that is present concerning the physical device's verification testing and acceptance criteria related to its packaging and shelf-life.

Here's the information based on the provided text, aligning with the closest relevant aspects of your request:

Acceptance Criteria and Device Performance for Inion BioRestore (Packaging Modification)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit in Document)	Reported Device Performance
Biological Safety	Device must be biologically safe in new configuration.	Evaluation conducted; deemed safe.
Sterilization	Device must maintain sterility in new configuration.	Validation conducted; deemed sterile.
Shelf Life	Device must maintain properties for a specified shelf life (5 years).	Studies performed; 5-year shelf life confirmed and verified for new packaging.
Transportation and Handling	Packaging system must provide physical protection to the sterile barrier, prevent damage to products, and ensure functionality is not compromised during shipping/handling.	All acceptance criteria fulfilled.

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

Sample Size: Not explicitly stated for each specific test (biological safety, sterilization, shelf life, transportation). The document mentions "evaluation was conducted," "validation was conducted," "studies were performed," and "a test was performed," implying a sample was used for each.
Data Provenance: Not explicitly stated regarding country of origin or specific patient data as this relates to a physical device's integrity and sterility, not clinical data from patients. The testing appears to be laboratory-based and engineering-based (e.g., sterilization validation, physical handling tests). The submission itself originates from Tampere, Finland (Manufacturer: Inion Oy).

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

Not Applicable in the context of an AI device's ground truth. For this physical device's packaging verification, the "ground truth" would be established by validated scientific and engineering methods, adhering to relevant standards (e.g., ISO, ASTM for sterilization, shelf-life, and transportation testing). These tests are typically performed by qualified laboratory personnel and engineers, but specific numbers and qualifications are not provided in this regulatory summary.

4. Adjudication Method for the Test Set

Not Applicable in the context of an AI device's ground truth adjudication. For physical device testing, results are adjudicated against pre-defined engineering and performance specifications, not through consensus of expert readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, not done. This type of study is relevant for AI-assisted diagnostic devices, not for the physical device (bone graft substitute) described here, nor its packaging modifications.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

No, not applicable. This refers to AI algorithm performance, which is not the subject of this 510(k) submission.

7. Type of Ground Truth Used

For the physical device's performance related to packaging and shelf-life, the "ground truth" is based on:
- Validated laboratory measurements (e.g., sterility testing, material degradation analysis).
- Engineering specifications and standards (e.g., for packaging integrity, transport resilience).
- Biological safety assessments based on established toxicology and biocompatibility standards.

8. Sample Size for the Training Set

Not Applicable. This refers to an AI training set, which is not relevant to this submission.

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

Not Applicable. This refers to an AI training set's ground truth, which is not relevant to this submission.

Summary regarding the device (Inion BioRestore) as a whole (not just AI/Software):

The Inion BioRestore is described as a resorbable bone void filler device made of bioactive, biodegradable glass. The 510(k) submission (K191764) is specifically for a modification to the device, introducing "additional packaging sizes and packaging configurations" for existing morsels. The document emphasizes that "There are no changes to the implant, i.e. Inion BioRestore morsels are the same." Therefore, the submission primarily focuses on ensuring that the new packaging does not negatively impact the safety, sterility, or efficacy of the device, and that it maintains its shelf life and integrity during transport.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.

Inion Ov Tiina Tyni Regulatory Affairs Manager Lääkärinkatu 2 Tampere 33520 Finland

Re: K191764

Trade/Device Name: Inion BioRestore Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: June 26, 2019 Received: July 1, 2019

Dear Tiina Tyni:

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

{1}------------------------------------------------

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 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 (OS) 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,

Laurence D. Coyne, 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) K191764

Device Name Inion BioRestore

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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 conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K191764

SPECIAL 510(k) SUMMARY Inion BioRestore - modification

Image /page/3/Picture/2 description: The image shows the word "INION" in white letters against a green background. Above the word, the number "4-1" is displayed in a smaller font, also in white. The text and number are centered in the image.

Manufacturer and submitter	Inion Oy,Lääkärinkatu 2,FIN-33520 Tampere, FINLAND
Date	June 26, 2019
Contact person	Tiina Tyni, Regulatory Affairs ManagerPhone: +358 10 830 6600Fax: +358 10 830 6601tiina.tyni@inion.com
Establishment registrationnumber	9710629
Trade name of the device	Inion BioRestore
Device classification andproduct code	Class IIClassification Panel: OrthopaedicProduct Code: MQVCommon name: Filler, bone void, calcium compoundRegulation number: 888.3045
Predicate device	Inion BioRestore (K070998)
Conformance withperformance standards	Compliance to voluntary consensus standards is listed inthe application.

Device description and principles of operation

With this modification, additional packaging sizes and packaging configurations are introduced for the Inion BioRestore™ morsels.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the word "INION" in white letters against a green background. Above the word, the number "4-2" is written in black. The font of the word "INION" is bold and sans-serif. The green background is a solid color, providing a stark contrast to the white letters.

Indications for use

Similarities to predicate device

There are no changes to the implant, i.e. Inion BioRestore morsels are the same.

Differences to predicate device

New package sizes (5cc, 6cc, 8cc and 10cc) are added to the portfolio. These will be packaged in the new syringe packaging to improve handling properties.

New package sizes (0.25cc. 0.5 cc. 1.cc. 1.6 cc. 2.0 cc. 2.5 cc. 4.6 and 5.0 cc) are added to the portfolio. These will be packaged in the current packaging (tube).

Verification testing for substantial equivalence determination

Based on the risk analysis, the following verification activities were identified and performed: biological safety evaluation was conducted for the new package configuration; sterilization validation was conducted; and shelf life studies were performed to confirm and verify the shelf life of five years for the new Inion BioRestore™ packaging configuration.

A transportation and handling test was performed to verify the ability of the packaging system to provide physical protection to the sterile barrier and to ensure that no damage of the products takes place, and that functionality of products is not compromised during shipping or handling. The results show that all acceptance criteria were fulfilled.

As demonstrated by the verification and validation testing, providing the new package sizes and package configurations of Inion BioRestore™ morsels do not raise new or increased risks concerning the safety or efficacy of the devices, when used in accordance with their indications for use. Inion BioRestore ™ morsels can be expected to perform safely and effectively in their intended use; and the product-specific benefits can be considered to clearly overweigh the identified product-specific risks.

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.