(30 days)
Not Found
No
The summary describes a passive bone graft substitute material and its packaging. There is no mention of any computational or analytical functions, let alone AI/ML.
Yes.
The device is a bone void filler intended to facilitate bone healing and repair, which is a therapeutic function.
No
The device is a bone graft substitute, intended to fill bony voids and promote bone growth, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a biodegradable bone graft substitute made of bioactive, biodegradable glass, provided as physical implants (cylinders, blocks, and morsels). This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a bone graft substitute for filling bony voids or gaps in the skeletal system. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details the material and function of the implant in promoting bone growth and repair. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific substances (analytes) in these samples.
- Providing information for the diagnosis, monitoring, or prognosis of a disease or condition.
The device is a medical implant used for surgical repair, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
MQV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the extremities, spine 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
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.
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.
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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
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Indications for Use
510(k) Number (if known) K191764
Device Name Inion BioRestore
Indications for Use (Describe)
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.
| 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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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 Manager
Phone: +358 10 830 6600
Fax: +358 10 830 6601
tiina.tyni@inion.com |
| Establishment registration
number | 9710629 |
| Trade name of the device | Inion BioRestore |
| Device classification and
product code | Class II
Classification Panel: Orthopaedic
Product Code: MQV
Common name: Filler, bone void, calcium compound
Regulation number: 888.3045 |
| Predicate device | Inion BioRestore (K070998) |
| Conformance with
performance standards | Compliance to voluntary consensus standards is listed in
the application. |
Device description and principles of operation
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.
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
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.
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.