(86 days)
Not Found
No
The document describes a bone void filler made of bioactive glass granules and does not mention any computational or algorithmic components, let alone AI or ML.
Yes
The device is described as a bone void filler that resorbs and is replaced with bone during the healing process, promoting new bone formation, which aligns with the definition of a therapeutic device.
No
This device, BonAlive® granules, is a bone void filler intended for use in the skeletal system. Its description clearly states its purpose is to facilitate bone tissue growth and act as a scaffold for new bone formation, which is a therapeutic function, not diagnostic.
No
The device description clearly states that BonAlive® granules is composed of physical granules made of bioactive glass, which is a material, not software. It is a sterile medical device that is physically implanted into the body.
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 void filler for surgical use in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the material composition and how it interacts with bone tissue to promote healing and integration. This is consistent with a medical device used for treatment or repair, not for analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
BonAlive® granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BonAlive® granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product contains a bone void filler that resorbs and is replaced with bone during the healing process. When used in the extremities and pelvis, BonAlive® granules is intended to be used alone.
Product codes (comma separated list FDA assigned to the subject device)
MOV
Device Description
BonAlive® granules is composed of osteostimulative calcium-phosphorous-sodium-silicate (glass 553P4) granules (size 0.5-0.8 mm or 1.0-2.0 mm) and is a sterile medical device. This synthetic, osteoconductive material is comprised of SiO2, Na2O, CaO and P2O5. Bioactive glass is characterized by its ability to attach firmly to living tissue. Other properties include its ability to facilitate bone tissue growth, bond chemically with surrounding bone, and promote new bone formation in the implanted area.
In aqueous solution (e.g. body fluids), bioactive glass works by leaching out ions and developing a silica-gel layer which acts as a template for a calcium phosphate (CaP) precipitation. The CaP crystallizes to hydroxyapatite, which resembles the mineral phase of natural bone in its chemical composition and structure, thus enabling bonding of the bioactive glass to the surrounding bone.
The BonAlive® granules resorb and are replaced with bone slowly over a period of years. The bioactive glass in the BonAlive® granules is radiodense thus enabling postoperative radiologic evaluation.
Best results are obtained by ensuring close contact of the device with surrounding bone tissue and by carefully following the Instructions for Use.
BonAlive® granules is sterilized by irradiation and is available in different granule and unit sizes.
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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
The following testing has been performed to support substantial equivalence to the predicate:
- Apatite
- Composition Heavy Metals ●
- Crystallinity
- Particle Size Distribution
- Surface Area
- Manufacturing & Specifications Validation
The BonAlive Granules meets all the requirements for overall design and confirms that the output meets the design inputs and specifications. The BonAlive Granules passed all testing stated above as shown by the acceptable results obtained. The BonAlive Granules complies with the applicable voluntary, national and international standards and guidance.
Biocompatibility:
Biocompatibility testing was conducted in accordance with ISO-10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" The following biocompatibility studies were successfully performed with the BonAlive® granules: cytotoxicity, sensitization, systemic toxicity, and muscle implantation.
The granules predicate device was depyrogenated at 250 degrees Celsius for one hour prior to dry heat sterilization. Bacterial endotoxins were investigated in a LAL gel clot test. The analysis was performed according to Ph. Eur. 2.6.14 method A. The log reduction in endotoxin levels in the dry heat depyrogenation cycles was 4.6 logs. The results met USP requirement for bacterial endotoxins. Similarly, as for the predicate device, a depyrogenation step at 250 degrees Celsius is performed for the granules subject device prior the gamma irradiation. The granules material and the depyrogenation method are the same for the predicate and the subject devices, thus the log reduction in the endotoxin levels for the predicate and the subject devices are equivalent. The testing performed on the predicate device supports the pyrogen status of the subject device. The predicate and subject devices are substantially equivalent in their nonpyrogenic nature.
Sterility and Shelf Life:
The BonAlive Granules and Applicator (Granules) are sterilized with radiation. The sterility of the Granules was assured by using a validated sterilization method qualified in accordance with EN ISO 11137. After the sterilization cycle was completed, the Granules were placed on real-time shelf-life testing for a length of time to determine any degradation or loss of sterility over the anticipated shelf-life period of five (5) years. The validations and shelf life testing were completed successfully in accordance with ISO 11607.
Clinical Performance Data:
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 & 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.
BonAlive Biomaterials Ltd. % Elisa Maldonado-Holmertz RA/QA Consultant Obelix Biotech Solutions 12416 Fairfax Ridge Place Austin, Texas 78738
Re: K191274
Trade/Device Name: BonAlive® Granules Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: May 10, 2019 Received: May 15, 2019
Dear Ms. Maldonado-Holmertz:
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.
1
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 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.
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) K191274
Device Name
BonAlive® Granules
Indications for Use (Describe)
BonAlive® granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BonAlive® granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product contains a bone void filler that resorbs and is replaced with bone during the healing process. When used in the extremities and pelvis, BonAlive® granules is intended to be used alone.
| 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) |
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3
Section 005 - 510(k) Summary
1. Submission Sponsor
Jimmy Lucchesi Chief Technology Officer BonAlive Biomaterials Ltd. Biolinja 12 20750 Turku Finland Email: Jimmy.Lucchesi@bonalive.com Tel number: +358 50 552 4671
2. Submission Correspondent
Obelix Consulting, LLC 12416 Fairfax Ridge Place Austin, TX 78738 USA Elisa Maldonado-Holmertz RA/QA Consultant Email: elisamh@obelixconsult.com Tel number: 512.431.6069
3. Date Prepared
10 May 2019
4. Device Identification
| Type of 510(k) Submission: | Traditional |
|---|---|
| Trade or Proprietary Name: | BonAlive Granules |
| Common or Usual Name: | Filler, Bone Void, Calcium Compound |
| Regulation Description: | Resorbable calcium salt bone void filler device |
| Regulation Classification: | 888.3045 |
| Product Code: | MQV |
| Class of Device: | Class II |
| Review Panel: | Office of Device Evaluation (ODE) |
| Division of Orthopedic Devices (DOD) | |
| Restorative and Repair Devices Branch (RRDB) | |
| Reason for Submission: | New device |
| Prior Related Submissions: | Submission K110024 received NSE due to |
| osteostimulation and antibacterial claims. This | |
| current submission has removed such claims. | |
| Multiple Devices: | None |
4
5. Legally Marketed Predicate Device(s)
K071199 (Rx Only) BonAlive Granules by Vivoxid Ltd. (now called BonAlive Biomaterials, Ltd.)
6. Device Description
BonAlive® granules is composed of osteostimulative calcium-phosphorous-sodium-silicate (glass 553P4) granules (size 0.5-0.8 mm or 1.0-2.0 mm) and is a sterile medical device. This synthetic, osteoconductive material is comprised of SiO2, Na2O, CaO and P2O5. Bioactive glass is characterized by its ability to attach firmly to living tissue. Other properties include its ability to facilitate bone tissue growth, bond chemically with surrounding bone, and promote new bone formation in the implanted area.
In aqueous solution (e.g. body fluids), bioactive glass works by leaching out ions and developing a silica-gel layer which acts as a template for a calcium phosphate (CaP) precipitation. The CaP crystallizes to hydroxyapatite, which resembles the mineral phase of natural bone in its chemical composition and structure, thus enabling bonding of the bioactive glass to the surrounding bone.
The BonAlive® granules resorb and are replaced with bone slowly over a period of years. The bioactive glass in the BonAlive® granules is radiodense thus enabling postoperative radiologic evaluation.
Best results are obtained by ensuring close contact of the device with surrounding bone tissue and by carefully following the Instructions for Use.
BonAlive® granules is sterilized by irradiation and is available in different granule and unit sizes.
7. Indication for Use Statement
BonAlive® granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BonAlive® granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product contains a bone void filler that resorbs and is replaced with bone during the healing process. When used in the extremities and pelvis, BonAlive® granules is intended to be used alone.
RX Only
5
8. Substantial Equivalence Discussion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Comparison of Characteristics | |||
|---|---|---|---|
| Manufacturer | SUBJECT DEVICE | ||
| BonAlive Biomaterials, Ltd | PREDICATE DEVICE | ||
| Vivoxid Ltd (now called | |||
| BonAlive Biomaterials, Ltd.) | SIGNIFICANT | ||
| DIFFERENCES | |||
| Trade Name | BonAlive Granules | BonAlive Granules | None |
| 510(k) Number | - | K071199 | |
| Product Code | MQV | MQV | None |
| Regulation Number | 888.3045 | 888.3045 | None |
| Regulation Name | Resorbable calcium salt | ||
| bone void filler device | Resorbable calcium salt | ||
| bone void filler device | None | ||
| Indications for Use | BonAlive® granules is | ||
| indicated only for bony | |||
| voids or gaps that are not | |||
| intrinsic to the stability of | |||
| the bony structure. | |||
| BonAlive® granules is | |||
| indicated to be gently | |||
| packed into bony voids or | |||
| gaps of the skeletal system | |||
| (i.e. the extremities and | |||
| pelvis). These defects may | |||
| be surgically created | |||
| osseous defects or osseous | |||
| defects created from | |||
| traumatic injury to the | |||
| bone. The product | |||
| contains a bone void filler | |||
| that resorbs and is | |||
| replaced with bone during | |||
| the healing process. When | |||
| used in the extremities and | |||
| pelvis, BonAlive® granules | |||
| is intended to be used | |||
| alone. | BonAlive® granules is | ||
| indicated only for bony | |||
| voids or gaps that are not | |||
| intrinsic to the stability of | |||
| the bony structure. | |||
| BonAlive® granules is | |||
| indicated to be gently | |||
| packed into bony voids or | |||
| gaps of the skeletal system | |||
| (i.e. the 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. When | |||
| used in the extremities and | |||
| pelvis, BonAlive® granules | |||
| is intended to be used | |||
| alone. The device is not | |||
| intended for use in | |||
| posterolateral spine | |||
| applications. | None |
Comparison of Characteristics
6
| Manufacturer | New Product | PREDICATE | SIGNIFICANT |
|---|---|---|---|
| Manufacturer | BonAlive Biomaterials, Ltd | Vivoxid Ltd (now called | |
| BonAlive Biomaterials, Ltd.) | DIFFERENCES | ||
| Trade Name | BonAlive Granules | BonAlive Granules | None |
| indicated for use in load- | |||
| bearing applications, | |||
| therefore, standard | |||
| internal or external | |||
| stabilization techniques | |||
| must be followed to obtain | |||
| rigid stabilization. | |||
| Rx or OTC | Rx | Rx | None |
| Physical Form | Amorphous, non-porous | ||
| random-shaped particles | Amorphous, non-porous | ||
| random-shaped particles | None | ||
| Color | Brown | Slightly pink | Color is different |
| Materials | |||
| Composition | SiO2, Na2O, CaO and P2O5 | SiO2, Na2O, CaO and P₂O5 | None |
| Granule sizes: | |||
| 0.5-0.8 mm | |||
| 1.0-2.0 mm | Granules sizes: | ||
| 0.5-0.8 mm | |||
| 1.0-2.0 | |||
| 2.0-3.15 mm | Largest granule size | ||
| 2.0-3.15 mm is | |||
| obsolete | |||
| Product volumes: | |||
| 1 cc | |||
| 2.5 cc | |||
| 5 cc | |||
| 10 cc | Product volumes: | ||
| 1 cc | |||
| 2 cc | |||
| 4 cc | |||
| 16 cc | Volumes are | ||
| different | |||
| Biocompatibility | Biocompatible | ||
| ISO 10993 | Biocompatible | ||
| ISO 10993 | None | ||
| Sterilization, SAL | Gamma | ||
| Sterile, SAL 10-6 | Dry Heat | ||
| Sterile, SAL 10-6 | None | ||
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | None |
| Single Use/ | |||
| Reuse | Single use only | Single use only | None |
| Mode of action | Works by leaching out ions | ||
| that react with the body | |||
| fluids transforming the | |||
| glass surface chemically | |||
| into one that by its | |||
| chemical composition and | |||
| structure resembles the | |||
| mineral phase found in | |||
| natural bone. | Works by leaching out ions | ||
| that react with the body | |||
| fluids transforming the | |||
| glass surface chemically | |||
| into one that by its | |||
| chemical composition and | |||
| structure resembles the | |||
| mineral phase found in | |||
| natural bone. | None | ||
| Properties | Synthetic | Synthetic | None |
7
| Manufacturer | New Product
BonAlive Biomaterials, Ltd | PREDICATE
Vivoxid Ltd (now called
BonAlive Biomaterials, Ltd.) | SIGNIFICANT
DIFFERENCES |
|--------------|-------------------------------------------|----------------------------------------------------------------------|----------------------------|
| Trade Name | BonAlive Granules | BonAlive Granules | None |
| | Osteoconductive | Osteoconductive | |
9. Non-Clinical Performance Data
The following testing has been performed to support substantial equivalence to the predicate:
- Apatite
- Composition Heavy Metals ●
- Crystallinity
- Particle Size Distribution
- Surface Area
- Manufacturing & Specifications Validation
As part of demonstrating safety and effectiveness of BonAlive Granules, and in showing substantial equivalence to the predicate device, BonAlive completed a number of tests. The BonAlive Granules meets all the requirements for overall design and confirms that the output meets the design inputs and specifications. The BonAlive Granules passed all testing stated above as shown by the acceptable results obtained.
The BonAlive Granules complies with the applicable voluntary, national and international standards and guidance.
10. Biocompatibility
Biocompatibility testing was conducted in accordance with ISO-10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" The following biocompatibility studies were successfully performed with the BonAlive® granules: cytotoxicity, sensitization, systemic toxicity, and muscle implantation.
The granules predicate device was depyrogenated at 250 degrees Celsius for one hour prior to dry heat sterilization. Bacterial endotoxins were investigated in a LAL gel clot test. The analysis was performed according to Ph. Eur. 2.6.14 method A. The log reduction in endotoxin levels in the dry heat depyrogenation cycles was 4.6 logs. The results met USP requirement for bacterial endotoxins.
Similarly, as for the predicate device, a depyrogenation step at 250 degrees Celsius is performed for the granules subject device prior the gamma irradiation. The granules material and the depyrogenation method are the same for the predicate and the subject devices, thus the log reduction in the endotoxin levels for the predicate and the subject devices are equivalent. The testing performed on the predicate device supports the pyrogen status of the subject device. The predicate and subject devices are substantially equivalent in their nonpyrogenic nature.
8
11. Sterility and Shelf Life
The BonAlive Granules and Applicator (Granules) are sterilized with radiation. The sterility of the Granules was assured by using a validated sterilization method qualified in accordance with EN ISO 11137. After the sterilization cycle was completed, the Granules were placed on real-time shelf-life testing for a length of time to determine any degradation or loss of sterility over the anticipated shelf-life period of five (5) years. The validations and shelf life testing were completed successfully in accordance with ISO 11607.
12. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
13. Statement of Substantial Equivalence
A device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device. BonAlive Granules is substantially equivalent to its predicate.