(98 days)
No
The summary describes a synthetic bone substitute material and its physical and biological properties. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to fill bony voids or gaps and is replaced with bone during the healing process, indicating a therapeutic purpose to aid in bone repair.
No
The device is an implantable bone substitute intended to fill bony voids, not to diagnose medical conditions.
No
The device description clearly states it is a synthetic and biocompatible bone substitute device composed of bioactive glass granules, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that GlassBone Granules is an implant intended to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural function within the body.
- Device Description: The description confirms it's a synthetic and biocompatible bone substitute device.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. GlassBone Granules does not perform this function. It is implanted into the body.
Therefore, based on the provided information, GlassBone Granules is a medical device, specifically an implantable bone substitute, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
GlassBone Granules is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. GlassBone Granules resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
GlassBone Granules is a synthetic and biocompatible bone substitute device (bioactive glass 45S5). GlassBone Granules is composed by weight of 45S5 bioactive glass granules (45% SiO2, 6% P2O5, 24.5% CaO and 24.5% Na2O).
It is sterilized with gamma irradiation and is single use and is available in different 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., extremities and pelvis)
Indicated Patient Age Range
adults and pediatric patients ≥ 6 years old
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)
Bench testing:
Bench testing was conducted according to FDA Guidance "Resorbable Calcium Salt Bone Void Filler Device - Class II Special Controls Guidance Document for Industry and FDA Staff" and ASTM F1538.
- . pH
- Solubility .
- Apatite
- Composition - Heavy Metals
- Crystallinity
- Particle Size
- . Surface Area
Animal testing and biocompatibility:
Biocompatibility testing was conducted in accordance with ISO-10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process".
- Physico-chemical characterization
- Cytotoxicity
- Sensitization
- Irritation or intracutaneous reactivity
- Material mediated pyrogenicity
- Acute systemic toxicity
- Local effects of implantation
- Genotoxicity
Sterility and Shelf Life:
The following testing was performed on GlassBone Granules:
- ISO 11137 Radiation Sterilization Validation ●
- ISO 11607 Packaging for terminally sterilized medical devices ●
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.
Noraker, SAS believes that the bench and non-clinical performance data supports the safety of GlassBone Granules, and the device should perform effectively as intended in the specified use conditions. The non-clinical performance data demonstrates that GlassBone Granules performs comparably to the predicate device that is currently marketed for the same intended use and presents no new concerns about safety and effectiveness.
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.
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.
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December 23, 2024
Noraker % Elisa Maldonado-Holmertz RA/QA Consultant Obelix Consulting 806 Jefferson Street Bastrop, Texas 78602
Re: K242782
Trade/Device Name: GlassBone Granules Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: November 12, 2024 Received: November 13, 2024
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Digitally signed by JESSE MUIR JESSE MUIR -S Date: 2024.12.23 09:42:12 -05'00
Jesse Muir, 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
3
Indications for Use
Submission Number (if known)
Device Name
GlassBone Granules
Indications for Use (Describe)
GlassBone Granules is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. GlassBone Granules 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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4
510(k) SUMMARY
SUBMITTER
Submission Sponsor:
Catherine FLACARD Compliance & Innovation Chief Officer Noraker, SAS 60, Avenue Rockefeller 69008 Lyon France Email: c.flacard@noraker.com Tel number: +33 (0)4 78 93 30 92
Submission Correspondent:
Elisa Maldonado-Holmertz RA/QA Consultant Obelix Consulting, LLC 806 Jefferson St Bastrop, TX 78602 USA Email: elisamh@obelixconsult.com Tel number: +1 512 431 6069
Date Prepared: 13 September 2024
SUBJECT DEVICE
Name of Device: GlassBone Granules Common or Usual Name: Filler, Bone Void, Calcium Compound Classification Name: Resorbable calcium salt bone void filler device (21 CFR 888.3045) Regulatory Class: Class II Product Code: MQV
PREDICATE DEVICE
BonAlive Granules - K231528
5
This predicate has not been subject to a design-related recall.
REFERENCE DEVICE
NovaBone Resorbable Bone Graft Substitute - K052494 This predicate has not been subject to a design-related recall.
DEVICE DESCRIPTION
GlassBone Granules is a synthetic and biocompatible bone substitute device (bioactive glass 4555). GlassBone Granules is composed by weight of 4555 bioactive glass granules (45% SiO2, 6% P2O5, 24.5% CaO and 24.5% Na2O).
It is sterilized with gamma irradiation and is single use and is available in different unit sizes.
INDICATIONS FOR USE
GlassBone Granules is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. GlassBone Granules resorbs and is replaced with bone during the healing process.
Rx only.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
GlassBone Granules is substantially equivalent to the following predicate and reference device:
| Manufacturer | Subject Device
Noraker SAS | Primary predicate
BonAlive Biomaterials, Ltd | Reference Device
NovaBone | SIGNIFICANT
DIFFERENCES |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Trade Name | GlassBone® Granules | BonAlive® Granules | Resorbable Bone Graft Substitute
(Particulate) | None |
| 510(k) Number | - | K231528 | K052494 | - |
| Product Code | MQV | MQV | MQV | None |
| Regulation
Number | 888.3045 | 888.3045 | 888.3045 | None |
| Regulation Name | Resorbable calcium salt bone void
filler device | Resorbable calcium salt bone void
filler device | Resorbable calcium salt bone void
filler device | None |
| Indications for
Use | GlassBone Granules is an implant
intended to fill bony voids or gaps of
the skeletal system (i.e., extremities | Bonalive® Orthopedics granules is an
implant intended to fill bony voids or
gaps of the skeletal system (i.e., | NovaBone Resorbable Bone graft
substitute is indicated only for bony | None |
| Manufacturer | Subject Device
Noraker SAS | Primary predicate
BonAlive Biomaterials, Ltd | Reference Device
NovaBone | SIGNIFICANT
DIFFERENCES |
| Trade Name | GlassBone® Granules | BonAlive® Granules | Resorbable Bone Graft Substitute
(Particulate) | None |
| | and pelvis). These osseous defects
may be the result of benign bone
cysts and tumors (in adults and
pediatric patients ≥ 6
years old), are surgically created or
the result of traumatic injury to the
bone and are not intrinsic to the
stability of the
bony structure. GlassBone Granules
resorbs and is replaced with bone
during the healing process. | extremities
and pelvis). These osseous defects
may be the result of benign bone
cysts and tumors (in adults and
pediatric patients ≥ 6
years old), are surgically created or
the result of traumatic injury to the
bone and are not intrinsic to the
stability of the
bony structure. Bonalive®
Orthopedics granules resorbs and is
replaced with bone during the healing
process. | voids or gaps that are not intrinsic to
the stability of the bony structure.
NovaBone 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. | |
| Rx or OTC | Rx | Rx | Rx | None |
| Physical Form | Amorphous, non-porous random-
shaped particles | Amorphous, non-porous random-
shaped particles | Amorphous, non-porous random-
shaped particles | None |
| Color | Brown | Brown | White | None |
| Materials
Composition | Bioactive glass
45S5 Bioglass (SiO₂, P₂O₅, CaO and
Na₂O) | Bioactive glass
S53P4 glass (SiO₂, P₂O₅, CaO and
Na₂O) | Bioactive glass
45S5 Bioglass (SiO₂, P₂O₅, CaO and
Na₂O) | None |
| Product Sizes | Granule sizes:
0.5-1mm
1-3mm
Product volumes:
0.5cc
1 cc
5 cc
10 cc
16 cc | Granule sizes:
0.5-0.8 mm
1.0-2.0 mm
Product volumes:
1 cc
2.5 cc
5 cc
10 cc | Granule sizes:
90-710μm
Product volumes:
2 cc
5 cc
10 cc
15 cc | Similar without
affecting safety or
effectiveness |
| Biocompatibility | Biocompatible
ISO 10993 | Biocompatible
ISO 10993 | Biocompatible
ISO 10993 | None |
| Sterilization | Gamma, SAL 10⁻⁶ | Gamma, SAL 10⁻⁶ | EtO, SAL 10⁻⁶ | None |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | None |
| Single Use/
Reuse | Single use only | Single use only | Single use only | None |
| Mode of action | Works by leaching 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 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 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 |
| Manufacturer | Subject Device
Noraker SAS | Primary predicate
BonAlive Biomaterials, Ltd | Reference Device
NovaBone | SIGNIFICANT
DIFFERENCES |
| Trade Name | GlassBone® Granules | BonAlive® Granules | Resorbable Bone Graft Substitute
(Particulate) | None |
| Properties | Synthetic
Osteoconductive | Synthetic
Osteoconductive | Synthetic
Osteoconductive | None |
| MR safety | MR Safe | MR Safe | Unknown | None |
6
7
NON CLINICAL PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
Bench testing:
Bench testing was conducted according to FDA Guidance "Resorbable Calcium Salt Bone Void Filler Device - Class II Special Controls Guidance Document for Industry and FDA Staff" and ASTM F1538.
- . pH
- Solubility .
- Apatite
- Composition - Heavy Metals
- Crystallinity
- Particle Size
- . Surface Area
Animal testing and biocompatibility:
Biocompatibility testing was conducted in accordance with ISO-10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process".
- Physico-chemical characterization
- Cytotoxicity
- Sensitization
- Irritation or intracutaneous reactivity
- Material mediated pyrogenicity
- Acute systemic toxicity
- Local effects of implantation
- Genotoxicity
8
Sterility and Shelf Life
The following testing was performed on GlassBone Granules:
- ISO 11137 Radiation Sterilization Validation ●
- ISO 11607 Packaging for terminally sterilized medical devices ●
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.
Statement of Substantial Equivalence
Noraker GlassBone Granules is substantially equivalent to the predicate device when comparing the following characteristics:
- •Indications for Use
- •Principles of Use
- •Fundamental Technology
- •Basic Design
- •Materials Used
- •Where used
- •Standards met
- •Sterilization Method
GlassBone Granules meet all requirements for overall design and confirms that the output meets the design inputs and specifications. The GlassBone Granules passed all testing stated above as shown by acceptable results obtained.
GlassBone Granules complies with the applicable voluntary, national, and international standards and guidance.
Noraker, SAS believes that the bench and non-clinical performance data supports the safety of GlassBone Granules, and the device should perform effectively as intended in the specified use conditions. The non-clinical performance data demonstrates that GlassBone Granules performs comparably to the predicate device that is currently marketed for the same intended use and presents no new concerns about safety and effectiveness.