(267 days)
Not Found
No
The summary describes a bone graft substitute material and its physical properties and performance in bench and animal testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is described as a 'bone void filler' intended for 'treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone,' which implies a therapeutic purpose.
No
Explanation: The device is a bone graft substitute used as a filler for bone voids or gaps, which resorbs and is replaced by bone during healing. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states that NanoBone is a physical material (hydroxylapatite embedded in a silica gel matrix) intended for use as a bone void filler, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that NanoBone is a "bone void filler" for surgical and traumatic bone defects. It is a material implanted into the body to aid in bone healing.
- Device Description: The description details the composition and structure of the material itself, not a diagnostic test or reagent.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the material's properties, biocompatibility, and ability to promote bone healing in animal models, not on diagnostic accuracy metrics.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. NanoBone is a therapeutic device used to fill bone voids.
N/A
Intended Use / Indications for Use
NanoBone® bone graft substitutes are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® bone graft substitutes are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® bone graft substitutes are intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
NanoBone consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxylapatite (HA) embedded in a highly porous silica gel matrix. The interconnected and open porous structure of NanoBone is similar to human cancellous bone. NanoBone is available as an irregular granulate.
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
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)
Bench testing has shown the NanoBone products meet the requirements of all relevant requirements for Calcium Salt Bone Void Fillers, including ASTM F1185.
Additional testing was performed to characterize and evaluate the performance of the NanoBone products. This testing included: Chemical / elemental analysis, Phase purity / XRD, Dissolution testing, Animal testing, Biocompatibility testing, Sterilization validation.
Animal testing was performed to demonstrate substantial equivalence including determination of radiographic, histologic and histomorphometric characteristics of the subject device and the controls in a critical-sized defect model in the sheep tibia. The study time points included 6 weeks, 12 weeks, and 26 weeks. Autograft bone filled defects (positive control) and empty unfilled defects (negative control) also were evaluated at these same time points.
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.
K040082, K082575, K060432, K041613
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2015
ARTOSS GmbH Dr. Walter Gerike Managing Partner Friedrich-Barnewitz-Str.3 18119 Rostock Germany
Re: K141189
Trade/Device Name: NanoBone® bone graft substitutes - NanoBone® | granulate Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: December 22, 2014 Received: January 7, 2015
Dear Dr. Gerike:
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. 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
1
Page 2 - Dr. Walter Gerike
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141189
Device Name NanoBone® bone graft substitutes - NanoBone® | granulate
Indications for Use (Describe)
NanoBone® bone graft substitutes are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® bone graft substitutes are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone graft substitutes are intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by 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
NanoBone®
510(k) Summary
(as required by 21 CFR 807.92)
NanoBone® bone graft substitutes NanoBone® | granulate
510(k) K141189
| Submitter | ARTOSS GmbH
Friedrich-Barnewitz-Staße 3
18119 Rostock, Germany
Telephone: +49 (0) 381 5 43 45 - 701
Fax: +49 (0) 381 5 43 45 - 702 |
| ----------- | ------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| Contact Person | Walter Gerike
Managing Partner
ARTOSS GmbH
gerike@artoss.com |
| ---------------- | ----------------------------------------------------------------------- |
|---|
| Date Prepared | 28 January 2015 |
|---|---|
| --------------- | ----------------- |
| Trade Name | NanoBone® granulate |
|---|---|
| Common Name | Bone Void Filler |
| Classification | Resorbable calcium salt bone void filler |
| Name | (21 CFR 888.3045, Product Code MQV) |
| Class | Class II |
| Predicate | Actifuse™ Bone Graft Substitute, K040082, K082575 |
|---|---|
| Devices | NovaBone, NovaBone AR, K060432, K041613 |
4
| Intended Use | NanoBone® bone graft substitutes are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® bone graft substitutes are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® bone graft substitutes are intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process. |
|---|---|
| -------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Description | |
|---|---|
| NanoBone consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxylapatite (HA) embedded in a highly porous silica gel matrix. The interconnected and open porous structure of NanoBone is similar to human cancellous bone. NanoBone is available as an irregular granulate. |
| Technological
Characteristics
- Comparison to
Predicate
Devices | The NanoBone and its predicates have the same intended use, to
fill bony voids and gaps that are not intrinsic to the stability of
the bony structure. These defects may be surgically created
osseous defects or those created from traumatic injury to the
bone.
All forms of the NanoBone material have the same the same
indications, contraindications, risks and potential adverse events
as the predicate devices. The NanoBone products have the same
basic technologies and are composed of equivalent materials. |
| ----------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Performance
Data | Bench testing has shown the NanoBone products meet the
requirements of all relevant requirements for Calcium Salt Bone
Void Fillers, including ASTM F1185. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Additional testing was performed to characterize and evaluate
the performance of the NanoBone products. This testing
included: Chemical / elemental analysis Phase purity / XRD Dissolution testing Animal testing Biocompatibility testing Sterilization validation |
5
| Animal testing was performed to demonstrate substantial |
|---|
| equivalence including determination of radiographic, histologic |
| and histomorphometric characteristics of the subject device and |
| the controls in a critical-sized defect model in the sheep tibia. |
| The study time points included 6 weeks, 12 weeks, and 26 |
| weeks. Autograft bone filled defects (positive control) and empty |
| unfilled defects (negative control) also were evaluated at these |
| same time points. |
| Conclusion | |
|---|---|
| The NanoBone® granulate has the same intended use and | |
| similar technological characteristics as the predicate devices. | |
| Performance data demonstrates that the product performs as | |
| intended, and is substantially equivalent to its predicates. |