(267 days)
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.
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.
The provided document describes the NanoBone® bone graft substitutes - NanoBone® | granulate device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing acceptance criteria for a novel device or an AI/ML powered device. Due to this, much of the requested information about AI model performance is not present in the document.
However, I can extract information related to the device's performance data and the studies performed to demonstrate its substantial equivalence as a medical device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a traditional medical device (bone graft substitute) and not an AI/ML powered device, "acceptance criteria" are related to meeting established standards and demonstrating equivalence to existing products, rather than metrics like sensitivity, specificity, or AUC.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance (NanoBone®) |
|---|---|---|
| Bench Testing | All relevant requirements for Calcium Salt Bone Void Fillers, including ASTM F1185 | Met: Products meet all relevant requirements, including ASTM F1185. |
| Material Characterization | Chemical/elemental composition, phase purity/XRD, dissolution characteristics | Characterized: Testing performed for chemical/elemental analysis, phase purity/XRD, and dissolution testing. (Specific results not detailed in this summary, but implied to be acceptable for equivalence). |
| Biocompatibility | Biocompatibility standards | Validated: Biocompatibility testing performed. (Specific results not detailed, but implied to be acceptable). |
| Sterilization | Sterilization validation standards | Validated: Sterilization validation performed. (Specific results not detailed, but implied to be acceptable). |
| In Vivo Performance | Radiographic, histologic, and histomorphometric characteristics comparable to controls in bone healing | Demonstrated: Animal testing showed substantial equivalence through determination of these characteristics in a critical-sized defect model. |
2. Sample size used for the test set and the data provenance
- Animal Testing (analogous to a test set for in-vivo performance):
- The document mentions "a critical-sized defect model in the sheep tibia."
- The sample size for the animal study (number of sheep or defects) is not specified in the provided text.
- Data Provenance: This was a prospective animal study. The country of origin is not explicitly stated, but the manufacturer is ARTOSS GmbH in Germany, suggesting it could have been conducted there or in a collaborating country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Ground truth for the animal study would have been established by methods such as radiographic analysis, histological examination, and histomorphometric analysis.
- The document does not specify the number or qualifications of experts (e.g., veterinary radiologists, pathologists) who established this ground truth.
4. Adjudication method for the test set
- The document does not specify an adjudication method for the animal study's assessments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document is for a bone graft substitute, not an AI/ML powered device. Therefore, no MRMC study, human reader improvement with AI, or effect size is mentioned or relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical bone graft substitute, not an algorithm or AI/ML device.
7. The type of ground truth used
- For the in-vivo performance (animal study), the ground truth relied on direct biological and imaging evidence:
- Radiographic characteristics: Imaging used to assess bone healing.
- Histologic characteristics: Microscopic examination of tissue samples.
- Histomorphometric characteristics: Quantitative microscopic analysis of tissue structures.
- Controls: Autograft bone-filled defects (positive control) and empty unfilled defects (negative control) served as benchmarks.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/ML powered device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
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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
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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
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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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NanoBone®
510(k) Summary
(as required by 21 CFR 807.92)
NanoBone® bone graft substitutes NanoBone® | granulate
510(k) K141189
| Submitter | ARTOSS GmbHFriedrich-Barnewitz-Staße 318119 Rostock, GermanyTelephone: +49 (0) 381 5 43 45 - 701Fax: +49 (0) 381 5 43 45 - 702 |
|---|---|
| ----------- | ------------------------------------------------------------------------------------------------------------------------------------------------ |
| Contact Person | Walter GerikeManaging PartnerARTOSS GmbHgerike@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 |
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| 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. |
| TechnologicalCharacteristics- Comparison toPredicateDevices | The NanoBone and its predicates have the same intended use, tofill bony voids and gaps that are not intrinsic to the stability ofthe bony structure. These defects may be surgically createdosseous defects or those created from traumatic injury to thebone.All forms of the NanoBone material have the same the sameindications, contraindications, risks and potential adverse eventsas the predicate devices. The NanoBone products have the samebasic technologies and are composed of equivalent materials. |
|---|---|
| ----------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| PerformanceData | Bench testing has shown the NanoBone products meet therequirements of all relevant requirements for Calcium Salt BoneVoid Fillers, including ASTM F1185. |
|---|---|
| Additional testing was performed to characterize and evaluatethe performance of the NanoBone products. This testingincluded: Chemical / elemental analysis Phase purity / XRD Dissolution testing Animal testing Biocompatibility testing Sterilization validation |
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| 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 andsimilar technological characteristics as the predicate devices.Performance data demonstrates that the product performs asintended, and is substantially equivalent to its predicates. |
§ 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.