(163 days)
No
The description focuses on the material composition and physical properties of the bone void filler. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a bone void filler intended for use in the treatment of osseous defects resulting from traumatic injury or surgical creation, providing a bone void filler that resorbs and is replaced by bone during the healing process, which directly pertains to treating a medical condition.
No
The device is a bone void filler intended for treatment of osseous defects, which is a therapeutic function, not diagnostic.
No
The device description clearly states that NanoBone® SBX Putty is a physical substance consisting of granulate embedded in an aqueous gel, intended for implantation as a bone void filler. This is a physical medical 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® SBX Putty is a "bone void filler" for surgically created or traumatic osseous defects. This describes a device that is implanted into the body to aid in bone healing.
- Device Description: The description details the composition of the putty, which is a material intended for physical implantation.
- Performance Studies: The performance studies involve animal implantation and evaluation of bone formation and product resorption within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is used inside the body as a therapeutic and structural aid.
N/A
Intended Use / Indications for Use
NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® SBX Putty is 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
MQV
Device Description
NanoBone® SBX Putty consists of NanoBone granulate embedded in an aqueous gel. NanoBone granulate consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxyapatite (HA) embedded in a highly porous silica gel matrix. The high porosity of the product includes nano pores, micro pores, and macro pores. The interconnected and open porous structure of the macro pores of the NanoBone® is similar to human cancellous bone.
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
Prescription Use
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
Bench testing has shown the NanoBone® SBX Putty meets the requirements of all relevant requirements for calcium salt bone void filler devices, including ASTM F1185.
Testing was performed to characterize and evaluate the performance of the NanoBone® products. The testing included:
• Chemical / elemental analysis
• Phase purity / XRD
• Dissolution testing
• Biocompatibility assessment / testing
• Sterilization validation
• Pyrogenicity testing
• Animal testing
Performance testing was undertaken to demonstrate that NanoBone® SBX Putty is capable of healing a critically-sized defect in a clinically relevant implantation site. A well-established critical-sized femoral condyle defect model in the mature New Zealand white rabbit was used. Thirty rabbits were divided into two groups of fifteen. Test articles were implanted bilaterally in 5mm diameter and 10mm deep defects in the lateral aspect of the femoral condyles. Fifteen experimental defects were implanted with NanoBone® SBX Putty. Fifteen control defects were implanted with NanoBone® granulate and another fifteen control defects were implanted with Actifuse® ABX Putty. Five rabbits from each group were sacrificed at 4, 8, and 12 weeks after implantation.
The safety and performance of each test article were evaluated using histology, histomorphometry, micro CT, and image analysis. Outcome measures were new bone formation and product resorption. Based upon the results of this testing, NanoBone SBX Putty performs satisfactorily as a bone void filler and in a manner substantially equivalent to the predicates NanoBone granulate (K141189) and Actifuse ABX Putty (K071206).
Key Metrics
Outcome measures were new bone formation and product resorption.
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem consists of a stylized design of three human profiles facing right, with flowing lines beneath them, resembling a bird or abstract form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 26, 2016
ARTOSS GmbH Dr. Walter Gerike Managing Partner Friedrich-Barnewitz-Strasse 3 Rostock 18119 GERMANY
Re: K161351
Trade/Device Name: NanoBone® SBX Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 18, 2016 Received: September 20, 2016
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 (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) 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,
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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
Indications for Use
510(k) Number (if known) K161351
Device Name NanoBone® SBX Putty
Indications for Use (Describe)
NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® SBX Putty is 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)
| Exemptions Under Part 286.801 Subpart J | Own Use Consumption (Part 286.801 Subpart A) |
|---|---|
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
NanoBone®
510(k) Summary
(as required by 21 CFR 807.92)
NanoBone® SBX Putty
510(k) K161351
| 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 | 10/25/2016 |
| Trade Name | NanoBone® SBX Putty |
|---|---|
| Common Name | Bone Void Filler |
| Classification | |
| Regulation | Resorbable calcium salt bone void filler |
| 21 CFR 888.3045, Product Code MQV | |
| Class | Class II Special Controls |
| Panel code | Orthopedic / 888 |
| Predicate Devices | ARTOSS NanoBone® granulate (K141189) |
| ApaTech Actifuse ™ ABX E-Z-fil (K071206) | |
| Intended Use and | |
| Indications | NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps that |
| are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty is | |
| indicated for use in the treatment of surgically created osseous defects or osseous | |
| defects resulting from traumatic injury to the bone. NanoBone® SBX Putty is | |
| 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. | |
| Technological | |
| Characteristics- | |
| Comparison to | |
| Predicate Devices | pores. The interconnected and open porous structure of the macro pores of the |
| NanoBone® is similar to human cancellous bone. |
NanoBone® SBX Putty is composed of the same porous calcium phosphate as
used in the NanoBone® predicate (K141189), with the same aqueous gel as the
predicate Actifuse ABX E-Z-fil (K071206).
The NanoBone® SBX Putty and the predicate NanoBone granulate (K141189) 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.
NanoBone® SBX Putty has the same indications, contraindications, risks, basic
technology, equivalent materials, and potential adverse events as the NanoBone®
granulate predicate (K141189). The only difference between the predicate ARTOSS
NanoBone® granulate and the Subject device is the addition of an aqueous carrier
and primary packaging in an applicator.
The Subject devices are therefore substantially equivalent to its predicates. |
| Performance Data | Bench testing has shown the NanoBone® SBX Putty meets the requirements of all
relevant requirements for calcium salt bone void filler devices, including ASTM
F1185.
Testing was performed to characterize and evaluate the performance of the
NanoBone® products. The testing included:
• Chemical / elemental analysis
• Phase purity / XRD
• Dissolution testing
• Biocompatibility assessment / testing
• Sterilization validation
• Pyrogenicity testing
• Animal testing
Performance testing was undertaken to demonstrate that NanoBone® SBX
Putty is capable of healing a critically-sized defect in a clinically relevant
implantation site. A well-established critical-sized femoral condyle defect
model in the mature New Zealand white rabbit was used. Thirty rabbits
were divided into two groups of fifteen. Test articles were implanted
bilaterally in 5mm diameter and 10mm deep defects in the lateral aspect of
the femoral condyles. Fifteen experimental defects were implanted with
NanoBone® SBX Putty. Fifteen control defects were implanted with
NanoBone® granulate and another fifteen control defects were implanted
with Actifuse® ABX Putty. Five rabbits from each group were sacrificed at 4,
8, and 12 weeks after implantation.
The safety and performance of each test article were evaluated using
histology, histomorphometry, micro CT, and image analysis. Outcome
measures were new bone formation and product resorption. Based upon
the results of this testing, NanoBone SBX Putty performs satisfactorily as a
bone void filler and in a manner substantially equivalent to the predicates
NanoBone granulate (K141189) and Actifuse ABX Putty (K071206) |
Description NanoBone® SBX Putty consists of NanoBone granulate embedded in an aqueous gel. NanoBone granulate consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxyapatite (HA) embedded in a highly porous silica gel matrix. The high porosity of the product includes nano pores, micro pores, and macro
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| Conclusions | NanoBone® SBX Putty 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. |
|---|---|
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |