(56 days)
No
The device description focuses on the material composition and biological interaction of a bone graft, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
"Therapeutic device" implies the device itself is performing a treatment. This device is a bone void filler that resorbs and provides a scaffolding for new bone growth, supporting the natural healing process rather than actively treating an ailment itself. Its function is to facilitate repair, not directly provide therapy.
No
The device is described as a bone void filler that is implanted to aid in bone healing, not to diagnose a condition.
No
The device description clearly describes a physical bone graft material composed of particulate and a binder, intended for surgical implantation. It is 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 NovaBone IRM is a bone void filler to be packed into bony voids or gaps in the skeletal system. This is a therapeutic and structural application within the body.
- Device Description: The description details the composition and mechanism of action of the material when implanted in living tissue, focusing on its interaction with bone growth and absorption.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor a disease, or screen for a health issue.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. NovaBone IRM is a medical device used for surgical repair and regeneration within the body.
N/A
Intended Use / Indications for Use
NovaBone IRM - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone IRM (Irrigation Resistant Matrix) 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.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
NovaBone IRM is an osteoconductive bioactive device used for grafting osseous defects. It is a premixed composite of bioactive calcium-phospho-silicate particulate and a synthetic, absorbable binder. The bioactive particulate is composed solely of elements that exist naturally in normal bone (Ca, P, Na, Si, O). The device requires no mixing or preparation prior to application. NovaBone IRM is supplied ready-to-use, to be applied directly to the intended graft site. The binder is then absorbed from the site such that only the bioactive particulate remains.
Upon absorption of the binder, the remaining particulate material undergoes a timedependent kinetic modification of the surface that occurs when implanted in living tissue. Specifically, a series of surface reactions results in the formation of a calcium phosphate layer on the particles that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. Animal testing has demonstrated that the majority of the particulate material is absorbed within six months of implantation, with >98% of the material being absorbed by twelve months. The timeframe for full absorption in humans has not been determined, but is expected to be at least twelve months.
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)
A biocompatibility assessment for NovaBone IRM supports safety of the device for implantation in bone voids. The results of a rabbit femoral defect model further support biocompatibility and show the device performance to be substantially equivalent to NovaBone Putty (K112773) for filling of osseous defects. The composite of descriptive information, biocompatibility data, functional in vivo results in the rabbit model demonstrate that the safety and performance of NovaBone IRM is substantially equivalent NovaBone Putty (K112773), when used as a bone void filler in the extremities and pelvis per the defined indications for use.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the shape of a bird or wing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 18, 2017
NovaBone Products, LLC % Ms. Lisa C. Simpson Consultant Simpson Regulatory Solutions, LLC 4401 NW 18th Place Gainesville, Florida 32605
Re: K163310
Trade/Device Name: NovaBone IRM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: November 21, 2016 Received: November 23, 2016
Dear Ms. Simpson:
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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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/ResourcesforYou/Industry/default.htm. 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
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
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163310
Device Name NovaBone IRM
Indications for Use (Describe)
NovaBone IRM - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone IRM (Irrigation Resistant Matrix) 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
3
510(k) Summary of Safety & Effectiveness
Image /page/3/Picture/1 description: The image shows the logo for NOVABONE. The logo is written in a sans-serif font, with the letters in teal and blue. The letter 'O' in 'BONE' is replaced with a white starburst. A registered trademark symbol is located in the upper right corner of the logo.
Date Prepared: November 19, 2016
510(k) Holder / Submitter:
NovaBone Products, LLC 13510 NW US Highway 441 Alachua, FL 32615
Contact: Gregory Pomrink Director, R&D and RA Ph: (386) 518-6973 / Fax: (386) 462-7525 Email: gpomrink(@novabone.com
Regulatory Contact:
Simpson Regulatory Solutions, LLC 4401 NW 18 Place Gainesville, FL 32605
Contact: Lisa C. Simpson Email: regulatorysolutions(@icloud.com Ph: (352) 562-5122
Name of Device:
| Trade Names: | NovaBone IRM |
|---|---|
| Common Name: | Osteoconductive Bone Void Filler Synthetic |
| Resorbable Bone Graft Material | |
| Regulation Number: | 21 CFR 888.3045 Regulation Name: Bone Void Filler |
| Regulatory Class: | Class II |
| Product Code: | MQV |
Legally Marketed Predicate Devices:
- K112773' NovaBone Putty MIS (primary predicate) K141207 NovaBone Bioactive Strip (reference predicate)
1 FDA clearances for NovaBone Putty product line also include K060728, K08009, K082672, K101860, K110368, and K 112773, which represent various packaging formats and indications for use changes.
4
510(k) Summary of Safety & Effectiveness
Device Description
NovaBone IRM is an osteoconductive bioactive device used for grafting osseous defects. It is a premixed composite of bioactive calcium-phospho-silicate particulate and a synthetic, absorbable binder. The bioactive particulate is composed solely of elements that exist naturally in normal bone (Ca, P, Na, Si, O). The device requires no mixing or preparation prior to application. NovaBone IRM is supplied ready-to-use, to be applied directly to the intended graft site. The binder is then absorbed from the site such that only the bioactive particulate remains.
Upon absorption of the binder, the remaining particulate material undergoes a timedependent kinetic modification of the surface that occurs when implanted in living tissue. Specifically, a series of surface reactions results in the formation of a calcium phosphate layer on the particles that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. Animal testing has demonstrated that the majority of the particulate material is absorbed within six months of implantation, with >98% of the material being absorbed by twelve months. The timeframe for full absorption in humans has not been determined, but is expected to be at least twelve months.
Indications for Use
NovaBone IRM - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone IRM (Irrigation Resistant Matrix) 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.
Technological Characteristics and Substantial Equivalence
The proposed NovaBone IRM device is substantially equivalent to the primary predicate, NovaBone Putty (K112773). Both devices incorporate 45S5 bioactive glass in a synthetic binder that facilitates handling and are used as bone void fillers in the extremities and pelvis. The bioglass particles sizes for the proposed device are the same as the reference predicate, NovaBone Bioactive Strip (K141207). The packaging formats for NovaBone IRM are equivalent to that of NovaBone Putty (K112773). A biocompatibility assessment for NovaBone IRM supports safety of the device for implantation in bone voids. The results of a rabbit femoral defect model further support biocompatibility and show the device performance to be substantially equivalent to NovaBone Putty (K112773) for filling of osseous defects.
Conclusion
The composite of descriptive information, biocompatibility data, functional in vivo results in the rabbit model demonstrate that the safety and performance of NovaBone IRM is substantially equivalent NovaBone Putty (K112773), when used as a bone void filler in the extremities and pelvis per the defined indications for use.