(95 days)
Not Found
No
The summary describes a bone graft material and does not mention any AI or ML components or functionalities.
Yes
The device is a bone void filler that resorbs and is replaced by bone during the healing process, explicitly stating its role in the body's healing process for specific skeletal defects.
No
The text describes NovaBone MacroPor-Si* as a "bone void filler" that is "resorbed and replaced with bone during the healing process." This indicates a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states it is a "bone void filler device" composed of physical materials (particulate and binder) supplied as a "pliable cohesive material." This indicates 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 the device is a "bone void filler" for bony voids or gaps in the skeletal system. This is a therapeutic or surgical application, not a diagnostic one.
- Device Description: The description details the composition and function of the material as a bone graft that is implanted and resorbed. This is consistent with a medical device used in surgery, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
NovaBone MacroPor-Si*- Bioactive Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroPor-Sit 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.
NovaBone MacroPor-Sit is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
NovaBone MacroPor-Si* is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. The mixed device is supplied sterile, packaged in a PET-G tray and outer peel pouch. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles then are slowly absorbed and replaced by new bone tissue during the healing process.
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)
In vivo performance data are presented in support of the new device. Animal testing has demonstrated that the majority of the material is absorbed within six months of implantation, with >98% of the material being absorbed by 12 months. The timeframe for full absorption in humans has not been determined, but is expected to be at least 12 months.
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.
K060728,K080009,K082672,K101860, K060432,K090731
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.
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Image /page/0/Picture/1 description: The image shows the logo for NOVABONE. The logo is in black and white, with the word "NOVABONE" in large, bold letters. Below the word "NOVABONE" is the phrase "DRIVING INNOVATION IN OSTEOBIOLOGICS" in smaller letters. The logo is simple and modern, and it conveys a sense of innovation and expertise.
JUL - 5 2011
510(k) Summary NovaBone MacroPor-Si* - Bioactive Bone Graft
03/31/11
Submitter Information: 1.
| Name: | NovaBone Products, LLC |
|---|---|
| Address: | 13631 Progress Boulevard, Suite 600 |
| Alachua, FL 32615 | |
| Telephone: | (386) 462-7661 |
| Facsimile: | (386) 418-1636 |
| Contact: | David M. Gaisser |
Name of Device: 2.
| Trade Name: | NovaBone MacroPor-Si+ - Bioactive Synthetic Bone Graft |
|---|---|
| Common Name: | Osteoconductive Bone Void Filler |
| Synthetic Resorbable Bone Graft Material | |
| Regulation Number: | 21 CFR 888.3045 |
| Regulation Name: | Resorbable Calcium Salt Bone Void Filler Device |
| Regulatory Class: | Class II |
| Product Code: | MQV |
3. Legally Marketed Predicate Device:
| Predicate #1: | NovaBone Putty - Bioactive Synthetic Graft
[K060728, K080009, K082672, K101860] |
|---------------|------------------------------------------------------------------------------------|
| Predicate #2: | NovaBone Porous – Bone Graft Scaffold
[K060432, K090731] |
4. Device Description
NovaBone MacroPor-Si* is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. The mixed device is supplied sterile, packaged in a PET-G tray and outer peel pouch. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles then are slowly absorbed and replaced by new bone tissue during the healing process.
ട. Intended Use
NovaBone MacroPor-Si - Bioactive Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroPor-Sit 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.
Image /page/0/Picture/16 description: The image shows the text 'p-12 of 126' with a line through it, and below that is the text 'Pg 1 of 2'. The text appears to be handwritten in black ink on a white background. The image is a close-up of the text, and the text is slightly blurry.
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NovaBone MacroPor-Sit is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
Technological Characteristics and Substantial Equivalence 6.
The technological characteristics of the new NovaBone MacroPor-Sit device are similar to the predicate devices. The new device and the predicates are designed as osteoconductive space-filling devices to be gently packed into defect sites and used as non-structural scaffolds for the body's natural healing and bone regeneration process. The indications for the new device are similar to those of the predicate devices. The device is intended to be used alone.
The primary component of NovaBone MacroPor-Sit is bioactive glass (45SS Bioglass) particulate. This synthetic material is both biocompatible and osteoconductive. The NovaBone MacroPor-Si* also includes a synthetic binder as an inert carrier for ease of device handling and delivery, forming a premixed cohesive material. The binder is biocompatible and is absorbed after implantation, opening space between the bioactive glass particles for cell infiltration and bone formation. The bioactive glass particulate remains for a longer post-implantation period, acting as a scaffold for bone ingrowth. This particulate is absorbed and replaced by new bone tissue. Animal testing has demonstrated that the majority of the material is absorbed within six months of implantation, with >98% of the material being absorbed by 12 months. The timeframe for full absorption in humans has not been determined, but is expected to be at least 12 months.
The NovaBone MacroPor-Si+ device of this submission is a modification to the predicate NovaBone Putty device. A portion of the particulate bioactive glass component of the NovaBone Putty device has been replaced with a chemicallyidentical bioactive glass component, but having a porous structure. The porous component of the modified Putty device is identical to the NovaBone Porous predicate. The device is designed to be gently packed into osseous defect sites and used as a non-structural scaffold for the body's natural healing and bone regeneration process. The device acts as a synthetic, inorganic, biocompatible and osteoconductive scaffold into which new bone will grow.
7. Conclusion
The NovaBone MacroPor-Si+ device is a modification of the predicate NovaBone Putty and NovaBone Porous devices, replacing a portion of the amorphous bioactive glass particulate content of the NovaBone Putty device with the porous bioactive glass particulate of the NovaBone Porous predicate to provide a device with increased porosity for tissue ingrowth. This device modification does not result in a change in technological characteristics of the device. NovaBone MacroPor-Sit is a safe and effective device for use as a non-structural osteoconductive bone void filler for osseous defects. In vivo performance data are presented in support of the new device.
p. 13 of 126
pg 2 of 2
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NovaBone Products, LLC % Mr. David M. Gaisser 13631 Progress Boulevard, Suite 600 Alachua, Florida 32615
JUL - 5 2011
Re: K110925
Trade/Device Name: NovaBone MacroPor-Si* - Bioactive Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: May 24, 2011 Received: May 25, 2011
Dear Mr. Gaisser:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. David M. Gaisser
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 go to http://www.fda.gov/AboutfDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
NovaBone MacroPor-Si* - Bioactive Bone Graft Device Name:
Indications For Use:
NovaBone MacroPor-Si*- Bioactive Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroPor-Sit 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.
NovaBone MacroPor-Sit is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
Prescription Use _ XX
OR (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110925