(27 days)
No
The summary describes a synthetic bone graft scaffold and does not mention any AI or ML components or functionalities.
No.
The device acts as a bone void filler and scaffold to facilitate bone healing, which is a restorative rather than therapeutic function in the context of this device.
No
Explanation: The device description states it is a "bone void filler" that acts as a scaffold for new bone growth and is replaced by bone during healing. It is not used to identify or analyze a medical condition.
No
The device description clearly indicates it is a physical, resorbable bone void filler made of synthetic material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- NovaBone Porous Function: The description clearly states that NovaBone Porous is a synthetic bone graft scaffold intended to be implanted directly into bony voids or gaps in the skeletal system. It acts as a physical scaffold for bone growth and is resorbed by the body.
- No Sample Testing: There is no mention of this device being used to test samples taken from a patient. Its function is entirely within the body as an implantable material.
Therefore, NovaBone Porous falls under the category of an implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
NovaBone Porous is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Porous 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 an osteoconductive scaffold that resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
NovaBone Porous is an osteoconductive bioactive device. It is a one-component, resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate, fused into a bulk porous form having a multidirectional interconnected porosity. On implantation, NovaBone Porous undergoes a timedependent surface modification, resulting in the formation of a calcium phosphate layer on the device surfaces. The device acts as a scaffold, with new bone infiltrating the porous structure. NovaBone Porous is progressively resorbed 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060432, K060728, K080009, K082672
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo for NOVABONE SYNTHETIC BONE GRAFT PRODUCTS. The word "NOVABONE" is in large, bold, black letters. Below the word is the phrase "SYNTHETIC BONE GRAFT PRODUCTS" in smaller, black letters.
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, "K690731". The characters are written in a simple, clear style, with each digit and letter easily distinguishable. The sequence appears to be a code or identifier, possibly a serial number or a reference code.
APR 1 5 2009
Special 510(k): Device Modification Summary NovaBone Porous - Bone Graft Scaffold
03/16/09
Submitter Information: 1.
| Name: | NovaBone Products, LLC |
|---|---|
| Address: | 13709 Progress Boulevard, #33 |
| Alachua, FL 32615 | |
| Telephone: | (386) 462-7660 |
| Facsimile: | (386) 418-1636 |
| Contact: | David M. Gaisser |
2. Name of Device:
| Trade Name: | NovaBone Porous – Synthetic Bone Graft Scaffold |
|---|---|
| Common Name: | Osteoconductive Bone Void Filler |
| Synthetic Resorbable Bone Graft Material | |
| Regulation Number: | 21 CFR 888.3045 |
| Regulation Name: | Bone Void Filler |
3. Legally Marketed Predicate Device:
| Predicate #1: | NovaBone Porous - Bone Graft Scaffold
[K060432] |
|---------------|---------------------------------------------------------------------------|
| Predicate #2: | NovaBone Putty - Bioactive Synthetic Graft
[K060728, K080009, K082672] |
| Predicate #3: | NovaBone-AR - Resorbable Bone Graft Substitute
[K041613] |
4. Device Description
NovaBone Porous is an osteoconductive bioactive device. It is a one-component, resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate, fused into a bulk porous form having a multidirectional interconnected porosity. On implantation, NovaBone Porous undergoes a timedependent surface modification, resulting in the formation of a calcium phosphate layer on the device surfaces. The device acts as a scaffold, with new bone infiltrating the porous structure. NovaBone Porous is progressively resorbed and replaced by new bone tissue during the healing process.
5. Intended Use
NovaBone Porous is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Porous is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and These defects may be surgically created osseous defects or osseous pelvis). defects created from traumatic injury to the bone. The product provides an
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osteoconductive scaffold that resorbs and is replaced with bone during the healing process.
Technological Characteristics Q.
The technological characteristics of the NovaBone Porous device are identical to the NovaBone Porous device as cleared per K060432, and are similar to those of the NovaBone Putty and NovaBone-AR predicates. The devices 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 device indications are the same as for the predicate. The device per this submission is modified to include a syringe package format to aid in material preparation and delivery.
The NovaBone Porous device is a single-phase bioactive glass (45S5 Bioglass®) device. The device implant material is unmodified from that described in K060432, with the device being in particulate form. The design modification made per this submission is to include a syringe package format to contain the device material, the syringe being similar to that for the NovaBone-AR predicate per K041613 and the NovaBone Putty predicate per K082672.
7. Warnings and Precautions
NovaBone Porous does not possess sufficient mechanical strength to support loadbearing defects prior to hard tissue ingrowth and is not indicated for use in loadbearing applications. NovaBone Porous is intended for use by clinicians familiar with bone grafting and internal/external fixation techniques. In cases of fracture fixation or where load support is required, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes. NovaBone Porous must not be used to gain screw purchase or to stabilize screw placement.
8. Complications
Possible complications are the same as to be expected of autogenous bone grafting procedures. These may include: superficial wound infection, deep wound infection, deep wound infection with osteomyelitis, delayed union, loss of reduction, failure of fusion, loss of bone graft, graft protrusion and / or dislodgement, and general complications that may arise from anesthesia and / or surgery.
9. Conclusion
The NovaBone Porous design modification subject to this submission is to include a filled-syringe package format to augment the current package formats. This device modification does not result in a change in technological characteristics of the device. NovaBone Porous continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NovaBone Products, LLC % Mr. David M. Gaisser 13709 Progress Boulevard, #33 Alachua, Florida 32615
APR ] 5 2009
Re: K090731
Trade/Device Name: NovaBone Porous - Synthetic Bone Graft Scaffold Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: March 16, 2009 Received: March 19, 2009
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 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 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.
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Page 2 - Mr. David M. Gaisser
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please . contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbare Brehm
Mark N. Mel kerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k): Design Modification NovaBone Products, LLC NovaBone Porous - Synthetic Bone Graft Scaffold
STATEMENT OF INDICATIONS FOR USE
K 01073 510(k) Number (if known):
NovaBone Porous - Synthetic Bone Graft Scaffold Device Name:
Indications For Use:
NovaBone Porous - Synthetic Bone Graft Scaffold is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Porous 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.
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)
Clifford Buelow for MXM
Division Sign-Off
rative. and Neurological De
510(k) Number K090731
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