(52 days)
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No
The document describes a synthetic bone graft substitute material and its intended use, with no mention of AI or ML technology in its function, design, or performance evaluation.
Yes
The device is described as a resorbable bone graft substitute that provides a bone void filler and is replaced with bone during the healing process, clearly indicating a therapeutic purpose.
No
Explanation: The device is described as a "resorbable bone graft substitute" and a "bone void filler" which functions to promote bone healing. It does not perform any diagnostic functions or provide information about a patient's medical condition.
No
The device description clearly states that NovaBone is a physical material (particulate) composed of synthetic calcium phospho-silicate (Bioglass) and is intended to be packed into bony voids. 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 NovaBone is a bone graft substitute used to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural application within the body.
- Device Description: The description details a synthetic material (Bioglass) designed to be implanted and resorb, acting as a scaffold for bone regeneration. This is a medical device used for treatment.
- 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) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. NovaBone is used inside the body to facilitate bone healing.
N/A
Intended Use / Indications for Use
NovaBone is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine 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 is a one-component resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate designed specifically for its absorbability and osteoconductive nature. NovaBone is progressively resorbed and replaced by new bone tissue during the healing process.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skeletal system (i.e. the extremities, spine and pelvis)
Indicated Patient Age Range
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Intended User / Care Setting
clinicians familiar with bone grafting and internal/external fixation techniques.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vivo study data were presented supporting a superior rate of osteconduction and bone formation at early post-implantation periods compared to hydroxyapatite devices. In vitro cell culture data were presented to demonstrate and define the osteostimulative nature of the NovaBone device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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510(k) Summary NovaBone - Resorbable Bone Graft Substitute
09/09/05
1. Submitter Information:
| 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 - Resorbable Bone Graft Substitute |
|---|---|
| Common Name: | Osteoconductive Bone Void Filler |
| Synthetic Resorbable Bone Graft Material | |
| Classification Name: | Unknown |
3. Legally Marketed Predicate Device:
| Predicate #1: | NovaBone – Resorbable Bone Graft Substitute |
|---|---|
| [K021336] |
4. Device Description
NovaBone is a one-component resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate designed specifically for its absorbability and osteoconductive nature. NovaBone is progressively resorbed and replaced by new bone tissue during the healing process.
ട. Intended Use
NovaBone is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine 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.
6. Technological Characteristics
The technological characteristics of NovaBone device have not changed. The device is designed as an osteoconductive space-filling particulate device to be
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gently packed into defect sites and used as a non-structural scaffold for the body's natural healing and bone regeneration process. The device acts as a particulate, synthetic, inorganic, biocompatible and osteoconductive material.
The NovaBone device is a single-phase bioactive glass (45S5 Bioglass) particulate device. No changes to the device or its indications have been made with this submission. The purpose of this premarket notification is to expand the product claims to cover the claim of the device being osteostimulative. After implantation, surface reactions result in the absorption of the device material and concurrent new bone tissue formation. These surface reactions result in an osteostimulative affect, defined as the stimulation of osteoblast proliferation and differentiation during in vitro osteoblast cell culture studies as evidenced by increased DNA content and elevated osteocalcin and alkaline phosphatase levels.
7. Warnings and Precautions
NovaBone does not possess sufficient mechanical strength to support load-bearing defects prior to hard tissue ingrowth. 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 is intended for use by clinicians familiar with bone grafting and internal/external fixation techniques. NovaBone 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
NovaBone functions as a bone void filler for non-structural osseous defects. In vivo study data were presented supporting a superior rate of osteconduction and bone formation at early post-implantation periods compared to hydroxyapatite devices. In vitro cell culture data were presented to demonstrate and define the osteostimulative nature of the NovaBone device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized human figure with three overlapping profiles, representing the department's focus on people and health. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV -- 3 2005
David M. Gaisser VP. Operations/RA/QA NovaBone Products, LLC 13709 Progress Boulevard, #33 Alachua, Florida 32615
Re: K052494
Trade/Device Name: NovaBone - Resorbable Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: September 9, 2005 Received: September 21, 2005
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 -David M. Gaisser
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mellon
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Confidential
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name: NovaBone - Resorbable Bone Graft Substitute
Indications For Use:
NovaBone Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine 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)
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number Kosz494