(71 days)
NovaBone-AR is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone-AR 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.
NovaBone-AR is a synthetic resorbable osteoconductive bone graft substitute particulate composed of two similar calcium phospho-silicate bioactive glass materials. The major component is a melt-derived calcium-phosphorus-sodiumsilicate (Bioglass) designed specifically for its absorbability and ostcoconductive nature. The second component is a calcium-phosphorus-silicate bioactive glass, chemically similar to the major component, but derived via a solution-gelation (sol-gel) process. The secondary sol-gel component is more rapidly absorbed from the graft site than the standard melt-derived component, opening additional space between the Bioglass particles for tissue infiltration and replacement by host bonc during the healing process.
The provided text is a 510(k) Premarket Notification for NovaBone-AR - Resorbable Bone Graft Substitute from 2004. This document is a regulatory submission for a medical device and, as such, does not contain the type of study data and acceptance criteria you're requesting for software, AI, or diagnostic devices.
The 510(k) process for this type of medical device (a bone graft substitute) focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through technological characteristics, biocompatibility, and intended use, rather than analytical performance metrics like sensitivity, specificity, or AUC which would be relevant for diagnostic software.
Therefore, I cannot extract the following information, as it is not present in the provided document:
- A table of acceptance criteria and the reported device performance: This document describes the device and its intended use, but does not present quantitative performance metrics or acceptance criteria in the manner you've requested.
- Sample size used for the test set and the data provenance: There is no "test set" in the context of analytical performance for this type of device. The document mentions "In vivo performance data comparing NovaBone-AR and/or the individual sol-gel component to NovaBone are summarized," but it does not provide details on sample size, data provenance, or the specific studies.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/diagnostic device.
- The type of ground truth used: For a bone graft substitute, "ground truth" would typically refer to histological analysis of bone regeneration in animal models or human biopsies, but the document does not detail this. Instead, it relies on the established performance of the predicate devices.
- The sample size for the training set: Not applicable, as this is not an AI/diagnostic device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/diagnostic device.
In summary, the provided document outlines the characteristics and intended use of a bone graft substitute to demonstrate substantial equivalence to predicate devices, rather than presenting detailed performance studies with acceptance criteria relevant to software or AI-driven diagnostics.
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AUG 2 5 2004
Image /page/0/Picture/2 description: The image shows the logo for "NOVABONE SYNTHETIC BONE GRAFT PRODUCTS". The word "NOVABONE" is in large, bold, black letters, with a stylized starburst design incorporated into the letter "O". Below the main logo, the words "SYNTHETIC BONE GRAFT PRODUCTS" are printed in a smaller, sans-serif font.
510(k) Summary NovaBone-AR - Resorbable Bone Graft Substitute
06/10/04
Submitter Information: 1.
| Name: | NovaBone Products, LLC |
|---|---|
| Address: | 13709 Progress Boulevard, #33Alachua, FL 32615 |
| Telephone: | (386) 462-7660 |
| Facsimile: | (386) 418-1636 |
| Contact: | David M. Gaisser |
Name of Device: 2.
| Trade Name: | NovaBone-AR – Resorbable Bone Graft Substitute |
|---|---|
| Common Name: | Osteoconductive Bone Void FillerSynthetic Resorbable Bone Graft Material |
| Classification Name: | Unknown |
Legally Marketed Predicate Device: 3.
| Predicate #1: | NovaBone - Resorbable Bone Graft Substitute[K021336] |
|---|---|
| Predicate #2: | NovaBone-BBG - Resorbable Bone Graft Substitute[K033994] |
4. Device Description
NovaBone-AR is a synthetic resorbable osteoconductive bone graft substitute particulate composed of two similar calcium phospho-silicate bioactive glass materials. The major component is a melt-derived calcium-phosphorus-sodiumsilicate (Bioglass) designed specifically for its absorbability and ostcoconductive nature. The second component is a calcium-phosphorus-silicate bioactive glass, chemically similar to the major component, but derived via a solution-gelation (sol-gel) process. The secondary sol-gel component is more rapidly absorbed from the graft site than the standard melt-derived component, opening additional space between the Bioglass particles for tissue infiltration and replacement by host bonc during the healing process.
Intended Use న్.
NovaBone-AR is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone-AR is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis).
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510(k) Premarket Notification NovaBone Products, LLC NovaBone-AR - Resorbable Bone Graft Substitute
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 6.
The technological characteristics of NovaBone-AR and the predicate devices NovaBone and NovaBone-BBG are similar. All are designed to be osteoconductive space-filling particulates to be gently packed into defect sites and to be used as a non-structural scaffold for the body's natural healing and bone regeneration process. To meet this design, the three devices are similar in nature, all being particulate, synthetic, inorganic, biocompatible and osteoconductive materials.
The main technological difference between NovaBone-AR and the NovaBone predicate is that while the predicate NovaBonc is a single-material Bioglass devices, the NovaBone-AR contains Bioglass and a second sol-gel derived bioactive glass composition. The sol-gel glass is composed of calcium, phosphorus, and silicon, similar to the Bioglass component, but without the sodium. This two-component NovaBone-AR is identical to the NovaBone-BBG predicate, the NovaBone-BBG being cleared for different indications.
For all three devices, the materials are substantially absorbed within the six-month timeframe normally associated with bone remodeling, the devices being replaced by new bone tissue. The sol-gel phase of the NovaBone-AR and the NovaBone-BBG predicate is more soluble than the standard melt-derived Bioglass, permitting a more rapid initial absorption and therefore providing more space for bone infiltration at an earlier period than for the predicates.
In vivo performance data comparing NovaBone-AR and/or the individual sol-gel component to NovaBone are summarized.
Warnings and Precautions 7.
NovaBone-AR 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-AR is intended for use by clinician familiar with bone grafting and internal/external fixation techniques. NovaBone-AR must not be used to gain screw purchase or to stabilize screw placement.
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510(k) Premarket Notification NovaBone Products, LLC NovaBone-AR - Resorbable Bone Graft Substitute
Complications 8.
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 ancsthesia and / or surgery.
9. Conclusion
NovaBone-AR is claimed to be substantially equivalent to the NovaBone and NovaBone-BBG predicates as a non-structural osteoconductive bone void filler for osseous defects. Side-by-side comparative in vivo performance data were presented. Additional supporting in vitro data were supplied.
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Image /page/3/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 a stylized eagle or bird-like symbol with three distinct lines forming the body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2004
Mr. David M. Gaisser VP. Operations/RA/QA NovaBone Products, LLC 13709 Progress Boulevard, #33 Alachua, Florida 32615
Re: K041613
Trade Name: NovaBone -- R - Resorbable Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MOV Dated: June 11, 2004 Received: June 15, 2004
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 (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
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely vours.
L. Mark N. Mikkelsen
Celia M. Witten, Ph.D., M.D. 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): _ k 04 1613 ----------------------------------------
Device Name: ________ NovaBone -AR - Resorbable Bone Graft Substitute
Indications For Use:
NovaBone-AR Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone-AR 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.
(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 | K041613 |
Prescription Use X
OR (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 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.