(65 days)
NovaBone Putty - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral 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 Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
NovaBone Putty 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 and is packaged in single-use containers in multiple formats. 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.
This 510(k) submission (K110368) is for a modification to an existing device, NovaBone Putty, specifically a change in packaging. Therefore, there are no acceptance criteria or a study detailed in the provided text that "proves the device meets the acceptance criteria" in the way a clinical trial might for a new device's performance.
Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, asserting that the change in packaging does not alter the device's fundamental characteristics or performance.
Here's an analysis based on your requested information, acknowledging the nature of this particular 510(k):
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the typical sense for a device performance study. For a packaging modification, the "acceptance criteria" revolve around maintaining the safety, effectiveness, and technological characteristics of the original device. The "reported performance" is that the device itself remains unchanged and functions as intended, with the new packaging being stable and appropriate.
| Acceptance Criteria (Implied for Packaging Modification) | Reported Device Performance (as stated in submission) |
|---|---|
| Device's technological characteristics remain identical previously cleared predicate devices (K060728, K080009, K082672, K101860). | "The technological characteristics of the NovaBone Putty device of the current submission are identical to the NovaBone Putty device cleared per K060728, K080009, K082672, and K101860." The device itself is unchanged. |
| The device's intended use remains the same. | "The device indications are the same as for the predicate." |
| Packaging is suitable and does not compromise the device's sterility, integrity, or function. | "Information as to packaging validation is provided." (Details not explicitly in provided text, but implied to be sufficient for FDA clearance). |
| The device remains safe and effective as a non-structural osteoconductive bone void filler. | "NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission is about a packaging change for an already cleared device. There is no "test set" in the context of evaluating a medical AI algorithm or a new therapeutic device's clinical performance. The "data provenance" would relate to the validation of the new packaging, which isn't detailed in this document but would typically involve material compatibility testing, sterility testing, and shelf-life studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No ground truth establishment for a patient-based test set is relevant for a packaging modification.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or adjudication process for clinical outcomes described.
5. 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. This device is a bone void filler, not an AI diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of clinical performance ground truth. For a packaging modification, the "ground truth" would be the verified physical and chemical properties of the device and packaging, and their interaction, as determined by laboratory testing and regulatory compliance.
8. The Sample Size for the Training Set
Not applicable. There is no training set for an AI algorithm or a new clinical device being developed from scratch.
9. How the Ground Truth for the Training Set was Established
Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for NovaBone. The logo is in black and white and features the word "NOVABONE" in large, block letters. Below the word "NOVABONE" is the phrase "DRIVING INNOVATION IN OSTEOBIOLOGICS" in smaller letters.
APR 1 4 7011
02/04/11
Special 510(k): Device Modification Summary NovaBone Putty - Bioactive Synthetic Bone Graft
Submitter Information: 1.
| Name: | NovaBone Products, LLC |
|---|---|
| Address: | 13631 Progress Boulevard, #600 |
| Alachua, FL 32615 | |
| Telephone: | (386) 462-7661 |
| Facsimile: | (386) 418-1636 |
| Contact: | David M. Gaisser |
2. Name of Device:
| Trade Name: | NovaBone Putty - Bioactive Synthetic Bone Graft |
|---|---|
| Common Name: | Osteoconductive Bone Void Filler |
| Synthetic Resorbable Bone Graft Material | |
| Regulation Number: | 21 CFR 888.3045 |
| Regulation Name: | Bone Void Filler |
Legally Marketed Predicate Device: 3.
NovaBone Putty - Bioactive Synthetic Graft Predicate #1: [K060728. K080009. K082672. K101860]
Device Description 4.
NovaBone Putty 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 and is packaged in single-use containers in multiple formats. 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.
5. Intended Use
NovaBone Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral 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.
{1}------------------------------------------------
NovaBone Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
6. Technological Characteristics and Substantial Equivalence
The technological characteristics of the NovaBone Putty device of the current submission are identical to the NovaBone Putty device cleared per K060728, K080009, K082672, and K101860. The device is designed as an osteoconductive space-filling device to be gently packed into defect sites and used as nonstructural scaffolds for the body's natural healing and bone regeneration process. The device indications are the same as for the predicate.
The primary component of NovaBone Putty is bioactive glass (45S5 Bioglass) particulate. This synthetic material is both biocompatible and osteoconductive. The NovaBone Putty includes a synthetic binder as an inert carrier for ease of 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 Putty device of this submission has been modified from that of the predicate solely in terms of the device packaging; the device itself is unchanged. The predicate devices are packaged in PET-G clamshell trays and polypropylene syringes. The purpose of this submission is to expand the package format options to include a polypropylene jar for larger volume device delivery. The NovaBone Putty device action as a synthetic, inorganic, biocompatible and osteoconductive scaffold into which new bone will grow is unchanged. Information as to packaging validation is provided.
7. Conclusion
The device modification subject to this submission is to include a new package format. This new sealed jar package format has been added to provide an additional bulk product package option. This device modification does not result in a change in technological characteristics of the NovaBone Putty device. NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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
APR 1 4 2011
Re: K110368
Trade/Device Name: NovaBone Putty - Bioactive Synthetic Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: March 17, 2011 Received: March 18, 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
{3}------------------------------------------------
Page 2 -- Mr. David M. Gaisser
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 100-1050.
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/ucm 1178001/photos 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 Previ 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 Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
A. D. B. R. ta
fu
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________ NovaBone Putty - Bioactive Synthetic Bone Graft
Indications For Use:
NovaBone Putty - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral 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 Putty 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)
(Divi (Division Sign of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110368
§ 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.