(173 days)
Not Found
No
The description focuses on the material composition and physical properties of a bone graft substitute, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a bone void filler that provides a bone graft substitute, which is a structural or material replacement, not a therapeutic agent that treats a disease or condition.
No
The device is a bone graft substitute used to fill bony voids or gaps; it is not used to diagnose a medical condition.
No
The device description clearly states that NanoFUSE® DBM is a physical, putty-like bone-void filler comprised of biological and synthetic materials, packaged in syringes. It 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 NanoFUSE® DBM is a bone graft substitute placed into bony voids or gaps of the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details a material used to fill bone defects and remodel into the skeletal system. This is consistent with a surgical implant or bone graft material, not a device used to perform tests on samples from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), 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. NanoFUSE® DBM does not fit this description.
N/A
Intended Use / Indications for Use
NanoFUSE® DBM is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e., the extremities, pelvis and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NanoFUSE® DBM must be used with autograft as a bone graft extender in the posterolateral spine. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
Product codes
MQV, MBP
Device Description
NanoFUSE® DBM is a malleable, putty-like, bone-void filler for use in general orthopedic applications. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles (45s5 bioactive glass), both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe (20 cc or 3 cc), double-wrapped in peel-back pouches, and final packaged in a dust cover paperboard carton. The 20 cc syringe will be filled with either of two different fill quantities of dry powder, identified as 10 cc or 5 cc final product volume. The 3 cc syringe will be filled with dry powder, identified as 2 cc final product volume. NanoFUSE® DBM is intended for single patient use only. At point of use, the surgeon will reconstitute the product with an appropriate sterile solution of his/her choice (sterile saline, water for injection, or autologous whole blood). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. NanoFUSE® DBM is progressively resorbed and replaced by host bone during the osteo-remodeling 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, pelvis and posterolateral spine)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
NanoFUSE® DBM has a history of safe and effective clinical use. Additionally, biocompatibility testing and in vitro bench testing has previously been conducted to evaluate the biological safety and performance characteristics of NanoFUSE® DBM according to ISO 10993. The use of NanoFUSE® DBM in the posterolateral spine was evaluated in vivo. The use of NanoFUSE® DBM in the spine has been evaluated in vivo, and found to be substantially equivalent to cleared predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/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 image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2015
Nanotherapeutics. Incorporated Doris Snow, Ph.D. Senior Director Regulatory Affairs 13859 Progress Boulevard, Suite 300 Alachua, Florida 32615
Re: K142104 Trade/Device Name: NanoFUSE® DBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: December 16, 2014 Received: December 19, 2014
Dear Dr. Snow:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Doris Snow, Ph.D.
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 contact the Division of Industry and Consumer Education 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. 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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K142104
Device Name: NanoFUSE® DBM
Indications for Use:
NanoFUSE® DBM is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e., the extremities, pelvis and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NanoFUSE® DBM must be used with autograft as a bone graft extender in the posterolateral spine. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image contains the word "nanotherapeutics" in bold, black font. To the left of the word is a blue symbol that looks like three overlapping circles. The symbol is a lighter shade of blue than the text. The text and symbol are aligned horizontally.
| SECTION 05 | 510(k) SUMMARY OF SAFETY & EFFECTIVENESS | |
|---|---|---|
| NanoFUSE® DBM | ||
| Date: | December 16, 2014 | |
| Submitted by: | Nanotherapeutics, Inc. | |
| 13859 Progress Blvd., Suite 300 | ||
| Alachua, FL 32615 | ||
| Representative: | Doris Snow, Ph.D. | |
| Sr. Director, Regulatory Affairs | ||
| Phone: (386) 462-9663 | ||
| FAX: (386) 462-2087 | ||
| Proprietary Name: | NanoFUSE® DBM | |
| Common Name: | Bone Void Filler, Bone Graft Substitute | |
| Classification Name: | Filler, Calcium Sulfate Preformed Pellets, 21 CFR § 888.3045 | |
| Classification Codes: | MBP - Class II | |
| Predicate Devices: |
| Trade/Proprietary Name | Manufacturer | 510(k) Number |
|---|---|---|
| NanoFUSE® DBM | Nanotherapeutics | K120279 |
| Description: | NanoFUSE® DBM is a malleable, putty-like, bone-void filler for use in
general orthopedic applications. The product is comprised of human
demineralized bone matrix (DBM) and synthetic calcium phosphor-
silicate particulate material particles (45s5 bioactive glass), both coated
with gelatin derived from porcine skin. These coated particles are
packaged dry in a single use, polypropylene syringe (20 cc or 3 cc),
double-wrapped in peel-back pouches, and final packaged in a dust
cover paperboard carton. The 20 cc syringe will be filled with either of
two different fill quantities of dry powder, identified as 10 cc or 5 cc final
product volume. The 3 cc syringe will be filled with dry powder, identified
as 2 cc final product volume. NanoFUSE® DBM is intended for single
patient use only. At point of use, the surgeon will reconstitute the product with an
appropriate sterile solution of his/her choice (sterile saline, water for injection, or autologous whole blood). The coated particles rehydrate in
less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. NanoFUSE® DBM is progressively resorbed and replaced by host bone during the osteo-remodeling process. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | NanoFUSE® DBM is indicated to be gently placed into bony voids or
gaps of the skeletal system that are not intrinsic to the stability of the
bony structure (i.e., the extremities, pelvis and posterolateral spine).
These defects may be surgically created osseous defects or osseous |
4
defects created from traumatic injury to the bone. NanoFUSE® DBM must be used with autograft as a bone graft extender in the posterolateral spine. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
The applicant version of NanoFUSE® DBM is identical to the currently Characteristics: legally marketed medical device NanoFUSE® DBM, also manufactured by Nanotherapeutics, Inc. with respect to technological characteristics. NanoFUSE® DBM is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles (45s5 bioactive glass), both coated with gelatin derived from porcine skin. It is provided dry and is reconstituted at the point of use into a paste-like, malleable form that can be molded or manipulated into bony defects.
Technological
NanoFUSE® DBM is reconstituted by the addition of fluid and waiting at least 30 seconds before expelling the contents from the syringe. At 30 seconds, the product extrudes as a very fluid paste and, with time, the gelatin carrier absorbs the fluid, becomes progressively thicker, and eventually sets in a rubbery mass.
| Comparison
Feature | NanoFUSE® DBM -
Predicate | NanoFUSE® DBM -
Applicant |
|------------------------------|----------------------------------|----------------------------------------------------|
| Form | Syringe | Same |
| Materials of
Construction | DBM, bioactive glass,
gelatin | Same |
| Comparable
Sizes | Yes | Yes |
| Osteoinductivity
Assay | Cell bioassay | in vivo athymic rat
implant or cell
bioassay |
| Sterility | Yes - Radiation | Same |
| Anatomic Sites | Extremities, pelvis | Extremities, pelvis,
posterolateral spine |
Safety and NanoFUSE® DBM has a history of safe and effective clinical use. Effectiveness: Additionally, biocompatibility testing and in vitro bench testing has previously been conducted to evaluate the biological safety and performance characteristics of NanoFUSE® DBM according to ISO 10993. The use of NanoFUSE® DBM in the posterolateral spine was evaluated in vivo. Substantial The use of NanoFUSE® DBM in the spine does not alter the fundamental Equivalence: scientific technology of the device. The use of NanoFUSE® DBM in the spine has been evaluated in vivo, and found to be substantially
equivalent to cleared predicate devices.