(173 days)
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.
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.
Here's an analysis of the provided text regarding the NanoFUSE® DBM device, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for marketing clearance. It does not typically include detailed clinical trial results or performance metrics in the same way a PMA (Pre-Market Approval) or a more extensive clinical study report would. Therefore, much of the requested information, particularly quantitative performance metrics and details about ground truth establishment, training sets, and MRMC studies, is not present in this document.
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The NanoFUSE® DBM device is a bone void filler intended for use in general orthopedic applications, specifically in bony voids or gaps of the skeletal system (extremities, pelvis, and posterolateral spine). The document describes a 510(k) submission, which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. Therefore, the "acceptance criteria" are primarily related to showing substantial equivalence to the predicate, with specific focus on biological safety, performance characteristics, and the new indication for use in the posterolateral spine.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) submission, the "acceptance criteria" are implied by the comparison to the predicate and the specific tests conducted. Quantitative performance metrics as commonly seen in diagnostic device evaluations are not explicitly stated for this type of device in this document.
| Acceptance Criteria (Implied by 510(k) Submission) | Reported Device Performance (Summary from Document) |
|---|---|
| Technological Characteristics Equivalence | The applicant's NanoFUSE® DBM is stated to be identical to the currently legally marketed NanoFUSE® DBM with respect to technological characteristics (Form, Materials of Construction, Comparable Sizes). It 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 reconstituted at the point of use into a paste-like, malleable form. |
| Biocompatibility | Biocompatibility testing was conducted according to ISO 10993 to evaluate biological safety. (Specific results are not provided in this summary, but the implication is that it met the standards for substantial equivalence). |
| Bench Testing Performance | In vitro bench testing was conducted to evaluate performance characteristics according to ISO 10993. (Specific results are not provided, but the implication is that it met the standards for substantial equivalence). The rehydration time (less than 30 seconds to form a fluid paste that progressively thickens and sets into a rubbery mass) is described as a performance characteristic. |
| Osteoinductivity | For the predicate device, a "Cell bioassay" was used. For the applicant device, "in vivo athymic rat implant or cell bioassay" was specified. The intent is to demonstrate that the device retains osteoinductive potential. |
| Sterility | "Yes - Radiation" for both predicate and applicant, implying the sterility method and outcome are equivalent. |
| Effectiveness for New Anatomic Site | The primary focus of this 510(k) appears to be the expanded indication for use in the "posterolateral spine." This was evaluated in vivo. The document states it was "found to be substantially equivalent to cleared predicate devices" for this indication. (Specific clinical outcomes or direct comparative measures are not detailed in this summary). |
| History of Safe and Effective Clinical Use | The device "has a history of safe and effective clinical use" (referring to the existing, similar NanoFUSE® DBM, likely the predicate itself). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in this 510(k) summary. The document mentions an "in vivo" evaluation for the posterolateral spine indication, and possibly an "in vivo athymic rat implant or cell bioassay" for osteoinductivity, but no details on the number of subjects/animals are provided.
- Data Provenance: Not specified. Given the nature of a 510(k), it likely includes a combination of internal bench testing, animal studies, and potentially a summary of existing clinical data for the predicate device. Country of origin for data is not mentioned, nor is a definitive statement on retrospective or prospective nature of all data, though "in vivo" studies would be prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts & Qualifications: Not applicable/not specified. This document is not evaluating a diagnostic device that requires expert interpretation for a "ground truth" test set. The evaluation is primarily based on material properties, biocompatibility, and in vivo assessment of bone formation/integration.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This document does not describe a process that would require expert adjudication of a test set, as might be found in a diagnostic imaging study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, this type of study is not mentioned as it is typically relevant for diagnostic devices where human readers interpret medical images or data. NanoFUSE® DBM is a therapeutic/device implant, not a diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This concept applies to AI algorithms. NanoFUSE® DBM is a physical medical device (bone void filler). The "device performance" refers to its biological and mechanical properties, not an algorithmic output.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for a bone void filler generally involves:
- Histology/Pathology: For in vivo studies, this would confirm bone formation, material degradation, and biocompatibility in animal models. The document mentions "in vivo" evaluation for the spine and "in vivo athymic rat implant" for osteoinductivity, implying such histological assessment.
- Biocompatibility Standards: Compliance with ISO 10993 standards serves as a "ground truth" for biocompatibility.
- Bench Test Results: Measurable physical/chemical properties from in vitro bench testing.
- Clinical Outcomes/Radiographic Evidence: While not detailed in this summary, a full clinical evaluation for a similar device would typically involve radiographic evidence of bone healing/integration and clinical follow-up for adverse events.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified. This concept is for AI/machine learning models. NanoFUSE® DBM is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. (See #8).
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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
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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 300Alachua, FL 32615 | |
| Representative: | Doris Snow, Ph.D.Sr. Director, Regulatory AffairsPhone: (386) 462-9663FAX: (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 ingeneral orthopedic applications. The product is comprised of humandemineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles (45s5 bioactive glass), both coatedwith gelatin derived from porcine skin. These coated particles arepackaged dry in a single use, polypropylene syringe (20 cc or 3 cc),double-wrapped in peel-back pouches, and final packaged in a dustcover paperboard carton. The 20 cc syringe will be filled with either oftwo different fill quantities of dry powder, identified as 10 cc or 5 cc finalproduct volume. The 3 cc syringe will be filled with dry powder, identifiedas 2 cc final product volume. NanoFUSE® DBM is intended for singlepatient use only. At point of use, the surgeon will reconstitute the product with anappropriate sterile solution of his/her choice (sterile saline, water for injection, or autologous whole blood). The coated particles rehydrate inless 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 orgaps of the skeletal system that are not intrinsic to the stability of thebony structure (i.e., the extremities, pelvis and posterolateral spine).These defects may be surgically created osseous defects or osseous |
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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.
| ComparisonFeature | NanoFUSE® DBM -Predicate | NanoFUSE® DBM -Applicant |
|---|---|---|
| Form | Syringe | Same |
| Materials ofConstruction | DBM, bioactive glass,gelatin | Same |
| ComparableSizes | Yes | Yes |
| OsteoinductivityAssay | Cell bioassay | in vivo athymic ratimplant or cellbioassay |
| 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.
§ 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.