NanoFUSE® 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 posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

Device Description

NanoFUSE® is a malleable, putty-like, bone-void filler. The product is comprised of a 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, medical grade polymer syringe, double-wrapped in peel-back pouches, in a dust cover paperboard carton. An empty sterile syringe for addition of the hydration fluid of choice is also included in the sterile barrier packaging. NanoFUSE® is intended for single patient use only and is non-pyrogenic. Instructions for use are provided by way of a package insert in the paperboard carton.

At point of use, the surgeon reconstitutes the product with an appropriate sterile solution of 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 mixed with autograft and gently extruded by the surgeon into the bone void. NanoFUSE® is progressively resorbed and replaced by host bone during the osteo-remodeling process.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the NanoFUSE® line of resorbable calcium salt bone void filler devices. As such, it describes the device and its intended use, and compares it to predicate devices. It does not present a study with acceptance criteria and device performance results in the way a clinical study or a software algorithm study would.

Therefore, I cannot extract the information required in your prompt's format from the provided text. The document focuses on showing substantial equivalence to existing devices based on material composition, packaging, intended use, and in vivo animal studies, rather than clinical performance metrics and acceptance criteria for a diagnostic or AI device.

Specifically, the document contains:

A product description: NanoFUSE® is a bone void filler made of synthetic calcium phosphor-silicate particulate material (45S5 bioactive glass) coated with gelatin derived from porcine skin. It's provided dry and reconstituted at the point of use.
Indications for Use: To be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to its stability (e.g., posterolateral spine and pelvis). It must be used with autograft as a bone graft extender.
Predicate Devices: NanoFUSE® DBM (primary predicate, K142104) and NovaBone Putty – Bioactive Synthetic Bone Graft (reference predicate, K110368).
Safety and Effectiveness Data: Mentions biocompatibility data adoption from the primary predicate (NanoFUSE® DBM) due to shared materials. It also states that in vivo rabbit model studies (24 weeks and 52 weeks) were conducted to evaluate posterolateral spine use and demonstrated substantial equivalence to the comparative control (NanoFUSE® DBM).

However, it lacks the following information for a study proving device meets acceptance criteria:

A table of acceptance criteria and reported device performance: This document does not provide quantitative performance metrics or a table comparing them to pre-defined acceptance criteria. The "substantial equivalence" claim is qualitative based on material and animal study findings.
Sample size used for the test set and data provenance: It mentions "two studies (24 weeks and 52 weeks)" in the rabbit model, but no specific sample sizes for the test set are given, nor details about data provenance (e.g., country of origin, retrospective/prospective).
Number of experts and their qualifications for ground truth: Not applicable, as this is an animal study for substantial equivalence, not a human reader or AI performance study.
Adjudication method: Not applicable.
MRMC comparative effectiveness study, effect size: Not applicable, as this is not an AI-assisted human reader study.
Standalone (algorithm only) performance: Not applicable, as this is a medical device (bone void filler), not a software algorithm.
Type of ground truth used: For the animal studies, the "ground truth" would be histological examination or other biological markers of bone remodeling/fusion, but this is not explicitly detailed.
Sample size for the training set: Not applicable, as this is not a machine learning/AI device.
How ground truth for the training set was established: Not applicable.

In conclusion, the provided text describes a traditional 510(k) submission for a physical medical device, focusing on substantial equivalence to predicates rather than a performance study with acceptance criteria as one would find for a diagnostic test or an AI/ML device.

Summary

{0}------------------------------------------------

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 symbol of three human profiles facing to the 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

February 16, 2017

Amend Surgical, Inc. % Lisa Simpson Regulatory Consultant Simpson Regulatory Solutions, LLC 4401 NW 18 Place Gainesville, Florida 32605

Re: K161996

Trade/Device Name: 0.5cc NanoFUSE®, 1.0cc NanoFUSE®, 2cc NanoFUSE®, 5cc NanoFUSE®, 10cc NanoFUSE® Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: January 13, 2017 Received: January 17, 2017

Dear Ms. Simpson:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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.

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

SECTION 4 INDICATIONS FOR USE

510(k) Number (if known): _K161996

Device Name: NanoFUSE®

Indications for Use:

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)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Amend Surgical. The logo features a stylized letter "A" in gold and silver, with the word "AMEND" in bold, black letters to the left of the "A". Below "AMEND" is the word "SURGICAL" in a smaller, gray font.

Device:	NanoFUSE®
Date:	January 13, 2017
Submitted by:	Amend Surgical, Inc.13859 Progress Blvd., Suite 600Alachua, FL 32615Ph: (844) 281-3169Fax: n/a
RegulatoryRepresentative:	Lisa C. Simpson(consultant)Simpson Regulatory Solutions, LLC4401 NW 18 PlaceGainesville, FL 32605
Proprietary Name:	NanoFUSE®
Common Name:	Bone Void Filler, Bone Graft Substitute
Classification Name:	Resorbable calcium salt bone void filler device
Regulation:	21 CFR § 888.3045
Classification Code:	MQV - Class II

Predicate Devices:

Trade/Proprietary Name	Manufacturer	510(k)Number
NanoFUSE® DBM(primary predicate)	Amend Surgical, Inc. /Nanotherapeutics, Inc.*	K142104
NovaBone Putty – BioactiveSynthetic Bone Graft(reference predicate)	NovaBone Products, LLC	K110368
*Device was cleared by NanoTherapeutics, Inc. Subsequently, 510(k) ownership wastransferred to Amend Surgical, Inc. per a contractual agreement.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the logo for Amend Surgical. The logo features a stylized "A" shape in gold and gray, positioned above the word "AMEND" in bold, black letters. Below "AMEND" is the word "SURGICAL" in a smaller, gray font.

Description:

Indications for Use:

Technological Characteristics:

NanoFUSE® is comprised of synthetic calcium phosphor-silicate material particles (45S5 bioactive glass) 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.

The bioactive glass and gelatin binder in NanoFUSE® is identical to that utilized for the legally marketed primary predicate device (K142104, NanoFUSE® DBM). However, NanoFUSE® DBM incorporates demineralized bone matrix (DBM) whereas the NanoFUSE 510(k) subject device does not.

Both NanoFUSE® and NanoFUSE DBM contain 45S5 bioactive glass and an inert carrier. NanoFUSE DBM is designated as the primary predicate device and was used as a comparative control for in vivo studies in the rabbit.

NanoFUSE® is reconstituted by the addition of fluid of choice (sterile saline, water for injection or autologous whole blood). The product extrudes as a very fluid paste and, with

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Amend Surgical. The logo features the word "AMEND" in bold, black letters, with the word "SURGICAL" in a smaller, lighter font underneath. Above the word "AMEND" is a stylized, triangular shape in gold and silver, resembling the letter "A".

time, the gelatin carrier absorbs the fluid, becomes progressively thicker, and eventually sets in a rubbery mass.

ComparisonFeature	NanoFUSE® DBMPrimaryPredicateK142104	NanoFUSE®510(k)SubjectDevice	NovaBone PuttyReferencePredicateK110368
Materials ofConstruction	45S5 bioactive glassPorcine GelatinDemineralized BoneMatrix (DBM)	45S5 bioactive glassPorcine Gelatin	45S5 bioactive glassSynthetic Binder
Sizes	2cc to 10cc	0.5cc to 10cc	1cc to 10cc
PackagingForms	Syringe	Syringe	Clamshell TraySyringeJar
How Provided	Sterile	Sterile	Sterile
	Single Use	Single Use	Single Use
Preparation	Hydrate withsterile saline,water for injection(WFI), orautologous wholeblood.	Hydrate withsterile saline,water for injection(WFI), orautologous wholeblood.	Ready to Use(no hydration needed)
AnatomicSites	Posterolateral Spine	Posterolateral Spine	Posterolateral Spine
	PelvisExtremities	Pelvis	PelvisExtremities
Intended foruse withautograft?	Yes	Yes	Optional
Mode ofAction	Mode of Action:	Mode of Action:	Mode of Action:
	45S5 Bioactive Glass:OsteoconductiveScaffoldDBM:Osteoinductive Potential	45S5 Bioactive Glass:OsteoconductiveScaffold	45S5 Bioactive Glass:OsteoconductiveScaffold

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Amend Surgical. The logo features a stylized "A" in gold and silver above the word "AMEND" in bold, black letters. Below "AMEND" is the word "SURGICAL" in a smaller, lighter font.

Safetv and Effectiveness:

The device is provided sterile, for single use only and has a one-vear shelf life, Biocompatibility data from the NanoFUSE® DBM primary predicate device (K142104) was adopted for the NanoFUSE® 510(k) subject device as the NanoFUSE® DBM includes the same 45S5 bioactive glass and porcine gelatin. Also, the packaging for NanoFUSE® DBM is the same as the proposed NanoFUSE device. The use of NanoFUSE® in the posterolateral spine was evaluated in vivo in the rabbit model. Two studies (24 weeks and 52 weeks) demonstrate the device performance is substantially equivalent to the comparative control, NanoFUSE DBM (K142104). These studies further support the biocompatibility of the NanoFUSE® device.

Substantial Equivalence:

The bioglass and porcine gelatin in NanoFUSE® are identical to those utilized for the primary predicate device, NanoFUSE® DBM (K142104). NanoFUSE® and NanoFUSE® DBM (K142104) have the same packaging and both devices are labeled as nonpyrogenic. NanoFUSE® is not indicated for use in the extremities as are the predicate devices; therefore, the indications for use relative to NanoFUSE® DBM (K142104) were modified accordingly.

NanoFUSE® is similar in formulation to NovaBone Putty (K110368) as both include 45S5 bioactive glass and an inert carrier to facilitate handling; neither device contains DBM. The proposed NanoFUSE device, NanoFUSE® DBM predicate (142104) and NovaBone Putty predicate (K110368) are all provided sterile, for single use only and are intended for use in the posterolateral spine and pelvis.

NanoFUSE DBM (K142104) was chosen as the comparative control for posterolateral spine studies in the rabbit because the formulation contains the same bioglass and gelatin constituents. Both the 24-week study and 52-week rabbit spine study results demonstrate NanoFUSE® in vivo performance to be substantially equivalent to NanoFUSE DBM (K142104), in consideration that the predicate device includes DBM, which provides an osteoinductive advantage.

Based on the composite of descriptive information and supporting animal data, NanoFUSE® is deemed substantially equivalent to NanoFUSE DBM (K142104), the primary predicate device, when used as a bone graft extender, in accordance with the indications for use and instructional information provided in the device labeling.

Regulation Number and Section

§ 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.