OsteoFlo® NanoPutty®- Quadphasic Synthetic Bone Graft is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or the result of traumatic injury to the bone. The device resorbs and is replaced with bonedus ing the healing process.

Device Description

The OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft is an osteoconductive, non-hardening bone void filler. The device is comprised of macroporous calcium phosphate particulates in a bioresorbable polymer binder. The quadphasic particles are composed of HA, a-TCP, B-TCP and bioactive glass. The device also contains micro-sized HA particles. On implantation, the binder is resorbed and bone forms on and between the porous particles as they are gradually resorbed. OsteoFlo® NanoPutty can be easily packed into osseous defects and adheres to bone surfaces. The device is ready to use, requiring no mixing before application. The single-use device is supplied sterile in multiple package formats.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft. As such, it does not contain a study proving the device meets acceptance criteria in the typical sense of a clinical trial or performance study with defined statistically significant acceptance criteria for efficacy.

Instead, this document provides evidence for substantial equivalence to a legally marketed predicate device. This means the manufacturer is asserting their device is as safe and effective as a device already on the market, rather than proving a novel therapeutic effect against strict, predefined performance metrics.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, there aren't formal "acceptance criteria" for a specific performance metric like sensitivity or specificity. Instead, the acceptance is based on demonstrating that the new device is as safe and effective as the predicate.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Material Characteristics (Composition, particle size, porosity)	OsteoFlo NanoPutty: Quadphasic macroporous calcium phosphate particulates (HA, α-TCP, β-TCP, bioactive glass) in a bioresorbable polymer binder; micro-sized HA particles
Intended Use (Bone void filling, resorption, replacement with bone)	OsteoFlo NanoPutty: Indicated to fill bony voids or gaps of the skeletal system (extremities and pelvis) not intrinsic to stability; resorbs and is replaced with bone during healing process.
Mechanism of Operation (Pre-mixed putty, binder resorption, osteoconductive scaffold)	OsteoFlo NanoPutty: Applied as pre-mixed putty, synthetic binder resorbs to expose quadphasic particles, which act as osteoconductive scaffolds for new bone formation as they are slowly resorbed.
Biocompatibility	Demonstrated in compliance with ISO 10993-1:2018.
Sterilization Validation	Validated in compliance with ISO 11137-1:2006 and ISO 11137-2:2013 (E-beam radiation; SAL 10-6).
Packaging Validation	Validated in compliance with ISO 11607-1:2009 and ISO 11607-2:2006.
Shelf-life Testing	Tested in compliance with ASTM 1980-16.
In Vivo Performance (Local biological effects, bone formation, absence of adverse events/failures)	OsteoFlo NanoPutty: In vivo evaluation in a critical-size rabbit femoral defect model demonstrated performance substantially equivalent to the predicate, with no evidence of adverse events or device-related failures.

Study Details for Substantial Equivalence

Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated as a numerical sample size for the in vivo rabbit study. The document mentions "a critical-size rabbit femoral defect model." This typically implies a small number of animals (e.g., 5-10 per group) used for preclinical evaluation in medical device submissions, but an exact 'n' is not provided.
- Data provenance: Preclinical in vivo study. Country of origin not specified, but typically conducted in a controlled lab environment. This is a prospective study (the rabbit study was designed and executed to compare the device to the predicate).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The in vivo study's evaluation of "local biological effects and bone formation" would be assessed by trained histopathologists or researchers specializing in bone biology, but their number and specific qualifications are not detailed in this regulatory summary. The "ground truth" here is objective biological/histological analysis, not expert interpretation of an image or signal.
Adjudication method for the test set:
- Not applicable. This is not a study requiring adjudication of human-interpreted results. The assessment of in vivo bone formation and biological effects is typically performed by a single or limited number of expert pathologists/researchers on tissue samples.
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 document describes a material and its in vivo biological performance, not an AI or imaging-based diagnostic device that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document describes a material device, not an algorithm.
The type of ground truth used:
- For the in vivo study, the ground truth was histological analysis and biological assessment of tissue regeneration and local effects in the rabbit femoral defect model.
The sample size for the training set:
- Not applicable. This device is not an AI algorithm requiring a training set. The "training" for such a device would be the R&D and manufacturing processes to ensure the material consistently meets its specifications.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned for this type of device.

Summary

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August 14, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

SurGenTec, LLC Travis Greenhalgh CEO 911 Clint Moore Rd Boca Raton, Florida 33487

Re: K200064

Trade/Device Name: OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 23, 2020 Received: July 24, 2020

Dear Mr. Greenhalgh:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Laura C. Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200064

Device Name

OsteoFlo® NanoPutty®- Quadphasic Synthetic Bone Graft

Indications for Use (Describe)

OsteoFlo® NanoPuty - Quadphasic Synthetic Bone Graft is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or the result of traumatic injury to the bone. The device resorbs and is replaced with bonedus ing the healing process.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

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Premarket Notification 510(k) Summary OsteoFlo NanoPutty Bone Void Filler - K200064

Submitter Information: 1.

Owner:	SurGenTec, LLC
Address:	911 Clint Moore RdBoca Raton, FL 33487
Contact:	Travis Greenhalgh, CEO
Telephone:	(916) 759-7999
Email:	travis@SurGenTec.com
Date Submitted:	December 9, 2019

2. Name of Device:

Trade Name:	OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft
Common Name:	Bone Void Filler
Classification Name:	Resorbable Calcium Salt Bone Void Filler
Device Regulation:	21 CFR 888.3045
Regulatory Class:	Class II
Product Code:	MQV

3. Legally Marketed Predicate Device:

Predicate: NovaBone Putty - Bioactive Synthetic Bone Graft NovaBone Products, LLC K110368, K101860, K082672

The following devices also are cited as reference devices within the submission:

Bioactive Bone Graft Putty: K132071; Biostructures, LLC
NovaBone MacroPor-Si+: K110925; NovaBone Products, LLC
NanOss BVF-E: K081558; Pioneer Surgical Technology

Device Description 4.

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OsteoFlo® NanoPutty can be easily packed into osseous defects and adheres to bone surfaces. The device is ready to use, requiring no mixing before application. The single-use device is supplied sterile in multiple package formats.

5. Indications for Use

The OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or the result of traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

Technological Characteristics and Substantial Equivalence 6.

OsteoFlo® NanoPutty - Ouadphasic Synthetic Bone Graft is substantially equivalent to the predicate NovaBone Putty Bioactive Synthetic Graft. The devices have the same intended use and basic method of operation. The table below compares the indications and key technological attributes of the OsteoFlo NanoPutty device to the predicate.

Comparator	New Device	Predicate
	OsteoFlo NanoPutty	NovaBone Putty [K110368]
Product Code;Common Name	Resorbable Calcium Salt Bone Void Filler Device(21 CFR 888.3045)
Indications forUse	OsteoFlo® NanoPutty –Quadphasic Synthetic BoneGraft is indicated to fill bonyvoids or gaps of the skeletalsystem (i.e. the extremities andpelvis) that are not intrinsic tothe stability of the bonystructure. These osseous defectsmay be surgically created or theresult of traumatic injury to thebone. The device resorbs and isreplaced with bone during thehealing process.	NovaBone Putty is indicated for bonyvoids or gaps that are not intrinsic tothe stability of the bony structure.NovaBone Putty is indicated to begently packed into bony voids or gapsof the skeletal system (i.e. theextremities, posterolateral spine, andpelvis). These defects may besurgically created osseous defects orosseous defects created from traumaticinjury to the bone. The productprovides a bone void filler that resorbsand is replaced with bone during thehealing process.
Intended Use	Both devices are intended for use as bone void fillers for repair of defectsin the skeletal system. The devices are intended to be resorbed duringdefect healing and replaced with new bone tissue.
Mechanism ofOperation	The device is applied as a pre-mixed putty. The syntheticbinder is resorbed to exposequadphasic particles. Theparticles act as osteoconductivescaffolds for new boneformation as they are slowlyresorbed	The device is applied as a pre-mixedputty. The synthetic binder is resorbedto expose bioactive glass particles.The particles act as osteoconductivescaffolds for new bone formation asthey are slowly resorbed
MaterialComposition	Quadphasic macroporouscalcium phosphate particulatesin a bioresorbable polymer	Bioactive glass particles, 90-710 μm,in a bioresorbable polymer binder

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Comparator	New DeviceOsteoFlo NanoPutty	PredicateNovaBone Putty [K110368]
	binder
Sterility	Sterile; SAL 10-6;E-beam radiation; Single-Use	Sterile, SAL 10-6;γ radiation; Single-Use
Product Size	1.0 ml – 10 ml	2.5 ml – 15 ml

7. Performance Data

The following non-clinical performance data were provided to demonstrate substantial equivalence of the subject device to the predicate.

Biocompatibility per ISO 10993-1:2018
. Sterilization validation per ISO 11137-1:2006 and ISO 11137-2:2013
Packaging validation per ISO 11607-1:2009 and ISO 11607-2:2006 ●
Shelf-life testing per ASTM 1980-16 ●
Material characterization, including x-ray diffraction, particle size, and ● particle porosity and surface area
. In vivo evaluation in a critical-size rabbit femoral defect model

The in vivo evaluation compared the performance of the device to the NovaBone Putty predicate. Evaluation of local biological effects and bone formation demonstrated performance substantially equivalent to the predicate, with no evidence of adverse events or device related failures.

8. Conclusion

The design characteristics of the OsteoFlo NanoPutty device do not raise different questions of safety and effectiveness. Non-clinical study data supports that the device is safe and effective. These data support that the OsteoFlo NanoPutty device is substantially equivalent to the predicate device.

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.