OsteoFlo® HydroPutty™ is indicated for 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 defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device provides a bone void filler that is resorbed with host bone during the healing process.

Device Description

The OsteoFlo® HydroPutty™ is a resorbable bone void filler comprised of porous carbonated apatite granules and bioglass, in a synthetic polymer binder. The OsteoFlo® HydroPutty™ is intended to be easily packed into osseous defects. The single-use device is supplied sterile via gamma radiation and dry. The device requires mixing with aqueous sterile saline solution in a 1:1 ratio prior to use. The OsteoFlo® HydroPutty™ is supplied as either a pre-filled syringe or vial, in 1, 2.5, 5 and 10mL configurations.

AI/ML Overview

The provided document is a 510(k) summary for the OsteoFlo® HydroPutty™ bone void filler device. It does not include acceptance criteria or a study that specifically proves the device meets such criteria in the traditional sense of a performance study with metrics like sensitivity, specificity, or accuracy, as would be typical for an AI/software device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. The "acceptance criteria" here are effectively the successful completion of these non-clinical tests, showing that the device meets established standards for biocompatibility, sterility, packaging, shelf-life, and material characteristics, and performs comparably to the predicate in an in vivo animal study.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical Equivalence)

Acceptance Criteria (Demonstrated through Non-Clinical Tests)	Reported Device Performance (as summarized in the document)
Biocompatibility per ISO 10993-1:2018	Evaluation demonstrated compliance with biocompatibility standards.
Sterilization validation per ISO 11137-1:2006 and ISO 11137-2:2013	Validation demonstrated effective sterilization.
Packaging validation per ISO 11607-1:2009 and ISO 11607-2:2006	Validation demonstrated packaging integrity.
Shelf-life testing per ASTM 1980-16	Testing confirmed the device's shelf-life.
Bacterial endotoxin testing per ANSI/AAMI ST72:2019	Testing demonstrated compliance with endotoxin limits.
Material characterization (x-ray diffraction, particle size, porosity, surface area)	Characterization confirmed material properties.
In vivo evaluation in a critical-size rabbit femoral defect model	Demonstrated effectiveness in terms of device absorption and bone formation, comparable to predicate in in vivo performance.

2. Sample Size Used for the Test Set and the Data Provenance

The document describes an "in vivo evaluation in a critical-size rabbit femoral defect model."

Sample Size: The exact number of rabbits used in this animal model is not specified in the provided text.
Data Provenance: The study was an animal model (in vivo rabbit study), which is typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information (experts establishing ground truth for a test set) is typically relevant for studies evaluating the diagnostic accuracy or interpretive performance of a device (e.g., AI algorithms for image analysis). For a bone void filler device evaluated in an in vivo animal model, the "ground truth" for bone formation and absorption would likely be established through histological analysis, micro-CT imaging, and other quantitative measures performed by veterinary pathologists or researchers. The document does not provide details on the number or qualifications of such experts, as it is a summary focused on substantial equivalence.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies where human readers are interpreting data and consensus is needed for ground truth. Since this study involved an in vivo animal model and non-clinical tests, such a method would generally not be applicable or described in this context.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI assistance on human reader performance, which is not relevant for a bone void filler device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone algorithm performance study was not done. This concept is applicable to AI/software devices, not physical medical devices like a bone void filler.

7. The Type of Ground Truth Used

For the in vivo evaluation, the ground truth would be based on direct biological observation and quantitative assessment of bone formation and device absorption in the rabbit model (e.g., histological analysis, radiographic imaging, micro-CT evaluations). The document states "Effectiveness, in terms of device absorption and bone formation, has been shown in the animal study."

8. The Sample Size for the Training Set

This concept is specific to machine learning/AI models. As this document describes a physical medical device (bone void filler) and not an AI algorithm, there is no "training set" as understood in AI development.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no AI training set.

Summary

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October 2, 2023

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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K231716

Trade/Device Name: OsteoFlo® HydroPuttyTM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: August 31, 2023 Received: August 31, 2023

Dear Travis 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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Jesse Muir Digitally signed by
Jesse Muir Jesse Muir -S -S Date: 2023.10.02 13:40:35 -04'00' Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K231716

Device Name

OsteoFlo® HydroPutty TM

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo for Surgentec. The logo features a stylized blue and gray symbol on the left, resembling a stylized letter 'S' or a series of interconnected shapes. To the right of the symbol is the company name, "SURGENTEC," in a bold, sans-serif font. A registration mark is present in the upper right corner of the logo.

K231716

510(k) Summary

Device Trade Name:	OsteoFlo® HydroPutty™
Manufacturer:	SurGenTec, LLC911 Clint Moore Rd,Boca Raton, FL 33487
Contact:	Travis GreenhalghCEO561.990.7882
Date Prepared:	September 28, 2023
Classification:	Class II per 21 CFR 888.3045: Resorbable calcium salt bone voidfiller device
Product Codes:	MQV
Primary Predicate:	NovaBone Putty (K110368)
Additional Predicate:	OsteoFlo NanoPutty (K200064)

Indications For Use:

OsteoFlo® HydroPutty™ 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.

Device Description:

Predicate Device:

The OsteoFlo® HydroPutty™ is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices:

Primary Predicate: NovaBone Putty (K110368) Additional Predicate: OsteoFlo NanoPutty (K200064)

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Image /page/4/Picture/0 description: The image shows the logo for Surgentec. The logo consists of a stylized "S" symbol on the left, followed by the word "SURGENTEC" in a bold, sans-serif font. The "S" symbol is made up of three curved shapes in blue and gray, arranged in a circular pattern. The word "SURGENTEC" is in black, and there is a small trademark symbol to the right of the "C".

The subject and predicate devices have the same device characteristics (sterile, single-use, synthetic bone void filler which are applied as a malleable putty). These devices serve as absorbable scaffolds for new bone formation to repair orthopedic osseous defects in the skeletal system that are not intrinsic to the stability of the bony structure, and which are surgically created or the results of traumatic injury. The differences in physical component chemistry, particle format, or form do not impact device function. With no differences in biocompatibility, general intended use, or method of operation, the OsteoFlo® HydroPutty™ is determined to be substantially equivalent to the cited predicate devices.

Performance Testing Summary:

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

· Biocompatibility evaluation 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
· Bacterial endotoxin testing per ANSI/AAMI ST72:2019
· 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 Routine monitoring for bacterial endotoxins will be conducted per AAMI ST72:2019

Substantial Equivalence:

In summary, non-clinical testing conducted on the OsteoFlo® HydroPuttyTM demonstrates that the device is substantially equivalent to the predicate devices. Effectiveness, in terms of device absorption and bone formation, has been shown in the animal study, with no new risks to biological safety, device sterility, or packaging raised by other validation testing.

Clinical Data:

No clinical tests were submitted or relied upon in this premarket notification submission to support a decision of substantial equivalence.

Conclusion:

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. OsteoFlo® HydroPutty™ is as safe, as effective, and performs as well as, or better, than the predicate devices.

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.