The Synflate Vertebral Balloon System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

Device Description

The Synflate Vertebral Balloon System is a comprehensive array of instrumentation (Vertebral Access Kit as well as a Biopsy Kit), vertebral augmentation balloons (inclusive of balloon-catheter, stiffening wire, and syringe with luer lock), and Inflation System (previously cleared via K110604). All instruments and implants are provided sterile and packaged separately.

The Synflate balloon catheter includes a stiffening wire and syringe with luer lock. The balloon is inflated within the vertebral body via the Inflation System.

The Synflate balloon catheter is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Synthes Synflate Vertebral Balloon System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific, quantifiable acceptance criteria or detailed reported device performance in a table format. It broadly mentions:

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Mechanical Properties	Not explicitly defined with specific numerical targets. The aim was to "characterize the properties and functionality" and allow "comparison with established acceptance criteria." This implies internal manufacturer-defined criteria.
Balloon Pressure Limits	The device was tested to assess "balloon pressure and volume limitations." No specific values are provided.
Volume Limitations	The device was tested to assess "balloon pressure and volume limitations." No specific values are provided.
Burst Characteristics	The device was tested to assess "burst characteristics." No specific values or thresholds are provided.
Functionality (Fracture Reduction/Void Creation)	The device's "ability...to be used for the reduction of fractures and/or creation of a void in cancellous bone" was assessed. The conclusion stated it is "as safe and effective as the predicate devices identified." This suggests a qualitative assessment of functionality against a benchmark.
Safety and Effectiveness	The overall conclusion of the non-clinical testing was that the Synflate System is "as safe and effective as the predicate devices identified."

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

Sample Size: Not explicitly stated. The document mentions "Mechanical and biomechanical testing was performed" but does not give specific numbers of units or tests performed.
Data Provenance: The tests were "performed in order to provide data to support a substantial equivalence determination." This implies the tests were conducted by the manufacturer, Depuy Synthes Spine, as part of their 510(k) submission. It is a non-clinical (benchtop) study, not involving human subjects. Therefore, country of origin related to patient data or retrospective/prospective classification is not applicable.

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

This question is not applicable to this submission. The "test set" in this context refers to the physical devices undergoing mechanical and biomechanical testing, not a dataset requiring expert interpretation for ground truth. The "ground truth" for these tests would be the measured physical properties and performance characteristics against engineering specifications.

4. Adjudication Method for the Test Set

This question is not applicable. Since the "test set" consists of physical devices undergoing objective mechanical measurements, there is no need for expert adjudication of results in the way commonly seen in clinical image-based studies. The "adjudication" would be based on comparison of measured values against predefined engineering acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed to demonstrate the safety and effectiveness of this system." The submission relies solely on non-clinical (mechanical and biomechanical) testing to demonstrate substantial equivalence to predicate devices.

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

This question is not applicable as this device is a medical instrument (vertebral balloon system), not an algorithm or AI-powered device.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests would be engineering specifications and established mechanical testing standards/methods. The device's performance was compared against these predefined physical and functional requirements, and against the established performance characteristics of the predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. Since this is a physical medical device and not an AI/machine learning algorithm, there is no "training set."

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

This question is not applicable for the same reason as point 8.

Summary

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® SYNTHES®
Spine

Spine

MAY 2 0 2013

6	510(k) Summary	MAY 2
	Name of Firm:	Depuy Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380
	510(k) Contact:	Stacey BonnellSenior, Regulatory Affairs Specialist - Depuy Synthes SpineTelephone: 610-719-5895 Facsimile: 610-719-5102Email: bonnell.stacey@synthes.com
	Date Prepared:	January 18, 2013
	Trade Name:	Synthes Synflate Vertebral Balloon System
	Classification:	Orthopaedic and Rehabilitation Devices PanelClass II21 CFR 888.1100 - Arthroscope, OrthopedicClass II; Product Code HRX21 CFR 888.3027 - Cement, Bone, VertebroplastyClass II; Product Code NDN
	Predicate Devices:	Synthes Vertebral Body Balloon (VBB) System (K110604)Kyphon KyphX Xpander Inflatable Bone Tamp (K041454)
	Device Description:	The Synflate Vertebral Balloon System is a comprehensive array ofinstrumentation (Vertebral Access Kit as well as a Biopsy Kit), vertebralaugmentation balloons (inclusive of balloon-catheter, stiffening wire,and syringe with luer lock), and Inflation System (previously cleared viaK110604). All instruments and implants are provided sterile andpackaged separately.
		The Synflate balloon catheter includes a stiffening wire and syringe withluer lock. The balloon is inflated within the vertebral body via theInflation System.
		The Synflate balloon catheter is intended to be used for the reduction offractures and/or creation of a void in cancellous bone in the spine. Thisincludes use during percutaneous vertebral augmentation. The system isto be used with cleared spinal polymethylmethacrylate (PMMA) bonecements indicated for use during percutaneous vertebral augmentationprocedures, such as kyphoplasty.
	Intended Use /Indications for Use:	The Synflate Vertebral Balloon System is intended to be used for thereduction of fractures and/or creation of a void in cancellous bone in thespine. This includes use during percutaneous vertebral augmentation.The system is to be used with cleared spinal polymethylmethacrylate(PMMA) bone cements indicated for use during percutaneous vertebralaugmentation procedures, such as kyphoplasty

Synthes Synflate Vertebral Balloon System Traditional 510(k)

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Comparison of thetechnologicalcharacteristics of thedevice to thepredicate device:	The design features, material, and indications for use of the SynflateSystem are substantially equivalent to the predicate devices identified.Additionally, the safety and effectiveness of this system is adequatelysupported by documentation within this premarket notification.
Performance Data(Non-clinical and/orClinical)	Mechanical and biomechanical testing was performed in order toprovide data to support a substantial equivalence determination. Thesetests were performed to characterize the properties and functionality ofthe Synflate System, as well as to allow comparison with establishedacceptance criteria. Mechanical and biomechanical testing wasperformed to assess balloon pressure and volume limitations, burstcharacteristics, and ability of the device to be used for the reduction offractures and/or creation of a void in cancellous bone. The conclusionsdrawn from testing demonstrate that the Synflate System is as safe andeffective as the predicate devices identified.Clinical data was not needed to demonstrate the safety and effectivenessof this system.

Comparison of thetechnologicalcharacteristics of thedevice to thepredicate device:

The design features, material, and indications for use of the SynflateSystem are substantially equivalent to the predicate devices identified.Additionally, the safety and effectiveness of this system is adequatelysupported by documentation within this premarket notification.

Performance Data(Non-clinical and/orClinical)

Mechanical and biomechanical testing was performed in order toprovide data to support a substantial equivalence determination. Thesetests were performed to characterize the properties and functionality ofthe Synflate System, as well as to allow comparison with establishedacceptance criteria. Mechanical and biomechanical testing wasperformed to assess balloon pressure and volume limitations, burstcharacteristics, and ability of the device to be used for the reduction offractures and/or creation of a void in cancellous bone. The conclusionsdrawn from testing demonstrate that the Synflate System is as safe andeffective as the predicate devices identified.Clinical data was not needed to demonstrate the safety and effectivenessof this system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, topped by three horizontal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2013

Depuy Synthes Spine % Ms. Stacev Bonnell Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K130146

Trade/Device Name: Synthes Synflate Vertebral Balloon System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: March 26, 2013 Received: March 27, 2013

Dear Ms. Bonnell:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Stacey Bonnell

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Image /page/3/Picture/7 description: The image shows the name "Erin I. Keith" in a stylized font. The letters "I" and "." are designed with concentric lines, creating a unique visual effect. The name is presented in a clear, bold typeface, making it easily readable.

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

Enclosure

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@ SYNTHES Spine

5 Indications for Use Statement

510(k) Number:

Device Name: Synthes Synflate Vertebral Balloon System

Indications for Use:

The Synflate Vertebral Balloon System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with clearad spiral polymethylmethacrylate (PMMA) bone cements indicated for use during percutated us vertebral augmentation procedures, such as kyphoplasty.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne - A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130146

Synthes Synflate Vertebral Balloon System Traditional 510(k)

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”