The Osseoflex® SB 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. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.

Device Description

The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® needle to fill the previously created void(s).

An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device.

AI/ML Overview

This document describes the performance testing for the Osseoflex SB, 10 Gauge Straight Balloon.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Bench Tests Performed	Acceptance Criteria	Reported Device Performance (Implied from Conclusion)
Balloon Profile and Tamp (Catheter) Working Length (TM-003)	• Balloon profile ≤ 2.79 mm (0.109 in) • Balloon catheter working length > 16.5 cm	Met or exceeded requirements
Balloon Compliance (TM-004)	• Balloon working length (L) ≤ 24 mm • Balloon diameter (D) ≤ 19 mm	Met or exceeded requirements
Maximum Pressure (TM-006)	The inflatable bone tamp exceeds the maximum inflation pressure, 27 atm (~400 psi) without failure.	Met or exceeded requirements (device withstood pressure without failure)
Bond Tensile Strengths (TM-007)	Bond tensile strength ≥ 15 N (3.37 lbf). The tensile force specification was adopted directly from ISO 10555 (Single Use Intravascular Catheters). This tensile force may be applied to the device during use when the balloon is deflated and retracted back through the access cannula.	Met or exceeded requirements
Balloon Maximum Volume (TM-008)	Maximum inflation volume to be greater than the maximum recommended volume with 95% confidence and 90% reliability.	Met or exceeded requirements
Balloon Fatigue, Unconstrained (TM-009)	Inflate to maximum recommended volume of, hold for 30 seconds / deflate; without leaks for 20 cycles.	Met or exceeded requirements (device performed without leaks for 20 cycles)
Balloon Inflation, Deflation Time (TM-010)	Deflation times to be < 5 seconds with 90/90% confidence/ reliability.	Met or exceeded requirements (device deflated in under 5 seconds with specified confidence/reliability)

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

The document does not explicitly state the sample sizes for each specific test (TM-003, TM-004, etc.) within the "PERFORMANCE DATA" section. It broadly states that "The results of the non-clinical tests show that the Osseoflex SB, 10 Gauge Straight Balloon meets or exceed all performance requirements."

The data provenance is for non-clinical bench tests. These are laboratory tests and do not involve human or animal subjects, so country of origin or retrospective/prospective does not apply in the typical sense.

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

Not applicable. These are non-clinical bench tests, and the "ground truth" is established by the predefined engineering and performance specifications and international standards (like ISO 10555 mentioned for tensile strength). No human experts are used to establish ground truth for this type of testing.

4. Adjudication Method for the Test Set

Not applicable. As these are bench tests with objective measurements against predefined criteria, an adjudication method for conflicting expert opinions is not relevant.

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

No, an MRMC comparative effectiveness study was not done. This document describes non-clinical bench testing of a device (inflatable bone tamp) and not an AI or diagnostic imaging system.

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

Yes, the performance data presented is for standalone device performance (algorithm only, if one considers the device's mechanical function as an "algorithm") without human interaction during the test execution itself, beyond operating the testing equipment.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on engineering specifications, design requirements, and relevant international standards (e.g., ISO 10555 for bond tensile strength). These criteria define what constitutes acceptable performance for the device.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this document describes non-clinical performance testing for a medical device, not a machine learning model.

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

Not applicable. As there is no training set mentioned, the establishment of its ground truth is irrelevant to this document.

Summary

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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 is circular and features the department's name around the perimeter. In the center is an abstract image of a bird-like figure, composed of three human profiles facing to the right.

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

April 9, 2015

Osseon LLC Mr. Keith Burger Director of Research and Development 2330 Circadian Way Santa Rosa, California 95407

Re: K150607

Trade/Device Name: Osseoflex SB Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: March 6, 2015 Received: March 10, 2015

Dear Mr. Burger:

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 - Mr. Keith Burger

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K150607

Device Name Osseoflex SB

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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9.0 510(K) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

I. SUBMITTER

Osseon LLC 2305 Circadian Way Santa Rosa, CA 95407

Phone: 707-636-5940 Fax: 707-636-5941

Contact Person: Keith Burger, Director of Research and Development Date Prepared: April 7, 2015

II. DEVICE

Name of Device: Osseoflex SB Common or Usual Name: Inflatable Bone Tamp Classification Name: Primarily - Arthroscope; Secondarily - Cement, Bone Vertebroplasty Regulatory Class: Class II per 21CFR §888.1100; Class II per 21CFR §888.3027 Product Code: NDN; HRX

III. PREDICATE DEVICE

Osseoflex SB, 10 Gauge K141930, August 21, 2014

DEVICE DESCRIPTION IV.

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INDICATIONS FOR USE V.

The Osseoflex® SB is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

Summary of Technological Characteristics of the Additional Size
Compared to the Current Size (Predicate)
Characteristic	Line Extension		Current Size (Predicate)
Trade Name, Model	Osseoflex SB,OT-0224	Osseoflex SB,OT-0222	Osseoflex SB,OF-0224	Osseoflex SB,OF-0222
Cannula size	10G
Max inflation volume	4ml	2ml	4ml	2ml
Balloon Inflation Medium	60% Contrast
Balloon Material	Polyurethane
Balloon Diameter at nominalvolume	18 mm	14 mm	18 mm	14 mm
Balloon Length at nominalvolume	21 mm	14 mm	21 mm	14 mm
Balloon Shape	Cylindrical	Spherical	Cylindrical	Spherical
Max inflation pressure	400 psi (27 ATM)
Device Modification	StraightStylet	StraightStylet	SteerableStylet	SteerableStylet

The overall materials, specifications and manufacturing processes for the current device to the line extension device have not changed.

The only difference is the replacement of the steerable stylet in the current device with a straight stylet in the modified device.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Bench Tests Performed	Acceptance Criteria
Balloon Profile and Tamp(Catheter) Working Length	• Balloon profile ≤ 2.79 mm (0.109 in)• Balloon catheter working length > 16.5 cm

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(TM-003)
Balloon Compliance (TM-004):	Balloon working length (L) $\leq$ 24 mm Balloon diameter (D) $\leq$ 19 mm
Maximum Pressure (TM-006)	The inflatable bone tamp exceeds the maximum inflation pressure, 27 atm (~400 psi) without failure.
Bond Tensile Strengths (TM-007)	Bond tensile strength $\geq$ 15 N (3.37 lbf). The tensile force specification was adopted directly from ISO 10555 (Single Use Intravascular Catheters) requirements. This tensile force maybe applied to the device during use when the balloon is deflated and retracted back through the access cannula.
Balloon Maximum Volume (TM-008)	Maximum inflation volume to be greater than the maximum recommended volume with 95% confidence and 90% reliability.
Balloon Fatigue, Unconstrained (TM-009)	Inflate to maximum recommended volume of, hold for 30 seconds / deflate; without leaks for 20 cycles.
Balloon Inflation, Deflation Time (TM-010)	Deflation times to be < 5 seconds with 90/90% confidence/ reliability.

CONCLUSION VIII.

The results of the non-clinical tests show that the Osseoflex SB, 10 Gauge Straight Balloon meets or exceed all performance requirements, and are substantially equivalent to the predicate device.

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.”