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 perculancous vertebral augmentation. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutancous 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. The articulating or steering feature of the device assists the clinician in directing the device to the pre-existing channel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

Device: Osseoflex® SB (2mL)

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Test (TM #)	Acceptance Criteria	Reported Device Performance
Balloon Profile and Tamp (Catheter) Working Length (TM-003)	Balloon profile ≤ 3.48 mm (0.137 in) Balloon catheter working length > 16.5 cm (length of access cannula)	The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". Specific numerical results for this test are not provided.
Balloon Compliance (TM-004)	Balloon working length (L) is 16 mm (reference) at the maximum recommended volume 2 mL. Balloon diameter (D) is 15 mm maximum at the maximum recommended volume 2 mL. (15 mm diameter ensures balloon does not pass through vertebral end plates).	The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". Specific numerical results for this test are not provided.
Maximum Pressure (TM-006)	The inflatable bone tamp exceeds the maximum inflation pressure, 27 atm (~400 psi) without failure.	The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". Specific numerical results for this test are not provided.
Bond Tensile Strengths (TM-007)	Bond tensile strength ≥ 15 N (3.37 lbf). (Adopted from ISO 10555 requirements).	The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". Specific numerical results for this test are not provided.
Balloon Maximum Volume (TM-008)	Maximum inflation volume 2 mL with 95% confidence and 90% reliability.	The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". T specific numerical result verifying the 95% confidence and 90% reliability is not provided.
Balloon Fatigue, Unconstrained (TM-009)	Inflate to maximum recommended volume of 2 mL, hold for 30 seconds / deflate; without leaks for 20 cycles.	The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". Specific numerical results confirming 20 cycles without leaks are not provided.
Balloon Inflation, Deflation Time (TM-010)	The Osseoflex SB 2ml samples deflation times to be clinically equivalent to other marketed inflatable bone tamps.	The document states that the "results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements". While clinical equivalence is the criterion, specific data comparing deflation times is not presented.

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

The document does not specify the exact sample sizes used for each non-clinical performance test. It only summarizes that "non-clinical tests" were conducted. The data provenance is from non-clinical laboratory testing, performed by Osseon LLC, as indicated by the "Summary of Non-Clinical Tests Conducted." There is no indication of country of origin for the data (beyond the company being US-based) or whether it was retrospective or prospective in nature (as it's laboratory testing, it would inherently be prospective).

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

Not applicable. The tests conducted were non-clinical performance tests for a medical device (inflatable bone tamp), not a diagnostic or AI-assisted system requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

Not applicable, as this was non-clinical laboratory testing against pre-defined engineering specifications, not a study requiring human adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "N/A – No clinical test were conducted for this submission."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is a medical device (inflatable bone tamp), not an algorithm or AI system. The performance tests are for the physical properties and functionality of the device itself.

7. The Type of Ground Truth Used:

The "ground truth" for these tests consisted of pre-defined engineering specifications and performance requirements (acceptance criteria) based on device design and relevant standards (e.g., ISO 10555 for bond tensile strength).

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set.

Summary

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JUN 1 9 2014

Attachment 4:

510(k) Summary

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

510(k) Owner

Osseon LLC 2330 Circadian Way Santa Rosa, CA 95407 Phone: 707-636-5940 Fax: 707-636-5941

Official .Contact

Keith Burger Director of Research and Development

Device Information

Trade or Proprietary Name:

Common Name:

Osseoflex® SB

Common Name:

L. S. Ashworth

Classification Name:

Classification Panel:

Regulation:

Product Code(s)

Legally marketed device(s) to which equivalence is claimed Reason for 510(k)

Device Description

Inflatable Bone Tamp

Primary: Arthroscope Secondary: Cement, Bone Vertebroplasty

Orthopedic

Class II per 21CFR §888.1100 Class II per 21CFR §888.3027

HRX; NDN

Osseoflex SB Inflatable Bone Tamp K 122533

New Device

Osseon LLC Osseoflex SB, 2ml Special 510(k)

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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. The articulating or steering feature of the device assists the clinician in directing the device to the pre-existing channel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.

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.

Summary of Technological Characteristics of the Additional SizeCompared to the Current Size (Predicate)
Characteristic	Additional Size	Current Size (Predicate)
Trade Name, Model	Osseoflex SB,OF-8222	Osseoflex SB,OF-0005
Cannula size	8G	8G
Balloon Inflation Medium	60% Contrast	60% Contrast
Balloon Material	Polyurethane	Polyurethane
Balloon Diameter at nominal volume	15 mm max	15 mm max
Balloon Length at nominal volume	16 mm	15 mm
Balloon Shape	Spherical	Cylindrical
Max inflation pressure	400 psi (27 ATM)	400 psi (27 ATM)

Osseon LLC Osseoflex SB, 2ml

Special 510(k)

Intended Use

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Company of Children And List and A A Marcel Company of Children Company of Children	Angel Build Build Build Build Build Build Artistics	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
September 1998 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 199Max inflation volume	Zmi	4m

Summary of Non-Clinical Tests Conducted for Determination of SubstantialEquivalence
Performance Test Summary
Test Performed	Acceptance Criteria
Balloon Profile andTamp (Catheter)Working Length (TM-003)	Balloon profile $\le$ 3.48 mm (0.137 in) Balloon catheter working length > 16.5 cm (length of access cannula)
Balloon Compliance(TM-004):	Balloon working length (L) is 16 mm (reference) at the maximum recommended volume 2 mL. Balloon diameter (D) is 15 mm maximum at the maximum recommended volume 2 mL. The 15 mm diameter maximum specification is to ensure that the diameter of the balloon will not grow large enough to possibly go through the end plates of the vertebrae.
	Maximum Pressure(TM-006)	The inflatable bone tamp exceeds the maximum inflation pressure, 27 atm (~400 psi) without failure.
	Bond TensileStrengths (TM-007)	Bond tensile strength $\ge$ 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 MaximumVolume (TM-008)	Maximum inflation volume 2 mL with 95% confidence and 90% reliability.
	Balloon Fatigue,Unconstrained (TM-009)	Inflate to maximum recommended volume of 2 mL, hold for 30 seconds / deflate; without leaks for 20 cycles.
Balloon Inflation,Deflation Time (TM-010)	The Osseoflex SB 2ml samples deflation times to be clinically equivalent to other marketed inflatable bone tamps.
Summary of Clinical Tests Conducted for Determination of Substantial Equivalence
N/A – No clinical test were conducted for this submission
Conclusions Drawn from Non-Clinical and Clinical Data
The results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements, and are substantially equivalent to the predicate device.

. ,

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

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

June 19, 2014

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

Re: K140937

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: May 30, 2014 Received: June 2, 2014

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 that I Dr. I has I 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); Jabeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Mr. Keith Burger

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" (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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins

for

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

Enclosure

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017

See PRA Statemant below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known) K140937

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)

Laurence D. Coyne -A

(Division Sign-OST) Division of Orthopedic Devices SID(k) Number: K 140937

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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 I he barbon and the services 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:

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FORM FDA 3881 (1/14)

PSC Publicitang Services (201) 443-604 D

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.”