OSSEOFLEX SB

K140937 · Osseon, LLC · NDN · Jun 19, 2014 · Orthopedic

Device Facts

• Record ID: K140937
• Device Name: OSSEOFLEX SB
• Applicant: Osseon, LLC
• Product Code: NDN · Orthopedic
• Decision Date: Jun 19, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Osseoflex SB is an inflatable bone tamp used in balloon kyphoplasty. Device consists of a balloon catheter with an articulating/steering feature controlled by a knob; allows clinician to direct the distal end through a pre-existing access channel in the vertebral body. Operated by a physician under fluoroscopic observation. Input: manual manipulation of the steering knob. Transformation: inflation of the distal balloon with 60% contrast medium to create a cavity and reduce vertebral fractures. Output: a void in cancellous bone for subsequent filling with PMMA bone cement. Benefits: fracture reduction and cavity creation for cement interdigitation in spinal procedures.

Clinical Evidence

No clinical data; bench testing only. Performance testing included balloon profile, working length, compliance, maximum pressure, bond tensile strength, maximum volume, fatigue (20 cycles), and inflation/deflation time. All tests met acceptance criteria.

Technological Characteristics

Inflatable bone tamp; polyurethane balloon; 8G cannula; 60% contrast medium inflation; 400 psi max pressure; 15mm max diameter; 16mm length. Articulating/steering mechanism via manual knob. Sterilization not specified. No software/electronics.

Indications for Use

Indicated for patients requiring reduction of fractures and/or creation of a void in cancellous bone in the spine during percutaneous vertebral augmentation (kyphoplasty).

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Osseoflex SB Inflatable Bone Tamp (K122533)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

### 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

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

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 Size<br>Compared to the Current Size (Predicate) | | |
|-------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------|
| Characteristic | Additional Size | Current Size (Predicate) |
| Trade Name, Model | Osseoflex SB,<br>OF-8222 | Osseoflex SB,<br>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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| September 1998 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 199<br>Max inflation volume | Zmi | 4m |

| Summary of Non-Clinical Tests Conducted for Determination of Substantial<br>Equivalence | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Test Summary | | |
| Test Performed | Acceptance Criteria | |
| Balloon Profile and<br>Tamp (Catheter)<br>Working Length (TM-<br>003) | Balloon profile $\le$ 3.48 mm (0.137 in) Balloon catheter working length > 16.5 cm (length of access cannula) | |
| Balloon Compliance<br>(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<br>(TM-006) | The inflatable bone tamp exceeds the maximum inflation pressure, 27 atm (~400 psi) without failure. |
| | Bond Tensile<br>Strengths (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 Maximum<br>Volume (TM-008) | Maximum inflation volume 2 mL with 95% confidence and 90% reliability. |
| | Balloon Fatigue,<br>Unconstrained (TM-<br>009) | Inflate to maximum recommended volume of 2 mL, hold for 30 seconds / deflate; without leaks for 20 cycles. |
| Balloon Inflation,<br>Deflation Time (TM-<br>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

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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)

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| FOR FDA USE ONLY |
|------------------|
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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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