AVAflex Vertebral Balloon System

K151125 · Care Fusion · HRX · Nov 24, 2015 · Orthopedic

Device Facts

• Record ID: K151125
• Device Name: AVAflex Vertebral Balloon System
• Applicant: Care Fusion
• Product Code: HRX · Orthopedic
• Decision Date: Nov 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).

Device Story

The AVAflex Vertebral Balloon System is an inflatable bone tamp (IBT) used in balloon kyphoplasty procedures. The device consists of a balloon catheter that is inserted into the vertebral body. A physician inflates the balloon at the distal end of the catheter using a contrast medium to create a cavity in the cancellous bone. This process reduces the vertebral fracture and creates a void for the subsequent injection of bone cement. The balloon is radiopaque to allow for visualization during the procedure. By creating a cavity and facilitating controlled cement interdigitation, the device helps stabilize the fracture and restore vertebral height. It is intended for use by physicians in a clinical or surgical setting.

Clinical Evidence

No clinical tests were conducted for this submission. Substantial equivalence was demonstrated through non-clinical bench testing, including constrained/unconstrained burst pressure/volume testing, balloon wall thickness measurements, and cadaveric simulated use testing.

Technological Characteristics

The device is an inflatable bone tamp featuring a cylindrical balloon catheter. Key specifications include a maximum inflation pressure of 400 psi (27 ATM) and an inflation volume of 3-6 mL. It is compatible with 11G cannulas and utilizes radiopaque markers for visualization. The device is designed for use with contrast medium for inflation and CareFusion Radiopaque Bone Cement for fixation.

Indications for Use

Indicated for patients requiring reduction and fixation of vertebral fractures or creation of a void in cancellous bone for kyphoplasty procedures.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• CareFusion Inflatable Bone Tamps (K131824)
• Radiopaque Bone Cement (K043518)

Submission Summary (Full Text)

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

November 24, 2015

CareFusion Ms. Jov Greidanus Manager, Regulatory Affairs 75 North Fairway Drive Vernon Hills, Illinois 60061

Re: K151125

Trade/Device Name: AVAflex Vertebral Balloon System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, NDN Dated: September 30, 2015 Received: October 2, 2015

Dear Ms. Greidanus:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 [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" (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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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Form Approved OMB No 0910-0120

Expiration Date January 31, 2017

See PRA Statement below

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) Unknown K151125

Device Name

AVAflex Vertebral Balloon System

Indications for Use (Describe)

Intended for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).

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

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# 510(k) SUMMARY K151125

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

| SUBMITTER INFORMATION | | | |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Name | CareFusion | | |
| Address | 75 North Fairway Drive, Vernon Hills IL 60061 USA | | |
| Phone number | [phone] | | |
| Fax number | [phone] | | |
| Establishment<br>Registration Number | 1423507 | | |
| Name of contact person | Joy Greidanus | | |
| Date prepared | September 30, 2015 | | |
| NAME OF DEVICE | | | |
| Trade or proprietary<br>name | AVAflex Vertebral Balloon System | | |
| Common or usual name | Inflatable Bone Tamp | | |
| Classification name | Arthroscope | | |
| Classification panel | Orthopedic | | |
| Regulation | Class II per 21CFR §888.1100, Procode HRX<br>Class II per 21CFR §888.3027, Procode NDN | | |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | CareFusion Inflatable Bone Tamps, K131824<br>Radiopaque Bone Cement, K043518 | | |
| Reason for 510(k)<br>submission | Modifications to device | | |
| Device description | The Inflatable Bone Tamp (IBT) was designed for use in balloon kyphoplasty.<br>The balloon serves to create a cavity in the vertebral body, thereby reducing<br>the fracture and preventing cement leakage, while still allowing for cement<br>interdigitation. The balloon catheter is the functional part of the device that<br>creates a cavity and reduces the fracture. The balloon catheter provides a<br>conduit through which the physician can inflate the balloon at the distal end of<br>the catheter. | | |
| Intended use of the<br>device | Intended for the reduction and fixation of fractures and/or creation of a void in<br>cancellous bone in the spine for kyphoplasty (for use with CareFusion<br>Radiopaque Bone Cement). | | |

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# SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

| Characteristic | New Device | Predicate<br>CareFusion Vertebral Balloon K131824 |
|----------------------------------------------|--------------------------|---------------------------------------------------|
| Compatible cannula<br>size | 11G | 10G |
| Balloon inflation<br>medium | 60% contrast recommended | 60% contrast recommended |
| Markers | Radiopaque | Radiopaque |
| Balloon shape | Cylindrical | Cylindrical |
| Maximum<br>recommended inflation<br>pressure | 400 psi (27 ATM) | 400 psi (27 ATM) |
| Maximum<br>recommended inflation<br>volume | 3-6 mL | 4-8 mL |

## PERFORMANCE DATA

# SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

### Performance Test Summary-New Device

| Characteristic | Standard/Test/FDA Guidance | Results Summary |
|----------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------|
| Inflation pressure | Constrained burst test | The balloon catheters exceeded the<br>requirements for the minimum burst pressure in a<br>constrained environment. |
| Inflation volume | Unconstrained burst test | The balloon catheters exceeded the<br>requirements for the minimum burst volume in an<br>unconstrained environment. |
| Balloon double wall<br>thickness | Calibrated measurement | The double wall thickness of the balloons was<br>substantially equivalent to that of the predicate<br>device. |
| Simulated use | Cadaver | Cadaveric simulated use testing demonstrated<br>substantial equivalence in performance. |

# SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

N/A - No clinical tests were conducted for this submission.

# CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The results of the non-clinical tests show that the CareFusion Flexible IBT System meets or exceeds all performance requirements, and is substantially equivalent to the predicate device.