AVAmax Vertebral Balloon

K150523 · Care Fusion · HRX · Oct 29, 2015 · Orthopedic

Device Facts

• Record ID: K150523
• Device Name: AVAmax Vertebral Balloon
• Applicant: Care Fusion
• Product Code: HRX · Orthopedic
• Decision Date: Oct 29, 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

AVAmax Vertebral Balloon is an inflatable bone tamp used in balloon kyphoplasty. Device consists of a balloon catheter; physician inserts catheter into vertebral body under imaging guidance. Balloon is inflated with contrast medium to create a cavity in cancellous bone, reducing the fracture and preparing the site for bone cement injection. Procedure performed in clinical settings (e.g., OR) by physicians. Device helps restore vertebral height and prevents cement leakage while allowing for cement interdigitation. Benefits include fracture reduction and stabilization.

Clinical Evidence

No clinical tests were conducted for this submission. Substantial equivalence is supported by non-clinical bench testing, including constrained and unconstrained burst pressure/volume testing and cadaveric simulated use studies.

Technological Characteristics

Inflatable bone tamp; cylindrical balloon catheter; radiopaque markers; compatible with 11G and 13G cannulas; balloon lengths 10mm, 15mm, 20mm; max inflation pressure 400 psi (27 ATM); max inflation volume 2-4 mL; inflation medium 60% contrast; sterile, single-use.

Indications for Use

Indicated for patients requiring reduction and fixation of spinal 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 (K131820)

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

October 29, 2015

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

Re: K150523

Trade/Device Name: AVAmax Vertebral Balloon Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, NDN Dated: September 17, 2015 Received: September 18, 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 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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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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Expiration Date January 31, 2017

See PRA Statement below

Form Approved OMB No 0910-0120

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

# Indications for Use

510(k) Number (if known) Unknown K150523

Device Name

AVAmax Vertebral Balloon

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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# 510(k) SUMMARY K150523

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 17, 2015 |
| NAME OF DEVICE | |
| Trade or proprietary<br>name | AVAmax Vertebral Balloon |
| 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, K131820 |
| Reason for 510(k)<br>submission | Modifications to device; additional sizes and material. |
| 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<br>TO THE PREDICATE DEVICE | | |
|------------------------------------------------------------------------------------------------|--------------------------|----------------------------------------------------------|
| Characteristic | New Device | Predicate<br>11G CareFusion Vertebral Balloon<br>K131820 |
| Compatible cannula size | 11G, 13G | 11G |
| Balloon lengths | 10mm, 15mm, 20mm | 15mm, 20mm |
| Balloon inflation medium | 60% contrast recommended | 60% contrast recommended |
| Markers | Radiopaque | Radiopaque |
| Balloon shape | Cylindrical | Cylindrical |
| Maximum recommended inflation pressure | 400 psi (27 ATM) | 400 psi (27 ATM) |
| Maximum recommended inflation volume | 2-4 mL | 4-6 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 requirements for the minimum burst pressure in a constrained environment |
| Inflation volume | Unconstrained burst test | The balloon catheters exceeded the requirements for the minimum burst volume in an unconstrained environment |
| Balloon double wall thickness | Calibrated measurement | The double wall thickness of the balloons was substantially equivalent to that of the predicate devices |
| Simulated Use | Cadaver | Cadaveric simulated use testing demonstrated 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 balloon catheters meet or exceed all performance requirements, and are substantially equivalent to the predicate devices.