AVAFLEX VERTEBRAL BALLOON SYSTEM

K131824 · Care Fusion · HRX · Oct 3, 2013 · Orthopedic

Device Facts

• Record ID: K131824
• Device Name: AVAFLEX VERTEBRAL BALLOON SYSTEM
• Applicant: Care Fusion
• Product Code: HRX · Orthopedic
• Decision Date: Oct 3, 2013
• 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 kyphoplasty procedures. The device consists of a balloon catheter that is inserted into the vertebral body; the physician inflates the balloon using a contrast medium to create a cavity in cancellous bone and reduce the fracture. This cavity allows for the subsequent delivery of CareFusion Radiopaque Bone Cement, which provides fixation while minimizing leakage. The device is operated by a physician in a clinical setting. The system is designed to facilitate fracture reduction and bone cement interdigitation, potentially benefiting patients by stabilizing spinal fractures.

Clinical Evidence

No clinical tests were conducted for this submission; substantial equivalence was determined based on non-clinical bench testing.

Technological Characteristics

Materials: Polyurethane (balloon/catheter), stainless steel (wire mandrel). Design: Cylindrical balloon. Performance: Max inflation pressure 400 psi (27 ATM); max inflation volume 4-8 mL. Inflation medium: 60% contrast. Sterilization: Not specified. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring kyphoplasty for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine.

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 (K103064)
• CareFusion Inflatable Bone Tamps (K093463)
• CareFusion Inflatable Bone Tamps (K090211)
• Radiopaque Bone Cement (K043518)

Submission Summary (Full Text)

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## 510(k) SUMMARY

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

| SUBMITTER INFORMATION | |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | CareFusion |
| Address | 1500 Waukegan Road MPWM, McGaw Park, IL 60085 USA |
| Phone number | [phone] |
| Fax number | [phone] |
| Establishment<br>Registration Number | 1423507 |
| | OCT 0 3 2013 |
| Name of contact person | Joy Greidanus |
| Date prepared | June 18, 2013 |
| 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: |
| Product Code(s) | TBD |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | CareFusion Inflatable Bone Tamps, K103064, K093463, K090211<br>Radiopaque Bone Cement, K043518 |
| Reason for 510(k)<br>submission | New 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<br>TO THE PREDICATE DEVICE | | |
|--------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------|
| Characteristic | New Device | Predicate |
| | | CareFusion Vertebral Balloon (K103064) |
| Balloon inflation<br>medium | 60% contrast recommended | 60% contrast recommended |
| Balloon and catheter<br>materials | Polyurethane | Polyurethane |
| Wire mandrel material | Stainless steel | Stainless steel |
| Balloon shape | Cylindrical | Cylindrical |
| Maximum<br>recommended inflation<br>pressure | 400 psi (27 ATM) | 400 psi (27 ATM) |
| Maximum<br>recommended inflation<br>volume | 4 mL - 8 mL | 4 mL - 6mL |
| PERFORMANCE DATA | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF<br>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 |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL<br>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
performance requirements, and is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is enclosed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

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

October 3, 2013

CareFusion Ms: Joy Greidanus Manager, Regulatory Affairs 75 North Fairway Drive Vernon Hills, Illinois 60061

Rc: K131824

Trade/Device Name: Intlatable Bone Tamp Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN. HRX Dated: August 28. 2013 Received: August 29, 2013

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 docs 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 - Ms. Joy Greidanus

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/dcfault.htm for the CDRI/'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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

## Erin lị Keith

for

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

Enclosure

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K131824

CareFusion - June 2013 - Traditional 510(k): Flexible Inflatable Bone Tamp System

Image /page/4/Picture/2 description: The image contains the logo for CareFusion. The logo consists of a circular graphic on the left and the word "CareFusion" on the right. The circular graphic appears to contain a stylized design, possibly representing a heart or a leaf.

1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.7404 FAX: [phone]

510(k) Number (if known):

Unknown at this time

Inflatable Bone Tamp

Device Name:

Indications For 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).

Prescription Use ____ (Per 21 CFR 801 Subpart D) ---------- (Per 21 CFR 807 Subpart C) And/Or Over-The Counter Use_ (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -S

(Division Sign-Off) Division of Orthopedie Devices 510(k) Number: K131824