AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020

K093463 · Care Fusion · NDN · Feb 26, 2010 · Orthopedic

Device Facts

• Record ID: K093463
• Device Name: AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
• Applicant: Care Fusion
• Product Code: NDN · Orthopedic
• Decision Date: Feb 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Inflatable Bone Tamp (IBT) is a balloon catheter system used in balloon kyphoplasty. The device consists of a balloon at the distal end of a catheter and a wire stiffener to facilitate insertion through an access cannula. The physician inserts the catheter into the vertebral body; the balloon is then inflated to create a cavity and reduce the fracture. This process prepares the site for the subsequent injection of bone cement, which is intended to stabilize the fracture while minimizing leakage. The device is used in a clinical setting by a physician. The primary benefit is the creation of a controlled cavity for cement interdigitation, aiding in spinal fracture fixation.

Clinical Evidence

Bench testing only. Performance testing demonstrated functional equivalence to predicate devices. Materials were evaluated for biological safety per ISO 10993-1.

Technological Characteristics

Balloon catheter system with wire stiffener. Materials evaluated per ISO 10993-1. Functional principle: mechanical inflation of a balloon to create a cavity in cancellous bone. Intended for use with Radiopaque Bone Cement.

Indications for Use

Indicated for patients requiring reduction and fixation of fractures in cancellous bone in the spine for kyphoplasty procedures.

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

• Kyphx Inflatable Bone Tamp (K090211)
• K041454
• K981251
• Radiopaque Bone Cement (K043518)

Submission Summary (Full Text)

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K0934663-

Image /page/0/Picture/1 description: The image shows the logo for CareFusion. The logo consists of a stylized letter C inside of a shield on the left, and the word "CareFusion" in bold sans-serif font on the right. The logo is black and white.

FEB 2 S 2010

CareFusion 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847,578 6610 FAX: [phone]

## SMDA REQUIREMENTS

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Inflatable Bone Tamp

CareFusion Sponsor: 1500 Waukegan Road MPWM McGaw Park, IL 60085 Regulatory Affairs: Contact Sharon Nichols Telephone: [phone] Date Summary Prepared: November 2009 Common Name: Inflatable Bone Tamp Regulation Description: Primary - Arthroscope Secondary - Cement, bone, vertebroplasty Device Class and Class II per 21CFR §888.1100, Procode Regulation Number: HRX: Class II per 21CFR §888.3027, Procode NDN: Cardinal Health Inflatable Bone Tamp, Predicate Devices: K090211 Kyphx Inflatable Bone Tamp, K041454, K981251 Radiopaque Bone Cement, K043518

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Description:

Intended Use:

Characteristics:

Summary of Technological

The Inflatable Bone Tamp (IBT) was designed for use in Balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture and preventing cement leakage, 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. The wire stiffener provides stiffness to the balloon catheter to facilitate insertion through the access cannula

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

The proposed device and the predicate devices are composed of the same or similar design, materials and manufacturing characteristics.

All materials used in the fabrication of the Inflatable Bone Tamp were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". These materials also were evaluated in accordance with industry recognized test methods and were found to be acceptable for the intended use.

Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed predicate devices with regard to functional characteristics.

Non-Clinical Testing:

Summary of testing:

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

CareFusion % Ms. Sharon Nichols Regulatory Affairs Manager 1500 Waukegan Road McGaw Park, Illinois 60085

FEB 2 3 2010

Re: K093463

Trade/Device Name: Inflatable Bone Tamp Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, HRX Dated: February 3, 2010 Received: February 4, 2010

Dear Ms. Nichols:

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 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.

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Page 2 - Ms. Sharon Nichols

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.goy/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 Small Manufacturers, International and Consumer Assistance 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,

Arbane buchn

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for CareFusion. The logo consists of a circular icon on the left and the word "CareFusion" on the right. The icon appears to be a stylized shield or emblem with a checkmark-like shape inside. The text "CareFusion" is in a bold, sans-serif font.

CareFusion 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 FAX: [phone]

## Indication for Use

510(k) Number (if known):

Device Name:

Indications For Use:

unknown at this time

Inflatable Bone Tamp

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

Prescription Use X

Over-The Counter Use

(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)

OF

Concurrence of CDRH, Office of Device Evaluation (ODE)

thull D. FOR M. MELKERSON

(Division Sign-Off) (Øivision Sign-Childer, Ørthopedic, Division of Surgices Division of Sale
and Restorative Devices

510(k) Number K093

000028