INFLATABLE BONE TAMP

K090211 · Cardinal Health, Inc. · NDN · Jul 1, 2009 · Orthopedic

Device Facts

• Record ID: K090211
• Device Name: INFLATABLE BONE TAMP
• Applicant: Cardinal Health, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Jul 1, 2009
• 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 Cardinal Health Radiopaque Bone Cement).

Device Story

Inflatable Bone Tamp (IBT) used in balloon kyphoplasty; designed to create cavity in vertebral body to reduce fracture and prevent cement leakage while allowing cement interdigitation. Device consists of balloon catheter and wire stiffener; wire stiffener provides stiffness to facilitate insertion through access cannula. Physician inflates balloon at distal end of catheter to create cavity. Used in clinical setting by physicians. Output is mechanical cavity creation within cancellous bone; facilitates subsequent bone cement delivery. Benefits include fracture reduction and controlled cement placement.

Clinical Evidence

Bench testing only. Materials evaluated per ISO 10993 Part-1. Performance testing demonstrated functional equivalence to predicate devices.

Technological Characteristics

Balloon catheter with wire stiffener. Materials evaluated per ISO 10993-1. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring reduction and fixation of fractures in cancellous bone in the spine via kyphoplasty. Used in conjunction with Cardinal Health Radiopaque Bone Cement.

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

Submission Summary (Full Text)

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K090211

CardinalHealt McGaw Park, Illinois 60085-6787 AX: 847.785.2506

JUL - 1 2009

## SMDA REQUIREMENTS

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

Sponsor:

Cardinal Health 1430 Waukegan Road MPKB McGaw Park, IL 60085

Regulatory Affairs: Contact

Telephone:

Date Summary Prepared:

Common Name:

Regulation Description:

Device Class and Regulation Number:

Predicate Devices:

## Description:

Sharon Nichols

[phone]

January 2009

Inflatable Bone Tamp

Primary - Arthroscope Secondary - Cement, bone, vertebroplasty

Class II per 21CFR §888.1100, Procode HRX: Class II per 21CFR §888.3027, Procode NDN:

Kyphx Inflatable Bone Tamp, K041454, K981251 Radiopaque Bone Cement, K043518

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,

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Intended Use:

Summary of Technological Characteristics:

Summary of testing:

Non-Clinical Testing:

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 Cardinal Health 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 tested 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.

000036

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JUL -- 1 2009.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardinal Health % Ms. Sharon Nichols 1430 Waukegan Road MPKB-3B McGaw Park, Illinois 60085

Re: K090211

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: May 29, 2009 Received: June 3, 2009

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.

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/cdrh/comp/ 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.gov/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Barbarafneum

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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CardinalHealt

Cardinal Health 1430 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 K0902 ||

Inflatable Bone Tamp

Intended for the reduction and fixation of fractures in cancellous bone in the spine for kyphoplasty (for use with Cardinal Health 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)

or

Concurrence of CDRH, Office of Device Evaluation (ODE)

*(Division Sign-Off)*

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090211

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