KYPHON EXPRESS II INFLATABLE BONE TAMPS

K123771 · Medtronic · HRX · Dec 21, 2012 · Orthopedic

Device Facts

• Record ID: K123771
• Device Name: KYPHON EXPRESS II INFLATABLE BONE TAMPS
• Applicant: Medtronic
• Product Code: HRX · Orthopedic
• Decision Date: Dec 21, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KYPHON Xpander™ II Inflatable Bone Tamps and Kyphon® Express™ II Inflatable Bone Tamps are intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

Device Story

Inflatable bone tamp used for fracture reduction and void creation in cancellous bone; spine, hand, tibia, radius, calcaneus. Device consists of coaxial dual lumen shaft, Y-adapter for inflation syringe, and distal inflatable balloon. Radiopaque markers at balloon ends allow fluoroscopic visualization for positioning. Physician inflates balloon with contrast-media solution to create cavity; cavity may be filled with bone cement. Used in clinical/surgical settings. Benefits include controlled bone void creation and fracture reduction.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities, including tolerance analyses, confirmed device functionality.

Technological Characteristics

Coaxial dual lumen shaft; inflatable balloon at distal tip; Y-adapter for inflation/deflation. Radiopaque markers for fluoroscopic visualization. Manual operation via inflation syringe using contrast-media solution. Materials equivalent to predicate.

Indications for Use

Indicated for patients requiring fracture reduction or void creation in cancellous bone of the spine, hand, tibia, radius, or calcaneus. Includes use during balloon kyphoplasty with cleared PMMA-based bone cement.

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

• KYPHON Xpander™ II Inflatable Bone Tamp (K101864)

Submission Summary (Full Text)

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K12377

# Kyphon® Express™ II Inflatable Bone Tamp 510(k) Summarv December 6, 2012

DEC 2 1 2012

| I. Company: | Medtronic Sofamor Danek<br>1800 Pyramid Place<br>Memphis, TN 38132<br>Telephone: [phone]<br>FAX: [phone] |
|------------------------------|------------------------------------------------------------------------------------------------------------------------|
| II. Contact: | Hetal Jawahar Thakker<br>Senior Regulatory Affairs Specialist |
| III. Proprietary Trade Name: | Kyphon® Express™ II Inflatable Bone Tamp |
| IV. Common Name: | Inflatable Bone Tamp |
| V. Classification Name: | Arthroscope (21CFR888.1100)<br>Orthopedic Manual Surgical Instrument (21CFR 888.4540) |
| Class: | II |
| Product Code: | HRX, HXG |

#### VI. Product Description

The Kyphon® Express™ II Inflatable Bone Tamps are designed for reduction of fractures. The main components are a coaxial dual lumen shaft. Y .- Adapter with a port to connect the inflation syringe for inflation/deflation, and the inflatable balloon located at the distal tip.

### VII. Indications for Use

The KYPHON Xpander™ II Inflatable Bone Tamps and Kyphon® Express™ II Inflatable Bone Tamps are intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

#### VIII. Summary of Technological Characteristics

The fundamental scientific technology of the subject Kyphon® Express™ II Inflatable Bone Tamps is identical to the predicate KYPHON Xpander™ II Inflatable Bone Tamps.

Both the subject Kyphon® Express™ II Inflatable Bone Tamps and predicate KYPHON Xpander™ II Inflatable Bone Tamps consist of shaft, Y-Adapter and the inflatable balloon located at the distal tip. The Inflatable Bone Tamp is connected to an inflation syringe in order to inflate/deflate the balloon. Two radiopaque markers located at the distal and proximal end of the deflated balloon allow fluoroscopic visualization of the IBT during positioning prior to inflation. Once positioned, the balloon is inflated with contrast-media solution to create a cavity in the vertebral body, which may be subsequently filled with bone cement.

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# IX. Identification of the Legally Marketed Predicate Device Used to Claim Substantial Equivalence

In order to demonstrate substantial equivalence to legally marketed predicate devices, KYPHON Xpander™ II Inflatable Bone Tamp (K101864, SE Oct 14, 2010) is used as the predicate for the Kyphon® Express™ II Inflatable Bone Tamps.

# X. Brief Discussion of the Non-Clinical Tests Submitted

Assessment of the device modifications have been completed in accordance with Medtronic design control processes. The Kyphon® Express™ II Inflatable Bone Tamps have the same design characteristics, packaging, use the same sterilization process, and are made of equivalent materials as the predicate KYPHON Xpander™ II Inflatable Bone Tamps. Mechanical testing and other verification/validation activities, including tolerance analyses were conducted to confirm that the modified device functions as intended and does not raise any new issues of safety or effectiveness.

# XI. Conclusions Drawn from the Non-Clinical Tests

The subject and predicate Inflatable Bone Tamps are identical in terms of indications for use, intended use, performance specifications, and fundamental technological characteristics. A risk analysis and associated verification/validation testing was completed for the device modifications. Based on the risk analysis and additional supporting documentation provided in this premarket notification. Medtronic believes the subject Kyphon® Express™ II Inflatable Bone Tamps to be substantially equivalent to the legally marketed predicate KYPHON Xpander™ II Inflatable Bone Tamps.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

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

Medtronic % Medtronic Spine, LLC Hetal Jawahar Thakker Senior Regulatory Affairs Specialist 1221 Crossman Avenue Sunnyvale, California 94089

Re: K123771

Trade/Device Name: Kyphon® Express™ II Inflatable Bone Tamps Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HXG, NDN Dated: December 6, 2012 Received: December 7, 2012

Dear Hetal Jawahar Thakker:

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

December 21, 2012

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## Page 2 - Hetal Jawahar Thakker

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 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.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 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,

# Peter D. Rumm -S

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

Enclosure

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510(k) Number (if known):

Device Name: Kyphon® Express™ II Inflatable Bone Tamps

Indications for Use:

The KYPHON Xpander™ II Inflatable Bone Tamps and Kyphon® Express™ II Inflatable Bone Tamps are intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division of Orthopedic Devices : iu(k) Number_ 1237