IVAS 2-10MM (10 GUAGE) BALLON CATHETER

K103807 · Stryker Corporation · NDN · Jun 28, 2011 · Orthopedic

Device Facts

• Record ID: K103807
• Device Name: IVAS 2-10MM (10 GUAGE) BALLON CATHETER
• Applicant: Stryker Corporation
• Product Code: NDN · Orthopedic
• Decision Date: Jun 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker® iVAS Inflatable Vertebral Augmentation System (system) is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

Device Story

Stryker iVAS balloon catheter is an inflatable bone tamp; distal end features inflatable balloon. Device inserted percutaneously into vertebral body; balloon inflated to create void in cancellous bone or reduce fractures. Used during percutaneous vertebral augmentation procedures (e.g., kyphoplasty). Operated by physicians in clinical settings. System requires use with cleared spinal PMMA bone cements. Output is mechanical void creation; facilitates subsequent cement delivery. Benefits include fracture reduction and stabilization of vertebral body.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing only, including functional testing (insertion/retraction force, force to puncture, burst, simulated use) and biocompatibility testing per ISO-10993.

Technological Characteristics

Inflatable bone tamp with distal balloon component. Materials are biocompatible per ISO-10993. Device is a mechanical instrument for percutaneous use. No software or electronic components described.

Indications for Use

Indicated for patients requiring reduction of spinal fractures or creation of a void in cancellous bone during percutaneous vertebral augmentation procedures. Used in conjunction with cleared spinal PMMA bone cements.

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

• Stryker® iVAS Balloon Catheter (K093419)
• Kyphx Xpander Inflatable Bone Tamps (K041454)

Submission Summary (Full Text)

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K103807

l of 2

4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 ff: 269 324 5412
www.stryker.com

JUN 2 8 2011

## stryker

్రామ్నా

Instruments

| 510(k) Summary | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>(p) 269-323-7700<br>(f) 269-324-5412 |
| Contact Person: | Melissa Kann |
| Registration No.: | 1811755 |
| Trade Name: | Stryker® iVAS Balloon Catheter |
| Common Name: | Inflatable Bone Tamp |
| Classification Name: | Arthroscope<br>Cement, Bone, Vertebroplasty |
| Regulation Number: | §888.1100<br>§888.3027 |
| Product Code: | HRX<br>NDN |
| Predicate Device: | Stryker® iVAS Balloon Catheter (K093419)<br>Kyphx Xpander Inflatable Bone Tamps (K041454) |
| Device Description: | The Stryker® iVAS balloon catheter is a bone tamp with an inflatable component<br>(balloon) at the distal end. The balloon is inflated to create a void within the<br>vertebral body. |
| Indications for Use: | The Stryker® iVAS Inflatable Vertebral Augmentation System (system) is<br>intended to be used for the reduction of fractures and/or creation of a void in<br>cancellous bone in the spine. This includes use during percutaneous vertebral<br>augmentation. The system is to be used with cleared spinal<br>Polymethylmethacrylate (PMMA) bone cements indicated for use during<br>percutaneous vertebral augmentation procedures, such as kyphoplasty |
| Testing: | The Stryker® iVAS balloon catheter meets the specification and performance<br>characteristics and are substantially equivalent to the predicate devices. The<br>testing which was conducted included functional testing, such as insertion and<br>retraction force, force to puncture, burst and simulated use. |
| Biocompatibility: | Biocompatibility testing of the Stryker® iVAS balloon catheter confirmed that the<br>device meets the applicable requirements of the FDA Blue Book Memorandum<br>G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of<br>Medical Devices Part -1: Evaluation and Testing and are biocompatible. |

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Instruments

Substantial Equivalence (SE) Rational:

The Stryker® IVAS balloon catheter is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the Stryker® iVAS Balloon Catheter and the Kyphx Xpander Inflatable Bone Tamp. The products have the same fundamental scientific technology, basic design, functional characteristics and the same clinical applications.

Safety and Effectiveness:

The Stryker® iVAS balloon catheter does not raise any new safety and efficacy concerns when compared to a similar device already legally marketed. Therefore, the Stryker® iVAS balloon catheter is equivalent to the existing predicate devices.

Submitted by:

Melissa Kann Regulatory Affairs Supervisor

10-June-2011

eussa kanu
Signature

Signature

Date Submitted:

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

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

Stryker Corporation % Ms. Melissa Kann Regulatory Affairs Supervisor 4100 E. Milham Ave Kalamazoo, Michigan 49001

JUN 2 8 2011

Re: K103807

Trade Name: iVAS 2-10mm (10 Gauge) Balloon Catheter Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: June 06, 2011 Received: June 08, 2011

Dear Ms. Kann:

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

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Page 2 - Ms. Melissa Kann

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 forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

E.L. Keith

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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510(K) Number (if known):

Device Name: Stryker Inflatable Vertebral Augmentation System (iVAS)

## Indications for Use

The Stryker® iVAS Inflatable Vertebral Augmentation System (system) is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

Prescription Use _ X _________________________________________________________________________________________________________________________________________________________

and/or

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103807