IVAS BALLOON CATHETER

K113154 · Stryker Corporation · NDN · Jan 24, 2012 · Orthopedic

Device Facts

• Record ID: K113154
• Device Name: IVAS BALLOON CATHETER
• Applicant: Stryker Corporation
• Product Code: NDN · Orthopedic
• Decision Date: Jan 24, 2012
• 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 Polymethylmethacrylate (PMMA) bone cements and Cortoss® Bone Augmentation Material indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

Device Story

Stryker iVAS is an inflatable bone tamp used in percutaneous vertebral augmentation. Device consists of a catheter with an inflatable balloon at the distal end. Operated by physicians in clinical settings; balloon is inserted into the vertebral body and inflated to create a void in cancellous bone or reduce fractures. Following void creation, the balloon is deflated and removed, allowing for the subsequent injection of cleared bone cement (PMMA or Cortoss). Procedure facilitates stabilization of vertebral fractures. Device is a mechanical instrument; no electronic or software components.

Clinical Evidence

Bench testing only. Testing included functional performance evaluations: insertion and retraction force, force to puncture, burst testing, and simulated use. Biocompatibility testing confirmed compliance with ISO 10993-1 requirements.

Technological Characteristics

Inflatable bone tamp consisting of a catheter with a distal balloon. Materials confirmed biocompatible per ISO 10993-1. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring percutaneous vertebral augmentation for fracture reduction or void creation in spinal cancellous bone. Used in conjunction with cleared spinal PMMA bone cements or Cortoss® Bone Augmentation Material for procedures such as kyphoplasty.

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 (K103807)
• Stryker® iVAS Balloon Catheter (K093419)
• Kyphx Xpander Inflatable Bone Tamps (K041454)

Submission Summary (Full Text)

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

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## JAN 2 4 2012

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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: | Meghan Arreaza |
| 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 (K103807)<br>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 and Cortoss® Bone<br>Augmentation Material indicated for use during percutaneous vertebral<br>augmentation procedures, such as kyphoplasty. |
| Testing | The Stryker® iVAS balloon catheter meets the specification and performance<br>characteristics and is 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 stimulated 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 of Testing and is 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 previously cleared Stryker® iVAS balloon catheters and the Kyphx Xpander Bone Tamps. The products have the same functional 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 devices already legally marketed. Therefore, the Stryker® iVAS balloon catheter is equivalent to the existing devices.

Submitted by:

Meghan Arreaza

21 Oct 2011

Regulatory Affairs Representative

Mlykm Aulaja

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Signature

Date Submitted:

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

Styker Instruments % Ms. Meghan Arreaza Regulatory Affairs Representative 4100 East Milham Avenue Kalamazoo, Michigan 49001

JAN 2 4 2012

Re: K113154

Trade/Device Name: Stryker Inflatable Vertebral Augmentation System (IVAS) Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: October 21, 2011 Received: October 26, 2011

Dear Ms. Arreaza:

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

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Page 2 - Ms. Meghan Arreaza

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/Resourcesfor You/Industry/default.htm.

Sincerely vours,

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Mark N. Me 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 The Ourylore NAO Innatable tress 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 Polymethylmethacrylate (PMMA) bone cements and Cortoss® Bone Android opinal - el indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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)

Signature (Sign Off)

(Division Sign-Off) (DWision Sign-Only)
Division of Surgical, Orthopedic, Division of Surges and Restorative Devices

510(k) Number K113154