VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS

K120867 · Medos International SARL · OLO · Sep 20, 2012 · Neurology

Device Facts

• Record ID: K120867
• Device Name: VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
• Applicant: Medos International SARL
• Product Code: OLO · Neurology
• Decision Date: Sep 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The VIPER® and EXPEDIUM® navigated instruments are image guided surgical instruments for use in the implantation of VIPER® and EXPEDIUM® pedicle screws in an open or percutaneous approach. The navigated instruments are designed for use only with Brainlab Image Guided Surgery hardware and software. The navigated instruments are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, where the use of the VIPER® and/or EXPEDIUM® Spine Systems is indicated and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

Device Story

Navigated surgical instruments (awls, probes, taps, screwdrivers, Jamshidi needles) modified for integration with Brainlab Image Guided Surgery (IGS) systems. Instruments feature tracking arrays (passive markers) on handles or shafts; tracked by Brainlab IGS hardware/software to map instrument position to patient preoperative/intraoperative 2D/3D image data. Used in OR by surgeons to guide pedicle screw implantation. Provides real-time visual feedback of instrument trajectory relative to patient anatomy on IGS display; assists in accurate screw placement; reduces reliance on continuous fluoroscopy. Benefits include improved surgical precision and potentially reduced radiation exposure.

Clinical Evidence

Bench testing only. Verification and validation of instrument integration into Brainlab Navigation Software performed.

Technological Characteristics

Materials: Stainless steels (630, 431, 301, 303, 316, 17-4PH, 455, 465, 18-8, 420), Silicone Elastosil R 401/80, Radel®, titanium nitride, aluminum 6061-T6. Passive optical tracking via marker arrays. Non-sterile, reusable. Compatible with Brainlab navigation software versions (VectorVision Spine 5.5/5.6, Kolibri Spine 2.0, VectorVision Trauma 2.6, VectorVision Fluoro3D 1.6/2.0, Spine & Trauma iCT 1.0, Trauma 3.0, Spine & Trauma 3D 2.0).

Indications for Use

Indicated for patients requiring pedicle screw implantation via open or percutaneous approach where stereotactic surgery is appropriate and rigid anatomical structures (pelvis/vertebra) can be referenced against CT, MR, or fluoroscopic image data.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Brainlab VectorVision Fluoro 3D system (K070106)

Submission Summary (Full Text)

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120867

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| A. | Submitter Information | |
|----|------------------------------------------------|-----------------------------------------------------------------------------------|
| | Manufacturer: | Medos International, Sárl<br>Chemin-Blanc 38<br>Le Locle, CH-NE 2400, Switzerland |
| | Submitter: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 |
| | Contact Person: | Laura Bleyendaal<br>325 Paramount Drive<br>Raynham, MA 02767 |
| | Telephone number: | [phone] |
| | Fax number: | [phone] |
| | Email: | [e-mail] |
| B. | Date Prepared | May 2012 |
| C. | Device Name | |
| | Trade/Proprietary Name: | VIPER® and EXPEDIUM® navigated<br>instruments |
| | Common/Usual Name: | Stereotaxic Instrument |
| | Device Classification<br>and Regulatory Class: | Class II, per 21 CFR § 882.4560 |
| | Device Product and Panel<br>Code: | OLO; Orthopedic |

## D. Predicate Device Name

510(K) SUMMARY

Brainlab VectorVision Fluoro 3D system (K070106) Trade name:

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#### E. Device Description

The VIPER® and EXPEDIUM® navigated instruments are surgical instruments, for use in the implantation of VIPER® and EXPEDIUM® pedicle screws, which have been modified for use with Brainlab image guided surgery (IGS) hardware and software. The navigated instrument shafts mate with modified handles containing tracking arrays with Brainlab proprietary designs, or contain a dedicated interface for receiving a Brainlab owned tracking array. The passive tracking arrays cnable the VIPER® and EXPEDIUM® navigated instruments to be tracked by the Brainlab system to virtual computer image space on a patient's preoperative or intra-operative 2D or 3D image data.

#### F. Indications for Use

The VIPER® and EXPEDIUM® navigated instruments are image guided surgical instruments for use in the implantation of VIPER® and EXPEDIUM® pedicle screws in an open or percutaneous approach. The navigated instruments are designed for use only with Brainlab Image Guided Surgery hardware and software. The navigated instruments are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, where the use of the VIPER® and/or EXPEDIUM® Spine Systems is indicated and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

MEDOS International, Sárl

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G. Summary of Similarities and Differences in Technological Characteristics, Performance and Indications for Use

| | G. Summary of Similarities and Differences in Technological Characteristics, Performance and Indications for Use | Predicate Brainlab VectorVision Fluoro 3D system (K070106) |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | VIPER® and EXPEDIUM® navigated instruments<br>The VIPER® and EXPEDIUM® navigated instruments are image guided surgical instruments for use in the implantation of VIPER® and EXPEDIUM® pedicle screws in an open or percutaneous approach. The navigated instruments are designed for use only with Brainlab Image Guided Surgery hardware and software. The navigated instruments are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, where the use of the VIPER® and/or EXPEDIUM® Spine Systems is indicated and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. | Brainlab VectorVision fluoro3D is intended as an intra-operative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intra-operative 2D or 3D image data. VectorVision fluoro3D enables computer-assisted navigation of medical image data which can either be acquired preoperatively or intra-operatively by an appropriate image acquisition system. The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and individually-calibrated surgical tools. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. |
| Passive<br>Marker/ Array | Yes; same tracking arrays as predicate instruments | Yes |
| Instruments | Awls, Probes, Taps, Screwdrivers and Jamshidi Needle | Awls, Probes, Chisels and Drill Guide with Trocar Insert |
| Sterility | Non-sterile | Non-sterile |
| Computer Aided | Yes | Yes |
| Reusable | Yes | Yes |
| Compatible Brainlab Navigation Software | Navigation Software VectorVision Spine (Version 5.5 and 5.6)<br>Navigation Software Kolibri Spine (Version 2.0)<br>Navigation Software VectorVision Trauma (Version 2.6)<br>Navigation Software VectorVision Fluoro3D (Version 1.6 and 2.0)<br>Navigation Software Spine & Trauma iCT (Version 1.0)<br>Navigation Software Trauma (Version 3.0)<br>Navigation Software Spine & Trauma 3D (Version 2.0) | Navigation Software VectorVision Spine (Version 5.5 and 5.6)<br>Navigation Software Kolibri Spine (Version 2.0)<br>Navigation Software VectorVision Trauma (Version 2.6)<br>Navigation Software VectorVision Fluoro3D (Version 1.6 and 2.0)<br>Navigation Software Spine & Trauma iCT (Version 1.0)<br>Navigation Software Trauma (Version 3.0)<br>Navigation Software Spine & Trauma 3D (Version 2.0) |

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### H. Materials

The VIPER® and EXPEDIUM® navigation handles are manufactured from stainless steels 630, 431, 301, 303, 316, Silicone Elastosil R 401/80, Radel® and titanium nitride. The navigated instrument shafts are manufactured from stainless steels 17-4PH, custom 455, custom 465, 18-8, 316, 316L, 420, and aluminum 6061-T6.

## Performance Data I.

Verification and validation of the VIPER® and EXPEDIUM® navigated instruments integration into the Brainlab Navigation Software was performed.

## J. Conclusion

The VIPER® and EXPEDIUM® navigated instruments intended use, principles of operation and technological characteristics are substantially equivalent to those of the predicate Brainlab instruments.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

SEP 20 2012

Medos International Sarl % Johnson and Johnson (Depuy Spine) Ms. Laura Bleynedaal Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

Re: K120867

Trade/Device Name: VIPER® and EXPEDIUM® navigated instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HAW Dated: September 04, 2012 Received: September 05, 2012

Dear Ms. Bleynedaal:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreated 776 the enactment date of the Medical Device Amendments, or to Commerce prior to May 20, 1978, tive excordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic rece (110) that to her subject to the general controls provisions of the Act. The T ou may, therefore, manel as act include requirements for annual registration, listing of general controls provision gractice, labeling, and prohibitions against misbranding and devices, good manufacturing particles, not evaluate information related to contract liability adultieration. Trease note: ODFET assess and 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 If your device is classified (see above) into the major regulations affecting your device can be may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may found in the Oods of I casial 115 concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination ante of the Att Please be auvised that FDA s issuation of a coloride with other requirements of the Act
that FDA has made a determination that your device complies with other requirements of that FDA has made a determination that Jour acceral agencies. You must of any Federal statures and regulations as annuality of the registration and listing (21

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# Page 2 - Ms. Laura Bleynedaal

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.

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,

Lia 9

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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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K120867

Device Name: VIPER® and EXPEDIUM® navigated instruments

Indications For Use:

The VIPER® and EXPEDIUM® navigated instruments are image guided surgical instruments for use in the implantation of VIPER® and EXPEDIUM® pedicle screws in an open or percutaneous approach. The navigated instruments are designed for use only with Brainlab Image Guided Surgery hardware and software. The navigated instruments are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, where the use of the VIPER® and/or EXPEDIUM® Spine Systems is indicated and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR § 801 Subpart D)

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(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)

Nel R.P. Ryder fir hxm

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number