ISYS 1 (U.S),ACCESSORY, NON-STERILE

K131433 · Isys Medizintechnik GmbH · JAK · Mar 11, 2014 · Radiology

Device Facts

• Record ID: K131433
• Device Name: ISYS 1 (U.S),ACCESSORY, NON-STERILE
• Applicant: Isys Medizintechnik GmbH
• Product Code: JAK · Radiology
• Decision Date: Mar 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The iSYS 1 device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the surgeon in the positioning of a needle or electrode where both computed tomography (CT) and fluoroscopic imaging can be used for target trajectory planning and intraoperative tracking. The needle or electrode is then manually advanced by the surgeon. Trajectory planning is made with software that is not part of the iSYS device.

Device Story

iSYS 1 is a modular, 4-DOF electromechanical robotic arm for interventional radiology. It functions as a remote-operated needle/electrode guidance platform. Input consists of trajectory planning data generated by external third-party navigation or imaging software (CT, cone-beam CT, fluoroscopy). The device uses fiducial markers for registration and localization within the imaging field. The system is mounted to the CT table or side rail via adapters. A physician operates the device via a cable-connected handheld control unit to position the needle guide. The device provides mechanical guidance for the needle, which the surgeon then manually advances. It is used in clinical settings to assist in procedures such as biopsies or fluid drainage. Benefits include precise, remote-controlled needle positioning and orientation, reducing manual effort and improving localization safety compared to traditional methods.

Clinical Evidence

Bench testing only. Testing included electrical and mechanical safety (EN 60601-1, EN 60601-1-8, ISO 60601-1-2), electromagnetic compatibility (FCC Part 15), and performance validation. Performance tests verified needle placement accuracy under clinical conditions, imaging modality compatibility, artifact production, mechanical stability under payload, and alarm system effectiveness. Accuracy was validated using Philips Allura Xper Guide FD 20 and Siemens Axiom Artis Zeego systems.

Technological Characteristics

4-DOF electromechanical arm; materials include metal, electronics, Polyamide, Polyethylene, and Prolen. Powered (115VAC/230VAC). Connectivity via cable-connected control unit. Mechanical accuracy < 1 mm. Fiducial marker-based registration. Sterile covers used for patient contact. Complies with IEC/EN 60601-1 and ISO 60601-1-2.

Indications for Use

Indicated for use by trained physicians to assist in the positioning of a needle or electrode during interventional procedures, utilizing CT or fluoroscopic imaging for trajectory planning and intraoperative tracking.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• PinPoint (K974513)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of several curved lines.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Decument Control Center - WO66-6608 Silver Spring, MD 20993-0002

March 11, 2014

iSYS Medizintechnik GmbH c/o Mrs. Cornelia Damsky 56 Wesicon Road Stamford. CT 06902

Re: K131433

Trade/Device Name: iSYS I · Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Date: February 11, 2014

Dear Mrs. Damsky:

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 accordunce 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 cither 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 complics 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 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 331-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mrs. Cornelia Damsky

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

### Joyce M. Whang -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

d

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K131433

Device Name isys 1

Indications for Use (Describe)

The ISYS I device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the surgeon in the positioning of a needle or electrode where both computed tomography (CT) and fluoroscopic imaging cony planning and intraoperative tracking. The needle or electrode is the surgeon. Trajectory planning is made with software that is not part of the iSYS device.

Type of Use (Select one or both, as applicable)

🇿 Prescription Use (Part 21 CFR 801 Subpart D)

[] Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Joyce M. Whang -S

FORM FDA 3881 (1/14)

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| Section |
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| 005 |

Image /page/4/Picture/2 description: The image shows a logo for iSYS Medizintechnik GmbH. The logo features the letters "SYS" in a stylized font, with the word "Medizintechnik" written below it in a smaller font. The letters are underlined with a curved line. The letters "GmbH" are written below the word "Medizintechnik".

### 510(k) SUMMARY

| 1. | Applicant: | iSYS Medizintechnik GmbH |
|-----|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Address: | Bergwerksweg 21<br>6370 Kitzbühel / Austria |
| 3. | Contact Person: | Dr. Michael Vogele<br>Tel. [phone] |
| 4. | Preparation Date: | January 20, 2014 |
| 5. | Device Submitted: | iSYS 1 (U.S.) |
| 6. | Proprietary Name: | iSYS 1 (U.S.) |
| 7. | Common Name: | Robotic Positioning Unit |
| 8. | Classification Name: | System, X-ray, Tomography, computed<br>Product Code JAK, MAXX, Reg.No. 892.1750 |
| 9. | Substantial Equivalence: | The iSYS 1 is substantially equivalent to the following<br>legally marketed devices:<br>PinPoint manufactured by Philips Medical.<br><br>The characteristics of this device are similar to those of<br>the predicate devices identified on the comparison<br>chart, which follows. It is our opinion that the iSYS 1<br>does not have technological characteristics that raise<br>additional types of questions related to terms of safety<br>and effectiveness. |
| 10. | Device Description: | The iSYS 1 is a modular needle guidance platform for<br>interventional radiology and related fields. Core<br>components are a 4 DOF micro positioning unit which<br>allows the submillimetric needle positioning from<br>simple needle angulations up to positioning and<br>angulations with adjustable pivot point and a control<br>unit which is directed by a cable connected control<br>panel. The passive macro positioning unit and different<br>table adapters allow different setups of the system<br>around the patient in the region of interest. The needle-<br>guide-kit (manufactured by ECOLAB) provides<br>disposable components that ensure precise and sterile<br>needle guidance.<br><br>Planning of the tool position/orientation as well as<br>validation of the correctness of the tool position must<br>be performed with an external planning and<br>measurement system which is not part of the iSYS-1<br>Interventional Platform. The position of iSYS 1 is<br>visible for most imaging systems due to the used<br>markers. During treatment the tool is controlled by the |

| | | ------------------<br>-------------<br>---------------------------------- | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------|
| | ----------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1 | | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | with county county and parts and<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | <br>------------------- | | ------------------------------------- |

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| Section<br>005 | | 510k Summary<br>510(k) Number: K131433<br>Image: [logo] |
|----------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 11. | Intended Use: | user.<br>The intended use of the iSYS1 device is to function as a remote-operated positioning and guidance system during interventional procedures. Positioning is done in remote control manner; planning of the position/angulation is done based on 2D/3D patient data (CT, cone-beam CT, fluoroscopy) by external planning software - for example using an external navigation system, or planning software coming with the used imaging device. Also verification of the correct position and orientation of the tool prior to/during/after the intervention is done by means of these external devices. The iSYS1-System is then acting as a guideway during the manual insertion of the interventional tool - usually a needle type device, and the like. |
| 12. | Indications for Use | The iSYS 1 device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the surgeon in the positioning of a needle or electrode where both computed tomography (CT) and fluoroscopic imaging can be used for target trajectory planning and intraoperative tracking. The needle or electrode is then manually advanced by the surgeon. Trajectory planning is made with software that is not part of the iSYS device |
| 13. | Clinical Use | The Side Rail Adapter is attached to the side rail for the setup; the Table Top Adapter is attached directly onto the CT table. Both Adapters are equipped with a "starburst" connector, to which the Multifunctional Arm (MFA) can be attached. The MFA is equipped with one "starburst" connector at the bottom and one "spoon" connector at the top. The "spoon" connector has its counterpart on the Robotic Positioning Unit for the setup. The Control Unit is attached directly to the side rail. The Robotic Positioning Unit is connected by a cable to the Control Unit, which has cable connections to both the electric power supply and to a Handheld Control Unit. The Needle Guide Extensions are screw-fixed onto the Robotic Positioning Modules. The Sterile Cover is directly fixed onto the Needle Guide Joints and can be drawn over the robotic parts. The Needle Insert is placed into the appropriate connector of the Needle Guide, to prepare needle usage. The Handheld Control Unit can be clamped onto the side rail and covered with a drape. Planning of the tool position/orientation as well as validation of the correctness of the tool position must be performed with an external planning and measurement system |

| Doc No: PD_75_11535 | Revision 06 from: 10.03.2014 | 2/9 | | |
|---------------------|------------------------------|----------------|------------|----------------|
| Created by: | Approved by: | Invalid since: | Source: | Approval Date: |
| Oliver Spitz | Dr. Michael Vogele | | FO_42_1996 | 06.06.2011 |

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| Section<br>005 | 510k Summary<br>510(k) Number: K131433 | Image: SYS Medizintechnik GmbH logo |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| 14. Biocompatibility: | (imaging or navigation software).<br>The iSYS 1 is not in contact with patient. At any time when in use a sterile cover sheet is to be placed between the patient and the system. Additionally there are no new materials introduced in the manufacture of the iSYS 1. Therefore, no biocompatibility studies were performed for this device. | |
| 15. Performance Data: | Operating temperature/humidity range: 15 to 30°C; 30 to 70% relative humidity with no condensation<br><br>Storage temperature/humidity range: 10 to 50°C; 30 to 70% relative humidity with no condensation<br><br>Power Supply: 50W; 115VAC/230VAC; 50-60Hz; cable: C14 according to IEC/EN 60320-1, US498, CSA C22.2 no. 42;<br><br>Sterilization of the sterile accessories has been validated by Bioseal and Preferred Medical, the companies responsible for packaging and sterilizing the iSYS accessories.<br><br>The accuracy of the intervention depends on the resolution and capabilities of the imaging device or software. The mechanical accuracy of iSYS1 is below 1 mm, but that gives no accuracy value for treatments | |

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

| Doc No: PD_75_11535 | Revision 06 from: 10.03.2014 | | | 3/9 |
|---------------------|------------------------------|----------------|------------|----------------|
| Created by: | Approved by: | Invalid since: | Source: | Approval Date: |
| Oliver Spitz | Dr. Michael Vogele | | FO_42_1996 | 06.06.2011 |

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### Device Comparison Summary:

| Reference | PinPoint | iSYS 1 (for new submission) | Equivalence ? |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------|
| 510k-Number | K974513 | K131433 | |
| Manufacturer | PHILIPS MEDICAL SYSTEMS<br>(CLEVELAND), INC.<br>595 Miner rd.<br>Cleveland, OH 44143<br>USA | iSYS Medizintechnik<br>GmbH<br>Bergwerksweg 21<br>A-6370 Kitzbuehel<br>Austria | |
| Design | | | |
| General device description | Five jointed, position-sensing stereotactic arm, mounted on the CT gantry, and indicated for invasive procedures | Computer controlled electromechanical multi-joined arm indicated for invasive procedures | Yes |
| Localization means | Robot arm absolute encoders | Fiducial markers on tool holder. | *3) |
| Image-guided | Yes | Yes | Yes |
| Planning software | No, not cleared under this 510k (K955268) | No (third party) | Yes |
| Registration method | During installation | Fiducial markers | *4) |
| Instrumentation | Cannula<br>Laser needle guide | Marker<br>Tool Holder<br>Sterile Covers<br>(third party) | Yes |
| Instrument fixation | Cannula attached to the arm (optional: laser needle guidance) | Special tool holders for several applications mounted to the Robot | Yes |
| Instrument calibration | Factory Calibration<br>Optional: intra operative | Intra operative | *1) |
| System immobilization between patient and device | Yes | Yes | Yes |
| Planning and Navigation Software | | | |
| N/A. | | | |
| System Operation | | | |
| Fiducial markers registration with | No | No | Yes |

| Doc No: | PD 75 11535 | Revision 06 from: | 10.03.2014 | | 4/9 |
|-------------|--------------|-------------------|--------------------|----------------|------------|
| Created by: | Oliver Spitz | Approved by: | Dr. Michael Vogele | Invalid since: | |
| | | | | Source: | FO 42 1996 |
| | | | | Approval Date: | 06.06.2011 |

-

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| Section |
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| 005 |

#

Image /page/8/Picture/2 description: The image shows a logo for iSYS Medizintechnik GmbH. The logo features the text "iSYS" in a stylized font, with two diagonal lines above the "i". Below "iSYS" is the word "Medizintechnik" in a smaller, sans-serif font. Underneath that is "GmbH", also in a smaller font.

A

| Reference | PinPoint | iSYS 1 (for new<br>submission) | Equivalence<br>? |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| pointer probe | | | |
| Optical<br>registration | No | No | Yes |
| Ultrasound<br>Registration | No | No | Yes |
| Accuracy<br>verification | Yes, external anatomical<br>verification | Yes, performed by user | Yes |
| Provide<br>mechanical<br>guidance for tools | Yes | Yes | Yes |
| Instrument guide<br>position<br>adjustment | Manual | Manual | Yes |
| Physician carries<br>out final gesture<br>through tool guide | Yes | Yes | Yes |
| Indication for use | The PinPoint is an<br>accessory to a CT<br>system intended to<br>provide the radiologist<br>with a means of<br>simulating and initiating<br>interventional<br>procedures by<br>interactively relating the<br>patient's CT image<br>volume to the actual<br>target field.<br>This accessory includes<br>mounting the<br>stereotactic arm on a<br>CT-Gantry, a flat panel<br>TV monitor, cabling,<br>biopsy phantom and<br>software.<br>In addition the CT is<br>intended to produce<br>cross-sectional images<br>of the body by computer<br>reconstruction of X-ray<br>transmission data from | The iSYS 1 device is a<br>user-controlled<br>electromechanical arm<br>with a needle guide. It is<br>intended to assist the<br>surgeon in the<br>positioning of a needle or<br>electrode where both<br>computed tomography<br>(CT) and fluoroscopic<br>imaging can be used for<br>target trajectory planning<br>and intraoperative<br>tracking. The needle or<br>electrode is then<br>manually advanced by<br>the surgeon. Trajectory<br>planning is made with<br>software that is not part<br>of the iSYS device. | Yes |

| Doc No: | PD_75_11535 | Revision 06 from: 10.03.2014 | | 5/9 |
|--------------|--------------------|------------------------------|------------|----------------|
| Created by: | Approved by: | Invalid since: | Source: | Approval Date: |
| Oliver Spitz | Dr. Michael Vogele | | FO_42_1996 | 06.06.2011 |

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## Section

#

Image /page/9/Picture/2 description: The image shows a logo for iSYS Medizintechnik GmbH. The logo features the letters "SYS" in a stylized font, with the word "Medizintechnik" written in a smaller font below it. The letters are accompanied by a small circle above the "I" and two diagonal lines to the left of the letters. The letters "GmbH" are written in a smaller font below the word "Medizintechnik".

| Reference | PinPoint | iSYS 1 (for new<br>submission) | Equivalence<br>? |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| | the same axial plane<br>taken at different angles.<br>This device may include<br>signal analysis and<br>display equipment,<br>patient and equipment<br>supports, components<br>and accessories.<br>PinPoint is not limited to<br>any particular region of<br>the body. It is equally<br>viable for planning head<br>and spine interventions<br>as it is in the abdomen.<br>It is expected that its<br>major use will be in the<br>planning of biopsies of<br>abdominal organs and<br>drainage of fluid<br>collections in the<br>abdomen. However,<br>more complicated<br>procedures such as<br>Brachy therapy and<br>bone pinnings will be<br>planned using the<br>PinPoint. | | |
| Intended Use | The PinPoint is an<br>accessory to a CT<br>system intended to<br>provide the radiologist<br>with a means of<br>simulating and initiating<br>interventional<br>procedures by<br>interactively relating the<br>patient's CT image<br>volume to the actual<br>target field.<br>The system produces<br>cross sectional images<br>by computer<br>reconstruction of x-ray<br>transmission data from<br>the same axial plane<br>taken at different angles.<br>A stereotactic arm on a | The intended use of the<br>iSYS1 device is to<br>function as a remote-<br>operated positioning and<br>guidance system during<br>interventional<br>procedures. Positioning<br>is done in remote control<br>manner; planning of the<br>position/angulation is<br>done based on 2D/3D<br>patient data (CT, cone-<br>beam CT, fluoroscopy)<br>by external planning<br>software - for example<br>using an external<br>navigation system, or<br>planning software<br>coming with the used<br>imaging device. Also | Yes |

| Doc No: PD_75_11535 | Revision 06 from: 10.03.2014 | | | 6/9 |
|---------------------|------------------------------|----------------|------------|----------------|
| Created by: | Approved by: | Invalid since: | Source: | Approval Date: |
| Oliver Spitz | Dr. Michael Vogele | | FO_42_1996 | 06.06.2011 |

{10}------------------------------------------------

| Section<br>005 | 510k Summary<br>510(k) Number: K131433 | | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Reference | PinPoint | iSYS 1 (for new<br>submission) | Equivalence<br>? |
| | CT Gantry, a flat panel<br>TV monitor, and biopsy<br>phantom are used as<br>accessories to produce<br>these images. The<br>primary intend of the<br>system is to provide<br>guidance for biopsies in<br>the abdomen, spine and<br>head. | verification of the correct<br>position and orientation<br>of the tool prior<br>to/during/after the<br>intervention is done by<br>means of these external<br>devices. The iSYS1-<br>System is then acting as<br>a guideway during the<br>manual insertion of the<br>interventional tool –<br>usually a needle type<br>device, and the like. | |
| Anatomical site | Total Body | Total body | Yes |
| User | Radiologist | Physician | *2) |
| Accessory | V-Channel Cannula<br>Cylindrical Cannula | Sterile Covers<br>Table Adapters<br>Cable Sets | Yes |
| Real-time<br>instrument<br>position | Yes | Yes | Yes |
| Mechanical<br>Guidance of<br>instruments | Yes | Yes | Yes |
| Technology | | | |
| Powered | Yes | Yes | Yes |
| CE-Conformity | No | Yes | Yes |
| Computer-<br>controlled | Yes | Yes | Yes |
| Materials | Metal, electronics and<br>plastics | Metal, electronics<br>Polyamide<br>Polyethylene<br>Prolen | Yes |

.

:

| Doc No: PD 75_11535 | Revision 06 from: 10.03.2014 | | | 7/9 |
|---------------------|------------------------------|----------------|------------|----------------|
| Created by: | Approved by: | Invalid since: | Source: | Approval Date: |
| Oliver Spitz | Dr. Michael Vogele | | FO_42_1996 | 06.06.2011 |

{11}------------------------------------------------

Image /page/11/Picture/2 description: The image shows a logo for a company called "SYS Medizintechnik GmbH". The logo features the letters "SYS" in a stylized font, with the word "Medizintechnik" written below it in a smaller font. The letters are partially encircled by a curved line. The letters are also preceded by two diagonal lines.

### Similarities and Differences:

All three devices are intraoperative instruments used by physician for assisting the spatial positioning and orientation of a surgical tool.

iSYS 1 is equivalent to:

- . PinPoint for assisting the spatial positioning and orientation of a surgical tool.
- PinPoint for being localized by the navigation or imaging software,
- PinPoint for being guided by an imaging device .
- PinPoint for providing a registration method for the imaging device. .
- PinPoint for instrumentation and instrument fixation. ●
- . PinPoint for being immobilized in relation to the patient.
- PinPoint for providing accuracy verification, tool guidance and position ● adiustment.
- . PinPoint for the physician making the final gesture.
- . PinPoint for having the same indications for use and region of interest.

### Differences:

*1) PinPoint provides a factory instrument calibration of the encoders. During intervention the physician using iSYS1 and PinPoint verifies the position of the needle or needle-type instrument (tool). Verification of the tool position requires greater physical effort but provides for exact (depending on the imaging system) tool localization. The localization of the tool is not required for the iSYS 1 and, thus, this has no effect on safety or effectiveness.

*2) While the PinPoint is indicated to be used by radiologists only, the iSYS 1 is indicated to be used by any trained physician. This has no effects on safety and effectiveness.

*3) PinPoint provides encoders for localization, whereas iSYS uses fudicial markers on the tool. Using fiducial markers provides better localization safety.

*4) While the Pinpoint is registered during installation, the iSYS 1 uses fiducial markers for registration. Again, using fiducial markers provides better localization safety.

#### Non-Clinical Performance Data:

Non-clinical testing has mainly been performed to prove electrical and mechanical safety of the devices. Similar to the predicate devices, iSYS 1 was tested according to EN ISO 60601-1 2nd edition:

- EN 60601-1:1990 + A1:1993 + A2:1995 .
- EN 60601-1-8:2004 + A1:2006 .

The Electromagnetic Compatibility of the iSYS1 System has been tested according to FCC Part15 (Edition 1st October 2010) and ISO 60601-1-2:2007 and meets the acceptance criteria of both.

Performance tests have been performed to prove:

- the accuracy of the needle placement under clinical conditions, .
- the compatibility with the imaging modality, .
- the tendency to produce artifacts, .

| Doc No: PD_75_11535 | Revision 06 from: 10.03.2014 | | 8/9 | |
|---------------------|------------------------------|----------------|------------|----------------|
| Created by: | Approved by: | Invalid since: | Source: | Approval Date: |
| Oliver Spitz | Dr. Michael Vogele | | FO_42_1996 | 06.06.2011 |

{12}------------------------------------------------

Image /page/12/Picture/2 description: The image shows the logo for iSYS Medizintechnik GmbH. The logo features the letters "iSYS" in a stylized font, with two diagonal lines above the letters. Below the letters, the word "Medizintechnik" is written in a smaller font, and below that, the letters "GmbH" are written in an even smaller font. A curved line is drawn below the letters, giving the impression of a base or foundation.

- the mechanical stability of the system despite external payload under worst ● conditions
- the mechanical stability of the table adapters despite external payload, .
- . the accuracy in remote-control mode
- the accuracy of needle guidance ●
- functionality of hardware modules
- . effectiveness of hardware safety measures for the software,
- and the effectiveness of the alarm systems .

The results of these performance tests support that the predicate devices and iSYS 1 are substantially equivalent.

### Conclusion:

It is our opinion that the iSYS 1 System (U.S.) does not have technological characteristics that raise additional types of safety or effectiveness questions, and we consider them to be an enhancement to the existing devices.

To validate the accuracy of the iSYS 1 an external reference system has to be used. We have used and validated the accuracy of the iSYS 1 System (U.S.) with the Philips Allura Xper Guide FD 20 X-ray system and the Axiom Artis Zeego from Siemens Healthcare, and passed all tests.

| Doc No: PD 75 11535 | Revision 06 from: 10.03.2014 | | | 9/9 |
|---------------------|------------------------------|----------------|------------|----------------|
| Created by: | Approved by: | Invalid since: | Source: | Approval Date: |
| Oliver Spitz | Dr. Michael Vogele | | FO 42 1996 | 06.06.2011 |