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

• K Number: K131433
• Device Name: ISYS 1 (U.S),ACCESSORY, NON-STERILE
• Manufacturer: ISYS MEDIZINTECHNIK GMBH
• Date Cleared: 2014-03-11 ( 298 days)
• Product Code: JAK
• Regulation Number: 892.1750

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 Description

The iSYS 1 is a modular needle guidance platform for interventional radiology and related fields. Core components are a 4 DOF micro positioning unit which allows the submillimetric needle positioning from simple needle angulations up to positioning and angulations with adjustable pivot point and a control unit which is directed by a cable connected control panel. The passive macro positioning unit and different table adapters allow different setups of the system around the patient in the region of interest. The needle-guide-kit (manufactured by ECOLAB) provides disposable components that ensure precise and sterile needle guidance. 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 which is not part of the iSYS-1 Interventional Platform. The position of iSYS 1 is visible for most imaging systems due to the used markers. During treatment the tool is controlled by the user.

Predicate Devices

JAK

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on electromechanical control and user-driven planning, with no mention of AI/ML algorithms for image analysis, planning, or control. The planning software is explicitly stated as external and not part of the device.

Therapeutic

No.

The device assists in positioning a needle or electrode but does not directly deliver therapy itself; the therapy (e.g., drug delivery, ablation) is manually performed by the surgeon after the device guides the tool's placement.

Diagnostic

No
The device is described as an electromechanical arm with a needle guide intended to assist in the positioning of a needle or electrode for interventional procedures, not for diagnostic purposes. It aids in physical intervention based on planning made with external software and systems.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as an electromechanical arm, micro positioning unit, control unit, control panel, macro positioning unit, table adapters, and a needle-guide-kit. Performance studies also focus on electrical and mechanical safety and functionality of hardware modules. While software is mentioned for trajectory planning, it is explicitly stated as not being part of the iSYS device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• iSYS 1 Function: The iSYS 1 device is an electromechanical arm designed to assist a surgeon in positioning a needle or electrode within the patient's body during a procedure. It uses imaging for guidance but does not analyze biological samples.

The description clearly indicates the device is used for surgical assistance and guidance, not for analyzing samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 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.

Product codes

JAK

Device Description

The iSYS 1 is a modular needle guidance platform for interventional radiology and related fields. Core components are a 4 DOF micro positioning unit which allows the submillimetric needle positioning from simple needle angulations up to positioning and angulations with adjustable pivot point and a control unit which is directed by a cable connected control panel. The passive macro positioning unit and different table adapters allow different setups of the system around the patient in the region of interest. The needle-guide-kit (manufactured by ECOLAB) provides disposable components that ensure precise and sterile needle guidance.

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 which is not part of the iSYS-1 Interventional Platform. The position of iSYS 1 is visible for most imaging systems due to the used markers. During treatment the tool is controlled by the user.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

computed tomography (CT) and fluoroscopic imaging

Anatomical Site

Total body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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, .
• 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

PinPoint manufactured by Philips Medical.

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.

Summary

0

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.

1

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)

3

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden lime for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gether and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

Section
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
6370 Kitzbühel / Austria
3.	Contact Person:	Dr. Michael Vogele
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
Product Code JAK, MAXX, Reg.No. 892.1750
9.	Substantial Equivalence:	The iSYS 1 is substantially equivalent to the following
legally marketed devices:
PinPoint manufactured by Philips Medical.

The characteristics of this device are similar to those of
the predicate devices identified on the comparison
chart, which follows. It is our opinion that the iSYS 1
does not have technological characteristics that raise
additional types of questions related to terms of safety
and effectiveness. |
| 10. | Device Description: | The iSYS 1 is a modular needle guidance platform for
interventional radiology and related fields. Core
components are a 4 DOF micro positioning unit which
allows the submillimetric needle positioning from
simple needle angulations up to positioning and
angulations with adjustable pivot point and a control
unit which is directed by a cable connected control
panel. The passive macro positioning unit and different
table adapters allow different setups of the system
around the patient in the region of interest. The needle-
guide-kit (manufactured by ECOLAB) provides
disposable components that ensure precise and sterile
needle guidance.

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 which is not part of the iSYS-1
Interventional Platform. The position of iSYS 1 is
visible for most imaging systems due to the used
markers. During treatment the tool is controlled by the |

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5

| Section
005 | | 510k Summary
510(k) Number: K131433
Image: [logo] |
|----------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 11. | Intended Use: | user.
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

6

| Section
005 | 510k Summary
510(k) Number: K131433 | Image: SYS Medizintechnik GmbH logo |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| 14. Biocompatibility: | (imaging or navigation software).
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

Storage temperature/humidity range: 10 to 50°C; 30 to 70% relative humidity with no condensation

Power Supply: 50W; 115VAC/230VAC; 50-60Hz; cable: C14 according to IEC/EN 60320-1, US498, CSA C22.2 no. 42;

Sterilization of the sterile accessories has been validated by Bioseal and Preferred Medical, the companies responsible for packaging and sterilizing the iSYS accessories.

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

7

Device Comparison Summary:

Reference	PinPoint	iSYS 1 (for new submission)	Equivalence ?
510k-Number	K974513	K131433
Manufacturer	PHILIPS MEDICAL SYSTEMS
(CLEVELAND), INC.
595 Miner rd.
Cleveland, OH 44143
USA	iSYS Medizintechnik
GmbH
Bergwerksweg 21
A-6370 Kitzbuehel
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
Laser needle guide	Marker
Tool Holder
Sterile Covers
(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
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

8

Section
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
submission) | Equivalence
? |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| pointer probe | | | |
| Optical
registration | No | No | Yes |
| Ultrasound
Registration | No | No | Yes |
| Accuracy
verification | Yes, external anatomical
verification | Yes, performed by user | Yes |
| Provide
mechanical
guidance for tools | Yes | Yes | Yes |
| Instrument guide
position
adjustment | Manual | Manual | Yes |
| Physician carries
out final gesture
through tool guide | Yes | Yes | Yes |
| Indication for use | The PinPoint is an
accessory to a CT
system intended to
provide the radiologist
with a means of
simulating and initiating
interventional
procedures by
interactively relating the
patient's CT image
volume to the actual
target field.
This accessory includes
mounting the
stereotactic arm on a
CT-Gantry, a flat panel
TV monitor, cabling,
biopsy phantom and
software.
In addition the CT is
intended to produce
cross-sectional images
of the body by computer
reconstruction of X-ray
transmission data from | 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. | 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

9

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
submission) | Equivalence
? |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| | the same axial plane
taken at different angles.
This device may include
signal analysis and
display equipment,
patient and equipment
supports, components
and accessories.
PinPoint is not limited to
any particular region of
the body. It is equally
viable for planning head
and spine interventions
as it is in the abdomen.
It is expected that its
major use will be in the
planning of biopsies of
abdominal organs and
drainage of fluid
collections in the
abdomen. However,
more complicated
procedures such as
Brachy therapy and
bone pinnings will be
planned using the
PinPoint. | | |
| Intended Use | The PinPoint is an
accessory to a CT
system intended to
provide the radiologist
with a means of
simulating and initiating
interventional
procedures by
interactively relating the
patient's CT image
volume to the actual
target field.
The system produces
cross sectional images
by computer
reconstruction of x-ray
transmission data from
the same axial plane
taken at different angles.
A stereotactic arm on a | 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 | 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
005 | 510k Summary
510(k) Number: K131433 | | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Reference | PinPoint | iSYS 1 (for new
submission) | Equivalence
? |
| | CT Gantry, a flat panel
TV monitor, and biopsy
phantom are used as
accessories to produce
these images. The
primary intend of the
system is to provide
guidance for biopsies in
the abdomen, spine and
head. | 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. | |
| Anatomical site | Total Body | Total body | Yes |
| User | Radiologist | Physician | *2) |
| Accessory | V-Channel Cannula
Cylindrical Cannula | Sterile Covers
Table Adapters
Cable Sets | Yes |
| Real-time
instrument
position | Yes | Yes | Yes |
| Mechanical
Guidance of
instruments | Yes | Yes | Yes |
| Technology | | | |
| Powered | Yes | Yes | Yes |
| CE-Conformity | No | Yes | Yes |
| Computer-
controlled | Yes | Yes | Yes |
| Materials | Metal, electronics and
plastics | Metal, electronics
Polyamide
Polyethylene
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