(298 days)
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.
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.
The iSYS 1 device is a user-controlled electromechanical arm with a needle guide intended to assist surgeons in positioning a needle or electrode using CT and fluoroscopic imaging for trajectory planning and intraoperative tracking.
Here's an analysis of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format. However, it indicates general performance aspects that were tested and confirmed. Based on the "Performance Data" and "Non-Clinical Performance Data" sections, the implied acceptance criterion is that the device demonstrates mechanical accuracy, compatibility, stability, and proper functionality within specified operating conditions.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical accuracy (below 1 mm) | Mechanical accuracy of iSYS1 is below 1 mm (note: this is the device's inherent mechanical accuracy, not overall treatment accuracy which depends on imaging). |
| Compatibility with imaging modality | Tested and proven compatible. |
| Tendency to produce artifacts | Tested for. (Implied: acceptable level of artifacts or no significant artifacts). |
| Mechanical stability under worst-case external payload | Tested for. (Implied: stable under worst-case conditions). |
| Mechanical stability of table adapters under external payload | Tested for. (Implied: stable under external payload). |
| Accuracy in remote-control mode | Tested for. (Implied: accurate in remote-control mode). |
| Accuracy of needle guidance | Tested for. (Implied: accurate needle guidance). |
| Functionality of hardware modules | Tested for functionality. (Implied: modules functional). |
| Effectiveness of hardware safety measures for the software | Tested for effectiveness. (Implied: effective safety measures). |
| Effectiveness of alarm systems | Tested for effectiveness. (Implied: alarm systems effective). |
| Compliance with electrical and mechanical safety standards (EN ISO 60601-1, EN 60601-1-8) | Device tested and found compliant. |
| Compliance with Electromagnetic Compatibility (FCC Part15, ISO 60601-1-2) | Device tested and found compliant. |
| Accuracy validated with external reference systems | Validated with Philips Allura Xper Guide FD 20 X-ray system and Axiom Artis Zeego from Siemens Healthcare; "passed all tests." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical or image-based evaluations with patient data. The performance studies mentioned appear to be more focused on non-clinical, bench-top testing to verify mechanical and electrical characteristics.
- Sample Size: Not specified for any clinical or image-based test set involving patients. The performance tests refer to "clinical conditions" for accuracy of needle placement, but no sample size or patient count is given.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The tests focus on device performance rather than patient outcomes from a specific country. The manufacturer is iSYS Medizintechnik GmbH from Austria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The ground truth for performance tests appears to be based on engineering measurements and validation against known standards (e.g., accuracy below 1mm, compliance with electrical safety standards). For "accuracy of the needle placement under clinical conditions," it's not specified how ground truth was established or by whom.
4. Adjudication Method for the Test Set
Not applicable, as a clinical test set requiring expert adjudication for ground truth is not detailed in the provided information.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The iSYS 1 is a mechanical device for needle guidance, not an AI or image interpretation system for "human readers." Therefore, an MRMC study comparing human readers with and without AI assistance is outside the scope of this device's evaluation as described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The iSYS 1 is an electromechanical arm designed to assist a surgeon (human-in-the-loop). It is not an algorithm-only device. The planning of the tool position/orientation and validation of its correctness are performed with external planning and measurement systems, and the needle/electrode is manually advanced by the surgeon.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance data, the ground truth is primarily engineering specifications, physical measurements (e.g., mechanical accuracy below 1mm), and adherence to established electrical and mechanical safety standards (EN ISO 60601-1, EN 60601-1-8) and EMC standards (FCC Part15, ISO 60601-1-2). For "accuracy of the needle placement under clinical conditions," the specific type of ground truth (e.g., imaging confirmation, direct measurement) is not detailed.
8. The Sample Size for the Training Set
Not applicable. The iSYS 1 device is a mechanical system, not an AI or machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
{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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
{2}------------------------------------------------
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 PRAStaff@fda.hhs.gov
"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 216370 Kitzbühel / Austria |
| 3. | Contact Person: | Dr. Michael VogeleTel. +43 (0) 664 2411140 |
| 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, computedProduct Code JAK, MAXX, Reg.No. 892.1750 |
| 9. | Substantial Equivalence: | The iSYS 1 is substantially equivalent to the followinglegally marketed devices:PinPoint manufactured by Philips Medical.The characteristics of this device are similar to those ofthe predicate devices identified on the comparisonchart, which follows. It is our opinion that the iSYS 1does not have technological characteristics that raiseadditional types of questions related to terms of safetyand effectiveness. |
| 10. | Device Description: | The iSYS 1 is a modular needle guidance platform forinterventional radiology and related fields. Corecomponents are a 4 DOF micro positioning unit whichallows the submillimetric needle positioning fromsimple needle angulations up to positioning andangulations with adjustable pivot point and a controlunit which is directed by a cable connected controlpanel. The passive macro positioning unit and differenttable adapters allow different setups of the systemaround the patient in the region of interest. The needle-guide-kit (manufactured by ECOLAB) providesdisposable components that ensure precise and sterileneedle guidance.Planning of the tool position/orientation as well asvalidation of the correctness of the tool position mustbe performed with an external planning andmeasurement system which is not part of the iSYS-1Interventional Platform. The position of iSYS 1 isvisible for most imaging systems due to the usedmarkers. During treatment the tool is controlled by the |
| ----------------------------------------------------------------- | ||||
|---|---|---|---|---|
| ----------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1 | |||
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | with county county and parts and------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------- | ------------------------------------- |
{5}------------------------------------------------
| Section005 | 510k Summary510(k) Number: K131433Image: [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}------------------------------------------------
| Section005 | 510k Summary510(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 condensationStorage temperature/humidity range: 10 to 50°C; 30 to 70% relative humidity with no condensationPower 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 44143USA | iSYS MedizintechnikGmbHBergwerksweg 21A-6370 KitzbuehelAustria | |
| 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 | CannulaLaser needle guide | MarkerTool HolderSterile 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 CalibrationOptional: 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 newsubmission) | Equivalence? |
|---|---|---|---|
| pointer probe | |||
| Opticalregistration | No | No | Yes |
| UltrasoundRegistration | No | No | Yes |
| Accuracyverification | Yes, external anatomicalverification | Yes, performed by user | Yes |
| Providemechanicalguidance for tools | Yes | Yes | Yes |
| Instrument guidepositionadjustment | Manual | Manual | Yes |
| Physician carriesout final gesturethrough tool guide | Yes | Yes | Yes |
| Indication for use | The PinPoint is anaccessory to a CTsystem intended toprovide the radiologistwith a means ofsimulating and initiatinginterventionalprocedures byinteractively relating thepatient's CT imagevolume to the actualtarget field.This accessory includesmounting thestereotactic arm on aCT-Gantry, a flat panelTV monitor, cabling,biopsy phantom andsoftware.In addition the CT isintended to producecross-sectional imagesof the body by computerreconstruction of X-raytransmission data from | The iSYS 1 device is auser-controlledelectromechanical armwith a needle guide. It isintended to assist thesurgeon in thepositioning of a needle orelectrode where bothcomputed tomography(CT) and fluoroscopicimaging can be used fortarget trajectory planningand intraoperativetracking. The needle orelectrode is thenmanually advanced bythe surgeon. Trajectoryplanning is made withsoftware that is not partof 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 newsubmission) | Equivalence? |
|---|---|---|---|
| the same axial planetaken at different angles.This device may includesignal analysis anddisplay equipment,patient and equipmentsupports, componentsand accessories.PinPoint is not limited toany particular region ofthe body. It is equallyviable for planning headand spine interventionsas it is in the abdomen.It is expected that itsmajor use will be in theplanning of biopsies ofabdominal organs anddrainage of fluidcollections in theabdomen. However,more complicatedprocedures such asBrachy therapy andbone pinnings will beplanned using thePinPoint. | |||
| Intended Use | The PinPoint is anaccessory to a CTsystem intended toprovide the radiologistwith a means ofsimulating and initiatinginterventionalprocedures byinteractively relating thepatient's CT imagevolume to the actualtarget field.The system producescross sectional imagesby computerreconstruction of x-raytransmission data fromthe same axial planetaken at different angles.A stereotactic arm on a | The intended use of theiSYS1 device is tofunction as a remote-operated positioning andguidance system duringinterventionalprocedures. Positioningis done in remote controlmanner; planning of theposition/angulation isdone based on 2D/3Dpatient data (CT, cone-beam CT, fluoroscopy)by external planningsoftware - for exampleusing an externalnavigation system, orplanning softwarecoming with the usedimaging 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}------------------------------------------------
| Section005 | 510k Summary510(k) Number: K131433 | ||
|---|---|---|---|
| Reference | PinPoint | iSYS 1 (for newsubmission) | Equivalence? |
| CT Gantry, a flat panelTV monitor, and biopsyphantom are used asaccessories to producethese images. Theprimary intend of thesystem is to provideguidance for biopsies inthe abdomen, spine andhead. | verification of the correctposition and orientationof the tool priorto/during/after theintervention is done bymeans of these externaldevices. The iSYS1-System is then acting asa guideway during themanual insertion of theinterventional tool –usually a needle typedevice, and the like. | ||
| Anatomical site | Total Body | Total body | Yes |
| User | Radiologist | Physician | *2) |
| Accessory | V-Channel CannulaCylindrical Cannula | Sterile CoversTable AdaptersCable Sets | Yes |
| Real-timeinstrumentposition | Yes | Yes | Yes |
| MechanicalGuidance ofinstruments | Yes | Yes | Yes |
| Technology | |||
| Powered | Yes | Yes | Yes |
| CE-Conformity | No | Yes | Yes |
| Computer-controlled | Yes | Yes | Yes |
| Materials | Metal, electronics andplastics | Metal, electronicsPolyamidePolyethyleneProlen | 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 |
§ 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.