(183 days)
No
The description focuses on electromechanical control and image guidance for positioning, with no mention of AI/ML for planning, control, or image analysis. The planning software is explicitly stated as external and not part of the device.
No
The device is described as assisting the surgeon in positioning a needle or instrument, and the needle or electrode is manually advanced by the surgeon. It functions as a guidance system and does not directly provide therapy.
No
The device is intended to assist in the positioning of a needle or instrument for surgical intervention, not to diagnose a condition. It uses imaging for guidance, but does not perform diagnostic functions itself.
No
The device description explicitly lists multiple hardware components, including a robotic positioning unit, control unit, positioning arm, strain relief box, power and network unit, sterile drapes, connecting cables, and a cart. Furthermore, the performance studies section mentions "Hardware Verification testing."
Based on the provided information, the Micromate™ device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Micromate™ Function: The description clearly states that the Micromate™ device is an electromechanical arm with a needle guide intended to assist surgeons in positioning needles or instruments during surgical procedures. It uses imaging (CT and fluoroscopy) for planning and tracking, but it does not analyze biological specimens.
- Intended Use: The intended use is to assist in surgical procedures, not to perform diagnostic tests on samples.
- Device Description: The components and function described are related to surgical guidance and positioning, not laboratory analysis of specimens.
- Performance Studies: The performance studies focus on the accuracy of the device's positioning and alignment, which are relevant to surgical guidance, not the accuracy of diagnostic test results.
Therefore, the Micromate™ device falls under the category of a surgical guidance or robotic assistance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Micromate™ 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 instrument 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 Micromate™ device
Product codes
JAK
Device Description
The Micromate™ system allows the percutaneous execution of a surgical intervention by providing instrument guidance according to one or more pre-operative plans defined in an external planning or navigation station. The alignment to the surgical plan is performed through a manual gross-positioning using a Positioning Arm, followed by automatic or joystick-controlled movement with image guidance, such as CT and fluoroscopic image. After alignment, the advancement of surgical instruments and delivery of therapy is performed manually by the surgeon, while the position is retained by the system and relying on the displayed navigation information or real-time images.
The system comprises the following main components:
- . Targeting Platform, a robotic positioning unit that aligns to the surgical plan and holds the surgical instruments through an end-effector acting as a tool-guide adapter.
- . Control Unit, a handheld device that allows the automatic or manual control of the Targeting Platform movement and can communicate with an external planning and navigation station.
- . Positioning Arm, a multi-functional arm that is used to gross-position the Targeting Platform in such a way the trajectory is reachable.
- . Strain Relief Box, which distributes power and data through the Micromate™ system.
- . Power and Network Unit, which connects the system to power and allows an optional direct point-to-point connection to an external planning and navigation station for input of real-time navigation data.
- . Sterile Drapes for the Control Unit and Targeting Platform (this one containing also needle guides) for instrument guidance.
- . Connecting Cables
- A cart for transport and storage .
The system can be mounted to different bed/table through specific adapter accessories and all components are covered with a sterile drape during use. Third-party needle or tool guides are connected to the Targeting Platform end-effector through a customized mechanical interface that preserves the sterile barrier.
Micromate™ is not patient contacting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT) and fluoroscopic imaging, 2D/3D patient data (CT, cone-beam CT, fluoroscopy)
Anatomical Site
Total body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, 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
Non-Clinical Performance Data
Testing was conducted on the Micromate™ system to establish that the system is substantially equivalent to the predicate and reference devices and demonstrate and verify that the device will perform as intended according to the outlined design requirements below:
- IEC 60601-1:2005+AMD1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
- . IEC 60601-1-2:2014 - Medical Electrical Equipment - Part 1-2: General requirements for safety; Electromagnetic Compatibility - Requirements and Tests
- Software Verification and Validation testing verifying the operating system software requirements are met and software performs as intended
- . Hardware Verification testing ensuring the hardware requirements identified for the system are met and hardware performs as intended (this includes, but is not limited to, reliability lifetime testing, functional testing, performance testing including accuracy)
- Usability Engineering was conducted in accordance with IEC 62366 demonstrating that the usability and human factors requirements were adequately met.
The accuracy of the intervention is adjunct to the capabilities of the operator and depends on the resolution of the imaging device or software, among other factors. As calculated from actual clinical data, the 95% confidence interval (CI) accuracy of Micromate™ in clinical use is between 0.00 mm to 1.14 mm and 0.25 degrees to 1.70 degrees from the surgical plan. This corresponds to an average accuracy of alignment to the trajectory on Entry Point view of 0.43 +/- 0.5mm, and an average angular deviation of the needle when being inserted along the trajectory of 0.79 +/- 0.41 degrees. Micromate™ has no influence on the accuracy of the needle placement on target in terms of depth, as the instrument is manually delivered and advanced by the physician, under live imaging. All results were obtained in combination with the Philips Allura Xper FD20 X-ray system.
The mechanical accuracy of the Micromate™ system itself is below 1 mm (relative mechanical accuracy 0.03 mm and absolute mechanical accuracy 0.2 mm), as measured by commanding the Targeting Platform to a predetermined location in air.
Key Metrics
95% confidence interval (CI) accuracy of Micromate™ in clinical use is between 0.00 mm to 1.14 mm and 0.25 degrees to 1.70 degrees from the surgical plan.
Average accuracy of alignment to the trajectory on Entry Point view of 0.43 +/- 0.5mm.
Average angular deviation of the needle when being inserted along the trajectory of 0.79 +/- 0.41 degrees.
Mechanical accuracy of the Micromate™ system itself is below 1 mm (relative mechanical accuracy 0.03 mm and absolute mechanical accuracy 0.2 mm).
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
June 22, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ISYS Medizintechnik GMBH % Cornelia Damsky President CDI Regulatory Consultants 6552 Hermosa Beach Lane DELRAY BEACH FL 33446
Re: K203720
Trade/Device Name: Micromate™ Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 24, 2021 Received: May 26, 2021
Dear Cornelia 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 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203720
Device Name Micromate™
Indications for Use (Describe)
The Micromate™ 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 instrument where both comography (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 Micromate™ 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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the logo for Interventional Systems. The logo features a stylized "i" with a blue dot above a black vertical line, next to the word "INTERVENTIONAL" in bold, black letters. Below "INTERVENTIONAL" is the word "systems" in a smaller, teal font.
005 510(k) Summary
-
- Applicant: iSYS Medizintechnik GmbH
- Address: Bergwerksweg 21
- 6370 Kitzbuehel / Austria
- Dr. Michael Vogele 3. Contact Person:
- Tel. +43 (0) 664 2411140
- January 19, 2021 4. Preparation Date:
-
- Trade Name: Micromate TM
- Common Name: 6. Robotic Positioning Unit
- Classification 7. System, X-ray, Tomography, computed Name: Product Code JAK, Reg. No. 892.1750
-
- Substantial The Micromate™ is substantially equivalent to the following legally mar-Equivalence: keted devices:
Predicate Device:
iSYS1 (iSYS Medizintechnik GmbH), K131433 Product Code JAK, Reg. No. 892.1750
Reference Device:
Stealth Autoguide™ System (Medtronic Navigation Inc.), K191597 Product Code HAW, Reg. No. 882.4560
The characteristics of this device are similar to those of the predicate devices identified on the comparison chart, which is provided with the premarket notification submission. It is our opinion that the Micromate™ system does not have technological characteristics that raise additional types of questions related to terms of safety and effectiveness.
-
- Device The Micromate™ system allows the percutaneous execution of a surgical Description: intervention by providing instrument guidance according to one or more pre-operative plans defined in an external planning or navigation station. The alignment to the surgical plan is performed through a manual grosspositioning using a Positioning Arm, followed by automatic or joystick-controlled movement with image guidance, such as CT and fluoroscopic image. After alignment, the advancement of surgical instruments and delivery of therapy is performed manually by the surgeon, while the position is retained by the system and relying on the displayed navigation information or realtime images.
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Image /page/4/Picture/0 description: The image shows the logo for Interventional Systems. The logo features a stylized "i" with a blue dot above a black vertical line. To the right of the "i" are the words "INTERVENTIONAL" in bold, black letters, with the word "systems" in a smaller font and a lighter color below it.
The system comprises the following main components:
- . Tarqeting Platform, a robotic positioning unit that aligns to the surgical plan and holds the surgical instruments through an end-effector acting as a tool-guide adapter.
- . Control Unit, a handheld device that allows the automatic or manual control of the Targeting Platform movement and can communicate with an external planning and navigation station.
- . Positioning Arm, a multi-functional arm that is used to gross-position the Targeting Platform in such a way the trajectory is reachable.
- . Strain Relief Box, which distributes power and data through the Micromate™ system.
- . Power and Network Unit, which connects the system to power and allows an optional direct point-to-point connection to an external planning and navigation station for input of real-time navigation data.
- . Sterile Drapes for the Control Unit and Targeting Platform (this one containing also needle guides) for instrument guidance.
- . Connecting Cables
- A cart for transport and storage .
The system can be mounted to different bed/table through specific adapter accessories and all components are covered with a sterile drape during use. Third-party needle or tool guides are connected to the Targeting Platform end-effector through a customized mechanical interface that preserves the sterile barrier.
Micromate™ is not patient contacting.
- The intended use of the Micromate™ device is to function as a remote-10. Intended Use: operated positioning and quidance system during interventional procedures. Positioning is done in a remote controlled 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 Micromate™ system is then acting as a guideway during the manual insertion of the interventional tool - usually a needle type device, and the like- through a third-party needle guide, manufactured by Exact MM (K101689): P/N E2183 (Device Cover with 11G-14G needle guide) or P/N E2184 (Device Cover with 15G-21G needle guide). During operation, the device is covered with a sterile drape, which is part of the P/N E2183 and
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Image /page/5/Picture/0 description: The image shows the logo for Interventional Systems. The logo features a stylized "i" with a blue circle above a black vertical line. To the right of the "i" is the text "INTERVENTIONAL" in black, with "systems" in a smaller, light blue font below it. The logo is simple and modern, using a clean font and a limited color palette.
E2184. An additional third-party Control Unit Drape is available, also manufactured by Exact MM (K101689): P/N 11718EU (Handheld Device Cover).
Applications include, but are not limited to, interventions like biopsy procedures, tumor ablation, nerve blocking, electrode placement, etc.
-
- Indications for use: The Micromate™ 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 Micromate™ device
-
- Clinical Use: Depending on the used operating table, the user selects a specific table adapter and attaches it to the table (a Table Top Adapter for C-arm couchtops, a Standard Baseplate and respective adapters for a CT-table or Fluoro-CT table, Side-Rail Adapters for side-rails on any table). All adapters are equipped with a starburst connector, to which the multi-functional Positioning Arm is connected. The Positioning Arm is equipped with one starburst adapter at the bottom and a spoon adapter at the top, to which the Targeting Platform is connected with a counterpart. A Strain Relief Box (for power distribution and cable management) and the Control Unit for handheld remote control of the Targeting Platform are connected to a siderail. Both the Targeting Platform and the Control unit are connected to the Strain Relief Box with cables. The Strain Relief Box is then connected to a Power and Network Unit, responsible for the power and data input into the system, respectively through a power cord that is connected to the mains outlet and a network cable that can be plugged into an external planning or navigation station. An end-effector is connected to the Targeting Platform and the assembly (comprised of the Targeting Platform carrying and Endeffector and the Positioning Arm) are covered with a sterile drape. A sterile disposable needle guide is connected to the End-effector interface with the sterile drape in place. The Control Unit can optionally be covered with the respective sterile drape. The Targeting Platform is gross-positioning within the region of interest, by locking the Positioning Arm when the Targeting Platform is in the desired position. Planning of the tool position/orientation as well as validation of the correctness of the tool position must be performed with an external planning or navigation station. The Targeting Platform is remotely controlled using the Control Unit for fine positioning and to align the needle guide axis to the surgical plan. The surgical instruments are then inserted manually by the user into the needle guide and advanced to the planned target. For procedures requiring the placement of multiple instruments, each instrument can be released from the needle guide after placement and the alignment to additional planned surgical trajectories performed similarly.
iSYS Medizintechnik GmbH, Bergwerksweg 21, 6370 Kitzbühel, Austria, Geschäftsführer: Dr. Michael Vogele, Thomas Pfeifer Firmensitz: Kitzbühel, Firmenbuchgericht: LG Innsbuchn: 348982 i, UID-Nr.: ATU65852918, St.Nr.: 103/0640
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Image /page/6/Picture/0 description: The image shows the logo for Interventional Systems. The logo features a stylized letter "i" in black, with a blue dot above it. To the right of the "i" are the words "INTERVENTIONAL" in bold black letters, with the word "systems" in a smaller, lighter blue font below it.
- Biocompatibility: The Micromate™ is not in contact with the patient. At any time, when in 13. use, a third-party sterile drape is to be placed between the patient and the system. No biocompatibility studies were considered necessary for this device.
-
- Performance Data: Operating conditions: 10-30°C (50-86°F), 30-70% RH, non-condensing, 0.689 bar-1.019 bar, altitude up to 3000m (9842 ft). Shipping conditions: 0-40°C (32–104°F), 20–80% RH, non-condensing, 0.689 bar–1.019 bar. Storage conditions: 0–30°C (32–86°F), 20–80% RH, non-condensing, 0.689 bar–1.019 bar. Power supply: 30VA, 100-240 VAC, 50/60 Hz.
Sterilization of the sterile accessories has been validated by Exact Medical Manufacturing (K101689), the legal manufacturer of the sterile drapes and needle quides compatible with the Micromate™.
The accuracy of the intervention is adjunct to the capabilities of the operator and depends on the resolution of the imaging device or software, among other factors. As calculated from actual clinical data, the 95% confidence interval (CI) accuracy of Micromate™ in clinical use is between 0.00 mm to 1.14 mm and 0.25 degrees to 1.70 degrees from the surgical plan. This corresponds to an average accuracy of alignment to the trajectory on Entry Point view of 0.43 ± 0.5mm, and an average angular deviation of the needle when being inserted along the trajectory of 0.79 ± 0.41 degrees. Micromate™ has no influence on the accuracy of the needle placement on target in terms of depth, as the instrument is manually delivered and advanced by the physician, under live imaging. All results were obtained in combination with the Philips Allura Xper FD20 X-ray system.
The mechanical accuracy of the Micromate™ system itself is below 1 mm (relative mechanical accuracy 0.03 mm and absolute mechanical accuracy 0.2 mm), as measured by commanding the Targeting Platform to a predetermined location in air.
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Image /page/7/Picture/0 description: The image shows the logo for Interventional Systems. The logo features a stylized "i" with a blue dot above a black vertical line. To the right of the "i" is the text "INTERVENTIONAL" in bold, black letters, with "systems" in a smaller, lighter blue font directly below.
Device comparison summary
| Reference | iSYS1
(predicate device) | Stealth Autoguide™
System
(reference device) | Micromate™
(subject device) | Equivalence?¹ |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| 510(k)-Number | K131433 | K191597 | K203720 | YES |
| Manufacturer | iSYS Medizintechnik GmbH
Bergwerksweg 21
6370 Kitzbühel
Austria | Medtronic Navigation, Inc.
826 Coal Creek Circle
Louisville, Colorado 80027
United States | iSYS Medizintechnik GmbH
Bergwerksweg 21
6370 Kitzbühel
Austria | |
| | | DESIGN | | |
| General Device
Description | Computer controlled electro-
mechanical multi-jointed arm
indicated for invasive proce-
dures | Computer controlled elec-
tromechanical multi-joined
arm indicated for use as a
stereotactic instrument | Computer controlled electro-
mechanical multi-jointed arm
indicated for both stereotac-
tic and non-stereotactic inva-
sive procedures | YES (4) |
| Localization
Means | Fiducial markers on tool
holder | Optical markers on tool
holder | Fiducial markers on tool
holder | YES (7) |
| Image-guided | Yes | Yes | Yes | YES (1,3,11) |
| Planning software | Third-party | Yes (StealthStation) | Third-party | YES (1) |
| Registration
method | By navigation/imaging soft-
ware during intervention | By navigation/imaging
software during interven-
tion | By navigation/imaging soft-
ware during intervention | YES (4,7) |
| Instrumentation | Marker
Tool Holder
Sterile Covers (third-party) | Reusable surgical instru-
ments
Navigated Trajectory
Guide, Tool Holders, Drill
Guides, Cranial reducing
Tubes, Height Guides and
Tapping Tube
(K162604) | Tool Guides
Sterile Drapes
Manufacturer: Exact MM
(K101689)
Device Cover with 11G-14G
needle guide, P/N E2183
Device Cover with 15G-21G
needle guide, P/N E2184
Handheld Device Cover, P/N
11718EU | YES (13) |
| Instrument
Fixation | Special tool holders for dif-
ferent applications mounted
to the device | Special tool holders for dif-
ferent applications
mounted to the Stealth Au-
toguide™ | Special tool holders for dif-
ferent applications mounted
to the device | YES (9) |
| Instrument
Calibration | Intra-operative | Intra-operative | Intra-operative | YES (8) |
| Planning and Navigation Software | | | | |
| N/A | | | | |
| System Operation | | | | |
| Fiducial markers
with registration
with pointer probe | No | No | No | YES (14) |
| Optical
Registration | No | Yes | No | Yes (15) |
| Ultrasound
Registration | No | No | No | YES (16) |
| Accuracy
Verification | Yes, performed by user | Yes, performed by user | Yes, performed by user | YES (17) |
| Provide mechani-
cal guidance for
tools | Yes | Yes | Yes | YES (4) |
| Instrument Guide
Position
Adjustment | Robotic movement (man-
ual/joystick or automatic) | Robotic movement (man-
ual/joystick or automatic) | Robotic movement (man-
ual/joystick or automatic) | YES (4,12) |
| Physician carries
out final gesture
through tool guide | Yes | Yes | Yes | YES (10) |
| Intended Use | The intended use of the
iSYS1 device is to function
as a remote-operated posi-
tioning and guidance system
during interventional proce-
dures. Positioning is done in
remote control manner; plan-
ning of the position/angula-
tion is done based on 2D/3D
patient data (CT, cone-beam
CT, fluoroscopy) by external
planning software – for ex-
ample using an external nav-
igation system, or planning
software coming with the
used imaging device.
Also, verification of the cor-
rect position and orientation
of the tool prior to/during/af-
ter 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.
Applications include, but are
not limited to, interventions
like biopsy procedures, tu-
mor ablation, nerve blocking,
electrode placement, etc. | The Stealth Autoguide™
System is a positioning
and guidance system in-
tended for the spatial posi-
tioning and orientation of
instrument holders or tool
guides to be used by neu-
rosurgeons to guide stand-
ard neurosurgical instru-
ments, based on a pre-op-
erative plan and feedback
from an image-guided nav-
igation system with three-
dimensional imaging soft-
ware. | The intended use of the Mi-
cromate™ device is to func-
tion as a remote-operated
positioning and guidance
system during interventional
procedures. Positioning is
done in a remote controlled
manner; planning of the po-
sition/angulation is done
based on 2D/3D patient data
(CT, cone-beam CT, fluoros-
copy) by external planning
software - for example using
an external navigation sys-
tem, or planning software
coming with the used imag-
ing device.
Also, verification of the cor-
rect position and orientation
of the tool prior to/during/af-
ter the intervention is done
by means of these external
devices. The Micromate™
system is then acting as a
guideway during the manual
insertion of the interventional
tool - usually a needle type
device, and the like- through
a third-party needle guide,
manufactured by Exact MM
(K101689): P/N E2183 (De-
vice Cover with 11G-14G
needle guide) or P/N E2184
(Device Cover with 15G-21G
needle guide). During opera-
tion, the device is covered
with a sterile drape, which is
part of the P/N E2183 and
E2184. An additional third-
party Control Unit Drape is
available, also manufactured
by Exact MM (K101689):
P/N 11718EU (Handheld
Device Cover).
Applications include, but are
not limited to, interventions
like biopsy procedures, tu-
mor ablation, nerve blocking,
electrode placement, etc | YES (2,5) |
| Indications for Use | The iSYS 1 device is a user-
controlled electromechanical
arm with a needle guide. It is
intended to assist the sur-
geon in the positioning of a
needle or electrode where
both computed tomography
(CT) and fluoroscopic imag-
ing can be used for target
trajectory planning and in-
traoperative 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 Stealth Autoguide™
System is a remotely-oper-
ated positioning and guid-
ance system, indicated for
any neurological condition
in which the use of stereo-
tactic surgery may be ap-
propriate (for example,
stereotactic biopsy, stereo-
tactic EEG, laser tissue
ablation, etc.). | The Micromate™ device is a
user-controlled electrome-
chanical arm with a needle
guide. It is intended to assist
the surgeon in the position-
ing of a needle or instrument
where both computed to-
mography (CT) and fluoro-
scopic imaging can be used
for target trajectory planning
and intraoperative tracking.
The needle or electrode is
then manually advanced by
the surgeon. Trajectory plan-
ning is made with software
that is not part of the Micro-
mate™ device. | YES (2,5) |
| Anatomical site | Total body | Brain | Total body | YES (2) |
| User | Physician | Neurosurgeon | Physician | YES (3) |
| Accessory | Table Adapters
Cable Sets
Marker
Tool Holder
Tool Guides (third party)
Sterile Covers (third-party) | Sterile Drapes
Head Clamp Adapter
Cable Sets
Reusable surgical instru-
ments
Navigated Trajectory
Guide, Tool Holders, Drill
Guides, Cranial reducing
Tubes, Height Guides and
Tapping Tube
(K162604) | Table Adapters
Cable Sets
Marker
Tool Holder
Third party accessories
Tool Guides
Sterile Drapes
Manufacturer: Exact MM
(K101689)
Device Cover with 11G-14G
needle guide, P/N E2183
Device Cover with 15G-21G
needle guide, P/N E2184
Handheld Device Cover, P/N
11718EU | YES (4,6) |
| Real-time instru-
ment position | Yes (on third-party planning
or navigation station, or on
imaging device) | Yes (on StealthStation, us-
ing navigation) | Yes (on third-party planning
or navigation station, or on
imaging device) | YES (11) |
| Mechanical
Guidance of
Instruments | Yes | Yes | Yes | YES (4,13) |
| Technology | | | | |
| Powered | Yes | Yes | Yes | YES (4) |
| CE-Conformity | Yes | Yes | Yes | YES |
| Computer-con-
trolled | Yes | Yes | Yes | YES (4) |
| Materials | Metal, electronics and plas-
tics | Metal, electronics and
plastics | Metal, electronics and plas-
tics | YES (4) |
1 The numbers between brackets correspond to the numbered equivalence claims in the section "Similarities and Differences".
iSYS Medizintechnik GmbH, Bergwerksweg 21, 6370 Kitzbühel, Austria, Geschäftsführer: Dr. Michael Vogele, Thomas Pfeifer Firmensitz: Kitzbühel, Firmenbuchgericht: LG Innsbuchnr.: 348982 i, UID-Nr.: ATU65852918, St.Nr.: 103/0640
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Image /page/8/Picture/0 description: The image contains a logo with the letter 'i' in a stylized font. The word 'INTERVENTIONAL' is written in bold, uppercase letters to the right of the 'i'. Below 'INTERVENTIONAL', the word 'systems' is written in a smaller, non-bold font.
iSYS Medizintechnik GmbH, Bergwerksweg 21, 6370 Kitzbühel, Austria, Geschäftsführer: Dr. Michael Vogele, Thomas Pfeifer Firmensitz: Kitzbühel, Firmenbuchgericht: LG Innsbuchnr.: 348982 i, UID-Nr.: ATU65852918, St.Nr.: 103/0640
9
Image /page/9/Picture/0 description: The image contains a logo for Interventional Systems. The logo features a blue dot above a black number "1", followed by the word "INTERVENTIONAL" in black and the word "systems" in blue. The logo is simple and modern, with a focus on the company's name.
iSYS Medizintechnik GmbH, Bergwerksweg 21, 6370 Kitzbühel, Austria, Geschäftsführer: Dr. Michael Vogele, Thomas Pfeifer Firmensitz: Kitzbühel, Firmenbuchgericht: LG Innsbuchnr.: 348982 i, UID-Nr.: ATU65852918, St.Nr.: 103/0640
10
Image /page/10/Picture/0 description: The image contains a logo for a company called "Interventional Systems". The logo features a stylized letter "i" in black, with a blue dot above it. To the right of the "i", the word "INTERVENTIONAL" is written in bold, black letters. Below that, the word "systems" is written in a smaller, lighter blue font.
iSYS Medizintechnik GmbH, Bergwerksweg 21, 6370 Kitzbühel, Austria, Geschäftsführer: Dr. Michael Vogele, Thomas Pfeifer Firmensitz: Kitzbühel, Firmenbuchgericht: LG Innsbuchnr.: 348982 i, UID-Nr.: ATU65852918, St.Nr.: 103/0640
11
Image /page/11/Picture/0 description: The image shows the logo for Interventional Systems. The logo consists of a stylized letter "i" in black, with a blue circle above it. To the right of the "i" is the text "INTERVENTIONAL" in black, with the word "systems" in a smaller, blue font below it. The logo is simple and modern, with a focus on the company's name.
Similarities and Differences:
All three devices are intraoperative instruments used by surgeons for assisting the spatial positioning and orientation of a surgical tool.
The iSYS1 system is the first-generation robotic platform of iSYS Medizintechnik GmbH and Micromate™ is an evolution of iSYS1, preserving the operating principle and the intended use and indications, with a changed system architecture and control mechanism.
Furthermore, although the Micromate™ system and the Stealth Autoguide™ have different indications and a slightly different intended use, the hardware design of the main system components is the same, whereas software and the necessary table/bed adapters is also different.
The following list identifies the similarities and differences between the devices.
Micromate™ is equivalent to:
-
- iSYS1 for having a third-party planning software.
-
- iSYS1 for having the same intended use and indications, both in a wider, but compatible field of applications than that of the Stealth Autoguide™ .
-
- iSYS1 for being used by any trained physician.
-
- Stealth Autoquide™ system which is built according to the exact same core system architecture and same hardware design
-
- iSYS1 and Stealth Autoguide™ system for having the same operating principle by allowing an alignment to a surgical plan, thus assisting in the spatial positioning, orientation and guidance of a surgical tool.
-
- iSYS1 and Stealth Autoguide™ system for having the same type of accessories.
-
- iSYS1 and Stealth Autoquide™ system for being localized by an external navigation or imaging software.
-
- iSYS1 and Stealth Autoguide™ system for providing registration means for the imaging device and intra-operative calibration on the registration step.
-
- iSYS1 and Stealth Autoguide™ system for having the same instrument fixation means.
-
- iSYS1 and Stealth Autoguide™ system for having the final instrument guidance being performed by the physician.
-
- iSYS1 and Stealth Autoguide™ system for having real-time position information provided by an external platform and not by the device.
-
- iSYS1 and Stealth Autoquide™ system for supporting manual and automatic robotic movements.
-
- iSYS1 and Stealth Autoguide™ system for having tool guides as instrumentation.
-
- iSYS1 and Stealth Autoguide™ for not requiring fiducial registration with pointer probe.
-
- iSYS1 for not requiring optical registration for procedures performed with pre- and intra-operative imaging.
-
- iSYS1 and Stealth Autoguide™ for not requiring ultrasound registration.
-
- iSYS1 and Stealth Autoguide™ for having the user verifying the final accuracy.
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Image /page/12/Picture/0 description: The image shows the logo for Interventional Systems. The logo features a stylized "i" with a blue dot above a black vertical line. To the right of the "i" are the words "INTERVENTIONAL" in bold black letters and "systems" in a smaller, lighter blue font.
Differences:
- The Stealth Autoguide™ system uses only optical navigation as a way to provide real-time . position information whereas Micromate™ and the iSYS1 contain fiducial markers on the endeffector.
- . The Stealth Autoguide™ system is used in combination with the StealthStation for planning and navigation. The iSYS1 and Micromate™ have an open software interface that can be used to align the systems to a surgical plan defined on a third-party planning station.
- . The Stealth Autoquide™ system is used in combination with reusable surgical instruments specific to the defined indications, whereas the iSYS1 and Micromate™ rely on third-party sterile needle guides/tool guides and sterile drapes. Micromate™ uses different pre-approved sterile accessories than those used with iSYS1.
- While the Stealth Autoguide™ is indicated to be used by neurosurgeons only, the iSYS1 and ● Micromate™ are indicated to be used by any trained physician. This has no effects on safety and effectiveness.
- While the Stealth Autoguide™ uses proprietary reusable sterilizable instruments, the iSYS1 . and Micromate™ use third-party sterile disposables.
- The Stealth Autoguide™ utilizes optical navigation and optical registration, whereas the ● iSYS1 and the Micromate™ do not. Instead, the iSYS1 and Micromate™ rely on the live fluoroscopy imaging and/or marker fiducials on the tool holder
Non-Clinical Performance Data
Testing was conducted on the Micromate™ system to establish that the system is substantially equivalent to the predicate and reference devices and demonstrate and verify that the device will perform as intended according to the outlined design requirements below:
- IEC 60601-1:2005+AMD1:2012 Medical Electrical Equipment Part 1: General Require-● ments for Basic Safety and Essential Performance
- . IEC 60601-1-2:2014 - Medical Electrical Equipment - Part 1-2: General requirements for safety; Electromagnetic Compatibility - Requirements and Tests
- Software Verification and Validation testing verifying the operating system software require-. ments are met and software performs as intended
- . Hardware Verification testing ensuring the hardware requirements identified for the system are met and hardware performs as intended (this includes, but is not limited to, reliability lifetime testing, functional testing, performance testing including accuracy)
- Usability Engineering was conducted in accordance with IEC 62366 demonstrating that the usability and human factors requirements were adequately met.
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Image /page/13/Picture/0 description: The image shows the logo for Interventional Systems. The logo features a stylized "i" with a blue circle above a black vertical line. To the right of the "i" is the text "INTERVENTIONAL" in black, with "systems" in a smaller, light blue font below it. The logo is simple and modern, using a clean font and a limited color palette.
Statement of safety and effectiveness:
The Micromate™ is substantially equivalent to the legally marketed device iSYS1 (iSYS Medizintechnik GmbH). It is our opinion that the Micromate™ system does not have technological characteristics that raise additional types of questions related to terms of safety and effectiveness.
Conclusion:
The Micromate™ system has been shown through comparison, pre-clinical and clinical performance data to be substantially equivalent to or better than the identified predicate device. The system has the same intended use and similar indications for use as the predicate device, while having similar technological characteristics and principles of operation.
The minor differences in indications or technological aspects do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled.
iSYS Medizintechnik GmbH, Bergwerksweg 21, 6370 Kitzbühel, Austria, Geschäftsführer: Dr. Michael Vogele, Thomas Pfeifer Firmensitz: Kitzbühel, Firmenbuchgericht: LG Innsbuchn: 348982 i, UID-Nr.: ATU65852918, St.Nr.: 103/0640