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

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 realtime 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.

AI/ML Overview

The provided document describes a medical device, the Micromate™, and its substantial equivalence to predicate devices, primarily the iSYS1. It does not contain a detailed study proving the device meets specific acceptance criteria in the way one might expect for a new AI/ML-driven diagnostic device undergoing performance evaluation.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared device (iSYS1) based on similar technological characteristics and performance data. The "performance data" section states the measured accuracy of the Micromate™ in clinical use, which serves as evidence of its performance, but it doesn't explicitly link these measurements to predefined acceptance criteria in a tabular format as requested.

However, I can extract the reported performance data from the document and present it as if it were the outcome of a study aimed at demonstrating performance.

Here's an analysis based on the provided text, addressing the points you requested to the best of my abilitygiven the lack of specific "acceptance criteria" and a formal "study" in the AI/ML sense.

Device: Micromate™ (Medical Robotic Positioning Unit)

Purpose of the "Study" (Performance Data Section): To demonstrate the clinical accuracy of the Micromate™ device in assisting needle/instrument positioning, supporting its substantial equivalence claim.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria that the device had to meet to be cleared. Instead, it provides reported clinical performance data. For the purpose of this exercise, I will present the reported performance as if these were the metrics assessed in a "study" to support the device's capability.

Performance Metric	"Acceptance Criteria" (Implicit/Target)	Reported Device Performance (Clinical Use Data)
Accuracy of alignment to trajectory (Entry Point view)	Sufficient for safe and effective interventional procedures using CT/fluoroscopic imaging	0.43 ± 0.5 mm (average accuracy)
Angular deviation of needle	Sufficient for safe and effective interventional procedures using CT/fluoroscopic imaging	0.79 ± 0.41 degrees (average angular deviation)
95% Confidence Interval (CI) accuracy (position)	Not explicitly stated but expected to be within clinically acceptable limits (e.g., typically a few mm for image-guided procedures)	0.00 mm to 1.14 mm
95% Confidence Interval (CI) accuracy (angle)	Not explicitly stated but expected to be within clinically acceptable limits (e.g., typically a few degrees)	0.25 degrees to 1.70 degrees
Mechanical accuracy of system (standalone)	< 1 mm	Relative mechanical accuracy: 0.03 mmAbsolute mechanical accuracy: 0.2 mm

Note on "Acceptance Criteria": The document implies that the device's performance needs to be comparable to existing, legally marketed devices (predicates) and sufficient for its indicated use. The actual numerical targets for "acceptance" are not explicitly defined in this summary but are inferred from the context of clinical applicability. The listed performance metrics are the results used to demonstrate the device's capabilities.

Study Details:

Sample Size used for the test set and data provenance:
- Test Set Size: Not explicitly stated. The document mentions "actual clinical data" was used to calculate the 95% CI, but the number of cases or patients yielding this data is not provided.
- Data Provenance: "Actual clinical data." The document does not specify the country of origin or whether the data was retrospective or prospective. Given the manufacturer (iSYS Medizintechnik GmbH in Austria) and the predicate device, it's plausible the data originates from a European clinical setting, but this is not confirmed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes a robotic positioning system rather than a diagnostic AI algorithm requiring expert ground truth for interpretation (e.g., lesion detection). The "accuracy" metrics are physical measurements of the device's alignment and positioning capabilities relative to a planned trajectory.
- Therefore, the concept of "experts establishing ground truth" for image annotations or clinical diagnoses does not directly apply here. The "ground truth" for trajectory alignment would be the planned trajectory itself, and the measurement would be the deviation from that plan, verified by imaging after positioning. No specific mention of expert review of the clinical accuracy measurements is given, but it is implied that clinical use data was collected and analyzed.
Adjudication method for the test set:
- Not applicable in the context of this device's performance evaluation. The accuracy is a direct physical measurement of alignment against a pre-defined plan observed through imaging, not a subjective interpretation requiring adjudication.
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:
- No. This is a robotic positioning device, not an AI diagnostic algorithm for image interpretation. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant or described. The human operator (physician) uses the device to achieve the planned trajectory, but the "accuracy" refers to the device's mechanical and alignment precision.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a form of standalone testing was performed for the device's mechanical accuracy. The document states: "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." This represents a "standalone" evaluation of the robot's physical precision, independent of patient interaction or a full surgical workflow.
- The primary clinical performance data, however, ("actual clinical data") implicitly involves a human-in-the-loop (the surgeon manually advancing the instrument).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation appears to be the pre-operative surgical plan (defined using external planning software based on CT/fluoroscopic imaging) and the actual physical position/orientation of the needle guide as measured relative to this plan, under real-time imaging during clinical use.
- The "mechanical accuracy" ground truth is a predetermined physical location in air that the robot is commanded to, and its deviation from this physical target is measured.
The sample size for the training set:
- Not applicable. This document describes a medical robotic device, not an AI/ML algorithm that undergoes "training" on a dataset in the conventional sense. The device's operation is based on electromechanical principles and software control, not deep learning or statistical model training.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the AI/ML context for this device. The device's functionality is developed through engineering design, calibration, and verification/validation testing against design specifications and international standards, rather than data-driven machine learning.

Summary

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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

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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

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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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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

K203720

1. 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:
1. 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
1. 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.

1. 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 .

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.

1. 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
1. 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.
1. 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 GmbHBergwerksweg 216370 KitzbühelAustria	Medtronic Navigation, Inc.826 Coal Creek CircleLouisville, Colorado 80027United States	iSYS Medizintechnik GmbHBergwerksweg 216370 KitzbühelAustria
		DESIGN
General DeviceDescription	Computer controlled electro-mechanical multi-jointed armindicated for invasive proce-dures	Computer controlled elec-tromechanical multi-joinedarm indicated for use as astereotactic instrument	Computer controlled electro-mechanical multi-jointed armindicated for both stereotac-tic and non-stereotactic inva-sive procedures	YES (4)
LocalizationMeans	Fiducial markers on toolholder	Optical markers on toolholder	Fiducial markers on toolholder	YES (7)
Image-guided	Yes	Yes	Yes	YES (1,3,11)
Planning software	Third-party	Yes (StealthStation)	Third-party	YES (1)
Registrationmethod	By navigation/imaging soft-ware during intervention	By navigation/imagingsoftware during interven-tion	By navigation/imaging soft-ware during intervention	YES (4,7)
Instrumentation	MarkerTool HolderSterile Covers (third-party)	Reusable surgical instru-mentsNavigated TrajectoryGuide, Tool Holders, DrillGuides, Cranial reducingTubes, Height Guides andTapping Tube(K162604)	Tool GuidesSterile DrapesManufacturer: Exact MM(K101689)Device Cover with 11G-14Gneedle guide, P/N E2183Device Cover with 15G-21Gneedle guide, P/N E2184Handheld Device Cover, P/N11718EU	YES (13)
InstrumentFixation	Special tool holders for dif-ferent applications mountedto the device	Special tool holders for dif-ferent applicationsmounted to the Stealth Au-toguide™	Special tool holders for dif-ferent applications mountedto the device	YES (9)
InstrumentCalibration	Intra-operative	Intra-operative	Intra-operative	YES (8)
Planning and Navigation Software
N/A
System Operation
Fiducial markerswith registrationwith pointer probe	No	No	No	YES (14)
OpticalRegistration	No	Yes	No	Yes (15)
UltrasoundRegistration	No	No	No	YES (16)
AccuracyVerification	Yes, performed by user	Yes, performed by user	Yes, performed by user	YES (17)
Provide mechani-cal guidance fortools	Yes	Yes	Yes	YES (4)
Instrument GuidePositionAdjustment	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 carriesout final gesturethrough tool guide	Yes	Yes	Yes	YES (10)
Intended Use	The intended use of theiSYS1 device is to functionas a remote-operated posi-tioning and guidance systemduring interventional proce-dures. Positioning is done inremote control manner; plan-ning of the position/angula-tion is done based on 2D/3Dpatient data (CT, cone-beamCT, fluoroscopy) by externalplanning software – for ex-ample using an external nav-igation system, or planningsoftware coming with theused imaging device.Also, verification of the cor-rect position and orientationof the tool prior to/during/af-ter the intervention is doneby means of these externaldevices. The iSYS1-Systemis then acting as a guidewayduring the manual insertionof the interventional tool -usually a needle type device,and the like.Applications include, but arenot limited to, interventionslike biopsy procedures, tu-mor ablation, nerve blocking,electrode placement, etc.	The Stealth Autoguide™System is a positioningand guidance system in-tended for the spatial posi-tioning and orientation ofinstrument holders or toolguides to be used by neu-rosurgeons to guide stand-ard neurosurgical instru-ments, based on a pre-op-erative plan and feedbackfrom 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-operatedpositioning and guidancesystem during interventionalprocedures. Positioning isdone in a remote controlledmanner; planning of the po-sition/angulation is donebased on 2D/3D patient data(CT, cone-beam CT, fluoros-copy) by external planningsoftware - for example usingan external navigation sys-tem, or planning softwarecoming with the used imag-ing device.Also, verification of the cor-rect position and orientationof the tool prior to/during/af-ter the intervention is doneby means of these externaldevices. The Micromate™system is then acting as aguideway during the manualinsertion of the interventionaltool - usually a needle typedevice, and the like- througha third-party needle guide,manufactured by Exact MM(K101689): P/N E2183 (De-vice Cover with 11G-14Gneedle guide) or P/N E2184(Device Cover with 15G-21Gneedle guide). During opera-tion, the device is coveredwith a sterile drape, which ispart of the P/N E2183 andE2184. An additional third-party Control Unit Drape isavailable, also manufacturedby Exact MM (K101689):P/N 11718EU (HandheldDevice Cover).Applications include, but arenot limited to, interventionslike biopsy procedures, tu-mor ablation, nerve blocking,electrode placement, etc	YES (2,5)
Indications for Use	The iSYS 1 device is a user-controlled electromechanicalarm with a needle guide. It isintended to assist the sur-geon in the positioning of aneedle or electrode whereboth computed tomography(CT) and fluoroscopic imag-ing can be used for targettrajectory planning and in-traoperative tracking. Theneedle or electrode is thenmanually advanced by thesurgeon. Trajectory planningis made with software that isnot part of the iSYS device.	The Stealth Autoguide™System is a remotely-oper-ated positioning and guid-ance system, indicated forany neurological conditionin which the use of stereo-tactic surgery may be ap-propriate (for example,stereotactic biopsy, stereo-tactic EEG, laser tissueablation, etc.).	The Micromate™ device is auser-controlled electrome-chanical arm with a needleguide. It is intended to assistthe surgeon in the position-ing of a needle or instrumentwhere both computed to-mography (CT) and fluoro-scopic imaging can be usedfor target trajectory planningand intraoperative tracking.The needle or electrode isthen manually advanced bythe surgeon. Trajectory plan-ning is made with softwarethat 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 AdaptersCable SetsMarkerTool HolderTool Guides (third party)Sterile Covers (third-party)	Sterile DrapesHead Clamp AdapterCable SetsReusable surgical instru-mentsNavigated TrajectoryGuide, Tool Holders, DrillGuides, Cranial reducingTubes, Height Guides andTapping Tube(K162604)	Table AdaptersCable SetsMarkerTool HolderThird party accessoriesTool GuidesSterile DrapesManufacturer: Exact MM(K101689)Device Cover with 11G-14Gneedle guide, P/N E2183Device Cover with 15G-21Gneedle guide, P/N E2184Handheld Device Cover, P/N11718EU	YES (4,6)
Real-time instru-ment position	Yes (on third-party planningor navigation station, or onimaging device)	Yes (on StealthStation, us-ing navigation)	Yes (on third-party planningor navigation station, or onimaging device)	YES (11)
MechanicalGuidance ofInstruments	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 andplastics	Metal, electronics and plas-tics	YES (4)

1 The numbers between brackets correspond to the numbered equivalence claims in the section "Similarities and Differences".

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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.

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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.

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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.

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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:

1. iSYS1 for having a third-party planning software.
1. iSYS1 for having the same intended use and indications, both in a wider, but compatible field of applications than that of the Stealth Autoguide™ .
1. iSYS1 for being used by any trained physician.
1. Stealth Autoquide™ system which is built according to the exact same core system architecture and same hardware design
1. 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.
1. iSYS1 and Stealth Autoguide™ system for having the same type of accessories.
1. iSYS1 and Stealth Autoquide™ system for being localized by an external navigation or imaging software.
1. iSYS1 and Stealth Autoguide™ system for providing registration means for the imaging device and intra-operative calibration on the registration step.
1. iSYS1 and Stealth Autoguide™ system for having the same instrument fixation means.
1. iSYS1 and Stealth Autoguide™ system for having the final instrument guidance being performed by the physician.
1. iSYS1 and Stealth Autoguide™ system for having real-time position information provided by an external platform and not by the device.
1. iSYS1 and Stealth Autoquide™ system for supporting manual and automatic robotic movements.
1. iSYS1 and Stealth Autoguide™ system for having tool guides as instrumentation.
1. iSYS1 and Stealth Autoguide™ for not requiring fiducial registration with pointer probe.
1. iSYS1 for not requiring optical registration for procedures performed with pre- and intra-operative imaging.
1. iSYS1 and Stealth Autoguide™ for not requiring ultrasound registration.
1. 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.

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.