The Micromate™ Navi+ device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the user in the positioning of 8-19 gauge needles in the chest, abdomen and musculoskeletal structures when computed tomography (CT) optical navigation can be used for target trajectory planning and intra-operative tracking. The needle is then manually advanced by the user. Trajectory planning is made with software that is a part of the Micromate™ Navi+ device.

Device Description

The Micromate™ Navi+ system allows the percutaneous execution of a surgical intervention by providing instrument guidance according to one or more pre-operative plans defined by an internal planning and navigation software (MicroNav). 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 optical CT navigation (tracked by camera). After alignment, the advancement of surgical instruments and delivery of therapy is performed manually by the user, while the position is retained by the targeting platform of Micromate™ Navi+, relying on the displayed navigation information or real-time images from third party imaging device.

The Micromate Navi+ device is intended for biopsy and percutaneous tumor ablation procedures, in the abdomen, thorax and musculoskeletal tissue.

The Micromate™ Navi+ 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, device that allows the automatic or manual control of the Targeting Platform movement and can communicate with an internal planning and navigation station,
Positioning Arm, a multi-functional arm that is used to gross-position the Targeting Platform in such a way the traiectory 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 internal planning and navigation station for input of real-time navigation data,
Connecting Cables.

and following Accessories:

Sterile Drapes for the Control Unit and Targeting Platform,
Needle guides for instrument guidance, packaged together with a drape for the sterile covering of the Targeting Platform,
Sterile Tracker, to which off-the-shelf mounting spheres can be attached, to enable optical tracking for the localization of the Targeting Platform in space,
A trolley for transport and storage,
Medical grade PC,
Camera tracking system,
Planning and navigation software (MicroNav).

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Micromate™ Navi+ device, which is a user-controlled electromechanical arm with a needle guide intended to assist in positioning 8-19 gauge needles in the chest, abdomen, and musculoskeletal structures under CT optical navigation.

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numbered or bulleted list with specific numerical thresholds for clinical performance. However, it details the performance achieved which, implicitly, must have met internal or regulatory acceptance thresholds for substantial equivalence. The key performance metrics reported are accuracy measurements.

Metric (Implicit Acceptance Criteria)	Reported Device Performance
Bench-Test Accuracy (Lateral Deviation)	1.04 ± 0.60 mm
Bench-Test Accuracy (Angular Deviation)	0.75 ± 0.47º
Clinical Guidance Accuracy - Abdominal (Lateral Deviation)	1.48 ± 1.18 mm
Clinical Guidance Accuracy - Abdominal (Angular Deviation)	1.04 ± 0.97º
Clinical Guidance Accuracy - Musculoskeletal (Lateral Deviation)	0.62 ± 0.41 mm
Clinical Guidance Accuracy - Musculoskeletal (Angular Deviation)	0.61 ± 0.41º
Clinical Guidance Accuracy - Thoracic (Lateral Deviation)	1.76 ± 1.26 mm
Clinical Guidance Accuracy - Thoracic (Angular Deviation)	1.34 ± 0.82º
Overall Clinical Guidance Accuracy (Lateral Deviation)	1.33 ± 1.13 mm
Overall Clinical Guidance Accuracy (Angular Deviation)	1.02 ± 0.83º
Worst-Case Expectable Clinical Accuracy - Abdomen	6.93 mm
Worst-Case Expectable Clinical Accuracy - Musculoskeletal	4.12 mm
Worst-Case Expectable Clinical Accuracy - Thorax	7.41 mm
Worst-Case Expectable Clinical Accuracy - Overall	6.40 mm
Needle Readjustment Rate	0.13 ± 0.45 times per procedure
Navigation Accuracy per ASTM F2554-18 (95% CI)	Below 2mm (lateral), Below 2º (angular) from trajectory

The document states: "The overall scope of accuracy testing supported, with high statistical confidence, a positive conclusion on the safe and effective use of the device in a clinical setting." This suggests that the reported accuracy values and the low needle readjustment rate were deemed acceptable by the manufacturer and, subsequently, by the FDA for substantial equivalence.

2. Sample Size and Data Provenance

Test Set Sample Size:
- Clinical Guidance Accuracy: 54 interventions (19 abdominal lesions, 19 thoracic lesions, and 16 musculoskeletal lesions). This constitutes the number of procedures in which performance data was collected.
- Bench Test Accuracy: The sample size for the bench test is not explicitly stated in terms of number of measurements, but it refers to the validation per ASTM F2554-18.
Data Provenance: The text does not specify the country of origin for the clinical study data or whether it was retrospective or prospective. It only mentions the manufacturer's location as Austria. It states "data gathered in simulated clinical environment" for pre-clinical performance data and then discusses "clinical guidance accuracy," implying a clinical study for that part.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). For the clinical guidance accuracy, it would implicitly be the outcome of surgical procedures, likely assessed post-procedure by imaging or surgical confirmation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. Ground truth appears to be based on the outcome of the interventional procedures as measured by CT imaging after needle placement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted. The study focuses on the device's accuracy in assisting human users, not on comparing outcomes of human readers with vs. without AI assistance in interpretation. The device is a navigation system for needle placement, not primarily an AI for image interpretation.

6. Standalone (Algorithm Only) Performance

The device is described as a "user-controlled electromechanical arm." Its "planning and navigation software (MicroNav)" is an integral part of the device assisting the user. The study focuses on the device's accuracy in assisting the user in needle placement. Therefore, a standalone (algorithm only without human-in-the-loop) performance study, in the sense of an AI interpreting images, is not applicable or described in this context. The "bench-test accuracy" could be considered a form of standalone performance for the mechanical/software system, independent of a live clinical user's influence beyond initial setup.

7. Type of Ground Truth Used

The ground truth for accuracy validation appears to be based on objective measurement of the actual needle position relative to the planned trajectory using imaging (CT) after the procedure. This is inferred from "lateral deviation" and "angular deviation" measurements in both "simulated use environment" (bench-test) and "clinical guidance accuracy." It is not explicitly stated to be "expert consensus" or "pathology outcomes data" in the traditional sense of diagnostic AI.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set for the planning and navigation software (MicroNav). This information is typically not included in a 510(k) summary relating to substantial equivalence unless significant changes in software algorithms or AI training are explicitly being reviewed.

9. How the Ground Truth for the Training Set was Established

The document does not specify how the ground truth for the training set of the MicroNav software was established. Given the nature of a medical device 510(k) submission, the focus is on verification and validation (V&V) of the final product, rather than the developmental steps like training data ground truth establishment, unless it directly impacts the safety and effectiveness of the device in a novel way. However, software verification and validation testing are mentioned, performed in accordance with FDA Guidance and IEC 62304.

Summary

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October 10, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health and Human Services logo, which features an abstract image of a human figure. To the right of this is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font. The word "FDA" is in a larger, bolder font than the rest of the text.

ISYS Medizintechnik GMBH % Pedro Costa Bergwerksweg 21, Salzburg Kitzbuehel, AT 6370 AUSTRIA

Re: K230130

Trade/Device Name: Micromate™ Navi+ Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 8, 2023 Received: September 8, 2023

Dear Pedro Costa:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part

820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Lu Jiang

Lu Jiang, Ph. D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K230130

Device Name Micromate™ Navi+

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X 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 consists of a blue icon on the left and the words "INTERVENTIONAL SYSTEMS" on the right. The icon is a stylized representation of three curved lines that converge at the bottom. The text is in a bold, sans-serif font and is also blue.

510(k) Summary (K230130)

1. Applicant: iSYS Medizintechnik GmbH
1. Address: Berawerkswea 21

6370 KITZBÜHEL / AUSTRIA

Pedro Costa 3. Contact Person:
Tel. +351 919 073 292 e-mail: Pedro.Costa@interventional-systems.com
1. Preparation Date: December 2022.
Micromate™ Navi+ Trade Name: 5.
1. Common Name: Robotic Positioning Unit
Classification 7. Computed tomography x-ray system Name: Product Code JAK, Reg.No. 892.1750
Substantial Equiva-Micromate™ Navi+ is substantially equivalent to the following legally mar-8. keted devices: lence:

Predicate Device:

Micromate™ (iSYS Medizintechnik GmbH), K203720 Product Code JAK, Reg. No. 892.1750

Reference Device:

Excelsius GPS System (Globus Medical Inc), K171651 Product Code OLO, Reg. No. 882.4560

1. Purpose The purpose of this submission is clearance of Micromate™ Navi+ as a new version of previously cleared Micromate™ (K203720) device that is complemented with additional/changed accessories and components, aimed to improve device performance by supporting and augmenting the already existing features as well as to expand its capabilities to Optical Navigation workflow.
  The characteristics of Micromate™ Navi+ device are equivalent to those of the predicate and/or reference device identified on the comparison table, which is provided with the premarket notification submission. It is our opinion that Micromate™ Navi+ system does not have technological characteristics that raise additional questions related to terms of safety and effectiveness.
1. Device Description: The Micromate™ Navi+ system allows the percutaneous execution of a surgical intervention by providing instrument guidance according to one or more pre-operative plans defined by an internal planning and navigation software (MicroNav). 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 optical CT navigation (tracked by camera). After alignment, the advancement of surgical instruments and delivery of therapy is performed manually by the user, while the position is retained by the targeting platform of

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Image /page/4/Picture/0 description: The image contains a logo for Interventional Systems. The logo consists of a blue icon on the left and the text "INTERVENTIONAL SYSTEMS" on the right. The icon is a stylized representation of three curved lines, resembling a hand or a wave. The text is in a bold, sans-serif font, with "INTERVENTIONAL" on the top line and "SYSTEMS" on the bottom line.

Micromate™ Navi+, relying on the displayed navigation information or real-time images from third party imaging device.

The Micromate Navi+ device is intended for biopsy and percutaneous tumor ablation procedures, in the abdomen, thorax and musculoskeletal tissue.

The Micromate™ Navi+ 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, device that allows the automatic or manual control of the Targeting Platform movement and can communicate with an internal planning and navigation station,
. Positioning Arm, a multi-functional arm that is used to gross-position the Targeting Platform in such a way the traiectory 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 internal planning and navigation station for input of real-time navigation data,
. Connecting Cables.

and following Accessories:

Sterile Drapes for the Control Unit and Targeting Platform, .
Needle guides for instrument guidance, packaged together with a . drape for the sterile covering of the Targeting Platform,
Sterile Tracker, to which off-the-shelf mounting spheres can be at-● tached, to enable optical tracking for the localization of the Targeting Platform in space,
A trolley for transport and storage, .
. Medical grade PC,
. Camera tracking system,
Planning and navigation software (MicroNav). .

For listed accessories following table is the proposal of classification according to Title 21 of the Code of Federal Requlations (CFR), Parts 862-892:

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Image /page/5/Picture/0 description: The image contains a logo for a company called Interventional Systems. The logo consists of a stylized blue hand-like symbol on the left, followed by the words "INTERVENTIONAL" and "SYSTEMS" stacked on top of each other in blue. The hand-like symbol is made up of four curved lines that converge at the bottom.

Accessory:	Is intended for use with one or more parent devices?	Is intended to support, supplement, and/or augment the performance of one or more parent devices?	Proposed accessory classification	Comment
MicroNav (planning and navigation software)	Yes, according to MicroNav intended use:	The MicroNav is intended to support the alignment of an external targeting platform (such as Micromate ™) to a plan defined pre- or intra-operatively by the user, in image-guided procedures.	Inclusion in the same classification as the parent device.Regulation No. 892.1750System, X-ray, Tomography, computed.Product Code: JAKClass II
Medical grade PC	Yes, Cybermed S24 Medical grade PC is intended to support Micromate™ by providing PC hardware environment for proper operation of MicroNav software and necessary communication/data transfer to other accessories or components of the system, temporary storage of provided data, conversion, and display of provided DICOM images.Intended use: CyberMed S series products are designed for general pc application in the health care environment. It can be used for Radiology, PACS (Picture Archiving Communication Systems),LIS (Lab Information Systems), COW (Computer on Wheels), and Electronic Medical Record purposes. It shall not be used for life-supporting systems.		Inclusion in the same classification as the parent device.Regulation No. 892.1750System, X-ray, Tomography, computedProduct Code JAKClass II	Medical grade PC used as component in already 510(k) cleared deviceDevice name: Practical Navigation Surgical Guidance System (PNSGS)Applicant: Practical Navigation, LLC (K202184)
Atracsys camera	Yes, the SpryTrack sTk180 Optical Tracking System is a flexible, real-time tracking technology based on a stereo camera approach intended to support and augment Micromate™ during the navigated workflow procedure.		Inclusion in the same classification as the parent device.Regulation No. 892.1750System, X-ray, Tomography, computedProduct Code JAKClass II	/
Trolley(Supplier: ITD GmbH)	Yes: Third party trolley manufactured by ITD GmbH (FDA registration number 3007713438). The uni-cart single-column cart is small, manoeuvrable and ideal for space-saving, mobile use. It offers a high degree of stability for the integration of small medical devices and monitors for patient monitoring intended to support Micromate™ by providing a platform for storage and transport of device components and accessories.		FDA listed device:Device name: Uni-cartRegistered Establishment Name: ITD GMBHRegulation No. 868.6175Class I510(k) exempt	/
Optical tracker	Yes, according to intended use: Optical tracker is a rigid frame intended to provide necessary position in space of tracking spheres in accordance to Micromate end-effector.		Already 510(k) cleared:EXACT MEDICAL MANUFACTURING, INC (K101689)	/
Tracking spheres	Yes, disposable Tracking spheres is intended to be used for patient referencing and tool registration in image guided surgeries.Indications for use: For use as a stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgery. It is indicated for any medical condition in which the use of sterotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure can be identified relative to a CT or MB-based model of the anatomy		Already 510(k) cleared: I.Z.I. CORP. (K022074)	/

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Image /page/6/Picture/0 description: The image contains the logo for Interventional Systems. The logo consists of a blue icon on the left and the words "INTERVENTIONAL SYSTEMS" on the right. The icon is a stylized representation of three curved lines that resemble fingers or a hand. The words "INTERVENTIONAL SYSTEMS" are stacked on top of each other, with "INTERVENTIONAL" on the top line and "SYSTEMS" on the bottom line.

The system can be mounted to different bed/table through a specific adapter for each type of table. Third-party sterile instruments, tool guides and optical tracker (with spheres) are connected over the sterile drape to the Targeting Platform end-effector.

Micromate™ Navi+ is not patient contacting.

The intended use of the Micromate™ Navi+ device is to function as a re-11. Intended Use: mote-operated positioning and guidance system for needle placement during interventional procedures. Positioning is done in a remote-controlled manner; planning of the position/anqulation is done based on 2D/3D patient data (CT) using an internal image-guided planning and navigation system. The verification of the correct position and orientation of the tool prior to/during/after the intervention is done by means of external imaging devices. The Micromate™ Navi+ 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 Medical Manufacturing Inc. (K101689): P/N E2178 (Micromate Needle Guide, 8-11G), P/N E2183 (Micromate Needle Guide, 10-14G)

and P/N E2184 (Micromate Needle Guide, 15-21G). During operation, the device is covered with a sterile drape, which is part of the P/N2178, P/N E2183 and E2184. An additional third-party Control Unit Drape is available, also manufactured by Exact Medical Manufacturing Inc. (K101689): P/N 11718EU (Micromate Control Unit Drape), tracker frame P/N: E6842, and tracker spheres P/N: 2010 (K022074).

Micromate Navi+ is Intended only for adult use.

Indications for use: The Micromate™ Navi+ device is a user-controlled electromechanical arm 12. with a needle quide. It is intended to assist the user in the positioning of 8-19 gauge needles in the chest, abdomen and musculoskeletal structures when computed tomography (CT) optical navigation can be used for target trajectory planning and intra-operative tracking. The needle is then manually advanced by the user. Trajectory planning is made with software that is a part of the Micromate™ Navi+ device.

13. Clinical use

Preparing the system:

After bringing sterile disposables into the operating room, bring the Micromate™ to the vicinity of the operating table, outside of the sterile field. Position the image-guided panning and navigation station. Prepare the patient according to hospital procedure by placing it in the appropriate position on the OR table.

Mounting the system on OR environment O

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Image /page/7/Picture/0 description: The image shows the logo for Interventional Systems. The logo consists of a blue abstract graphic on the left and the words "INTERVENTIONAL SYSTEMS" in blue on the right. The word "INTERVENTIONAL" is above the word "SYSTEMS".

The Targeting Platform is affixed to the OR Table using a multi-functional mechanical O support arm, ensuring that the Targeting Platform has sufficient range of motion to be placed over the surgical site
Inserting the adequate end-effector type as per selected workflow in predicted slot on O targeting platform
Connecting cables between system components O
Draping the system with third-party sterile drape cover (sterile barrier to isolate non-sterile O system components)
The compact tracking Camera is rigidly affixed to the OR table using a multifunctional O mechanical support arm in the appropriate position to track the surgical site (option for navigated workflow)
Perform image recording according to CT navigation workflow. On an external CT sys- O tem perform a volume scan.
Bring the targeting platform to HOME position. O

CT Navigated workflow:

Prerequisites:

The tracker camera is mounted. o
Tracker with tracking spheres is mounted on the Micromate Targeting Platform end effec-O tor
Both positioning arms, for camera and Micromate Targeting Platform are locked. o Workflow steps:
o Load the study (image data) into a planning and navigation from a PACS query, direct Communication with the CT or by data on USB flash drive
The software detects the position of the targeting platform in medical images, in relation O to the surgical anatomy based on fiducial markers on the targeting platform
The system optically tracks its position in real-time, using a peripheral tracking camera. O and transmits that information to the software
Confirmation of the valid RMS registration assessment (green mark) is done by navigation O station for both for the Camera and for the Tracker
Select the instrument type and size and confirm O
O Define single plan or multiple plans of intervention
Perform the gross-positioning of targeting platform by adjusting the positioning arm o
Using the available tools on the external modality, check validity of the trajectory (entry O and target point) and confirm
Perform the intervention (manual insertion of guided instrument performed by the user). o
1. Biocompatibility The Micromate™ Navi+ is not in contact with the patient. At any time, when in 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.

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Image /page/8/Picture/0 description: The image shows the logo for Interventional Systems. The logo consists of a blue graphic on the left and the words "INTERVENTIONAL SYSTEMS" on the right. The graphic is a stylized representation of three curved lines. The text is in a bold, sans-serif font and is also blue.

Device comparison summary

Reference	Micromate™(predicate device)K203720	Micromate™ Navi+(subject device)K230130	Excelsius GPS™(reference device)K171651
510(k) Number	K203720	K230130	K171651
Manufacturer	iSYS MedizintechnikGmbH Bergwerksweg 21 6370Kitzbühel Austria	iSYS MedizintechnikGmbH Bergwerksweg 21 6370Kitzbühel Austria	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
	DESIGN
General DeviceDescription	Computer controlled electrome-chanical multi-jointed arm indi-cated for both stereotactic andnon-stereotactic invasiveprocdures.The Micromate™ system allowsthe percutaneous execution of asurgical intervention by providinginstrument guidance accordingto one or more pre-operativeplans defined in an externalplanning or navigation station.The alignment to the surgicalplan is performed through amanual gross positioning using aPositioning Arm, followed by au-tomatic or joystick-controlledmovement with image guidance,such as CT and fluoroscopic im-age.	Computer controlled electrome-chanical multi-jointed arm indi-cated for both stereotactic andnon-stereotactic invasiveprocedures.The Micromate™ Navi+ systemallows the percutaneous execu-tion of a surgical intervention byproviding instrument guidanceaccording to one or more pre-op-erative plans defined in planningor navigation station.The alignment to the surgicalplan is performed through a man-ual gross positioning using a Po-sitioning Arm, followed by auto-matic or joystick-controlledmovement with image guidance,such as CT.	The EXCELSIUS GPS™ is aRobotic Positioning Systemthat includes acomputer controlled roboticarm, hardware, and softwarethat enables real timesurgical navigation and roboticguidance using radiological pa-tient images(preoperative CT, intraopera-tive CT and fluoroscopy), usinga dynamic referencebase and positioning camera
LocalizationMethod	Optical system (infraredcamera)	Optical system (infraredcamera)	Optical system (infraredcamera)
Planning soft-ware	Third-party	Yes (MicroNav)	Yes (EXCELSIUS™ GPSPlanning and NavigationApplication software)
Registrationmethod	By navigation/imaging softwareduring intervention	By navigation/imaging softwareduring intervention. Registrationfixture during 3D intraoperativeimages is part of the TargetingPlatform's end-effector.	Registration fixture during 3Dintraoperative images. Fluoro-scopic merge to pre-op CTRegistration fixture in placeduring fluoroscopy
Instrumentation	Tool Guides P/N: 11718EU(Sterile Drapes Manufacturer:Exact MM (K101689), P/NE2178 (Micromate Needle GuideSet, 8-11G), P/N E2183 (Micro-mate Needle Guide Set, 10-14G)and P/N E2184 (Micromate Nee-dle Guide Set, 15-21G). Duringoperation, the device is coveredwith a sterile drape, which is partof the P/N2178, P/N E2183 andE2184. An additional third-partyControl Unit Drape is available,	Tool Guides P/N: 11718EU(Sterile Drapes Manufacturer:Exact Medical Manufacturing Inc.(K101689), P/N E2178 (Micro-mate Needle Guide, 8-11G), P/NE2183 (Micromate NeedleGuide,10-14G) and P/N E2184(Micromate Needle Guide, 15-21G). During operation, the de-vice is covered with a steriledrape, which is part of theP/N2178, P/N E2183 and E2184.An additional third-party ControlUnit Drape is available, alsomanufactured by Exact Medical	N/A

	also manufactured by Exact MM(K101689): P/N 11718EU (Mi-cromate Control Unit Drape	Manufacturing Inc. (K101689):P/N 11718EU (Micromate Con-trol Unit Drape
InstrumentFixation andInstrumentGuidePositionAdjustment	Special tool holders for differentapplications mounted to thedeviceTrajectory and location set bythe robot. Instruments are manu-ally positioned by the userthrough the needle guides on therobotic arm.	Special tool holders for differentapplications mounted to thedeviceTrajectory and location set by therobot. Instruments are manuallypositioned by the user throughthe needle guides on the roboticarm.	Trajectory and location set bythe robotic arm. Instrumentsare manually positioned by theuser through the Guide Tubeon the robotic arm.
	System Operation
Principles ofoperation	Positioning and guidance systemintended for the spatial position-ing and orientation of instrumentholders or tool guides to be usedto hold and guide standard in-struments, based on a pre-oper-ative, operative (real time) planor feedback from an image-guided navigation system or tra-jectory planning station with two-dimensional or three-dimen-sional imaging software.• Provide a mechanical connec-tion to positioning devices on in-terventional tables.• Align to an active surgical planin a planning or navigation sys-tem.• Provide manual or automaticmotion control.• Support the insertion and re-lease of instrumentation, throughan accessory end-effector.	Positioning and guidance systemintended for the spatial position-ing and orientation of instrumentholders or tool guides to be usedto hold and guide standard in-struments, based on a pre-oper-ative, operative (real time) planor feedback from an image-guided navigation system or tra-jectory planning station with two-dimensional or three-dimensionalimaging software.• Provide a mechanical connec-tion to positioning devices on in-terventional tables.• Align to an active surgical planin a planning or navigation sys-tem.• Provide manual or automaticmotion control.• Support the insertion and re-lease of instrumentation, throughan accessory end-effector.	Intraoperativepreoperative imagesPatient registrationSurgical planningReal-time tracking of navigatedinstrumentsGuidance of instruments
Input Images	N/A	3D Pre-operative images3D Intraoperative images2D Intraoperative images	3D Pre-operative images3D Intraoperative images2D Intraoperative images
Trajectoryplanningparameters	N/A	Entry point, target point, length ofthe trajectory, diameter of the in-strument	Entry point, target point, lengthof the instrument, diameter
Camera system	N/A	Stereo	Stereo
Image-guided	YES	YES	YES
Accuracyverificationlandmarks	N/A	YES (Scout scans, live fluoros-copy imaging, or acquisition of anew volume scan for re-registra-tion)	YES (Landmark anatomical ar-ray)
AccuracyVerification	Yes (performed by user)	Yes (performed by user)	Yes
Intended Use	The intended use of the Micro-mate™ device is to function as aremote-operated positioning andguidance system during inter-ventional procedures. Position-ing is done in a remote con-trolled manner; planning of theposition/angulation is donebased on 2D/3D patient data	The intended use of the Micro-mate™ Navi+ device is to func-tion as a remote-operated posi-tioning and guidance system forneedle placement during inter-ventional procedures. Positioningis done in a remote-controlledmanner; planning of the posi-tion/angulation is done based on	N/A

	(CT, cone-beam CT, fluoros-copy) by external planning soft-ware - for example using an ex-ternal navigation system, orplanning software coming withthe used imaging device.Also, verification of the correctposition and orientation of thetool prior to/during/after the inter-vention is done by means ofthese external devices. The Mi-cromate™ system is then actingas a guideway during the manualinsertion of the interventional tool- usually a needle type device,and the like- through a third-party needle guide, manufac-tured by Exact MM (K101689):P/N E2178 (Micromate NeedleGuide Set, 8-11G), P/N E2183(Micromate Needle GuideSet,10-14G) and P/N E2184 (Mi-cromate Needle Guide Set, 15-21G). During operation, the de-vice is covered with a steriledrape, which is part of theP/N2178, P/N E2183 and E2184.An additional third-party ControlUnit Drape is available, alsomanufactured by Exact MM(K101689): P/N 11718EU (Mi-cromate Control Unit Drape).Applications include, but are notlimited to, interventions like bi-opsy procedures, tumor ablation,	internal image-guided planningand navigation system.The verification of the correct po-sition and orientation of the toolprior to/during/after the interven-tion is done by means of externalimaging devices. The Micro-mate™ Navi+ system is then act-ing as a guideway during themanual insertion of the interven-tional tool - usually a needle typede-vice, and the like- through athird-party needle guide, manu-factured by Exact Medical Manu-facturing Inc. (K101689): P/NE2178 (Micromate NeedleGuide, 8-11G), P/N E2183 (Mi-cromate Needle Guide,10-14G)and P/N E2184 (Micromate Nee-dle Guide, 15-21G). During oper-ation, the device is covered witha sterile drape, which is part ofthe P/N2178, P/N E2183 andE2184. An additional third-partyControl Unit Drape is available,also manufactured by ExactMedical Manufacturing Inc.(K101689): P/N 11718EU (Micro-mate Control Unit Drape), trackerframe P/N: E6842, and trackerspheres P/N: 2010 (K022074).Micromate Navi+ is Intendedonly for adult use.
	nerve blocking, electrode place-

	ment, etc.
Indications forUse	The Micromate™ device is a	The Micromate™ Navi+ device is	The EXCELSIUS GPS™ is in-
	user-controlled electromechani-	a user-controlled electromechan-	tended for use as an aid for
	cal arm with a needle guide. It is	ical arm with a needle guide. It is	precisely locating anatomical
	intended to assist the user in the	intended to assist the user in the	structures and for the spatial
	positioning of a needle or instru-	positioning of 8-19 gauge nee-	positioning and orientation of
	ment where both computed to-	dles in the chest, abdomen and	an instrument holder or Guide
	mography (CT) and fluoroscopic	musculoskeletal structures when	Tube to be used by users for
	imaging can be used for target	computed tomography (CT) opti-	navigating and/or guiding com-
	trajectory planning and intraoper-	cal navigation can be used for	patible surgical instruments in
	ative tracking. The needle or	target trajectory planning and in-	open or percutaneous proce-
	electrode is then manually ad-	tra-operative tracking. The nee-	dures provided that the re-
	vanced by the user. Trajectory	dle is then manually advanced by	quired fiducial markers and
	planning is made with softwarethat is not part of the Micro-mate™ device.	the user. Trajectory planning ismade with software that is a partof the Micromate™ Navi+ device.	rigid patient anatomy can beidentified on CT scans or fluor-oscopy. The system is indi-
			cated for the placement of spi-
			nal and orthopedic bone
			screws.
Anatomicalsite	Total body	Total body	The system is indicated for theplacement
			of spinal and orthopedic bonescrews.
User	Physician	Physician	N/A
Real-time in-strument posi-tion	Yes (on third-party planning ornavigation station, or on imagingdevice)	Yes (on planning or navigationstation, or on imaging device)	Yes
Technology
Powered	Yes	Yes	Yes
CE-Conformity	Yes	Yes	Yes
Computer-con-trolled	Yes	Yes	Yes
Materials	Metal, electronics and plastics	Metal, electronics and plastics	N/A

iSYS Medizintechnik GmbH, Bergwerksweg 21, 6370 Kitzbühel, Austria,

Geschäftsführer: Dr. Michael Vogele, Thomas Pfeifer, Srdan Milosavljevic, Pedro Costa

Firmensitz: Kitzbühel, Firmenbuchgericht: LG Innsbuchnr.: 348982 i, UID-Nr.: ATU65852918, St.Nr.: 103/0640

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Image /page/9/Picture/0 description: The image shows the logo for Interventional Systems. The logo consists of a blue icon on the left and the words "INTERVENTIONAL SYSTEMS" on the right. The icon is a stylized hand with three fingers and a thumb. The text is in a sans-serif font and is also blue.

Geschäftsführer: Dr. Michael Vogele, Thomas Pfeifer, Srdan Milosavljevic, Pedro Costa
Firmensitz: Kitzbühel Firmenbuchgericht: LG Innsbruck Firmenbuchnr. 348982 i UID.Nr · ATU65852918 St Nr. 103/0640

Firmensitz: Kitzbühel, Firmenbuchgericht: LG Innsbuchn: 348982 i, UID-Nr.: ATU65852918, St.Nr.: 103/0640

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Image /page/10/Picture/0 description: The image shows the logo for Interventional Systems. The logo consists of a blue abstract symbol on the left and the words "INTERVENTIONAL SYSTEMS" in blue on the right. The word "INTERVENTIONAL" is above the word "SYSTEMS".

SYS Medizintechnik GmbH, Bergwerksweg 21, 6370 Kitzbühel, Austria,

Firmensitz: Kitzbühel, Firmenbuchgericht: LG Innsbuchn: 348982 i, UID-Nr.: ATU65852918, St.Nr.: 103/0640

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Image /page/11/Picture/0 description: The image shows the logo for Interventional Systems. The logo consists of a blue icon on the left and the words "INTERVENTIONAL SYSTEMS" on the right. The icon is a stylized hand with three fingers, each made of two parallel lines. The words "INTERVENTIONAL SYSTEMS" are stacked on top of each other, with "INTERVENTIONAL" on top and "SYSTEMS" on the bottom.

Similarities and Differences:

The Micromate™ system is the second generation robotic platform of iSYS Medizintechnik GmbH and Micromate™ Navi+ is an evolution of Micromate™, preserving the intended use and indications for use, with a changed system architecture and intervention planning input, further expanding available features and workflow set equivalent to suggested FDA cleared devices. Details of equivalence are presented in the device comparison table.

The Micromate™ Navi+ system and the Micromate™ have same indications and the same intended use, the hardware and firmware design of the control unit and targeting platform is the same, whereas Micromate™ Navi+ system comprises of additional/changed accessories internal planning software, trolley, and third-party external accessories: medical PC, camera and the necessary table/bed adapters are also different. Expanding features are supported by additional positioning arm for camera.

The following list identifies the similarities and differences between the devices.

Micromate™ Navi+ is equivalent to:

1. Micromate™ for having the same general intended use. The intended use of the Micromate Navi+ is a subset of Micromate™ intended use. The Micromate™ Navi+ is therefore equivalent to predicate in this respect within its indications for use
1. Micromate™ for having the same principle of operation
1. Micromate™ robot execution system which is built according to the exact same core system architecture and same hardware design for Control unit and Targeting Platform
1. Micromate™ 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. Micromate™ system for supporting manual and automatic robotic movements.
1. Micromate™ system for having the user verifying the final accuracy
1. Micromate™ system for having the same instrument fixation means
1. Micromate™ and Excelsius GPS system for being image-guided robotic systems
1. Micromate™ and Excelsius GPS system for providing registration means for the imaging device
1. Micromate™ and Excelsius GPS system for having tool guides as instrumentation
1. Micromate™ and Excelsius GPS system for performing of automatic registration of observed objects
1. Micromate™ and Excelsius GPS system for having the final instrument guidance being performed by the physician.

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Image /page/12/Picture/0 description: The image shows the logo for Interventional Systems. The logo consists of a blue icon on the left and the words "INTERVENTIONAL SYSTEMS" in blue on the right. The icon is a stylized representation of a hand with three fingers.

1. Excelsius GPS for having the similar planning and navigation software capable of visualizing acquired radiological images (2D, 3D) and interventional plan created by user, and navigating the system during the execution of previously created plan
1. Excelsius GPS system for having real-time position information provided by a planning software
1. Excelsius GPS system for having equivalent trajectory planning parameters
1. Excelsius GPS for having possibilities for camera (optical) tracking of guided instruments

Differences:

1. Excelsius GPS for registration approach, while keeping the same basic principle of matching patient s anatomy location to location in space of tracking spheres attached to device's end effector.
  Excelsius GPS has patient registration performed by referencing between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy), while Micromate™ Navi+ registration is automatically obtained by triangulation, by comparing the measured positions of the disposable marker spheres (connected to the disposable tracker) in the camera coordinate system, to their pre-specified position in space in relation to the also estimated, position of the subject device end-effector fiducials. This relation allows to calculate the transformation matrix between the camera image space and the subject device image space (which is the CT volume coordinate system).
1. Excelsius GPS for indicated anatomy application. Micromate™ Navi+ is indicated for any image-guided procedure that involves placing or manipulating instruments based on acquired radiology or real time images with, or without, navigation while Excelsius GPS is indicated for placement of spinal and orthopedic bone screws. Although anatomical range of Excelsius GPS is subset of subject device anatomical range, due to general operating principle of locating the target, anatomical structure range is not limiting the reference device equivalence.
1. Excelsius GPS for using dynamic reference frame Micromate™ Navi+ uses tracker frame attached to the robot`s end effector. The use of a dynamic reference frame is state-of-theart for spine surgery, but depends on the fixation of the frame to a rigid anatomical location, such as bone. In the case of spine surgery, the dynamic reference frame is attached to the spinous process of an adjacent vertebra or other spinal anatomical landmark, as there is a nearly perfect rigid relationship between the structures. That does not hold true for soft tissue and for the relationship between soft tissue and bone. This aspect does not raise additional questions reqarding usability or safety. Micromate Navi+'s approach is simpler as it does not require the attachment of another tracked frame and the issues related to frame occlusion and handling. It is also safer, as Micromate Navi+ requires the user to confirm with live imaging or additional scans the position of instruments anytime that is necessary, and especially before the full insertion of the instruments, which is more accurate than relying on tracked data and overlaying navigation data on previously acquired CT scans, which may not reflect the actual location of structures.
1. Excelsius GPS for some additional ergonomic features: Image merging (image fusion) and plan save/load. Micromate™ Navi+ do not have these additional features, but this is not affecting the safety of the workflow neither is reducing the performance.
1. Excelsius GPS for accuracy verification method Micromate™ Navi+ uses the scout scans instead of pointing a navigated instrument to anatomical location. The user can acquire a new registration scan in case we are inaccurate. The user judges the position of the device itself based on live imaging, or other imaging methods.

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Image /page/13/Picture/0 description: The image contains a logo for Interventional Systems. The logo consists of a stylized blue hand-like graphic on the left, with the words "INTERVENTIONAL" and "SYSTEMS" in blue text to the right of the graphic. The hand-like graphic is made up of four curved lines that converge at the bottom.

Non-Clinical Performance Data

Testing was conducted on the Micromate™ Navi+ system to establish that the system is substantially equivalent to the predicate and reference devices and verify that the device will perform as intended according to the outlined design requirements below:

Description

Safety

Verified the effectiveness of all risk controls determined in the device risk analysis. No new issues of safety or effectiveness were raised.

General Requirements and Performance

Verified all components against their design specifications. All requirements were met and no new issues of safety or effectiveness were raised.

Electrical Safety and Electromagnetic Compatibility:

Testing was performed to assure compliance with recognized safety standards: IEC 60601-1: 2005+AMD1:2012 standard for electrical safety and IEC 60601-1-2:2014 standard for electromagnetic compatibility.

Software Verification and Validation Testing:

Performed for each requirement specification. Verifying the operating system software requirements are met and software performs as intended. Performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in medical devices, FDA guidance on general principles of software validation and IEC 62304:2006 Medical Device Software - Software life cycle processes.

Hardware Verification testing:

Bench testing ensures 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:

Usability Engineering conducted in accordance with IEC 62366 and FDA quidance "Applying Human Factors and Usability Engineering to Medical Devices" demonstrating that the usability and human factors requirements were adequately met.

Measurement of Positional Accuracy of Computer Assisted Surgical Systems:

The navigation accuracy was validated per ASTM F2554-18, and the 95% Confidence Interval (C1) accuracy is also below 2mm and 2º from the trajectory.

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Image /page/14/Picture/0 description: The image contains a logo with the words "INTERVENTIONAL SYSTEMS" to the right of a blue graphic. The graphic is a stylized image of three curved lines that resemble fingers or a hand. The text is in a bold, sans-serif font and is also blue.

Accuracy Validation

The system's bench-test accuracy was validated in a simulated use environment using the claimed compatible instruments and achieved an average accuracy of 1.04 ± 0.60mm of lateral deviation and 0.75 ± 0.47º anqular deviation to the planned traiectory, at the instrument tip.

The system's clinical guidance accuracy for the claimed indications was validated in 54 interventions (19 abdominal lesions, 19 thoracic lesions, and 16 musculoskeletal lesions) using the claimed compatible instruments. The system achieved an average clinical guidance accuracy of 1.48 ± 1.18mm of lateral deviation and 1.04 ± 0.97º of anqular deviation in abdominal procedures, 0.62 ± 0.41mm of lateral deviation and 0.61 ± 0.41º of angular deviation in musculoskeletal procedures, 1.76 ± 1.26mm of lateral deviation and 1.34 ± 0.82º of angular deviation in thoracic procedures. The overall clinical guidance accuracy in the whole cohort was 1.33 ± 1.13mm of lateral deviation and 1.02 ± 0.83º of angular deviation.

An estimate of the worst-case expectable clinical accuracy was calculated by combining the 99% confidence interval of the clinical guidance accuracy with the 99% confidence interval of the navigation accuracy, as measured per the bench accuracy test. The calculated value was 6.93mm for the abdomen, 4.12mm for the musculoskeletal tissue, 7.41mm for the thorax, and 6.40mm overall, for a needle readjustment rate of 0.13 ± 0.45 times per procedure. The overall scope of accuracy testing supported, with high statistical confidence, a positive conclusion on the safe and effective use of the device in a clinical setting.

Statement of safety and effectiveness data

The Micromate™ Navi+ is substantially equivalent to the legally marketed predicate device. It is our opinion that the subject device system does not have technological characteristics that raise additional questions related to safety and effectiveness.

Conclusion

Micromate™ Navi+ system has been shown through comparison, pre-clinical and performance data gathered in simulated clinical environment, to be substantially equivalent to the identified predicate device. The system claims are a subset of those of the predicate device, for which safety and effectiveness was proven through verification and validation activities, while having the additional technological characteristics and principles of operation equivalent to reference device.

New technological aspects, such as the internal planning and navigation software do not alter the fundamental intended use, indications for use neither the basic operating principle 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.