The IOPS® (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor equipped compatible catheters and guidewires used in endovascular interventions in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

Device Description

The IOPS system displays the position and orientation of sensor equipped guidewires and catheters utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously acquired CT scan data. IOPS registers the location and orientation of the sensors in real time superimposing navigation of the catheters and guidewires to the patient's vascular map.

AI/ML Overview

The provided text is a 510(k) summary for the Intra-Operative Positioning System (IOPS®). It describes the device, its intended use, technological characteristics, and non-clinical testing performed to establish substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria for performance based on a test set, expert ground truth, or MRMC studies.

Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared device (IOPS 1.0, K190106) due to minor hardware changes (for obsolescence) and a software update. The non-clinical testing mentioned is primarily related to electrical safety, electromagnetic compatibility, and immunity to RFID readers, which are general safety and performance standards rather than specific acceptance criteria for the navigational accuracy or clinical effectiveness in the context of the device's indications for use.

Therefore, I cannot populate the requested table or answer most of the questions, as the information is not present in the provided document. The document confirms:

No specific acceptance criteria table for device performance (e.g., accuracy, precision) is provided.
No study proving the device meets clinical performance acceptance criteria is detailed.
No information about a test set, its sample size, or data provenance for clinical performance evaluation is given.
No mention of experts establishing ground truth, adjudication methods, or MRMC studies for clinical performance.
No standalone algorithm performance study is described for clinical outcomes.
No information on ground truth type (expert consensus, pathology, outcomes data) for clinical performance.
No details are given about a training set for the software, its size, or how its ground truth was established.

The summary strongly implies that the core navigation technology (Aurora® V3 System) is an off-the-shelf, integrated component, and the submission's focus is on labeling modifications and general safety compliance for the updated IOPS system.

Therefore, the response is:

The provided document, a 510(k) summary for the Intra-Operative Positioning System (IOPS®), does not contain the specific information requested regarding acceptance criteria for device performance, the study methods used to prove these criteria, details on test sets, ground truth establishment, expert involvement, or MRMC studies.

The submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (IOPS 1.0, K190106) based on minor hardware updates (for obsolescence) and a software revision. The non-clinical testing mentioned (ANSI AAMI ES60601-1, IEC 60601-1-2, AIM 7351731 Rev. 2.00) relates to general electrical safety, essential performance, electromagnetic compatibility, and RFID immunity, rather than clinical performance metrics of the device's navigation capabilities against a defined ground truth.

Specifically, the following information is not available in the provided text:

Table of acceptance criteria and reported device performance: Not provided. The submission states the navigation system has a "high degree of accuracy" and "position error of approximately ±1 mm," which it deems "sufficient," but these are descriptive statements, not formally presented as acceptance criteria for a study.
Sample size used for the test set and data provenance: No information on a test set used to evaluate the device's clinical performance against specific acceptance criteria.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no such clinical performance test set or ground truth establishment process is described.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size: Not described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No information about a standalone performance study for clinical efficacy.
The type of ground truth used: For the device's intended use (navigation), the text implies that the Aurora® system calculates sensor positions with high accuracy. For clinical application, the IOPS uses pre-operative CT scans and correlated tracking pad data, alongside real-time sensor readings, to superimpose location on a vascular map. However, there is no explicit mention of ground truth in the context of a performance study to prove the device meets acceptance criteria. The ±1mm accuracy is stated as a system capability, not a study outcome.
The sample size for the training set: Not provided. The document mentions "proprietary software" for image generation and processing, but no details on training data.
How the ground truth for the training set was established: Not provided.

The key takeaway is that this 510(k) summary focuses on demonstrating substantial equivalence through standard safety and performance testing and minor modifications, rather than a de novo clinical performance study with specific acceptance criteria as might be seen for novel AI-driven diagnostic devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

June 21, 2023

Centerline Biomedical, Inc. Amanda Shade Sr. Quality & Regulatory Manager 1000 Cedar Avenue Cleveland, Ohio 44106

Re: K230309

Trade/Device Name: Intra-Operative Positioning System (IOPS®) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: May 19, 2023 Received: May 22, 2023

Dear Amanda Shade:

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

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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 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 medical devices and radiation-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,

Marco

for

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices 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) K230309

Device Name Intra-Operative Positioning System (IOPS®)

Indications for Use (Describe)

The IOPS® (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor equipped compatible catheters and guidewires used in endovascular interventions in the system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Centerline Biomedical. The logo consists of a blue target symbol on the left and the words "Centerline" and "Biomedical" on the right. The word "Centerline" is above the word "Biomedical", and there is a horizontal line between the two words.

004. 510(k) Summary

As required by section 807.92(c)

Centerline Biomedical Inc. is requesting marketing clearance for the labeling modification of the Intra-Operative Positioning System (IOPS®) previously cleared under K190106.

A. Submitted By:	Centerline Biomedical, Inc.10000 Cedar AvenueCleveland, OH 44106Registration Number: 3012154226
B. Date:	May 19, 2023
C. Contact Person:	Amanda Shade, Sr. Quality & Regulatory Manager
Contact Telephone:	(216) 206-7364
D. Device Trade Name:	Intra-Operative Positioning System (IOPS®)
Device Classification Name:	Programmable diagnostic computer (21 CFR 870.1425)
Device Classification:	Class II
Reviewing Panel:	Cardiovascular
Product Code:	DQK
E. Predicate Device:	Intra-Operative Positioning System (IOPS) (K190106)

F. Device Description:

Sub-system	Identification	Function	Picture
ReusableComponents	Mobile Cart (MC-1)	Stores all components whennot in use; provides systemmobility
	Onboard Monitor	Displays patient maps andsuperimposed images
	Computer	Provides an operatingsystem
	Keyboard	Allows data input
	Mouse	Allows data input
	Uninterruptiblepower supply (UPS)	Provides power whenelectricity is not available
Sub-system	Identification	Function	Picture
	Video SplitterCablesIOPS SoftwareApplication	The video out enables theMobile Cart tosimultaneously display theuser interface on theonboard monitor andprovide a video signal for anexternal display.Allows data transferSoftware which createsvascular map used to showlocation of sensorizedcatheter and guidewires realtime.Vascular map is generatedfrom a preoperative CT scanwhich is processed tosegment the vasculature andperform centerline andsurface analysis.	Image: Mobile Cart
	System Control Unit(SCU)	Collects information fromthe SIUs, calculates theposition and orientation ofeach sensor and interfaceswith the host computer.	Image: System Control Unit
	Sensor InterfaceUnit (SIU)	Amplifies and digitizes theelectrical signals from thesensors and provides anincreased distance betweenthe SCU and sensors, whileminimizing the potential fordata noise	Image: Sensor Interface Unit
	ElectromagneticField Generator	Emits a low-intensity,varying electromagneticfield and establishes theposition of the trackingvolume	Image: Electromagnetic Field Generator
Sub-system	Identification	Function	Picture
	Mounting brackets	Affixes field generator to operating table	Image: Mounting brackets
Single UseSterileAccessories(All clearedperK190106)	Guidewire (ATW-2)	Sensorized wire used to navigate through vasculature to facilitate placement of a catheter	Image: Guidewire (ATW-2)
	Reverse CurveCatheter (RCC-1)	Sensorized tube used to navigate through vasculature	Image: Reverse Curve Catheter (RCC-1)
	Simple CurveCatheter (SCC-1)	Sensorized tube used to navigate through vasculature	Image: Simple Curve Catheter (SCC-1)
	Tracking Pad (TP-1)	Pad that registers patient movement	Image: Tracking Pad (TP-1)
	Guidewire Handle(SSH-1)	Provides interface between the sensorized guidewire and the SIU	Image: Guidewire Handle (SSH-1)

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Image /page/4/Picture/0 description: The image shows the logo for Centerline Biomedical. The logo consists of a circular target-like design on the left, with the words "Centerline" above "Biomedical" on the right. A horizontal line separates the two words. The target design is made up of concentric circles in shades of blue.

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Image /page/5/Picture/0 description: The image is a logo for Centerline Biomedical. The logo consists of a circular target-like design on the left, with the words "Centerline Biomedical" on the right. The word "Centerline" is on the top line, and the word "Biomedical" is on the bottom line. A horizontal line extends from the center of the target to the space between the two words.

Principle of Action:

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The system is intended for use by trained clinicians for patients undergoing endovascular interventional procedures of the descending aorta, such as stent grafting. The system promotes more efficient use of operating room time and minimizes the need for fluoroscopy. The clinician uses the IOPS catheters and guidewires to navigate through the aorta to access branch vessels near to, or involved in, the lesion. The catheters and guidewires are not for angiographic or diagnostic use.

The main principles of action for the IOPS are similar to those used in Global Positioning System (GPS) tracking. The navigation components generate a time-varying magnetic field in which the position and orientation of sensor embedded catheters and guidewires are read. The computing unit visually displays the location of the sensor on the patient's vascular map.

Embedded sensors are located in the tip of the IOPS catheter and guidewire. When the sensor enters the electromagnetic field, small voltages are induced in the sensor coils. The size of the voltage depends on the location of the sensor coil in the overall EM field. Transformations are induced, which are combinations of translation and rotation values that describe the position and orientation of the embedded sensors. The data is transferred via cables to a sensor interface unit (SIU), which digitizes the sensor data and transmits it to the system control unit (SCU). The SCU calculates a 5DOF (degrees of freedom) transformation for each sensor producing X,Y,Z, pitch and yaw location information. Data is transferred via cables to the system control unit (SCU) and processed with proprietary software to generate the sensor location which is transposed onto the patient's vascular map.

The patient's vascular map is generated using a contrast enhanced, high resolution CT scan (up to 6 months prior to the procedure) which is part of the standard care of patients undergoing endovascular interventional procedures. The IOPS creates a 3D rendering of that structure. A bone segmented 3D rendering is also created to provide anatomical, skeletal points visible in relation to the vascular rendering.

Before the patient is placed on the OR table, a tracking pad embedded with sensors is affixed to the small of the back in a location proximate to the volume of interest. The tracking pad corrects for patient movement and ensures the overlay of the live tracking to the previously acquired vascular map is aligned. By correlating the vascular rendering, the position of the tracking pad, and its relation to the same fiducial points, the sensor locations are superimposed on the vascular rendering with a position error of approximately ±1 mm. Because the human aorta is approximately 25 mm in diameter and the branch arteries are approximately 5-10 mm in diameter, this accuracy is sufficient to precisely position the catheter and guidewire tips within an artery.

The mobile IOPS is brought into the operating room, wheels are locked, and the power cable is plugged into a 120V wall outlet. The IOPS is powered on and an Ethernet port is connected to the hospital's picture archiving and communication system (PACS), if desired. Alternatively, data can be imported/exported using a USB drive.

The electromagnetic field generator is affixed to the underside of the patient table and the SIU is attached to the side rail of patient table approximately 1 meter from the field generator. After the

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Image /page/7/Picture/0 description: The image contains the logo for Centerline Biomedical. The logo consists of a circular target-like design on the left, with the words "Centerline" above "Biomedical" on the right. A horizontal line extends from the center of the target to the text, visually connecting the two elements of the logo.

patient is placed on the OR table, a cone beam CT (CBCT) is acquired using fluoroscopy with a flat panel detector (FPD). The scan is uploaded to the hospital's PACS. The CBCT is registered to the initial CT using the IOPS software and the 3D renderings.

During the procedure, the surgeon observes the movement of the sensors within the catheter and guidewire on the 3D rendering of the vasculature. The rendering can be rotated and manipulated allowing the surgeon to view branch vessel ostia in three dimensions from an optimal view angle.

Component Description:

The IOPS mobile cart houses a monitor, computer, keyboard, pointing device, uninterruptable power supply (UPS), and cables. IOPS includes a tracking system composed of a system control unit (SCU), sensor interface unit (SIU), field generator, mounting brackets, and cables. These components are reusable and not patient contacting.

The IOPS includes proprietary software used to generate the 3D rendering of the vascular structure from data collected from the patient scans. The software generates the patient's vascular model which is displayed on the monitor of the IOPS and collects data provided by the SCU of the tracking system. The software overlays the sensor position from the tracking system data on to the patient's 3D vascular map. The software enables the user to view the 3-D rendered image from any direction and zoom in and out. The software notifies the user of errors or degraded accuracy. The software corrects for patient motion. The software operates in one of two modes: live recording and playback simulation. The live recording file is a combination of text markers, text values, and base-64 encoded data.

Navigation System:

The navigation system is a commercially available, advanced electromagnetic spatial measurement system purchased off-the-shelf from Northern Digital Imaging and is integrated into other cleared commercial devices. The Aurora® V3 System is designed to calculate the position and orientation of sensors within a defined volume to a high degree of accuracy. The Aurora® sensors are embedded into the IOPS catheter and guidewire.

The Aurora® system used in IOPS includes a windowed field generator, system control unit (SCU), sensor interface unit (SIU), and sensors which are embedded in disposable tools such as catheters and guidewires.

The catheter and guidewire are connected to the SIU which is connected to the SCU. When the embedded sensors are placed inside the electromagnetic detection region, a voltage is induced. The characteristics of the induced voltage depend on a combination of the sensor position and orientation and the strength and phase of the varying magnetic fields.

The SIU converts the voltages, induced in the sensors, to digital signals which are sent to the SCU.

The SCU controls the operation of the Aurora® System. It acts as an interface between the tracking system components and the CPU. The SCU supplies power to the field generator and controls the field generator's electromagnetic output. It collects sensor data via the SIU and calculates sensor positions and orientations, then sends the position and orientation data to the CPU.

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Image /page/8/Picture/0 description: The image contains the logo for Centerline Biomedical. The logo consists of a circular target-like design on the left, with the words "Centerline" above "Biomedical" on the right. A horizontal line separates the two words. The target design is made up of concentric circles in shades of blue.

The field generator provides a low-intensity (~100 micro-Tesla), varying electromagnetic field creating a volume in which sensor positions and orientations are read. The field generator is affixed to the operating room table with mounting brackets.

A system dedicated CPU, monitor, keyboard, and pointing device are housed within the IOPS cart. The computer uses transmission control protocol/internet protocol (TCP/IP) to communicate with the hospital's PACS, if desired, and houses the software used to create images and process the tracking system data. Alternatively, data can be imported/exported using a USB drive.

An uninterruptable power supply (UPS) is housed within the IOPS cart. In the event that power is not able to be supplied to the system, the UPS is able to power the IOPS for a minimum of 10 minutes.

Workflow of the system:

Image /page/8/Figure/5 description: The image shows a block diagram of a system with several components. The components are grouped into three main categories: Accessories, Tracking System, and Mobile Cart. The Accessories category includes Catheter, Guidewire, Guidewire Handle, and Tracking Pad with Fiduciary Spheres. The Tracking System category includes EM Field Generator, SCU, and SIU. The Mobile Cart category includes USB Drive, Computer with IOPS Application, Video Splitter, Hospital Network, UPS, Onboard Monitor, and External Display.

Single Use Sterile Accessories:

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Image /page/9/Picture/0 description: The image shows the logo for Centerline Biomedical. The logo consists of a circular target-like design on the left, with the words "Centerline" above "Biomedical" on the right. A horizontal line extends from the center of the target to separate the two words.

The accessories marketed with the Intra-Operative Positioning System (IOPS®) have been previously cleared under K190106 and the indications for use are consistent with the cleared indications.

The tracking pads are surface devices which contact intact skin for a duration of < 24 hours. The catheters and guidewires are externally communicating devices which come in contact with circulating blood for duration of ≤ 24 hours.

The tracking pad is affixed to the small of the patient's back in a location proximate to the volume of interest. It is manufactured from Covestro Texin RxT70A polyurethane, Covestro Makrolon 2458 polycarbonate, and Vancive MED 5634 EVA foam with acrylic adhesive. Each registration marker contains three radio-opaque glass beads. The radio-opaque glass bead placement can be confirmed with fluoroscopy.

Guidewire handle connects to the sensorized guidewire to allow detection and visualization of the guidewire tip position, in real time, on a 3D rendering of the patient's vascular map. Catheters and guidewires are inserted into the femoral artery, brachial artery, or axillary artery and navigate through the aorta to access branch vessels near to, or involved in, the lesion. Two types of catheters are offered with IOPS: a simple curve catheter and a reverse curve catheter. Catheters, guidewires, tracking pads, and guidewire handles are provided sterile, pyrogen free, and intended for single use.

G. Intended Use:

The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor equipped compatible catheters and guidewires used in endovascular interventions in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

H. Technological Characteristics:

The intended use of the IOPS has not changed from the predicate device (IOPS 1.0). Minor changes to the hardware were introduced during IOPS 1.2 to support obsolescence of old computer components (e.g., motherboard, video card, and monitor), a new keyboard/mouse, and the addition of an HDMI splitter to support a second video output. The software was changed from version 1.0.5056 to 1.3.40.

Proposed Labeling: I.

The Intended Use of the modified device as described in its labeling has not changed. The proposed labeling changes include:

Delete "WARNING: DO NOT place the IOPS equipment within 1 meter of RFID ● readers. There is a potential for electromagnetic interference which may affect the operation of the IOPS".
Delete contraindication for use of IOPS on patients with pacemakers. ●
Delete contraindication for use of IOPS with ICD (Implantable Cardioverter ● Defibrillator).
Add warnings related to patients with pacemakers, implantable cardioverter-● defibrillators (ICD), and cardiac implantable electronic devices (CIED).

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Image /page/10/Picture/0 description: The image contains the logo for Centerline Biomedical. The logo consists of a circular target-like design on the left, with the words "Centerline" above "Biomedical" on the right. A horizontal line extends from the center of the target to separate the two words.

Delete "CAUTION: DO NOT use an external cardiac defibrillator on a patient while ● catheters and/or guidewires are inserted unless absolutely necessary (lifesaving)".
Change Applied Part designations from Type BF to Defibrillation-proof Type BF.

J. Non-clinical Testing:

Testing according to the following FDA-recognized consensus standards were performed on the Intra-Operative Positioning System to establish equivalency to the predicate device in safety and effectiveness:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and ● A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
AIM 7351731 Rev. 2.00 (2017-02-23) Medical Electrical Equipment and System ● Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers

K. Conclusion:

The completed testing associated with the proposed labeling changes has demonstrated that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).