smart-sync is intended to generate a gating signal for MR scanners (1.5T and 3T) for motion compensation by detecting the heartbeat of a patient using Doppler ultrasound. Thus, smart-sync is intended to improve the image quality by reducing movement artefacts for MR images of the whole body, where motion compensation of the heart movement is necessary.

smart-sync is intended to be used on pregnant women, where the fetus is examined. smart-sync is also intended to be used for adult MR examinations.

smart-sync is not intended to monitor any physiological parameters.

Device Description

smart-sync is an MRI-compatible Doppler ultrasound system that determines the cardiac cycle of patients and synchronizes it with the MRI imaging, smart-sync can be used for the synchronization of the heartbeat both for fetuses and adults.

The heartbeat of the patient is detected by positioning an ultrasound sensor above the patient's heart. The ultrasound sensor is fixated with a flexible belt. The reflection of Doppler ultrasound signals is analyzed, and a trigger signal is derived for every heartbeat. smart-sync sends the Doppler ultrasound signal and the trigger signal (synchronization signal) to the MRI scanner utilizing a wireless connection.

AI/ML Overview

The provided document is a 510(k) summary for the device "smart-sync." It describes the device's intended use, technological characteristics, and a summary of non-clinical and clinical performance data. However, it does not provide detailed information about specific acceptance criteria or a comprehensive study report with quantitative performance metrics for the AI component of the device.

Based on the provided text, the "smart-sync" device does not appear to be an AI/ML-driven device in the context of image analysis or diagnostic aid. It is described as a Doppler ultrasound system that generates a gating signal for MR scanners to compensate for motion by detecting a patient's heartbeat. Its primary function is to improve image quality by reducing movement artifacts, not to perform analysis or diagnosis using AI.

Therefore, many of the requested points regarding AI/ML device testing (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to the "smart-sync" device as described in this 510(k) summary.

Here's what can be extracted and inferred from the provided text, addressing the points where information is available or can be logically deduced:

Device Name: smart-sync
Product Code: LNH
Regulation Name: Magnetic resonance diagnostic device

Acceptance Criteria and Device Performance (as far as can be inferred for this type of device):

The "acceptance criteria" for a motion-gating device like smart-sync would primarily revolve around its ability to reliably detect the heartbeat and provide an accurate gating signal to the MRI machine, leading to improved image quality. The document refers to "clinical performance" and "effectiveness in improving image quality," but it does not specify quantitative metrics or thresholds for these.

Since this is a non-AI device focused on mechanical/electrical performance, traditional AI performance metrics (like sensitivity, specificity, AUC) are not directly relevant. The "performance" is about its ability to generate a correct and timely gating signal and the resulting visual improvement in MR images.

Acceptance Criterion (Inferred for a Gating Device)	Reported Device Performance (Inferred/Stated)
Reliable Heartbeat Detection: Ability to accurately detect and track the cardiac cycle.	"The heartbeat of the patient is detected by positioning an ultrasound sensor...""Clinical tests and performance tests show that the subject device smart-sync is safe and effective for the intended patient population.""The bench tests show that the subject device smart-sync is effective in providing gating signals for cardiac MR acquisition...""Clinical studies from clinicians at different hospitals across Europe and the US show that the subject device smart-sync is effective in improving the image quality for cardiac MRI examinations..."
Accurate Gating Signal Generation: Ability to produce a timely and correct trigger signal for the MRI scanner.	"...a trigger signal is derived for every heartbeat. smart-sync sends the Doppler ultrasound signal and the trigger signal (synchronization signal) to the MRI scanner utilizing a wireless connection.""The bench tests show that the subject device smart-sync is effective in providing gating signals for cardiac MR acquisition, which can be used by the MRI to improve the image quality."
Improved MR Image Quality: Reduction of motion artifacts in MR images due to cardiac motion.	"smart-sync is intended to improve the image quality by reducing movement artefacts for MR images of the whole body, where motion compensation of the heart movement is necessary.""Clinical studies from clinicians at different hospitals across Europe and the US show that the subject device smart-sync is effective in improving the image quality for cardiac MRI examinations..."
Safety and Compatibility: MRI safety, electrical safety, electromagnetic compatibility.	"MRI Safety Classification: MRI Conditional""RF power levels: 4 W/kg""The bench tests also prove the safety of the subject device smart-sync and the compliance with applicable international safety and performance standards.""Usability tests show that the application of the subject device is safe to use for the intended user group radiographers and radiologists."
Measurement Range (Heart Rate):	Fetal: 60 - 240 BPMAdult: 30-120 BPM

1. A table of acceptance criteria and the reported device performance:
See table above. Quantitative acceptance thresholds (e.g., minimum percentage reduction in motion artifact, or specific ECG/gating signal accuracy) are not provided in the document. The performance is described qualitatively as "effective in improving image quality" and "safe."

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated in terms of a numerical count of patients or studies. The text mentions "Clinical studies from clinicians at different hospitals across Europe and the US." This implies a multi-site study, but without specific numbers.
Data Provenance: "Europe and the US" (country of origin). The studies appear to be "clinical studies," implying a prospective or at least a clinical trial setting rather than purely retrospective database analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable in the context of AI/ML-driven diagnostic device evaluation.
For a device like smart-sync, the "ground truth" would be the actual cardiac rhythm and the resulting improvement (or lack thereof) in image quality as assessed by radiologists in a clinical setting. The document mentions "clinicians at different hospitals" and "radiographers and radiologists" as the intended user group who would assess image quality.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable (as this is not an AI diagnostic device and no AI-specific adjudication of ground truth for classification tasks is described).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. The device is a motion compensation tool, not an AI assistance tool for human readers. No MRMC study comparing human performance with/without AI assistance is mentioned because AI assistance is not its function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. The device is described as generating a gating signal for the MR scanner, which is a standalone function in this context (i.g., it produces a signal based on its sensor input). However, this is not an "AI algorithm only" performance test in the typical sense of diagnostic AI. The performance is then assessed in a clinical context by human readers evaluating the resulting MR images.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's effectiveness appears to be primarily clinical assessment of image quality by clinicians/radiologists based on whether motion artifacts are reduced and images are improved. The accuracy of heartbeat detection would be the underlying "ground truth" for the device's direct function.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning model development.

9. How the ground truth for the training set was established:

Not Applicable. As per point 8.

Summary of Key Findings from the Document regarding "smart-sync":

Device Type: MRI-compatible Doppler ultrasound system for cardiac gating.
Purpose: To generate a gating signal for MR scanners (1.5T and 3T) to compensate for heart movement, thereby improving image quality by reducing motion artifacts.
Patient Groups: Adults and pregnant women (fetus examined from 30th gestational week).
Technology: Uses Doppler ultrasound to detect myocardial wall and blood flow motion, deriving a trigger signal. Wireless transmission to MRI scanner.
Performance Evaluation:
- Bench Tests: Demonstrated effectiveness in providing gating signals and compliance with safety standards.
- Clinical Studies: Conducted at hospitals in Europe and the US, indicating effectiveness in improving image quality for cardiac MRI examinations in the intended patient population.
- Usability Tests: Confirmed safe use by radiographers and radiologists.
Substantial Equivalence: Claimed based on clinical evidence, non-clinical bench testing, electrical safety, electromagnetic compatibility, product verification and validation, showing it does not raise different questions of safety and effectiveness compared to predicate devices (ECG-based gating cables) and a reference device (Doppler-based fetal monitors). The different acquisition method (Doppler ultrasound vs. ECG) was addressed through comparison with a Doppler reference device and analytical comparison showing similar cardiac information can be derived.

Summary

{0}------------------------------------------------

February 4, 2022

Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

northh medical GmbH % Kai-Kristoph Fehrs Chief Quality Officer, QA/RA Roentgenstrasse 24 22335 Hamburg GERMANY

Re: K212271

Trade/Device Name: smart-sync Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: December 15, 2021 Received: December 28, 2021

Dear Kai-Kristoph Fehrs:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

CAPT Patrick Hintz, MSIH, CIH, USPHS Associate Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K212271

Device Name smart-sync

Indications for Use (Describe)

smart-sync is intended to be used on pregnant women, where the fetus is examined. smart-sync is also intended to be used for adult MR examinations.

smart-sync is not intended to monitor any physiological parameters.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Northh Medical. The logo features a stylized electrocardiogram (EKG) waveform in blue on the left side. To the right of the waveform, the word "northh" is written in a modern, sans-serif font, also in blue. Below "northh", the word "medical" is written in a smaller font size and a slightly lighter shade of blue.

510(K) SUMMARY

SUBMITTER INFORMATION

Establishment Name:	northh medical GmbH
Establishment Address:	Röntgenstr. 2422335 HamburgGermany
Company Phone:	+49 40 23969451
Company Fax:	Not available
Contact person:	Kai-Kristoph FehrsChief Quality Officerkf@northh.de
Organization Number:	624524
Date Summary Prepared:	2021-07-09

DEVICE IDENTIFICATION

Trade Name:	smart-sync
Common Name:	Ultrasound gating device for MRI scanners
Classification Name:	System, nuclear magnetic resonance imaging (892.1000, LNH, class 2)

PREDICATE AND REFERENCE DEVICES

Primary Predicate Device

smart-sync is substantially equivalent to the following primary predicate device:

Primary Predicate Device	Manufacturer	510(k) No	ClearanceDate
High Impedance Cardiac Gating Cable	GE Medical Systems	K981190	06/30/1998

Additional Predicate Device

Due to technological differences to the primary predicate device, an additional predicate device is included in this submission.

Additional Predicate Device	Manufacturer	510(k) No	ClearanceDate
Expression MR400 MRI Patient MonitoringSystem*	Invivo Corporation	K152330	12/23/2015

The subject device is compared with the wireless ECG module of the Expression MR400.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for Northhh Medical. The logo features the word "northhh" in a sans-serif font, with the "hh" underlined by a teal line. Below "northhh" is the word "medical" in a smaller, sans-serif font, also in teal. To the left of the text is a stylized teal line that resembles a heartbeat signal.

Reference Device

Due to a different acquisition method of the cardiac cycle, the following reference device is included in this submission.

Reference Device	Manufacturer	510(k) No	ClearanceDate
Philips Avalon Fetal / Maternal MonitorsFM20, FM30, FM40 and FM50	PHILIPS MedizinSysteme	K140535	11/25/2014

DEVICE DESCRIPTION

Image /page/4/Figure/6 description: The image shows two drawings of a pregnant woman lying inside of a medical imaging machine. In the left drawing, the woman is lying on her back with a device on her stomach that is scanning her baby. The right drawing shows the woman lying on her back with a heart monitor attached to her chest.

Figure 1: Fetal application

Figure 2: Adult application

DISCUSSION - INDICATIONS FOR USE

The intended use of the subject device smart-sync and the primary predicate device High Impedance Cardiac Gating Cable can be summarized to "cardiac gating of the MRI scanner to reduce motion artifacts". Thus, the intended use of the subject device and the primary device are identical.

The additional predicate device Expression MR400 Patient Monitoring System is intended for monitoring and provides gating signals for MRI scanners. Thus, the additional predicate device includes a similar intended use "providing gating signals to the MRI scanner" as the subject device smart-sync.

The subject device and predicate devices are indicated for use by physicians to reduce motion artifacts for MR examinations.

Clinical tests and performance tests show that the subject device smart-sync is safe and effective for the intended patient population "fetuses in gestational age of week 30 and alter and for adults".

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for Northh Medical. The logo features the word "northh" in a sans-serif font, with the "northh" part of the logo in a darker color than the "medical" part. To the left of the word "northh" is a stylized graphic that resembles a heartbeat line.

INTENDED USE

smart-sync is intended to be used on pregnant women, where the fetus is examined. smart-sync is also intended to be used for adult MR examinations.

smart-sync is not intended to monitor any physiological parameters.

Patient group

smart-sync is intended to be used on the following patient groups:

Adults
Pregnant women from their 30th gestational week where the fetus is being examined. ● Fetal movement in the early weeks of pregnancy might not make it possible to perform an MRI scan.

Indications

smart-sync is intended for MRI scans requested by doctors and where synchronization with the patient's heartbeat is required.

Contraindications

smart-sync is not intended for the following groups of people:

. smart-sync is not intended for people with MRI exclusion criteria such as cardiac pacemakers or implants.
. smart-sync is not intended for people with skin damage in the area where the ultrasound sensor is applied.

TECHNOLOGY CHARACTERISTICS

Characteristics	Subject Device	PrimaryPredicate Device	AdditionalPredicate Device
Device Name	smart-sync	High Impedance CardiacGating Cable	Expression MR400 MRIPatient Monitoring System
510(k) Number	N/A	K981190	K152330
Acquisitionmethod	Doppler ultrasound	Electrocardiography	Electrocardiography
Measurement ofcardiac cycle	myocardial wall and bloodflow motion	R-Wave of ECG signal	R-Wave of ECG signal
MRI SafetyClassification	MRI Conditional	MRI Conditional	MRI Conditional
Field Strength	1.5T and 3T	Up to 3T	Up to 3T
RF power levels	4 W / kg	4 W / kg	4 W / kg
Battery powered	Yes	No	Yes
Battery Type	Lithium Polymer	N/A	Lithium Polymer
SignalTransmission toMRI scanner	Wireless	Cable	Wireless

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Northh Medical. The logo features a stylized heartbeat symbol on the left, followed by the word "northh" in a modern, sans-serif font. Below "northh" is the word "medical" in a smaller, similar font. The entire logo is in a teal color.

Characteristics	Subject Device	PrimaryPredicate Device	AdditionalPredicate Device
Frequency	2402–2482 MHz	N/A	2402–2482 MHz
Modulation Type	GFSK	N/A	GFSK
EIRP	4dBm (peak)	N/A	0dBm (peak)

The comparison of the technological charateristics shows that the characteristics of subject device smart-sync are identical or similar to the primary predicate device High Impedance Cardiac Gating Cable and to the wireless ECG module of the additional predicate device Expression MR400 MRI Patient Monitoring System, except for the acquisition method of the cardiac cycle. Technological differences shown are discussed and concluded to have no additional impact on safety and effectiveness or performance of the device.

SUMMARY OF NON-CLINICAL PERFORMANCE DATA

The different acuisition method of the subject device smart-sync is compared with the reference device Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50.

Characteristics	Subject Device	Reference Device
Device Name	smart-sync	Philips Avalon Fetal /Maternal Monitors FM20,FM30, FM40 and FM50
510(k) Number	N/A	K140535
Acquisitionmethod	Doppler ultrasound	Doppler ultrasound
Measurement ofcardiac cycle	myocardial wall and bloodflow motion	myocardial wall and bloodflow motion
MRI SafetyClassification	MRI Conditional	MRI Conditional
MeasurementMethod	static pulsed Doppler (D)	static pulsed Doppler (D)
MeasurementRange	Fetal: 60 - 240 BPMAdult: 30-120 BPM	50 to 240 bpm
Average outputpower	40kPa	(40.4 ± 4.3) kPa
UltrasoundFrequency	1,025 MHz ± 25 kHz	1 MHz ± 100 Hz
Ultrasound Burst- Repetition Rate	3.0 kHz	3.0 kHz
Ultrasound Burst- Duration	max 90 periods @ 1.025MHz≤ 100 µs	≤ 100 µs

The comparison of the acquisition method "Doppler ultrasound" shows that characteristics of the subject device smart-sync are identical or similar with the reference device Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM30, FM40 and FM50.

A direct performance comparison of the subject device smart-sync and the predicate devices the GE High impedance cardiac gating cable and the wireless ECG module of the Expression MR400 MRI Patient Monitoring System is technically not possible. The predicate devices do not generate a comparable gating signal. An analytical comparison of the acquisition method shows that the same cardiac information can be derived from Doppler ultrasound as with electrocardiography.

As the subject device smart-sync and the predicate devices are gating devices for MRI scanners the device's performance can be evaluated with the resulting MR image quality. Thus, the effectiveness of the subject device in improving the image quality for cardiac MR examination is provided in clinical tests.

{7}------------------------------------------------

Company: northh medical Product: smart-sync Submission: Traditional 510(k) K-Number: K212271

Image /page/7/Picture/1 description: The image contains the logo for Northh Medical. The logo features the word "northh" in a sans-serif font, with the "h"s connected by a thin line. Below "northh" is the word "medical" in a smaller font. To the left of the word "northh" is a stylized graphic that resembles a heartbeat line.

The bench tests show that the subject device smart-sync is effective in providing gating signals for cardiac MR acquisition, which can be used by the MRI to improve the image quality. The bench tests also prove the safety of the subject device smart-sync and the compliance with applicable international safety and performance standards.

SUMMARY OF CLINICAL PERFORMANCE DATA

Clinical studies from clinicians at different hospitals across Europe and the US show that the subject device smart-sync is effective in improving the image quality for cardiac MRI examinations for the intended patient population "fetus in 30th week of gestation and adults".

Usability tests show that the application of the subject device is safe to use for the intended user group radiographers and radiologists.

It is concluded that smart-sync is safe to use, and that smart-sync achieves its clinical performance to improve the image quality of MRI examinations for the intended patient population (pregnant women, where the fetus is examined in gestational age of week 30 and later, and for adults).

SUMMARY

The results of the substantial equivalence assessment, taken together with clinical evidence, nonclinical bench testing, electrical safety and electromagnetic compatibility, product verification and validation demonstrate that "smart-syno" does not raise different questions of safety and effectiveness when compared to the predicate devices "High Impedance Cardiac Gating Cable" and "Expression MR400 MRI Patient Monitoring System" and the reference device "Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM30, FM40 and FM50".

The provided data shows that smart-sync performs as intended, and has performance characteristics that are substantially equivalent to the predicate devices and that the different acquisition method Doppler ultrasound compared to the predicate device does not raise additional questions to safety and effectiveness.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.