smart-sync

{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 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. 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. 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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. 24<br>22335 Hamburg<br>Germany | | Company Phone: | +49 40 23969451 | | Company Fax: | Not available | | Contact person: | Kai-Kristoph Fehrs<br>Chief Quality Officer<br>kf@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 | Clearance<br>Date | |-------------------------------------|--------------------|-----------|-------------------| | 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 | Clearance<br>Date | |----------------------------------------------------|--------------------|-----------|-------------------| | Expression MR400 MRI Patient Monitoring<br>System* | 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 | Clearance<br>Date | |-----------------------------------------------------------------------|----------------------------|-----------|-------------------| | Philips Avalon Fetal / Maternal Monitors<br>FM20, FM30, FM40 and FM50 | PHILIPS Medizin<br>Systeme | 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 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. # 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 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. ## 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 | Primary<br>Predicate Device | Additional<br>Predicate Device | |------------------------------------------|------------------------------------------|----------------------------------------|---------------------------------------------------| | Device Name | smart-sync | High Impedance Cardiac<br>Gating Cable | Expression MR400 MRI<br>Patient Monitoring System | | 510(k) Number | N/A | K981190 | K152330 | | Acquisition<br>method | Doppler ultrasound | Electrocardiography | Electrocardiography | | Measurement of<br>cardiac cycle | myocardial wall and blood<br>flow motion | R-Wave of ECG signal | R-Wave of ECG signal | | MRI Safety<br>Classification | 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 | | Signal<br>Transmission to<br>MRI 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 | Primary<br>Predicate Device | Additional<br>Predicate 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 /<br>Maternal Monitors FM20,<br>FM30, FM40 and FM50 | | 510(k) Number | N/A | K140535 | | Acquisition<br>method | Doppler ultrasound | Doppler ultrasound | | Measurement of<br>cardiac cycle | myocardial wall and blood<br>flow motion | myocardial wall and blood<br>flow motion | | MRI Safety<br>Classification | MRI Conditional | MRI Conditional | | Measurement<br>Method | static pulsed Doppler (D) | static pulsed Doppler (D) | | Measurement<br>Range | Fetal: 60 - 240 BPM<br>Adult: 30-120 BPM | 50 to 240 bpm | | Average output<br>power | 40kPa | (40.4 ± 4.3) kPa | | Ultrasound<br>Frequency | 1,025 MHz ± 25 kHz | 1 MHz ± 100 Hz | | Ultrasound Burst<br>- Repetition Rate | 3.0 kHz | 3.0 kHz | | Ultrasound Burst<br>- Duration | max 90 periods @ 1.025<br>MHz<br>≤ 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.