HeraBEAT™ US is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. HeraBEAT™ US is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.

Device Description

HeraBEAT™ US is a hand-held, battery powered audio Doppler device integrated with 2MHz probe, used for detecting and displaying the fetal heart rate (FHR) and FHR sound. The device uses an optical sensor to distinguish between the FHR and the maternal heart rate (MHR) to eliminate "crosstalk" in the FHR display.

HeraBEAT™ US includes the following components:

The handheld HeraBEAT™ US device that incorporates an ultrasound transducer, rechargeable battery, and internal microcontroller and Bluetooth Low Energy (BLE) chip for wireless data transfer from the HeraBEAT™ US device to the user's smartphone.
The HeraBEAT™ application, which is downloaded from an app store to the user's smartphone. The HeraBEAT™ application is used to communicate with the HeraBEAT™ US device using wireless BLE. It controls the operation of the device and receives the FHR values for numerical display to the user. It plays the FHR sound and stores the FHR values in a history log.

HeraBEAT™US is supplied with a battery charger (power supply), two tubes of commercially available Aquasonic 100 Ultrasound Transmission Gel (cleared under K802146), carry case and User Manual.

AI/ML Overview

The HeraBEAT™ US fetal ultrasonic monitor is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. It is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.

Here's an analysis of its acceptance criteria and the supporting study information:

1. Acceptance Criteria and Reported Device Performance

The document implicitly defines acceptance criteria through its comparison to the predicate device, MD800. The key performance metric is Fetal Heart Rate (FHR) measurement accuracy.

Acceptance Criteria (Based on Predicate Device)	Reported Device Performance (HeraBEAT™ US)
FHR measuring range: 50-240 bpm (Predicate: 50-210 bpm)	FHR measuring range: 50-240 bpm
Accuracy: +/- 2bpm	Accuracy: +/- 2bpm
Resolution: 1 bpm	Resolution: 1 bpm
Ultrasound nominal frequency: 2 MHz	Ultrasound nominal frequency: 2 MHz

Note: The HeraBEAT™ US has a wider FHR measuring range (240 bpm) compared to the predicate (210 bpm), which suggests an improvement or at least equivalent capability. The accuracy and resolution are identical to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a sample size for a clinical test set for FHR measurement accuracy. It mentions "Bench Performance Testing" where "Clinical measurement accuracy was conducted per the acoustic output measurement methodology as recommended in the FDA guidance document." This suggests the accuracy was validated using simulated signals or known standards in a lab environment, not necessarily a study with a test set of actual patients.

Therefore, details on data provenance (country of origin, retrospective/prospective) and the type of ground truth are not applicable as there is no described clinical test set for FHR accuracy.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document as there is no described clinical test set with human-established ground truth for FHR measurement. The accuracy was assessed against acoustic output measurement methodologies, not expert interpretation of fetal heart sounds/rates from patients.

4. Adjudication Method

This information is not provided in the document. As there is no described clinical test set involving human interpretation and ground truth establishment, adjudication methods are not applicable.

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

There is no mention of an MRMC comparative effectiveness study in the provided document. The submission focuses on substantial equivalence based on technical characteristics and bench testing.

6. Standalone Performance Study

The document describes "Bench Performance Testing" where "Clinical measurement accuracy was conducted per the acoustic output measurement methodology as recommended in the FDA guidance document 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers,' dated September 9, 2008." This indicates that the device's accuracy in measuring FHR was assessed using a controlled, standalone method, likely with calibrated equipment or simulated signals, to verify its technical specifications. However, this is distinct from a clinical standalone study involving human patients.

7. Type of Ground Truth Used

For the "Bench Performance Testing" of FHR measurement accuracy, the ground truth was established by:

Acoustic output measurement methodology per FDA guidance: This implies the use of validated standards and equipment to measure the acoustic output and resulting FHR determination, rather than expert consensus, pathology, or outcomes data from patients.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set for the HeraBEAT™ US device. Given that it's a fixed-function fetal doppler, it's unlikely to rely on typical machine learning training sets in the same way an AI-powered diagnostic image analysis tool would. Its performance is based on established signal processing and measurement principles inherent in the hardware and software design.

9. How Ground Truth for the Training Set Was Established

This information is not applicable as no training set is mentioned for the device.

Summary

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

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

November 14, 2019

HeraMED Ltd. % Sheila Hemeon-Heyer, JD, RAC President and Founder Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst. MA 91002

Re: K191110

Trade/Device Name: HeraBEAT™US Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: April 24, 2019 Received: April 26, 2019

Dear Sheila Hemeon-Heyer:

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

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

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 (OS) 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,

Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K191110

Device Name

HeraBEAT™ US

Indications for Use (Describe)

HeraBEATIM US is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. HeraBEAT™ US is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.

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."

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

Page 1 of 4

510(k) SUMMARY K191110

Device Manufacturer:	HeraMED Ltd.6 Meir Ariel StreetNetanya, 4059300, Israel
510(k) Contact:	Sheila Hemeon-HeyerPresident and FounderHeyer Regulatory Solutions LLC413-330-8578Sheila@Heyer-Regulatory.com
Date Prepared:	November 13, 2019
Name of Device:	HeraBEAT™ US
Common or Usual Name:	Fetal Ultrasonic Monitor and Accessories
Classification:	Product Code:Regulation No:Regulatory Class:Classification Panel:	KNG21 C.F.R. §884.2660IIObstetrics/Gynecology
Predicate Device:	MD800, cleared under K112911

This predicate device has not been subject to a design related recall.

Intended Use / Indications for Use

Device Description

HeraBEAT™ US includes the following components:

The handheld HeraBEAT™ US device that incorporates an ultrasound transducer, . rechargeable battery, and internal microcontroller and Bluetooth Low Energy (BLE) chip for wireless data transfer from the HeraBEAT™ US device to the user's smartphone.
The HeraBEAT™ application, which is downloaded from an app store to the user's .

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

smartphone. The HeraBEAT™ application is used to communicate with the HeraBEAT™ US device using wireless BLE. It controls the operation of the device and receives the FHR values for numerical display to the user. It plays the FHR sound and stores the FHR values in a history log.

HeraBEAT™US is supplied with a battery charger (power supply), two tubes of commercially available Aquasonic 100 Ultrasound Transmission Gel (cleared under K802146), carry case and User Manual.

Device & Predicate Device(s):	K191110	K112911
General Device Characteristics
Device Name	HeraBEAT™ US	MD800
Indications for Use	HeraBEAT™ US is intendedto detect fetal heart beats,display fetal heart rate, andplay the fetal heart sound.HeraBEAT™US is indicatedfor use by medicalprofessionals in clinical orhome care settings forsingleton pregnancies from12 weeks gestation.	The Fetal Doppler is ahand-held, batterypowered audio Dopplerdevice used fordetecting fetal heartbeats.
Intended patient population	Pregnant women	Pregnant women
Intended device operator	Healthcare professionals	Healthcareprofessionals
Gestational age	12 weeks	12 weeks
Environment of use	Professional and homehealthcare environment	Professional and homehealthcare environment
FHR measurement method	Doppler ultrasound	Doppler ultrasound
Device Features
Battery/Power Supply	Lithium ion rechargeablebattery supplied with charger	2 AA alkaline batteries,assumed replaceable
Display	Smart phone application	LCD
Bluetooth	Yes	-
Technical Specifications
Working mode	Continuous wave	Continuous wave
Ultrasound nominal frequency	2 MHz	2 MHz
FHR measuring range	50-240 bpm	50-210 bpm
Resolution	1bpm	1 bpm
Accuracy	+/- 2bpm	+/- 2bpm

Substantial Equivalence Discussion

The HeraBEAT™US device has the same intended use and similar technological characteristics and principles of operation as the MD800 fetal ultrasonic monitor. Different technological features include the use of Bluetooth technology, different battery/power supply,

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

different ingress protection, and different display modalities. The technological differences between the HeraBEAT™US device and the predicate device do not raise different questions of safety and effectiveness.

Non-clinical Performance Data

Bench Performance Testing

Clinical measurement accuracy was conducted per the acoustic output measurement methodology as recommended in the FDA guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," dated September 9, 2008.

Biocompatibility

HeraBEAT™ US is a surface contact device with a short-term (<24 hours) contact duration with intact skin. Per the recommendations of the 2016 FDA quidance document "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing Within A Risk Management Process," the following tests were performed:

Cytotoxicity Test per ISO 10995-5:2009 .
Intracutaneous Irritation Test per ISO 10993-10:2010 ●
Guinea Pig Maximization Sensitization Test per ISO 10993-10:2010 ●

Software Validation

The HeraBEAT™ US software meets the requirements of IEC 62304:2015-06 (ed. 1.1) Medical device software - Software life cycle processes. Software documentation, including software verification and validation testing is in accordance with FDA's 2005 guidance document. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.".

Electrical Safety and EMC Testing

The HeraBEAT™ US device was tested to and found to be in compliance with the following safety tests:

. IEC 60601-1:2005/A1:2012 (ed. 3.1) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2015 (ed. 2.0) Medical electrical equipment Part 1-11: General . requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-37:2015 (ed. 2.1) Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical

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

diagnostic and monitoring equipment

. IEC 60601-1-2:2014 (ed. 4.0) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 62471:2006-07 (ed. 1.0) Photobiological safety of lamps and lamp systems. The ● device was confirmed to meet the EXEMPT category of light emissions.

Use-life testing:

Devices underwent simulated repeated use conditions and were evaluated for key performance and FHR measurement accuracy. The results demonstrated that the subject device can be used for three years under normal use conditions.

RF Wireless Transmission

The HeraBEAT™ US Bluetooth communication between the device and mobile app was subjected to wireless co-existence and quality of service (QoS) testing in accordance with FDA's guidance document, "Radio Frequency Wireless Technology in Medical Devices," August 13, 2013, and was found to be compliant for the device's intended use and indications for use.

Conclusion

The results of the performance testing described above demonstrate that the HeraBEAT™ US is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 884.2660 Fetal ultrasonic monitor and accessories.

(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).