NeoBeat and NeoBeat Mini are indicated to continuously measure and display the heart rate of neonates using dry electrodes on the torso during transition, stabilization and/or resuscitation. The devices are intended to be used in healthcare facilities. NeoBeat is intended for use on newborns approximately 1.5-5 kg. NeoBeat Mini is intended for newborns approximately 0.5-2 kg.

Device Description

The NeoBeat Newborn Heart Rate Meter is a battery-powered device placed on the torso of a newborn, indicated to measure the heart rate. NeoBeat does not store, display or output an ECG signal. The device is placed around the torso of the neonate such that the ECG dry electrodes contact the neonate's skin. It can be oriented caudally or cranially. In normal operation, the LED display presents the heart rate in large numerals. The display can also present other information, such as signal quality and error codes. The device comes with a charging stand.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NeoBeat/NeoBeat Mini device based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Heart Rate Accuracy	≤ ±1% or ±1 bpm (when tested in accordance with IEC 60601-2-27, Clause 201.12.1.101.15)
	Clinically: ±3 bpm with good signal quality, and ±6 bpm during reduced signal quality.

Study Information

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: 19 clinical cases representing over 4 hours of ECG data.
- Data Provenance: The 19 cases were randomly selected from a large database containing newborn ECGs from four countries outside the United States.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: 2
- Qualifications: An ICU physician and a scientific expert in ECG signal processing and analysis.
Adjudication method for the test set:
- Not explicitly stated, but it implies a consensus given "Heart rate based on expert annotation was considered 'ground truth'." This suggests the two experts either agreed directly or their combined annotation formed the ground truth.
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:
- No MRMC comparative effectiveness study was done. This study focused on the algorithm's standalone performance compared to expert-annotated ground truth, not on human reader improvement with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The study compared "Heart rate based on NeoBeat's algorithm" to the "ground truth" heart rate established by experts.
The type of ground truth used:
- Expert consensus (specifically, expert annotation of QRS complexes).
The sample size for the training set:
- Not explicitly stated. The document mentions a "large database containing newborn ECGs from four countries outside the United States" with "over 1000 cases of ECGs" collected from researchers. While this database was used to select the test cases, it is strongly implied that this database would have been used for training/development, but the exact size of the training set is not specified separately from the total database.
How the ground truth for the training set was established:
- Not explicitly stated for the training set. For the test set, it was established by expert annotation of QRS complexes by an ICU physician and a scientific expert. It is reasonable to infer a similar method for the training set, given the nature of the data and the use of expert annotation for the test set.

Summary

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June 25, 2024

Laerdal Medical AS % Daniel Dillon, M.S., Rac Senior Regulatory Scientist MED Institute 1330 Win Hentschel Blvd West Lafayette, Indiana 47906

Re: K232111

Trade/Device Name: NeoBeat, NeoBeat Mini Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: June 24, 2024 Received: June 24, 2024

Dear Daniel Dillon:

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

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

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

For comprehensive regulatory information about 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,

Jennifer W. Shih -S

Jennifer Kozen 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

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Indications for Use

510(k) Number (if known) K232111

Device Name

NeoBeat and NeoBeat Mini

Indications for Use (Describe)

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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510(k) Summary - K232111

NeoBeat Newborn Heart Rate Meter 21 CFR 870.2300 Date Prepared: June 20, 2024

Submitted By	Mari Kaada, Corporate Quality and Regulatory Director
	Laerdal Medical AS
	Tanke Svilandsgate 30
	P.O. Box 377
	4002 Stavanger
	Norway
	T: (011) 47-51-51-16-30
	Mari.Kaada@laerdal.com

Device Information

Trade Name:	NeoBeat/NeoBeat Mini
Common/Usual Name:	Heart Rate Meter
Classification Name:	Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)
Regulation:	21 CFR 870.2300
Product Code:	MWI
Device Class:	Class II
Classification Panel:	Cardiovascular

Indications for Use

NeoBeat and NeoBeat Mini are indicated to continuously measure and display the heart rate of neonates using dry electrodes on the torso during transition, stabilization and/or resuscitation. The devices are intended to be used in healthcare facilities. NeoBeat is intended for use on newborns approximately 1.5-5 kg. The NeoBeat Mini is intended for newborns approximately 0.5-2 kg.

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Predicate Device

The NeoBeat Newborn Heart Rate Meter is substantially equivalent to the predicate device, the Guangdong Biolight M800 Handheld Monitor (510(k) No. K131762, cleared June 6, 2014).

Device Description

The NeoBeat Newborn Heart Rate Meter is a battery-powered device placed on the torso of a newborn, indicated to measure the heart rate. NeoBeat does not store, display or output an ECG signal.

The device is placed around the torso of the neonate such that the ECG dry electrodes contact the neonate's skin. It can be oriented caudally or cranially. In normal operation, the LED display presents the heart rate in large numerals. The display can also present other information, such as signal quality and error codes. The device comes with a charging stand.

Substantial Equivalence

The NeoBeat Newborn Heart Rate Meter is substantially equivalent to the predicate device, the Guangdong Biolight M800 Handheld Monitor (510(k) No. K131762). The table below presents the similarities and differences between the two devices for substantial equivalence purposes, comparing the NeoBeat Newborn Heart Rate Meter to the heart rate indication and function of the Biolight M800.

The differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness. Performance data are available to support substantial equivalence and were developed using acceptable scientific methods for evaluation.

	NeoBeat Newborn Heart Rate Meter(K232111)	Biolight M800 Monitor(K131762)
Intended Use
	Indication foruse	NeoBeat and NeoBeat Mini are indicated tocontinuously measure and display the heartrate of neonates using dry electrodes on thetorso during transition, stabilization and/orresuscitation. The devices are intended to beused in healthcare facilities. NeoBeat isintended for use on newbornsapproximately 1.5-5 kg. NeoBeat Mini isintended for newborns approximately0.5-2 kg.
Patientpopulation	Neonates	Adult, pediatric and neonates
	NeoBeat Newborn Heart Rate Meter(K232111)	Biolight M800 Monitor(K131762)
Users	Healthcare professionals involved innewborn care (Rx only).	Healthcare professionals (Rx only)
Intended Use	Measure and display heart HR	Measure, display and monitor HR
Technology
Design	Integrated display and electrodes; lead wiresunnecessary	Display and detachable leads; no electrodes
Display	LED	Thin Film Transistor (TFT) LCD
Alarm	None: Measurement only	Visual and audio alarms
HR detectionmethod	ECG	Same
HR displayrange	20 bpm - 250 bpm	10 bpm - 300 bpm
HR accuracy	≤±1% or ±1 bpm, when tested inaccordance with IEC 60601-2-27,Clause 201.12.1.101.15; data from clinicaltesting show that NeoBeat has an accuracyof ±3 bpm with good signal quality and±6 bpm during reduced signal quality.	±1% or ±1 bpm, whichever is greater
Patient-contactmaterials	Polyamide (main body), thermoplasticpolyurethane (“TPU"; main body); stainlesssteel (electrodes)	TPU (ECG cable)
Standards
	AAMI/IEC 60601-1:2005 + AMD1:2012,Medical electrical equipment - Part 1:General requirements for basic safety andessential performance	IEC 60601-1, Medical electrical equipment -Part I: General requirements for basic safetyand essential performance, 1998; AmendmentI, 1991; Amendment 2, 1995.
	IEC 60601-1-2:2014, Medical electricalequipment - Part 1-2: General requirementsfor basic safety and essential performance -Collateral Standard: Electromagneticdisturbances - Requirements and tests	IEC 60601-1-2:2007, Medical electricalequipment - Part 1-2: General requirementsfor basic safety and essential performance -Collateral standard: Electromagneticcompatibility - Requirements and tests.
	Not applicable	IEC 60601-2-27:2005, Medical electricalequipment - Part 2-27: Particular requirementsfor the safety including essential performance,of electrocardiographic monitoring equipment.

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Discussion of Tests and Test Results

Design verification and design validation testing demonstrates that the NeoBeat Newborn Heart Rate Meter meets its functional requirements and performance specifications. In particular,

Testing demonstrates the validation of the detection algorithm. The testing included: .
- Estimating NeoBeat's heart rate accuracy based on 19 clinical cases, including . resuscitation cases, representing over 4 hours of ECG data. The 19 cases were randomly selected from a large database containing newborn ECGs from four countries outside the United States. The database contains over 1000 cases of ECGs collected from researchers using NeoBeat on both term and pre-term newborns within the first few minutes of birth, including resuscitation cases. The QRS complexes of the 19 cases were then annotated by two experts, an ICU physician and a scientific expert in ECG signal processing and analysis. Heart rate based on expert annotation was considered "ground truth". Heart rate based on NeoBeat's algorithm was then compared to the "ground truth" heart rate to determine accuracy. NeoBeat had an RMS heart rate accuracy of ±3 bpm with good signal quality and ±6 bpm during reduced signal quality.
- . Testing in accordance with applicable clauses of IEC 60601-2-27, Particular requirements for the basic safety, and essential performance of electrocardiographic monitoring equipment.
- Testing on a newborn that demonstrates that electrode placement on the torso does not . affect heart rate accuracy.
Testing demonstrates that the device can be cleaned and disinfected by the reprocessing . instructions given in the device labeling.
Testing in accordance with FDA's guidance, Applying Human Factors and Usability ● Engineering to Medical Devices (February 3, 2016), demonstrates that the device is safe and effective for the intended users, uses and use environments in the United States, with respect to human factors principles as compared to the predicate.
Testing demonstrates the device can function acceptably during its labeled expected . service life.

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Testing in accordance with AAMI/IEC 60601-1:2005 + AMD1:2012, Medical electrical . equipment - Part 1: General requirements for basic safety and essential performance, and IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, demonstrates the electrical safety and electromagnetic compatibility of the device.
Biocompatibility testing in accordance with FDA guidance, Use of International ● Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (September 2020) demonstrates an appropriate biocompatibility profile for the device.

Conclusion

The results of these tests support the conclusion that the NeoBeat Newborn Heart Rate Meter performs acceptably and does not raise any different questions regarding safety or effectiveness compared to the predicate device, thus supporting a determination of substantial equivalence.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).