The Keikku is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation data of the patient (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on a network can listen to the auscultation data of a patient on site or at a different location on the network. The Keikku is intended for use on pediatric and adult patients. The Keikku is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.

Device Description

The Keikku (Rx) is a digital stethoscope device designed for use by health care professionals in clinical settings and by lay users in non-clinical environments under healthcare provider supervision. The Keikku electronically amplifies, filters and transfers body sounds through the accompanying mobile application and is used for storage, sharing and transmitting the data for telemedicine use. It also enables lay users, under supervision from a healthcare provider, to listen to their body sounds (lungs, heart, arteries, veins, gastrointestinal tract, etc.), record and share it with their physicians during telehealth sessions. The Keikku consists of two primary components: 1. The Keikku device is an electronic stethoscope. The Keikku device is used for recording audio, converting it to digital data, and transmitting the data to a mobile device via Bluetooth®. It includes volume adjustment via rotation, tap feature for starting and ending the recording, and an LED light indicator for indicating the status of the device. 2. The Keikku App. The app captures audio data from the Keikku device and provides data visualization and annotation, secure data storage, audio playback, and sharing features. These features enable a healthcare professional to monitor patients, seek second opinions from a specialist or use the device for telemedicine use.

AI/ML Overview

The provided text describes the Keikku Electronic Stethoscope and its substantial equivalence determination to predicate devices. However, it does not contain specific acceptance criteria or a detailed study that proves the device meets such criteria in the format explicitly requested.

The document states that "The test passed and met the predefined acceptance criteria" for performance testing related to audio frequency and NSR response, but it does not specify what those acceptance criteria were or present the reported device performance in a table. It also refers to usability evaluation as having "passing results" without detailing the study or its criteria.

Therefore, I cannot fully complete the requested table and answer all questions due to the lack of explicit information in the provided text.

Based on the available information, here is what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Implied)
Performance Testing: Audio frequency response similar to predicate and reference devices.	Passed (similar to Eko Core and 3M Littmann electronic stethoscope in terms of audio frequency and NSR response).
Performance Testing: NSR (Noise-to-Signal Ratio) response similar to predicate and reference devices.	Passed (similar to Eko Core and 3M Littmann electronic stethoscope in terms of audio frequency and NSR response).
Biocompatibility: Compliance with ISO 10993-1.	Passed (evaluated in compliance with ISO 10993-1).
Cleaning and Disinfection: Validation successful.	Passed (All tests successfully completed).
Software Validation: Compliance with FDA's "Content of Premarket Submissions for Device Software Functions" guidance.	Passed (Software verification and validation testing were conducted, and documentation was provided as recommended).
Electrical Safety: Compliance with IEC 60601-1.	Passed (conducted on the Keikku Electronic Stethoscope).
EMC: Compliance with IEC 60601-1-2.	Passed (conducted on the Keikku Electronic Stethoscope).
Usability: Passing results.	Passed (Usability study was conducted with passing results).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided text for any of the performance studies.
Data Provenance: Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not specified. The document repeatedly refers to "tests" and "evaluations" but does not mention expert involvement in establishing ground truth for any test sets beyond general usability studies.

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

Not specified.

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

No MRMC comparative effectiveness study is mentioned. The device's primary function is as an electronic stethoscope for amplification, filtering, and transmission of auscultation data, not an AI-assisted diagnostic tool for human readers.

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

This question is not directly applicable in the context of an electronic stethoscope as described. The device itself (Keikku Electronic Stethoscope) performs sound capture, amplification, and filtering. It is inherently a "standalone" device in its primary functionality. However, it works with an accompanying mobile application for data visualization, storage, and sharing, and facilitates human practitioners' listening. There's no separate "algorithm only" performance reported that would be distinct from the device's inherent operation.

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

The document primarily describes engineering and validation testing (biocompatibility, cleaning/disinfection, electrical safety, EMC, software). For the "Performance Testing," it states the purpose was "to verify the Keikku's performance is similar to that of its predicate and reference devices, Eko Core and 3M Littmann electronic stethoscope, in terms of audio frequency and NSR response." This implies the "ground truth" for performance was defined by the established performance characteristics of the predicate and reference devices, rather than a clinical ground truth like pathology or expert consensus on clinical diagnoses.

8. The sample size for the training set

Not applicable as the document does not describe any machine learning models that would require a "training set." The Keikku device provides amplification, filtering, and transmission, but it's not described as having an AI component that is "trained" in the typical sense.

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

Not applicable (see point 8).

Summary

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April 10, 2024

Lapsi Health Holding B.V % Orly Maor Consultant 25 Sirkin Street Kfar Saba, 4442157 Israel

Re: K233313

Trade/Device Name: Keikku Electronic stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: September 29, 2023 Received: September 29, 2023

Dear Orly Maor:

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.

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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).

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 QS 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 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,

Robert T. Kazmierski -S

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices

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Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

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

510(k) Number (if known)

K233313

Device Name

Keikku Electronic Stethoscope 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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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:

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"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 FDA 3881 (6/20)

Page 1 of 1 FDA

PSC Publishing Services (301) 443-6740 ER

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Traditional Premarket Notification Submission - 510(k) Keikku Electronic Stethoscope 510(k) Number K233313

Date Prepared: April 5, 2024

I. SUBMITTER

Lapsi Health Holding B.V. Laarderhoogtweg 25, Amsterdam The Netherlands www.lapsihealth.com

Regulatory Correspondent:

Katja Koskinen, Regulatory Officer Lapsi Health Holding B.V. Laarderhoogtweg 25, Amsterdam -The Netherlands katja@lapsihealth.com

DEVICE II.

Name of Device: Keikku Electronic Stethoscope Common or Usual Name: Keikku Electronic Stethoscope Classification Name: 21 CFR 870.1875; Stethoscope, Electronic Regulatory Class: II Product Code: DQD.

III. PREDICATE DEVICE

Lapsi Health Holding B.V. believes that the Keikku Electronic Stethoscope is substantially equivalent to the following predicate device:

Eko CORE manufactured by Eko Devices, Inc. cleared under K200776, Classification name Electronic stethoscope, Product code: DQD, Regulation: 21 CFR 870.1875
The following device is used as a reference device:
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 manufactured by Eko ● Devices, Inc. cleared under K083903, Classification name Electronic stethoscope, Product code: DQD, Regulation: 21 CFR 870.1875

DEVICE DESCRIPTION IV.

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telemedicine use. It also enables lay users, under supervision from a healthcare provider, to listen to their body sounds (lungs, heart, arteries, veins, gastrointestinal tract, etc.), record and share it with their physicians during telehealth sessions.

The Keikku consists of two primary components:

1. The Keikku device is an electronic stethoscope. The Keikku device is used for recording audio, converting it to digital data, and transmitting the data to a mobile device via Bluetooth®. It includes volume adjustment via rotation, tap feature for starting and ending the recording, and an LED light indicator for indicating the status of the device.
1. The Keikku App. The app captures audio data from the Keikku device and provides data visualization and annotation, secure data storage, audio playback, and sharing features. These features enable a healthcare professional to monitor patients, seek second opinions from a specialist or use the device for telemedicine use.

INDICATIONS FOR USE V.

OF TECHNOLOGICAL CHARACTERISTICS VI. COMPARISON WITH THE PREDICATE DEVICE

The Keikku Electronic Stethoscope has the same intended use as the predicate device. Its indications for use are identical to that of the predicate device.

The Keikku Electronic Stethoscope has similar technological characteristics as the predicate device as demonstrated in the table below:

Specification/Feature	Keikku electronicstethoscopeK	Eko COREK200776	Littmann 3200K083903	Comparison
Regulation number andProduct Code	DQD , 870.1875	DQD , 870.1875	DQD, 870.1875	Same
Intended use	ElectronicStethoscope	ElectronicStethoscope	ElectronicStethoscope	Same
Indications foruse	The Keikku is anelectronicstethoscope thatenablesamplification,filtering, andtransmission ofauscultation data ofthe patient (heart,lungs, bowel,	The Eko CORE isan electronicstethoscope thatenablesamplification,filtering, andtransmission ofauscultation sounddata (heart, lungs,bowel, arteries, and	The 3MTMLittmann®ElectronicStethoscope Model3200 is intended formedical diagnosticpurposes only. Itmay be used for thedetection andamplification of	Same as EKOcore
Specification/Feature	Keikku electronicstethoscopeK	Eko COREK200776	Littmann 3200K083903	Comparison
	arteries, and veins),whereby a clinicianat one location onnetwork can listen tothe auscultation dataof a patient on siteor at a differentlocation on thenetwork. TheKeikku is intendedfor use on pediatricand adult patients.The Keikku isintended to be usedby professionalusers in a clinicalenvironment or bylay users in anonclinicalenvironment. Thedevice is notintended for self-diagnosis.	veins), whereby aclinician at onelocation on networkcan listen to theauscultation soundsof a patient on siteor at a differentlocation on thenetwork. EkoCORE is intendedfor use on pediatricand adult patients.The Eko CORE isintended to be usedby professionalusers in a clinicalenvironment or bylay users in anonclinicalenvironment. Thedevice is notintended for self-diagnosis.	sounds from theheart, lungs,arteries, veins, andother internalorgans with the useof selectivefrequency ranges. Itcan be used on anyperson undergoinga physicalassessment
Intended patientpopulation	Adults and pediatric	Adults andpediatric	Adults andpediatric	Same
Prescribed	Rx	OTC	Rx	Same as thereference
Chest-piece	Yes	Yes	Yes	Same
SoundProcessing	Digital signalprocessing	Digital signalprocessing	Digital signalprocessing	Same
Amplification	Increases thevolume to reach aconstant value, up to42dB	Increases thevolume up to 40xamplification	Up to 28dBacoustic gain,equivalent to 24times amplification	Same as thepredicate
Auscultationpositionguide	Yes, using the videosession	Yes, using theSoftwareApplication	NA	Similar
SignalTransmission	Wireless Network,Bluetooth	Wireless Network,Bluetooth	NA	Same
Display	Smartphone (iOS orAndroid) device	Smartphone (iOSor Android)	liquid crystaldisplay (LCD)	Same aspredicate
Form Factor	Wireless headsets	Similar totraditionalstethoscope +optional wirelessheadsets	Similar totraditionalstethoscope	Same aspredicate
Specification/Feature	Keikku electronicstethoscopeK	Eko COREK200776	Littmann 3200K083903	Comparison
Environment ofuse	Professional users ina clinicalenvironment or bylay users in anonclinicalenvironment.	Professional usersin a clinicalenvironment or bylay users in anonclinicalenvironment.	Professional usersin a clinicalenvironment	Same aspredicate
Application	Real time	Real time	Real time	Same
Bluetooth	5 LE	4.2 LE	Class 2 Bluetooth	Same
Diaphragm	Silicon rubber	Epoxy/Fiberglass	Polyurethanecoated silicon	Differenthowever hasno impact onperformanceas wasdetermined bytesting.
Pickup sensor	MEMS microphone	MEMS microphone	Unknown	Same as EKOcore
FrequencyResponse	Extended: 50-800Hz	Bell: 20 - 200Hz.Diaphragm: 100 -500HzExtended: 50 -500Hz	Bell: 20-200HzDiaphragm: 100-500Hz Extendedrange: 50-500 Hz.	Similar
Power Source	Rechargeablebattery	Rechargeablebattery	AA battery	Same as EKOcore
IP	IP44	IP22	IPX4 (chest pieceonly)	Similar
Signal inputmethod	Sound wavescollected via adigital microphone	Toggle betweenanalog andamplified listeningmodes	Sound wavescollected via atransducer	Similar
Signal storage	Keikku app (iOSand Android)	EKO software (iOSand Android)	via Bluetooth linkto a PC	Same as EKOcore

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility

Biocompatibility evaluation in compliance with ISO 10993-1 was evaluated.

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-Cleaning and Disinfection Testing

Cleaning and disinfection validation were performed. All tests were successfully completed.

Performance Testing -

Performance testing included comparison testing of the Keikku Electronic Stethoscope to its predicate and reference device. The main purpose of this test was to verify the Keikku's performance is similar to that of its predicate and reference devices, Eko Core and 3M Littmann electronic stethoscope, in terms of audio frequency and NSR response. The test passed and met the predefined acceptance criteria.

Software Validation -

The Keiiku Electronic Stethoscope is categorized as Enhanced. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".

Electrical Safely and EMC -

Electrical Safety per IEC 60601-1, Electromagnetic compatibility (EMC) per IEC 60601-1-2 and usability per IEC 60601-1-6 were conducted on the Keikku Electronic Stethoscope. The tests passed.

Usability Evaluation -

Usability study was conducted with passing results.

VIII. CONCLUSION

The Keikku Electronic Stethoscope was determined to be substantially equivalent to the predicate and reference device.

Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.