(194 days)
No
The summary describes a digital stethoscope that amplifies, filters, and transmits audio data. It mentions data visualization, storage, playback, and sharing features in the accompanying app. There is no mention of any analytical capabilities, pattern recognition, or algorithms that would typically indicate the use of AI or ML for interpreting or analyzing the auscultation data. The performance testing focuses on audio frequency and NSR response comparison, not on diagnostic or analytical performance.
No
The device is described as an electronic stethoscope for amplifying, filtering, and transmitting auscultation data, which is a diagnostic tool, not a therapeutic one.
No
The device is an electronic stethoscope that amplifies, filters, and transmits auscultation data. While the data can be used by clinicians for diagnosis, the device itself is not described as performing diagnostic functions or providing diagnostic outputs. It is a tool for data acquisition, not diagnosis. The "Intended Use" explicitly states, "The device is not intended for self-diagnosis."
No
The device description explicitly states that the Keikku consists of two primary components: the Keikku device (an electronic stethoscope hardware component) and the Keikku App (software).
Based on the provided information, the Keikku device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The definition of an IVD involves testing samples like blood, urine, tissue, etc., outside of the body to obtain information about a person's health.
- The Keikku directly interacts with the patient's body. The Keikku is an electronic stethoscope that is placed on the patient's skin to listen to internal body sounds. It is a diagnostic tool used in vivo (within the living body), not in vitro (in glass/outside the body).
- The intended use and device description focus on auscultation. The primary function is to amplify, filter, and transmit body sounds for listening and analysis by a clinician. This is a physical examination technique, not a laboratory test on a specimen.
Therefore, the Keikku falls under the category of a medical device used for physical examination and diagnosis, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DQD
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:
-
- 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.
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, lungs, bowel, arteries, and veins
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
professional users in a clinical environment or by lay users in a nonclinical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility
Biocompatibility evaluation in compliance with ISO 10993-1 was evaluated.
-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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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.
1
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
2
Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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)
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.
| 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)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (6/20)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 ER
4
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.
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
5
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:
-
- 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.
-
- 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.
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.
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 electronic
stethoscope
K | Eko CORE
K200776 | Littmann 3200
K083903 | Comparison |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Regulation number and
Product Code | DQD , 870.1875 | DQD , 870.1875 | DQD, 870.1875 | Same |
| Intended use | Electronic
Stethoscope | Electronic
Stethoscope | Electronic
Stethoscope | Same |
| Indications for
use | The Keikku is an
electronic
stethoscope that
enables
amplification,
filtering, and
transmission of
auscultation data of
the patient (heart,
lungs, bowel, | The Eko CORE is
an electronic
stethoscope that
enables
amplification,
filtering, and
transmission of
auscultation sound
data (heart, lungs,
bowel, arteries, and | The 3MTM
Littmann®
Electronic
Stethoscope Model
3200 is intended for
medical diagnostic
purposes only. It
may be used for the
detection and
amplification of | Same as EKO
core |
| Specification/
Feature | Keikku electronic
stethoscope
K | Eko CORE
K200776 | Littmann 3200
K083903 | Comparison |
| | arteries, and veins),
whereby a clinician
at one location on
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. | veins), whereby a
clinician at one
location on network
can listen to the
auscultation sounds
of a patient on site
or at a different
location on the
network. Eko
CORE is intended
for use on pediatric
and adult patients.
The Eko CORE 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. | sounds from the
heart, lungs,
arteries, veins, and
other internal
organs with the use
of selective
frequency ranges. It
can be used on any
person undergoing
a physical
assessment | |
| Intended patient
population | Adults and pediatric | Adults and
pediatric | Adults and
pediatric | Same |
| Prescribed | Rx | OTC | Rx | Same as the
reference |
| Chest-piece | Yes | Yes | Yes | Same |
| Sound
Processing | Digital signal
processing | Digital signal
processing | Digital signal
processing | Same |
| Amplification | Increases the
volume to reach a
constant value, up to
42dB | Increases the
volume up to 40x
amplification | Up to 28dB
acoustic gain,
equivalent to 24
times amplification | Same as the
predicate |
| Auscultation
position
guide | Yes, using the video
session | Yes, using the
Software
Application | NA | Similar |
| Signal
Transmission | Wireless Network,
Bluetooth | Wireless Network,
Bluetooth | NA | Same |
| Display | Smartphone (iOS or
Android) device | Smartphone (iOS
or Android) | liquid crystal
display (LCD) | Same as
predicate |
| Form Factor | Wireless headsets | Similar to
traditional
stethoscope +
optional wireless
headsets | Similar to
traditional
stethoscope | Same as
predicate |
| Specification/
Feature | Keikku electronic
stethoscope
K | Eko CORE
K200776 | Littmann 3200
K083903 | Comparison |
| Environment of
use | Professional users in
a clinical
environment or by
lay users in a
nonclinical
environment. | Professional users
in a clinical
environment or by
lay users in a
nonclinical
environment. | Professional users
in a clinical
environment | Same as
predicate |
| Application | Real time | Real time | Real time | Same |
| Bluetooth | 5 LE | 4.2 LE | Class 2 Bluetooth | Same |
| Diaphragm | Silicon rubber | Epoxy/Fiberglass | Polyurethane
coated silicon | Different
however has
no impact on
performance
as was
determined by
testing. |
| Pickup sensor | MEMS microphone | MEMS microphone | Unknown | Same as EKO
core |
| Frequency
Response | Extended: 50-800Hz | Bell: 20 - 200Hz.
Diaphragm: 100 -
500Hz
Extended: 50 -
500Hz | Bell: 20-200Hz
Diaphragm: 100-
500Hz Extended
range: 50-500 Hz. | Similar |
| Power Source | Rechargeable
battery | Rechargeable
battery | AA battery | Same as EKO
core |
| IP | IP44 | IP22 | IPX4 (chest piece
only) | Similar |
| Signal input
method | Sound waves
collected via a
digital microphone | Toggle between
analog and
amplified listening
modes | Sound waves
collected via a
transducer | Similar |
| Signal storage | Keikku app (iOS
and Android) | EKO software (iOS
and Android) | via Bluetooth link
to a PC | Same as EKO
core |
6
7
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.
8
-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.