The Electronic Stethoscope DS101 is intended for the detection, and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.

The Electronic Stethoscope Omni-Steth is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.

Device Description

The proposed Electronic Stethoscopes Models DS101 and Omni-Steth detect and display the sounds from the heart, lungs, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs from a patient's body. After amplifying and filtering, the sounds are also sent to the user's ears bilaterally through the active speaker embedded at the bottom of the stethoscopes. Sound processing is conducted with the aid of a digital signal processor. Power to the device is provided by two AAA1.2V batteries. The one-hand operable user interface consists of a full-color OLED display, the Record button, arrow keys, the OK button, and a tube connector to output sounds to the headset consisting of tubes and ear tips.

The proposed devices can detect and display an acoustic based heart rate when presented with consistent heart sounds.

In addition, using a Bluetooth wireless link, the proposed stethoscopes can exchange raw audio data with external devices such as personal computers.

Note: The models DS101 and Omni-Steth are standalone devices and do not require Bluetooth data transfer to fulfill their intended use.

The differences between the proposed stethoscope models DS101 and Omni-Steth are cosmetic: specifically, the design of top housing and keyboard layout. The OLED Display information are identical.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (electronic stethoscopes). It outlines the device's features, intended use, and comparison to predicate devices, along with performance data from non-clinical studies. However, it explicitly states that "clinical testing was deemed unnecessary" because the device's intended use, operating principle, and fundamental technology are the same as existing predicate devices.

Therefore, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria through clinical evaluation, an MRMC comparative effectiveness study, or a standalone algorithm performance study. The performance data section focuses on non-clinical evaluations like electrical safety, EMC, software verification, biocompatibility, usability, wireless coexistence, splash water, heart rate performance, and audio performance, primarily through bench testing and comparisons to predicate devices.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

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

The document does not present formal acceptance criteria in a tabular format, nor does it detail specific performance metrics with numerical targets and results for clinical efficacy. Instead, it states compliance with various standards and demonstrates substantial equivalence through comparative bench testing.

Based on the "Performance Data" section, here's a summary of the performance claims and the studies that support them:

Performance Aspect	Acceptance Criteria (Implied)	Reported Device Performance and Study
Risk Analysis	Compliance with ISO 14971:2007; identified risks controlled to acceptable levels.	Risk analysis conducted. Identified risks mitigated, and residual risks found at acceptable levels.
Electrical Safety	Compliance with ANSI/AAMI ES 60601-1:2005/(R)2012.	Complies with ANSI/AAMI ES 60601-1:2005/(R)2012. Tested by SGS Taiwan Limited.
EMC	Compliance with IEC 60601-1-2:2014 and FCC Part 15.	Complies with IEC 60601-1-2:2014 and FCC Part 15. Acceptable results for radiated emissions, immunity to electrostatic discharges, immunity to radio frequency electromagnetic fields, and power frequency magnetic fields. Tested by SGS Taiwan Limited.
Software V&V	Compliance with "Guidance for the content of premarket submissions for software contained in medical devices, May 11, 2005" and IEC/TR80002-1:2009. Failure or latent flaw could indirectly result in minor injury (moderate concern).	Documentation submitted in accordance with requirements. The software's "level of concern" is considered "moderate."
Biocompatibility	Compliance with AAMI ANSI ISO 10993-1:2009.	Complies with AAMI ANSI ISO 10993-1:2009.
Usability	Compliance with IEC 62366:2015, Clause 5.3 and 5.7.3. Acceptable usability, learnability, efficiency, satisfaction, and no identified hazards.	Usability is acceptable. Test participants successfully completed tasks and expressed satisfaction with learnability, efficiency, and size. No use problems or hazards identified.
Wireless Coexistence	Compliance with ANSI C63.27-2017. Minimal interference, stable heart rate and peak-to-value.	Complies with ANSI C63.27-2017. Little interference from Bluetooth and Wi-Fi noted over different test distances; heart rate and peak-to-value remained stable.
Splash Water Test	Compliance with IEC / EN 60529:2001 (IPX4). Normal device function after testing.	Complies with IEC / EN 60529:2001 (IPX4). Device’s function was normal after testing.
Heart Rate Performance	Substantial equivalence to predicate devices (3M 3200 and DS3011A) within 30-180 bpm heart rate range.	Substantially equivalent to 3M 3200 and DS3011A within the heart rate range of 30-180 bpm. (Bench testing results compared to predicate devices).
Audio Performance	Substantial equivalence to predicate devices (3M 3200 and DS3011A) for specified audio characteristics (e.g., below 1 kHz, bell/diaphragm/wide frequency modes).	Substantially equivalent to 3M 3200 for audio frequency below 1 kHz. Substantially equivalent to DS3011A for bell, diaphragm, and wide frequency band modes. (Bench testing results compared to predicate devices).

2. Sample size used for the test set and the data provenance

Usability Evaluation (Non-clinical):
- Sample Size: 15 physicians and 15 registered nurses (Total: 30 participants)
- Data Provenance: Conducted in San Diego, California and Saint Louis, Missouri, USA. The setting simulated clinic, out-patient clinic, and in-hospital settings.
Heart Rate Performance Testing & Audio Performance Testing (Non-clinical):
- These were bench tests comparing the proposed device to predicate devices (IMEDIPLUS Electronic Stethoscope DS3011A and 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200). The "sample size" here refers to the number of devices tested, not human subjects or patient data. The document does not specify the number of units tested for these bench tests, or the origin of any acoustic data used for these comparisons.
For clinical data: The document explicitly states: "There is no difference in the intended use, operating principle, and fundamental technology, in comparison to the predicate device, thus clinical testing was deemed unnecessary." Therefore, no clinical test set was used, and no related sample size or data provenance for clinical data is available.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Since no clinical study was performed, there was no clinical ground truth established by experts in this submission.
For the Usability Evaluation, 15 physicians and 15 registered nurses participated. Their role was as users of the device for the usability test, not as experts establishing a diagnostic ground truth. No specific qualifications beyond "physician" and "registered nurse" were provided.

4. Adjudication method for the test set

Not applicable, as no clinical test set or diagnostic adjudication process was described. The usability test involved participants providing feedback, but this is not a diagnostic adjudication.

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, an MRMC comparative effectiveness study was not done. This device is an electronic stethoscope that amplifies and records sounds; it is not an AI-powered diagnostic algorithm that assists human readers in interpreting images or data. The submission focuses on the substantial equivalence of its physical and functional aspects to predicate stethoscopes.

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

Not directly applicable in the context of an "algorithm only" performance for diagnosis. The device itself is a tool for clinicians. While it performs internal processing (e.g., heart rate detection, sound amplification/filtration), the document does not present it as a standalone diagnostic algorithm in the way AI for medical imaging would be. The performance bench tests (heart rate and audio) could be considered "standalone" in that they evaluate the device's technical output, but not a diagnostic "algorithm" in isolation from human use.

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

No clinical ground truth (expert consensus, pathology, outcomes data) was used or established because clinical testing was deemed unnecessary.
For the non-clinical performance tests:
- Heart Rate Performance: Ground truth was implicitly established by comparing the device's heart rate detection to that of the already cleared predicate devices (3M 3200 and IMEDIPLUS DS3011A) in controlled bench test settings.
- Audio Performance: Ground truth was similarly established by comparing the audio output (frequency bands) to the predicate devices in bench tests.
- Usability: "Ground truth" for usability was successful completion of tasks and participant satisfaction, reported through feedback collected during the study.

8. The sample size for the training set

Not applicable. This submission is for an electronic stethoscope, not a machine learning or AI model that requires a "training set" of data in the conventional sense. The device's functionality is based on established acoustic and electronic principles, not on learned patterns from a dataset.

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

Not applicable (as per point 8).

Summary

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Image /page/0/Picture/0 description: The image contains 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 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.

September 11, 2018

Imediplus, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041

Re: K182196

Trade/Device Name: Cardiart Electronic Stethoscope: Model DS101; Omni-Steth Electronic Stethoscope: Model Omni-Steth Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: August 11, 2018 Received: August 14, 2018

Dear Dave Yungvirt:

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Stephen C. Browning -S5

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182196

Device Name

Cardiart Electronic Stethoscope: Model DS101 Omni-Steth Electronic Stethoscope: Model Onmi-Steth

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) Number: K182196

SUBMITTER: -

Submitter's Name:	IMEDIPLUS INC.
Address:	2F, 12, ShengYi Rd. Sec. 2, Chupei City, Hsinchu County30261, Taiwan (R.O.C.)
Telephone:	+886-3-658-7700
Contact Name:	Moriah Hsieh
Telephone:	+886-3-658-7700 ext #325
Fax:	+886-3-658-9535
Email:	moriah.hsieh@imediplus.com
Date Prepared:	24 August 2018

II. DEVICE:

Trade Name andModel:	Cardiart Electronic Stethoscope: Model DS101 andOmni-Steth Electronic Stethoscope: Model Onmi-Steth
Common or UsualName:	Electronic Stethoscope
ClassificationNumber:	870.1875
Classification Name:	Stethoscope
Product Code:	DQD
Product Class:	II
Classification Panel:	Cardiovascular

III. PREDICATE DEVICE:

	Device Name	Manufacturer	Classification
PrimaryPredicateK173663	IMEDIPLUS Electronic StethoscopeDS3011A	IMEDIPLUSINC.	DQD870.1875
SecondaryPredicateK083903	3M™ LITTMANN® ELECTRONICSTETHOSCOPE MODEL 3200	3M COMPANY	DQD870.1875

This Secondary Predicate K083903 with the same intended use, classification and product code as the proposed device is included to support the Bluetooth wireless technology that is implemented in the subject device for which scientific methods exists to evaluate this new technology as outlined in the FDA guidance "Radio Frequency Wireless Technology in Medical Devices" (Aug 14, 2013).

IV. DEVICE DESCRIPTION

The proposed Electronic Stethoscopes Models DS101 and Omni-Steth detect and

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display the sounds from the heart, lungs, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs from a patient's body. After amplifying and filtering, the sounds are also sent to the user's ears bilaterally through the active speaker embedded at the bottom of the stethoscopes. Sound processing is conducted with the aid of a digital signal processor. Power to the device is provided by two AAA1.2V batteries. The one-hand operable user interface consists of a full-color OLED display, the Record button, arrow keys, the OK button, and a tube connector to output sounds to the headset consisting of tubes and ear tips.

The proposed devices can detect and display an acoustic based heart rate when presented with consistent heart sounds.

In addition, using a Bluetooth wireless link, the proposed stethoscopes can exchange raw audio data with external devices such as personal computers.

Note: The models DS101 and Omni-Steth are standalone devices and do not require Bluetooth data transfer to fulfill their intended use.

The differences between the proposed stethoscope models DS101 and Omni-Steth are cosmetic: specifically, the design of top housing and keyboard layout. The OLED Display information are identical.

Trade Name	CaRDIART Electronic Stethoscope	Omni-Steth Electronic Stethoscope
Model Name	DS101	Omni-Steth
DeviceAppearance	Image: Cardiart Electronic Stethoscope Device Appearance	Image: Omni-Steth Electronic Stethoscope Device Appearance
Keyboardlayout	Image: Cardiart Electronic Stethoscope Keyboard layout	Image: Omni-Steth Electronic Stethoscope Keyboard layout

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V. INTENDED USE AND INDICATIONS FOR USE

Cardiart Electronic Stethoscope (Model DS101)

The Electronic Stethoscope DS101 is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diaqnostic purposes in clinic or hospital.

Omni-Steth Electronic Stethoscope (Model Omni-Steth)

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technology of the proposed electronics stethoscopes Models DS101 and Omni-Steth are identical to the predicate IMEDIPLUS electronic stethoscope Model DS301 1A in terms of principle of operation, materials, design, user interface, frequency ranges, and auscultation organs. The following include the modifications to the previous design implemented in the proposed stethoscopes:

1. New PCB (Printed Circuit Board) layout
1. New housing with water resistance (IPX4)
1. Rearrangement of the information on OLED display
1. Data transmission via Bluetooth
1. Two AAA 1.2V batteries as power supply
1. Display of Phonocardiogram

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K182196

Page 4 of 11

Comparison table

ItemS	Comparison Items	Subject Device		Secondary PredicateDevice	Primary PredicateDevice	Same/SimilararDifferent/New
1	RegulatoryRegulatoryNoClassification	CARDIART ElectronicStethoscope (DS101)	Omni-Steth ElectronicStethoscope (Omni-Steth)	3M 3200 (K083903)	DS3011A (K173663)	Same
2	Power SourceBatteriestype	Two AAA battery	Two AAA battery	One AA battery	One NP-120 Lithiumbattery	Similar with3M 3200 ;DifferentfromDS3011A
	BatteryLife	> 7 Hours	> 7 Hours	50-60 Hours	24 Hours	Different
	SpecialAdaptors	No	No	No	Yes	Same with3M 3200 ;DifferentfromDS3011A
3	FeaturesBinauralheadset	Yes	Yes	Yes	Yes	Same
	Chest-pieceTechnology	Single Sided	Single Sided	Single Sided	Single Sided	Same
	Chest-pieceWeight	18g	18g	98g	69g	Different
	ClinicalArea	Auscultation	Auscultation	Auscultation	Auscultation	Same
	DiaphragmDiameter	4.7cm	4.7cm	5.1cm	4.1cm	Similar with3M 3200and
						DS3011A
	DiaphragmMaterial	Silicone	Silicone	Polyurethane-CoatedSilicone	Silicone	Same withDS3011A;Differentfrom 3M3200
	Ear-tipsType	Soft Sealing	Soft Sealing	Soft Sealing	Soft Sealing	Same
	HeadsetMaterial	Brass alloy to electroplate	Brass alloy to electroplate	Wide diameteraerospace alloy /Anodized aluminum	Brass alloy toelectroplate	Same withDS3011A
	Length	81 cm	81 cm	69 cm	77 cm	Similar withDS3011A
	Net Weight	214g	213g	185 g	304 g	Different
	Tube Color	Black · Burgundy · Navy Blue	Black · Burgundy · Navy Blue	Black · Burgundy · NavyBlue	Black · Burgundy · NavyBlue	Same
4	Intended Use
	IntendedUse	The CARDIART ElectronicStethoscope is intended forthe detection, amplificationand recording of sounds fromthe heart, lungs, anterior andposterior chest, abdomen,neck, limbs, arteries, veinsand other internal organs withselective frequency ranges.The stethoscope chest-pieceis designed for use with child,adolescent and adult patients.It is used for any subjectundergoing a physicalexamination and intended onlyfor medical diagnosticpurposes in clinic or hospital.	The Omni-Steth ElectronicStethoscope is intended forthe detection, amplificationand recording of sounds fromthe heart, lungs, anterior andposterior chest, abdomen,neck, limbs, arteries, veinsand other internal organs withselective frequency ranges.The stethoscope chest-pieceis designed for use with child,adolescent and adult patients.It is used for any subjectundergoing a physicalexamination and intended onlyfor medical diagnosticpurposes in clinic or hospital.	The 3M™ Littmann®Electronic StethoscopeModel 3200 is intendedfor medical diagnosticpurposes only. It may beused for the detectionand amplification ofsounds from the heart,lungs, arteries, veins,and other internalorgans with the use ofselective frequencyranges. It can be usedon any personundergoing a physicalassessment.	The IMEDIPLUSElectronic StethoscopeDS3011A is intended forthe detection,amplification andrecording of soundsfrom the heart, lungs,anterior and posteriorchest, abdomen, neck,limbs, arteries, veinsand other internalorgans with selectivefrequency ranges. Andthe stethoscope chest-piece is designed foruse with child,adolescent and adultpatients. It is used forany subject undergoinga physical examinationand intended only for	Same withDS3011A;similar to3M 3200.Thepopulationis specificto child,adolescentsand adults.
					medical diagnosticpurposes in clinic orhospital.
5	Functional
	DisplayScreen	OLED 1.46" Full Color	OLED 1.46" Full Color	LCD Monochrome	OLED 1.46" Full Color	Same withDS3011A;similar to3M 3200.
	BarcodeReader	No	No	No	Yes	Same with3M 3200
	ThreeFilterModes	Yes	Yes	Yes	Yes	Same
	FrequencyRange ofFilter Mode	Bell (20-200 Hz), Diaphragm(100-500 Hz) and Wide (20-1000Hz)	Bell (20-200 Hz), Diaphragm(100-500 Hz) and Wide (20-1000Hz)	Bell (20-200 Hz),Diaphragm (100-500Hz) and Extend range(20-2000 Hz)	Bell (20-200 Hz),Diaphragm (100-500Hz) and Wide (20-1000Hz)	Same withDS3011A ;Similar to3M 3200
	HumanMachineInterface	One-hand user interface forauscultation position selection,recording, and functionselection.	One-hand user interface forauscultation position selection,recording, and functionselection.	Yes	One-hand user interfacefor patient's IDscanning, auscultationposition selection,recording, and functionselection.	Similar withDS3011A
	RecordingNumber ofthe soundtrack	Yes ( File name:Year+Month+Hour+Minute+Second)	Yes ( File name:Year+Month+Hour+Minute+Second)	Yes (File name: 00x)	Yes (File name:Barcode ID)	Same with3M3200
	Recordingthe OrganandPosition oftheSoundTrack	Yes	Yes	No	Yes	Same withDS3011A
6	Software Comparison
	Heart RateDetection	Yes	Yes	Yes	Yes	Same
	Heart Rate	Yes	Yes	Yes	Yes	Same
Display
Recordingthe SoundTrack	Yes	Yes	Yes	Yes	Same
Playbackthe SoundTrack	Yes	Yes	Yes	Yes	Same
VolumeControl	Yes	Yes	Yes	Yes	Same
VolumeControlScale	Yes1-10 level	Yes1-10 level	Yes0-9	Yes1-10 level	Same withDS3011A
SoundAmplification	Yes24 times	Yes24 times	Yes24 times	Yes24 times	Same
Filter modeselection	Yes,Bell, Diaphragm, and Widemodes	Yes,Bell, Diaphragm, and Widemodes	YesBell, Diaphragm andExtend Modes	Yes,Bell, Diaphragm, andWide modes	Same withDS3011A
Automaticturn-off	Yes	Yes	Yes	Yes	Same
Monitor thebatterylevel	Yes	Yes	Yes	Yes	Same
Display thePhonogram	Yes,Display the synchronizedphonogram on the screenduring the auscultation withthe CARDIART ElectronicStethoscope	Yes,Display the synchronizedphonogram on the screenduring the auscultation withthe Omni-Steth ElectronicStethoscope	Yes,Display on 3MLittmann® ZargisStethAssist Heart andLung SoundVisualization Software	Yes, Display thesynchronizedphonogram on thescreen during theauscultation with theIMEDIPLUS ElectronicStethoscope DS3011A	Similar with3M 3200
Softwareof theConnectedDevice	Yes,IMEDIPLUS DS101-DMsoftware (DS101 DataManagement software)(1) Receive and storage thedata of sound tracks(2) Display the phonogram ofthe sound tracks	Yes,IMEDIPLUS DS101-DMsoftware (DS101 DataManagement software)(1) Receive and storage thedata of sound tracks(2) Display the phonogram ofthe sound tracks	Yes,3M Littmann® ZargisStethAssist Heart andLung SoundVisualization Software	Yes, IMEDIPLUSDS3011A-DM software(DS3011A DataManagement software)(1) Receive andstorage the data ofsound tracks(2) Display thephonogram of the sound tracks	Similarwith3M3200.
					phonogram of the soundtracks(3) Reply the audiodata in the connecteddevice installed withIMEDIPLUS DS3011A-DM software but thissoftware could notoperate the IMEDIPLUSElectronic StethoscopeDS3011A to replay thesound track from theconnected device.
7		Function of Data Transfer and the Interface
	DataTransfer oftheRecordedSoundTracks	Yes,Bluetooth, (transmits the audiodata from the stethoscope tothe connected device)	Yes,Bluetooth, (transmits the audiodata from the stethoscope tothe connected device)	YesBluetoothPermits the dataexchange from theelectronic stethoscopeto the personalcomputer	Yes, Micro SD card andBluetooth(1) Micro SD card,(Permits the dataexchange from theelectronic stethoscopeto the personalcomputer)(2) Bluetooth,(transmits the audiodata from thestethoscope to theconnected device)	Similar with3M 3200
	Capable ofStoringDataand Latestsoundtracks forplayback	Save up to 160 10-secondsound tracks;Latest 160 sound tracks forplayback.	Save up to 160 10-secondsound tracks;Latest 160 sound tracks forplayback.	Save up to twelve 30-second sound tracks;Latest 12 sound tracksfor playback.	Save up to 600 10-second sound tracks;Latest 50 sound tracksfor playback.	Similar with3M 3200andDS3011A
8	Service and Occupation
	WarrantyPeriod	1 Years	1 Years	2 Years	2 Years	Different
	Occupatio	Anesthesiologist, Cardiologist,	Anesthesiologist, Cardiologist,	Anesthesiologist,	Anesthesiologist.	Same
n	Emergency Physician,EMT/EMS,Family Practitioner,Internist,Medical Assistant,Medical Student,Nurse,Nursing Student,Pediatrician, Physician,Respiratory Specialist,Teacher/Professor/Instructor,and Veterinarian.	Emergency Physician,EMT/EMS,Family Practitioner,Internist,Medical Assistant,Medical Student,Nurse,Nursing Student,Pediatrician, Physician,Respiratory Specialist,Teacher/Professor/Instructor,and Veterinarian.	Cardiologist, EmergencyPhysician, EMT/EMS,Family Practitioner,Internist,Medical Assistant,Medical Student,Nurse,Nursing Student,Pediatrician, Physician,Respiratory Specialist,Teacher/Professor/Instructor,and Veterinarian.	Cardiologist, EmergencyPhysician, EMT/EMS,Family Practitioner,Internist, MedicalAssistant, MedicalStudent, Nurse, NursingStudent, Pediatrician,Physician, RespiratorySpecialist,Teacher/Professor/Instructor, and Veterinarian.
TeachingAccessoriesIncluded	User manual	User manual	CD-ROMUser manual	User manual	Same withDS3011A

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VII. PERFORMANCE DATA

Non-Clinical

Risk Analysis

The risk analysis was conducted in accordance with the ISO 14971:2007 standard, which specifies the process for identifying hazards, estimating and evaluating associated risks, controlling the risks, and monitoring the effectiveness of the controls. All the risks of the identified potential hazards caused by the modifications of subject device were identified and evaluated based on severity and occurrence probability. ldentified risks were mitigated by implementing risk control measures which were verified to ensure any residual risks were at acceptable levels.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and electromagnetic compatibility reports are tested and issued by SGS Taiwan Limited. According to the test reports, the IMEDIPLUS Electronic Stethoscope (Model DS101/Omni-Steth) complies with the safety standards of ANSI/ AAMI ES 60601-1:2005/(R)2012. the EMC standard of IEC 60601-1-2:2014 and FCC Part 15. The results of radiated emissions, immunity to electrostatic discharges, immunity to radio frequency electromagnetic fields, and power frequency magnetic fields are acceptable.

Software Verification and Validation Testing

The provided software verification and validation documentation was submitted in accordance with the requirements of "Guidance for the content of premarket submissions for software contained in medical devices, Mav 11, 2005" and IEC/TR80002-1:2009. The level of concern of the software for this device is considered as "moderate" since a failure or latent flaw could indirectly result in minor injury to the patient or operator according to incorrect or delayed information or the action of a care provider.

Biocompatibility Evaluation

The biocompatibility was evaluated in accordance with the AAMI ANSI ISO 10993-1:2009 standard and results demonstrate that the proposed devices conform.

Usability Evaluation

The usability evaluation demonstrated that the proposed devices comply with the requirement of Clause 5.3 and 5.7.3 of the international medical device usability engineering standard, IEC 62366:2015. Under conditions of the test specified the usability is acceptable.

The testing took place from June 1 to June 18, 2018, and all participants were screened as appropriate for the intended user of the device. 15 physicians and 15 registered nurses participated in the study conducted in San Diego, California and Saint Louis, Missouri. The conference room, which is the venue of the testing, simulated the clinic or the out-patient clinic and in-hospital setting as in actual use. The lighting level, the fluorescent lamp of white (neutral shades) commonly used in hospitals and clinical room, is about 500 lux. The sound level is under the range 80 dB. In addition, no special training is needed for using the device, all participants consented and were instructed to read the user manual. Hence, the

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participants received the user manual before executing the HFE/UE test to learn the process and it was confirmed that all participants had read the user manual. During the test the participants who use our product for the first time, completed all the testing tasks on their own after reading the user manual. They successfully completed the tasks and gave feedback during the interview. The outputs and results did not indicate any use problem and there was no need to perform design modification of user interface or labeling.

The result of the testing shows that the user interface design is simple and easy for user to learn. It is the "Learnability". There are three modes to be selected for auscultation. Recording the sounds of the three modes within one operation can significantly improves the efficiency of the auscultation and recording of patients' information. It is the "Efficiency". All participants were satisfied with the size of the Omni-Steth Electronic Stethoscope and considered the user interface and operation procedures easy to use and memorize, they also praised the function of playing back recordings received from the DS101 DM Software (Data Management) to the device. The participants gave high recognition to the device representing the "Satisfaction". In addition, Omni-Steth Electronic Stethoscope and the DS101 DM Software (Data Management) achieved the goals of having all participants help demonstrate the safety of the device and no hazards were identified. Overall, the participants indicated the usability of the device is acceptable and therefore the devices are safe and effective.

Wireless Coexistence

The wireless coexistence test results demonstrated that the proposed devices comply with the requirement of ANSI C63.27-2017 - American National Standard for Evaluation of Wireless Coexistence. The result is shown that little interference from Bluetooth and Wi-Fi interfacing over different test distances was noted, and that the heart rate and peak-to-value remained stable.

Splash Water Test

The splash water test results demonstrate the proposed devices comply with IEC / EN 60529:2001 (IPX4 splashing water Test Protected) and the device's function was normal after testing.

Heart Rate Performance Testing

The comparison bench testing results of heart rate detection function among IMEDIPLUS Electronic Stethoscope DS101, 3M 3200 and IMEDIPLUS Electronic Stethoscope DS3011A provide a detailed analysis of the similarities and differences. The report demonstrates that the heart rate detection of IMEDIPLUS Electronic Stethoscope DS101 is substantially equivalent to 3M 3200 (Secondary Predicate Device) and DS3011A (Primary Predicate Device) within the heart rate range of 30-180 bpm.

Audio Performance Testing

The comparison bench testing results of audio performance among DS101, DS101 DM Software (Data Management), 3M 3200 and DS3011A provide a detailed analysis of the similarities and differences. The report demonstrates that the audio performance of IMEDIPLUS Electronic Stethoscope DS101 and DS101 DM Software (Data Management) are substantially equivalent to the Secondary Predicate device

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3M 3200 while audio frequency is below 1 kHz. In addition, the IMEDIPLUS Electronic Stethoscope DS101 and DS101 DM Software (Data Management) are substantially equivalent to the predicate device IMEDIPLUS Electronic Stethoscope DS3011A for bell, diaphragm and wide frequency band mode.

Clinical

There is no difference in the intended use, operating principle, and fundamental technology, in comparison to the predicate device, thus clinical testing was deemed unnecessary. Exchange of audio data with external devices is accomplished in the predicate device with a Micro SD card and via a Bluetooth wireless link in the proposed devices.

VII. CONCLUSIONS AND SUMMARY

The proposed electronic stethoscopes models DS101 and Omni-Steth have the same intended use and fundamental scientific technology as the predicate model DS3011A, which received 510(k) clearance K173663. Modifications incorporated in the subject device include new PCB layout, new housing with water resistance (IPX4), rearrangement of the information on OLED display, data transmission via Bluetooth, two AAA 1.2V batteries as power supply and phonocardiogram display. Results of risk analysis and performance data demonstrate that the design outputs of the modified device meet the design requirements and residual risk levels are acceptable. In summary, the proposed electronic stethoscopes described in this submission are substantially equivalent to the predicate device without raising any new issues of safety or effectiveness.

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.