Predicate Devices

IMEDIPLUS Electronic Stethoscope DS301 K160023

Reference Devices

3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 K083903

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes digital signal processing and data management software, but there is no mention of AI or ML algorithms for analysis or interpretation of the sounds.

Therapeutic

No
The device is described as an electronic stethoscope intended for the detection, amplification, and recording of sounds for diagnostic purposes, not for treating or curing a medical condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "intended diagnostic purposes in clinic or hospital."

SaMD (Software as a Medical Device)

No

The device description clearly details a physical electronic stethoscope with hardware components (chest-piece, speaker, display, keypad, barcode reader, battery, etc.) that picks up and processes sounds. While it includes accompanying software for data management, the core medical device is the hardware stethoscope.

IVD (In Vitro Diagnostic)

Based on the provided information, the IMEDIPLUS Electronic Stethoscope DS3011A is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Function: The IMEDIPLUS Electronic Stethoscope DS3011A is used to detect, amplify, and record sounds from within the patient's body. It does not analyze biological specimens.
Intended Use: The intended use clearly states it's for detecting and recording sounds from various internal organs during a physical examination for diagnostic purposes. This is a direct interaction with the patient's body, not an analysis of a specimen taken from the body.

Therefore, the IMEDIPLUS Electronic Stethoscope DS3011A falls under the category of a medical device used for physical examination and diagnosis, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The IMEDIPLUS Electronic Stethoscope DS3011A 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.

Product codes

DQD

Device Description

When you turn on the IMEDIPLUS Electronic Stethoscope DS3011A for the first time. the IMEDIPLUS Electronic Stethoscope DS3011A in your hand requires your setting password for the security. Your authorization to operate this handheld electronic stethoscope is necessary for the operation.

The IMEDIPLUS Electronic Stethoscope DS3011A picks up the sounds from the heart, lung, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs from a patient's body. When picking up the sounds, the phonogram of sounds could simultaneously display after pushing the button 'OK' or 'REC' for recording. When you auscultate with DS3011A, the sounds are conducted simultaneously to the user's ears bilaterally by active speaker embedded at the bottom of the IMEDIPLUS Electronic Stethoscope DS3011A. At the meantime, sound processing is operated with the aid of a digital signal processor. The IMEDIPLUS Electronic Stethoscope DS3011A could identify the recording number by 1-D barcode reader, indicate the sound location by intuitive keypad, and record the sounds from different sites.

The one-hand user interface includes a full-color OLED display, an intuitive keypad at the anterior part, a barcode reader at the posterior part, a chest-piece at the superior part, a tube connector for output of sounds at the inferior part, and a recording button at the left part.

After opening the Electronic Stethoscope DS3011A with your setting password and connection with a wireless device by Bluetooth, the IMEDIPLUS Electronic Stethoscope DS3011A could transmit digital data of recorded sounds under the operation of IMEDIPLUS DS3011A_DM Software (DS3011A Data Management) installed in the connected device. The effective range of transmission by Bluetooth will be influenced when some objects blocking between the IMEDIPLUS Electronic Stethoscope DS3011A and the connected device. (such as wall, human, big objectives as barrier) Reducing the distance or allowing the line of sight between the IMEDIPLUS Electronic Stethoscope DS3011A and the connected device will improve the connection by Bluetooth.

The IMEDIPLUS DS3011A_DM Software (DS3011A Data Management) will only operate under the user's authorization with the seething password. The IMEDIPLUS DS3011A-DM Software (IMEDIPLUS DS3011A-Datamanagement Software) installed in mobile device provides the users to connect with the IMEDIPLUS Electronic Stethoscope DS3011A, receive the recorded data of sounds, storage the data, display the phonograms, and replay the recorded audio data with the speaker of effective frequency range from 20 to 1000Hz.

The IMEDIPLUS Electronic Stethoscope DS3011A could also exchange audio data with an external personal computing device by micro SD card. Every single audio file stored in the micro SD card was labeled with the user's ID, recording number and indicated position. The IMEDIPLUS Electronic Stethoscope DS3011A does not incorporate any other off-the-shelf (OTS) software. The recorded audio data only can be replayed by the IMEDIPLUS Electronic Stethoscope DS3011A, the IMEDIPLUS Electronic Stethoscope DS301, and the IMEDIPLUS DS3011A_DM Software (DS3011A_Data Management) installed in the mobile device with the speaker of effective range from 20 to 1000Hz. The IMEDIPLUS Electronic Stethoscope DS3011A operates on one (1) NP-120 lithium battery with an included power management system to prolong the battery life.

The associated accessories include:

· Rechargeable Lithium-ion Battery.
· Battery charger which includes adaptor and charger.
Micro SD card for exchanging audio data.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs

Indicated Patient Age Range

child, adolescent and adult patients

Intended User / Care Setting

Used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital. Relevant occupations include Anesthesiologist, Cardiologist, Emergency Physician, EMT/EMS, Family Practitioner, Internist, Medical Assistant, Medical Student, Nurse, Nursing Student, Pediatrician, Physician, Respiratory Specialist, Teacher/Professor/Instructor, and Veterinarian.

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)

Electrical safety and electromagnetic compatibility (EMC): Tested and issued by SGS Taiwan Limited. Complies with IEC 60601-1, EN 60601-1-2, CISPR 11, IEC 60601-1-2, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11 and FCC Part 15.

Software Verification and Validation Testing: Complies with "guidance for the content of premarket submissions for medical devices software, May 11, 2005" and IEC/TR80002-1:2009. The level of concern for the software is considered "moderate".

Reliability and MTBF Testing: Reports tested and issued by DEKRA Integrated Service Technology, Inc. Provides conditions for operation, storage and transportation, and demonstrates shelf life.

Battery and Photobiological Safety Testing: Tested and issued by SGS Taiwan Limited. Battery complies with IEC 62133:2012 and UN38.3. Photobiological aspects comply with IEC 62471:2006 and EN 62471:2008.

Usability Evaluation: Complies with IEC 62366:2015 Clause 5.3 and 5.7.3, and IEC 60601-1-6.

Clinical Evaluation: Performed by 4 clinical doctors; included three subject groups (4 children, 4 adolescents, and 7 adults). Statistical analysis of the questionnaire showed the device meets basic safety and effectiveness principles for heart, chest, intestines, and neck auscultation in child, adolescent, adult, and other ethnic groups.

Wireless Coexistence: Complies with ANSI C63.27-2017.

Performance Testing-Bench:

Heart rate detection function: Detailed analysis of DS3011A, 3M 3200, and DS301. Demonstrated substantial equivalence of DS3011A to 3M 3200 and DS301 for heart rates between 30-180 bpm.
Audio performance: Detailed analysis of DS3011A, DS3011A_DM software, 3M 3200, and DS301. Demonstrated substantial equivalence of DS3011A and DS3011A_DM software to 3M 3200 when audio frequency is below 1 kHz. Also, substantial equivalence to DS301 for bell, diaphragm, and wide frequency band modes.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

IMEDIPLUS Electronic Stethoscope DS301 K160023

Reference Device(s)

3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 K083903

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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.

August 17, 2018

IMEDIPLUS INC. Shirley Lai Regulatory Specialist 2F, 12, Shengvi Rd.Sec.2 Chupei City, Hsinchu County 30261 Taiwan (R.O.C.)

Re: K173663

Trade/Device Name: Electronic Stethoscope DS3011A Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: July 16, 2018 Received: July 18, 2018

Dear Shirley Lai:

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/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 mediation-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, Shawn W. Forrest -A 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K173663

Device Name

IMEDIPLUS Electronic Stethoscope DS3011A

Type of Use (Select one or hoth, as annlicable)

Indications for Use (Describe)

The IMEDIPLUS Electronic Stethoscope DS3011A 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 diagnostic purposes in clinic or hospital.

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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IMEDIPLUS INC.

Deficiency Reply Electronic Stethoscope DS3011A

Section 5

Document Title: 510(k) Summary File Name: 018_510(k)Summary

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| Image: iMEDI logo | Document Title:
510(k) Summary | | |
|-------------------|-----------------------------------|-------|-----------|
| Document No.: | DS3011A-SDUS01-00501 | Page: | 2 of 20 |
| Product Name: | Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: | 018_510(k)Summary | Date: | 2018/8/17 |

510(k) Summary

The Assigned 510(k) Number: K173663/S002 Date Prepared: August 17, 2018.

l. Submitter Information:

Submitter: IMEDIPLUS INC. Address: 2F, 12, ShengYi Rd. Sec. 2, Chupei City, Hsinchu County 30261, Taiwan (R.O.C.) Phone Number: +886-3-658-7700 Fax Number: +886-3-658-9535

Contact Person: Shirley Lai E-mail: shirley.lai@imediplus.com Phone Number: +886-3-658-7700#326 Fax Number: +886-3-658-9535 Date Prepared: August 17, 2018.

II. Predicate Device

Predicate Device:

IMEDIPLUS Electronic Stethoscope DS301.

Reference Device:

3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200

| | Device Name | Manufacturer | Model | 510(k)
Number |
|---------------------|-------------------------------------------------------|----------------|---------|------------------|
| Candidate
Device | IMEDIPLUS Electronic
Stethoscope DS3011A | IMEDIPLUS INC. | DS3011A | K173663 |
| Predicate
Device | IMEDIPLUS Electronic
Stethoscope DS301 | IMEDIPLUS INC. | DS301 | K160023 |
| Reference
Device | 3M™ LITTMANN®
ELECTRONIC STETHOSCOPE
MODEL 3200 | 3M COMPANY | 3M 3200 | K083903 |

Predicate Device Identification Table 1

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| Image: IMEDI logo | Document Title:
510(k) Summary |
|----------------------------------------------|-----------------------------------|
| Document No.: DS3011A-SDUS01-00501 | Page: 3 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: A4 |
| 510(k) File Name: 018_510(k)Summary | Date: 2018/8/17 |

III. Device

Table 2 Common Name and Classification

No.	Product Code	Device	Regulation Section	Classification	Panel
1	DQD	Stethoscope,
Electronic	870.1875	II	Cardiovascular

IV. Device Description

When you turn on the IMEDIPLUS Electronic Stethoscope DS3011A for the first time. the IMEDIPLUS Electronic Stethoscope DS3011A in your hand requires your setting password for the security. Your authorization to operate this handheld electronic stethoscope is necessary for the operation.

The IMEDIPLUS Electronic Stethoscope DS3011A picks up the sounds from the heart, lung, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs from a patient's body. When picking up the sounds, the phonogram of sounds could simultaneously display after pushing the button 'OK' or 'REC' for recording. When you auscultate with DS3011A, the sounds are conducted simultaneously to the user's ears bilaterally by active speaker embedded at the bottom of the IMEDIPLUS Electronic Stethoscope DS3011A. At the meantime, sound processing is operated with the aid of a digital signal processor. The IMEDIPLUS Electronic Stethoscope DS3011A could identify the recording number by 1-D barcode reader, indicate the sound location by intuitive keypad, and record the sounds from different sites.

The one-hand user interface includes a full-color OLED display, an intuitive keypad at the anterior part, a barcode reader at the posterior part, a chest-piece at the superior part, a tube connector for output of sounds at the inferior part, and a recording button at the left part.

After opening the Electronic Stethoscope DS3011A with your setting password and connection with a wireless device by Bluetooth, the IMEDIPLUS Electronic Stethoscope DS3011A could transmit digital data of recorded sounds under the operation of IMEDIPLUS DS3011A_DM Software (DS3011A Data Management) installed in the connected device. The effective range of transmission by Bluetooth will be influenced when some objects blocking between the IMEDIPLUS Electronic Stethoscope DS3011A and the connected device. (such as wall, human, big objectives as barrier) Reducing the distance or allowing the line of sight between the IMEDIPLUS Electronic Stethoscope DS3011A and the connected device will improve the connection by Bluetooth.

The IMEDIPLUS DS3011A_DM Software (DS3011A Data Management) will only operate under the user's authorization with the seething password. The IMEDIPLUS DS3011A-DM Software (IMEDIPLUS DS3011A-Datamanagement Software) installed in mobile device provides the users to connect with the IMEDIPLUS Electronic Stethoscope DS3011A, receive the recorded data of sounds, storage the data, display the phonograms, and replay the recorded

6

| Image: iMEDI logo | Document Title:
510(k) Summary |
|----------------------------------------------|-----------------------------------|
| Document No.: DS3011A-SDUS01-00501 | Page: 4 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: A4 |
| 510(k) File Name: 018_510(k)Summary | Date: 2018/8/17 |

audio data with the speaker of effective frequency range from 20 to 1000Hz.

The IMEDIPLUS Electronic Stethoscope DS3011A could also exchange audio data with an external personal computing device by micro SD card. Every single audio file stored in the micro SD card was labeled with the user's ID, recording number and indicated position. The IMEDIPLUS Electronic Stethoscope DS3011A does not incorporate any other off-the-shelf (OTS) software. The recorded audio data only can be replayed by the IMEDIPLUS Electronic Stethoscope DS3011A, the IMEDIPLUS Electronic Stethoscope DS301, and the IMEDIPLUS DS3011A_DM Software (DS3011A_Data Management) installed in the mobile device with the speaker of effective range from 20 to 1000Hz. The IMEDIPLUS Electronic Stethoscope DS3011A operates on one (1) NP-120 lithium battery with an included power management system to prolong the battery life.

The associated accessories include:

· Rechargeable Lithium-ion Battery.
· Battery charger which includes adaptor and charger.
Micro SD card for exchanging audio data.

V. Indication for Use

The IMEDIPLUS Electronic Stethoscope DS3011A 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.

VI. Comparison of Technology Characteristics between the Predicate Devices (The IMEDIPLUS Electronic Stethoscope DS3011 A reference with 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 and predicate the IMEDIPLUS Electronic Stethoscope DS301) (A) Same technological elements among these 3 candidates (Table 3)

Binaural headset send sounds to user's ears. (a)
Chest-piece pick up sounds from patient's internal organs. (b)
Sound amplifier amplify the sounds from chest-piece. (c)
Battery power the device. (d)
Digital signal processor sound processing. (e)
Display show the operation information. (f)
Keypad control and setup the device. (g)
Detect and display heart rate monitor patient's heart rate. (h)
Record record a sound track. (i)
(i) Playback-playback a sound track.
Filter Selection select certain mode of filter for clinical auscultation, (k) including B/ D/ W mode.
(I) Sound amplification level adjustment - control the level of sound amplification.

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| Image: [IMEDI logo] | Document Title:
510(k) Summary | |
|----------------------------------------------|-----------------------------------|-----------|
| Document No.: DS3011A-SDUS01-00501 | Page: | 5 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: 018_510(k)Summary | Date: | 2018/8/17 |

Table 3 Same Technological Elements among These 3 Candidates
Items	Comparison
Items	Candidate Device
DS3011A	Reference Device
3M 3200 (K083903)	Predicate Device
DS301 (K160023)
1	Regulatory
	Regulatory
No	870.1875	870.1875	870.1875
	Classification	Class II	Class II	Class II
2	Power Source
	Batteries
Enclosed	One NP-120 Lithium
battery	One AA battery	One NP-120 Lithium
battery
	Battery Life	24 Hours	50-60 Hours	24 Hours
	Special
Adaptors	Yes	No	Yes
3	Features
	Binaural
headset	Same	Same	Same
	Chest-piece
Technology	Single Sided	Single Sided	Single Sided
	Chest-piece
Weight	69 g	98 g	69 g
	Clinical Area	Auscultation	Auscultation	Auscultation
	Diaphragm
Diameter	4.1cm	5.1cm	4.1cm
	Diaphragm
Material	Silicon	Polyurethane-Coated
Silicone	Silicon
	Ear-tips Type	Soft Sealing	Soft Sealing	Soft Sealing
	Headset
Material	Brass alloy to electroplate	Wide diameter
aerospace alloy /
Anodized aluminum	Brass alloy to
electroplate
	Length	77 cm	69 cm	77 cm
	Net Weight	304 g	185 g	304 g
	Tube Color	Black 、Burgundy、Navy
Blue	Black 、Burgundy、Navy
Blue	Black 、Burgundy、Navy
Blue
4	Intended Use
	Intended Use	The IMEDIPLUS
Electronic Stethoscope
DS3011A 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	The 3M™ Littmann®
Electronic Stethoscope
Model 3200 is intended
for medical diagnostic
purposes only. It may be
used for the detection
and amplification of
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.	The IMEDIPLUS
Electronic Stethoscope
DS301 is intended for
the detection,
amplification and
recording of sounds
from the heart, lung,
anterior/posterior
chest, abdomen, neck,
limbs, arteries, veins
and other internal
organs with use of
selective frequency
ranges. And the
stethoscope chest-
piece is designed for
use with child,
adolescent and adult
patients. It is used
for any subject

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| Image: iMEDI logo | Document Title:
510(k) Summary | | |
|-------------------|-----------------------------------|-------|----------------|
| Document No.: | DS3011A-SDUS01-00501 | Page: | 6 of 20 |
| Product Name: | Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: | 018_510(k)Summary | Date: | 2018/8/17 |

| | | only for medical
diagnostic purposes in
clinic or hospital. | | undergoing a physical
examination and
intended only for
medical diagnostic
purposes in clinic or
hospital. |
|-----|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 5 | Functional
Screen | OLED 1.46" Full Color | LCD Monochrome | OLED 1.46" Full Color |
| | Barcode
Reader | Yes | No | Yes |
| | Three Filter
Modes | Yes | Yes | Yes |
| | Frequency
Range of
Filter Mode | Bell (20-200 Hz),
Diaphragm (100-500 Hz)
and Wide (20-1000Hz) | Bell (20-200 Hz),
Diaphragm (100-500
Hz) and Extend range
(20-2000 Hz) | Bell (20-200 Hz),
Diaphragm (100-500
Hz) and Wide (20-
1000Hz) |
| | Human
Machine
Interface | One-hand user interface
for patient's ID scanning,
auscultation position
selection, recording, and
function selection. | Yes | One-hand user
interface for patient's
ID scanning,
auscultation position
selection, recording,
and function selection. |
| | Recording
Number of
the sound
track | Yes | No | Yes |
| | Recording
the Organ
and Position
of the
Sound Track | Yes | No | Yes |
| Dip | Software Comparison | | | |
| | Heart Rate
Detection | Yes | Yes | Yes |
| | Heart Rate
Display | Yes | Yes | Yes |
| | Recording
the Sound
Track | Yes | Yes | Yes |
| | Playback the
Sound Track | Yes | Yes | Yes |
| | Volume
Control | Yes | Yes | Yes |
| | Volume
Control Scale | Yes
1-10 level | Yes
0-9 | Yes |
| | Amplification | Yes,
24 times | Yes,
24 times | Yes,
24 times |
| | Filter mode
selection | Yes,
Bell, Diaphragm, and
Wide modes | Yes,
Bell, Diaphragm and
Extend Modes | Yes,
Bell, Diaphragm, and
Wide modes |
| | Automatic
turn-off | Yes | Yes | Yes |
| | Monitor the
battery level | Yes | Yes | Yes |
| | Password
Setting | Yes,
The user needs to enter | No | No |

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| Image: Imedi logo | Document Title:
510(k) Summary | |
|----------------------------------------------|-----------------------------------|-----------|
| Document No.: DS3011A-SDUS01-00501 | Page: | 7 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: 018_510(k)Summary | Date: | 2018/8/17 |

| | Display the
Phonogram | the password for the
operation of the device | No | No |
|---|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | Software of
the
Connected
Device | Yes,
IMEDIPLUS DS3011A-
DM software (DS3011A
DataManagement
software)
(1) Receive and store
the data of sound
tracks
(2) Display the
phonogram of the
sound tracks
(3) Reply the audio data
in the connected
device installed with
IMEDIPLUS
DS3011A-DM
software but this
software could not
operate the
IMEDIPLUS
Electronic
Stethoscope
DS3011A to replay
the sound track from
the connected device. | Yes,
3MTM Littmann®
Zargis StethAssistTM
Heart and Lung Sound
Visualization Software | No |
| 7 | Function of Data Transfer and the Interface | | | |
| | Data
Transfer of
the Recorded
Sound
Tracks | Yes,
Micro SD card and
Bluetooth
(1) Micro SD card,
(Permits the data
exchange from the
electronic stethoscope to
the personal computer)

(2) Bluetooth, (transmits
the audio data from
the stethoscope to the
connected device) | Yes
Bluetooth
Permits the data
exchange from the
electronic stethoscope
to the personal
computer | Yes
Micro SD card
Permits the data
exchange from the
electronic stethoscope
to the personal
computer |
| | Capable of
Storing Data
and Latest
sound tracks
for playback | Save up to 600 10-second
sound tracks;
Latest 50 sound tracks for
playback. | Save up to twelve 30-
second sound tracks;
Latest 12 sound tracks
for playback. | Save up to 999 10-
second sound tracks;
Latest 15 sound tracks
for playback. |
| 8 | Service and Occupation | | | |

10

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510(k) Summary | |
|----------------------------------------------|-----------------------------------|-----------|
| Document No.: DS3011A-SDUS01-00501 | Page: | 8 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: 018_510(k)Summary | Date: | 2018/8/17 |

| Warranty

Period	2 Years	2 Years
Occupation	Anesthesiologist,
Cardiologist, Emergency
Physician, EMT/EMS,
Family Practitioner,
Internist,
Medical Assistant,
Medical Student,
Nurse,
Nursing Student,
Pediatrician, Physician,
Respiratory Specialist,
Teacher/Professor/Instruct
or, and Veterinarian.	Anesthesiologist,
Cardiologist, Emergency
Physician, EMT/EMS",
Family Practitioner,
Internist,
Medical Assistant,
Medical Student,
Nurse,
Nursing Student,
Pediatrician, Physician,
Respiratory Specialist,
Teacher/Professor/Instru
ctor, and Veterinarian.	Anesthesiologist,
Cardiologist,
Emergency Physician,
EMT/EMS,
Family Practitioner,
Internist,
Medical Assistant,
Medical Student,
Nurse,
Nursing Student,
Pediatrician,
Physician,
Respiratory Specialist,
Teacher/Professor/Inst
ructor, and
Veterinarian.
Teaching
Accessories
Included	User manual	CD-ROM
User manual	User manual

11

| Image: IMEDI logo | Document Title:
510(k) Summary | | |
|-------------------|-----------------------------------|-------|-----------|
| Document No.: | DS3011A-SDUS01-00501 | Page: | 9 of 20 |
| Product Name: | Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: | 018_510(k)Summary | Date: | 2018/8/17 |

(B) Comparison between the Electronic Stethoscope DS3011A and the reference device, the 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200

(a) The differences between these two devices: (Table 4)

(1) 1D Barcode reader identify the user's ID and recording number.
Micro SD card storage and exchange for sound tracks. (2)
(3) Organ position indication - indicate the auscultated organ.
(4) Auscultation position indication used to indicate the auscultation position of organ.
(5) Intuitive keypad - select the organ position between heart and lung during auscultation.
(6) A/P CHEST Key switch the organ position between "Anterior Chest" and "Posterior Chest".
Password the user needs to enter the password to access (7) device.
Phonogram display for real time monitoring sound wave. (8)

(b) The same elements between these two devices: (Table 4)

Both of these connect with Bluetooth. (1)
(2) Binaural headset - send sounds to user's ears.
Chest-piece pick up sounds from patient's internal organs. (3)
(4) Sound amplifier - amplify the sounds from chest-piece.
(5) Battery - power the device.
Digital signal processor sound processing. (6)
Display show the operation information. (7)
(8) Keypad - control and setup the device.
Detect and display heart rate monitor patient's heart rate. (ਰ)
(10) Record and playback - record and playback a sound track.
(11) Select filter - select certain mode of filter for clinical auscultation, including B/ D/ W mode.
Sound amplification level adjustment control the level of sound (12) amplification.
(13) Monitor battery level - indicate the battery level.

12

Image: [IMEDI logo] Document Title:	510(k) Summary
Document No.:	DS3011A-SDUS01-00501	Page:	10 of 20
Product Name:	Electronic Stethoscope DS3011A	Ver.:	A4
510(k) File Name:	018_510(k)Summary	Date:	2018/8/17

Table 4 Same and Differences Technological Elements between DS3011A and 3M 3200

| Features Candidate
Device
DS3011A | Reference
Device
3M 3200 | Same/Different |
|---------------------------------- | 1D Barcode reader | Micro SD card | Organ position indication | Auscultation position indication | Intuitive keypad | A/P CHEST Key | Password | Phonogram display on the screen | Wireless connection by Bluetooth | Binaural headset | Chest-piece | Sound amplification | Battery | Digital signal processor | Display | Keypad | Detect and display the heart rate | Yes | Record | Playback | Filter selection | Sound amplification level adjustment | Yes | Monitor Battery level | allu Jivi JZVV
----|--------------------------------------------------|--------------------------------|----------------|
| Yes | No | Different |
| Yes | No | Different |
| Yes | No | Different |
| Yes | No | Different |
| Yes | No | Different |
| Yes | No | Different |
| Yes | No | Different |
| Yes | No | Different |
| Yes | Yes | Same |
| Yes | Yes | Same |
| Yes | Yes | Same |
| Yes | Yes | Same |
| Yes | Yes | Same |
| Yes | Yes | Same |
| Yes | Yes | Same |
| Yes | Yes | Same |
| Yes | Same |
| Yes | Yes | Same |
| Yes | Yes | Same |
| Yes | Yes | Same |
| Yes | Same |
| Yes | Yes | Same |

(C) Comparison between the Electronic Stethoscope DS3011A and the predicate device, the IMEDIPLUS Electronic Stethoscope DS301 (a) The differences between these two devices (Table 5)

Bluetooth interface transmit sound data to the connected (1) device installed with DS3011A_DM software (DS3011A Data Management).
DS3011A DM software (DS3011A Data Management) used to (2) receive sound data.
(3) Password - the user needs to enter the password to access device.
Phonogram display on the screen of IMEDIPLUS Electronic (4) Stethoscope DS3011A - to display the phonogram while auscultating and replaying the data of audio sounds.

13

Image: Imedi Logo	Document Title:	510(k) Summary
Document No.:	DS3011A-SDUS01-00501	Page:	11 of 20
Product Name:	Electronic Stethoscope DS3011A	Ver.:	A4
510(k) File Name:	018_510(k)Summary	Date:	2018/8/17

(b) The same elements between these two devices (Table 5)

(1) 1D Barcode reader - identify the user's ID and recording number.
Micro SD card exchange for sound tracks. (2)
Organ position indication indicate the auscultated organ. (3)
Auscultation position indication used to indicate the auscultation (4) position of organ.
(5) Intuitive keypad - select the organ position between heart and lung during auscultation.
A/P CHEST Key switch the organ position between "Anterior Chest" (6) and "Posterior Chest".
(7) Binaural headset - send sounds to user's ears.
Chest-piece pick up sounds from patient's internal organs. (8)
Sound amplification amplify the sounds from chest-piece. (છ)
(10) Battery power the device.
(11) Digital signal processor sound processing.
(12) Display show the operation information.
(13) Keypad control and setup the device.
(14) Detect and display heart rate monitor patient's heart rate.
(15) Record record a sound track.
(16) Playback-playback a sound track.
(17) Filter selection select certain mode of filter for clinical auscultation, including B/ D/ W mode.
(18) Sound amplification level adjustment control the level of sound amplification.
(19) Monitor Battery level indicate the battery level.

14

Image: iMEDI logo	Document Title: 510(k) Summary
Document No.: DS3011A-SDUS01-00501	Page:	12 of 20
Product Name: Electronic Stethoscope DS3011A	Ver.:	A4
510(k) File Name: 018_510(k)Summary	Date:	2018/8/17

Table 5 Same and Different Technological Elements between DS3011A and DS301

| Features | Candidate Device
DS3011A | Predicate Device
DS301 | Same/Differe
nt |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------|
| Wireless connection | Yes | No | Different |
| Connected device software | Yes
DS3011A DM software
(DS3011A Data Management
software)
1.Receive the data of sounds
2.Data storage
3.Display the phonogram
4.Replay the recorded data
with the spectrum of selected
frequency mode
5. The audio data could be
displayed with the connected
device but not on the DS3011A
screen. | No | Different |
| Password | Yes | No | Different |
| Phonogram display on the
screen | Yes | No | Different |
| 1D Barcode reader | Yes | Yes | Same |
| Micro SD card | Yes | Yes | Same |
| Organ position indication | Yes | Yes | Same |
| Auscultation position indication | Yes | Yes | Same |
| Intuitive keypad | Yes | Yes | Same |
| A/P CHEST Key | Yes | Yes | Same |
| Binaural headset | Yes | Yes | Same |
| Chest-piece | Yes | Yes | Same |
| Sound amplification | Yes | Yes | Same |
| Battery | Yes | Yes | Same |
| Digital signal processor | Yes | Yes | Same |
| Display | Yes | Yes | Same |
| Keypad | Yes | Yes | Same |
| Detect and display heart rate | Yes | Yes | Same |
| Record | Yes | Yes | Same |
| Playback | Yes | Yes | Same |
| Filter selection | Yes | Yes | Same |
| Sound amplification level
adjustment | Yes | Yes | Same |
| Monitor battery level | Yes | Yes | Same |

15

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510(k) Summary | | |
|-------------------|----------------------------------------------|-------|-----------|
| | Document No.: DS3011A-SDUS01-00501 | Page: | 13 of 20 |
| | Product Name: Electronic Stethoscope DS3011A | Ver.: | A4 |
| | 510(k) File Name: 018_510(k)Summary | Date: | 2018/8/17 |

Table 6 summarizes the technological characteristics among DS3011A, 3M 3200 and DS301.

Table 6 Summarized Technological Characteristics

| Features | Candidate Device
DS3011A | Reference Device
3M 3200 | Predicate Device
DS301 | Same/Similar
Different /New |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| | Regulatory | | | |
| Regulatory No | 870.1875 | 870.1875 | 870.1875 | Same |
| Classification | Class II | Class II | Class II | Same |
| | Power Source | | | |
| Source type | Battery | Battery | Battery | Same |
| Battery type | One Rechargeable
NP-120 lithium
battery | One AA battery | One Rechargeable
NP-120 lithium
battery | Same with
DS301; different
from 3M 3200. |
| Battery operation time | 24 Hours | 50-60 Hours | 24 Hours | Same with
DS301; different
from 3M 3200. |
| | Intended use | | | |
| Intended use | The IMEDIPLUS
Electronic
Stethoscope
DS3011A 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. | 3M™ LITTMANN®
ELECTRONIC
STETHOSCOPE
MODEL 3200 is for
medical diagnostic
purposes only. It
may be used to
detect and amplify
sounds from the
heart, lungs,
arteries, veins, and
other internal organs
with the use of
selected frequency
ranges. It can be
used on any person
undergoing a
physical
examination. | The IMEDIPLUS
Electronic
Stethoscope
DS301 is intended
for the detection,
amplification and
recording of sounds
from the heart,
lung,
anterior/posterior
chest, abdomen,
neck, limbs,
arteries, veins and
other internal
organs with use of
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. | Same with
DS301; similar to
3M 3200.
The population is
specific to
children,
adolescents and
adults. |
| | Functional | | | |
| Binaural
headset | Yes | Yes | Yes | Same |
| Chest-piece | Yes | Yes | Yes | Same |
| Sound
processing | Digital signal
processor | Digital signal
processor | Digital signal
processor | Same |
| Display | Yes | Yes | Yes | Same |

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Document No.: DS3011A-SDUS01-00501	Page: 14 of 20
Product Name: Electronic Stethoscope DS3011A	Ver.: A4
510(k) File Name: 018_510(k)Summary	Date: 2018/8/17

| Display type | 1.46" Full Color OLED | LCD | 1.46" Full Color OLED | Same with DS301; different from 3M 3200.
OLED is provided with the characteristics of wide view angle, high response time, high brightness, low power consumption and full color. |
|--------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Filter selection | Bell (20-200 Hz) Diaphragm (100-500 Hz) | Bell (20-200 Hz) Diaphragm (100-500 Hz) | Bell (20-200 Hz) Diaphragm (100-500 Hz) | Same |
| | Wide (20-1000Hz) | Extend range (50-500 Hz) | Wide (20-1000Hz) | Same with DS301; different from 3M 3200.
See the bench test report of audio. |
| Detect and display heart rate function | Yes | Yes | Yes | Same |
| Detect and display heart rate range | 30-180 bpm | 30-199 bpm | 30-180 bpm | Same with DS301; different from 3M 3200. |
| Record function | Yes | Yes | Yes | Same |
| Playback function | Yes | Yes | Yes | Same |
| Amount of record and playback sound tracks | Save up to 600 10-second sound tracks;
Latest 50 sound tracks for playback. | Save up to twelve 30-second sound tracks;
Latest 12 sound tracks for playback. | Save up to 999 10-second sound tracks;
Latest 15 sound tracks for playback. | Different. |
| Sound Amplification | Yes, Up to 24X | Yes, Up to 24X | Yes, Up to 24X | Same |
| Volume control | Yes | Yes | Yes | Same |
| Volume control level | 1-10 level | 1-9 level | 1-10 level | Same with DS301; different from 3M 3200. |
| Automatic power off | Yes | Yes | Yes | Same |
| Monitor battery | Yes | Yes | Yes | Same |

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510(k) Summary | | |
|-------------------|-----------------------------------|-------|-----------|
| Document No.: | DS3011A-SDUS01-00501 | Page: | 15 of 20 |
| Product Name: | Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: | 018_510(k)Summary | Date: | 2018/8/17 |

level function
Monitor battery
level degrees	5 degrees	4 degrees	5 degrees	Same with
DS301; different
from 3M 3200.
Occupation	Anesthesiologist,
Cardiologist,
Emergency
Physician,
EMT/EMS,
Family Practitioner,
Internist,
Medical Assistant,
Medical Student,
Nurse,
Nursing Student,
Pediatrician,
Physician,
Respiratory
Specialist,
Teacher/Professor
/Instructor,
Veterinarian.	Anesthesiologist,
Cardiologist,
Emergency
Physician,
EMT/EMS,
Family Practitioner,
Internist,
Medical Assistant,
Medical Student,
Nurse,
Nursing Student,
Pediatrician,
Physician,
Respiratory
Specialist,
Teacher/Professor/In
structor,
Veterinarian.	Anesthesiologist,
Cardiologist,
Emergency
Physician,
EMT/EMS,
Family Practitioner,
Internist,
Medical Assistant,
Medical Student,
Nurse,
Nursing Student,
Pediatrician,
Physician,
Respiratory
Specialist,
Teacher/Professor
/Instructor,
Veterinarian.	Same
Sound track
transfer
function	Yes	Yes	Yes	Same
Sound track
transfer
interface	Micro SD card
Bluetooth	Bluetooth	Micro SD card	(1) Micro SD
card: same as
DS301
(2) Bluetooth:
same as
3M3200
Barcode
Reader	Yes,
1D Barcode reader	No	Yes,
1D Barcode reader	Same with
DS301; new for
3M 3200
Organ position
indication	Yes,
To indicate the
organ to auscultate.	No	Yes,
To indicate the
organ to auscultate.	Same with
DS301; new for
3M 3200
Auscultation
position
indication	Yes,
To indicate the
auscultation
position of organ.	No	Yes,
To indicate the
auscultation
position of organ.	Same with
DS301; new for
3M 3200
Intuitive
keypad	Yes,
To choose the
organ position
between heart and
lung during
auscultation.	No	Yes,
To choose the
organ position
between heart and
lung during
auscultation.	Same with
DS301; new for
3M 3200
A/P CHEST
key	Yes,
To switch the organ
position between
"Anterior Chest"
and "Posterior
Chest".	No	Yes,
To switch the organ
position between
"Anterior Chest"
and "Posterior
Chest".	Same with
DS301; new for
3M 3200
Password	Yes,
The user needs to
enter the password	No	No	New

18

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510(k) Summary |
|----------------------------------------------|-----------------------------------|
| Document No.: DS3011A-SDUS01-00501 | Page: 16 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: A4 |
| 510(k) File Name: 018_510(k)Summary | Date: 2018/8/17 |

	to access device
Phonogram
display on the
screen	Yes,
To real time
monitoring sound
wave.	No	No	New
Connected
device
software	Yes,
DS3011A_DM
software (DS3011A
Data Management
software) receive
sounds data from
IMEDIPLUS
Electronic
Stethoscope
DS3011A.
1.Receive the data
of sounds
2.Data storage
3.Display the
phonogram
4.Replay the
recorded data with
the spectrum of
selected frequency
mode	Yes,
3M™ Littmann®
StethAssist™ Heart
and Lung Sound
Visualization
Software
1.Receive the data
of sounds
2.Data storage
3.Display the
phonogram
4.Replay the
recorded data with
the spectrum of
selected frequency
mode	No	New for DS301;
similar to 3M

|

VII. Performance Data

The following performance data are provided in support of the substantial equivalence determination.

Biocompatibility

Generally, the duration of contact to the patient's skin is less than 5 minutes and less than 3-hour contact to the doctor's skin. Due to the short contact, and all the materials of contacting parts have been used in common medical device industry for years, the risk of biological hazards are assessed low based on FDA #G95-1 and ISO10993-1. It is assessed no need to perform the biocompatibility laboratory tests.

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 DS3011A complies with the safety standard of IEC 60601-1 and the EMC stands of EN 60601-1-2, CISPR 11, IEC 60601-1-2, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11 and FCC Part 15.

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510(k) Summary | | |
|-------------------|-----------------------------------|-------|-----------|
| Document No.: | DS3011A-SDUS01-00501 | Page: | 17 of 20 |
| Product Name: | Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: | 018_510(k)Summary | Date: | 2018/8/17 |

Software Verification and Validation Testing

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

Reliability and MTBF Testing

Reliability and mean time between failure (MTBF) reports are tested and issued by DEKRA Intearated Service Technology, Inc. The reliability report shows the conditions of operation, storage and transportation environment for the IMEDIPLUS Electronic Stethoscope DS3011A. The MTBF report demonstrates the shelf life.

Battery and Photobiological Safety Testing

Battery and photobiological safety reports are tested and issued by SGS Taiwan Limited. According to the battery test reports, the battery complies with the IEC 62133:2012(Second Edition) and UN38.3 (Section 38.3 Lithium metal and lithium ion batteries in UN ST/SG/AC.10/11/Rev.5/Amend.1 Recommendation on the TRANSPORT OF DANGEROUS GOODS Manual of tests and Criteria Fifth revised edition) standards. The photobiological test report shows the IMEDIPLUS Electronic Stethoscope DS3011A complies with the IEC 62471: 2006 (First Edition) and EN 62471:2008 standards.

Usability Evaluation

The usability evaluation complies with the requirement of Clause 5.3 and 5.7.3 of the international medical device usability engineering standard, IEC 62366:2015, and IEC 60601-1-6.

Clinical Evaluation

The clinical evaluation is performed by 4 clinical doctors, who are clinically certified and qualified professionals, and three subject groups (4 children, 4 adolescents and 7 adults) are specified to conduct the clinical evaluation. The statistical analysis of the questionnaire shows that the medical equipment (IMEDIPLUS Electronic Stethoscope DS3011A) can meet the basic principles of safety and effectiveness when used in Child, Adolescent, Adult and other ethnic groups for heart, chest, intestines and neck auscultation.

Wireless Coexistence

The wireless coexistence report complies with the requirement of ANSI C63.27-2017 -American National Standard for Evaluation of Wireless Coexistence.

20

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| Document No.: DS3011A-SDUS01-00501 | Page: | 18 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: 018_510(k)Summary | Date: | 2018/8/17 |

Performance Testing-Bench

The bench testing report of heart rate detection function among IMEDIPLUS Electronic Stethoscope DS3011A. 3M 3200 and IMEDIPLUS Electronic Stethoscope DS301 provides a detailed analysis of the similarities and differences. The report demonstrates that the heart rate detection of IMEDIPLUS Electronic Stethoscope DS3011A is substantially equivalent to the predicate device 3M 3200 and DS301 with the condition of heart rate between 30-180 bpm.

The bench testing report of audio performance among DS3011A, DS3011A_DM software (DS3011A Data Management), 3M 3200 and DS301 provides a detailed analysis of the similarities and differences. The report demonstrates that the audio performance of IMEDIPLUS Electronic Stethoscope DS3011A and DS3011A_DM software (DS3011A Data Management) are substantially equivalent to the reference device 3M 3200 while audio frequency operates below 1 kHz. In addition, the IMEDIPLUS Electronic Stethoscope DS3011A and DS3011A DM software (DS3011A Data Management) are substantially equivalent to the predicate device IMEDIPLUS Electronic Stethoscope DS301 for bell, diaphragm and wide frequency band mode.

21

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510(k) Summary |
|-------------------|--------------------------------------------|
| Document No.: | DS3011A-SDUS01-00501
Page: 19 of 20 |
| Product Name: | Electronic Stethoscope DS3011A
Ver.: A4 |
| 510(k) File Name: | 018_510(k)Summary
Date: 2018/8/17 |

List of Standards

The IMEDIPLUS Electronic Stethoscope DS3011A conforms to the following standards:

[1] ISO14971, Medical devices-application of risk management to medical devices, 2007-03-01.
IEC 62304, Medical Device Software Software Life Cycle Processes, [2] 2015-06.
ાંડા AAMI TIR45, Guidance on the use of agile practices in the development of medical device software, 2012-08-20.
IEC/TR80002-1, Medical device software -- Part 1: Guidance on the (4 application of ISO 14971 to medical device software, 2009-09-01.
AAMI ANSI IEC 62366-1, Medical Devices Part 1: Application Of [5] Usability Engineering To Medical Devices, 2015-02.
[6] AAMI ANSI ISO 10993-1. Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, 2009-10-15.
ISO 15223-1, Medical Devices Symbols To Be Used With Medical [7] Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements, 2016-11-01.
IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General 181 Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests, 2007-03-30
IEC 62133, Secondary cells and batteries containing alkaline or other non-വ acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications, 2012-12-06.
[10] IEC 62471, Photobiological Safety Of Lamps And Lamp Systems, 2006-07-26.
[11] ANSI C63.27-2017 -American National Standard for Evaluation of Wireless Coexistence. 2017-11-05.

22

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Document No.:	DS3011A-SDUS01-00501	Page:	20 of 20
Product Name:	Electronic Stethoscope DS3011A	Ver.:	A4
510(k) File Name:	018_510(k)Summary	Date:	2018/8/17

Performance Data Summary

The IMEDIPLUS Electronic Stethoscope DS3011A has similar safety and effectiveness profiles to that of the predicate devices, reference 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 and predicate IMEDIPLUS Electronic Stethoscope DS301.

VIII. Conclusions

The information provided in this Abbreviated 510(k) submission shows that the IMEDIPLUS Electronic Stethoscope DS3011A is substantially equivalent to the predicate IMEDIPLUS Electronic Stethoscope DS301, cleared under K160023.