Electronic Stethoscope DS3011A

K173663 · Imediplus, Inc. · DQD · Aug 17, 2018 · Cardiovascular

Device Facts

• Record ID: K173663
• Device Name: Electronic Stethoscope DS3011A
• Applicant: Imediplus, Inc.
• Product Code: DQD · Cardiovascular
• Decision Date: Aug 17, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Handheld electronic stethoscope; captures acoustic signals from heart, lungs, abdomen, neck, limbs, and vasculature via chest-piece. Features digital signal processor for amplification and filtering (Bell, Diaphragm, Wide modes). User interface includes OLED display, keypad, and 1D barcode reader for patient/recording identification. Operates via rechargeable lithium battery. Records audio to internal storage or micro SD card; transmits data via Bluetooth to mobile device running DS3011A_DM software. Software enables data reception, storage, phonogram visualization, and playback. Used by clinicians (physicians, nurses, EMTs, etc.) for auscultation. Provides real-time phonogram display and heart rate monitoring. Benefits include enhanced sound amplification, objective recording for diagnostic review, and digital data management.

Clinical Evidence

Clinical evaluation performed with 4 certified clinical doctors and 15 subjects (4 children, 4 adolescents, 7 adults). Questionnaire-based statistical analysis confirmed device met safety and effectiveness principles for heart, chest, intestinal, and neck auscultation across specified patient groups.

Technological Characteristics

Materials: Silicon diaphragm, brass alloy headset. Sensing: Electronic chest-piece with digital signal processor. Power: NP-120 rechargeable lithium battery. Form factor: Handheld with 1.46" OLED display. Connectivity: Bluetooth, micro SD card. Software: DS3011A_DM data management software. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62133, IEC 62471, ANSI C63.27.

Indications for Use

Indicated for child, adolescent, and adult patients undergoing physical examination for medical diagnostic purposes in clinical or hospital settings.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*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.

Predicate Devices

• IMEDIPLUS Electronic Stethoscope DS301 (K160023)

Reference Devices

• 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 (K083903)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

| <span style="font-size:10px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> 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:<br>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: [phone] Fax Number: [phone]

Contact Person: Shirley Lai E-mail: [e-mail] Phone Number: [phone]#326 Fax Number: [phone] 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)<br>Number |
|---------------------|-------------------------------------------------------|----------------|---------|------------------|
| Candidate<br>Device | IMEDIPLUS Electronic<br>Stethoscope DS3011A | IMEDIPLUS INC. | DS3011A | K173663 |
| Predicate<br>Device | IMEDIPLUS Electronic<br>Stethoscope DS301 | IMEDIPLUS INC. | DS301 | K160023 |
| Reference<br>Device | 3M™ LITTMANN®<br>ELECTRONIC STETHOSCOPE<br>MODEL 3200 | 3M COMPANY | 3M 3200 | K083903 |

Predicate Device Identification Table 1

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| Image: IMEDI logo | Document Title:<br>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,<br>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

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

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

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

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| Image: Imedi logo | Document Title:<br>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<br>Phonogram | the password for the<br>operation of the device | No | No |
|---|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | Software of<br>the<br>Connected<br>Device | Yes,<br>IMEDIPLUS DS3011A-<br>DM software (DS3011A<br>DataManagement<br>software)<br>(1) Receive and store<br>the data of sound<br>tracks<br>(2) Display the<br>phonogram of the<br>sound tracks<br>(3) Reply the audio data<br>in the connected<br>device installed with<br>IMEDIPLUS<br>DS3011A-DM<br>software but this<br>software could not<br>operate the<br>IMEDIPLUS<br>Electronic<br>Stethoscope<br>DS3011A to replay<br>the sound track from<br>the connected device. | Yes,<br>3MTM Littmann®<br>Zargis StethAssistTM<br>Heart and Lung Sound<br>Visualization Software | No |
| 7 | Function of Data Transfer and the Interface | | | |
| | Data<br>Transfer of<br>the Recorded<br>Sound<br>Tracks | Yes,<br>Micro SD card and<br>Bluetooth<br>(1) Micro SD card,<br>(Permits the data<br>exchange from the<br>electronic stethoscope to<br>the personal computer)<br><br>(2) Bluetooth, (transmits<br>the audio data from<br>the stethoscope to the<br>connected device) | Yes<br>Bluetooth<br>Permits the data<br>exchange from the<br>electronic stethoscope<br>to the personal<br>computer | Yes<br>Micro SD card<br>Permits the data<br>exchange from the<br>electronic stethoscope<br>to the personal<br>computer |
| | Capable of<br>Storing Data<br>and Latest<br>sound tracks<br>for playback | Save up to 600 10-second<br>sound tracks;<br>Latest 50 sound tracks for<br>playback. | Save up to twelve 30-<br>second sound tracks;<br>Latest 12 sound tracks<br>for playback. | Save up to 999 10-<br>second sound tracks;<br>Latest 15 sound tracks<br>for playback. |
| 8 | Service and Occupation | | | |

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

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| Image: IMEDI logo | Document Title:<br>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.

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| 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 | allu Jivi JZVV<br>Candidate<br>Device<br>DS3011A | Reference<br>Device<br>3M 3200 | Same/Different |
|--------------------------------------|--------------------------------------------------|--------------------------------|----------------|
| 1D Barcode reader | Yes | No | Different |
| Micro SD card | Yes | No | Different |
| Organ position indication | Yes | No | Different |
| Auscultation position indication | Yes | No | Different |
| Intuitive keypad | Yes | No | Different |
| A/P CHEST Key | Yes | No | Different |
| Password | Yes | No | Different |
| Phonogram display on the screen | Yes | No | Different |
| Wireless connection by Bluetooth | 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 the 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 |

#### (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<br>DS3011A | Predicate Device<br>DS301 | Same/Differe<br>nt |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------|
| Wireless connection | Yes | No | Different |
| Connected device software | Yes<br>DS3011A DM software<br>(DS3011A Data Management<br>software)<br>1.Receive the data of sounds<br>2.Data storage<br>3.Display the phonogram<br>4.Replay the recorded data<br>with the spectrum of selected<br>frequency mode<br>5. The audio data could be<br>displayed with the connected<br>device but not on the DS3011A<br>screen. | No | Different |
| Password | Yes…