(28 days)
Not Found
No
The description mentions digital signal processing for sound processing but does not mention AI, ML, or any related terms like neural networks or deep learning. The performance studies focus on basic device functionality, electrical safety, software validation, and usability, not on the performance of any AI/ML algorithms.
No
The device is described as being "intended only for medical diagnostic purposes" for the detection, amplification, and recording of sounds within the body, which is a diagnostic rather than therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended only for medical diagnostic purposes in clinic or hospital."
No
The device description explicitly states that the device includes hardware components such as a chest piece, active speaker, digital signal processor, OLED display, buttons, tube connector, and is powered by batteries. While it has software for sound processing and display, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Electronic Stethoscope DS101 and Omni-Steth detect, amplify, and record sounds from within the patient's body (heart, lungs, etc.). They do not analyze specimens taken from the body.
- Intended Use: The intended use is for "detection, and recording of sounds from the heart, lungs... and other internal organs" and for "medical diagnostic purposes in clinic or hospital" during a physical examination. This aligns with the function of a stethoscope, which is a non-invasive diagnostic tool used directly on the patient.
Therefore, the device falls under the category of a medical device used for physical examination and diagnosis based on internal body sounds, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Electronic Stethoscope DS101 is intended for the detection, and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
The Electronic Stethoscope Omni-Steth is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
Product codes (comma separated list FDA assigned to the subject device)
DQD
Device Description
The proposed Electronic Stethoscopes Models DS101 and Omni-Steth detect and display the sounds from the heart, lungs, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs from a patient's body. After amplifying and filtering, the sounds are also sent to the user's ears bilaterally through the active speaker embedded at the bottom of the stethoscopes. Sound processing is conducted with the aid of a digital signal processor. Power to the device is provided by two AAA1.2V batteries. The one-hand operable user interface consists of a full-color OLED display, the Record button, arrow keys, the OK button, and a tube connector to output sounds to the headset consisting of tubes and ear tips.
The proposed devices can detect and display an acoustic based heart rate when presented with consistent heart sounds.
In addition, using a Bluetooth wireless link, the proposed stethoscopes can exchange raw audio data with external devices such as personal computers.
Note: The models DS101 and Omni-Steth are standalone devices and do not require Bluetooth data transfer to fulfill their intended use.
The differences between the proposed stethoscope models DS101 and Omni-Steth are cosmetic: specifically, the design of top housing and keyboard layout. The OLED Display information are identical.
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.
Intended users 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)
Non-Clinical Performance Data:
- Risk Analysis: Conducted in accordance with ISO 14971:2007. Identified risks were mitigated and residual risks were acceptable.
- Electrical Safety and Electromagnetic Compatibility (EMC): Complies with ANSI/AAMI ES 60601-1:2005/(R)2012, IEC 60601-1-2:2014, and FCC Part 15. The results for radiated emissions, immunity to electrostatic discharges, immunity to radio frequency electromagnetic fields, and power frequency magnetic fields are acceptable.
- Software Verification and Validation Testing: Documentation submitted in accordance with "Guidance for the content of premarket submissions for software contained in medical devices, May 11, 2005" and IEC/TR80002-1:2009. Software level of concern is "moderate".
- Biocompatibility Evaluation: Evaluated in accordance with AAMI ANSI ISO 10993-1:2009 and conforms.
- Usability Evaluation: Complies with IEC 62366:2015 (Clause 5.3 and 5.7.3).
- Sample size: 15 physicians and 15 registered nurses.
- Data source: Study conducted in San Diego, California and Saint Louis, Missouri, from June 1 to June 18, 2018.
- Key results: Participants successfully completed tasks after reading the user manual. No use problems or need for design modification of user interface or labeling. User interface is simple and easy to learn (Learnability). Efficiency of auscultation and recording significantly improved. High satisfaction with size and ease of use/memorization. Devices are safe and effective.
- Wireless Coexistence: Complies with ANSI C63.27-2017. Little interference from Bluetooth and Wi-Fi noted; heart rate and peak-to-value remained stable.
- Splash Water Test: Complies with IEC / EN 60529:2001 (IPX4). Device function was normal after testing.
- Heart Rate Performance Testing: Comparison bench testing showed that the heart rate detection of IMEDIPLUS Electronic Stethoscope DS101 is substantially equivalent to 3M 3200 (Secondary Predicate Device) and DS3011A (Primary Predicate Device) within the heart rate range of 30-180 bpm.
- Audio Performance Testing: Comparison bench testing showed that the audio performance of IMEDIPLUS Electronic Stethoscope DS101 and DS101 DM Software (Data Management) are substantially equivalent to 3M 3200 (Secondary Predicate device) when audio frequency is below 1 kHz. Also substantially equivalent to IMEDIPLUS Electronic Stethoscope DS3011A for bell, diaphragm, and wide frequency band mode.
Clinical Performance Data: Not needed due to no difference in intended use, operating principle, and fundamental technology compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 11, 2018
Imediplus, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041
Re: K182196
Trade/Device Name: Cardiart Electronic Stethoscope: Model DS101; Omni-Steth Electronic Stethoscope: Model Omni-Steth Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: August 11, 2018 Received: August 14, 2018
Dear Dave Yungvirt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Stephen C. Browning -S5
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182196
Device Name
Cardiart Electronic Stethoscope: Model DS101 Omni-Steth Electronic Stethoscope: Model Onmi-Steth
Indications for Use (Describe)
The Electronic Stethoscope DS101 is intended for the detection, and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
The Electronic Stethoscope Omni-Steth is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
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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3
510(k) Number: K182196
SUBMITTER: -
| Submitter's Name: | IMEDIPLUS INC. |
|---|---|
| Address: | 2F, 12, ShengYi Rd. Sec. 2, Chupei City, Hsinchu County |
| 30261, Taiwan (R.O.C.) | |
| Telephone: | +886-3-658-7700 |
| Contact Name: | Moriah Hsieh |
| Telephone: | +886-3-658-7700 ext #325 |
| Fax: | +886-3-658-9535 |
| Email: | moriah.hsieh@imediplus.com |
| Date Prepared: | 24 August 2018 |
II. DEVICE:
| Trade Name and
Model: | Cardiart Electronic Stethoscope: Model DS101 and
Omni-Steth Electronic Stethoscope: Model Onmi-Steth |
|---------------------------|---------------------------------------------------------------------------------------------------------|
| Common or Usual
Name: | Electronic Stethoscope |
| Classification
Number: | 870.1875 |
| Classification Name: | Stethoscope |
| Product Code: | DQD |
| Product Class: | II |
| Classification Panel: | Cardiovascular |
III. PREDICATE DEVICE:
| Device Name | Manufacturer | Classification | |
|---|---|---|---|
| Primary | |||
| Predicate | |||
| K173663 | IMEDIPLUS Electronic Stethoscope | ||
| DS3011A | IMEDIPLUS | ||
| INC. | DQD | ||
| 870.1875 | |||
| Secondary | |||
| Predicate | |||
| K083903 | 3M™ LITTMANN® ELECTRONIC | ||
| STETHOSCOPE MODEL 3200 | 3M COMPANY | DQD | |
| 870.1875 |
This Secondary Predicate K083903 with the same intended use, classification and product code as the proposed device is included to support the Bluetooth wireless technology that is implemented in the subject device for which scientific methods exists to evaluate this new technology as outlined in the FDA guidance "Radio Frequency Wireless Technology in Medical Devices" (Aug 14, 2013).
IV. DEVICE DESCRIPTION
The proposed Electronic Stethoscopes Models DS101 and Omni-Steth detect and
4
display the sounds from the heart, lungs, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs from a patient's body. After amplifying and filtering, the sounds are also sent to the user's ears bilaterally through the active speaker embedded at the bottom of the stethoscopes. Sound processing is conducted with the aid of a digital signal processor. Power to the device is provided by two AAA1.2V batteries. The one-hand operable user interface consists of a full-color OLED display, the Record button, arrow keys, the OK button, and a tube connector to output sounds to the headset consisting of tubes and ear tips.
The proposed devices can detect and display an acoustic based heart rate when presented with consistent heart sounds.
In addition, using a Bluetooth wireless link, the proposed stethoscopes can exchange raw audio data with external devices such as personal computers.
Note: The models DS101 and Omni-Steth are standalone devices and do not require Bluetooth data transfer to fulfill their intended use.
The differences between the proposed stethoscope models DS101 and Omni-Steth are cosmetic: specifically, the design of top housing and keyboard layout. The OLED Display information are identical.
| Trade Name | CaRDIART Electronic Stethoscope | Omni-Steth Electronic Stethoscope |
|---|---|---|
| Model Name | DS101 | Omni-Steth |
| Device | ||
| Appearance | Image: Cardiart Electronic Stethoscope Device Appearance | Image: Omni-Steth Electronic Stethoscope Device Appearance |
| Keyboard | ||
| layout | Image: Cardiart Electronic Stethoscope Keyboard layout | Image: Omni-Steth Electronic Stethoscope Keyboard layout |
5
V. INTENDED USE AND INDICATIONS FOR USE
Cardiart Electronic Stethoscope (Model DS101)
The Electronic Stethoscope DS101 is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diaqnostic purposes in clinic or hospital.
Omni-Steth Electronic Stethoscope (Model Omni-Steth)
The Electronic Stethoscope Omni-Steth is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technology of the proposed electronics stethoscopes Models DS101 and Omni-Steth are identical to the predicate IMEDIPLUS electronic stethoscope Model DS301 1A in terms of principle of operation, materials, design, user interface, frequency ranges, and auscultation organs. The following include the modifications to the previous design implemented in the proposed stethoscopes:
-
- New PCB (Printed Circuit Board) layout
-
- New housing with water resistance (IPX4)
-
- Rearrangement of the information on OLED display
-
- Data transmission via Bluetooth
-
- Two AAA 1.2V batteries as power supply
-
- Display of Phonocardiogram
6
K182196
Page 4 of 11
Comparison table
| Item
S | Comparis
on Items | Subject Device | | Secondary Predicate
Device | Primary Predicate
Device | Same/Similar
ar
Different
/New |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| 1 | Regulatory
Regulatory
No
Classification | CARDIART Electronic
Stethoscope (DS101) | Omni-Steth Electronic
Stethoscope (Omni-Steth) | 3M 3200 (K083903) | DS3011A (K173663) | Same |
| 2 | Power Source
Batteries
type | Two AAA battery | Two AAA battery | One AA battery | One NP-120 Lithium
battery | Similar with
3M 3200 ;
Different
from
DS3011A |
| | Battery
Life | > 7 Hours | > 7 Hours | 50-60 Hours | 24 Hours | Different |
| | Special
Adaptors | No | No | No | Yes | Same with
3M 3200 ;
Different
from
DS3011A |
| 3 | Features
Binaural
headset | Yes | Yes | Yes | Yes | Same |
| | Chest-
piece
Technology | Single Sided | Single Sided | Single Sided | Single Sided | Same |
| | Chest-
piece
Weight | 18g | 18g | 98g | 69g | Different |
| | Clinical
Area | Auscultation | Auscultation | Auscultation | Auscultation | Same |
| | Diaphragm
Diameter | 4.7cm | 4.7cm | 5.1cm | 4.1cm | Similar with
3M 3200
and |
| | | | | | | DS3011A |
| | Diaphragm
Material | Silicone | Silicone | Polyurethane-Coated
Silicone | Silicone | Same with
DS3011A;
Different
from 3M
3200 |
| | Ear-tips
Type | Soft Sealing | Soft Sealing | Soft Sealing | Soft Sealing | Same |
| | Headset
Material | Brass alloy to electroplate | Brass alloy to electroplate | Wide diameter
aerospace alloy /
Anodized aluminum | Brass alloy to
electroplate | Same with
DS3011A |
| | Length | 81 cm | 81 cm | 69 cm | 77 cm | Similar with
DS3011A |
| | Net Weight | 214g | 213g | 185 g | 304 g | Different |
| | Tube Color | Black · Burgundy · Navy Blue | Black · Burgundy · Navy Blue | Black · Burgundy · Navy
Blue | Black · Burgundy · Navy
Blue | Same |
| 4 | Intended Use | | | | | |
| | Intended
Use | The CARDIART Electronic
Stethoscope 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.
The stethoscope chest-piece
is designed for use with child,
adolescent and adult patients.
It is used for any subject
undergoing a physical
examination and intended only
for medical diagnostic
purposes in clinic or hospital. | The Omni-Steth Electronic
Stethoscope 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.
The stethoscope chest-piece
is designed for use with child,
adolescent and adult patients.
It is used for any subject
undergoing a physical
examination and intended only
for medical diagnostic
purposes in clinic or hospital. | The 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
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 | Same with
DS3011A;
similar to
3M 3200.
The
population
is specific
to child,
adolescents
and adults. |
| | | | | | medical diagnostic
purposes in clinic or
hospital. | |
| 5 | Functional | | | | | |
| | Display
Screen | OLED 1.46" Full Color | OLED 1.46" Full Color | LCD Monochrome | OLED 1.46" Full Color | Same with
DS3011A;
similar to
3M 3200. |
| | Barcode
Reader | No | No | No | Yes | Same with
3M 3200 |
| | Three
Filter
Modes | Yes | Yes | Yes | Yes | Same |
| | 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 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) | Same with
DS3011A ;
Similar to
3M 3200 |
| | Human
Machine
Interface | One-hand user interface for
auscultation position selection,
recording, and function
selection. | One-hand user interface for
auscultation position selection,
recording, and function
selection. | Yes | One-hand user interface
for patient's ID
scanning, auscultation
position selection,
recording, and function
selection. | Similar with
DS3011A |
| | Recording
Number of
the sound
track | Yes ( File name:
Year+Month+Hour+Minute+Se
cond) | Yes ( File name:
Year+Month+Hour+Minute+Se
cond) | Yes (File name: 00x) | Yes (File name:
Barcode ID) | Same with
3M3200 |
| | Recording
the Organ
and
Position of
the
Sound
Track | Yes | Yes | No | Yes | Same with
DS3011A |
| 6 | Software Comparison | | | | | |
| | Heart Rate
Detection | Yes | Yes | Yes | Yes | Same |
| | Heart Rate | Yes | Yes | Yes | Yes | Same |
| Display | | | | | | |
| Recording
the Sound
Track | Yes | Yes | Yes | Yes | Same | |
| Playback
the Sound
Track | Yes | Yes | Yes | Yes | Same | |
| Volume
Control | Yes | Yes | Yes | Yes | Same | |
| Volume
Control
Scale | Yes
1-10 level | Yes
1-10 level | Yes
0-9 | Yes
1-10 level | Same with
DS3011A | |
| Sound
Amplificati
on | Yes
24 times | Yes
24 times | Yes
24 times | Yes
24 times | Same | |
| Filter mode
selection | Yes,
Bell, Diaphragm, and Wide
modes | Yes,
Bell, Diaphragm, and Wide
modes | Yes
Bell, Diaphragm and
Extend Modes | Yes,
Bell, Diaphragm, and
Wide modes | Same with
DS3011A | |
| Automatic
turn-off | Yes | Yes | Yes | Yes | Same | |
| Monitor the
battery
level | Yes | Yes | Yes | Yes | Same | |
| Display the
Phonogra
m | Yes,
Display the synchronized
phonogram on the screen
during the auscultation with
the CARDIART Electronic
Stethoscope | Yes,
Display the synchronized
phonogram on the screen
during the auscultation with
the Omni-Steth Electronic
Stethoscope | Yes,
Display on 3M
Littmann® Zargis
StethAssist Heart and
Lung Sound
Visualization Software | Yes, Display the
synchronized
phonogram on the
screen during the
auscultation with the
IMEDIPLUS Electronic
Stethoscope DS3011A | Similar with
3M 3200 | |
| Software
of the
Connected
Device | Yes,
IMEDIPLUS DS101-DM
software (DS101 Data
Management software)
(1) Receive and storage the
data of sound tracks
(2) Display the phonogram of
the sound tracks | Yes,
IMEDIPLUS DS101-DM
software (DS101 Data
Management software)
(1) Receive and storage the
data of sound tracks
(2) Display the phonogram of
the sound tracks | Yes,
3M Littmann® Zargis
StethAssist Heart and
Lung Sound
Visualization Software | Yes, IMEDIPLUS
DS3011A-DM software
(DS3011A Data
Management software)
(1) Receive and
storage the data of
sound tracks
(2) Display the
phonogram of the sound tracks | Similar
with3M
3200. | |
| | | | | | 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. | |
| 7 | | Function of Data Transfer and the Interface | | | | |
| | Data
Transfer of
the
Recorded
Sound
Tracks | Yes,
Bluetooth, (transmits the audio
data from the stethoscope to
the connected device) | Yes,
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 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) | Similar with
3M 3200 |
| | Capable of
Storing
Data
and Latest
sound
tracks for
playback | Save up to 160 10-second
sound tracks;
Latest 160 sound tracks for
playback. | Save up to 160 10-second
sound tracks;
Latest 160 sound tracks for
playback. | Save up to twelve 30-
second sound tracks;
Latest 12 sound tracks
for playback. | Save up to 600 10-
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3M 3200
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DS3011A |
| 8 | Service and Occupation | | | | | |
| | Warranty
Period | 1 Years | 1 Years | 2 Years | 2 Years | Different |
| | Occupatio | Anesthesiologist, Cardiologist, | Anesthesiologist, Cardiologist, | Anesthesiologist, | Anesthesiologist. | Same |
| n | Emergency Physician,
EMT/EMS,
Family Practitioner,
Internist,
Medical Assistant,
Medical Student,
Nurse,
Nursing Student,
Pediatrician, Physician,
Respiratory Specialist,
Teacher/Professor/Instructor,
and Veterinarian. | Emergency Physician,
EMT/EMS,
Family Practitioner,
Internist,
Medical Assistant,
Medical Student,
Nurse,
Nursing Student,
Pediatrician, Physician,
Respiratory Specialist,
Teacher/Professor/Instructor,
and Veterinarian. | Cardiologist, Emergency
Physician, EMT/EMS,
Family Practitioner,
Internist,
Medical Assistant,
Medical Student,
Nurse,
Nursing Student,
Pediatrician, Physician,
Respiratory Specialist,
Teacher/Professor/Instructor,
and Veterinarian. | Cardiologist, Emergency
Physician, EMT/EMS,
Family Practitioner,
Internist, Medical
Assistant, Medical
Student, Nurse, Nursing
Student, Pediatrician,
Physician, Respiratory
Specialist,
Teacher/Professor/Instructor, and Veterinarian. | | |
| Teaching
Accessories
Included | User manual | User manual | CD-ROM
User manual | User manual | Same with
DS3011A | |
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VII. PERFORMANCE DATA
Non-Clinical
Risk Analysis
The risk analysis was conducted in accordance with the ISO 14971:2007 standard, which specifies the process for identifying hazards, estimating and evaluating associated risks, controlling the risks, and monitoring the effectiveness of the controls. All the risks of the identified potential hazards caused by the modifications of subject device were identified and evaluated based on severity and occurrence probability. ldentified risks were mitigated by implementing risk control measures which were verified to ensure any residual risks were at acceptable levels.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and electromagnetic compatibility reports are tested and issued by SGS Taiwan Limited. According to the test reports, the IMEDIPLUS Electronic Stethoscope (Model DS101/Omni-Steth) complies with the safety standards of ANSI/ AAMI ES 60601-1:2005/(R)2012. the EMC standard of IEC 60601-1-2:2014 and FCC Part 15. The results of radiated emissions, immunity to electrostatic discharges, immunity to radio frequency electromagnetic fields, and power frequency magnetic fields are acceptable.
Software Verification and Validation Testing
The provided software verification and validation documentation was submitted in accordance with the requirements of "Guidance for the content of premarket submissions for software contained in medical devices, Mav 11, 2005" and IEC/TR80002-1:2009. The level of concern of the software for this device is considered as "moderate" since a failure or latent flaw could indirectly result in minor injury to the patient or operator according to incorrect or delayed information or the action of a care provider.
Biocompatibility Evaluation
The biocompatibility was evaluated in accordance with the AAMI ANSI ISO 10993-1:2009 standard and results demonstrate that the proposed devices conform.
Usability Evaluation
The usability evaluation demonstrated that the proposed devices comply with the requirement of Clause 5.3 and 5.7.3 of the international medical device usability engineering standard, IEC 62366:2015. Under conditions of the test specified the usability is acceptable.
The testing took place from June 1 to June 18, 2018, and all participants were screened as appropriate for the intended user of the device. 15 physicians and 15 registered nurses participated in the study conducted in San Diego, California and Saint Louis, Missouri. The conference room, which is the venue of the testing, simulated the clinic or the out-patient clinic and in-hospital setting as in actual use. The lighting level, the fluorescent lamp of white (neutral shades) commonly used in hospitals and clinical room, is about 500 lux. The sound level is under the range 80 dB. In addition, no special training is needed for using the device, all participants consented and were instructed to read the user manual. Hence, the
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participants received the user manual before executing the HFE/UE test to learn the process and it was confirmed that all participants had read the user manual. During the test the participants who use our product for the first time, completed all the testing tasks on their own after reading the user manual. They successfully completed the tasks and gave feedback during the interview. The outputs and results did not indicate any use problem and there was no need to perform design modification of user interface or labeling.
The result of the testing shows that the user interface design is simple and easy for user to learn. It is the "Learnability". There are three modes to be selected for auscultation. Recording the sounds of the three modes within one operation can significantly improves the efficiency of the auscultation and recording of patients' information. It is the "Efficiency". All participants were satisfied with the size of the Omni-Steth Electronic Stethoscope and considered the user interface and operation procedures easy to use and memorize, they also praised the function of playing back recordings received from the DS101 DM Software (Data Management) to the device. The participants gave high recognition to the device representing the "Satisfaction". In addition, Omni-Steth Electronic Stethoscope and the DS101 DM Software (Data Management) achieved the goals of having all participants help demonstrate the safety of the device and no hazards were identified. Overall, the participants indicated the usability of the device is acceptable and therefore the devices are safe and effective.
Wireless Coexistence
The wireless coexistence test results demonstrated that the proposed devices comply with the requirement of ANSI C63.27-2017 - American National Standard for Evaluation of Wireless Coexistence. The result is shown that little interference from Bluetooth and Wi-Fi interfacing over different test distances was noted, and that the heart rate and peak-to-value remained stable.
Splash Water Test
The splash water test results demonstrate the proposed devices comply with IEC / EN 60529:2001 (IPX4 splashing water Test Protected) and the device's function was normal after testing.
Heart Rate Performance Testing
The comparison bench testing results of heart rate detection function among IMEDIPLUS Electronic Stethoscope DS101, 3M 3200 and IMEDIPLUS Electronic Stethoscope DS3011A provide a detailed analysis of the similarities and differences. The report demonstrates that the heart rate detection of IMEDIPLUS Electronic Stethoscope DS101 is substantially equivalent to 3M 3200 (Secondary Predicate Device) and DS3011A (Primary Predicate Device) within the heart rate range of 30-180 bpm.
Audio Performance Testing
The comparison bench testing results of audio performance among DS101, DS101 DM Software (Data Management), 3M 3200 and DS3011A provide a detailed analysis of the similarities and differences. The report demonstrates that the audio performance of IMEDIPLUS Electronic Stethoscope DS101 and DS101 DM Software (Data Management) are substantially equivalent to the Secondary Predicate device
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3M 3200 while audio frequency is below 1 kHz. In addition, the IMEDIPLUS Electronic Stethoscope DS101 and DS101 DM Software (Data Management) are substantially equivalent to the predicate device IMEDIPLUS Electronic Stethoscope DS3011A for bell, diaphragm and wide frequency band mode.
Clinical
There is no difference in the intended use, operating principle, and fundamental technology, in comparison to the predicate device, thus clinical testing was deemed unnecessary. Exchange of audio data with external devices is accomplished in the predicate device with a Micro SD card and via a Bluetooth wireless link in the proposed devices.
VII. CONCLUSIONS AND SUMMARY
The proposed electronic stethoscopes models DS101 and Omni-Steth have the same intended use and fundamental scientific technology as the predicate model DS3011A, which received 510(k) clearance K173663. Modifications incorporated in the subject device include new PCB layout, new housing with water resistance (IPX4), rearrangement of the information on OLED display, data transmission via Bluetooth, two AAA 1.2V batteries as power supply and phonocardiogram display. Results of risk analysis and performance data demonstrate that the design outputs of the modified device meet the design requirements and residual risk levels are acceptable. In summary, the proposed electronic stethoscopes described in this submission are substantially equivalent to the predicate device without raising any new issues of safety or effectiveness.