(268 days)
Not Found
No
The document describes basic digital signal processing for sound amplification and recording, but there is no mention of AI or ML algorithms for analysis, interpretation, or diagnosis.
No.
The device is described as being used "only for medical diagnostic purposes," indicating its role in identifying conditions rather than treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended only for medical diagnostic purposes."
No
The device description clearly outlines physical components like a chest-piece, active speaker, passive sound tubes, OLED display, keypad, barcode reader, tube connector, and a digital signal processor. It also mentions a battery and accessories like a charger and micro SD card. These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the IMEDIPLUS Electronic Stethoscope DS301 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The IMEDIPLUS Electronic Stethoscope DS301 works by detecting, amplifying, and recording sounds directly from within the patient's body (heart, lungs, etc.). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "detection, amplification and recording of sounds from the heart, lung... and other internal organs" and is used for "physical examination." This is a direct, non-invasive assessment of the patient's internal sounds.
Therefore, the device falls under the category of a medical device used for physical examination and diagnostic purposes in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The IMEDIPLUS Electronic Stethoscope DS301 is intended for the detection, amplification and recording of sounds from the heart, lung, 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 IMEDIPLUS Electronic Stethoscope DS301 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. After detection and amplification, the sounds are transferred to the user's ears via an active speaker and passive sound tubes. It could also identify the recording number by 1-D barcode reader, indicate the sound location by intuitive keypad, and simultaneously record the sounds from different sites.
The one-hand user interface includes a full-color OLED display and 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. Sound processing is operated with the aid of a digital signal processor.
The IMEDIPLUS Electronic Stethoscope DS301 could also exchange audio data with an external personal computing device using micro SD card. Every single audio file stored in micro SD card was labeled with the user's ID, recording number and indicated position. And the recorded audio data only can be replayed by IMEDIPLUS Electronic Stethoscope DS301, but cannot be replayed by personal computing device.
The IMEDIPLUS Electronic Stethoscope DS301 does not incorporate any off-the-shelf (OTS) software.
The IMEDIPLUS Electronic Stethoscope DS301 operates on one 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 include adaptor and charger.
- Micro SD card for exchange audio data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, lung, 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
medical diagnostic purposes in clinic or hospital. 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".
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)
Biocompatibility
The duration of skin contact to the patient is generally less than 5 minutes and the duration of skin contact to the doctor is generally less than 3 hours. Because the duration is short and all the materials of contact parts are used in common medical device industry for years, the biological hazards are assessed as low risk based on FDA #G95-1 and ISO10993-1. It is assessed not 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 DS301 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 and IEC 61000-4-11.
Software Verification and Validation Testing
The provided software verification and validation comply with the requirements of IEC 62304:2006, AAMI TIR45:2012 and IEC/TR80002-1:2009. The software for this device is considered as a "moderate" level of concern, 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 Integrated Service Technology, Inc. The reliability report shows the conditions of operation, storage and transportation environment for the IMEDIPLUS Electronic Stethoscope DS301. 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 DS301 complies with the IEC 62471: 2006 (First Edition) and EN 62471:2008 standards.
Usability Evaluation
The usability evaluation complies with the requirement of Clause 5.3.2 and 5.8 of the international medical device usability engineering standard, IEC 62366:2007 and IEC 60601-1-6.
Performance Testing-Bench
The comparison report of heart rate calculation between IMEDIPLUS Electronic Stethoscope DS301 and 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 provide a detailed analysis of the similarities and differences. The reports demonstrate that the heart rate detection function of IMEDIPLUS Electronic Stethoscope DS301 are substantially equivalent to the predicate device 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 with the conditions of heart rate in 30-180 bpm
The comparison report of audio performance between IMEDIPLUS Electronic Stethoscope DS301 and 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 provide a detailed analysis of the similarities and differences. The reports demonstrate that the audio performance of IMEDIPLUS Electronic Stethoscope DS301 are substantially equivalent to the predicate device 3MTM LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 with the conditions of audio frequency below 1 kHz.
Clinical Evaluation
The clinical evaluation is performed by 4 testers, who are clinically certified and qualified professionals. Three subject groups (3 children, 3 adolescents and 3 adults) are defined to conduct the clinical evaluation. The statistical analysis of the questionnaire show that the medical equipment (IMEDIPLUS Electronic Stethoscope DS301) can meet the basic principles of safety and effectiveness when used in Child, Adolescent and Adult for auscultation of heart, chest, bowel and neck.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2016
Imediplus Inc. Shirley Lai Regulatory Specialist 2F, 12, ShengYi Rd. Sec. 2 Zhubei City, Hsinchu County, 30261 TW
Re: K160023
Trade/Device Name: Electronic Stethoscope DS301 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: August 23, 2016 Received: August 26, 2016
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mude Jellman
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) K160023
Device Name Electronic Stethoscope DS301.
Indications for Use (Describe)
The IMEDIPLUS Electronic Stethoscope DS301 is intended for the detection, amplification and recording of sounds from the heart, lung, 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
IMEDIPLUS INC.
510(k) Submission Electronic Stethoscope DS301
Section 5
510(k) Summary
Page 1 of 14
4
| 510(k) Summary | |||
|---|---|---|---|
| Product Name | Electronic Stethoscope DS301 | ||
| Page | 2 of 14 | ||
| Version | A4 |
510(k) Summary
The Assigned 510(k) Number:_
Date Prepared: Dec.18. 2015.
The Assigned 510(k) Number:___________________________________________________________________________________________________________________________________________________ K160023/S001 Deficiencies Formal Reply Date: August 27. 2016.
SUBMITTER INFORMATION: l.
Submitter: IMEDIPLUS INC. Address: 2F, 12, ShengYi Rd. Sec. 2, Chupei City, Hsinchu County 30261, TW 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: September 22, 2016.
5
| Image: IMEDI logo | 510(k) Summary | ||
|---|---|---|---|
| Product Name | Electronic Stethoscope DS301 | Page | 3 of 14 |
| Version | A4 |
PREDICATE DEVICE ll.
Predicate Device:
3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200
Predicate Device Identification Table 1.
| Subject Device | Predicate Device | Manufacturer | 510(k) Number |
|---|---|---|---|
| IMEDIPLUS | |||
| Electronic | |||
| Stethoscope | |||
| DS301 | 3MTM LITTMANN® | ||
| ELECTRONIC | |||
| STETHOSCOPE MODEL 3200 | 3M COMPANY | K083903 |
lll. DEVICE
Common Name and Classification Table 2.
| No. | Product
Code | Device | Regulation
Section | Classification | Panel |
|-----|-----------------|----------------------------|-----------------------|----------------|----------------|
| 1 | DQD | Stethoscope,
Electronic | 870.1875 | II | Cardiovascular |
DEVICE DESCRIPTION IV.
The IMEDIPLUS Electronic Stethoscope DS301 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. After detection and amplification, the sounds are transferred to the user's ears via an active speaker and passive sound tubes. It could also identify the recording number by 1-D barcode reader, indicate the sound location by intuitive keypad, and simultaneously record the sounds from different sites.
The one-hand user interface includes a full-color OLED display and 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. Sound processing is operated with the aid of a digital signal processor.
6
| Image: IMEDI logo | 510(k) Summary | ||
|---|---|---|---|
| Product Name | Electronic Stethoscope DS301 | Page | 4 of 14 |
| Version | A4 |
The IMEDIPLUS Electronic Stethoscope DS301 could also exchange audio data with an external personal computing device using micro SD card. Every single audio file stored in micro SD card was labeled with the user's ID, recording number and indicated position. And the recorded audio data only can be replayed by IMEDIPLUS Electronic Stethoscope DS301, but cannot be replayed by personal computing device.
The IMEDIPLUS Electronic Stethoscope DS301 does not incorporate any off-theshelf (OTS) software.
The IMEDIPLUS Electronic Stethoscope DS301 operates on one 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 include adaptor and charger. ●
- Micro SD card for exchange audio data.
V. INDICATION FOR USE
The IMEDIPLUS Electronic Stethoscope DS301 is intended for the detection, amplification and recording of sounds from the heart, lung, 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.
7
| Image: IMEDI logo | 510(k) Summary | ||
|---|---|---|---|
| Product Name | Electronic Stethoscope DS301 | Page | 5 of 14 |
| Version | A4 |
COMPARISION OF TECHNOLOGY CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The IMEDIPLUS Electronic Stethoscope DS301 and 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 are based on the following same technological elements:
- Binaural headset - used to send the sounds to user's ear.
- Chest-piece used to pick up sounds from patient's internal organ. ●
- Sound amplifier - used to amplify the sounds from chest-piece.
- Battery - used to power the device.
- Digital signal processor - used for sound processing.
- Display - used to show the operation information.
- Keypad - used to control and setup the device.
- Detect and display heart rate – used to monitor patient's heart rate.
- Record and playback – used to record and playback a sound track.
- Select filter - used to better emphasize the specific patient sounds of interest.
- Adjust sound amplification level – used to control the sound level.
- Monitor Battery Life used to indicate the battery life. ●
The following differences exist between the IMEDIPLUS Electronic Stethoscope DS301 and the predicate device (3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200):
- 1D Barcode reader – used to identify the user's ID and recording number.
- Micro SD card - used for sounds track exchange.
- Organ position indication - used to indicate the auscultated organ.
- Auscultation position indication - used to indicate the auscultation position of organ.
- Intuitive keypad – used to choose the organ position between heart and lunq during auscultation.
- A/P CHEST Key – used to change the organ position between "Anterior Chest" and "Posterior Chest".
8
| Image: IMEDI logo | 510(k) Summary | ||
|---|---|---|---|
| Product Name | Electronic Stethoscope DS301 | Page | 6 of 14 |
| Version | A4 |
Table 3 summarizes the technology characteristics between the IMEDIPLUS Electronic Stethoscope DS301 and predicate device.
| Features | Candidate Device
IMEDIPLUS Electronic
Stethoscope DS301 | Predicate Device
3M™ LITTMANN®
ELECTRONIC
STETHOSCOPE
MODEL 3200 | Same/Similar
Different /New | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Regulatory | | | | |
| Regulatory No | 870.1875 | 870.1875 | Same | |
| Classification | Class II | Class II | Same | |
| Power Source | | | | |
| Source type | Battery | Battery | Same | |
| Battery type | One Rechargeable
NP-120 lithium battery | One AA battery | Difference | |
| Battery
operation time | 24 Hours | 50-60 Hours | Difference | |
| Intended use | | | | |
| Intended use | The IMEDIPLUS
Electronic Stethoscope
DS301 is intended for
the detection,
amplification and
recording of sounds
from the heart, lung,
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 | 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. | Similar
The population
is specific to
child,
adolescent
and adult. | |
| | 510(k) Summary | | Page | 7 of 14 |
| Product Name | Electronic Stethoscope DS301 | | Version | A4 |
| Features | Candidate Device
IMEDIPLUS Electronic
Stethoscope DS301 | Predicate Device
3M™ LITTMANN®
ELECTRONIC
STETHOSCOPE
MODEL 3200 | Same/Similar
Different /New | |
| | patients. It is used for
any subject
undergoing a physical
examination and
intended only for
medical diagnostic
purposes in clinic or
hospital. | It can be used on
any person
undergoing a
physical
assessment. | | |
| Functional | | | | |
| Binaural
headset | Yes | Yes | Same | |
| Chest-piece | Yes | Yes | Same | |
| Sound
processing | Digital signal
processor | Digital signal
processor | Same | |
| Display
function | Yes, | Yes, | Same | |
| Display type | 1.46" Full Color OLED | LCD | Difference
OLED has
wide view
angle, high
responsive
time, high
brightness,
low power
consumption
and full color
characteristics | |
| Select filter | Bell (20-200 Hz)
Diaphragm (100-500
Hz) | Bell (20-200 Hz)
Diaphragm (100-
500 Hz) | Same | |
| Image: IMEDI+ logo | 510(k) Summary | | | |
| Product Name | Electronic Stethoscope DS301 | Page
Version | 8 of 14
A4 | |
| Features | Candidate Device
IMEDIPLUS Electronic Stethoscope DS301 | Predicate Device
3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 | Same/Similar
Different /New | |
| | Wide (20-1000Hz) | Extend range (50-500 Hz) | Difference,
See the bench test report of audio. | |
| Detect and display heart rate function | Yes, | Yes, | Same | |
| Detect and display heart rate range | 30-180 bpm | 30-199 bpm | Difference | |
| Record and playback function | Yes | Yes | Same | |
| Number of record and playback sounds | Save up to 999 10-second sound tracks;
Latest 15 sound tracks for playback. | Save up to twelve 30-second sound tracks;
Latest 12 sound tracks for playback. | Difference | |
| Sound Amplifier | Yes,
Up to 24X | Yes,
Up to 24X | Same | |
| Volume control | Yes | Yes | Same | |
| Volume control level | 1-10 level | 1-9 level | Difference | |
| Automatic power off | Yes | Yes | Same | |
| Monitor battery life function | Yes | Yes | Same | |
| Monitor battery life degrees | 5 degrees | 4 degrees | Difference | |
| | 510(k) Summary | | | |
| Product Name | Electronic Stethoscope DS301 | | Page | 9 of 14 |
| | | | Version | A4 |
| Features | Candidate Device
IMEDIPLUS Electronic
Stethoscope DS301 | Predicate Device
3M™ LITTMANN®
ELECTRONIC
STETHOSCOPE
MODEL 3200 | Same/Similar
Different /New | |
| 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
/Instructor",
"Veterinarian". | Same | |
| Sound track
transfer
function | Yes | Yes | Same | |
| Sound track
transfer
interface | Micro SD card | Bluetooth | Different | |
| Barcode
Reader | Yes,
1D Barcode reader | No | New | |
| Organ position
indication | Yes,
To indicate the
auscultation organ | No | New | |
| Image: IMEDI logo | | 510(k) Summary | | |
| Product Name | Electronic Stethoscope DS301 | | | Page 10 of 14 |
| | | | | Version A4 |
| Features | Candidate Device
IMEDIPLUS Electronic
Stethoscope DS301 | Predicate Device
3M™ LITTMANN®
ELECTRONIC
STETHOSCOPE
MODEL 3200 | Same/Similar
Different /New | |
| Auscultation
position
indication | Yes,
To indicate the
auscultation position of
organ. | No | New | |
| Intuitive
keypad | Yes,
To choose the organ
position between heart
and lung during
auscultation. | No | New | |
| A/P CHEST
key | Yes,
To change the organ
position between
"Anterior Chest" and
"Posterior Chest". | No | New | |
Table 3. Specification comparison table
9
10
11
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| Image: IMEDI logo | 510(k) Summary | ||
|---|---|---|---|
| Product Name | Electronic Stethoscope DS301 | Page | 11 of 14 |
| Version | A4 |
VII. PERFORMANCE DATA
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility
The duration of skin contact to the patient is generally less than 5 minutes and the duration of skin contact to the doctor is generally less than 3 hours. Because the duration is short and all the materials of contact parts are used in common medical device industry for years, the biological hazards are assessed as low risk based on FDA #G95-1 and ISO10993-1. It is assessed not 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 DS301 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 and IEC 61000-4-11.
Software Verification and Validation Testing
The provided software verification and validation comply with the requirements of IEC 62304:2006, AAMI TIR45:2012 and IEC/TR80002-1:2009. The software for this device is considered as a "moderate" level of concern, 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 Integrated Service Technology, Inc. The reliability report shows the conditions of operation, storage and transportation environment for the IMEDIPLUS Electronic Stethoscope DS301. The MTBF report demonstrates the shelf life.
14
| Image: Imedi logo | 510(k) Summary | ||
|---|---|---|---|
| Product Name | Electronic Stethoscope DS301 | Page | 12 of 14 |
| Version | A4 |
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 DS301 complies with the IEC 62471: 2006 (First Edition) and EN 62471:2008 standards.
Usability Evaluation
The usability evaluation complies with the requirement of Clause 5.3.2 and 5.8 of the international medical device usability engineering standard, IEC 62366:2007 and IEC 60601-1-6.
Performance Testing-Bench
The comparison report of heart rate calculation between IMEDIPLUS Electronic Stethoscope DS301 and 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 provide a detailed analysis of the similarities and differences. The reports demonstrate that the heart rate detection function of IMEDIPLUS Electronic Stethoscope DS301 are substantially equivalent to the predicate device 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 with the conditions of heart rate in 30-180 bpm
The comparison report of audio performance between IMEDIPLUS Electronic Stethoscope DS301 and 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 provide a detailed analysis of the similarities and differences. The reports demonstrate that the audio performance of IMEDIPLUS Electronic Stethoscope DS301 are substantially equivalent to the predicate device 3MTM LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 with the conditions of audio frequency below 1 kHz.
Clinical Evaluation
The clinical evaluation is performed by 4 testers, who are clinically certified and qualified professionals. Three subject groups (3 children, 3 adolescents and 3 adults) are defined to conduct the clinical evaluation. The statistical analysis of the
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| Product Name | Electronic Stethoscope DS301 | Page | 13 of 14 |
| Version | A4 |
questionnaire show that the medical equipment (IMEDIPLUS Electronic Stethoscope DS301) can meet the basic principles of safety and effectiveness when used in Child, Adolescent and Adult for auscultation of heart, chest, bowel and neck.
List of Standards
The IMEDIPLUS Electronic Stethoscope DS301 conforms to the following standards:
- [1] ISO14971, Medical devices-application of risk management to medical devices, 2007-03-01.
- [2] AAMI ANSI IEC 62304, Medical device software -- Software life cycle processes, 2006-05-01.
- AAMI TIR45, Guidance on the use of agile practices in the development (3) of medical device software, 2012-08-20.
- [4] IEC/TR80002-1, Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software, 2009-09-01.
- [5] IEC 62366-1, Medical devices -- Part 1: Application of usability engineering to medical devices, 2015-02-01.
- AAMI ANSI ISO 10993-1, Biological evaluation of medical devices -- Part ાંઠા 1: Evaluation and testing within a risk management process, 2009-10-15.
- [7] ISO 15223-1, Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements, 2012-07-01.
- IEC 60601-1-6, Medical electrical equipment Part 1-6: General [8] requirements for basic safety and essential performance - Collateral standard: Usability, 2010-01-27.
- [9] IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests, 2007-03-30
- [10] IEC 62133. Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications, 2012-12-06.
- [11] IEC 62471, Photobiological Safety Of Lamps And Lamp Systems, 2006-07-26.
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Performance Data Summary
The IMEDIPLUS Electronic Stethoscope DS301 has similar safety and effectiveness profiles with the predicate device, 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200.
VIII. CONCLUSIONS
The information provided in this 510(k) submission shows that the IMEDIPLUS Electronic Stethoscope DS301 is substantially equivalent to the predicate device, 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200, cleared under K083903. The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the IMEDIPLUS Electronic Stethoscope DS301 device should perform as intended in the specified use conditions. The clinical evaluation data demonstrate that the IMEDIPLUS Electronic Stethoscope DS301 device performs comparably to the predicate device. The IMEDIPLUS Electronic Stethoscope DS301 is able to achieve the same safety and effectiveness as the predicate device.