(261 days)
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.
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 IMEDIPLUS DS3011A_DM Software (DS3011A Data Management) will only operate under the user's authorization with the seething password. The IMEDIPLUS DS3011A-DM Software (IMEDIPLUS DS3011A-Datamanagement Software) installed in mobile device provides the users to connect with the IMEDIPLUS Electronic Stethoscope DS3011A, receive the recorded data of sounds, storage the data, display the phonograms, and replay the recorded audio data with the speaker of effective frequency range from 20 to 1000Hz. The IMEDIPLUS Electronic Stethoscope DS3011A could also exchange audio data with an external personal computing device by micro SD card. Every single audio file stored in the micro SD card was labeled with the user's ID, recording number and indicated position. The IMEDIPLUS Electronic Stethoscope DS3011A does not incorporate any other off-the-shelf (OTS) software. The recorded audio data only can be replayed by the IMEDIPLUS Electronic Stethoscope DS3011A, the IMEDIPLUS Electronic Stethoscope DS301, and the IMEDIPLUS DS3011A_DM Software (DS3011A_Data Management) installed in the mobile device with the speaker of effective range from 20 to 1000Hz. The IMEDIPLUS Electronic Stethoscope DS3011A operates on one (1) NP-120 lithium battery with an included power management system to prolong the battery life.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Aspect | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Assessed low risk due to short contact duration and use of common medical device materials (based on FDA #G95-1 and ISO10993-1). No laboratory tests needed. | Compliant: Risk assessed as low for biological hazards due to short patient skin contact (< 5 minutes), short doctor skin contact (< 3 hours), and materials commonly used in medical devices. No biocompatibility laboratory tests were deemed necessary. |
| Electrical Safety & EMC | Compliance with IEC 60601-1 and EN 60601-1-2, CISPR 11, IEC 60601-1-2, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11 and FCC Part 15. | Compliant: Test reports issued by SGS Taiwan Limited confirm compliance with IEC 60601-1 (safety) and a comprehensive list of EMC standards (EN 60601-1-2, CISPR 11, etc., including FCC Part 15). |
| Software V&V | Compliance with "guidance for the content of premarket submissions for medical devices software, May 11, 2005" and IEC/TR80002-1:2009. Software level of concern classified as "moderate." | Compliant: Software verification and validation comply with the specified FDA guidance and IEC/TR80002-1:2009. The software's level of concern is "moderate" (failure or flaw could indirectly cause minor injury). |
| Reliability & MTBF | Demonstrates conditions for operation, storage, and transportation, and shelf life. | Compliant: Reports from DEKRA Integrated Service Technology, Inc. show the device's reliability under various conditions and its shelf life. |
| Battery Safety | Compliance with IEC 62133:2012 and UN38.3. | Compliant: Battery test reports from SGS Taiwan Limited confirm compliance with IEC 62133:2012 (Second Edition) and UN38.3. |
| Photobiological Safety | Compliance with IEC 62471:2006 and EN 62471:2008. | Compliant: Photobiological test report from SGS Taiwan Limited confirms compliance with IEC 62471:2006 (First Edition) and EN 62471:2008. |
| Usability Evaluation | Compliance with Clause 5.3 and 5.7.3 of IEC 62366:2015 and IEC 60601-1-6. | Compliant: Usability evaluation complies with the specified clauses of IEC 62366:2015 and IEC 60601-1-6. |
| Clinical Evaluation | Medical equipment (DS3011A) can meet the basic principles of safety and effectiveness when used in Child, Adolescent, Adult and other ethnic groups for heart, chest, intestines and neck auscultation. | Compliant: A statistical analysis of a questionnaire from a clinical evaluation demonstrates the device's safety and effectiveness for its intended use across target patient populations (child, adolescent, adult) and body regions (heart, chest, intestines, neck). |
| Wireless Coexistence | Compliance with ANSI C63.27-2017. | Compliant: The wireless coexistence report shows compliance with ANSI C63.27-2017. |
| Heart Rate Detection | Substantially equivalent to predicate device 3M 3200 and DS301 for heart rates between 30-180 bpm. | Compliant: Bench testing shows the heart rate detection of DS3011A is substantially equivalent to the predicate devices (3M 3200 and DS301) for heart rates between 30-180 bpm. |
| Audio Performance | Substantially equivalent to reference device 3M 3200 for audio frequency below 1 kHz. Substantially equivalent to predicate device IMEDIPLUS Electronic Stethoscope DS301 for bell, diaphragm, and wide frequency band mode. | Compliant: Bench testing demonstrates that the audio performance of DS3011A and DS3011A_DM software are substantially equivalent to the reference device 3M 3200 for audio frequencies below 1 kHz, and substantially equivalent to the predicate device DS301 for bell, diaphragm, and wide frequency band modes. |
2. Sample Sizes used for the Test Set and Data Provenance
- Clinical Evaluation:
- Sample Size: 15 subjects (4 children, 4 adolescents, and 7 adults).
- Data Provenance: Not explicitly stated, but given the submission is from Taiwan, it is likely the data originated from Taiwan. The study is described as a "clinical evaluation," implying it was prospectively conducted.
- Bench Testing (Heart Rate Detection & Audio Performance):
- Sample Size: Not specified for the number of measurements, but the comparison involves three devices: IMEDIPLUS Electronic Stethoscope DS3011A, 3M 3200, and IMEDIPLUS Electronic Stethoscope DS301.
- Data Provenance: Retrospective comparison against established predicate and reference devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Clinical Evaluation:
- Number of Experts: 4 clinical doctors.
- Qualifications: Described as "clinically certified and qualified professionals." No further details on their specific specialties or years of experience are provided in this document.
4. Adjudication Method for the Test Set
- Clinical Evaluation: The text mentions "statistical analysis of the questionnaire" and that the medical equipment can meet the "basic principles of safety and effectiveness." It implies that the experts assessed the device's performance based on their clinical judgment of safety and effectiveness, likely through the questionnaire. It does not explicitly state a formal adjudication method like "2+1" or "3+1" for discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study as typically understood for diagnostic accuracy (e.g., comparing human readers with and without AI assistance on a case set) was not explicitly described.
- The clinical evaluation involved 4 clinicians using the device on 15 subjects, but the objective was to confirm safety and effectiveness, not to measure an improvement in human reader performance with AI assistance.
- The comparison studies were primarily bench tests against predicate/reference devices for specific technical functionalities (heart rate detection, audio performance), not human reader performance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Yes, for certain aspects. The "Bench Testing" for Heart Rate Detection and Audio Performance appears to be standalone algorithm performance, as it compares the DS3011A's objective measures against those of predicate and reference devices, without involving human interpretation or decision-making beyond operating the device for measurement.
7. The Type of Ground Truth Used
- Clinical Evaluation: The ground truth was established through the "clinical evaluation" conducted by "4 clinical doctors." This suggests a form of expert consensus/clinical judgment on the device's safety and effectiveness during actual use or simulated use. It's not explicitly tied to pathology or outcomes data from the subjects in this summary.
- Bench Testing (Heart Rate & Audio): The ground truth for these tests would be the established performance characteristics or specifications of the predicate and reference devices (3M 3200 and IMEDIPLUS DS301), and objective measurement standards for heart rate and audio frequency.
8. The Sample Size for the Training Set
- The document describes the device itself and its performance, but does not mention any AI or machine learning components that would require a "training set." The device is an electronic stethoscope that amplifies, records, and processes sounds, not an AI diagnostic tool that learns from data. Therefore, the concept of a training set is not applicable here.
9. How the Ground Truth for the Training Set was Established
- As there's no mention of AI/ML components requiring a training set, this question is not applicable to the provided information.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Shawn W. Forrest -A for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K173663
Device Name
IMEDIPLUS Electronic Stethoscope DS3011A
Type of Use (Select one or hoth, as annlicable)
Indications for Use (Describe)
The IMEDIPLUS Electronic Stethoscope DS3011A is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest-piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended diagnostic purposes in clinic or hospital.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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IMEDIPLUS INC.
Deficiency Reply Electronic Stethoscope DS3011A
Section 5
Document Title: 510(k) Summary File Name: 018_510(k)Summary
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| Image: iMEDI logo | Document Title:510(k) Summary | ||
|---|---|---|---|
| Document No.: | DS3011A-SDUS01-00501 | Page: | 2 of 20 |
| Product Name: | Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: | 018_510(k)Summary | Date: | 2018/8/17 |
510(k) Summary
The Assigned 510(k) Number: K173663/S002 Date Prepared: August 17, 2018.
l. Submitter Information:
Submitter: IMEDIPLUS INC. Address: 2F, 12, ShengYi Rd. Sec. 2, Chupei City, Hsinchu County 30261, Taiwan (R.O.C.) Phone Number: +886-3-658-7700 Fax Number: +886-3-658-9535
Contact Person: Shirley Lai E-mail: shirley.lai@imediplus.com Phone Number: +886-3-658-7700#326 Fax Number: +886-3-658-9535 Date Prepared: August 17, 2018.
II. Predicate Device
Predicate Device:
IMEDIPLUS Electronic Stethoscope DS301.
Reference Device:
3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200
| Device Name | Manufacturer | Model | 510(k)Number | |
|---|---|---|---|---|
| CandidateDevice | IMEDIPLUS ElectronicStethoscope DS3011A | IMEDIPLUS INC. | DS3011A | K173663 |
| PredicateDevice | IMEDIPLUS ElectronicStethoscope DS301 | IMEDIPLUS INC. | DS301 | K160023 |
| ReferenceDevice | 3M™ LITTMANN®ELECTRONIC STETHOSCOPEMODEL 3200 | 3M COMPANY | 3M 3200 | K083903 |
Predicate Device Identification Table 1
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| Image: IMEDI logo | Document Title:510(k) Summary |
|---|---|
| Document No.: DS3011A-SDUS01-00501 | Page: 3 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: A4 |
| 510(k) File Name: 018_510(k)Summary | Date: 2018/8/17 |
III. Device
Table 2 Common Name and Classification
| No. | Product Code | Device | Regulation Section | Classification | Panel |
|---|---|---|---|---|---|
| 1 | DQD | Stethoscope,Electronic | 870.1875 | II | Cardiovascular |
IV. Device Description
When you turn on the IMEDIPLUS Electronic Stethoscope DS3011A for the first time. the IMEDIPLUS Electronic Stethoscope DS3011A in your hand requires your setting password for the security. Your authorization to operate this handheld electronic stethoscope is necessary for the operation.
The IMEDIPLUS Electronic Stethoscope DS3011A picks up the sounds from the heart, lung, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs from a patient's body. When picking up the sounds, the phonogram of sounds could simultaneously display after pushing the button 'OK' or 'REC' for recording. When you auscultate with DS3011A, the sounds are conducted simultaneously to the user's ears bilaterally by active speaker embedded at the bottom of the IMEDIPLUS Electronic Stethoscope DS3011A. At the meantime, sound processing is operated with the aid of a digital signal processor. The IMEDIPLUS Electronic Stethoscope DS3011A could identify the recording number by 1-D barcode reader, indicate the sound location by intuitive keypad, and record the sounds from different sites.
The one-hand user interface includes a full-color OLED display, an intuitive keypad at the anterior part, a barcode reader at the posterior part, a chest-piece at the superior part, a tube connector for output of sounds at the inferior part, and a recording button at the left part.
After opening the Electronic Stethoscope DS3011A with your setting password and connection with a wireless device by Bluetooth, the IMEDIPLUS Electronic Stethoscope DS3011A could transmit digital data of recorded sounds under the operation of IMEDIPLUS DS3011A_DM Software (DS3011A Data Management) installed in the connected device. The effective range of transmission by Bluetooth will be influenced when some objects blocking between the IMEDIPLUS Electronic Stethoscope DS3011A and the connected device. (such as wall, human, big objectives as barrier) Reducing the distance or allowing the line of sight between the IMEDIPLUS Electronic Stethoscope DS3011A and the connected device will improve the connection by Bluetooth.
The IMEDIPLUS DS3011A_DM Software (DS3011A Data Management) will only operate under the user's authorization with the seething password. The IMEDIPLUS DS3011A-DM Software (IMEDIPLUS DS3011A-Datamanagement Software) installed in mobile device provides the users to connect with the IMEDIPLUS Electronic Stethoscope DS3011A, receive the recorded data of sounds, storage the data, display the phonograms, and replay the recorded
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| Image: iMEDI logo | Document Title:510(k) Summary |
|---|---|
| Document No.: DS3011A-SDUS01-00501 | Page: 4 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: A4 |
| 510(k) File Name: 018_510(k)Summary | Date: 2018/8/17 |
audio data with the speaker of effective frequency range from 20 to 1000Hz.
The IMEDIPLUS Electronic Stethoscope DS3011A could also exchange audio data with an external personal computing device by micro SD card. Every single audio file stored in the micro SD card was labeled with the user's ID, recording number and indicated position. The IMEDIPLUS Electronic Stethoscope DS3011A does not incorporate any other off-the-shelf (OTS) software. The recorded audio data only can be replayed by the IMEDIPLUS Electronic Stethoscope DS3011A, the IMEDIPLUS Electronic Stethoscope DS301, and the IMEDIPLUS DS3011A_DM Software (DS3011A_Data Management) installed in the mobile device with the speaker of effective range from 20 to 1000Hz. The IMEDIPLUS Electronic Stethoscope DS3011A operates on one (1) NP-120 lithium battery with an included power management system to prolong the battery life.
The associated accessories include:
- · Rechargeable Lithium-ion Battery.
- · Battery charger which includes adaptor and charger.
- Micro SD card for exchanging audio data.
V. Indication for Use
The IMEDIPLUS Electronic Stethoscope DS3011A is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest-piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
VI. Comparison of Technology Characteristics between the Predicate Devices (The IMEDIPLUS Electronic Stethoscope DS3011 A reference with 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 and predicate the IMEDIPLUS Electronic Stethoscope DS301) (A) Same technological elements among these 3 candidates (Table 3)
- Binaural headset send sounds to user's ears. (a)
- Chest-piece pick up sounds from patient's internal organs. (b)
- Sound amplifier amplify the sounds from chest-piece. (c)
- Battery power the device. (d)
- Digital signal processor sound processing. (e)
- Display show the operation information. (f)
- Keypad control and setup the device. (g)
- Detect and display heart rate monitor patient's heart rate. (h)
- Record record a sound track. (i)
- (i) Playback-playback a sound track.
- Filter Selection select certain mode of filter for clinical auscultation, (k) including B/ D/ W mode.
- (I) Sound amplification level adjustment - control the level of sound amplification.
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| Image: [IMEDI logo] | Document Title:510(k) Summary | |
|---|---|---|
| Document No.: DS3011A-SDUS01-00501 | Page: | 5 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: 018_510(k)Summary | Date: | 2018/8/17 |
| Table 3 Same Technological Elements among These 3 Candidates | ||||
|---|---|---|---|---|
| Items | ComparisonItems | Candidate DeviceDS3011A | Reference Device3M 3200 (K083903) | Predicate DeviceDS301 (K160023) |
| 1 | Regulatory | |||
| RegulatoryNo | 870.1875 | 870.1875 | 870.1875 | |
| Classification | Class II | Class II | Class II | |
| 2 | Power Source | |||
| BatteriesEnclosed | One NP-120 Lithiumbattery | One AA battery | One NP-120 Lithiumbattery | |
| Battery Life | 24 Hours | 50-60 Hours | 24 Hours | |
| SpecialAdaptors | Yes | No | Yes | |
| 3 | Features | |||
| Binauralheadset | Same | Same | Same | |
| Chest-pieceTechnology | Single Sided | Single Sided | Single Sided | |
| Chest-pieceWeight | 69 g | 98 g | 69 g | |
| Clinical Area | Auscultation | Auscultation | Auscultation | |
| DiaphragmDiameter | 4.1cm | 5.1cm | 4.1cm | |
| DiaphragmMaterial | Silicon | Polyurethane-CoatedSilicone | Silicon | |
| Ear-tips Type | Soft Sealing | Soft Sealing | Soft Sealing | |
| HeadsetMaterial | Brass alloy to electroplate | Wide diameteraerospace alloy /Anodized aluminum | Brass alloy toelectroplate | |
| Length | 77 cm | 69 cm | 77 cm | |
| Net Weight | 304 g | 185 g | 304 g | |
| Tube Color | Black 、Burgundy、NavyBlue | Black 、Burgundy、NavyBlue | Black 、Burgundy、NavyBlue | |
| 4 | Intended Use | |||
| Intended Use | The IMEDIPLUSElectronic StethoscopeDS3011A is intended forthe detection,amplification andrecording of sounds fromthe heart, lungs, anteriorand posterior chest,abdomen, neck, limbs,arteries, veins and otherinternal organs withselective frequencyranges. And thestethoscope chest-pieceis designed for use withchild, adolescent andadult patients. It is usedfor any subjectundergoing a physical | The 3M™ Littmann®Electronic StethoscopeModel 3200 is intendedfor medical diagnosticpurposes only. It may beused for the detectionand amplification ofsounds from the heart,lungs, arteries, veins,and other internalorgans with the use ofselective frequencyranges. It can be usedon any personundergoing a physicalassessment. | The IMEDIPLUSElectronic StethoscopeDS301 is intended forthe detection,amplification andrecording of soundsfrom the heart, lung,anterior/posteriorchest, abdomen, neck,limbs, arteries, veinsand other internalorgans with use ofselective frequencyranges. And thestethoscope chest-piece is designed foruse with child,adolescent and adultpatients. It is usedfor any subject |
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| Image: iMEDI logo | Document Title:510(k) Summary | ||
|---|---|---|---|
| Document No.: | DS3011A-SDUS01-00501 | Page: | 6 of 20 |
| Product Name: | Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: | 018_510(k)Summary | Date: | 2018/8/17 |
| only for medicaldiagnostic purposes inclinic or hospital. | undergoing a physicalexamination andintended only formedical diagnosticpurposes in clinic orhospital. | |||
|---|---|---|---|---|
| 5 | FunctionalScreen | OLED 1.46" Full Color | LCD Monochrome | OLED 1.46" Full Color |
| BarcodeReader | Yes | No | Yes | |
| Three FilterModes | Yes | Yes | Yes | |
| FrequencyRange ofFilter Mode | Bell (20-200 Hz),Diaphragm (100-500 Hz)and Wide (20-1000Hz) | Bell (20-200 Hz),Diaphragm (100-500Hz) and Extend range(20-2000 Hz) | Bell (20-200 Hz),Diaphragm (100-500Hz) and Wide (20-1000Hz) | |
| HumanMachineInterface | One-hand user interfacefor patient's ID scanning,auscultation positionselection, recording, andfunction selection. | Yes | One-hand userinterface for patient'sID scanning,auscultation positionselection, recording,and function selection. | |
| RecordingNumber ofthe soundtrack | Yes | No | Yes | |
| Recordingthe Organand Positionof theSound Track | Yes | No | Yes | |
| Dip | Software Comparison | |||
| Heart RateDetection | Yes | Yes | Yes | |
| Heart RateDisplay | Yes | Yes | Yes | |
| Recordingthe SoundTrack | Yes | Yes | Yes | |
| Playback theSound Track | Yes | Yes | Yes | |
| VolumeControl | Yes | Yes | Yes | |
| VolumeControl Scale | Yes1-10 level | Yes0-9 | Yes | |
| Amplification | Yes,24 times | Yes,24 times | Yes,24 times | |
| Filter modeselection | Yes,Bell, Diaphragm, andWide modes | Yes,Bell, Diaphragm andExtend Modes | Yes,Bell, Diaphragm, andWide modes | |
| Automaticturn-off | Yes | Yes | Yes | |
| Monitor thebattery level | Yes | Yes | Yes | |
| PasswordSetting | Yes,The user needs to enter | No | No |
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| Image: Imedi logo | Document Title:510(k) Summary | |
|---|---|---|
| Document No.: DS3011A-SDUS01-00501 | Page: | 7 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: 018_510(k)Summary | Date: | 2018/8/17 |
| Display thePhonogram | the password for theoperation of the device | No | No | |
|---|---|---|---|---|
| Software oftheConnectedDevice | Yes,IMEDIPLUS DS3011A-DM software (DS3011ADataManagementsoftware)(1) Receive and storethe data of soundtracks(2) Display thephonogram of thesound tracks(3) Reply the audio datain the connecteddevice installed withIMEDIPLUSDS3011A-DMsoftware but thissoftware could notoperate theIMEDIPLUSElectronicStethoscopeDS3011A to replaythe sound track fromthe connected device. | Yes,3MTM Littmann®Zargis StethAssistTMHeart and Lung SoundVisualization Software | No | |
| 7 | Function of Data Transfer and the Interface | |||
| DataTransfer ofthe RecordedSoundTracks | Yes,Micro SD card andBluetooth(1) Micro SD card,(Permits the dataexchange from theelectronic stethoscope tothe personal computer)(2) Bluetooth, (transmitsthe audio data fromthe stethoscope to theconnected device) | YesBluetoothPermits the dataexchange from theelectronic stethoscopeto the personalcomputer | YesMicro SD cardPermits the dataexchange from theelectronic stethoscopeto the personalcomputer | |
| Capable ofStoring Dataand Latestsound tracksfor playback | Save up to 600 10-secondsound tracks;Latest 50 sound tracks forplayback. | Save up to twelve 30-second sound tracks;Latest 12 sound tracksfor playback. | Save up to 999 10-second sound tracks;Latest 15 sound tracksfor playback. | |
| 8 | Service and Occupation |
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| Image: iMEDI logo | Document Title: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 |
| WarrantyPeriod | 2 Years | 2 Years | 2 Years |
|---|---|---|---|
| Occupation | Anesthesiologist,Cardiologist, EmergencyPhysician, EMT/EMS,Family Practitioner,Internist,Medical Assistant,Medical Student,Nurse,Nursing Student,Pediatrician, Physician,Respiratory Specialist,Teacher/Professor/Instructor, and Veterinarian. | Anesthesiologist,Cardiologist, EmergencyPhysician, EMT/EMS",Family Practitioner,Internist,Medical Assistant,Medical Student,Nurse,Nursing Student,Pediatrician, Physician,Respiratory Specialist,Teacher/Professor/Instructor, and Veterinarian. | Anesthesiologist,Cardiologist,Emergency Physician,EMT/EMS,Family Practitioner,Internist,Medical Assistant,Medical Student,Nurse,Nursing Student,Pediatrician,Physician,Respiratory Specialist,Teacher/Professor/Instructor, andVeterinarian. |
| TeachingAccessoriesIncluded | User manual | CD-ROMUser manual | User manual |
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| Image: IMEDI logo | Document Title:510(k) Summary | ||
|---|---|---|---|
| Document No.: | DS3011A-SDUS01-00501 | Page: | 9 of 20 |
| Product Name: | Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: | 018_510(k)Summary | Date: | 2018/8/17 |
(B) Comparison between the Electronic Stethoscope DS3011A and the reference device, the 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200
(a) The differences between these two devices: (Table 4)
- (1) 1D Barcode reader identify the user's ID and recording number.
- Micro SD card storage and exchange for sound tracks. (2)
- (3) Organ position indication - indicate the auscultated organ.
- (4) Auscultation position indication used to indicate the auscultation position of organ.
- (5) Intuitive keypad - select the organ position between heart and lung during auscultation.
- (6) A/P CHEST Key switch the organ position between "Anterior Chest" and "Posterior Chest".
- Password the user needs to enter the password to access (7) device.
- Phonogram display for real time monitoring sound wave. (8)
(b) The same elements between these two devices: (Table 4)
- Both of these connect with Bluetooth. (1)
- (2) Binaural headset - send sounds to user's ears.
- Chest-piece pick up sounds from patient's internal organs. (3)
- (4) Sound amplifier - amplify the sounds from chest-piece.
- (5) Battery - power the device.
- Digital signal processor sound processing. (6)
- Display show the operation information. (7)
- (8) Keypad - control and setup the device.
- Detect and display heart rate monitor patient's heart rate. (ਰ)
- (10) Record and playback - record and playback a sound track.
- (11) Select filter - select certain mode of filter for clinical auscultation, including B/ D/ W mode.
- Sound amplification level adjustment control the level of sound (12) amplification.
- (13) Monitor battery level - indicate the battery level.
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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 JZVVCandidateDeviceDS3011A | ReferenceDevice3M 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.
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| 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.
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| 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 DeviceDS3011A | Predicate DeviceDS301 | Same/Different |
|---|---|---|---|
| Wireless connection | Yes | No | Different |
| Connected device software | YesDS3011A DM software(DS3011A Data Managementsoftware)1.Receive the data of sounds2.Data storage3.Display the phonogram4.Replay the recorded datawith the spectrum of selectedfrequency mode5. The audio data could bedisplayed with the connecteddevice but not on the DS3011Ascreen. | No | Different |
| Password | Yes | No | Different |
| Phonogram display on thescreen | Yes | No | Different |
| 1D Barcode reader | Yes | Yes | Same |
| Micro SD card | Yes | Yes | Same |
| Organ position indication | Yes | Yes | Same |
| Auscultation position indication | Yes | Yes | Same |
| Intuitive keypad | Yes | Yes | Same |
| A/P CHEST Key | Yes | Yes | Same |
| Binaural headset | Yes | Yes | Same |
| Chest-piece | Yes | Yes | Same |
| Sound amplification | Yes | Yes | Same |
| Battery | Yes | Yes | Same |
| Digital signal processor | Yes | Yes | Same |
| Display | Yes | Yes | Same |
| Keypad | Yes | Yes | Same |
| Detect and display heart rate | Yes | Yes | Same |
| Record | Yes | Yes | Same |
| Playback | Yes | Yes | Same |
| Filter selection | Yes | Yes | Same |
| Sound amplification leveladjustment | Yes | Yes | Same |
| Monitor battery level | Yes | Yes | Same |
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| Image: Imedi Logo | Document Title:510(k) Summary | ||
|---|---|---|---|
| Document No.: DS3011A-SDUS01-00501 | Page: | 13 of 20 | |
| Product Name: Electronic Stethoscope DS3011A | Ver.: | A4 | |
| 510(k) File Name: 018_510(k)Summary | Date: | 2018/8/17 |
Table 6 summarizes the technological characteristics among DS3011A, 3M 3200 and DS301.
Table 6 Summarized Technological Characteristics
| Features | Candidate DeviceDS3011A | Reference Device3M 3200 | Predicate DeviceDS301 | Same/SimilarDifferent /New |
|---|---|---|---|---|
| Regulatory | ||||
| Regulatory No | 870.1875 | 870.1875 | 870.1875 | Same |
| Classification | Class II | Class II | Class II | Same |
| Power Source | ||||
| Source type | Battery | Battery | Battery | Same |
| Battery type | One RechargeableNP-120 lithiumbattery | One AA battery | One RechargeableNP-120 lithiumbattery | Same withDS301; differentfrom 3M 3200. |
| Battery operation time | 24 Hours | 50-60 Hours | 24 Hours | Same withDS301; differentfrom 3M 3200. |
| Intended use | ||||
| Intended use | The IMEDIPLUSElectronicStethoscopeDS3011A isintended for thedetection,amplification andrecording of soundsfrom the heart,lungs, anterior andposterior chest,abdomen, neck,limbs, arteries,veins and otherinternal organs withselective frequencyranges. And thestethoscope chest-piece is designedfor use with child,adolescent andadult patients. It isused for anysubject undergoinga physicalexamination andintended only formedical diagnosticpurposes in clinic orhospital. | 3M™ LITTMANN®ELECTRONICSTETHOSCOPEMODEL 3200 is formedical diagnosticpurposes only. Itmay be used todetect and amplifysounds from theheart, lungs,arteries, veins, andother internal organswith the use ofselected frequencyranges. It can beused on any personundergoing aphysicalexamination. | The IMEDIPLUSElectronicStethoscopeDS301 is intendedfor the detection,amplification andrecording of soundsfrom the heart,lung,anterior/posteriorchest, abdomen,neck, limbs,arteries, veins andother internalorgans with use ofselective frequencyranges. And thestethoscope chest-piece is designedfor use with child,adolescent andadult patients. It isusedfor any subjectundergoing aphysicalexamination andintended only formedical diagnosticpurposes in clinic orhospital. | Same withDS301; similar to3M 3200.The population isspecific tochildren,adolescents andadults. |
| Functional | ||||
| Binauralheadset | Yes | Yes | Yes | Same |
| Chest-piece | Yes | Yes | Yes | Same |
| Soundprocessing | Digital signalprocessor | Digital signalprocessor | Digital signalprocessor | Same |
| Display | Yes | Yes | Yes | Same |
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| Image: [IMEDI logo] Document Title: | 510(k) Summary |
|---|---|
| Document No.: DS3011A-SDUS01-00501 | Page: 14 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: A4 |
| 510(k) File Name: 018_510(k)Summary | Date: 2018/8/17 |
| Display type | 1.46" Full Color OLED | LCD | 1.46" Full Color OLED | Same with DS301; different from 3M 3200.OLED is provided with the characteristics of wide view angle, high response time, high brightness, low power consumption and full color. |
|---|---|---|---|---|
| Filter selection | Bell (20-200 Hz) Diaphragm (100-500 Hz) | Bell (20-200 Hz) Diaphragm (100-500 Hz) | Bell (20-200 Hz) Diaphragm (100-500 Hz) | Same |
| Wide (20-1000Hz) | Extend range (50-500 Hz) | Wide (20-1000Hz) | Same with DS301; different from 3M 3200.See the bench test report of audio. | |
| Detect and display heart rate function | Yes | Yes | Yes | Same |
| Detect and display heart rate range | 30-180 bpm | 30-199 bpm | 30-180 bpm | Same with DS301; different from 3M 3200. |
| Record function | Yes | Yes | Yes | Same |
| Playback function | Yes | Yes | Yes | Same |
| Amount of record and playback sound tracks | Save up to 600 10-second sound tracks;Latest 50 sound tracks for playback. | Save up to twelve 30-second sound tracks;Latest 12 sound tracks for playback. | Save up to 999 10-second sound tracks;Latest 15 sound tracks for playback. | Different. |
| Sound Amplification | Yes, Up to 24X | Yes, Up to 24X | Yes, Up to 24X | Same |
| Volume control | Yes | Yes | Yes | Same |
| Volume control level | 1-10 level | 1-9 level | 1-10 level | Same with DS301; different from 3M 3200. |
| Automatic power off | Yes | Yes | Yes | Same |
| Monitor battery | Yes | Yes | Yes | Same |
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| Image: iMEDI logo | Document Title:510(k) Summary | ||
|---|---|---|---|
| Document No.: | DS3011A-SDUS01-00501 | Page: | 15 of 20 |
| Product Name: | Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: | 018_510(k)Summary | Date: | 2018/8/17 |
| level function | ||||
|---|---|---|---|---|
| Monitor batterylevel degrees | 5 degrees | 4 degrees | 5 degrees | Same withDS301; differentfrom 3M 3200. |
| Occupation | Anesthesiologist,Cardiologist,EmergencyPhysician,EMT/EMS,Family Practitioner,Internist,Medical Assistant,Medical Student,Nurse,Nursing Student,Pediatrician,Physician,RespiratorySpecialist,Teacher/Professor/Instructor,Veterinarian. | Anesthesiologist,Cardiologist,EmergencyPhysician,EMT/EMS,Family Practitioner,Internist,Medical Assistant,Medical Student,Nurse,Nursing Student,Pediatrician,Physician,RespiratorySpecialist,Teacher/Professor/Instructor,Veterinarian. | Anesthesiologist,Cardiologist,EmergencyPhysician,EMT/EMS,Family Practitioner,Internist,Medical Assistant,Medical Student,Nurse,Nursing Student,Pediatrician,Physician,RespiratorySpecialist,Teacher/Professor/Instructor,Veterinarian. | Same |
| Sound tracktransferfunction | Yes | Yes | Yes | Same |
| Sound tracktransferinterface | Micro SD cardBluetooth | Bluetooth | Micro SD card | (1) Micro SDcard: same asDS301(2) Bluetooth:same as3M3200 |
| BarcodeReader | Yes,1D Barcode reader | No | Yes,1D Barcode reader | Same withDS301; new for3M 3200 |
| Organ positionindication | Yes,To indicate theorgan to auscultate. | No | Yes,To indicate theorgan to auscultate. | Same withDS301; new for3M 3200 |
| Auscultationpositionindication | Yes,To indicate theauscultationposition of organ. | No | Yes,To indicate theauscultationposition of organ. | Same withDS301; new for3M 3200 |
| Intuitivekeypad | Yes,To choose theorgan positionbetween heart andlung duringauscultation. | No | Yes,To choose theorgan positionbetween heart andlung duringauscultation. | Same withDS301; new for3M 3200 |
| A/P CHESTkey | Yes,To switch the organposition between"Anterior Chest"and "PosteriorChest". | No | Yes,To switch the organposition between"Anterior Chest"and "PosteriorChest". | Same withDS301; new for3M 3200 |
| Password | Yes,The user needs toenter the password | No | No | New |
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| Image: IMEDI logo | Document Title:510(k) Summary |
|---|---|
| Document No.: DS3011A-SDUS01-00501 | Page: 16 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: A4 |
| 510(k) File Name: 018_510(k)Summary | Date: 2018/8/17 |
| to access device | ||||
|---|---|---|---|---|
| Phonogramdisplay on thescreen | Yes,To real timemonitoring soundwave. | No | No | New |
| Connecteddevicesoftware | Yes,DS3011A_DMsoftware (DS3011AData Managementsoftware) receivesounds data fromIMEDIPLUSElectronicStethoscopeDS3011A.1.Receive the dataof sounds2.Data storage3.Display thephonogram4.Replay therecorded data withthe spectrum ofselected frequencymode | Yes,3M™ Littmann®StethAssist™ Heartand Lung SoundVisualizationSoftware1.Receive the dataof sounds2.Data storage3.Display thephonogram4.Replay therecorded data withthe spectrum ofselected frequencymode | No | New for DS301;similar to 3M3200. |
VII. Performance Data
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility
Generally, the duration of contact to the patient's skin is less than 5 minutes and less than 3-hour contact to the doctor's skin. Due to the short contact, and all the materials of contacting parts have been used in common medical device industry for years, the risk of biological hazards are assessed low based on FDA #G95-1 and ISO10993-1. It is assessed no need to perform the biocompatibility laboratory tests.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and electromagnetic compatibility reports are tested and issued by SGS Taiwan Limited. According to the test reports, the IMEDIPLUS Electronic Stethoscope DS3011A complies with the safety standard of IEC 60601-1 and the EMC stands of EN 60601-1-2, CISPR 11, IEC 60601-1-2, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11 and FCC Part 15.
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| Image: Imedi logo | Document Title:510(k) Summary | ||
|---|---|---|---|
| Document No.: | DS3011A-SDUS01-00501 | Page: | 17 of 20 |
| Product Name: | Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: | 018_510(k)Summary | Date: | 2018/8/17 |
Software Verification and Validation Testing
The provided software verification and validation comply with the requirements of "quidance for the content of premarket submissions for medical devices software, May 11, 2005" and IEC/TR80002-1:2009. The level of concern of the software for this device is considered as a "moderate", since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Reliability and MTBF Testing
Reliability and mean time between failure (MTBF) reports are tested and issued by DEKRA Intearated Service Technology, Inc. The reliability report shows the conditions of operation, storage and transportation environment for the IMEDIPLUS Electronic Stethoscope DS3011A. The MTBF report demonstrates the shelf life.
Battery and Photobiological Safety Testing
Battery and photobiological safety reports are tested and issued by SGS Taiwan Limited. According to the battery test reports, the battery complies with the IEC 62133:2012(Second Edition) and UN38.3 (Section 38.3 Lithium metal and lithium ion batteries in UN ST/SG/AC.10/11/Rev.5/Amend.1 Recommendation on the TRANSPORT OF DANGEROUS GOODS Manual of tests and Criteria Fifth revised edition) standards. The photobiological test report shows the IMEDIPLUS Electronic Stethoscope DS3011A complies with the IEC 62471: 2006 (First Edition) and EN 62471:2008 standards.
Usability Evaluation
The usability evaluation complies with the requirement of Clause 5.3 and 5.7.3 of the international medical device usability engineering standard, IEC 62366:2015, and IEC 60601-1-6.
Clinical Evaluation
The clinical evaluation is performed by 4 clinical doctors, who are clinically certified and qualified professionals, and three subject groups (4 children, 4 adolescents and 7 adults) are specified to conduct the clinical evaluation. The statistical analysis of the questionnaire shows that the medical equipment (IMEDIPLUS Electronic Stethoscope DS3011A) can meet the basic principles of safety and effectiveness when used in Child, Adolescent, Adult and other ethnic groups for heart, chest, intestines and neck auscultation.
Wireless Coexistence
The wireless coexistence report complies with the requirement of ANSI C63.27-2017 -American National Standard for Evaluation of Wireless Coexistence.
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| Image: iMEDI logo | Document Title:510(k) Summary | |
|---|---|---|
| Document No.: DS3011A-SDUS01-00501 | Page: | 18 of 20 |
| Product Name: Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: 018_510(k)Summary | Date: | 2018/8/17 |
Performance Testing-Bench
The bench testing report of heart rate detection function among IMEDIPLUS Electronic Stethoscope DS3011A. 3M 3200 and IMEDIPLUS Electronic Stethoscope DS301 provides a detailed analysis of the similarities and differences. The report demonstrates that the heart rate detection of IMEDIPLUS Electronic Stethoscope DS3011A is substantially equivalent to the predicate device 3M 3200 and DS301 with the condition of heart rate between 30-180 bpm.
The bench testing report of audio performance among DS3011A, DS3011A_DM software (DS3011A Data Management), 3M 3200 and DS301 provides a detailed analysis of the similarities and differences. The report demonstrates that the audio performance of IMEDIPLUS Electronic Stethoscope DS3011A and DS3011A_DM software (DS3011A Data Management) are substantially equivalent to the reference device 3M 3200 while audio frequency operates below 1 kHz. In addition, the IMEDIPLUS Electronic Stethoscope DS3011A and DS3011A DM software (DS3011A Data Management) are substantially equivalent to the predicate device IMEDIPLUS Electronic Stethoscope DS301 for bell, diaphragm and wide frequency band mode.
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| Image: iMEDI logo | Document Title:510(k) Summary |
|---|---|
| Document No.: | DS3011A-SDUS01-00501Page: 19 of 20 |
| Product Name: | Electronic Stethoscope DS3011AVer.: A4 |
| 510(k) File Name: | 018_510(k)SummaryDate: 2018/8/17 |
List of Standards
The IMEDIPLUS Electronic Stethoscope DS3011A conforms to the following standards:
- [1] ISO14971, Medical devices-application of risk management to medical devices, 2007-03-01.
- IEC 62304, Medical Device Software Software Life Cycle Processes, [2] 2015-06.
- ાંડા AAMI TIR45, Guidance on the use of agile practices in the development of medical device software, 2012-08-20.
- IEC/TR80002-1, Medical device software -- Part 1: Guidance on the (4 application of ISO 14971 to medical device software, 2009-09-01.
- AAMI ANSI IEC 62366-1, Medical Devices Part 1: Application Of [5] Usability Engineering To Medical Devices, 2015-02.
- [6] AAMI ANSI ISO 10993-1. Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, 2009-10-15.
- ISO 15223-1, Medical Devices Symbols To Be Used With Medical [7] Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements, 2016-11-01.
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General 181 Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests, 2007-03-30
- IEC 62133, Secondary cells and batteries containing alkaline or other non-വ acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications, 2012-12-06.
- [10] IEC 62471, Photobiological Safety Of Lamps And Lamp Systems, 2006-07-26.
- [11] ANSI C63.27-2017 -American National Standard for Evaluation of Wireless Coexistence. 2017-11-05.
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| Image: iMEDI logo | Document Title: | 510(k) Summary | |
|---|---|---|---|
| Document No.: | DS3011A-SDUS01-00501 | Page: | 20 of 20 |
| Product Name: | Electronic Stethoscope DS3011A | Ver.: | A4 |
| 510(k) File Name: | 018_510(k)Summary | Date: | 2018/8/17 |
Performance Data Summary
The IMEDIPLUS Electronic Stethoscope DS3011A has similar safety and effectiveness profiles to that of the predicate devices, reference 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 and predicate IMEDIPLUS Electronic Stethoscope DS301.
VIII. Conclusions
The information provided in this Abbreviated 510(k) submission shows that the IMEDIPLUS Electronic Stethoscope DS3011A is substantially equivalent to the predicate IMEDIPLUS Electronic Stethoscope DS301, cleared under K160023.
§ 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.