(180 days)
The Electronic Stethoscope is intended for the detection and amplification of sounds from the heart, lungs and other internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment for medical diagnostic purposes only.
The Mintti Electronic Stethoscope, model smartho-D2 is a healthcare device that picks up sounds of the heart, lungs and other internal organs with the use of selective frequency ranges from 10-2000Hz. After amplification and filtering, the sounds are transferred to the user's ears via an wired-connected headset.
The user interface includes a 5-button keypad and an 1.3' OLED display with a blue back-light. Sound processing is carried out with the aid of a digital signal processor.
The smartho-D2 does not incorporate any off-the-shelf (OTS) software, and it incorporates embedded software which controls all the features of the product, including sound capture, digital signal processing, volume control, OLED display and Bluetooth function.
The smartho-D2 operates on a certificated rechargeable 3.7V/2000mAh lithium ion battery.
The provided document is a 510(k) summary for the "Electronic Stethoscope - smartho-D2". It outlines the device's characteristics and its comparison to a predicate device, 3M™ Littmann® Electronic Stethoscope Model 3200 (K083903), to demonstrate substantial equivalence for regulatory clearance.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" and "reported device performance" in a separate table format. However, it provides a "Specific Comparison to Predicate" table which implicitly serves this purpose by comparing the proposed device's specifications to those of the predicate. The "Comment" column in this table indicates whether the characteristic is "Same" or "Different." For differences, the justification is that they "do not affect the basic design principle, usage, effectiveness and safety of the subject device." The performance testing section further supports these claims.
Here’s a table summarizing the implicit acceptance criteria based on the predicate comparison and the performance demonstrated by the proposed device:
| Feature/Specification | Acceptance Criteria (from Predicate) | Reported Device Performance (smartho-D2) | Status (Comment in Document) |
|---|---|---|---|
| Regulatory | |||
| Classification | Stethoscope, Electronic (Class II) | Stethoscope, Electronic (Class II) | Same |
| Regulation | 21 CFR 870.1875 | 21 CFR 870.1875 | Same |
| Product Code | DQD | DQD | Same |
| Indications for Use | Detection and amplification of sounds from heart, lungs, arteries, veins, and other internal organs for medical diagnostic purposes. | Detection and amplification of sounds from heart, lungs, and other internal organs for medical diagnostic purposes. | Different (justified as not raising different questions of safety/effectiveness) |
| Contraindications | None | None | Same |
| Power Supply Type | Battery | Battery | Same |
| Battery Type | AA alkaline, lithium, or NiMH | Rechargeable 3.7V/2000mAh lithium ion | Different (justified) |
| Battery Operation Time | 50-60 Hours | 48 Hours | Different (justified) |
| Binaural Headset | YES | YES | Same |
| Chest-piece | YES | YES | Same |
| Sound Processing | Digital signal processor | Digital signal processor | Same |
| Display Screen | LCD | 1.3' Color OLED | Different (justified) |
| Low Battery Indicator | YES | YES | Same |
| Automatic Power Off | YES | No | Different (justified) |
| Volume Control | 1-9 level | 1-4 level | Different (justified) |
| Sound Amplifier | Up to 24X | Up to 100X | Different (justified) |
| Signal Sampling Rate | 4 kHz | 8 kHz | Different (justified) |
| Frequency Response | Bell (20-1000 Hz), Diaphragm (20-2000 Hz), "Extended Range" (50-500 Hz) | 20-2000Hz (Heart Sound Mode: 20-500Hz, Lung Sound Mode: 200-2000Hz) | Different (justified) |
| Intuitive Keypad | No | NO | Same |
| A/P Chest Key | No | No | Same |
| Direct Listening | Yes (through attached binaurals) | Only via headset | Different (justified) |
| Recording and Playback | Yes (stores 12 30-sec tracks on device) | Not on the device itself | Different (justified) |
| Wireless Technology | Yes (Bluetooth 2.4 GHz) | Yes (Bluetooth 2.4 GHz) | Same |
| Ambient & Frictional Noise Reduction Technology | YES | YES | Same |
The study that "proves" the device meets these criteria is the "Performance Testing For Substantial Equivalence Evaluation" section, which includes:
- Non-Clinical Data: Biocompatibility testing, Reprocessing (Cleaning and Disinfection) validation, Electrical safety and electromagnetic compatibility (EMC) testing, Bench Testing, Software Verification and Validation Testing, Risk Analysis, and Wireless Function Testing.
- Clinical Data: None submitted.
The overall conclusion is that "The Mintti smartho-D2 Electronic Stethoscope is Substantially Equivalent (SE) to the 3M™ Littmann® Electronic Stethoscope Model 3200 cleared by K083903." This implies that the differences observed do not raise new questions of safety or effectiveness and are addressed by the performance testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient data. The non-clinical testing refers to testing on the device itself and its components. For example:
- Biocompatibility tests (Cytotoxicity, Skin Sensitization, Skin Irritation) were conducted on the "smartho-D2 Electronic Stethoscope." The sample size refers to the number of devices or components tested, not human subjects.
- Electrical safety and EMC testing were conducted on "the smartho-D2 Electronic Stethoscope device, consisting of all the modules and accessories."
- Bench testing was conducted on "the smartho-D2 Electronic Stethoscope device, consisting of all the accessories."
- The document explicitly states: "No animal or clinical testing was submitted in this 510(k)." This means there was no human or animal test set for performance on biological subjects.
- Data Provenance: Not explicitly stated for specific test data, but the submitter is Hefei Mintti Medical Technology Co., Ltd. China. Given the nature of the non-clinical testing (lab-based), the "country of origin" would likely be the location where these tests were performed, presumably China. The data would be prospective with respect to the tests conducted on the device, as they were performed to support this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- As "No animal or clinical testing was submitted in this 510(k)," there was no human or animal test set requiring experts to establish ground truth in a medical diagnostic context. The ground truth for electrical safety, biocompatibility, and functional performance (e.g., frequency response, amplification) is established by adherence to recognized international standards (e.g., ISO, IEC) and internal company specifications, with the assessment of experts in those respective engineering and scientific fields (e.g., electrical engineers, biocompatibility specialists) who perform the tests and interpret the results against the standard's criteria. Their qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Since no human or animal clinical test set with medical diagnostic outcomes was conducted, there was no adjudication method involving multiple human readers/experts comparing device output to clinical ground truth. The "adjudication" for non-clinical tests would involve comparison of test results against predefined pass/fail criteria from international standards or design specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. The device (Electronic Stethoscope - smartho-D2) is a simple electronic stethoscope for sound detection and amplification. It does not appear to incorporate AI, nor does the submission mention any AI features or claims of improving human reader performance. The device's function is to assist physicians by amplifying and filtering sounds, not to provide diagnostic interpretations or AI-assisted readings.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is a hardware product (an electronic stethoscope) with embedded software for control and signal processing, not a standalone algorithm providing diagnostic output. Therefore, no standalone algorithm performance study was conducted in the sense of an AI algorithm making a diagnosis without human input. The "standalone" performance testing refers to the device's functional performance (e.g., amplification, frequency response) as a physical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical performance testing:
- Biocompatibility: Ground truth is established by the pass/fail criteria specified in ISO 10993-1.
- Reprocessing: Ground truth is established by validation results demonstrating effective cleaning and disinfection, presumably against microbial reduction criteria.
- Electrical safety and EMC: Ground truth is established by compliance with IEC 60601 series standards' requirements.
- Bench Testing (functionality): Ground truth is established by design specifications (e.g., 10-2000Hz operating range, 100X amplification) that the device must meet, measured against calibrated test equipment.
- Software V&V: Ground truth is established by functional requirements and specifications that the software must fulfill, validated through testing.
- Risk Analysis: Ground truth is adherence to ISO 14971 principles and documented mitigation of identified risks.
- Wireless Function Testing: Ground truth is demonstrated by compliance with FDA Guidance on Wireless Technology, ensuring no adverse effect on safe and effective use.
- No clinical ground truth (expert consensus, pathology, or outcomes data from human/animal subjects) was used, as no clinical studies were submitted.
8. The sample size for the training set
- The document does not mention any "training set" as no machine learning or AI models are described for this device. The device is an electronic stethoscope that amplifies and filters sounds, not an algorithm that learns from data to make predictions or classifications.
9. How the ground truth for the training set was established
- Since there is no mention of a training set or machine learning, this question is not applicable to the information provided in the document.
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December 18, 2019
Hefei Mintti Medical Technology Co., Ltd. China Shengsheng Cai, General Manager C309, National University Science Park, 602 Huangshan Road, High-tech Zone, Hefei, 230088, CHINA
Re: K191667
Trade/Device Name: Electronic Stethoscope - smartho-D2 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD Dated: November 20, 2019 Received: November 26, 2019
Dear Shengsheng Cai:
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191667
Device Name Electronic Stethoscope - smartho-D2
Indications for Use (Describe)
The Electronic Stethoscope is intended for the detection and amplification of sounds from the heart, lungs and other internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment for medical diagnostic purposes only.
| 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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510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter: | Hefei Mintti Medical Technology Co., Ltd. ChinaC309, National University Science Park, 602Huangshan Road, High-tech ZoneHefei City, Anhui Province, 230088, ChinaTel.: +86 0551-636388104 |
|---|---|
| ContactPerson: | Shengsheng Cai |
| Prepare date: | December 16, 2019 |
| 2. Device nameandclassification: | Device Name: Electronic StethoscopeModels: smartho-D2Classification Name:21 CFR 870.1875 Stethoscope, ElectronicProduct code: DQDRegulatory Class: Class II |
| 3. Reason forSubmission | New Application. |
| 4. PredicateDevice(s): | 3M Health Care, 3M™ Littmann® Electronic Stethoscope Model 3200 cleared underK083903 |
| 5. DeviceDescription: | The Mintti Electronic Stethoscope, model smartho-D2 is a healthcare device thatpicks up sounds of the heart, lungs and other internal organs with the use ofselective frequency ranges from 10-2000Hz. After amplification and filtering, thesounds are transferred to the user's ears via an wired-connected headset.The user interface includes a 5-button keypad and an 1.3' OLED display with a blueback-light. Sound processing is carried out with the aid of a digital signal processor.The smartho-D2 does not incorporate any off-the-shelf (OTS) software, and itincorporates embedded software which controls all the features of the product,including sound capture, digital signal processing, volume control, OLED displayand Bluetooth function.The smartho-D2 operates on a certificated rechargeable 3.7V/2000mAh lithium ionbattery. |
| 6. Indicationsfor Use: | The Electronic Stethoscope is intended for the detection and amplification ofsounds from the heart, lungs and other internal organs with the use of a selectivefrequency. It can be used on any person undergoing a physical assessment formedical diagnostic purposes only. |
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7. Predicate Device Comparison
In comparison to the predicate device, the subject device has the same intended use, similar product design, and performance safety as the predicate device.
Please refer to the following table that notes differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness and safety of the subject device. No new questions are raised regarding effectiveness and safety.
| ITEM | Proposed Device | Predicate Device | Comment |
|---|---|---|---|
| smartho-D2 | 3M™ LITTMANN®ELECTRONICSTETHOSCOPEMODEL 3200 | ||
| Regulatory | |||
| Classification | Stethoscope, Electronic | Stethoscope, Electronic | Same |
| Regulation | Class II, 21 CFR 870.1875 | Class II, 21 CFR 870.1875 | Same |
| Product code | DQD | DQD | Same |
| Indications for Use | |||
| Indications forUse | The Electronic Stethoscope isintended for the detection andamplification of sounds fromthe heart, lungs, and otherinternal organs with the useof a selective frequency. Itcan be used on any personundergoing a physicalassessment for medicaldiagnostic purposes only. | 3M™ LITTMANN®ELECTRONICSTETHOSCOPE MODEL3200 is intended for medicaldiagnostic purposes only. Itmay be used for the detectionand amplification of soundsfrom theheart, lungs, arteries, veins,andother internal organs with theuse of selective frequencyranges.It can be used on anyperson undergoing a physicalassessment. | Different |
| Contraindications | None | None | Same |
| Power Supply | |||
| Source Type | Battery | Battery | Same |
| Battery Type | A rechargeable3.7V/2000mAh lithium ionbattery | One AA alkaline, lithium, orNiMH battery(rechargeable). | Different |
| BatteryOperation Time | 48 Hours | 50-60 Hours | |
| Technical Specifications | |||
| Binauralheadset | YES | YES | Same |
| Chest-piece | YES | YES | Same |
| Sound | Digital signal processor | Digital signal processor | Same |
| processing | |||
| Display Screen | 1.3' Color OLED | LCD | Different |
| Low Battery Indicator | YES | YES | Same |
| Automatic Power Off | No | YES | Different |
| Volume Control | 1-4 level | 1-9 level | |
| Sound Amplifier | Amplifies up to 100X | Amplifies up to 24X | Different |
| Signal Sampling Rate | 8 kHz | 4 kHz | Different |
| Frequency Response | 20 -2000HzHeart Sound Mode:20-500HzLung Sound Mode:200-2000Hz | Bell (20-1000 Hz)Diaphragm (20-2000 Hz)"Extended Range” (50-500 Hz) | Different |
| Intuitive keypad | NO | No | Same |
| A/P Chest key | No | No | Same |
| Direct Listening | Only transferred via headset | Littmann® Model 3200 allowsdirect listening to sounds inreal time through the device'sattached binaurals. | Different |
| Recording and Playback | Not on the device itself | Yes - stores twelve (12) 30second tracks on device | Different |
| Wireless Technology | Yes-uses Bluetooth® at 2.4 GHz | Yes-uses Bluetooth® at 2.4 GHz | Same |
| Ambient & Frictional Noise Reduction Technology | YES | YES | Same |
Table 1 Specific Comparison to Predicate
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As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The differences between the subject and predicate devices do not raise different questions of safety or effectiveness. Moreover, as demonstrated in the bench testing, the different indications and technological characteristics do not affect the safety and effectiveness of the smartho-D2 Electronic Stethoscope.
8. Performance Testing:
Performance data includes "Non-Clinical Data" and "Clinical Data". Summary of the data provided is below:
Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the smartho-D2 Electronic Stethoscope was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue-contacting for a duration of less than 24 hours. And Cytotoxicity, Skin Sensitization and Skin Irritation tests were conducted.
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Reprocessing: Cleaning and Disinfection
The sterilization and shelf life information provided are acceptable because the subject devices are non-sterile devices. The validation testing results for cleaning and disinfection of the subject devices are adequate and acceptable.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the smartho-D2 Electronic Stethoscope device, consisting of all the modules and accessories in the system complies with IEC 60601-1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11: 2010 MEDICAL ELECTRICAL EQUIPMENT –Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, and the IEC 60601-1-2: 2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.
Bench Testing
Bench testing was conducted on the smartho-D2 Electronic Stethoscope device, consisting of all the accessories in the system, which demonstrates that the smartho-D2 can perform over its intended range of operation (10-2000Hz). Comparative performance testing submitted in the 510(k) demonstrated the two devices perform in a substantially equivalent manner.
Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software in Medical Devices for software with a moderate level of concern.
Risk Analvsis
A risk analysis was conducted in accordance with ISO 14971: 2007 - Medical devices -Application of risk management to medical devices.
Wireless Function Testing
The wireless coexistence test is conducted per the FDA Guidance Radio Frequency Wireless Technology in Medical Devices dated on August 14, 2013 to demonstrate no effect on the safe and effective use of the device.
Clinical data:
No animal or clinical testing was submitted in this 510(k).
9. Substantial Equivalence Conclusion:
Differences between the indications for use and technological characteristics of the subject device compared to the predicate do not raise different questions of safety and effectiveness. The performance of the device is supported by performance testing, and risk management activities. The Mintti smartho-D2 Electronic Stethoscope is Substantially Equivalent (SE) to the 3M "" Littmann® Electronic Stethoscope Model 3200 cleared by K083903.
§ 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.