(274 days)
The AS-101 is an electronic stethoscope intended for the detection of sounds associated with the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. The device is intended to be operated only by healthcare professionals for diagnostic decision support in clinical settings.
The AccurSound Electronic Stethoscope AS-101 ("AS-101") is a device designed for healthcare professionals used in clinical settings. The AS-101 can detect and amplify the sounds of the heart, lungs, arteries, veins, and other internal organs.
The microphone-equipped disposable sensor detects and amplifies the sounds from the patient's body. The auscultation sound is digitally processed and filtered, electronically amplified in the hub unit. The anti-noise function reduces ambient noise and echoes, then transferred to the earpiece.
The multi-channel design allows healthcare professionals to attach disposable sensors onto patient's body, by switching modes from handheld single-channel recording to four-channel stationery and continuously auscultation based on different requirements of clinical applications or physical assessments.
The associated accessories include:
- Disposable sensor(s)
- Patient cable(s)
- Earphone
- Power adapter with power cord
The provided text is a 510(k) Premarket Notification for the AccurSound Electronic Stethoscope AS-101. It describes the device, its intended use, and compares it to a predicate device (3M Littmann Electronic Stethoscope, Model 3200).
However, the document explicitly states that this submission "does NOT include animal or clinical performance testing" and focuses solely on non-clinical (bench) testing. This means the document does not contain information about studies involving human subjects to assess clinical performance or comparative effectiveness with human readers.
Therefore, I cannot provide information for several of your requested points, as they pertain to clinical studies, AI performance studies, or human expert consensus, which are not detailed in this 510(k) summary.
Here's what I can extract and address based on the provided text:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):
Since no clinical study data is provided, the "acceptance criteria" discussed are for the device's engineering performance and safety, rather than clinical efficacy or diagnostic accuracy.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (as stated by declaration of compliance) |
|---|---|
| Electrical Safety and EMC compliance with ANSI/AAMI ES60601-1:2005/(R)2012/A1:2012, C1:2009/(R)2012/A2:2010/(R)2012 and ANSI/AAMI/IEC 60601-1-2:2014 | "in compliance with" |
| Biocompatibility evaluation in compliance with ISO 10993-1 | "performed." (Implies compliance, as no non-compliance is noted) |
| Software verification and validation (for moderate level of concern) as recommended by FDA Guidance for Software Contained in Medical Devices | "conducted, and documentation was provided as recommended" (Implies conformity) |
| Risk management according to ISO 14971:2019 | "according to ISO 14971:2019" (Implies conformity) |
| Human factor engineering in compliance with IEC 62366-1: 2015 | "in compliance with IEC 62366-1: 2015" |
| Bench tests for: LED Indicator Behavior, Button Selector, Hardware Sound Band Pass Filter, Total Harmonic Distortion and Noise, Acoustic Frequency Response, Sample Rate, Overall Sound Amplification Ratio, Multiple Channels, I2C Communication, Audio Comparison of Foam Sensors, Data Transmission, Degrees of Protection Provided by Enclosures. | "all tests were verified to meet the required acceptance criteria." (This is a general statement from Section 9. The specific quantitative results for each test are not provided in this summary, only the declaration that they met unspecified criteria.) |
Regarding the other requested information:
- Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set. The non-clinical tests would have their own sample sizes (e.g., number of devices tested), but this is not detailed for each specific test in the summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or human expert review.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication.
- 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: Not applicable. This device is an electronic stethoscope and is not an AI-assisted diagnostic tool in the typical sense that would involve interpretative reading and MRMC studies. The document explicitly states "This submission does NOT include animal or clinical performance testing."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electronic stethoscope intended for human use, not a standalone diagnostic algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" would be established engineering specifications and recognized safety standards.
- The sample size for the training set: Not applicable. This document is for a medical device (electronic stethoscope), not an AI/machine learning algorithm that would have a "training set."
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and compliance with relevant safety and performance standards, rather than clinical performance studies or AI validation.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 23, 2023
Heroic Faith International Ltd. Yuan-Ren Cheng VP & CIO 18F., No. 460, Section 4, Xinyi Road, Xinyi District Taipei City, 110 Taiwan
Re: K221805
Trade/Device Name: AccurSound Electronic Stethoscope AS-101 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: February 16, 2023 Received: February 21, 2023
Dear Yuan-Ren Cheng:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 mediation-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,
Robert T. Kazmierski -S
for
LCDR 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221805
Device Name
AccurSound Electronic Stethoscope AS-101
Indications for Use (Describe)
The AS-101 is an electronic stethoscope intended for the detection of sounds associated with the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. The device is intended to be operated only by healthcare professionals for diagnostic decision support in clinical settings.
| 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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Image /page/3/Picture/1 description: The image shows the logo for Heroic Faith. The logo consists of the words "HEROIC" and "FAITH" stacked on top of each other, with a red cross in the middle. To the right of the words is a red hexagon with a white design inside. Below the logo is the tagline "Saving Life Through Innovation."
510(k) Summary
1. Submission Details
Heroic Faith International Ltd. 18F., No. 460, Sec. 4, Xinyi Rd., Xinyi Dist., Taipei City, 110 Taiwan (R.O.C.) Phone: +886-22659-0291 Contract: Yuan-Ren Cheng, VP & CIO
2. Date Prepared
March 22, 2023
3. Device
| Trade name: | AccurSound Electronic Stethoscope AS-101 |
|---|---|
| Common name: | Electronic Stethoscope |
| Classification name: | Electronic Stethoscope (21 CFR 870.1875) |
| Device Class: | Class II |
| Product Code: | DQD |
| Classification Panel: | Cardiovascular |
4. Predicate Device
3M Littmann Electronic Stethoscope, Model 3200 (K083903)
5. Device Description
The AccurSound Electronic Stethoscope AS-101 ("AS-101") is a device designed for healthcare professionals used in clinical settings. The AS-101 can detect and amplify the sounds of the heart, lungs, arteries, veins, and other internal organs.
The microphone-equipped disposable sensor detects and amplifies the sounds from the patient's body. The auscultation sound is digitally processed and filtered, electronically amplified in the hub unit. The anti-noise function reduces ambient noise and echoes, then transferred to the earpiece.
The multi-channel design allows healthcare professionals to attach disposable sensors onto patient's body, by switching modes from handheld single-channel recording to four-channel stationery and continuously auscultation based on different requirements of clinical applications or physical assessments.
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Image /page/4/Picture/1 description: The image shows a logo with the words "HEROIC FAITH" in black, with the "T" in "HEROIC" and the "I" in "FAITH" in red. There is also a red horizontal line above the word "FAITH". To the right of the words is a red geometric shape. Below the words is the phrase "Saving Life Through Innovation" in a smaller font.
The associated accessories include:
- Disposable sensor(s)
- · Patient cable(s)
- Earphone
- Power adapter with power cord
6. Intended Use/ Indications for Use
The AS-101 is an electronic stethoscope intended for the detection and amplification of sounds associated with the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. The device is intended to be operated only by healthcare professionals for diagnostic decision support in clinical settings.
7. Comparison of technological characteristics with the predicate device
The AS-101 is substantially equivalent to the predicate device 3M Littmann Electronic Stethoscope Model 3200 in terms of indications for use, technological characteristics, and safety and effectiveness. The comparison between the subject and predicate devices is provided in the table below.
| Candidate deviceAccurSound® ElectronicStethoscope AS-101 | Predicate device K0839033M™ Littmann® ElectronicStethoscope Model 3200 | Identical/Similar/Different | |
|---|---|---|---|
| Product classification | |||
| Regulatorynumber | 870.1875 | 870.1875 | Identical |
| Product code | DQD | DQD | Identical |
| Classification | Class II | Class II | Identical |
| Power source | |||
| Power Source | AC-to-DC supply | AA alkaline, lithium, or NiMH battery | Different |
| Intended use | |||
| Intended use | The AS-101 is an electronicstethoscope intended for pickupand amplification of soundsassociated with the heart, lungs,arteries, veins, and other internalorgans. It can be used on anypatient undergoing physicalexaminations. It is intended to beoperated by medically qualifiedpersonnel for diagnostic purposesin clinics or hospitals. | 3M™ LITTMANN® ELECTRONICSTETHOSCOPE MODEL 3200 isintended for medical diagnosticpurposes only. It may be used for thedetection and amplification ofsounds from the heart, lungs,arteries, veins, and other internalorgans with the use of selectivefrequency ranges. It can be used onany patients undergoing a physicalassessment. | Identical |
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Image /page/5/Picture/1 description: The image shows a logo with the words "HEROIC FAITH" in black, with the "T" in "HEROIC" and the "I" in "FAITH" in red. There is a red geometric shape to the right of the words. Below the words, it says "Saving Life Through Innovation" in a smaller font.
AccurSound Electronic Stethoscope AS-101
510(k) Premarket Notification
| Device characteristics | |||
|---|---|---|---|
| Sterility | Not intended to be sterilized | Not intended to be sterilized | Identical |
| Control Hub:99.0 x 71.0 x 16.6 mm | Total length:690 mm | ||
| Dimension | Patient Cable: 1450 mm | N/A | Different |
| Sensor (chest-piece) diameter:19.0 x 34.0 x 8.0 mm | Diaphragm diameter:51 mm | ||
| Patient-contactingmaterials | Sensor: polyethylene foam singlecoated medical tape | Chest-piece: metal | Different |
| Single-use | Foam sensor is single-use | Reusable chest-piece and thediaphragm can be removed forcleaning | Different |
| Technological characteristics | |||
|---|---|---|---|
| Principle ofoperation | The Accursound® ElectronicStethoscope AS-101 pick upsounds, such as heart, lung, andother internal organs sound froma patient's body. Afteramplification and filtering, thesounds are sent to the userthrough a set of earpiece.The disposable sensor patch isdesigned for use with adult,pediatric, and infant patients.The user interface for thestethoscope includes a 4-buttonkeypad and five LED indicators.Five LED indicators include 4channel indicators and a powerindicator.Sound Processing is carried outwith a microcontroller anddelivered to audio output.Power is supplied by an externalpower source through a medical-grade AC-DC power adapter,which has an input requirement of100-240V. The power indicatorturns solid green when the poweris on. | The 3M™ Littman® ElectronicStethoscope Model 3200 picks upsounds, such as heart and lungsounds, from a patient's body. Afteramplification and filtering, thesounds are sent to the user through abinaural headset. The stethoscopechestpiece is designed for use withadult, pediatric, and infantpatients. The user interface for thestethoscope includes a 5-buttonkeypad and an LCD display. Soundprocessing is carried out with the aidof a digital signal processor.Stethoscope power is provided by asingle AA battery in the chestpiece. Apower management system isincluded to prolong battery life.Using its Bluetooth wireless link, thestethoscope can exchange audio datawith an external device such as apersonal computer (PC). | Similar |
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Image /page/6/Picture/1 description: The image shows the words "HEROIC FAITH" in black font, with the "T" in "HEROIC" and the line above the "AI" in "FAITH" in red. To the right of the words is a red hexagon with three white lines inside. Below the words is the phrase "Saving Life Through Innovation" in black font.
AccurSound Electronic Stethoscope AS-101
510(k) Premarket Notification
| Functions and performance | |||
|---|---|---|---|
| Audio | headphones | Binaural headset | Different |
| Chest-piece | Foam sensors | Metallic chest-piece | Different |
| Soundprocessing | Microcontroller as the digitalsignal processor | Digital signal processor | Identical |
| Display andbutton panel | A 4-button keypad and five LEDindicators. Five LED indicatorsinclude 4 channel indicators and apower indicator. | LCD5-button keypad | Different |
| Bluetooth | No | Yes | Different |
| Soundfrequencyrange | 20-2000 Hz | Bell mode: 20-200 HzDiaphragm mode: 100-500 HzExtended range: 50-500 Hz | Similar |
| Volume control | Yes | Yes | Identical |
| Volume controllevel | 1-9 level | 1-9 levels | Identical |
8. Performance Testing
Summary discussion of clinical data:
This submission does NOT include animal or clinical performance testing.
Summary discussion of non-clinical data:
The following non-clinical tests were conducted to evaluate the safety and performance of the AS-101 and provide evidence to support the verification and validation of AS-101:
- Electrical Safety and EMC tests are in compliance with ANSI/AAMI ES60601-1:2005/(R)2012/A1:2012, C1:2009/(R)2012/A2:2010/(R)2012 and ANSI/AAMI/IEC 60601-1-2:2014
- Biocompatibility evaluation in compliance with ISO 10993-1 was performed.
- Software level of concern is moderate. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- Risk management according to ISO 14971:2019.
- Human factor engineering is in compliance with IEC 62366-1: 2015.
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Image /page/7/Picture/1 description: The image shows the logo for Heroic Faith. The logo consists of the words "HEROIC FAITH" in black font, with a red cross in the middle of the word "HEROIC" and the letter "T" in the word "FAITH". To the right of the words is a red geometric shape. Below the logo is the phrase "Saving Life Through Innovation".
510(k) Premarket Notification
- Other bench test:
- . LED Indicator Behavior Test Report
- Button Selector Test Report
- Hardware Sound Band Pass Filter Test Report
- Total Harmonic Distortion and Noise Test Report
- . Acoustic Frequency Response Test Report
- Sample Rate Test Report
- Overall Sound Amplification Ratio Test Report
- . Multiple Channels Test Report
- I2C Communication Test Report
- . Audio Comparison of the Foam Sensors Test Report
- Data Transmission Test Report
- . Test for Degrees of Protection Provided by Enclosures Test Report
9. Substantial Equivalence
The subject device has same indications for use, technology, and operation principle as well as similar technical characteristics with the predicate device. Verification activities were performed on subject device and all tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the device do not affect the intended use of the device or raise any unsolved issues. There are no significant differences between subject device and the predicate device(s). We conclude that subject device is substantially equivalent to predicate devices.
10. Conclusion
Based on the information provided in this premarket notification, Heroic Faith International Ltd. believes the proposed Accursound Electronic Stethoscope AS-101 and its predicate device, the 3M Littmann Model 3200 Electronic Stethoscope are substantially equivalent in their intended use, both devices share similar design and technology characteristics.
§ 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.