(274 days)
Not Found
No
The description focuses on digital signal processing, filtering, and amplification, with no mention of AI, ML, or related concepts like pattern recognition or diagnostic algorithms beyond basic sound processing.
No
The device is described as an electronic stethoscope intended for detection and amplification of sounds for diagnostic decision support, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be operated only by healthcare professionals for diagnostic decision support in clinical settings." Additionally, it is used for "the detection of sounds associated with the heart, lungs, arteries, veins, and other internal organs," which are activities associated with medical diagnosis.
No
The device description explicitly mentions hardware components such as a microphone-equipped disposable sensor, a hub unit, and associated accessories like patient cables, earphones, and a power adapter. The performance studies also include hardware-specific tests like Electrical Safety, EMC, and various bench tests related to hardware functionality.
Based on the provided information, the AS-101 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- AS-101 Function: The AS-101 is an electronic stethoscope that detects and amplifies sounds from within the patient's body (heart, lungs, etc.). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for the "detection of sounds associated with the heart, lungs, arteries, veins, and other internal organs" and for "diagnostic decision support in clinical settings." This aligns with the function of a stethoscope, not an IVD.
Therefore, the AS-101 is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
DQD
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.
The associated accessories include:
- Disposable sensor(s)
- · Patient cable(s)
- Earphone
- Power adapter with power cord
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, lungs, arteries, veins, and other internal organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals for diagnostic decision support in clinical settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image 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
1
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
2
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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3
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.
4
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 device
AccurSound® Electronic
Stethoscope AS-101 | Predicate device K083903
3M™ Littmann® Electronic
Stethoscope Model 3200 | Identical/
Similar/
Different |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| | Product classification | | |
| Regulatory
number | 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 electronic
stethoscope intended for pickup
and amplification of sounds
associated with the heart, lungs,
arteries, veins, and other internal
organs. It can be used on any
patient undergoing physical
examinations. It is intended to be
operated by medically qualified
personnel for diagnostic purposes
in clinics or hospitals. | 3M™ LITTMANN® ELECTRONIC
STETHOSCOPE MODEL 3200 is
intended for medical diagnostic
purposes only. It may be used for the
detection and amplification of
sounds from the heart, lungs,
arteries, veins, and other internal
organs with the use of selective
frequency ranges. It can be used on
any patients undergoing a physical
assessment. | Identical |
5
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 | |||
| -contacting | |||
| materials | Sensor: polyethylene foam single | ||
| coated medical tape | Chest-piece: metal | Different | |
| Single-use | Foam sensor is single-use | Reusable chest-piece and the | |
| diaphragm can be removed for | |||
| cleaning | Different |
| Technological characteristics | |||
|---|---|---|---|
| Principle of | |||
| operation | The Accursound® Electronic | ||
| Stethoscope AS-101 pick up | |||
| sounds, such as heart, lung, and | |||
| other internal organs sound from | |||
| a patient's body. After | |||
| amplification and filtering, the | |||
| sounds are sent to the user | |||
| through a set of earpiece. | |||
| The disposable sensor patch is | |||
| designed for use with adult, | |||
| pediatric, and infant patients. | |||
| The user interface for the | |||
| stethoscope includes a 4-button | |||
| keypad and five LED indicators. | |||
| Five LED indicators include 4 | |||
| channel indicators and a power | |||
| indicator. | |||
| Sound Processing is carried out | |||
| with a microcontroller and | |||
| delivered to audio output. | |||
| Power is supplied by an external | |||
| power source through a medical- | |||
| grade AC-DC power adapter, | |||
| which has an input requirement of | |||
| 100-240V. The power indicator | |||
| turns solid green when the power | |||
| is on. | The 3M™ Littman® Electronic | ||
| Stethoscope Model 3200 picks up | |||
| sounds, such as heart and lung | |||
| sounds, from a patient's body. After | |||
| amplification and filtering, the | |||
| sounds are sent to the user through a | |||
| binaural headset. The stethoscope | |||
| chestpiece is designed for use with | |||
| adult, pediatric, and infant | |||
| patients. The user interface for the | |||
| stethoscope includes a 5-button | |||
| keypad and an LCD display. Sound | |||
| processing is carried out with the aid | |||
| of a digital signal processor. | |||
| Stethoscope power is provided by a | |||
| single AA battery in the chestpiece. A | |||
| power management system is | |||
| included to prolong battery life. | |||
| Using its Bluetooth wireless link, the | |||
| stethoscope can exchange audio data | |||
| with an external device such as a | |||
| personal computer (PC). | Similar |
6
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 |
| Sound | |||
| processing | Microcontroller as the digital | ||
| signal processor | Digital signal processor | Identical | |
| Display and | |||
| button panel | A 4-button keypad and five LED | ||
| indicators. Five LED indicators | |||
| include 4 channel indicators and a | |||
| power indicator. | LCD | ||
| 5-button keypad | Different | ||
| Bluetooth | No | Yes | Different |
| Sound | |||
| frequency | |||
| range | 20-2000 Hz | Bell mode: 20-200 Hz | |
| Diaphragm mode: 100-500 Hz | |||
| Extended range: 50-500 Hz | Similar | ||
| Volume control | Yes | Yes | Identical |
| Volume control | |||
| level | 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.
7
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.