(60 days)
No
The description focuses on digital signal processing, filtering, amplification, and noise reduction, which are standard audio processing techniques, not necessarily AI/ML. There is no mention of AI, ML, or related concepts like training or test sets.
No
The device is described as an electronic stethoscope intended for the detection and amplification of sounds for diagnostic decision support, not for treatment or therapy.
Yes
The device is described as providing "diagnostic decision support" and is intended for use by healthcare professionals for the "detection and amplification of sounds associated with the heart, lungs, arteries, veins, and other internal organs," which are activities related to diagnosis.
No
The device description explicitly mentions hardware components like a microphone-equipped sensor, a hub unit, and an earpiece, and the performance studies include electrical safety, EMC, and biocompatibility testing, which are relevant to hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The AS-101 is an electronic stethoscope that detects and amplifies sounds directly from the patient's body (heart, lungs, etc.). It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use describes direct patient interaction. The device is used for physical assessment and diagnostic decision support by listening to internal body sounds. This is a direct interaction with the patient, not an in vitro analysis of a specimen.
Therefore, the AS-101 falls under the category of a medical device used for physical examination and auscultation, not an IVD.
N/A
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.
Product codes
DQD
Device Description
This submission is for device "The AccurSound Electronic Stethoscope AS-101 ("AS-101")". This submission expands upon a previously 510(k)-cleared device(K221805) by introducing two new reusable sensors, whereas the original device only included disposable sensors..
The AccurSound Electronic Stethoscope AS-101 ("AS-101") in this submission 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 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 or reusable 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.
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
Any person
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.
Non-clinical tests were conducted to evaluate the safety and performance of the modified 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: Performance Test, Cleaning Robustness Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AccurSound Electronic Stethoscope AS-101 (K221805)
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
November 25, 2024
Image /page/0/Picture/1 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.
Heroic Faith International Ltd. % Tyra Chiu Regulatory Consultant Intellrac. ltd 1F., No. 4, Aly. 10, Ln. 467, Sec. 2, Zhonghua Rd. Zhongzheng Dist. Taipei, 100 Taiwan
Re: K242971
Trade/Device Name: AccurSound Electronic Stethoscope (AS101) Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: August 20, 2024 Received: September 26, 2024
Dear Tyra Chiu:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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
3
Indications for Use
Submission Number (if known)
Device Name
AccurSound Electronic Stethoscope (AS101)
Indications for Use (Describe)
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 underqoing 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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4
Image /page/4/Picture/0 description: The image shows a logo with the words "HEROIC FAITH" in black, with the "I" in "HEROIC" and the horizontal line in "FAITH" in red. To the right of the words is a red geometric shape. Below the words, in smaller black font, is the phrase "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
August 26, 2024
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
AccurSound Electronic Stethoscope AS-101 (K221805)
5. Device Description
This submission is for device "The AccurSound Electronic Stethoscope AS-101 ("AS-101")". This submission expands upon a previously 510(k)-cleared device(K221805) by introducing two new reusable sensors, whereas the original device only included disposable sensors..
The AccurSound Electronic Stethoscope AS-101 ("AS-101") in this submission 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 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 or reusable 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.
5
Image /page/5/Picture/0 description: The image shows a logo for "HEROIC FAITH". The words are stacked on top of each other, with the "T" in "HEROIC" and "FAITH" being a red cross. To the right of the words is a red hexagon made up of three arrows pointing towards the center. Below the words is the tagline "Saving Life Through Innovation".
The associated accessories include:
- Disposable sensor(s)
- Reusable sensors(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 modified AS-101 is substantially equivalent to previously 510(k)-cleared device AccurSound Electronic Stethoscope AS-101 (K221805) 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 K221805
AccurSound Electronic Stethoscope
AS-101 (K221805) | 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 | AC-to-DC supply | Identical |
| | 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 | 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. | Identical |
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Image /page/6/Picture/0 description: The image shows a logo with the words "HEROIC FAITH" stacked on top of each other. The "T" in faith is stylized as a red cross. To the right of the words is a red geometric shape. Below the logo is the phrase "Saving Life Through Innovation."
AccurSound Electronic Stethoscope AS-101
510(k) Premarket Notification
| in clinics or hospitals. | |||
|---|---|---|---|
| Device characteristics | |||
| Sterility | Not intended to be sterilized | Not intended to be sterilized | Identical |
| Dimension | Control Hub: | ||
| 99.0 x 71.0 x 16.6 mm | Control Hub: | ||
| 99.0 x 71.0 x 16.6 mm | Identical | ||
| Patient Cable: 1450 mm | Patient Cable: 1450 mm | ||
| Foam Sensor (chest-piece) | |||
| diameter:-19.0 x 34.0 x 8.0 mm | Foam Sensor (chest-piece) diameter: | ||
| 19.0 x 34.0 x 8.0 mm | |||
| Durable Sensor: 190×38×12 mm | |||
| Sturdy sensor: 190×38×12 mm | Different. | ||
| Introduce two | |||
| reusable sensors | |||
| Patient | |||
| -contacting | |||
| materials | Foam Sensor: polyethylene foam | ||
| single coated medical tape | |||
| Durable Sensor: Aluminum | |||
| Sturdy Sensor: stainless | Foam Sensor: polyethylene foam | ||
| single coated medical tape | Different. | ||
| Introduce two | |||
| reusable sensors |
| 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 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 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 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. | Identical |
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Image /page/7/Picture/0 description: The image shows the logo for Heroic Faith. The words "HEROIC FAITH" are stacked on top of each other, with the "T" in both words stylized as a red cross. To the right of the words is a red geometric shape. Below the logo is the tagline "Saving Life Through Innovation".
AccurSound Electronic Stethoscope AS-101
510(k) Premarket Notification
| Functions and performance | ||
|---|---|---|
| Audio | headphones | Identical |
| Chest-piece | Single use Foam sensors | |
| Reusable sensors | Different | |
| Introduce two | ||
| reusable sensors | ||
| Sound processing | Microcontroller as the 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. | Identical |
| Bluetooth | No | Identical |
| Sound frequency range | 20-2000 Hz | Identical |
| Volume control | Yes | Identical |
| Volume control level | 1-9 level | 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 modified 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.
8
Image /page/8/Picture/0 description: The image shows the logo for Heroic Faith. The words "HEROIC FAITH" are stacked on top of each other, with the "T" in both words stylized in red. Below the words is the phrase "Saving Life Through Innovation".
- Human factor engineering is in compliance with IEC 62366-1: 2015. ●
9
Image /page/9/Picture/0 description: The image shows the logo for Heroic Faith. The words "HEROIC FAITH" are stacked on top of each other, with the "T" in both words being red and forming a cross shape. To the right of the words is a red hexagon made up of three arrow shapes. Below the logo is the tagline "Saving Life Through Innovation".
- Other bench test:
- Performance Test
- Cleaning Robustness Test ●
9. Substantial Equivalence
The subject device is a modified device based on previous cleared device(K221805). The subject device has same indications for use, technology, operation principle and 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.
Conclusion 10.
Based on the information provided in this premarket notification, Heroic Faith International Ltd. believes the proposed modified AccurSound Electronic Stethoscope AS-101 and its predicate device, AccurSound Electronic Stethoscope AS-101 (K221805) are substantially equivalent in their intended use, both devices share same design and technology characteristics.