The BM-520 Electronic Stethoscope is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from heart, lungs, blood vessels, and other internal organs. It can be used on any person undergoing a physical assessment.

Device Description

The Sharp Electronic Stethoscope Model BM-520 is an electronic stethoscope to auscultate sounds from heart, lung, blood vessels, and other internal organs. It can be used on adults undergoing a physical assessment. The sounds can also be transmitted to an appropriately configured receiving device via Bluetooth® wireless communication.

AI/ML Overview

The provided text describes the Sharp Electronic Stethoscope Model BM-520. However, it does not contain details about specific acceptance criteria or an analytical study that proves the device meets such criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy for detecting specific conditions).

Instead, the submission document focuses on establishing substantial equivalence to predicate devices based on:

Intended Use: "medical diagnostic purposes only... detection and amplification of sounds from heart, lungs, blood vessels, and other internal organs... on any person undergoing a physical assessment."
Principles of Operation: "operates continuously to provide sounds from heart, lungs, and blood vessels. The sounds detected by the chest piece are output through the ear tips after being amplified and digitally filtered. At the same time, the sounds can be transmitted to an appropriately configured receiving device via Bluetooth® wireless communication. The BM-520 offers two selectable modes, Bell and Diaphragm. Volume is adjustable between 0 and 48 dB."
Functional Design: Not explicitly detailed but implied through the description of the device's operation.
Technological Characteristics: Similar to principles of operation, emphasizing the features like digital filtering, amplification, adjustable volume, and wireless communication.

The "Summary of Test Data" section states: "The Sharp BM-520 was developed and is produced under consideration of all applicable technical standards and internal specifications. The performance of the BM-520 has been verified in the course of bench testing and software validation testing."

This indicates that internal testing was conducted to ensure the device met its design specifications and general safety/performance standards, rather than a clinical study evaluating its diagnostic accuracy against a specific ground truth or clinical outcome.

Therefore, many of the requested details related to clinical performance studies cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Submission)	Reported Device Performance
Compliance with "applicable technical standards and internal specifications"	Verified by "bench testing and software validation testing"
Substantial equivalence to predicate devices (K050159, K041934, K083903 3M Littmann Stethoscope models).	"BM-520 to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use."
Functionality as an electronic stethoscope (amplification, digital filtering, selectable modes, adjustable volume)	Device description outlines these functionalities.
Bluetooth® wireless communication capability	Device description confirms this capability.

Note: The document does not provide specific numerical acceptance criteria (e.g., minimum amplification, frequency response ranges, signal-to-noise ratio) or corresponding numerical performance results from the bench testing.

2. Sample size used for the test set and the data provenance:

Not Applicable. The document describes bench testing and software validation, not a clinical test set with patient data.

3. 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 ground truth establishment by experts is described.

4. Adjudication method for the test set:

Not Applicable. No clinical test set or adjudication process is described.

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. This is not an AI/CAD device. It's an electronic stethoscope. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Applicable. This is a medical device for sound amplification, not an algorithm. Bench testing for device functionality was performed, which is a form of standalone performance verification, but not in the context of diagnostic accuracy.

7. The type of ground truth used:

Not Applicable. The submission focuses on substantial equivalence based on technical specifications and functionality, not clinical ground truth for diagnostic performance validation.

8. The sample size for the training set:

Not Applicable. This device does not use a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not Applicable.

In summary: The 510(k) submission for the Sharp Electronic Stethoscope Model BM-520 relies on demonstrating substantial equivalence to previously cleared predicate devices through similarities in intended use, principles of operation, and functional design. It references internal bench testing and software validation to confirm the device meets "applicable technical standards and internal specifications," but it does not detail a clinical study with specific acceptance criteria related to diagnostic performance or efficacy for a particular condition.

Summary

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121144

SHARP

5. 510(k) SUMMARY

Submitter:	Sharp Corporation2613-1, Ichinomoto-ChoTenri, Nara, Japan 632-8567
Contact Person:	Mr. Yoshiro YamamotoSupervisorResearch dept. 1 Healthcare Systems LaboratoriesCorporate Research and Development GroupTEL: +81-743-65-2142FAX: +81-743-65-3441email: yamamoto.yoshiro@sharp.co.jp
Date Prepared:	April 11, 2012
Trade Name:	Sharp Electronic Stethoscope Model BM-520
Common Name:	Electronic Stethoscope
Classification Name:	Stethoscope, Electronic
Product Code:	DQD
Classification:	Class II, 21 CFR 870.1875
Predicate Device:	K050159, K041934 3M Littmann Stethoscope, Model 3100K083903 3M Littmann Stethoscope, Model 3200
Device Description:	The Sharp Electronic Stethoscope Model BM-520 is an electronic stethoscope toauscultate sounds from heart, lung, blood vessels, and other internal organs. It canbe used on adults undergoing a physical assessment. The sounds can also betransmitted to an appropriately configured receiving device via Bluetooth® wirelesscommunication.
Statement ofIntended Use:	The BM-520 Electronic Stethoscope is intended for medical diagnostic purposesonly. It may be used for the detection and amplification of sounds from heart, lungs,blood vessels, and other internal organs. It can be used on any person undergoing aphysical assessment.
Summary ofTechnologicalCharacteristics:	The BM-520 operates continuously to provide sounds from heart, lungs, and bloodvessels. The sounds detected by the chest piece are output through the ear tips afterbeing amplified and digitally filtered. At the same time, the sounds can betransmitted to an appropriately configured receiving device via Bluetooth® wirelesscommunication. The BM-520 offers two selectable modes, Bell and Diaphragm.Volume is adjustable between 0 and 48 dB. Auto-shutoff feature after 1 minute ofinactivity to conserve battery life.

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SHARP

Summary of Test Data:

The Sharp BM-520 was developed and is produced under consideration of all applicable technical standards and internal specifications. The performance of the BM-520 has been verified in the course of bench testing and software validation testing.

Conclusion:

Sharp Corporation considers the BM-520 to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the logo.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 26 2012

Sharp Corporation c/o Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Drive, Suite 280 Richardson, TX 75080

K121144 Re:

Trade/Device Names: Sharp Electronic Stethoscope, Model BM-520 Regulatory Number: 21 CFR 870,1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II (Two) Product Code: DQD Dated: August 24, 2012 Received: August 29, 2012

Dear Ms. Rutherford:

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. 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.

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Page 2 - Ms. Diane Rutherford

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number:

K12 1144

Device Name: Sharp Electronic Stethoscope, Model BM-520

Indications for Use:

Prescription Use X (21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE (^N ANOTHER PAGE IF NEEDED)

Concurrence of CDHR, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K121149

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Regulation Number and Section

§ 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.