ELECTRONIC STETHOSCOPE

K121144 · Sharp Corporation · DQD · Sep 26, 2012 · Cardiovascular

Device Facts

• Record ID: K121144
• Device Name: ELECTRONIC STETHOSCOPE
• Applicant: Sharp Corporation
• Product Code: DQD · Cardiovascular
• Decision Date: Sep 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

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 Story

Electronic stethoscope for auscultation of heart, lung, blood vessel, and internal organ sounds. Chest piece detects acoustic signals; device amplifies and digitally filters sounds; output delivered via ear tips. Features selectable Bell and Diaphragm modes; adjustable volume (0-48 dB); auto-shutoff after 1 minute inactivity. Supports Bluetooth wireless transmission to external receiving devices. Used by clinicians during physical assessments. Benefits include enhanced sound detection and potential for remote monitoring via wireless transmission.

Clinical Evidence

Bench testing and software validation testing only. No clinical data provided.

Technological Characteristics

Electronic stethoscope with chest piece sensor, digital amplification, and filtering. Features Bluetooth wireless connectivity. Selectable Bell/Diaphragm modes. Volume adjustable 0-48 dB. Battery-powered with auto-shutoff. Software-based digital signal processing.

Indications for Use

Indicated for medical diagnostic purposes, specifically the detection and amplification of heart, lung, blood vessel, and internal organ sounds in any person undergoing a physical assessment.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*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.

Predicate Devices

• 3M Littmann Stethoscope, Model 3100 (K050159)
• 3M Littmann Stethoscope, Model 3100 (K041934)
• 3M Littmann Stethoscope, Model 3200 (K083903)

Submission Summary (Full Text)

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121144

SHARP

i

# 5. 510(k) SUMMARY

| Submitter: | Sharp Corporation<br>2613-1, Ichinomoto-Cho<br>Tenri, Nara, Japan 632-8567 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Yoshiro Yamamoto<br>Supervisor<br>Research dept. 1 Healthcare Systems Laboratories<br>Corporate Research and Development Group<br>TEL: [phone]<br>FAX: [phone]<br>email: [e-mail] |
| 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 3100<br>K083903 3M Littmann Stethoscope, Model 3200 |
| Device Description: | The Sharp Electronic Stethoscope Model BM-520 is an electronic stethoscope to<br>auscultate sounds from heart, lung, blood vessels, and other internal organs. It can<br>be used on adults undergoing a physical assessment. The sounds can also be<br>transmitted to an appropriately configured receiving device via Bluetooth® wireless<br>communication. |
| Statement of<br>Intended Use: | The BM-520 Electronic Stethoscope is intended for medical diagnostic purposes<br>only. It may be used for the detection and amplification of sounds from heart, lungs,<br>blood vessels, and other internal organs. It can be used on any person undergoing a<br>physical assessment. |
| Summary of<br>Technological<br>Characteristics: | The BM-520 operates continuously to provide sounds from heart, lungs, and blood<br>vessels. The sounds detected by the chest piece are output through the ear tips after<br>being amplified and digitally filtered. At the same time, the sounds can be<br>transmitted to an appropriately configured receiving device via Bluetooth® wireless<br>communication. The BM-520 offers two selectable modes, Bell and Diaphragm.<br>Volume is adjustable between 0 and 48 dB. Auto-shutoff feature after 1 minute of<br>inactivity 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 [phone] or [phone] 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:

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.

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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