(163 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on basic electronic amplification and transmission of sounds, not intelligent analysis.
No.
The device is described as an electronic stethoscope intended for medical diagnostic purposes, specifically for the detection and amplification of sounds. Its stated purpose involves assessment and diagnosis, not treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The BM-520 Electronic Stethoscope is intended for medical diagnostic purposes only." This directly indicates its function as a diagnostic device.
No
The device description explicitly states it is an "electronic stethoscope" and describes its function of auscultating sounds, which inherently involves hardware components for sound detection and amplification. The mention of Bluetooth transmission also implies hardware capabilities.
Based on the provided information, the BM-520 Electronic Stethoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens obtained from the human body. This typically involves testing blood, urine, tissue, or other bodily fluids outside of the body to diagnose diseases or conditions.
- The BM-520 Electronic Stethoscope is used for auscultation. This is the process of listening to internal sounds of the body, such as heartbeats and breathing, directly on the patient's body. It's a non-invasive diagnostic tool that doesn't involve collecting and testing specimens.
The intended use and device description clearly state that the BM-520 is for detecting and amplifying sounds from internal organs during a physical assessment. This aligns with the function of a traditional stethoscope, which is not considered an IVD.
N/A
Intended Use / 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.
Product codes
DQD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, lung, blood vessels, and other internal organs
Indicated Patient Age Range
any person
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K050159, K041934 3M Littmann Stethoscope, Model 3100, K083903 3M Littmann Stethoscope, Model 3200
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
121144
SHARP
i
5. 510(k) SUMMARY
| Submitter: | Sharp Corporation
2613-1, Ichinomoto-Cho
Tenri, Nara, Japan 632-8567 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Yoshiro Yamamoto
Supervisor
Research dept. 1 Healthcare Systems Laboratories
Corporate Research and Development Group
TEL: +81-743-65-2142
FAX: +81-743-65-3441
email: 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 3100
K083903 3M Littmann Stethoscope, Model 3200 |
| 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. |
| Statement of
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. |
| Summary of
Technological
Characteristics: | The BM-520 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. Auto-shutoff feature after 1 minute of
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.
2
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.
3
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
4
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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