The Sharp Pulse Oximeter Model BM-500 and BM-510 is a non-invasive pulse oximeter indicated for use in the spot-check measurement and display of arterial blood oxygen saturation (SpO2) and pulse rate in hospitals or primary care settings.

Device Description

The Sharp Pulse Oximeter is a multi-parameter module comprising of a main unit (BM-500) and the SpO2 Sensor (BM-510) connected via the sensor cord. The device operates continuously to provide spot-check measurements of oxygen saturation and pulse when a patient's finger is inserted into the sensor and the ON button is depressed.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit)	Reported Device Performance (Clinical Data)
Statistical alignment with blood gas analyzer SpO2 results between 70-100% saturation.	"The pulse oximeters demonstrated statistical alignment with the blood gas analyzer SpO2 results."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: 12 subjects
Data Provenance: The information provided does not specify the country of origin of the data, but the submitter is Sharp Corporation based in Japan.
Retrospective/Prospective: The study appears to be prospective, as hypoxia was "induced to different levels of oxyhemoglobin saturation" in subjects for the purpose of the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts: Not applicable. The ground truth was established by a blood gas analyzer, not human experts.
Qualifications of Experts: N/A

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The ground truth was established by objective medical equipment (blood gas analyzer).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The study involved comparing the device against a blood gas analyzer, not against human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance study was done. The device's SpO2 accuracy and pulse rate accuracy were assessed by comparing its readings directly with a blood gas analyzer.

7. The Type of Ground Truth Used:

Ground Truth: Objective medical equipment (blood gas analyzer). This serves as a direct, gold-standard measurement of arterial blood oxygen saturation.

8. The Sample Size for the Training Set:

The document does not explicitly mention a separate "training set" or its size. The clinical data description focuses on the evaluation of the device's accuracy with 12 subjects. While device development involves internal testing, the provided summary focuses on the clinical validation data.

9. How the Ground Truth for the Training Set Was Established:

Since a distinct "training set" is not detailed in the provided information, the method for establishing its ground truth is not described. The clinical validation ground truth was established by a blood gas analyzer.

Summary

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SHARP

510(k) SUMMARY

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K 113865

Submitter:	Sharp Corporation2613-1. Ichinomoto-Cho.Tenri, 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:	December 22, 2011
Trade Name:	Sharp Pulse Oximeter Model BM-500(Main Unit) and BM-510 (Sensor)
Common Name:	Pulse Oximeter
Classification Name:	Oximeter
Product Code:	DQA
Classification:	Class II, CFR 820.2700
Predicate Device:	K081285 - Nonin Medical, Inc Onyx II 9560K001085 - Nonin Medical, Inc Onyx 9500K053419 - Konica Minolta PULSOX-300/300i
Device Description:	The Sharp Pulse Oximeter is a multi-parameter module comprising of a main unit(BM-500) and the SpO2 Sensor (BM-510) connected via the sensor cord. Thedevice operates continuously to provide spot-check measurements of oxygensaturation and pulse when a patient's finger is inserted into the sensor and the ONbutton is depressed.
Statement ofIntended Use:	The Sharp Pulse Oximeter Model BM-500 and BM-510 is a non-invasive pulseoximeter indicated for use in the spot-check measurement and display of arterialblood oxygen saturation (SpO2) and pulse rate in hospitals or primary care settings.
Summary ofTechnologicalCharacteristics:	The Sharp Pulse Oximeter Model BM-500 and BM-510 is uses an optical sensorand transmittance technology to detect changes in the finger's arterial blood andconverts the optical signals into electric signals. The main unit then converts theelectric signals into numeric data that is displayed on the LCD screen displaying theblood oxygen saturation and pulse.
Summary ofNon-Clinical Data:	SpO2 accuracy and pulse rate accuracy were confirmed by the reference methodusing the pseudo pattern pulse wave. Electromagnetic compatibility and electricalsafety are ensured by testing.
Summary ofClinical Data:	Two pulse oximeters were placed on 12 subjects and compared to a blood gasanalyzer. Hypoxia was induced to different levels of oxyhemoglobin saturation(between 70-100%) by having subjects breathe mixtures of nitrogen, room air, andcarbon dioxide. Two hundred data points were plotted and regression analysis wasperformed. The pulse oximeters demonstrated statistical alignment with the bloodgas analyzer SpO2 results.
Conclusion:	Sharp Corporation considers the Pulse Oximeter Model BM-500 and BM-510 to besubstantially equivalent to the predicate devices listed above. This conclusion isbased on the similarities in primary intended use, principles of operation, functionaldesign, and materials, test results, and established medical use.

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SHARP

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

MAR 2 1 2012

Sharp Corporation C/O Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Drive, Suite 280 Richardson, Texas 75080

Re: K113865

Trade/Device Name: Sharp Pulse Oximeter Model BM-500 (Main Unit) and Model BM-510 (SpO2 Sensor) Regulation Number: 21 CFR 870.2700

Regulation Name: Oximeter

Regulatory Class: . II Product Code: DQA

Dated: March 6, 2012

Received: March 7, 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. 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.

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Page 2 - Ms. Rutherford

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/ReportaProblem/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,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number: K113865

Device Name: Sharp Pulse Oximeter Model BM-500 (Main Unit) and Model BM-510 (SpO2 Sensor)

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 ON ANOTHER PAGE IF NEEDED)

Concurrence of CDHR, Office of Device Evaluation (ODE)

L. Schutter

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).