(82 days)
No
The summary describes a standard pulse oximeter using optical sensors and transmittance technology for spot-check measurements. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies. The performance studies focus on comparing the device to a blood gas analyzer and predicate devices, not on evaluating AI/ML algorithm performance.
No.
The device is used for measurement and display of arterial blood oxygen saturation and pulse rate, which are diagnostic/monitoring functions, not therapeutic.
Yes
Explanation: The device is described as measuring and displaying arterial blood oxygen saturation (SpO2) and pulse rate, which are used to assess a patient's physiological state and can indicate potential health issues, falling under the definition of a diagnostic device.
No
The device description explicitly states it comprises a "main unit (BM-500)" and an "SpO2 Sensor (BM-510)" connected via a cord, indicating physical hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The Sharp Pulse Oximeter measures arterial blood oxygen saturation (SpO2) and pulse rate by placing a sensor on the patient's finger. This is a non-invasive measurement performed on the living body.
- Lack of Sample Analysis: The device does not analyze a sample taken from the body. It uses optical technology to measure light absorption through the finger.
Therefore, based on the provided information, the Sharp Pulse Oximeter is a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical sensor
Anatomical Site
finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals or primary care 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)
Two pulse oximeters were placed on 12 subjects and compared to a blood gas analyzer. Hypoxia was induced to different levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide. Two hundred data points were plotted and regression analysis was performed. The pulse oximeters demonstrated statistical alignment with the blood gas analyzer SpO2 results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081285 - Nonin Medical, Inc Onyx II 9560, K001085 - Nonin Medical, Inc Onyx 9500, K053419 - Konica Minolta PULSOX-300/300i
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
SHARP
- 510(k) SUMMARY
.. . . . . . . .
K 113865
| 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: | 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 9560
K001085 - Nonin Medical, Inc Onyx 9500
K053419 - 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. 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. |
| Statement of
Intended Use: | 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. |
| Summary of
Technological
Characteristics: | The Sharp Pulse Oximeter Model BM-500 and BM-510 is uses an optical sensor
and transmittance technology to detect changes in the finger's arterial blood and
converts the optical signals into electric signals. The main unit then converts the
electric signals into numeric data that is displayed on the LCD screen displaying the
blood oxygen saturation and pulse. |
| Summary of
Non-Clinical Data: | SpO2 accuracy and pulse rate accuracy were confirmed by the reference method
using the pseudo pattern pulse wave. Electromagnetic compatibility and electrical
safety are ensured by testing. |
| Summary of
Clinical Data: | Two pulse oximeters were placed on 12 subjects and compared to a blood gas
analyzer. Hypoxia was induced to different levels of oxyhemoglobin saturation
(between 70-100%) by having subjects breathe mixtures of nitrogen, room air, and
carbon dioxide. Two hundred data points were plotted and regression analysis was
performed. The pulse oximeters demonstrated statistical alignment with the blood
gas analyzer SpO2 results. |
| Conclusion: | Sharp Corporation considers the Pulse Oximeter Model BM-500 and BM-510 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 materials, test results, and established medical use. |
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SHARP
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings above three wavy lines, which likely symbolize water or waves.
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.
3
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
4
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:
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 hospital or primary care settings.
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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