(84 days)
M800 Handheld Pulse Oximeter is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities as well as in the home care environment.
The proposed device is a handheld device, which can display %SpO2, waveform, pulse rate value, pulse amplitude bar indication. It consists of detector and emitter LED, OLED display module, CPU, driving circuit, power supply circuit and battery. In addition, it has alarming function including physical parameter alarming and technical alarming. The physical alarming limit can be set by user. The modifications to M700 Handheld Pulse Oximeter are presented in Table 3-1 Modifications List on the next page.
The provided document is a 510(k) summary for the M800 Handheld Pulse Oximeter, which is a modification of the M700 Handheld Pulse Oximeter. The document focuses on demonstrating substantial equivalence to the predicate device and does not contain detailed information about a study to prove acceptance criteria for a new AI or diagnostic device.
Pulse oximeters are typically evaluated based on specific performance criteria related to the accuracy of SpO2 and pulse rate measurements. However, the provided text does not contain the detailed results of such a study. It only states: "Per the risk management during the design change control, the verification tests performed demonstrated that risks of each hazard are reduced to acceptable region."
Therefore, based on the provided text, I cannot complete the requested tables and sections as they pertain to a detailed study proving device meets acceptance criteria related to performance metrics like sensitivity, specificity, or reader improvement with AI. The document primarily highlights design modifications and claims substantial equivalence.
Information NOT present in the provided text:
- A table of specific acceptance criteria for SpO2 and pulse rate accuracy (e.g., A_rms values, bias, precision) and the reported device performance against these criteria.
- Sample size used for a test set to evaluate accuracy.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human reader improvement with AI.
- If a standalone (algorithm only) performance study was done.
- Type of ground truth used (e.g., arterial blood gas analysis for SpO2 accuracy).
- Sample size for a training set (as this is not an AI/ML device in the context of typical training sets).
- How ground truth for a training set was established.
The document is a 510(k) summary for a pulse oximeter, and these types of devices traditionally undergo verification and validation testing to ensure accuracy and compliance with standards (e.g., ISO 80601-2-61 for pulse oximeter basic safety and essential performance). However, the specific details of these tests and their results against quantitative acceptance criteria are not presented in this summary.
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Premarket Notification Special Section 510(k) Submission Report SN: JN00520100609FDA Submission Date: 11 JUN 2010
Exhibit #3 510(k) Summary
Image /page/0/Picture/3 description: The image shows the number K101694 at the top. Below the number is a logo with the letters BLT and the word BIOLIGHT. The logo also contains a graphic of a plant with three leaves.
Exhibit #3 510(k) Summary
SEP 0 8 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number is: K101694
| Date of Preparation | 11 JUN 2010 |
|---|---|
| Sponsor | Guangdong Biolight Meditech Co., Ltd [Reg #:3007305624]Innovation First Road, Technology Innovation CoastZhuhai, Guangdong, 519085, ChinaContact Person: Mr. Tianbao Li, Chief EngineerTel: +86-756-3399963 Fax: +86-756-3399989 E-mail: li_tb@blt.com.cn |
| SubmissionCorrespondent | Ms. Diana Hong / Mr. Lee FuShanghai Mid-Link Business Consulting Co., LtdSuite 5D, No.19, Lane 999, Zhongshan Road (S-2), Shanghai, 200030, ChinaT: +86-21-64264467 F: 240-238-7587 E: info@mid-link.net |
| Proposed Device | M800 Handheld Pulse OximeterModification to: M700 Handheld Pulse Oximeter (K081712) as predicate device21 CFR 870.2700 DQA Class II |
| Intended Use | M800 Handheld Pulse Oximeter is indicated for spot checking of functional arterialoxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients inhospital, hospital type facilities as well as in the home care environment. |
| Device Description | The proposed device is a handheld device, which can display %SpO2, waveform,pulse rate value, pulse amplitude bar indication. It consists of detector and emitterLED, OLED display module, CPU, driving circuit, power supply circuit and battery.In addition, it has alarming function including physical parameter alarming andtechnical alarming. The physical alarming limit can be set by user. The modificationsto M700 Handheld Pulse Oximeter are presented in Table 3-1 Modifications List onthe next page. |
| Test Summary | Per the risk management during the design change control, the verification testsperformed demonstrated that risks of each hazard are reduced to acceptable region. |
| Conclusion | The information in this 510(k) Summary demonstrate that the proposed device,M800 Handheld Pulse Oximeter, is Substantially Equiavlent (SE) to the predicatedevice, M700 Handheld Pulse Oximeter (K081712), with respect of effectivenessand safety. |
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Premarket Notification Special Section 510(k) Submission
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Report SN: JN00520100609FDA Submission Date: 11 JUN 2010
Exhibit #3
510(k) Summary
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Image /page/1/Picture/3 description: The image shows a logo with the letters "BLT" in bold, black font on the left side. Above the letters, there is a stylized graphic of a person with their arms raised. To the right of "BLT", there are Chinese characters, followed by the word "BIOLIGHT" in bold, black font. The logo appears to be for a company or organization called "Biolight".
| Table 5-4 Modifications List | ||
|---|---|---|
| ITEM | M700 Handheld Pulse Oximeter(Predicate/Existed) | M800 Handheld Pulse Oximeter(Proposed / Modified) |
| Display | LED Display, which can display the following information:Pulse RateSpO2Pulse StrengthSystem InformationStatus Information. | OLED Display, which can display the following information:Pulse RateSpO2Pulse StrengthSystem InformationStatus Information.In addition, it can display:SpO2 waveform, Alarming Limit andAlarming Information. |
| Audio | Beeper, which can audio indicate the followings:Sensor Detachment Indicating;Pulse Indicating;Key Pressing Indicating;Low Voltage Indicating; | Speaker, which can audio indicate the followings:Sensor Detachment Indicating;Pulse Indicating;Key Pressing Indicating;Low Voltage Indicating;In addition, it can indicate: Startingand Alarming. |
| Alarming | Without Alarming Function | With Alarming Function |
Table 3-1 Modifications List
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circular border.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Guangdong Biolight Meditech Company, Limited C/O Ms. Diana Hong Shanghai Midlink Business Consulting Company, Limited Suite 5D, No. 19, Lane 999 Zhongshan Road (S-2) Shanghai China 200030
SEP 0 8 2010
Re: K101694
Trade/Device Name: M800 Handheld Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 11, 2010 Received: August 11, 2010
Dear Ms. Hong:
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. Hong
Enclosure
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 (OS) 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,
Jawed 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
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Premarket Notification Special Section 510(k) Submission Report SN: JN00520100609FDA Submission Date: 11 JUN 2010
Section III Indication for Use Form
BLT. BIOLIGHT 廣萊特
SEP 0 8 2010
Section III Indication for Use Form
510(k) NUMBER (if known):
DEVICE NAME: M800 Handheld Pulse Oximeter
INDICATION FOR USE:
M800 Handheld Pulse Oximeter is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities as well as in the home care environment.
Prescription Use X (Part 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Z. Schulten
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101694
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§ 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).