(354 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data. The device description focuses on standard physiological monitoring functions and hardware components.
No
The device is described as a monitor that performs continuous or spot checks of vital signs; it gathers information but does not provide therapy or treatment.
No
The device is described as a monitor for continuously checking SpO2, PR, ECG, and HR. Monitoring devices provide real-time data but do not diagnose conditions.
No
The device description explicitly states it "consists of four functional modules, which are power supply module, parameter measurement module, main control and human-device interface," indicating the presence of hardware components beyond just software.
Based on the provided information, the M800 handheld monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The M800 monitor directly measures physiological parameters from the patient's body (SpO2, PR, ECG, HR) using sensors applied externally. It does not analyze biological samples.
The description clearly indicates it's a patient monitor for vital signs, which falls under the category of medical devices used for direct patient monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
M800 handheld monitor is intended for continuously monitoring or spot checking of SpO2, PR, ECG and HR of adult, pediatric and neonatal patients in hospital type facilities as well as in the home care environment.
Product codes
MWI, DRT, DQA
Device Description
The proposed device, M800 is a handheld patient monitor for continuously monitoring and spot checking of SpO2, PR, ECG and HR of adult, pediatric and neonatal patients.
The proposed device includes three display modes for monitoring results, data review function, and audio and visual alarming function.
It consists of four functional modules, which are power supply module, parameter measurement module, main control and human-device interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonatal patients
Intended User / Care Setting
hospital type facilities as well as in the home care environment.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- -IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, 1998; Amendment 1, 1991; Amendment 2, 1995.
- IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- ISO 9919:2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
- -IEC 60601-2-27: 2005, Medical electrical equipment - Part 2-27: Particular requirements for the safety including essential performance, of electrocardiographic monitoring equipment.
- A AMI / ANSI EC13:2002/(R)2007, Cardiac monitors, heart rate meters, and alarms. -
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Project #: M0082013Aa
Section 3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
K131762 The assigned 510(k) Number:
-
Date of Submission: 6/6/2014
-
Sponsor Identification
Guangdong Biolight Meditech Co., Ltd.
No.2 Innovation First Road, Technical Innovation Coast, Hi-tech Zone, Zhuhai, P.R. China
Establishment Registration Number: 3007305624
Contact Person: Jin Liang Position: R&D Director Tel: +86-756-3399967 Fax: +86-756-3399989 Email: liang j@blt.com.cn
-
- Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
- Submission Correspondent
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- Proposed Device Identification 4.
Proposed Device Name: Handheld Monitor Proposed Device Model: M800 Proposed Device Common Name: Patient Monitor
Regulatory Information: Classification Name: Monitor, Physiological, Patient(Without Arrhythmia Detection Or Alarms); Classification: II; Product Code: MWI; Regulation Number: 21 CFR 870.2300; Cardiovascular: Subsequent Product Code: DRT, DQA
Intended Use Statement:
M800 handheld monitor is intended for continuously monitoring or spot checking of SpO2, PR, ECG and HR of adult, pediatric and neonatal patients in hospital type facilities as well as in the home care environment.
-
ર. Predicate Device Identification
510(k) Number: K100046 Product Name: M Series Patient Monitor Manufacturer: Guangdong Biolight Meditech Co., Ltd. -
ર. Device Description
The proposed device, M800 is a handheld patient monitor for continuously monitoring and spot checking of SpO2, PR, ECG and HR of adult, pediatric and neonatal patients.
The proposed device includes three display modes for monitoring results, data review function, and audio and visual alarming function.
It consists of four functional modules, which are power supply module, parameter measurement module, main control and human-device interface.
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Project #: M0082013Aa
7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- -IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, 1998; Amendment 1, 1991; Amendment 2, 1995.
- IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- ISO 9919:2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.
- -IEC 60601-2-27: 2005, Medical electrical equipment - Part 2-27: Particular requirements for the safety including essential performance, of electrocardiographic monitoring equipment.
- A AMI / ANSI EC13:2002/(R)2007, Cardiac monitors, heart rate meters, and alarms. -
-
- Guidance
The following FDA guidance documents were followed when the submission data were prepared:
- -Pulse Oximeters - Premarket Notifications [510(k)s] Guidance for Industry and Food and Drug Administration Staff;
- -Guidance for Industry Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm).
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-
- Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
- Substantially Equivalent (SE) Conclusion
| Item | Proposed Device(s) | Predicate Device(s) |
|---|---|---|
| Product Code | MWI | Similar |
| Regulation Number | 21 CFR 870.2300 | Similar |
| Class | Class II | Same |
| Intended Use | M800 handheld monitor is intended for | |
| continuously monitoring or spot checking of | ||
| SpO2, PR, ECG and HR of adult, pediatric and | ||
| neonatal patients in hospital, hospital type | ||
| facilities as well as in the home care | ||
| environment. | Similar | |
| Display | TFT | Same |
| Alarm | Visual and audio alarming | Same |
| SpO2 Range | BLT Module: 0~100% | |
| Necllor Module: 0% to 100% | Same | |
| SpO2 Accuracy | BLT Module: 70% to 100%: ±2% | |
| 0% to 69%: unspecified | ||
| Necllor Module: | ||
| 70% to 100%: ±2% (adult/pediatric) | ||
| 70% to 100%: ±3% (neonate) | ||
| 70% to 100%: ±2% (low perfusion) | ||
| 0% to 69%, unspecified | Same | |
| PR Range | BLT Module: 25 bpm to 255 bpm | |
| Necllor Module: 20 bpm to 300 bpm | Same | |
| PR Accuracy | BLT Module: ±1% or ±1 bpm, whichever is | |
| the greater | ||
| Necllor Module: 20bpm~250bpm: ± 3 bpm | ||
| 251bpm~300bpm: unspecified | Same | |
| ECG Lead | 3 lead: I, II, III | Same |
| ECG Gain | 2.5mm/mV(×0.25), 5mm/mV(×0.5), | |
| 10mm/mV(×1) | Same | |
| Sweep Speed | 12.5mm/s, 25mm/s | Same |
| HR Rang | 10 bpm~300 bpm | Same |
| HR Accuracy | ±1% or ±1 bpm, whichever is the greater | Same |
| Table 3-1 Comparison of Technology Characteristics | |
|---|---|
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| Electrical Safety | Comply with IEC 60601-1 | Same |
|---|---|---|
| EMC | Comply with IEC 60601-1-2 | Same |
| Patient-contact | ||
| Material | ECG Cable: TPU | Same |
.
.
The proposed device, Handheld Monitor M800, is determined to be Substantially Equivalent (SE) to the predicate device, M Series Patient Monitor (K100046), in respect of safety and effectiveness.
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Image /page/5/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The text is stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The words are centered in the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2014
Guangdong Biolight Meditech Co., Ltd. c/o Ms. Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K131762
Trade/Device Name: Handheld Monitor (M800) Regulation Number: 21 CFR 870.2300 Regulation Name: Patient Monitor Regulatory Class: Class II Product Code: MWI, DRT, DQA Dated: April 29, 2014 Received: May 1, 2014
.
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.
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
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Page 2 - Ms. Diana Hong
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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/6/Picture/6 description: The image shows a logo with the letters FDA. The letters are stylized and enclosed in a box. There are lines drawn through the logo, possibly indicating that it is not valid or has been rejected. The logo is in black and white.
for 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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Section 2 Indications for Use
510(k) Number: Device Name: Handheld Monitor M800
Indications for Use:
M800 handheld monitor is intended for continuously monitoring or spot checking of SpO-, PR, ECG and HR of adult, pediatric and neonatal patients in hospital type facilities as well as in the home care environment.
ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D)
□
OVER-THE-COUNTER USE (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
· OR
Image /page/7/Picture/12 description: The image shows a document with the title "Concurrence of CDRH, Office of Device Evaluation (ODE)". There is a signature and a date stamp on the document. The date on the stamp is June 6, 2014, and the time is 15:13:12-04'00'. The document is labeled as "Page 1 of 1".
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