HANDHELD MONITOR

• K Number: K131762
• Device Name: HANDHELD MONITOR
• Manufacturer: GUANGDONG BIOLIGHT MEDITECH CO., LTD.
• Date Cleared: 2014-06-06 ( 354 days)
• Product Code: MWI , DQA , DRT
• Regulation Number: 870.2300
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: K100046
• Predicate For: K150869 , K232111

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 type facilities as well as in the home care environment.

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.

AI/ML Overview

The provided text describes the M800 Handheld Monitor and its substantial equivalence to a predicate device (M Series Patient Monitor K100046), rather than detailing a study proving the device meets specific acceptance criteria with defined metrics.

However, based on the information provided, we can infer the "acceptance criteria" are compliance with established medical device standards and the "study" is the non-clinical testing performed to demonstrate this compliance and substantial equivalence to the predicate device.

Here's an analysis based on the provided text, addressing the requested points where information is available or can be reasonably inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by compliance with various IEC, ISO, and AAMI/ANSI standards for medical electrical equipment and specific monitoring functions (pulse oximetry, ECG). The "reported device performance" is the claim of compliance with these standards and the listed technical specifications being "Same" or "Similar" to the predicate device.

Acceptance Criteria Category	Specific Acceptance Criteria (Standard/Metric)	Reported Device Performance
General Safety & Performance	IEC 60601-1 (General requirements)	Complies with IEC 60601-1
Electromagnetic Compatibility (EMC)	IEC 60601-1-2	Complies with IEC 60601-1-2
Pulse Oximetry	ISO 9919 (Pulse oximeter equipment)	Complies with ISO 9919. SpO2 Range (BLT Module): 0-100% (Same as predicate) SpO2 Range (Necllor Module): 0-100% (Same as predicate) SpO2 Accuracy (BLT Module): 70-100%: ±2%; 0-69%: unspecified (Same as predicate) SpO2 Accuracy (Necllor Module): 70-100%: ±2% (adult/pediatric), ±3% (neonate), ±2% (low perfusion); 0-69%: unspecified (Same as predicate)
Heart Rate (PR)	ISO 9919 (Pulse Oximeter PR)	PR Range (BLT Module): 25-255 bpm (Same as predicate) PR Range (Necllor Module): 20-300 bpm (Same as predicate) PR Accuracy (BLT Module): ±1% or ±1 bpm, whichever is greater (Same as predicate) PR Accuracy (Necllor Module): 20-250bpm: ±3 bpm; 251-300bpm: unspecified (Same as predicate)
Electrocardiography (ECG)	IEC 60601-2-27 (Electrocardiographic monitoring equipment)	Complies with IEC 60601-2-27. ECG Lead: 3 lead: I, II, III (Same as predicate) ECG Gain: 2.5mm/mV(×0.25), 5mm/mV(×0.5), 10mm/mV(×1) (Same as predicate) Sweep Speed: 12.5mm/s, 25mm/s (Same as predicate)
Heart Rate (HR)	AAMI/ANSI EC13 (Cardiac monitors, heart rate meters, and alarms)	Complies with AAMI/ANSI EC13. HR Range: 10-300 bpm (Same as predicate) HR Accuracy: ±1% or ±1 bpm, whichever is the greater (Same as predicate)
Patient-Contact Material	Not explicitly stated as a numerical criterion, but TPU for ECG cable.	ECG Cable: TPU (Same as predicate)

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

The document does not specify a "test set" in the context of clinical data for performance evaluation. The non-clinical tests relate to engineering and safety standards. Therefore, specific sample sizes for patients or data provenance (country of origin, retrospective/prospective) are not mentioned as this was likely an engineering verification and validation effort against standards, not a clinical trial with patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This was not a study involving expert-established ground truth on clinical data. The "ground truth" for the non-clinical tests would be the compliance requirements of the referenced standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document makes no mention of an MRMC comparative effectiveness study or human readers improving with AI assistance. The device is a patient monitor, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Yes, in essence. The "non-clinical tests" described are a form of standalone performance evaluation, confirming the device's adherence to technical standards and specifications directly, without human interpretation in the loop. The device itself is a measurement tool, and its performance is assessed against known physical or electrical standards.

7. Type of Ground Truth Used

The ground truth used for these non-clinical tests would be the requirements and specifications within the referenced international and national medical device standards (IEC 60601-1, IEC 60601-1-2, ISO 9919, IEC 60601-2-27, AAMI/ANSI EC13). For example, for an SpO2 accuracy test, the ground truth would be a precisely calibrated oxygen saturation level from a reference device or method.

8. Sample Size for the Training Set

Not applicable. This device is not described as utilizing an AI or machine learning algorithm that would require a "training set" of data. Its functionality is based on established physiological measurement principles.

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

Not applicable, as there is no mention of a training set or AI/ML components for this device.

Summary

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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:

1. Date of Submission: 6/6/2014

2. 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: [phone] Fax: [phone] Email: liang [e-mail]

• 3. Submission Correspondent
     Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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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. -
• 8. 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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• 9. 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.

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 forcontinuously monitoring or spot checking ofSpO2, PR, ECG and HR of adult, pediatric andneonatal patients in hospital, hospital typefacilities as well as in the home careenvironment.	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%: unspecifiedNecllor 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 bpmNecllor Module: 20 bpm to 300 bpm	Same
PR Accuracy	BLT Module: ±1% or ±1 bpm, whichever isthe greaterNecllor Module: 20bpm250bpm: ± 3 bpm251bpm300bpm: 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-contactMaterial	ECG Cable: TPU	Same

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

· OR

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Regulation Number and Section

§ 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).