HANDHELD MONITOR

K131762 · Guangdong Biolight Meditech Co., Ltd. · MWI · Jun 6, 2014 · Cardiovascular

Device Facts

• Record ID: K131762
• Device Name: HANDHELD MONITOR
• Applicant: Guangdong Biolight Meditech Co., Ltd.
• Product Code: MWI · Cardiovascular
• Decision Date: Jun 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Handheld patient monitor M800 performs continuous or spot-check monitoring of SpO2, PR, ECG, and HR. Device comprises power supply, parameter measurement, main control, and human-device interface modules. Inputs include physiological signals via ECG cables and SpO2 sensors. Device processes signals to display results on a TFT screen; provides data review and audio/visual alarms. Used in hospital and home care environments by clinicians or patients. Output allows healthcare providers to assess patient status and make clinical decisions regarding vital sign stability. Benefits include portable, real-time monitoring of critical physiological parameters.

Clinical Evidence

No clinical data. Substantial equivalence was established through bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing for pulse oximetry (ISO 9919) and electrocardiographic monitoring (IEC 60601-2-27, ANSI/AAMI EC13).

Technological Characteristics

Handheld monitor with TFT display. Materials: TPU for ECG cables. Parameters: SpO2 (0-100%), PR (20-300 bpm), ECG (3-lead: I, II, III). Connectivity: Standalone. Power: Internal power supply module. Standards: IEC 60601-1, IEC 60601-1-2, ISO 9919, IEC 60601-2-27, ANSI/AAMI EC13.

Indications for Use

Indicated for continuous or spot-check monitoring of SpO2, pulse rate (PR), ECG, and heart rate (HR) in adult, pediatric, and neonatal patients in hospital and home care settings.

Regulatory Classification

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.

Predicate Devices

• M Series Patient Monitor (K100046)

Submission Summary (Full Text)

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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 for<br>continuously monitoring or spot checking of<br>SpO2, PR, ECG and HR of adult, pediatric and<br>neonatal patients in hospital, hospital type<br>facilities as well as in the home care<br>environment. | Similar |
| Display | TFT | Same |
| Alarm | Visual and audio alarming | Same |
| SpO2 Range | BLT Module: 0~100%<br>Necllor Module: 0% to 100% | Same |
| SpO2 Accuracy | BLT Module: 70% to 100%: ±2%<br>0% to 69%: unspecified<br>Necllor Module:<br>70% to 100%: ±2% (adult/pediatric)<br>70% to 100%: ±3% (neonate)<br>70% to 100%: ±2% (low perfusion)<br>0% to 69%, unspecified | Same |
| PR Range | BLT Module: 25 bpm to 255 bpm<br>Necllor Module: 20 bpm to 300 bpm | Same |
| PR Accuracy | BLT Module: ±1% or ±1 bpm, whichever is<br>the greater<br>Necllor Module: 20bpm~250bpm: ± 3 bpm<br>251bpm~300bpm: unspecified | Same |
| ECG Lead | 3 lead: I, II, III | Same |
| ECG Gain | 2.5mm/mV(×0.25), 5mm/mV(×0.5),<br>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<br>Material | 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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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 [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)

□

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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