VITAL SIGNS MONITOR

K083821 · Edan Instruments, Inc. · DQA · May 14, 2009 · Cardiovascular

Device Facts

• Record ID: K083821
• Device Name: VITAL SIGNS MONITOR
• Applicant: Edan Instruments, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: May 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Vital Signs Monitor is indicated for use for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and CO2. The Vital Signs Monitor is intended to be used only under regular supervision of clinical personnel. It is adaptable to adult, pediatric, and neonatal usage in a hospital, hospital type facilities environment and intra-hospital moves. The Vital Signs Monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

Device Story

M3B Vital Signs Monitor provides continuous non-invasive monitoring of SpO2 and CO2; utilizes Nellcor OxiMax SpO2 technology; displays numeric and waveform data on 5.7-inch LCD; features visual/audible alarms for physiologic limits and system faults; includes nurse call and data storage; powered by built-in Lithium-ion battery. Used in hospital environments and during intra-hospital transport by clinical personnel. Output assists clinicians in patient status assessment and timely intervention.

Clinical Evidence

Bench testing only. Evidence includes software testing, safety testing, risk analysis, and final validation to demonstrate performance equivalent to predicate devices.

Technological Characteristics

5.7-inch LCD display; Nellcor OxiMax SpO2 module; CO2 measurement capability; built-in Lithium-ion battery; nurse call interface; alarm system for physiologic parameters and system faults. Designed for adult, pediatric, and neonatal use.

Indications for Use

Indicated for non-invasive continuous monitoring of SpO2 and CO2 in adult, pediatric, and neonatal patients in hospital settings under clinical supervision.

Regulatory Classification

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.

Predicate Devices

• Capnostream 20 (K060065)
• TidalWave SP, Model 710/715 (K032971)

Submission Summary (Full Text)

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Attachment A

K083821

# 510 (K) Summary of Safety and Effectiveness

This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807:92

| Submitter: | Edan Instruments, Inc<br>3/F - B, Nanshan Medical<br>Equipments Park, Nanhai Rd 1019#,<br>shekou, Nanshan Shenzhen,<br>518067 P.R. China<br>Tel: [phone]<br>Fax:[phone]<br>Responsible person: Jiang Yucai | MAY 14 2009 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Official correspondent: | William Stern | |

Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: [phone] X27 Fax: [phone]

Proprietary Name: Vital Signs Monitor (Model M3B)

Classification Name: 21 CFR 870.2700 Oximeter DQA

21 CFR 868.1400 analyzer, gas, carbon-dioxide, gaseous-p CCK

#### Predicate Devices:

| Predicate devices | Capnostream 20 | TidalWave SP,<br>Model 710/715 |
|-------------------|-----------------------------|-------------------------------------------|
| Manufacturer | Oridion 1987<br>Medical Ltd | Respironics<br>ovametrix,<br>Incorporated |
| K # | K060065 | K032971 |

Device Description:

M3B Vital Signs Monitor supplies the following features:

- 5.7 inch LCD display .
- Sp02, Pulse Rate, and Respironics CO2 measurement .
- Nellcor OxiMax SpO2 .
- Display numeric and waveform information simultaneously .
- Nurse call .
- Powerful storage capacity .
- Built-in Lithium-ion Battery ●
- Suitable for adult, pediatric and neonate patients .
- Visual and audible alarm .

### Comparison with predicate device

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# Attachment A

| Monitoring<br>functions | M3B Vital<br>Signs Monitor | Capnostream<br>20 | Tidal Wave<br>SP, Model<br>710/715 |
|-------------------------|----------------------------|-------------------|------------------------------------|
| SpO2,<br>Pulse Rate | yes | yes | yes |
| CO2<br>measurement | yes | yes | yes |

#### Intended Use:

The Vital Signs Monitor is indicated for use for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and CO2.

The Vital Signs Monitor is intended to be used only under regular supervision of clinical personnel. It is adaptable to adult, pediatric, and neonatal usage in a hospital, hospital type facilities environment and intra-hospital moves.

The Vital Signs Monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

#### Test Summary:

The following quality assurance measures were applied to the development of the Fetal & Maternal Monitor

- Software testing
- . Safety testing
- . Risk analysis
- . Final validation

## Conclusion:

Verification and validation testing was done on the M3B Vital Signs Monitor. This premarket notification submission demonstrates that M3B Vital Signs Monitor is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

MAY 14 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Edan Instruments, Incorporated C/o Mr. William Stern Multigon Industries, Incorporated 1 Odell Plaza Yonkers, New York 10701

Re: K083821

Trade/Device Name: Vital Signs Monitor (Model M3B) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, CCK Dated: May 5, 2009 Received: May 6, 2009

Dear Mr. Stern:

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.

If your device is classified (see above) into cither 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

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Page 2- Mr. Stern

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Quares

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use

KO83821 . 510(k) Number (if known):

Device Name:

Vital Signs Monitor (Model M3B)

The Vital Signs Monitor is indicated for use for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and CO2.

The Vital Signs Monitor is intended to be used only under regular supervision of clinical personnel. It is adaptable to adult, pediatric, and neonatal psage in a hospital environment and intra-hospital moves.

The Vital Signs Monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

Prescription Use (21 CFR Part 801 Subpart D)

Over the Counter Use _______ (21 CFR Part 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Or

y Lhuta

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k08382

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