ATLAS MONITOR, MODELS 200,210,220

K022084 · Welch Allyn, Inc. · DQA · Sep 26, 2002 · Cardiovascular

Device Facts

• Record ID: K022084
• Device Name: ATLAS MONITOR, MODELS 200,210,220
• Applicant: Welch Allyn, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 26, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The indications for use for the Atlas Monitor, model numbers 200, 210 and 220 include the monitoring of the following human physiological vital signs: - Blood Oxygenation (SpO2) measurement . - ECG waveform derived from 3 or 5 lead measurement . - Respiration rate/waveform derived from ECG or CO2 . - Temperature measurement via YSI 400 series probes . - Non-Invasive Blood Pressure (NIBP) measurement . - CO2 End-Tidal sidestream/waveform . - Heart Rate derived from selected source (ECG, SpO2) . The target populations are adult and pediatric populations. The monitor is intended for use within the healthcare facility setting.

Device Story

Multi-parameter vital signs monitor (Models 200, 210, 220) for healthcare facilities; displays ECG, CO2 waveforms, and numeric values on CRT/LEDs. Inputs: ECG leads, SpO2 optical probes, NIBP cuff/bladder, YSI 400 thermistor probes, and sidestream CO2 gas sampling. Operation: Oscillometric NIBP; red/infrared light absorption for SpO2; thermistor resistance for temperature; impedance respiration via ECG leads; side-stream CO2 via pump/dual thermopile sensor. Outputs: Real-time waveforms, numeric vital signs, and optional printed reports. Clinicians use data for patient assessment and clinical decision-making. Benefits: Continuous physiological monitoring to track patient status.

Clinical Evidence

Bench testing only. The device was tested for compliance with recognized national and international performance, safety, and electromagnetic compatibility standards. Risk analysis and mitigation were verified and validated per Welch Allyn quality system procedures (ISO 9001/EN46001).

Technological Characteristics

Multi-parameter monitor; CRT/LED display. ECG (3/5 lead); SpO2 (Nonin or Nellcor OEM modules); NIBP (oscillometric); Temperature (YSI 400 thermistor); ETCO2 (Pryon side-stream OEM module). Connectivity: RS423 I/O. Power: Internal voltage generation from single input. Standards: AAMI/EU harmonized standards for ECG; 21 CFR 820, ISO 9001, EN46001.

Indications for Use

Indicated for adult and pediatric patients in healthcare facilities for monitoring vital signs: SpO2, ECG (3/5 lead), respiration rate/waveform (ECG or CO2), temperature (YSI 400), NIBP, ETCO2, and heart rate.

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

• Atlas Monitor (K984033)
• Nellcor model N-395 pulse oximeter (K991823)
• Nellcor model N-395 pulse oximeter (K993637)

Submission Summary (Full Text)

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K022084

## 510(k) Summary of Safety and Effectiveness

May 28, 2002

Submitter Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153

Telephone: [phone] Fax: [phone]

Contact: Shawn Earle, Senior Quality Engineer

## Device Name:

Trade Name: Atlas Monitor Common Name: Vital Signs Monitor Classification Name: Cardiac Monitor (including cardiotachometer and rate alarm)

## Predicate Device:

The predicate device for the Atlas Monitor is the Atlas Monitor cleared for market under 510(k) submission K984033, except for the improved SpO2 channel. The predicate device for the improved SpO2 channel in the Atlas Monitor is the Nellcor model N-395 pulse oximeter cleared for market under 510(k) submissions K991823 and K993637.

## Device Description:

The Atlas Monitor is a multi-parameter device used to monitor human physiological vital signs. It combines a CRT to display ECG and CO2 waveforms and LED's for other numeric values. There are (3) different models available.

| FEATURES | MODEL 200 | MODEL 210 | MODEL 220 |
|-----------------------|---------------|-----------|------------------------------|
| ECG | Yes | Yes | Yes |
| SpO2 Nellcor MP506 | Yes | Yes | No |
| SpO2 Nonin | No | No | Yes |
| NIBP | Yes | Yes | Yes |
| Temperature | No | Yes | Yes |
| Impedance Respiration | No | Yes | Only if ETCO₂ is not running |
| ETCO₂ | No | No | Yes |
| Printer | Option | Option | Standard |
| Battery Backup | Not Available | Standard | Standard |
| RS423 I/O | Not Available | Standard | Standard |

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The ECG front end will meet all applicable AAMI and harmonized EU standards (see safety reference section for particular standards). The Atlas Monitor will provide a 5 wire front end and will be compatible with both a 3 wire and 5 wire cable. Diagnostic (0.05Hz to 100Hz) and monitor (0.5Hz to 40Hz) bandwidth will be provided. The corresponding ECG waveform is displayed on the CRT. User can select which lead the monitor is displaying. If optional printer is installed that waveform can be printed.

The SpO2 value is obtained by the measurement of the red and infrared light absorbed by the patient's tissue. A probe, consisting of a detector and emitter, is placed on a patient at a point where profusion of a body part is close to the skin surface, like a hand digit. The changes in absorption are used to determine oxygen saturation and heart rate. The pulse signal graph LED bar indicates the relative strength of the pulses detected by the SpO2 module. The control board requires a single voltage input and generates all the necessary internal voltages. Communication to the Atlas Main board is via an internal serial communication interface. The SpO2 capability in Atlas is obtained by the utilization of OEM modules.

The OEM SpO2 modules are manufactured by:

| OEM P/N: MMONX75 | Nonin Medical, Inc. |
|------------------|-------------------------------|
| | 2605 Fernbrook Lane |
| | North Plymouth, MN 55447-4755 |
| OEM P/N: MP205 | Nellcor Puritan Bennett, Inc. |
| | 4280 Hacienda Drive |
| | Pleasanton, CA 94588-2719 |

The NIBP portion of the Atlas monitor utilizes the oscillometric method of blood pressure determination. In this method, the patient's arm is compressed and blood flow occluded through the use of a cuff and bladder combination. Each time the patient's heartbeats, a slight variation of pressure occurs in the cuff. The cuff pressure is decreased in a step fashion. The device measures and catalogs the pressure pulses at each step in cuff pressure. The patient's systolic and diastolic pressures are determined through the examination of these pulses.

The temperature portion of the Atlas monitor uses well established precision YSI 400 probes to monitor surface temperature of a patient. The YSI probes work on the principle of interchangeable thermistors (NTC Type) that exhibits a steep drop in resistance as temperature changes, providing high sensitivity to temperature changes. Welch Allyn, Inc. does not manufacture probes but it does recommend use of YSI 400 probes manufactured by:

YSI Inc 1700/1725 Brannum Lane PO Box 279 Yellow Springs, OH 45387

The impedance respiration feature utilizes the ECG lead set and patient surface ECG electrodes, together with additional electronics processing. The respiration rate in breaths/minute is displayed in numerical format on the CRT.

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The end tidal CO2 (ETCO>) measurement is performed by utilizing an OEM PCB from:

Prvon Corporation N93 W14575 Whittaker Way Menomonee Falls, WI 53051

The Pryon side stream CO2 control board (LC101) is designed to acquire CO2 data utilizing an on board pump to aspirate a patient gas sample. Employing a proprietary side stream sensor, the C-cap bench. Patient waveform is obtained. The sensor is based on single beam single frequency and dual thermopile detector. The control board requires a single voltage input and generates all the necessary internal voltages. The control board outputs the CO2 waveform and performs all calculations for CO2 data and respiration rate, Communication to the Atlas main board is via an internal serial communication interface.

## Indications for Use:

The indications for use for the Atlas Monitor, model numbers 200, 210 and 220 include the monitoring of the following human physiological vital signs:

- Blood Oxygenation (SpO2) measurement .
- ECG waveform derived from 3 or 5 lead measurement .
- Respiration rate/waveform derived from ECG or CO2 .
- Temperature measurement via YSI 400 series probes .
- Non-Invasive Blood Pressure (NIBP) measurement .
- CO2 End-Tidal sidestream/waveform .
- Heart Rate derived from selected source (ECG, SpO2) .

The target populations are adult and pediatric populations. The monitor is intended for use within the healthcare facility setting.

## Technological Comparison to the Predicate Device:

The Atlas Monitor is the same as the Atlas Monitor cleared for market under 510(k) submission K984033. The improved SpO2 channel in the Atlas Monitor is a replacement for the SpO2 channel currently in the Atlas Monitor. Nellcor Puritan Bennett manufactures the SpO2 channel currently in the Atlas Monitor. The improved SpO2 channel is substantially equivalent to the SpO2 channel in the Nellcor model N-395 pulse oximeter. The Nellcor model N-395 was cleared for market under 510(k) submissions K991823 and K993637.

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## Summary of Performance Testing:

The Atlas Monitor and associated accessories have been tested and found to comply with the recognized national and international performance, safety and electromagnetic compatibility standards for medical devices and product specifications listed in the Atlas labeling.

A risk analysis, identifying potential hazards and documenting mitigation of the hazards, has been developed and verified/validated as part of Welch Allyn, Inc. product development procedures. Welch Allyn, Inc. Quality System conforms to 21 CFR 820 and is certified to ISO 9001 and EN46001.

## Conclusions:

As stated above, Welch Allyn, Inc. conclusion is that the Atlas Monitor is safe, effective, comply with the appropriate medical device standards and equivalent to the Atlas Monitor currently on the market.

This 510(k) Summary of Safety and Effectiveness may be copied and submitted to interested parties as required by 21 CFR 807.92

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 26 2002

Mr. Shawn Earle Senior Quality Engineer Welch Allyn, Incorporated 4341 State Road Street Skaneateles, New York 13153

Rc: K022084

Trade/Device Name: Atlas Monitor, Models 200, 210, 220 Regulation Number: 870. 2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 29, 2002 Received: September 3, 2002

Dear Mr. Earle:

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 either class II (Special Controls) or class III (PMA), it may be subject to such 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 docs 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.

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Page 2 - Mr. Earle

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Whilton

Timothy A. Ulatowski 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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#### INDICATIONS FOR USE

#### Applicant:

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220 USA

Telephonc: [phone] Fax: [phone]

501(k) Number: K 022084

Device Name: Atlas Monitor

### Indications for Use:

The indications for use for the Atlas Monitor, model numbers 200, 210 and 220 include the monitoring o the following human physiological vital signs:

- Blood Oxygenation (SpO2) measurement .
- ECG waveform derived from 3 or 5 lead measurement .
- Respiration rate/waveform derived from ECG or CO2 e
- Temperature measurement via YSI 400 series probes .
- Non-Invasive Blood Pressure (NIBP) measurement .
- CO2 End-Tidal side stream/waveform .
- Heart Rate derived from selected source (ECG, SpO2) .

The target populations are adult and pediatic populations. The monitor is intended for use within the healthcare facility setting.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
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| Prescription Use<br>(Per 21 CFR 801.109) | <div></div> |
|------------------------------------------------------------------------------------|-------------|
| Over-The-Counter Use | <div></div> |
| (Division Sign-Off) | <div></div> |
| Division of Anesthesiology, General Hospital,<br>Infection Control. Dental Devices | <div></div> |
| 510(k) Number: | K028084 |