ATLAS MONITOR

K984033 · Welch Allyn, Inc. · DRT · Jul 8, 1999 · Cardiovascular

Device Facts

• Record ID: K984033
• Device Name: ATLAS MONITOR
• Applicant: Welch Allyn, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Jul 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• 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

Multiparameter vital signs monitor (models 200, 210, 220) for healthcare facility use; inputs include ECG leads, SpO2 sensors, temperature probes (YSI 400), NIBP cuffs, and CO2 sidestream sampling lines. Device processes physiological signals to display waveforms on CRT and numeric values on LEDs; optional integrated printer. Clinicians use output for real-time patient monitoring and clinical decision-making. Benefits include continuous assessment of patient physiological status.

Clinical Evidence

No clinical data. Effectiveness established via bench testing, design reviews, and verification/validation of software per FDA guidance.

Technological Characteristics

Multiparameter monitor with CRT display and LED indicators. Compatible with YSI 400 series temperature probes. Conforms to EN60601.1, EN60601.1.2, EN60601.2.27, and EN60601.2.30 safety standards. Software developed per FDA Medical Device Software Submissions guidance.

Indications for Use

Indicated for monitoring SpO2, ECG (3/5 lead), respiration rate/waveform (ECG/CO2), temperature (YSI 400 probes), NIBP, CO2 (end-tidal sidestream), and heart rate in adult and pediatric patients within healthcare facilities.

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

• Welch Allyn Inc., Clinical Vital Signs Monitor model 52STP-E1 (K951193)
• BCI International Inc., Capnocheck Plus model 9004 (K970209)
• Datascope Corp., Passport Monitor Model XG (K911598)

Submission Summary (Full Text)

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# "510(k) SUMMARY" Summary of Safety and Effectiveness

| Submitter's Name & Address: | Welch Allyn Inc.<br>4341 State Street Road<br>Skaneateles Falls, New York 13153 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person & Telephone: | Zoran I. Psenicnik<br>[phone] |
| Date Summary Prepared: | Friday, November 06, 1998 |
| Device Name: | Classification Name - Monitor, Cardiac (including cardiotachometer<br>and rate alarm)<br>Common/Usual Name - Vital Signs Monitor<br>Proprietary Name - Atlas Vital Signs Monitor |
| Predicate Device: | Welch Allyn Inc., Clinical Vital Signs Monitor model 52STP-E1 (ref.<br>510(k) #K951193), BCI International Inc., Capnocheck Plus model<br>9004 (ref. 510(k) #K970209, and the Datascope Corp.,<br>Passport Monitor Model XG (ref. 510(k) #K911598). |

Device Description, Intended Use & Effectiveness:

The Atlas Monitor (including model numbers 200, 210, and 220) is a multiparameter 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. An optional printer is available on models 200 and 210 and it comes standard for 220 model.

The indications for use for the Atlas Monitor, include the monitoring of the following human physiological vital signs:

- 0 Blood Oxygenation (SpO2) measurement
- O ECG waveform derived from 3 or 5 Lead measurement
- D Respiration rate/waveform derived from ECG or CO2

D Temperature measurement via YSI 400 series probes

- O Non Invasive Blood Pressure (NIBP) measurement
- 0 CO2 Endtidal sidestream/waveform
- D Heart Rate derived from selected source (ECG, SpO3)

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

## Technological Characteristics:

See attachment "III" for a comparison of the Atlas Monitor to the predicate devices.

## Safety:

The system conforms to the following general safety standards:

| EN60601.1 | Medical Electrical Equipment, Part 1: General requirements<br>for Safety. Amendment 1 (1991), Amendment 2 (1995) |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EN60601.1.2 | Medical Electrical Equipment, Part 1: General requirements<br>for safety 2: Electromagnetic Compatibility - Requirements<br>and tests |
| CE Mark | Conforms with provisions of European Council Directive<br>93/42/EEC concerning medical devices |
| | The system also conforms to the following specific safety standards: |
| EN60601.2.27 | Medical Electronic Equipment, Part 2: Particular<br>Requirements for Safety - Specifications for Safety of<br>Electrocardiographic Monitoring Equipment |
| EN60601.2.30 | Medical Electronic Equipment, Part 2: Particular<br>Requirements for Safety - Specifications for Safety of<br>Automatic Cycling Indirect BP Monitoring Equipment |

#### Summary of Effectiveness:

The design of this device utilizes currently available technology found in many legally marketed devices. Completed design reviews and scheduled testing ensured that the Atlas Monitor performs within the environment(s) for which it is to be marketed. The safety testing is compliant with the indicated standards. The software design and development (including verification and validation testing) was performed using FDA's Reviewers guidance of Medical Device Software Submissions, May 29 1998 and internal company requirements. On the basis of these results and the above referenced testing it is our determination that the device is safe, effective and performs within its design parameters as well as the legally marketed predicate devices. Welch Allyn Inc. will not market this device if it does not completely meet its design intent and safety functions.

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Image /page/2/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three curved lines representing its wings. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 1999

Mr. Zoran Psenicnik WelchAllyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153

Re: K984033 Atlas Monitor Regulatory Class: II (two) Product Code: DRT Dated: April 12, 1999 Received: April 14, 1999

Dear Mr. Psenicnik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements

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concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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, 2 Misbranding by reference to premarket notification? (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J.Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Welch Allyn Atlas Monitor

### 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:

- O Blood Oxygenation (SpO2) measurement
- O ECG waveform derived from 3 or 5 Lead measurement
- Q Respiration rate/waveform derived from ECG or CO2
- □ Temperature measurement via YSI 400 series probes
- വ Non Invasive Blood Pressure (NIBP) measurement
- CO₂, End-tidal sidestream/waveform
- O 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.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-------------------------------------------------------------------|-----------------------------------------------|
| (Division Sign-Off) | for PBT 7/2/99 |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K984033 |
| Prescription Use (Per 21 CFR 801.109) | OR |
| | Over-The-Counter Use (Optional Format 1-2-96) |