(91 days)
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.
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 |
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 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.
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.
The end tidal CO2 (ETCO>) measurement is performed by utilizing an OEM PCB from Prvon Corporation. 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.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Welch Allyn Atlas Monitor. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain the detailed performance testing results, acceptance criteria, or study design information typically found in a clinical study report or a more comprehensive validation document.
Therefore, I cannot populate most of the requested fields because the information is not present in the provided text.
Here's what can be extracted:
Acceptance Criteria and Device Performance (Limited Information)
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Overall Safety and Effectiveness | "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." | |
| "Welch Allyn, Inc. conclusion is that the Atlas Monitor is safe, effective,... and equivalent to the Atlas Monitor currently on the market." | |
| ECG Performance | "The ECG front end will meet all applicable AAMI and harmonized EU standards..." |
| SpO2 Performance | The improved SpO2 channel is stated to be "substantially equivalent to the SpO2 channel in the Nellcor model N-395 pulse oximeter." (This implies it meets the performance characteristics of the predicate, but specific criteria for the Atlas Monitor itself are not detailed.) |
Missing Information (Not found in the provided text):
- Sample size used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. This type of device does not typically rely on expert human interpretation for its outputs like an AI diagnostic tool would. Its performance is validated against established measurement standards for vital signs.
- Adjudication method: Not applicable/specified.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a vital signs monitor, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The monitor operates standalone in terms of its vital signs acquisition and display. The summary indicates it was "tested and found to comply with recognized national and international performance, safety and electromagnetic compatibility standards," which implies standalone performance evaluation against these standards. However, specific details of these tests are not provided.
- The type of ground truth used: For vital signs monitors, ground truth is typically established using calibrated reference devices or validated physiological models according to recognized standards (e.g., AAMI, ISO standards). The document states compliance with "recognized national and international performance, safety and electromagnetic compatibility standards," which would implicitly define the ground truth methods used, but doesn't explicitly state them.
- The sample size for the training set: Not applicable. This product is a vital signs monitor, not an AI/machine learning device that requires a "training set" in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
510(k) Summary of Safety and Effectiveness
May 28, 2002
Submitter Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153
Telephone: (315) 685-4602 Fax: (315) 685-4091
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 |
{1}------------------------------------------------
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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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
{4}------------------------------------------------
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.
{5}------------------------------------------------
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{6}------------------------------------------------
INDICATIONS FOR USE
Applicant:
Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220 USA
Telephonc: (315) 685-4602 Fax: (315) 685-4091
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) |
|---|
| -------------------------------------------------------- |
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| Over-The-Counter Use | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital,Infection Control. Dental Devices | |
| 510(k) Number: | K028084 |
§ 870.2700 Oximeter.
(a)
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.(b)
Classification. Class II (performance standards).