PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX

K993531 · Datascope Corp. · DSI · Jan 13, 2000 · Cardiovascular

Device Facts

• Record ID: K993531
• Device Name: PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
• Applicant: Datascope Corp.
• Product Code: DSI · Cardiovascular
• Decision Date: Jan 13, 2000
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Passport 2 Vital Signs monitor is designed to monitor and display the following physiological parameter: ECG, Heart Rate derived from selected sources (SpO2, ECG, IBP and NIBP), SpO, level, ST Segment, Arrhythmia, Blood Pressure (both Invasive and Non-Invasive), Respiration Rate (derived from ECG or CO2), inspired or expired CO2, Temperature, and Gases (i.e., Five Anesthetic Gases, O2, N2O, and CO2). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs. The target populations are adult, pediatric and neonate, with the exception of the Lethal Arrhythmia Detection and ST Segment Analysis functions for which the target populations are adult and pediatric only. The monitor is intended for use in the health care facility setting. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse, anesthetists, or other hospital personnel trained in the use of the equipment. The Passport 2 Vital Signs monitor is not recommended for use in a patient's home or residence, during patient transport other than intra-hospital, or when it has not been ordered by a physician.

Device Story

Passport 2 is a transportable, multi-parameter physiological monitor for healthcare facilities. It collects inputs via ECG leads, SpO2 sensors, NIBP cuffs, IBP transducers, temperature probes, and CO2/gas modules. The device processes these signals to display real-time waveforms and numeric values, providing audible and visual alarms for parameter excursions. It supports connectivity to central stations, defibrillators, and nurse call systems. Physicians and nurses use the output to assess patient status and make clinical decisions. The device benefits patients by providing continuous, integrated monitoring of vital signs, enabling timely intervention for physiological abnormalities.

Clinical Evidence

Bench testing only. The device underwent extensive safety and performance testing to ensure compliance with functional requirements and industry standards, including ANSI/AAMI EC13, EC 11, SP-10, and various IEC 60601 series standards for electrical safety, electromagnetic compatibility, and software safety.

Technological Characteristics

Multi-parameter monitor with ECG, SpO2, NIBP/IBP, CO2, temperature, and gas monitoring capabilities. Uses YSI 400/700 series temperature probes. Connectivity via Comm Port to central stations, gas modules, and defibrillators. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-4 standards. Software-based alarm generation and signal processing.

Indications for Use

Indicated for monitoring ECG, heart rate, SpO2, ST segment, arrhythmia, invasive/non-invasive blood pressure, respiration rate, CO2, temperature, and anesthetic gases in adult, pediatric, and neonatal patients. Lethal arrhythmia detection and ST segment analysis are indicated for adult and pediatric patients only. Intended for use in healthcare facilities by trained medical personnel.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Spacelabs Ultraview 1050 Monitor (K972282 & K972502)
• Marquette Eagle 3000/3100 monitor (K961139, K960272 & K960418)
• Datascope Passport 5L-CE Vital Signs monitor (K974178)

Reference Devices

• Datascope Accutorr Plus NIBP monitor (K983575)
• Masimo SET 2000 Pulse Oximeter (K974903)
• MediCO2 Microstream CO2 module (K964239)
• Datascope Gas Module II (K974903)
• Datascope Visa Central Station monitor (K913576)
• Datascope Defibrillator (K930548)
• Masimo SET 2000 Pulse Oximeter Technology and Accessories (K990966)

Submission Summary (Full Text)

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K993531

# 510(k) Summary Datascope Passport 2TM Vital Signs Monitor

| Submitter: | Datascope Corp.<br>Patient Monitoring Division<br>580 Winters Avenue<br>Paramus, NJ 07652<br>Tel: [phone]<br>Fax: [phone] |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Susan E. Mandy<br>Manager, Clinical and Regulato<br>Datascope Corp. |

ory Affairs Patient Monitoring Division 580 Winters Avenue Paramus, NJ 07652 Tel: [phone] Fax: [phone]

Date Prepared: ● October 15, 1999

## Name of the device:

- Passport 2™ Vital Signs Monitor ● Trade/Proprietary Name:
Please note that during the product development process, the device was also referred to as "Enterprise" and "Enterprise Configured Monitor" (or "ECM") and these names will be found in some of the supporting documentation included in this submission.

- Multi-parameter patient monitoring system ● Common Name:

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| ● Classification: | | | |
|-------------------|------------------------------------------------------------|--------|----------|
| 21 CFR 870.1025 | Arrhythmia detector and alarm | 74 DSI | Class II |
| 21 CFR 870.1110 | Blood Pressure computer | 74 CAA | Class II |
| 21 CFR 870.1130 | Noninvasive blood pressure measurement<br>System | 74 BXD | Class II |
| 21 CFR 868.1400 | Analyzer, Gas,Carbon-Dioxide,<br>Gaseous-Phase | 73 CCK | Class II |
| 21 CFR 880.2910 | Monitor, Temperature (with probe) | 80 BWX | Class II |
| 21 CFR 870.2300 | Cardiac Monitor (Incl. Cardiotachometer<br>and rate alarm) | 74 DRT | Class II |
| 21 CFR 870.2700 | Oximeter | 74 BWS | Class II |

#### Legally Marketed Predicate Devices:

This submission compares the performance specifications and functionality of the Passport 2 Vital Signs Monitor with those of several similar devices: the Spacelabs Ultraview 1050 Monitor (K972282 & K972502), Marquette Eagle 3000/3100 monitor (K961139, K960272 & K960418), and Datascope Passport 5L-CE Vital Signs monitor (K974178). The functionality of the Passport 2 Vital Signs monitor is identical to that of the Spacelabs Ultraview 1050 monitor and Marquette Eagle 3000/3100 monitor.

In addition, several functions of the Passport 2 employ technology incorporated into previously cleared devices, and several modules or other devices that may be connected to the Passport 2 have received separate clearances from the Agency, as follows:

- The NIBP measurement system used in the Passport 2 is the same as that used in 1. Datascope's Accutorr Plus NIBP monitor, cleared under 510(k) Notification K983575.
- 2. The SpO2 measurement system used in the Passport 2 is the same as that used in the Masimo SET 2000 Pulse Oximeter, cleared under 510(k) Notification K974903.
- 3. The optional MediCO, Microstream CO2 module was cleared under 510(k) Notification K964239.
- The optional Datascope Gas Module II, to which the Passport 2 can be connected, 4. was cleared under 510(k) Notification K974903.
- Datascope's Visa Central Station monitor, to which the Passport 2 can be న్. connected, was cleared under 510(k) Notification K913576.
- Datascope's Defibrillator, to which the Passport 2 can be connected, was cleared 6. under 510(k) Notification K930548.

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#### Description:

Passport 2 is a transportable, multi-parameter physiological monitor designed to monitor ECG, Heart Rate derived from selected source (SpO2, ECG, IBP and NIBP), SpO2 level, ST Segment (adult and pediatric only), Arrhythmia (adult and pediatric only), Blood Pressure (both Invasive and Non-Invasive), Respiration Rate (derived from ECG or CO2), CO2 and Temperature, and for adult, pediatric, and neonatal patients who are under the care of a physician, within the confines of a health care facility.

The Passport 2 can display measurements of five Anesthetic Gases (Halothane, Enflurane, Isoflurane, Sevoflurane, and Desflurane), O2, No O, and CO2 via connection to the stand alone Gas Module II ( K974903). The optional MediCO2 Microstream™ CO2 module (K964239), which uses the Oridion Microstream™ CO2 provides EtCO2, FiCO2 and Respiration Rate monitoring.

The optional built-in recorder provides hard copies of all digital data and waveforms as well as Tabular & Graphic Trend Information. Through its Comm Port the Passport 2 can communicate with the Visa Central Station (K913576), Gas Module II (K974903), Defibrillator (K930548), a Hospital's Nurse Call System or a Remote Color Display.

## Statement of Intended Use:

The Passport 2 Vital Signs monitor is designed to monitor and display the following physiological parameter: ECG, Heart Rate derived from selected sources (SpO2, ECG, IBP and NIBP), SpO, level, ST Segment, Arrhythmia, Blood Pressure (both Invasive and Non-Invasive), Respiration Rate (derived from ECG or CO2), inspired or expired CO2, Temperature, and Gases (i.e., Five Anesthetic Gases, O2, N2O, and CO2). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.

The target populations are adult, pediatric and neonate, with the exception of the Lethal Arrhythmia Detection and ST Segment Analysis functions for which the target populations are adult and pediatric only.

The monitor is intended for use in the health care facility setting. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse, anesthetists, or other hospital personnel trained in the use of the equipment.

The Passport 2 Vital Signs monitor is not recommended for use in a patient's home or residence, during patient transport other than intra-hospital, or when it has not been ordered by a physician.

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#### Comparison of Technological Characteristics

The Passport 2 Vital Signs monitor is substantially equivalent to a combination of systems currently marketed by Spacelabs Medical, Marquette, and Datascope Corp. The design, components, storage technology and energy source of the Passport 2 are similar to those of its predicate devices. All these systems provide a means for interfacing with a patient, collecting parameter specific physiological data, and processing the data for alarm generation and display of numeric values and waveforms on a bedside or central monitoring system. There is only one notable difference between the technical specifications of the Passport 2 Vital Signs monitor and those of the three comparable systems described above. This difference relates to the Passport 2's measurement range for Systolic and Diastolic Pressure in the Pediatric Mode. In this instance, however, the specifications of the Passport 2 are identical to those of another previously cleared device, as the Passport 2 uses the NIBP algorithm from the Accutorr Plus Non Invasive Blood Pressure Monitor (K983575). Therefore, the NIBP function of the Passport 2 is substantially equivalent to the NIBP function of a previously cleared device.

# Testing:

The Passport 2 Vital Signs monitor has been subject to extensive safety and performance testing. Final testing for the monitor included various performance tests designed to ensure that the device meets all functional requirements and performance specifications. Some safety testing has been performed by third party agencies to ensure the device complies to applicable industry and safety standards. The Passport 2 Vital Signs monitor has also been tested to assure compliance to the requirements of various published standards, including ANSI/AAMI EC13 and EC 11, AAMI ECAR-1987, EN 864-1997, EN 865-1997, ANSI/AAMI SP-10, IEC 60601-1 (1988-12) with Amendment 1 (1991-11) & Amendment 2 (1995-03), IEC 60601-1-1 (1992-06) with Amendment 1 (1995-11), IEC 60601-1-2 (1993-04), IEC 60601-1-4 (1996-05), IEC 60601-2-27, IEC 60601-2-30, and EN 1441 (1997).

In conclusion, the Passport 2 Vital Signs monitor is substantially equivalent to the predicate devices and raises no new issues of safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three lines representing the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2000

Russell Olsen Director, Quality and Regulatory Affairs Datascope Corporation Patient Monitoring Division 580 Winters Avenue Paramus, NJ 07652

Re: K993531 Passport 2 Vital Signs Monitor Requlatory Class: III (three) Product Code: DSI Dated: October 16, 1999 Received: October 18, 1999

Dear Mr. Olsen:

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 A substantially equivalent determination assumes compliance to 895. 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 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.

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Page 2 - Mr. Russell Olsen

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, "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,

James Chang

or Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATION FOR USE STATEMENT

The indications for use for the Passport 2™ include the monitoring of the following human physiological parameters:

- ECG waveform derived from 3 or 5 lead measurements
- Heart Rate derived from selected sources (SpO2, ECG, IBP, NIBP)
- Blood Oxygenation (SpO2 )* measurement/waveform
- ST Segment Analysis
- . . Lethal Arrhythmia Detection
- Non Invasive Blood Pressure (NIBP) measurement
- . Invasive Blood Pressure (IBP) measurement/waveform measurable at two sites
- Respiration Rate/ waveform derived from ECG or CO2
- CO2 . Inspired and end tidal mainstream/waveform
- Temperature measurement via YSI 400/700 series probes

The target populations are adult, pediatric and neonate with the exception of the Lethal Arrhythmia Detection and ST Segment Analysis for which the target populations are adult and pediatric only. The monitor is intended for use in the health care facility setting.

The Passport 2 has the capability of interfacing with Datascope's Gas Module II, displaying the measurements of Anesthetic Gases, O3, N2O, and CO2.

* The Passport 2 monitors the SpO2 parameter via the Masimo SET® 2000 Pulse Oximeter Technology and Accessories (K990966). The Masimo SET® 2000 Pulse Oximeter Technology and Accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO,) and pulse rate (measured by an SpO2, sensor) and are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities. mobile, and home environments.

Sumes C
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_K99 353