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.

Device 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.

AI/ML Overview

The provided 510(k) summary for the Datascope Passport 2™ Vital Signs Monitor describes its intended use and general performance testing, but it does not contain specific acceptance criteria tables nor detailed studies proving the device meets those criteria.

Instead, the document primarily:

Identifies legally marketed predicate devices to establish substantial equivalence.
States that the device has undergone "extensive safety and performance testing" to ensure it "meets all functional requirements and performance specifications" and complies with various industry standards (e.g., ANSI/AAMI EC13, IEC 60601-1 series).
Mentions that certain components (NIBP system, SpO2 system, CO2 module, Gas Module II) are identical to or incorporate technology from previously cleared devices, making their performance substantially equivalent by reference.

Therefore, many of the requested details about specific acceptance criteria and the studies proving their achievement are not explicitly present in the provided text.

However, I can extract and infer information where possible based on the text provided.

Acceptance Criteria and Device Performance

The document does not provide a table of specific numerical acceptance criteria for each physiological parameter (e.g., accuracy range for NIBP, arrhythmia detection sensitivity/specificity) and the reported performance. It only states that the device was tested to "meet all functional requirements and performance specifications."

For example, for Non-Invasive Blood Pressure (NIBP), it notes:

Acceptance Criteria (Implied): The NIBP measurement system used in the Passport 2 is the same as that used in Datascope's Accutorr Plus NIBP monitor (K983575). Therefore, the implied acceptance criteria would be those met by the Accutorr Plus, likely conforming to standards like ANSI/AAMI SP-10.
Reported Device Performance: Not explicitly stated for Passport 2, but stated to be "identical" to the Accutorr Plus NIBP monitor.

Similarly, for SpO2:

Acceptance Criteria (Implied): The SpO2 measurement system is the same as that used in the Masimo SET 2000 Pulse Oximeter (K974903 and K990966). The implied acceptance criteria would be those met by the Masimo SET 2000, likely conforming to standards like ISO 80601-2-61.
Reported Device Performance: Not explicitly stated for Passport 2, but stated to be "identical" to the Masimo SET 2000 Pulse Oximeter.

For other parameters (ECG, Arrhythmia, Respiration Rate, CO2, Temperature), the document states that the Passport 2 was tested to comply with relevant standards (e.g., ANSI/AAMI EC13 and EC 11, AAMI ECAR-1987, EN 864-1997, EN 865-1997, IEC 60601-2-27, IEC 60601-2-30). However, the specific performance values (e.g., error margins, sensitivity/specificity rates) are not quantified in this summary.

Detailed Study Information (Based on Available Text)

Since no specific studies are detailed within this 510(k) summary, the following points are based on what can be inferred or stated as not provided:

A table of acceptance criteria and the reported device performance:
- Not provided in this summary. The document broadly states that the device "meets all functional requirements and performance specifications" and complies with various standards. For NIBP and SpO2, it refers to the performance of previously cleared devices whose technology is incorporated.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided in this summary. Details on specific test subjects (number, age, health status) or the nature of data (retrospective/prospective, origin) for any performance testing are absent. The primary testing mentioned is "safety and performance testing" which generally implies in-house verification and validation, possibly against simulators or human subjects for certain parameters, but details are missing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not provided in this summary. Ground truth establishment, if applicable to the device's functions (e.g., for arrhythmia detection comparison), is not discussed. For vital sign monitors, ground truth is typically established by reference devices or calibrated instruments.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided in this summary. Adjudication methods are typically relevant for subjective assessments or expert consensus in interpretation tasks, which are not detailed here for a vital signs monitor.
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/Not provided. This device is a vital signs monitor, not an AI-assisted diagnostic tool that involves "human readers" interpreting "cases" or "effect sizes of human improvement with AI." Its function is direct physiological measurement and display.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implied. The device itself is a standalone monitor that performs measurements (e.g., ECG, NIBP, SpO2) and algorithms (e.g., arrhythmia detection, ST segment analysis) without requiring human interpretation for its core function. Testing would focus on the accuracy and reliability of these algorithms against reference standards. The summary states "Final testing for the monitor included various performance tests designed to ensure that the device meets all functional requirements and performance specifications." This directly points to standalone performance testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Implied by device type. For vital signs monitors, ground truth is typically established using:
  - Reference standard instruments: For parameters like SpO2 (e.g., co-oximetry), NIBP (e.g., invasive arterial line measurement or a highly accurate reference NIBP device), Temperature (calibrated thermometer).
  - Standardized waveforms/inputs: For ECG feature detection (e.g., arrhythmia detection, ST segment analysis), validated databases of ECG signals or simulated signals with known characteristics may be used.
- Explicit details are not in the summary.
The sample size for the training set:
- Not applicable/Not provided. This document describes a traditional medical device, not a machine learning or AI-based system that uses a "training set" in the context of data-driven model development. The algorithms for vital sign processing in this device would have been developed through engineering principles, signal processing, and physiological modeling, not through training on large datasets in the modern AI sense.
How the ground truth for the training set was established:
- Not applicable/Not provided. As stated above, there is no "training set" in the AI/ML sense described for this device.

Summary

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K993531

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

Submitter:	Datascope Corp.Patient Monitoring Division580 Winters AvenueParamus, NJ 07652Tel: 800/288-2121Fax: 201-967-3686
Contact Person:	Susan E. MandyManager, Clinical and RegulatoDatascope Corp.

ory Affairs Patient Monitoring Division 580 Winters Avenue Paramus, NJ 07652 Tel: 201/967-2229 Fax: 201/967-3686

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 measurementSystem	74 BXD	Class II
21 CFR 868.1400	Analyzer, Gas,Carbon-Dioxide,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. Cardiotachometerand 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.
1. 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.
1. 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:

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 (301) 594-4648. 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 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.