The Passport V monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Passport V include the monitoring of the following human physiological parameters:

ECG waveform derived from 3 or 5 lead measurements
Heart Rate derived from selected sources (ECG, SpO2, IBP)
Pulse Oximetry (SpO2 )
ST Segment Analysis derived from 3 or 5 lead measurements
Arrhythmia Detection derived from 3 or 5 lead measurements
Non Invasive Blood Pressure (NIBP)
Invasive Blood Pressure (IBP) up to two (2) channels .
Carbon Dioxide (CO2)
Respiration Rate derived from ECG or CO2
Temperature
IV Drug Calculations

The Passport V has the capability of interfacing with Datascope Patient Monitoring Central Station and Gas Module products.

Device Description

The Passport V Monitor is a vital signs monitor intended for use in a health care facility under the direct supervision of a licensed healthcare practitioner. The Passport V provides high and low alarm limit settings for systolic, diastolic, mean arterial pressure, pulse rate, and pulse oximetry (SpO2). The Passport V may be powered by a rechargeable Lithium ion battery or through line-power. The Passport V may be equipped with optional infrared or predictive temperature and recorder modules, and may be mounted on an optional rolling stand for easy portability.

AI/ML Overview

The provided 510(k) summary for the Passport V Monitor does not contain specific acceptance criteria or a dedicated study section with detailed performance metrics. It generally states:

"The Passport V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. The device's software has been verified and validated in accordance with the appropriate test requirements."

This indicates that various performance tests were conducted to demonstrate compliance with relevant standards, but the summary does not explicitly list the acceptance criteria or the reported device performance in a table format.

Therefore, many of the requested details cannot be extracted from the given text.

Here's a breakdown of what can be inferred or stated as not available based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the document. The document refers to compliance with "recognized safety, performance and electromagnetic compatibility standards" and "appropriate test requirements" for software verification and validation, but specific numerical or qualitative criteria for each parameter (e.g., accuracy for heart rate, SpO2) are not provided.
Reported Device Performance: Not explicitly stated in the document. The document confirms that the device was tested and found to be in compliance, but it does not present the results of those tests (e.g., measured accuracy, bias, or precision of physiological parameters).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified.
Data Provenance: Not specified.

3. 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):

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

5. 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:

This device is a patient monitor, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant or expected for this type of device and is not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The Passport V monitor is a standalone device with algorithms for various physiological measurements (ECG, SpO2, NIBP, etc.). The statement "The Passport V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards" implies that its standalone performance was evaluated against these standards. However, specific details of these standalone performance tests (e.g., how accuracy of Heart Rate was measured without human intervention) are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For a patient monitor, ground truth would typically involve reference measurement devices (e.g., a calibrated ECG simulator for heart rate accuracy, a reference oximeter for SpO2, a calibrated pressure transducer for blood pressure). The document does not specify the exact methods or reference standards used to establish ground truth for its performance tests.

8. The sample size for the training set:

This device is not described as utilizing a machine learning algorithm that requires a "training set" in the conventional sense (i.e., for an AI model learning from data). It is a traditional patient monitor. Therefore, this information is not applicable and not provided.

9. How the ground truth for the training set was established:

As a traditional patient monitor, the concept of a "training set" and its associated ground truth establishment is not applicable.

Summary

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K091834

JUL 1 5 2009

510(k) Summary Passport V Monitor

This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92.

Date:	June 19, 2009
Submitter:	Datascope Patient Monitoring, Mindray DS USA, Inc.800 MacArthur Blvd.Mahwah, NJ 07430Contact: Kathleen KramerManager, Regulatory and Clinical AffairsTelephone: 201-995-8169Facsimile: 201-995-8605
Device Trade Name:	Passport V Monitor
Common Name:	Multi-parameter patient monitor (with Arrhythmia Detection or Alarms)
Device Classification:	21 CFR 870.1025- Arrhythmia detector and alarm21 CFR 868.1400- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase21 CFR 870.1110- Blood Pressure computer21 CFR 870.1130- Non-invasive blood pressure measurement system21 CFR 870.1425- Programmable diagnostic computer21 CFR 870.2300- Cardiac Monitor (Incl. Cardiotachometer and ratealarm)21 CFR 870.2700- Oximeter21 CFR 880.2910- Monitors, Temperature (with probe)
Predicate Devices:	Spectrum Monitor - K031849PM Series Patient Monitors - K070791Accutorr V Monitor - K091068
Device description:	The Passport V Monitor is a vital signs monitor intended for use ina health care facility under the direct supervision of a licensedhealthcare practitioner.The Passport V provides high and low alarm limit settings forsystolic, diastolic, mean arterial pressure, pulse rate, and pulseoximetry (SpO2). The Passport V may be powered by arechargeable Lithium ion battery or through line-power. ThePassport V may be equipped with optional infrared or predictive

Passport V Monitor 501(k) Summary

Page 1 OF 3

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temperature and recorder modules, and may be mounted on an optional rolling stand for easy portability.

The Passport V monitor is intended for intra hospital use under the Indications for Use: direct supervision of a licensed healthcare practitioner. The indications for use for the Passport V include the monitoring of the following human physiological parameters:

ECG waveform derived from 3 or 5 lead measurements
Heart Rate derived from selected sources (ECG, SpO2, IBP)
Pulse Oximetry (SpO2 )
ST Segment Analysis derived from 3 or 5 lead measurements
. Arrhythmia Detection derived from 3 or 5 lead measurements
Non Invasive Blood Pressure (NIBP) .
Invasive Blood Pressure (IBP) up to two (2) channels
Carbon Dioxide (CO2) .
Respiration Rate derived from ECG or CO2 .
Temperature
IV Drug Calculations .

The target populations are adult, pediatric and neonate with the exception of:

지 Arrhythmia detection and ST Segment Analysis for which the target populations are adult and pediatric only, and
IV Drug Calculations for which the target population is adult only. 교

Technological Comparison to Predicate Device:

The Passport V is substantially equivalent to the predicate devices, the Spectrum Monitor respecting the indications for use, basic operation, performance specifications, energy supply and materials (with the exception of the external housing material). The Passport V is substantially equivalent to the predicates PM Series and Accutorr V Monitors respecting CO2 and SpO2.

Summary of Performance Testing:

The Passport V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards.

A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. The device's software

Passport V Monitor 501(k) Summary

Page 2 of 3

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has been verified and validated in accordance with the appropriate test requirements.

Conclusion:

Based on the description, technological comparison, performance testing and the supporting documentation it can be concluded that the Passport V Monitor is safe, effective and substantially equivalent to the predicate devices.

Passport V Monitor 501(k) Summary

Page 3 OF 3

$\xi$

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the top half of the eagle. The words are in all caps and are in a sans-serif font.

Public Health Service

od and Drug Administration 00 Corporate Boulevard Rockville MD 20850

JUL 1 5 2009

Datascope Patient Monitoring, Mindray DS USA, Inc. c/o Ms. Kathleen Kramer Manager, Regulatory and Clinical Affairs 800 MacArthur Blvd Mahwah, NJ 07430

K091834 Re:

Passport V Monitor Regulation Number: 21 CFR 870. 1025 Regulation Name: Multi-Parameter Patient Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: Class II (two) Product Code: MHX Additional Product Codes: CCK, DSK, DXN, DQK, MSK, DQA, FLL Dated: June 19, 2009 Received: June 22, 2009

Dear Ms. Kramer:

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 r ou may) atols 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.

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Page 2 - Ms. Kathleen Kramer

Please be advised that FDA's issuance of a substantial equivalence determination does 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. 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

7Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and ·Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K091834

Device Name:

PASSPORT V MONITOR

Indications For Use:

ECG waveform derived from 3 or 5 lead measurements
Heart Rate derived from selected sources (ECG, SpO2, IBP)
Pulse Oximetry (SpO2 )
ST Segment Analysis derived from 3 or 5 lead measurements
Arrhythmia Detection derived from 3 or 5 lead measurements
Non Invasive Blood Pressure (NIBP)
Invasive Blood Pressure (IBP) up to two (2) channels .
Carbon Dioxide (CO2)
Respiration Rate derived from ECG or CO2
Temperature
IV Drug Calculations

The target populations are adult, pediatric and neonate with the exception of the:

Arrhythmia detection and ST Segment Analysis for which the target populations are 트 adult and pediatric only, and
IV Drug Calculations for which the target population is adult only I

The Passport V has the capability of interfacing with Datascope Patient Monitoring Central Station and Gas Module products.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
BZuckerma
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Page 1 of

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K091834

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.