PASSPORT V MONITOR, MODEL 0998-00-6100

K091834 · Datascope Corp., Patient Monitoring Division · MHX · Jul 15, 2009 · Cardiovascular

Device Facts

• Record ID: K091834
• Device Name: PASSPORT V MONITOR, MODEL 0998-00-6100
• Applicant: Datascope Corp., Patient Monitoring Division
• Product Code: MHX · Cardiovascular
• Decision Date: Jul 15, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Passport V Monitor is a multi-parameter vital signs monitor for intra-hospital use under licensed practitioner supervision. Inputs include ECG (3/5 lead), SpO2, IBP, NIBP, CO2, and temperature sensors. Device processes physiological signals to provide real-time waveforms, numerical values, and alarm notifications for high/low limits. Features include ST segment analysis, arrhythmia detection, and IV drug calculations. Powered by rechargeable Lithium-ion battery or line-power; supports optional temperature/recorder modules and rolling stand. Output displayed on-screen for clinician review to support immediate clinical decision-making. Interoperable with central stations and gas modules. Benefits include continuous patient surveillance and timely identification of physiological changes.

Clinical Evidence

Bench testing only. Device compliance with recognized safety, performance, and electromagnetic compatibility standards verified. Risk analysis performed to identify hazards and document mitigations. Software verified and validated per requirements.

Technological Characteristics

Multi-parameter monitor; inputs include ECG, SpO2, IBP, NIBP, CO2, temperature. Powered by rechargeable Lithium-ion battery or line-power. Features optional infrared/predictive temperature and recorder modules. Connectivity includes interface with central stations and gas modules. Software-based analysis for arrhythmia, ST segment, and IV drug calculations.

Indications for Use

Indicated for intra-hospital monitoring of ECG, heart rate, SpO2, ST segment, arrhythmia, NIBP, IBP, CO2, respiration rate, temperature, and IV drug calculations. Target populations: adults, pediatrics, and neonates. Contraindications: Arrhythmia detection and ST segment analysis limited to adults and pediatrics; IV drug calculations limited to adults.

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

• Spectrum Monitor (K031849)
• PM Series Patient Monitors (K070791)
• Accutorr V Monitor (K091068)

Submission Summary (Full Text)

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K091834

JUL 1 5 2009

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## 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.<br>800 MacArthur Blvd.<br>Mahwah, NJ 07430<br>Contact: Kathleen Kramer<br>Manager, Regulatory and Clinical Affairs<br>Telephone: [phone]<br>Facsimile: 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 alarm<br>21 CFR 868.1400- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase<br>21 CFR 870.1110- Blood Pressure computer<br>21 CFR 870.1130- Non-invasive blood pressure measurement system<br>21 CFR 870.1425- Programmable diagnostic computer<br>21 CFR 870.2300- Cardiac Monitor (Incl. Cardiotachometer and rate<br>alarm)<br>21 CFR 870.2700- Oximeter<br>21 CFR 880.2910- Monitors, Temperature (with probe) |
| Predicate Devices: | Spectrum Monitor - K031849<br>PM Series Patient Monitors - K070791<br>Accutorr V Monitor - K091068 |
| Device description: | The Passport V Monitor is a vital signs monitor intended for use in<br>a health care facility under the direct supervision of a licensed<br>healthcare practitioner.<br>The Passport V provides high and low alarm limit settings for<br>systolic, diastolic, mean arterial pressure, pulse rate, and pulse<br>oximetry (SpO2). The Passport V may be powered by a<br>rechargeable Lithium ion battery or through line-power. The<br>Passport V may be equipped with optional infrared or predictive |

Passport V Monitor 501(k) Summary

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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

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52

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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

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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 [phone]. 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 [phone] or [phone] 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:

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