(23 days)
No
The summary describes a standard vital signs monitor with no mention of AI or ML capabilities. The functions listed are typical for such devices and do not inherently require AI/ML.
No.
The device is a vital signs monitor, intended for monitoring physiological parameters, not for providing therapy or treatment.
No
Explanation: The device is a vital signs monitor that measures and monitors physiological parameters. While monitoring can be part of a diagnostic process, the device itself does not interpret the data to provide a diagnosis. Its function is to provide raw physiological data and display alarms.
No
The device description explicitly states it is a "vital signs monitor" and mentions hardware components like a rechargeable battery, line-power, optional temperature and recorder modules, and an optional rolling stand. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Passport V Function: The Passport V monitor is described as a vital signs monitor that measures physiological parameters directly from the patient's body. These include ECG, SpO2, NIBP, IBP, CO2, Respiration Rate, and Temperature. These are all measurements taken in vivo (within the living body).
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or samples taken from the patient.
Therefore, the Passport V monitor falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / 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 adult and pediatric only, and
- IV Drug Calculations for which the target population is adult only
The Passport V has the capability of interfacing with Datascope Patient Monitoring Central Station and Gas Module products.
Product codes
MHX, CCK, DSK, DXN, DQK, MSK, DQA, FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric and neonate with the exception of: 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.
Intended User / Care Setting
licensed healthcare practitioner / intra hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Spectrum Monitor - K031849, PM Series Patient Monitors - K070791, Accutorr V Monitor - K091068
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUL 1 5 2009
1
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 07430 | |
| Contact: Kathleen Kramer | |
| Manager, Regulatory and Clinical Affairs | |
| Telephone: 201-995-8169 | |
| 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 |
| 21 CFR 868.1400- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | |
| 21 CFR 870.1110- Blood Pressure computer | |
| 21 CFR 870.1130- Non-invasive blood pressure measurement system | |
| 21 CFR 870.1425- Programmable diagnostic computer | |
| 21 CFR 870.2300- Cardiac Monitor (Incl. Cardiotachometer and rate | |
| alarm) | |
| 21 CFR 870.2700- Oximeter | |
| 21 CFR 880.2910- Monitors, Temperature (with probe) | |
| Predicate Devices: | Spectrum Monitor - K031849 |
| PM Series Patient Monitors - K070791 | |
| Accutorr V Monitor - K091068 | |
| 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 |
Passport V Monitor 501(k) Summary
Page 1 OF 3
1
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
52
2
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
$\xi$
3
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.
4
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
5
Indications for Use
510(k) Number (if known):
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
Page 1 o
Page 1 of
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K091834