PASSPORT 5L-CE MODEL 0998-00-0131XXX

K974178 · Datascope Corp. · DRT · Jun 26, 1998 · Cardiovascular

Device Facts

• Record ID: K974178
• Device Name: PASSPORT 5L-CE MODEL 0998-00-0131XXX
• Applicant: Datascope Corp.
• Product Code: DRT · Cardiovascular
• Decision Date: Jun 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The indications for use for the Passport 5L-CE Monitor include the monitoring of the following human physiological vital signs: - 0 Blood Oxygenation (SpO2) measurement/waveform - ECG waveform derived from 3 or 5 Lead measurements 0 - O Respiration rate/waveform derived from ECG or CO2 - Temperature measurement via YSI 400/700 series probes ೦ - o Invasive Blood Pressure (IBP) measurement/waveform measurable at two sites - 0 Non Invasive Blood Pressure (NIBP) measurement - o CO2, Inspired and end tidal mainstream/waveform - Heart Rate derived from selected source ((SpO2, ECG, IBP, NIBP) o

Device Story

Passport 5L-CE is a multi-parameter vital signs monitor; inputs include ECG leads, SpO2 sensors, temperature probes, IBP transducers, NIBP cuffs, and CO2 sensors. Device processes physiological signals to display real-time waveforms and numerical values for heart rate, respiration, blood pressure, oxygenation, and temperature. Used in clinical environments by healthcare professionals to track patient status. Output provides continuous monitoring data to assist clinicians in assessing patient condition and making timely clinical decisions. Benefits include real-time physiological oversight and early detection of patient status changes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-parameter monitor; supports 3/5 lead ECG, SpO2, YSI 400/700 series temperature probes, IBP, NIBP, and mainstream CO2. Provides waveform and numerical data display.

Indications for Use

Indicated for monitoring human physiological vital signs including SpO2, ECG (3/5 lead), respiration rate, temperature (YSI 400/700), invasive/non-invasive blood pressure, CO2, and heart rate in clinical settings.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 26 1998

Mr. Russell Olsen Director, Product Assurance and Quality Engineering Datascope Corporation Patient Monitoring Division 580 Winters Avenue Paramus, NJ 07652

K974178 Re: Passport 5L-CE Vital Signs Monitor Regulatory Class: II (two) Product Code: DRT Dated: April 3, 1998 Received: April 6, 1998

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 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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory 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

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for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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" (21 CFR 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/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page I of I

510(k) Number (if known): K974178

Device Name: Passport 5L-CE

Indications For Use:

The indications for use for the Passport 5L-CE Monitor include the monitoring of the following human physiological vital signs:

- 0 Blood Oxygenation (SpO2) measurement/waveform
- ECG waveform derived from 3 or 5 Lead measurements 0
- O Respiration rate/waveform derived from ECG or CO2
- Temperature measurement via YSI 400/700 series probes ೦
- o Invasive Blood Pressure (IBP) measurement/waveform measurable at two sites
- 0 Non Invasive Blood Pressure (NIBP) measurement
- o CO2, Inspired and end tidal mainstream/waveform
- Heart Rate derived from selected source ((SpO2, ECG, IBP, NIBP) o

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use XX (Per 21 CFR 801.109) OR

Over-The-Counter Use__

(Optional Format 1-2-96)

V. Miller

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K974178