SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX

K031849 · Datascope Corp. · MHX · Sep 9, 2003 · Cardiovascular

Device Facts

• Record ID: K031849
• Device Name: SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX
• Applicant: Datascope Corp.
• Product Code: MHX · Cardiovascular
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Spectrum monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Spectrum device include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5 or 12 lead measurements Heart Rate derived from selected sources (ECG, SpO2, IBP, NIBP) Pulse Oximetry (SpO2, ) ST Segment Analysis derived from 3, 5 or 12 ECG lead measurements Arrhvthmia Detection derived from 3, 5 of 12 ECG lead measurements Interpretation of Resting 12 lead ECG Non Invasive Blood Pressure (NIBP) Invasive Blood Pressure (IBP) - up to four (4) channels Cardiac Output Respiration Rate/ waveform derived from ECG or CO2 CO2, inspired and end tidal microstream/ waveform Temperature - up to two channels Hemodynamic Calculations IV Drug Calculations The target populations are adult, pediatric and neonate with the exception of the: Arrhythmia detection, ST Segment Analysis, Cardiac Output, Hemodynamic Calculations, and Pulmonary Artery Wedge Pressure measurements, for which the target populations are adult and pediatric only, and Interpretation of Resting 12 Lead ECG and IV Drug Calculations, for which the target population is adult only. The Spectrum monitor has the capability of interfacing with Datascope's Intra Aortic Balloon Pumps, Central Stations and Gas Module products

Device Story

Spectrum Monitor is a multi-parameter patient monitor for intra-hospital use; displays, trends, and prints physiological data. Inputs: 3/5/12-lead ECG, SpO2 (Masimo/Nellcor), NIBP, IBP (up to 4 channels), respiration, temperature, CO2 (microstream), and anesthetic gases. Device processes signals to provide real-time waveforms and digital values; performs ST/arrhythmia analysis, 12-lead ECG interpretation, and hemodynamic/IV drug calculations. Operated by clinicians in hospital settings. Output displayed on 12.1-inch color screen; optional internal recorder provides hard copies. Interoperable with Datascope Intra-Aortic Balloon Pumps, central stations, and gas modules. Assists clinicians in patient status assessment and clinical decision-making.

Clinical Evidence

Bench testing only. Validation included requirements specification review, hardware and software testing, code design/reviews, environmental/EMC testing, safety testing, and performance testing. No clinical trial data presented.

Technological Characteristics

12.1-inch color display; multi-parameter monitoring (ECG, SpO2, NIBP, IBP, CO2, Temp). Connectivity: interfaces with IABP, central stations, gas modules. Software-based analysis for ST, arrhythmia, 12-lead ECG, and hemodynamic/drug calculations. Modular hardware architecture for external parameters. Sterilization: N/A (non-sterile).

Indications for Use

Indicated for adult, pediatric, and neonate patients for monitoring ECG, heart rate, SpO2, NIBP, IBP, respiration, CO2, and temperature. Adult and pediatric only: arrhythmia detection, ST segment analysis, cardiac output, hemodynamic calculations, and pulmonary artery wedge pressure. Adult only: resting 12-lead ECG interpretation and IV drug calculations. For intra-hospital use under licensed practitioner supervision.

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

• Passport 2® Vital Signs Monitor with View 12 ™ ECG Analysis Module (K020550)
• GE Medical Systems Dash 3000/4000 Patient Monitor (K030431)

Submission Summary (Full Text)

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SEP - 9 2003

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## 510(k) Summary of Safety and Effectiveness

| Date: | June 13, 2003 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Patient Monitoring Division<br>Datascope Corp. |
| Contact Person: | Susan E. Mandy<br>Director, Clinical & Regulatory Affairs<br>Patient Monitoring Division<br>Datascope Corp.<br>Telephone: [phone]<br>Fax: [phone] |
| Device trade name: | Spectrum Monitor |
| Common/usual name: | Multi-parameter patient monitor (with Arrhythmia Detection or Alarms) |
| Classification names: | 21 CFR 868.1400 -Analyzer, Gas,Carbon-Dioxide, Gaseous-Phase<br>21 CFR 870.1025- Arrhythmia detector and alarm<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 870.1435 - Single-function, pre-programmed diagnostic computer<br>21 CFR 870.2300-Cardiac Monitor (Incl. Cardiotachometer and rate alarm)<br>21 CFR 870.2700- Oximeter<br>21 CFR 880.2910-Monitor, Temperature (with probe) |
| Predicate Devices: | K020550 Passport 2® Vital Signs Monitor with View 12 ™ ECG Analysis Module<br>K030431 GE Medical Systems Dash 3000/4000 Patient Monitor |
| Device Description: | The Spectrum Monitor is an enhanced version of the Datascope Corp. Passport 2®<br>Vital Signs Monitor with View 12™ ECG Analysis Module, previously cleared by<br>FDA under K020550. There have been no significant changes to the Passport 2®<br>Vital Signs Monitor with View 12 ™ ECG Analysis Module since its clearance.<br>Datascope Corp. has modified the Passport 2® Vital Signs Monitor with View 12™<br>ECG Analysis Module by including the following parameters: Cardiac Output, Drug<br>Calculations, Hemodynamic Calculations, a second Temperature, and two<br>additional Invasive Blood Pressure Channels.<br>The Spectrum monitor is a device that is used to monitor, display, trend and print a<br>patient's physiological parameters. The device has a 12.1 inch color display and<br>has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, Non-<br>Invasive Blood Pressure (NIBP), Respiration, Continuous Temperature and IV Drug<br>Calculations. Optional software includes ST and Arrhythmia Analysis. Optional<br>hardware features include View12 ECG Analysis Module (which includes ST |

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Arrhythmia and 12 Lead interpretation), up to 4 Invasive Blood Pressure Channels, Microstream CO2, Anesthetic Gases, Nellcor Oxismart SpO2, second temperature source, dual trace recorder, and Cardiac Output. A comprehensive calculation package including Hemodynamic Calculations is available if the Spectrum is equipped with an External Parameter Module.

Digital displays are provided for Heart Rate, NIBP, SpO2, Respiration Rate, and Temperature. Optional digital displays are provided for up to four Invasive Blood Pressure, Anesthetic Agents, O2, and N20, ST and CO2, The optional internal recorder provides hard copies of all digital data and waveforms, as well as trend information.

- The Spectrum monitor is intended for intra- hospital use under the direct Intended Use: supervision of a licensed healthcare practitioner. The indications for use for the Spectrum device include the monitoring of the following human physiological parameters:
ECG waveform derived from 3, 5 or 12 lead measurements Heart Rate derived from selected sources (ECG, SpO2, IBP, NIBP) Pulse Oximetry (SpO2, ) ST Segment Analysis derived from 3, 5 or 12 ECG lead measurements Arrhvthmia Detection derived from 3, 5 of 12 ECG lead measurements Interpretation of Resting 12 lead ECG Non Invasive Blood Pressure (NIBP) Invasive Blood Pressure (IBP) - up to four (4) channels Cardiac Output Respiration Rate/ waveform derived from ECG or CO2 CO2, inspired and end tidal microstream/ waveform Temperature - up to two channels Hemodynamic Calculations IV Drug Calculations

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

Arrhythmia detection, ST Segment Analysis, Cardiac Output, Hemodynamic Calculations, and Pulmonary Artery Wedge Pressure measurements, for which the target populations are adult and pediatric only, and Interpretation of Resting 12 Lead ECG and IV Drug Calculations, for which the target population is adult only.

The Spectrum monitor has the capability of interfacing with Datascope's Intra Aortic Balloon Pumps, Central Stations and Gas Module products

The Spectrum Monitor is substantially equivalent to the Passport 20 Vital Signs Technology: Monitor with View 12 ™ ECG Analysis Module ( K020550) and the GE Medical Systems Dash 3000/4000 Patient Monitor ( K030431).

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The Spectrum Monitor complies with the voluntary standards identified in section Test Summary: six of this submission. Datascope's product development process required that the following activities be completed during the development of the Spectrum monitor:

> Requirements specification review Hardware and software testing Code design and code reviews Environmental/EMC testing Safety testing Performance testing Hardware and Software validation

Conclusion:

The results of all testing demonstrate that the Spectrum Monitor is as safe, as effective, and performs as well as the predicate devices.

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Public Health Service

Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an emblem featuring a stylized image of an eagle or bird with three distinct head profiles, creating a sense of depth and dimension.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2003

Datascope Corporation c/o Ms. Susan E. Mandy Director, Clinical and Regulatory Affairs Patient Monitoring Division 800 MacArthur Blvd. Mahwah, NJ 07430-0619

Re: K031849

Trade Name: Spectrum Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm. Regulatory Class: Class III (three) Product Code: MHX Dated: June 13, 2003 Received: June 16, 2003

Dear Ms. Mandy:

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 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 (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 mav publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Susan E. Mandy

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/dsma/dsmamain.html

> Sincerely yours, Bram D. Zuckerman, M.D. Director

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K031849

Device Name: Spectrum Patient Monitor

Indications For Use:

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

- ECG waveform derived from 3, 5 or 12 lead measurements .
- . Heart Rate derived from selected sources (ECG, SpO3, IBP, NIBP)
- Pulse Oximetry (SpO2, )
- ST Segment Analysis derived from 3, 5 or 12 ECG lead measurements ●
- . Arrhythmia Detection derived from 3, 5 of 12 ECG lead measurements
- Interpretation of Resting 12 lead ECG ●
- . Non Invasive Blood Pressure (NIBP)
- . Invasive Blood Pressure (IBP) - up to four (4) channels
- Cardiac Output
- Respiration Rate/ waveform derived from ECG or CO2 .
- CO2, inspired and end tidal microstream/ waveform .
- . Temperature - up to two (2) channels
- Hemodynamic Calculations .
- . IV Drug Calculations

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

- Arrhythmia detection, ST Segment Analysis, Cardiac Output, Hemodynamic � Calculations, for which the target populations are adult and pediatric only, and
- � Interpretation of Resting 12 Lead ECG and IV Drug Calculations for which the target population is adult only.

The Spectrum monitor has the capability of interfacing with Datascope's Intra Aortic Balloon Pumps, Central Stations and Gas Module products.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vellatt

510(k) Num

Prescription Use Only

(Optional Format 3-10-98)