SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX by DATASCOPE CORP.

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

Device Description

The Spectrum Monitor is an enhanced version of the Datascope Corp. Passport 2® Vital Signs Monitor with View 12™ ECG Analysis Module, previously cleared by FDA under K020550. There have been no significant changes to the Passport 2® Vital Signs Monitor with View 12 ™ ECG Analysis Module since its clearance. Datascope Corp. has modified the Passport 2® Vital Signs Monitor with View 12™ ECG Analysis Module by including the following parameters: Cardiac Output, Drug Calculations, Hemodynamic Calculations, a second Temperature, and two additional Invasive Blood Pressure Channels. The Spectrum monitor is a device that is used to monitor, display, trend and print a patient's physiological parameters. The device has a 12.1 inch color display and has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, Non- Invasive Blood Pressure (NIBP), Respiration, Continuous Temperature and IV Drug Calculations. Optional software includes ST and Arrhythmia Analysis. Optional hardware features include View12 ECG Analysis Module (which includes ST 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.

AI/ML Overview

The provided text describes a 510(k) summary for the "Spectrum Monitor" and a clearance letter from the FDA. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study design, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies is not available in the provided document.

However, I can extract the general claims about testing and the overall conclusion.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy thresholds) and corresponding reported performance metrics are not detailed. The document states that the device was subjected to various tests and complies with voluntary standards, implicitly suggesting performance met certain established benchmarks.

Acceptance Criteria Category	Reported Device Performance
General Safety & Effectiveness	"The Spectrum Monitor complies with the voluntary standards identified in section six of this submission."
"The results of all testing demonstrate that the Spectrum Monitor is as safe, as effective, and performs as well as the predicate devices."
Specific Parameter Performance	Not explicitly detailed for individual parameters (ECG, SpO2, NIBP, Arrhythmia Detection, etc.) within this summary. The device is described as enhanced and including additional parameters compared to its predicate.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the given 510(k) summary. The document does not describe a clinical study with a defined test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given 510(k) summary. There is no mention of expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided as no specific test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

This information is not provided. The document does not describe an MRMC study or any comparison of human readers with and without AI assistance. The focus is on the device's performance compared to predicate devices, not on improving human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

While the device itself is a standalone monitor, the document does not detail specific "algorithm only" performance studies in a way that aligns with typical AI/algorithm standalone studies. It broadly mentions "Hardware and Software validation" and "Performance testing" but does not break down the results for specific algorithms independently. Given the device's nature as a multi-parameter patient monitor, its performance inherently involves algorithms, but a distinct "standalone" performance study akin to AI diagnostic tools is not described.

7. The Type of Ground Truth Used

The type of ground truth used for performance testing (e.g., expert consensus, pathology, outcomes data) is not specified in the provided summary. The document states "Performance testing" and "Hardware and Software validation" were conducted, implying ground truth was established to verify these, but the method is not elaborated upon.

8. The Sample Size for the Training Set

This information is not provided. There is no mention of a "training set" in the context of this 510(k) summary, as the device is presented as an enhanced version of an existing monitor rather than a new AI model requiring a distinct training phase description.

9. How the Ground Truth for the Training Set was Established

This information is not provided as no training set is described.

Summary

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K031849
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510(k) Summary of Safety and Effectiveness

Date:	June 13, 2003
Submitter:	Patient Monitoring DivisionDatascope Corp.
Contact Person:	Susan E. MandyDirector, Clinical & Regulatory AffairsPatient Monitoring DivisionDatascope Corp.Telephone: (201)995-8025Fax: (201)995-8605
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-Phase21 CFR 870.1025- Arrhythmia detector and alarm21 CFR 870.1110- Blood Pressure computer21 CFR 870.1130- Non-invasive blood pressure measurement system21 CFR 870.1425- Programmable diagnostic computer21 CFR 870.1435 - Single-function, pre-programmed diagnostic computer21 CFR 870.2300-Cardiac Monitor (Incl. Cardiotachometer and rate alarm)21 CFR 870.2700- Oximeter21 CFR 880.2910-Monitor, Temperature (with probe)
Predicate Devices:	K020550 Passport 2® Vital Signs Monitor with View 12 ™ ECG Analysis ModuleK030431 GE Medical Systems Dash 3000/4000 Patient Monitor
Device Description:	The Spectrum Monitor is an enhanced version of the Datascope Corp. Passport 2®Vital Signs Monitor with View 12™ ECG Analysis Module, previously cleared byFDA under K020550. There have been no significant changes to the Passport 2®Vital Signs Monitor with View 12 ™ ECG Analysis Module since its clearance.Datascope Corp. has modified the Passport 2® Vital Signs Monitor with View 12™ECG Analysis Module by including the following parameters: Cardiac Output, DrugCalculations, Hemodynamic Calculations, a second Temperature, and twoadditional Invasive Blood Pressure Channels.The Spectrum monitor is a device that is used to monitor, display, trend and print apatient's physiological parameters. The device has a 12.1 inch color display andhas a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, Non-Invasive Blood Pressure (NIBP), Respiration, Continuous Temperature and IV DrugCalculations. Optional software includes ST and Arrhythmia Analysis. Optionalhardware 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 (301) 594-4646. 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 (301) 443-6597 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:

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)

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.