SPECTRUM MONITOR, MODEL 0998-00-1000-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 Monitor 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 or12 ECG lead measurements
Arrhythmia Detection derived from 3, 5 or 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
Bispectral Index (BIS)

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

Arrhythmia detection, ST Segment Analysis, Cardiac Output, Hemodynamic Calculations, Pulmonary Artery Wedge Pressure measurements, and
Interpretation of Resting 12 Lead ECG and IV Drug Calculations, for which the target population is adult only.
Bispectral Index. The BISx is intended for use under direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. Note: The clinical utility, risk/benefit, and application of the device have not undergone full evaluation in the pediatric population.

The Bispectral Index from available information is a complex technology, intended for use only as an adjunct to clinical judgment and training.

The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

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

Device Description

The Spectrum Monitor, which is the subject of this submission, is a modified version of the Datascope Spectrum Monitor, which was previously cleared by FDA under K031849, on September 9, 2003. There have been no significant changes to the Spectrum Monitor since its clearance. At this time, Datascope Corp. has added a new parameter to the device's monitoring capabilities, the measurement of Bispectral Index (BIS) via an interface to the Aspect Medical System's BISx™ module (K040183).

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 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® and Oximax® SpO2, a 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, CO, CO2, and BIS. The optional internal recorder provides hard copies of all digital data and waveforms, as well as trend information.

Bispectral Index (BIS) is continuous measure of the effects of certain anesthetic and sedative agents on a patient's brain. The Aspect BISx module monitors the hypnotic state of the brain based on acquisition and processing of EEG signals. It processes the raw EEG signal to produce Aspect's proprietary BIS Index, a single value that is correlated with the patient's level of hypnosis. The BISx mates on one side with a patient interface cable, which attaches to Aspect's BIS sensors, and on the other side with the Spectrum Monitor, where the BIS Index is displayed on the integrated display.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the Datascope Spectrum™ Monitor, dated February 2, 2007. It describes a modified version of an existing monitor with the addition of Bispectral Index (BIS) monitoring capabilities via an interface to Aspect Medical System's BISx™ module.

However, the document does not contain specific acceptance criteria or performance data in terms of quantifiable metrics (e.g., sensitivity, specificity, accuracy, error rates) for any of the monitored parameters, including the newly added BIS. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to design control processes.

Therefore, many of the requested items cannot be extracted from this document.

Here's an analysis of what information is available and what is missing:

1. A table of acceptance criteria and the reported device performance

Missing. The document states that "Datascope's product development process required that the following activities be completed during the development of the Spectrum Monitor: Requirements specification review, Software testing, Code design and code reviews, EMC testing, Safety testing, Software validation." And concludes that "The results of all testing demonstrate that the Spectrum Monitor is as safe, as effective, and performs as well as the predicate devices."

However, it does not provide any specific performance metrics or acceptance criteria that were used to evaluate the device and compare it to predicate devices. For example, it does not state "BIS accuracy must be +/- X points" or "Arrhythmia detection sensitivity must be Y%."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing. No details on sample size, data provenance, or study design (retrospective/prospective) are provided for any testing mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing. No information on experts or ground truth establishment for testing is included.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing. No adjudication methods are described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" or be evaluated in an MRMC comparative effectiveness study in the context of improving human interpretation. The BIS functionality is presented as an aid to clinical judgment, but not as an AI system that improves human "reading" of data in a comparative effectiveness study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Missing. The document does not provide performance data for any component, standalone or otherwise. The BISx module is described as providing a "single value that is correlated with the patient's level of hypnosis," but no performance metrics for this correlation are given.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Missing. No ground truth types are described for any testing.

8. The sample size for the training set

Missing. There is no mention of a "training set" as this is a medical device submission based on substantial equivalence, and the new BIS parameter is integrated via Aspect Medical System's BISx™ module, which is a previously cleared device (K040183). The submission for the Spectrum Monitor's modification primarily focuses on the integration and safety/effectiveness of the combined system, rather than de novo algorithm development and training.

9. How the ground truth for the training set was established

Missing. As no training set is mentioned, naturally, its ground truth establishment is also not discussed.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to predicate devices and adherence to design control processes. It does not present detailed performance data, acceptance criteria, or clinical study results in the format requested, which would be typical for a submission involving novel algorithms or significant performance claims for a new diagnostic or assistive AI feature. The addition of BIS is achieved by integrating a pre-cleared module, and the focus of this submission is on the safety and effectiveness of the combined system.

Summary

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Kob2098

510(k) Summary of Safety and Effectiveness

Date:	February 2, 2007
Submitter:	Patient Monitoring DivisionDatascope Corp.
Contact Person:	Kathleen KramerSupervisor, Clinical & Regulatory AffairsPatient Monitoring DivisionDatascope Corp.Telephone: (201) 995-8169Fax: (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:	K031849 Spectrum MonitorK051400 Datex Ohmeda S/5™ Anesthesia Monitor with L-ANE05 and L-ANE05ASoftware
Device Description:	The Spectrum Monitor, which is the subject of this submission, is a modified versionof the Datascope Spectrum Monitor, which was previously cleared by FDA underK031849, on September 9, 2003. There have been no significant changes to theSpectrum Monitor since its clearance. At this time, Datascope Corp. has added anew parameter to the device's monitoring capabilities, the measurement ofBispectral Index (BIS) via an interface to the Aspect Medical System's BISx™module (K040183).
	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 3 or 5 lead ECG, Masimo SET® SpO2, Non-InvasiveBlood Pressure (NIBP), Respiration, Continuous Temperature and IV DrugCalculations. Optional software includes ST and Arrhythmia Analysis. Optionalhardware features include View12 ECG Analysis Module (which includes STArrhythmia and 12 Lead interpretation), up to 4 Invasive Blood Pressure Channels,Microstream® CO2, Anesthetic Gases, Nellcor Oxismart® and Oximax® SpO2, asecond temperature source, dual trace recorder, and Cardiac Output.

FEB - 5 2007. .

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1062098
A comprehensive calculation package, including Hemodynamic Calculations, isavailable if the Spectrum is equipped with an External Parameter Module.Digital displays are provided for Heart Rate, NIBP, SpO2, Respiration Rate, andTemperature. Optional digital displays are provided for up to four Invasive BloodPressure, Anesthetic Agents, O2, and N20, ST, CO, CO2, and BIS. The optionalinternal recorder provides hard copies of all digital data and waveforms, as well astrend information.
Bispectral Index (BIS) is continuous measure of the effects of certain anesthetic andsedative agents on a patient's brain. The Aspect BISx module monitors the hypnoticstate of the brain based on acquisition and processing of EEG signals. It processesthe raw EEG signal to produce Aspect's proprietary BIS Index, a single value that iscorrelated with the patient's level of hypnosis. The BISx mates on one side with apatient interface cable, which attaches to Aspect's BIS sensors, and on the other sidewith the Spectrum Monitor, where the BIS Index is displayed on the integrateddisplay.
Intended Use:	The Spectrum Monitor is intended for intra hospital use under the direct supervisionof a licensed healthcare practitioner. The indications for use for the SpectrumMonitor 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 or12 ECG lead measurements□ Arrhythmia Detection derived from 3, 5 or 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□ Bispectral Index (BIS)
	The target populations are adult, pediatric and neonate with the exception of:□ Arrhythmia detection, ST Segment Analysis, Cardiac Output, HemodynamicCalculations, Pulmonary Artery Wedge Pressure measurements, andInterpretation of Resting 12 Lead ECG and IV Drug Calculations, for which thetarget population is adult only.□ Bispectral Index. The BISx is intended for use under direct supervision of alicensed healthcare practitioner or by personnel trained in its proper use. It is
K062098
The Bispectral Index from available information is a complex technology, intended for use only as an adjunct to clinical judgment and training.
The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The Spectrum Monitor has the capability of interfacing with Datascope's Intra Aortic Balloon Pumps, Central Stations, and Gas Module products.
Technology:	The Spectrum Monitor is substantially equivalent to the Spectrum Monitor (K031849) and the Datex Ohmeda S/5TM Anesthesia Monitor with L-ANE05 and L-ANE05A Software.
Test Summary:	Datascope's product development process required that the following activities be completed during the development of the Spectrum Monitor:
	$ Requirements specification review
	$ Software testing
	$ Code design and code reviews
	$ EMC testing
	$ Safety testing
	$ 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.

licensed healthcare pr actitioner or by personnel trained in its proper use. It it is a lead.
Intended for use on adult and pediatric patients within a hoppital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. Note: the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population.

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Image /page/3/Picture/2 description: The image shows a partial view of a circular emblem or logo. The text "DEPARTMENT OF HEALTH AND HUMAN...USA" is visible around the perimeter of the circle. The right side of the image features a stylized graphic, possibly representing a human figure or a symbol associated with health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2007

Datascope Corporation c/o Ms. Kathleen Kramer Supervisor, Clinical and Regulatory Affairs Patient Monitoring Division 800 MacArthur Blvd. Mahwah, NJ 07430

Re: K062098 Trade Name: Spectrum Monitor, Model 0998-00-1000-XXXX Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: February 1, 2007 Received: February 2, 2007

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 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

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Page 2 - Ms. Kathleen Kramer

800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Lochner

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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INDICATION FOR USE STATEMENT

510(k) Number (if known): K062098

Device Name: Spectrum Monitor

Indications for Use:

0 ECG waveform derived from 3, 5 or 12 lead measurements
Heart Rate derived from selected sources (ECG, SpO2, IBP, NIBP)
Pulse Oximetry (SpO2) 0
ST Segment Analysis derived from 3, 5 or12 ECG lead measurements 0
Arrhythmia Detection derived from 3, 5 or 12 ECG lead measurements
Interpretation of Resting 12 lead ECG D
Non Invasive Blood Pressure (NIBP)
Invasive Blood Pressure (IBP) up to four (4) channels 0
0 Cardiac Output
ם Respiration Rate/waveform derived from ECG or CO2
CO2, inspired and end tidal microstream/waveform o
Temperature up to two (2) channels ם
Hemodynamic Calculations ם
IV Drug Calculations a
Bispectral Index (BIS)

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

Arrhythmia detection, ST Segment Analysis, Cardiac Output, Hemodynamic Calculations, 0 Pulmonary Artery Wedge Pressure measurements, and
Interpretation of Resting 12 Lead ECG and IV Drug Calculations, for which the target population is 0 adult only.
ם Bispectral Index. The BISx is intended for use under direct supervision of a ficensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. Note: The clinical utility, risk/benefit, and application of the device have not undergone full evaluation in the pediatric population.

The Bispectral Index from available information is a complex technology, intended for use only as an adjunct to clinical judgment and training.

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K062098

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

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

R. V. Mines

Division Sign-Olf)
Division of Cardiovascular Devices

510(k) Number K062098

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.