CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM by WITT BIOMEDICAL CORP

The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

The CALYSTO Central Station and Patient Care Monitors are intended for complete physiologic monitoring, clinical data acquisition and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses.

Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

The CALYSTO Series IV ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. CALYSTO Series IV does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

Device Description

The modified device has the same intended use as the legally marketed predicate device. It is intended to be used for complete physiologic/hemodynamic monitoring and information gathering. It facilitates clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories.

AI/ML Overview

The provided text describes modifications to the CALYSTO Series IV Physio-monitoring and Information System. The submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a comprehensive study report in the way a PMA submission might.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth for a de novo device or a device with new functionality is not explicitly detailed in this document. The focus here is on showing that the modifications do not alter the fundamental safety and effectiveness of the device compared to its predicate.

Here's an analysis based on the provided text:

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

The document summarizes the testing as: "Verification, validation and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Pass/Fail criteria were based on the specifications cleared for the predicate device and the test results showed substantial equivalence."

This indicates that the acceptance criteria were the specifications of the predicate device, and the reported device performance was that it met these specifications, demonstrating substantial equivalence. Specific quantitative criteria and results for parameters like accuracy, precision, sensitivity, or specificity for the new modules are not provided in this summary.

Acceptance Criteria (Inferred)	Reported Device Performance
Performance, functionality, and reliability characteristics of the modified device are equivalent to the predicate device (K033030).	Test results showed substantial equivalence to the predicate device.
Specifications of the proposed Respironics Capno 5 End Tidal CO2 and Masimo MX-1 pulse oximetry modules are equivalent to the currently cleared predicate device's modules (Nellcor MP 506 for pulse oximetry).	The specifications and accuracy of the proposed modules are equivalent to the currently legally marketed predicate device (K033030).
Modifications do not change the intended use or operating parameters of the system.	The modifications do not change the intended use or operating parameters of the system. No contraindications have been added or removed as a result of the modifications.
No new safety concerns introduced by the modifications.	Implied by the substantial equivalence determination and the statement that "modifications do not change the intended use or operating parameters of the system" and "no contraindications have been added or removed."

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

Sample Size: Not specified. The document states "Verification, validation and testing activities," but does not detail the nature or scope of these activities in terms of sample size for clinical or simulated data.
Data Provenance: Not specified. Given the nature of medical device testing for 510(k) modifications, the testing would typically involve laboratory and/or simulated clinical environments. It's highly unlikely to involve patient data provenance in the way a diagnostic AI product might.

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):

Not applicable/Not specified. This submission is for modifications to a physiological monitor, not a diagnostic device that requires expert interpretation to establish ground truth for a test set. The validation would primarily focus on technical specifications and accuracy against established calibration standards or reference devices, not human expert consensus.

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

Not applicable/Not specified. Adjudication methods are typically used when human interpretation or diagnosis is part of establishing ground truth for diagnostic devices. This document describes a physiological monitoring system.

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 physiological monitor and central station system. It does not appear to incorporate AI for diagnostic assistance that would warrant an MRMC study comparing human reader performance.

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

The device itself is a standalone physiological monitor. The testing would have evaluated the performance of the integrated modules (End Tidal CO2 and pulse oximetry) in a standalone manner against their specifications. The document states, "The specifications and accuracy of the proposed modules are equivalent to the currently legally marketed predicate device." This implies standalone testing of component performance.

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

The ground truth for this type of device (physiological monitor) would be established by:

Reference standards: Calibrated test equipment, simulated physiological signals, or comparison against established "gold standard" medical devices.
Manufacturer specifications: The performance specifications provided by the manufacturers of the integrated modules (Respironics and Masimo), which would have been validated during their own development.

8. The sample size for the training set:

Not applicable. This device does not appear to use machine learning or AI that would require a "training set" in the conventional sense for a diagnostic algorithm. The modifications involve integrating established physiological monitoring modules.

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

Not applicable, as there is no apparent training set for an AI algorithm.

Summary

{0}------------------------------------------------

KO63547

Section 6 - 510(K) Summary

Submitted by:	Witt Biomedical Corporation (a wholly owned subsidiary of Philips HoldingUSA, Inc.)305 North DrivePhone: (321) 253-5693Fax: (321) 253-0372
Contact Person:	James Luker
Date Prepared:	November 20, 2006	JEC 21 2006
Proprietary Name:	CALYSTO Series IV, Patient Care Monitor and Central Station System
Common Name:	Physio-monitoring and Information System
Classification Name:	21 CFR § 870.2300 74 MWIMonitor, Physiological, Patient (without Arrhythmia detection or alarms)Class II
Predicate Device:	CALYSTO Series IV, Patient Care Monitor and Central Station SystemK033030
Device Description:	The modified device has the same intended use as the legally marketed predicate device. It is intended to be used for complete physiologic/hemodynamic monitoring and information gathering. It facilitates clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories.
Substantial Equivalence:	The modified CALYSTO Series IV System is substantially equivalent to the currently cleared CALYSTO Series IV System (K033030). Evidence of substantial equivalence is provided in section 10.
Intended Use:	The CALYSTO Series IV is intended for complete physiologic/hemodynamicmonitoring, clinical data acquisition and analytical assessment for cardiaccatheterization, invasive radiology and electrophysiology laboratories. Its users,responsible to interpret the data made available, will be professional health careproviders. CALYSTO Series IV provides the ability to transmit patient datafiles for storage, analysis and viewing at distributed locations within the clinicalfacility via intranet or internet, or may function as a stand-alone device.Use of CALYSTO Series IV is not intended where unattended patientmonitoring is desired or in situations where arrhythmia detection is required.The CALYSTO Central Station and Patient Care Monitors are intended forcomplete physiologic monitoring, clinical data acquisition and analyticalassessment within any healthcare environment. Its users, responsible to interpretthe data made available, will be professional health care providers. Useradjustable alarms (both visual and audible), alert the operator to anomalousoccurrences and facilitate timely responses.Use of CALYSTO Central Station and Patient Care Monitors is not intendedwhere unattended patient monitoring is desired or in situations wherearrhythmia detection is required.The CALYSTO Series IV ECG Management system is intended for

{1}------------------------------------------------

	receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. CALYSTO Series IV does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.
TechnologicalCharacteristics:	The modified device has the same technological characteristics as the legally marketed predicate device (K033030). The modifications consist of the implementation of the Respironics Capno 5 End Tidal CO2 mainstream and LoFlo sidestream End Tidal CO2 modules. In addition the Masimo MX-1 pulse oximetry module will be integrated with the current device as an option to the currently cleared Nellcor MP 506 pulse oximetry module. The specifications and accuracy of the proposed modules are equivalent to the currently legally marketed predicate device
Summary ofSubstantialEquivalence:	The modified CALYSTO Series IV system is substantially equivalent to the legally marketed predicate device. The modifications do not change the intended use or operating parameters of the system. No contraindications have been added or removed as a result of the modifications
Verification,Validation, andTesting:	Verification, validation and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Pass/Fail criteria were based on the specifications cleared for the predicate device and the test results showed substantial equivalence.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2006

Witt Biomedical Corp. c/o James Luker QA/RA Engineer 305 North Drive Melbourne, FL 32934

Re: K063547

Trade Name: Calysto Series IV Physio-Monitoring and Information System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Regulatory Class: Class II Product Code: MWI Dated: November 24, 2006 Received: November 17, 2006

Dear Mr. Luker:

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 may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Mr. Luker

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 may be obtained 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,

Blzimmerman for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

SECTION 5 -INDICATION FOR USE STATEMENT 510(k) Number:

Device Name: CALYSTO Series IV Physio-monitoring and Information System

Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required.

V 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)

Blummenon

Division Sign-Offi Division of Cardiovascular Devices 510(k) Number Kni, 354

Page 1 of 1

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).