ECG
Cardiac Output
Thoracic Fluid Content
Left Vent. Ejection Time
End Diastolic Volume
Systemic Vascular Resistance
Left Cardiac Work
Pre-Ejection Period
Heart Rate
Acceleration Index
Index of Contractility
Mean Blood Pressure
Diastolic Blood Pressure
Systolic Time Ratio
End diastolic Index
Cardiac Index
Stroke Volume
Systolic Blood Pressure

For the optional 12-lead ECG function (from K031422):

Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.

Device Description

The new product is the combination of two individually 510(k) cleared devices onto a single device platform. Both predicate devices presently use the identical common platform (CPU, display, printer, operating system) in their separate forms. The submission covers the changes necessary to the two predicate devices to allow co-residency of the Philips ECG PIM and its application software and the CardioDynamics ICG PIM and its application software into a single device. The new product combines the ECG functionality of the existing Philips PageWriter Trim III Cardiograph and the ICG functionality of the existing BioZDx monitor and allows switching between ECG and ICG applications. The ECG PIM is identical to PageWriter Trim Product including Philips' original product labeling and manuals. The PageWriter Trim application was modified by Philips to add an "Exit to ICG" function button and a common HIPPA-compliant timeout screen and password compatible with the existing CardioDynamics ICG application. The CardioDynamics application was modified to have an "Exit to ECG" button, and a "home" screen which allows initial selection of one of the two applications.

AI/ML Overview

This 510(k) submission describes the combination of two already cleared devices, not a new device with its own standalone performance characteristics in the traditional sense. The "acceptance criteria" and "device performance" here refer to the successful integration and continued functionality of the two predicate devices on a single platform.

Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Functional Equivalence of Combined Device: The new combined product must maintain all ECG functionality of the Philips PageWriter Trim III Cardiograph (K031422).	"The ECG PIM is identical to PageWriter Trim Product including Philips' original product labeling and manuals." "The ECG function of the BioZDx Hemodynamic Monitor and Philips 12-lead ECG is substantially equivalent and essentially identical to the predicate Philips PageWriter Trim III in its design, intended use, and principles of operation."
Functional Equivalence of Combined Device: The new combined product must maintain all ICG functionality of the CardioDynamics BioZDx Hemodynamic Monitor (K041294).	"The BioZDx Hemodynamic Monitor and Philips 12-lead ECG is substantially equivalent and essentially identical to the ICG function of the predicate BioZDx in terms of design, intended use and principles of operation."
Successful Integration of "Exit to ICG" function: The Philips PageWriter Trim III application must successfully integrate a button to switch to the ICG application.	"The PageWriter Trim application was modified by Philips to add an "Exit to ICG" function button..." "Test reports are included in Section J that verify the new functionality..."
Successful Integration of "Exit to ECG" function: The CardioDynamics ICG application must successfully integrate a button to switch to the ECG application.	"...The CardioDynamics application was modified to have an "Exit to ECG" button..." "Test reports are included in Section J that verify the new functionality..."
Common Home Screen: A "home" screen allowing initial selection of either application must be implemented and function correctly.	"...and a "home" screen which allows initial selection of one of the two applications." "Test reports are included in Section J that verify the new functionality..."
Common HIPAA-compliant Timeout Screen and Password: The combined device must implement a shared HIPAA-compliant timeout screen and password compatible with both applications.	"The Philips PageWriter Trim III application was further modified to add a HIPPA-compliant timeout screen that shares a common password with the ICG application." "Test reports are included in Section J that verify the new functionality and demonstrate compatibility of the two applications and two PIM's co-residing on the platform."
No Degradation of Functionality: The co-residency of the two applications must not adversely affect the functionality of either application.	"All testing (both at CardioDynamics and Philips) was performed with both PIMs attached." "The product design, along with the Windows CE operating system, only permits one of the two applications to be running at any given time." "Product testing focused on verifying the small number of changes to the code in each application, and that the addition of the alternate application to the system did not affect the functionality of either application." "The validation reports from CardioDynamics and Philips are included in Section J."
Minor ICG DSP firmware modification: Operation of the signal status indicator for the ICG DSP should be simplified.	"A small modification was made to the ICG DSP firmware to simplify the operation of the signal status indicator for the user. A verification report of this change is attached in Section J."
Labeling and Manual Updates: User manuals and device labels must be updated to reflect the combined product.	"The user manual for the new product (included in Section H) was modified to include the existence of the ECG functionality and references the Philips product documentation that is provided with the system." "Specific instructions are provided in the CDIC manual to contact CDIC rather than Philips for product support." "The only other label change from either predicate device is the addition of a "Philips 12-lead" label to the enclosure (included in Section H)."

Study Details:

This submission describes a verification and validation study focused on the integration of existing, cleared technologies, rather than a clinical performance study of a novel diagnostic algorithm.

Sample size used for the test set and the data provenance: Not applicable in the context of typical clinical validation for a diagnostic device. The "test set" here refers to the validation activities performed on the software and system integration. These tests would involve specific use-case scenarios and configurations of the combined device. The data provenance is not explicitly detailed in terms of origin country of the data or retrospective/prospective as it's validation of system function, not a clinical data set. It states, "Modifications to the Page Writer Trim III application software were completed and tested by the Philips PageWriter Trim III design team in China." and "All testing (both at CardioDynamics and Philips) was performed with both PIMs attached." This indicates testing was likely performed internally by the manufacturers.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, would be the expected functional behavior of the software and hardware integration, as defined by engineering specifications and user requirements. This is established by the design teams and verified against those specifications, rather than by clinical experts establishing a medical "ground truth."
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Software and system integration testing typically relies on predefined test cases and expected outcomes. The success or failure of a test case is usually deterministic based on whether the system performs as specified.
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: No. This is not an AI-based diagnostic device. It is a hardware and software integration of two existing medical devices.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a combined medical device with existing functionalities, not a new algorithm evaluated in standalone mode. The "standalone" performance here refers to the continued, independent functionality of the ECG and ICG components when integrated, which was tested.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for this type of submission is the engineering specifications and user requirements document (URS). The testing verified that the modified software met these predefined functional and performance requirements for integration and operation.
- "These new functions are described in Section I-4 "DDR-071-10 BioZ Dx Combo Product CardioDynamics User Software Requirements Specification""
- "The changes to the Philips PageWriter Trim III application are described in Section I-3, "CDIC BioZ Combo Product ECG Software Design Specification"."
- "Test reports are included in Section J that verify the new functionality and demonstrate compatibility of the two applications and two PIM's co-residing on the platform."
- "A verification report of this change is attached in Section J."
- "All software changes to the new product from the predicate devices are verified and validated within the body of system and software testing."
- "The validation reports from CardioDynamics and Philips are included in Section J."
The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary

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K051228/S1
P1/3

Section E - 510(k) Statement and Summary

Premarket Notification 510(k) Summary

SUBSTANTIAL EQUIVALENCE:

Identification of predicate devices, model, and manufacturer:

Predicate device 1:	CardioDynamics BioZDx Hemodynamic Monitor
Model	5100
Manufacturer:	CardioDynamics International Corporation (CDIC)
Predicate Device 510(k):	K041294 on 12/6/04
Predicate device 2:	Philips PageWriter Trim Cardiograph
Model:	PageWriter Trim III
Manufacturer:	Philips Medical Systems (Philips)
Predicate Device 510(k):	K031422 on 7/3/03
Reason for Submission:	The new product is the combination of two individually 510(k)cleared devices onto a single device platform. Both predicatedevices presently use the identical common platform (CPU,display, printer, operating system) in their separate forms. Thesubmission covers the changes necessary to the two predicatedevices to allow co-residency of the Philips ECG PIM and itsapplication software and the CardioDynamics ICG PIM and itsapplication software into a single device. The new productcombines the ECG functionality of the existing PhilipsPageWriter Trim III Cardiograph and the ICG functionality ofthe existing BioZDx monitor and allows switching betweenECG and ICG applications. The ECG PIM is identical toPageWriter Trim Product including Philips' original productlabeling and manuals. The PageWriter Trim application wasmodified by Philips to add an "Exit to ICG" function button anda common HIPPA-compliant timeout screen and passwordcompatible with the existing CardioDynamics ICG application.The CardioDynamics application was modified to have an "Exitto ECG" button, and a "home" screen which allows initialselection of one of the two applications.

The BioZDx Hemodynamic Monitor and Philips 12-lead ECG is substantially equivalent and essentially identical to its predicate devices, the BioZDx currently marketed by CardioDynamics International Corporation (CDIC) and the Philips PageWriter Trim III Cardiograph currently marketed by Philips Medical System. The justification for this substantial equivalence determination is presented below.

The BioZDx Hemodynamic Monitor and Philips 12-lead ECG is substantially equivalent and essentially identical to the ICG function of the predicate BioZDx in terms of design, intended use and principles of operation. The ECG function of the BioZDx Hemodynamic Monitor and Philips 12-

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K051228151 p 2/3

lead ECG is substantially equivalent and essentially identical to the predicate Philips PageWriter Trim III in its design, intended use, and principles of operation. The electronics package and platform (CPU, display, printer, and operating system) of the CDIC predicate device has always been that of the Philips PageWriter Trim III product with the ECG PIM and the application software removed. The new product contains the individual application software of both products with the addition of a home screen to select the application of choice on power-up, and the addition of an exit key to each applications to switch between functions. These new functions are described in Section I-4 "DDR-071-10 BioZ Dx Combo Product CardioDynamics User Software Requirements Specification"

The Philips PageWriter Trim III application was further modified to add a HIPPA-compliant timeout screen that shares a common password with the ICG application. The BioZDx predicate device already had the HIPPA-compliant timeout and password functions. Modifications to the Page Writer Trim III application software were completed and tested by the Philips PageWriter Trim III design team in China. The changes to the Philips PageWriter Trim III application are described in Section I-3, "CDIC BioZ Combo Product ECG Software Design Specification". Test reports are included in Section J that verify the new functionality and demonstrate compatibility of the two applications and two PIM's co-residing on the platform. All testing (both at CardioDynamics and Philips) was performed with both PIMs attached. The product design, along with the Windows CE operating system, only permits one of the two applications to be running at any given time.

A small modification was made to the ICG DSP firmware to simplify the operation of the signal status indicator for the user. A verification report of this change is attached in Section J.

The Application Software which provides the user interface for the separate ECG and ICG applications of the BioZDx System and Philips 12-lead ECG is loaded onto the platform using a software installation kit, identical to the method used for each of the predicate devices.

The user manual for the new product (included in Section H) was modified to include the existence of the ECG functionality and references the Philips product documentation that is provided with the system. Specific instructions are provided in the CDIC manual to contact CDIC rather than Philips for product support. The only other label change from either predicate device is the addition of a "Philips 12-lead" label to the enclosure (included in Section H).

There are no hardware changes from the predicate devices except the small "Philips 12-lead" label mentioned in the previous paragraph.

All accessories for the BioZDx and Philips 12-Lead ECG product are identical to those presently being marketed with the predicate devices.

All software changes to the new product from the predicate devices are verified and validated within the body of system and software testing. Product testing focused on verifying the small number of changes to the code in each application, and that the addition of the alternate application to the system did not affect the functionality of either application. The validation reports from CardioDynamics and Philips are included in Section J.

The ICG electrodes (BioZTect Sensor) to be used with the BioZDx device are sold separately, and are identical to those marketed for use with the BioZDx predicate device. The BioZTect Sensor received 510(k) Clearance (K001100) on 5-5-2000. The sample pack of ECG sensors shipped with the BioZDx Hemodynamic Monitor and Philips 12-Lead ECG (Vermed A10023) received 510(k) Clearance K030073.

The Device Master Record for the BioZDx Hemodynamic Monitor and Philips 12-Lead ECC product is held at CardioDynamics, where the product is manufactured using components manufactured by Philips and CardioDynamics. The ECG software is developed and maintained by Philips in China,

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and released on a controlled basis to CardioDynamics where the executable application is stored and loaded using procedures within the CardioDynamics Quality System.

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3/5

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

JUN 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CardioDynamics International Corporation c/o Mr. Dennis G. Hepp Chief Technology Officer 6175 Nancy Ridge Drive, Suite 300 San Diego, CA 92121

Re: K051228

Trade Name: BioZDx Hemodynamic Monitor and Phillips 12-lead ECG, Model 5200 Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: II (two) Product Code: DSB Dated: June 02, 2005 Received: June 03, 2005

Dear Mr. Hepp:

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.

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Page 2 - Mr. Dennis G. Hepp

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) 276-0295. 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,

Bhimmanfor

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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Indications for Use

510(k) Number (if known): _ Ko51229

Device Name: BioZDx HemoDynamic Monitor and 12-lead ECG

Indications For Use:

For the ICG function (from K041294):

The BioZDx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include:

ECG	Pre-Ejection Period	Systolic Time Ratio
Cardiac Output	Heart Rate	End diastolic Index
Thoracic Fluid Content	Acceleration Index	Cardiac Index
Left Vent. Ejection Time	Index of Contractility
End Diastolic Volume	Mean Blood Pressure	Stroke Volume
Systemic Vascular Resistance		Systolic Blood Pressure
Left Cardiac Work	Diastolic Blood Pressure

For the optional 12-lead ECG function (from K031422):

Prescription Use XXX (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)

Blimmerman
(Division Sign Off)

Page 1 of

Division of Cardiovascular Devices
510(k) Number_ K051228

Regulation Number and Section

§ 870.2770 Impedance plethysmograph.

(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.