For the ICG function: The BioZ Dx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include: Heart Rate (HR) Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP) Mean Arterial Blood Pressure (MAP) Stroke Index (SI) Stroke Volume (SV) Cardiac Index (CI) Cardiac Output (CO) Systemic Vascular Resistance (SVR) Systemic Vascular Resistance Index (SVRI) Left Cardiac Work (LCW) Acceleration Index (ACI) Velocity Index or Index of Contractility (VI, IC) Thoracic Fluid Content (TFC) Base Impedance (TFI or Zo) Thoracic Fluid Content Index (TFCI) Systolic Time Ratio (STR) Systolic Time Ratio Index (STRI) Pre-Ejection Period (PEP) Left Ventricular Ejection Time (LVET) Total Arterial Compliance (TAC) Total Arterial Compliance Index (TACI) Left Stroke Work Index (LSWI) Heather Index (HI) Q-C Interval (QC) Left Cardiac Work Index (LCWI) Electrocardiograph (ECG) Systemic Stroke Resistance Index (SSRI or SSVRI) End Diastolic Volume (EDV) End Diastolic Index (EDI) For the optional 12-lead ECG function: Where the clinician decides to evaluate the electrocardiogram of adult and pediatric as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to ruleout causes for symptoms.

Device Description

This submission covers Version 4.0b5 of the BioZ Dx System Software for the BioZ Dx (K051228), which is a noninvasive impedance cardiography (ICG) device that provides hemodynamic parameters based on the measurement of thoracic electrical bioimpedance. The BioZ Dx measures this change in impedance by injecting a high frequency, low amplitude alternating electrical current through the thorax between a pair of sensors placed on the neck and another pair placed on the mid-axillary line at the xiphoid process level. By detecting and measuring the change in thoracic impedance as a function of time, the BioZ Dx is able to calculate stroke volume, cardiac output and many other hemodynamic parameters. The device additionally includes the capability of performing a standard 12-Lead ECG test. The modified BioZ Dx software and firmware applies the same functions and scientific concepts as the predicate devices. Additional parameters have been added in this release that exists in the predicate devices, and a small number of routine software bugs were corrected with this release.

AI/ML Overview

The provided text does not contain acceptance criteria or a study proving the device meets them in the way typically expected for a medical device regulatory submission.

Instead, this document is a Premarket Notification 510(k) Summary for a modified medical device. Its primary purpose is to demonstrate substantial equivalence to existing, legally marketed predicate devices, not to establish new performance criteria or conduct a de novo performance study against defined acceptance criteria.

Here's why and what information is present:

Substantial Equivalence: The core argument for this 510(k) is that the "modified BioZ Dx software and firmware applies the same functions and scientific concepts as the predicate devices." This means they are not introducing a fundamentally new technology requiring entirely new performance benchmarks.
Performance Testing: The "Performance Testing" section states: "The results of verification and validation tests concluded that the functionality and performance characteristics of the modified BioZ Dx are comparable to the currently marketed predicate devices." This implies testing was done to ensure the modifications didn't degrade performance compared to the predicate, but it doesn't specify what those performance characteristics are or what the acceptance criteria were.

To directly answer your request based on the provided text:

Acceptance Criteria and Study for BioZ Dx Hemodynamic Monitor with 12-Lead ECG (Modified Software/Firmware)

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list specific acceptance criteria in measurable terms (e.g., accuracy percentages, precision ranges) for the hemodynamic parameters or ECG function. The "performance" reported is a determination of comparability to predicate devices.

Performance Aspect	Acceptance Criteria (Not explicitly stated, but implied from "comparable to predicate")	Reported Device Performance
Functionality and Performance Characteristics of Modified BioZ Dx Software/Firmware (including additional parameters)	Equivalent to or not degraded from predicate BioZ Dx device and other predicate devices from Analogic, GE, and CardioDynamics for specific additional parameters.	"The results of verification and validation tests concluded that the functionality and performance characteristics of the modified BioZ Dx are comparable to the currently marketed predicate devices." Also, "The modified BioZ Dx software and firmware applies the same functions and scientific concepts as the predicate devices. Additional parameters have been added in this release that exists in the predicate devices... These additional parameter calculations use measurements and/or parameters which already existed in the BioZ Dx predicate device."
Safety and Effectiveness	No new issues of safety, effectiveness, or performance.	"The results of all testing demonstrate that the modified BioZ Dx Hemodynamic Monitor with 12-Lead ECG do not raise any new issues of safety, effectiveness or performance of the device when compare to the existing predicate devices." "Risk management... revealed that the enhancements present no additional risks from the predicate devices."

2. Sample size used for the test set and the data provenance:

The document does not specify a patient sample size used for performance testing (verification and validation). It refers to "system level validations" and "unit and system level software and firmware verifications" but doesn't provide details on patient data, if any was used, or its origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not mention the use of experts to establish ground truth for a test set. The evaluation focuses on comparing the device to predicate devices and previous versions of the BioZ Dx for functional equivalency, rather than against an independently established clinical ground truth.

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

No adjudication method is mentioned, as the nature of the "performance testing" described is not a clinical study requiring such a process.

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:

No MRMC study was done, nor is AI assistance mentioned. This device (from 2007) is an Impedance Cardiograph and 12-Lead ECG monitor, not an AI-assisted diagnostic tool.

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

The document describes software and firmware verification and validation, which would constitute standalone testing of the algorithm/device's functionality. The primary conclusion is that its functionality and performance characteristics are "comparable" to predicate devices. However, no specific metrics from this "standalone" performance are provided beyond the statement of comparability.

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

The "ground truth" for this submission is implicitly the performance and accepted functionality of the predicate devices. The modified device's performance was compared to these established devices. It does not refer to external clinical ground truth like pathology or outcomes data.

8. The sample size for the training set:

No information is provided about a training set. This device is hardware with embedded software for calculations and displaying parameters; it is not a machine learning or AI algorithm that typically requires a distinct "training set."

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

As no training set is mentioned or applicable in the AI/ML sense, this question is not addressed by the document.

Summary

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Section 5 - Premarket Notification 510(k) Summary

SEF 26 2007

GENERAL INFORMATION:

Device Name and Classification

Product Name:	BioZ Dx Hemodynamic Monitor with 12-Lead ECG
Classification Name:	Plethysmography, Impedance
Common Name:	Impedance Cardiograph (ICG)
Classification Panel:	Cardiovascular
Regulation Number:	21 CFR 870.2770 (for ICG) and 21 CFR 870.2340 (for ECG)
Device Class:	II
Product Code:	74 DSB (for ICG) and 74 DPS (for ECG)

Manufacturer and Contact Person

CardioDynamics International Corporation 6175 Nancy Ridge Drive, # 300 San Diego, CA 92121 USA Phone: 858-535-0202 Fax: 858-535-0294

Paul L. Shaffer Director, Quality and Regulatory

Date of Summary Preparation: January 15, 2007

SUBSTANTIAL EQUIVALENCE:

Predicate Devices:

K051228 - CardioDynamics BioZ® Dx Hemodynamic Monitor with Philips 12-Lead ECG K011439 - CardioDynamics BioZ .com Hemodynamic Monitor (for additional parameters) K041434 - Analogic C3TM ICG Monitor (for additional parameters) K010164 - GE Medical Systems ICG Module (for additional parameters)

Device Description:

The modified BioZ Dx software and firmware applies the same functions and scientific concepts as the predicate devices. Additional parameters have been added in this release that exists in the predicate devices, and a small number of routine software bugs were corrected with this release.

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Intended Use:

The BioZ Dx device is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The device is intended to monitor hemodynamic parameters within hospitals and other healthcare facilities providing patient care. The modified BioZ Dx device has these same intended uses.

Additional parameter outputs are being displayed based on calculations incorporated into predicate CardioDynamic (Systemic Vascular Resistance Index and Left Cardiac Work Index), Analogic (Thoracic Fluid Content Index, Base Impedance, Heather Index, Q-C Interval & Stroke Index) and GE (Left Stroke Work Index) devices. These additional parameter calculations use measurements and/or parameters which already existed in the BioZ Dx predicate device.

Technology:

The modified BioZ Dx device has the same technological characteristics as the predicate BioZ Dx device. A human factors improvement has been made to the cable and electrode accessories whereby the connections with the dual element electrode and patient leadwires have unique connector fittings to further ensure proper connections. The accessory change was determined to be insignificant (not requiring a 510(k) submission), and was documented to file and implemented into the current BioZ Dx.

General Safety & Effectiveness Concerns:

The instructions for use for this device contain the necessary cautions and warnings to provide for safe and effective use for the device.

Risk management is an essential element of the design and development process, and hazard analysis assessments performed on the modified BioZ Dx device at the System and Software levels revealed that the enhancements present no additional risks from the predicate devices. The software hazard analysis for the modified device in included in section 16.1 and the system hazard analysis is included in section 18.1.

CardioDynamics International Corporation is presently certified to ISO13485:2003 by Nemko. No significant audit findings have been presented since initial ISO 13485 certification in May of 1998. All products are designed and manufactured under CDIC's Quality Management System, which includes Design Control and Good Manufacturing Practices.

Performance Testing:

There have been no hardware modifications between the modified BioZ Dx and the predicate BioZ Dx monitor device, thus the relevant electrical safety standards have not been impacted by this product change. The improvements to the cable/electrode accessories were confined to the patient sensor connector mechanism only, and there were no impacts to the electromagnetic compatibility standards when compared to the predicate BioZ Dx device.

Design Review is required, at a minimum, at the completion of each step in the design control process (i.e. Design Input, Design Output, Design Verification, Design Validation and Design Transfer). The design review process identifies the required deliverables for each step in the process and verifies the content and accuracy of each deliverable.

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The following quality assurance measures were conducted for the modified BioZ Dx device and are included in this submission:

. Risk analysis
. Design requirements and traceability
. Unit and system level software and firmware verifications
. System level validations

The results of verification and validation tests concluded that the functionality and performance characteristics of the modified BioZ Dx are comparable to the currently marketed predicate devices.

Conclusion:

The results of all testing demonstrate that the modified BioZ Dx Hemodynamic Monitor with 12-Lead ECG do not raise any new issues of safety, effectiveness or performance of the device when compare to the existing predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces left. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2007

CardioDynamics International Corporation c/o Mr. Paul L. Shaffer Director, Quality and Regulatory 6175 Nancy Ridge Drive #300 San Diego, CA 92121

Re: K070156

Trade/Device Name: BioZ Dx Hemodynamic Monitor with Philips 12-lead ECG Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB and DPS Dated: September 10, 2007 Received: September 12, 2007

Dear Mr. Shaffer:

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. Paul L. Shaffer

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blymmerman for

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):

Device Name: BioZ Dx HemoDynamic Monitor and Philips 12-lead ECG

Indications For Use:

For the ICG function:

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

Heart Rate (HR) Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP) Mean Arterial Blood Pressure (MAP) Stroke Index (SI) Stroke Volume (SV) Cardiac Index (CI) Cardiac Output (CO) Systemic Vascular Resistance (SVR) Systemic Vascular Resistance Index (SVRI) Left Cardiac Work (LCW) Acceleration Index (ACI) Velocity Index or Index of Contractility (VI, IC) Thoracic Fluid Content (TFC) Base Impedance (TFI or Zo)
Thoracic Fluid Content Index (TFCI) Systolic Time Ratio (STR) Systolic Time Ratio Index (STRI) Pre-Ejection Period (PEP) Left Ventricular Ejection Time (LVET) Total Arterial Compliance (TAC) Total Arterial Compliance Index (TACI) Left Stroke Work Index (LSWI) Heather Index (HI) Q-C Interval (QC) Left Cardiac Work Index (LCWI) Electrocardiograph (ECG) Systemic Stroke Resistance Index (SSRI or SSVRI) End Diastolic Volume (EDV) End Diastolic Index (EDI)

For the optional 12-lead ECG function:

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

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)

Blummen

iciovi 510(k) Number

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.