(208 days)
No
The description mentions "proprietary DSP electronic circuitry and software incorporating formulas and algorithms" and "enhanced fiducial point detection techniques and the addition of a statistical based modulation factor," but does not explicitly mention AI or ML. The focus is on traditional signal processing and algorithmic calculations.
No
The device is a monitor that measures hemodynamic parameters; it does not directly treat or alleviate a medical condition but provides diagnostic information.
Yes
The device measures and displays a patient's hemodynamic parameters (e.g., ECG, Cardiac Output, Blood Pressure) which are physiological data used to assess a patient's health status and aid in diagnosis.
No
The device description explicitly mentions "proprietary DSP electronic circuitry" and "attaching 8 electrodes to the patient, injecting a minimal current, and reading the returning voltage waveform," indicating the presence of hardware components beyond just software.
Based on the provided information, the BioZDx Hemodynamic Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro - "in glass"). This includes things like blood, urine, tissue, etc.
- The BioZDx Hemodynamic Monitor measures parameters directly from the patient's body using electrodes attached to the skin (in vivo - "in the living"). It uses Impedance Cardiography (ICG) to assess physiological functions.
The device is a non-invasive physiological monitoring device. It measures and displays real-time hemodynamic parameters based on electrical signals from the patient's body, not by analyzing samples taken from the patient.
N/A
Intended Use / Indications for Use
The BioZDx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include:
ECG Cardiac Output Thoracic Fluid Content Left Vent. Ejection Time End Diastolic Volume Systemic Vascular Resistance PressureLeft Cardiac Work Diastolic Blood Pressure
Pre-Ejection Period Heart Rate Acceleration Index Index of Contractility Mean Blood Pressure Systolic Time Ratio End diastolic Index Cardiac Index
Stroke Volume Systolic Blood
Product codes (comma separated list FDA assigned to the subject device)
DSB
Device Description
The BioZDx Hemodynamic Monitor utilizes CardioDynamics' proprietary DSP electronic circuitry and software incorporating formulas and algorithms to calculate the various hemodynamic parameters. The user inputs patient parameters into the user software, including patient gender, body frame size, height, weight, age and blood pressure. The Monitor then utilizes these parameters and measures the ICG signals to determine the hemodynamic properties of that particular patient interface circuity (which provides all data acquisition, processing, and isolation) is similar to the predicate devices, and tested to the same internal and Agency specifications All changes to the new product from the predicate device are verified and validated within the body of hardware and software testing. The validation reports are included in Section J for System, Hardware, and Signal Processing, and Section M for software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Both BioZ.pc and the BioZ.com predicate devices as well as the new BioZDx systems are portable in design and for use in the hospital, outpatient and clinical settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K041294
DEC - 8 2004
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 BioZ.pc |
|---|---|
| Model: | Part # BZ-500/501 |
| Manufacturer: | CardioDynamics International Corporation |
| Predicate Device 510(k): | K001081 on 6/31/2000 |
| Reason for Submission: | Repackaging and porting of functionality from an off-the-shelf PC platform to a Philips cardiograph for the user display and interface. Use of BioZDx ported software and change of operating system from Windows™ to Windows CETM. Improvements to patient cable including enhanced defib protection, and removable/replaceable left and right interconnect assemblies. Built-in rather than externally attached printer. |
| Predicate device 2: | CardioDynamics BioZ.com |
| Model: | Part # BZ-4110 |
| Manufacturer: | CardioDynamics International Corporation |
| Predicate Device 510(k): | K974725 on 3/18/1998 |
| Reason for Submission: | Repackaging and porting of functionality from an embedded PC platform to a Philips cardiograph for the user display and interface. Use of BioZDx ported software and change of operating system from Microsoft DOS 6.22 to Windows CETM. Improvements to patient cable including enhanced defib protection, and removable/replaceable left and right interconnect assemblies.. Built-in rather than externally attached printer. |
The BioZDx Hemodynamic Monitor is substantially equivalent to its predicate devices, the BioZ.pc System and the BioZ.com System currently marketed by CardioDynamics International Corporation. The justification for this substantial equivalence determination is presented below.
The BioZDx Hemodynamic Monitor is substantially equivalent to the BioZ.pc System in terms of design, intended use and principles of operation. The BioZDx Hemodynamic Monitor simply re-packages and repartitions the electronics of the product for the convenience of users who wish to have an integrated solution including a built-in printer which provides reports on standard ECG 8-1/2 x 11 grided paper.
The BioZDx has nearly identical DSP software structure to the predicate devices, with enhanced fiducial point detection techniques over those used in the predicate devices, and the addition of a statistical based modulation factor for dZ/dTmax rather than the empirical technique employed in the predicate devices. There were no unexpected test results due to these changes and the validation of these changes is included in Section J.
1
The user software has been simplified compared to either of the predicate devices and ported from DOS 6.22 running under Microsoft Windows to Microsoft Windows CE to take advantage of the features of the new user platform.
The new user platform is the hardware and core operating system software of the Philips PageWriter Trim Cardiograph, 510/k) K031422 on 7/3/2003, less the ECC-specific hardware and ECG application software. The Philips ECC-specific hardware and ECG application software have been replaced with their equivalent ICG counterparts.
The User Software which provides the user interface for the BioZDx system is loaded onto the PC using a software installation kit, similar to the method used for the predicate device. The predicate device used a floppy disk or an attached notebook PC for software installation. The BioZDx uses a pre-programmed PCMCIA flash memory card.. Both devices store the user software on the internal storage of the user platform component of the system. Both products use an identical software integrity check when the monitoring software is first activated, to insure that no corruption has occurred of any of the operating software used by the device.
The BioZDx provides a printed report as do the two predicate devices. In the BioZDx, the printer is internal to the device rather than attached externally. The report in the BioZDx contains the same information as the predicate devices, but is reformatted to standard grid ECG paper. Both the predicate devices and theBioZDx use the HPGL graphic language for formatting printouts and communication with the print engine.
The BioZDx product also includes an improved patient cable, with enhanced defib protection and removable/replaceable left and right distal interconnect sections. The defib protection components are identical to those used in the predicate devices, but they are moved to the patient cable yoke and closer to the patient. The distal patient cable sections also include identification chips to prevent users from operating the device with unapproved and unvalidated cable systems. All final product testing was performed with prototype versions of the improved patient cable.
CardioDynamics International Corporation has labeled the version of BioZDx software clearly on the installation kit flash memory card. The installation instructions in the kit, and the user manual instructions for use clearly specify the kit only for use with the BioZDx product.
Both BioZ.pc and the BioZ.com predicate devices as well as the new BioZDx systems are portable in design and for use in the hospital, outpatient and clinical settings. The intended use of the BioZDx (identical to the predicate device) is to noninvasively measure a patient's hemodynamic parameters using Impedance Cardiography (ICG). Monitoring is accomplished by attaching 8 electrodes to the patient (two dual electrodes on each side of the neck and thorax), injecting a minimal current through the upper electrodes, and reading the returning voltage waveform from the inner electrodes.
The BioZDx Hemodynamic Monitor utilizes CardioDynamics' proprietary DSP electronic circuitry and software incorporating formulas and algorithms to calculate the various hemodynamic parameters. The user inputs patient parameters into the user software, including patient gender, body frame size, height, weight, age and blood pressure. The Monitor then utilizes these parameters and measures the ICG signals to determine the hemodynamic properties of that particular patient interface circuity (which provides all data acquisition, processing, and isolation) is similar to the predicate devices, and tested to the same internal and Agency specifications All changes to the new product from the predicate device are verified and validated within the body of hardware and software testing. The validation reports are included in Section J for System, Hardware, and Signal Processing, and Section M for software.
2
The ICG electrodes (BioZTect Sensor) to be used with the BioZDx device are sold separately, and are identical to those marketed for use with both the BioZ.com predicate device products. The BioZTect Sensor received 510(k) Clearance (K011797) on 7-3-2001.
The predicate devices (the BioZ.com) and the new BioZDx Hemodynamic Monitor are IBM PC Family (Intel Pentium-class core processor-based) products, which differ primarily in partitioning and packaging. Both utilize Microsoft operating systems, either alone or within a Windows or Windows CE environment.
The predicate devices required the use of an external simulator device (the CardioDynamics BZ-4525 BioZ.sim device) to verify system performance and test patient cables. For user convenience, this function is built in to the BioZDx device.
Substantial equivalence is shown in the following table (on the next page):
3
.
| Attribute | BioZDx (New) | BioZ.pc (Predicate) | BioZ.com (Predicate) |
|---|---|---|---|
| Packaging | Separate computer and | ||
| Patient Interface Module | |||
| (PIM) | Separate computer and | ||
| Patient Interface Module | |||
| (PIM) | Self-contained instrument | ||
| (computer and Patient | |||
| Interface Electronics) | |||
| Pt. Interface Circuitry | |||
| and sensors | Same as BioZ.com and | ||
| BioZ.pc with addition of | |||
| continuous lead fail. All | |||
| accessories except patient | |||
| cable same as BioZ.com | Same as new device with | ||
| exception of continuous | |||
| lead fail. All accessories | |||
| except patient cable same | |||
| as new device | Same as new device with | ||
| exception of continuous | |||
| lead fail. All accessories | |||
| except patient cable same | |||
| as new device | |||
| Defib Protection | Moved to yoke of patient | ||
| cable | Internal to BioZ.pc | ||
| Instrument | Internal to BioZ.com | ||
| Instrument | |||
| CPU | Intel 586 equivalent PC | Intel 586 or Equivalent PC | Intel 386EX PC |
| CPU Packaging | Separate from patient | ||
| interface circuitry, | |||
| connected with serial link | Separate from patient | ||
| interface circuitry, | |||
| connected with serial link | Internal to BioZ.com | ||
| Instrument | |||
| CPU Communications | USB Serial | RS323 Serial (External) | RS232 Serial (Internal) |
| PC Operating System | Windows CE® | Windows 98 or NT® | DOS 6.22 |
| PC Software | |||
| Installation Kit | Manufactured and | ||
| supplied per CDIC | |||
| Manufacturing Procedure | |||
| 02-121 | Manufactured and | ||
| supplied per CDIC | |||
| Manufacturing Procedure | |||
| 02-121 | Manufactured and | ||
| supplied per CDIC | |||
| Manufacturing Procedure | |||
| 02-121 | |||
| Printer | Internal to Cardiograph | ||
| HPGL Protocol | Externally connected | ||
| HPGL Protocol | Externally connected | ||
| HPGL Protocol | |||
| User Interface | |||
| software | BioZDx ver V1.0x9 | BioZ.pc V1.52 | BioZ.com V2.26 |
| User Display | Internal VGA Screen | External PC VGA Screen | BioZ.com internal $\frac{1}{4}$ |
| VGA screen | |||
| Blood Pressure | |||
| Electronics | Internal to BioZ.dx PIM | ||
| Suntech Module | Internal to BioZ.pc PIM | ||
| Suntech Module | Internal to instrument | ||
| CAS or Suntech Module | |||
| Pulse Oximeter | |||
| Electronics | Discontinued as a product | ||
| feature | Internal to PIM | Externally connected to | |
| instrument via serial data | |||
| cable | |||
| DSP Packaging | Internal to PIM | Internal to PIM | Internal to BioZ.com |
| Instrument | |||
| DSP Firmware | CDIC ZMARC+ Ver | ||
| V00.04.16.10.09 | CDIC ZMARC Ver1.09 | CDIC ZMARC Ver 2.15 | |
| Patient Simulator | Built-In for user | ||
| convenience | Separate Device (BZ- |
-
| Separate Device (BZ- -
|
:
Table 1 Device Equivalency
4
Risk Analysis and Design Controls
A Risk Analysis assessment, performed on the BioZDx, revealed that the repartitioning of the circuitry present absolutely no additional safety risks. The System Hazard Analysis is included in Section J. The software Hazard Analysis is included in Section M.
CardioDynamics International Corporation is certified to EN13485, and audited by TUV Rhineland. No significant audit findings have been presented since EN14001 certification in May of 1998. All products designed and manufactured under CDIC's Quality System, which includes Design Control and Manufacturing Practices.
OSP-107 defines the following activities and deliverables related to all design activities:
- Design Input: Specific requirements for a design project, including any applicable statutory and . regulatory requirements.
- Design Output: The results of a design effort. The design output includes 1) the detailed . documentation covering all functional and performance characteristics of the device, including those related to safety, 2) the product and process documents needed to produce the device and maintain it throughout its life cycle.
- Design Verification: Confirmation that the design output meets the design input requirements. .
- Design Validation: The establishment, by objective evidence, that a device conforms to the users' . needs and intended uses.
- Design Transfer: The process of transferring knowledge (specifications) about the device from the . design group to the manufacturing group.
It is the responsibility of all members of the Engineering Department to ensure that the requirements of OSP-107 are met for all product designs and that each required deliverable is created and approved.
It is the responsibility of the representatives of the Marketing, Quality Assurance, Manufacturing and Executive departments to review, understand and approve each applicable deliverable of the Design Control process.
The result of following QSP-107 is a Device Design Record that includes design documentation associated with the design of the product. The completed Device Design Record provides a design history of the finished device and demonstrates the device design was developed, verified and validated in accordance to OSP-107. The accessories developed specifically as part of the BioZDx Hemodynamic Monitor are included in its Device Design Record.
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 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. The Design Control Form, OSDP-101-1, contains a list of the deliverables for each step, with the approved revision number. The signatures on both the Design Control Form and each of the approved documents constitute evidence of the design review process.
Design inputs provide the foundation for product development. All Design Inputs are as comprehensive and precise as possible without imposing design solutions. Upon completion of the design review activity
5
for the Design Input step, with agreement that the Design Inputs were correct and acceptable, the Design Input section of the Design Control Form is completed with all required signatures.
The Design Output deliverables are to be created by appropriate personnel to meet the specific Design Inout requirements. The Design Output deliverables demonstrate that the Design Input requirements have been met. These deliverables are listed in the Design Output section of the Design Control Form. Upon the completion of the design review activity for the Design Output step, with agreement that the listed Design Output deliverables were determined to be correct and acceptable, the Design Output section of the Design Control Form is completed with all required signatures.
Design Verification is performed by the appropriate personnel to verify the Design Outputs fulfill the Design Input requirements. The Design Verification deliverables indicate that the Design Outputs meet the specified Design Input requirements listed in the Design Verification section of the Design Control Form.
Design Validation is performed by the appropriate personnel to verify that the Design Outputs fulfills the users' needs and intended uses. The Design Validation documents indicate the Design Outputs meet the users' needs and intended uses, and are listed in the Design Validation section of the Design Control Form. Upon the completion of the design review activity for the Design Validation step, with agreement that the listed Design Validation deliverables are determined to be correct and acceptable, the Design Validation section of the Design Control Form is completed with all required signatures.
Design Transfer activity is performed by appropriate personnel to verify that the Design Output and Design Transfer deliverables are sufficient to produce a product that meets the Design Input requirements. The Design Transfer deliverables include manufacturing instruction and documentation, in addition to the Design Output deliverables that are sufficient to produce a device that meets the Design Input requirements and shall be listed in the Design Transfer section of the Design Control Form. Upon completion of the design review activity for the Design Transfer step, with agreement that the listed Design Transfer deliverables are determined to be correct and acceptable, the Design Transfer section of the Design Control Form is completed with all required signatures.
The design process can be considered complete when all sections of each Design Control Form created during the project are signed. Upon completion of the design output documents are submitted for Document Change Order (DCO).
Configuration Control and Quality Assurance are provided under CDIC Quality System Procedures. These procedures specify that all products must be DCO control, that all components used in product assembly have incoming inspection, and that all product is built only under controlled manufacturing documentation, manufacturing instruction and test procedures. Internal audits are performed to insure compliance with these procedures.
6
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 2004
Cardiodynamics International Corp. c/o Mr. Dennis G. Hepp Chief Technology Officer 6175 Nancy Ridge Drive, #300 San Diego CA 92121
Re: K041294
Trade Name: BioZDx Hemodynamic Monitor Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: II (two) Product Code: DSB Dated: May 13, 2004 Received: May 14, 2004
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. Iisting 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.
7
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 (301) 594-4648. 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.
B.Zimmerman fr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known):_K041294
Device Name: BioZDx HemoDynamic Monitor
Indications For Use:
The BioZDx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include:
ECG Cardiac Output Thoracic Fluid Content Left Vent. Ejection Time End Diastolic Volume Systemic Vascular Resistance PressureLeft Cardiac Work Diastolic Blood Pressure
Pre-Ejection Period Heart Rate Acceleration Index Index of Contractility Mean Blood Pressure Systolic Time Ratio End diastolic Index Cardiac Index
Stroke Volume Systolic Blood
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)
B. Simmons
n Sign-Off) cular Devices Division of Cardiov, 510(k) Number
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