(25 days)
No
The description mentions proprietary DSP electronic circuitry and software utilizing formulas and algorithms, but does not mention AI or ML.
No.
The device is intended to monitor and display a patient's hemodynamic parameters, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is intended to monitor and display a patient's hemodynamic parameters, providing information that aids in assessing a patient's health status. This falls under the definition of a diagnostic device as it helps identify and understand physiological conditions.
No
The device description explicitly states it includes hardware components: "CardioDynamics' proprietary DSP hardware and Patient Interface Circuitry", "BioZtect Sensors", and "BioZtect Patient Cable".
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the device "noninvasively measure[s] a patient's hemodynamic parameters using Impedance Cardiography (ICG)." This involves attaching electrodes to the patient's skin and measuring electrical signals. This is a non-invasive, in-vivo measurement, not an in-vitro test on a sample.
- Intended Use: The intended use is to "monitor and display a patient's hemodynamic parameters," which are physiological measurements taken directly from the patient.
Therefore, the BioZtect Sensor and BioZtect Cable, used with the GE Medical Systems Solar ICG Module, are considered medical devices for physiological monitoring, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The BioZtect Sensor and BioZtect Cable are used with the GE Medical Systems Solar ICG (Impedance Cardiography) Module (K010164) and are intended to monitor and display a patient's hemodynamic parameters. The following are parameters that are available, to be used as needed by the ICG Module:
Acceleration Index, Cardiac Output, Cardiac Index, ECG, End Diastolic Volume, End Diastolic Index, Heart Rate, Index of Contractility, Indexed Systemic Vascular Diastone Indon, Indexed Left Cardiac Work, Left Cardiac Work, Left Ventricular Ejection Time, Pre-Ejection Period, Stroke Volume, Stroke Index, Systolic Time Ratio, Systemic Vascular Resistance, Thoracic Fluid Content, Respiration Rate, Velocity Index
Product codes (comma separated list FDA assigned to the subject device)
74 DSB
Device Description
The ICG Module with accessories BioZtect Sensor and BioZtect Cable are substantially equivalent to the predicate BioZ.com System in terms of design, intended use and principle of operation, having minimally modified these accessories. Both systems are for use in the hospital, outpatient and clinical settings. The intended use is to noninvasively measure a patient's hemodynamic parameters using Impedance Cardiography (ICG). Monitoring is accomplished by attaching 8 electrodes to the patient (two 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 ICG Module 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 ICG Module, including patient gender, body frame size, height, weight, age and blood pressure. The module then utilizes these parameters and measures the ICG signals to determine the hemodynamic properties of that particular patient.
Both the predicate BioZ.com System and the ICG Module with accessories BioZtect Sensor and BioZtect Cable utilize a computer-based system. Each system contains the following:
- BioZ or ICG Module
a) CardioDynamics' proprietary DSP hardware and Patient Interface Circuitry
b) CardioDynamics proprietary DSP firmware and user software
-
BioZtect Sensors
-
BioZtect Patient Cable
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neck and thorax
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
i1797
JUL - 3 2001
Summary and Certification 2
Premarket Notification 510(k) Summary 2.1
SUBSTANCIAL EQUIVALENCE:
Identification of predicate devices, models, and manufacturers:
| Predicate electrode device: | CardioDynamics BioZtect Sensor within BioZ.com System |
|---|---|
| Model: | Part # BZ-4550 |
| Manufacturer: | CardioDynamics International Corporation |
| Predicate Device 510(k): | K001100 |
| Reason for Submission: | Modifications to electrode shape, material, gel, thickness, |
| and snap size | |
| Predicate cable device: | CardioDynamics BioZtect Cable within BioZ.com System |
| Model: | Part # BZ-4540 |
| Manufacturer: | CardioDynamics International Corporation |
| Predicate Device 510(k): | K001100 |
| Reason for Submission: | Modifications to leadwire connector size, change style of |
| module connector, addition of series inductors for each | |
| conductor, and addition of identification integrated circuit |
GEMS received acceptance of the 510(k) Notification Submission K010164 on 5/24/01 for the GE Medical Systems Solar ICG Module with standard cable and standard sensors.
The purpose of this submission is to file for the replacement accessories, the BioZtect Sensor and BioZtect Cable. These accessories, when used with the ICG Module, comprise a device that is substantially equivalent to the predicate device currently marketed by CardioDynamics International Corporation. The justification for this substantial equivalence determination is presented below.
1
The ICG Module with accessories BioZtect Sensor and BioZtect Cable are substantially equivalent to the predicate BioZ.com System in terms of design, intended use and principle of operation, having minimally modified these accessories. Both systems are for use in the hospital, outpatient and clinical settings. The intended use is to noninvasively measure a patient's hemodynamic parameters using Impedance Cardiography (ICG). Monitoring is accomplished by attaching 8 electrodes to the patient (two 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 ICG Module 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 ICG Module, including patient gender, body frame size, height, weight, age and blood pressure. The module then utilizes these parameters and measures the ICG signals to determine the hemodynamic properties of that particular patient.
Both the predicate BioZ.com System and the ICG Module with accessories BioZtect Sensor and BioZtect Cable utilize a computer-based system. Each system contains the following:
- BioZ or ICG Module
a) CardioDynamics' proprietary DSP hardware and Patient Interface Circuitry
b) CardioDynamics proprietary DSP firmware and user software
-
BioZtect Sensors
-
BioZtect Patient Cable
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
DEPARTMENT OF HEALTH & HUMAN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2001
Mr. Dennis G. Hepp Chief Technology Officer CardioDynamics International Corporation 6175 Nancy Ridge Drive, #300 San Diego, CA 92121
Re: K011797
Trade Name: BioZtect Sensor and BioZtect Cable Regulation Number: 870.2770 Regulatory Class: II (two) Product Code: 74 DSB Dated: June 7, 2001 Received: June 8, 2001
Dear Mr. Hepp:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish
3
Page 2 - Mr. Dennis G. Hepp
further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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.
Dak Tilla
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1.2 Indications for Use:
The BioZtect Sensor and BioZtect Cable are used with the GE Medical Systems Solar ICG (Impedance Cardiography) Module (K010164) and are intended to monitor and display a patient's hemodynamic parameters. The following are parameters that are available, to be used as needed by the ICG Module:
Acceleration Index, Cardiac Output, Cardiac Index, ECG, End Diastolic Volume, End Diastolic Index, Heart Rate, Index of Contractility, Indexed Systemic Vascular Diastone Indon, Indexed Left Cardiac Work, Left Cardiac Work, Left Ventricular Ejection Time, Pre-Ejection Period, Stroke Volume, Stroke Index, Systolic Time Ratio, Systemic Vascular Resistance, Thoracic Fluid Content, Respiration Rate, Velocity Index
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (PER 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Oark Tille
Division of Cardiovascular & Respiratory Devices
510(k) Number K011797