C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
Device Facts
| Record ID | K041434 |
|---|---|
| Device Name | C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS |
| Applicant | Analogic Corp. |
| Product Code | DSB · Cardiovascular |
| Decision Date | Aug 6, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2770 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The C3 ICG Monitor is intended to non-invasively monitor a patient's hemodynamic parameters when in the ICG mode. The hemodynamic parameters include: Acceleration Index (ACI), Pre-ejection Period (PEP), Cardiac Index (CI), Stroke Index (SI), Cardiac Output (CO), Stroke Volume (SV), Ejection Time Ratio (ETR), Systemic Vascular Resistance (SVR), Ejection Velocity Index (EVI), Systemic Vascular Resistance Index (SVRI), Heart Rate (HR), Systolic Time Ratio (STR), Heather Index (HI), Thoracic Fluid Content (TFC), Left Cardiac Work Index (LCWI), Thoracic Fluid Volume Index (TFI), Left-ventricular Ejection Time (LVET), Velocity Index (VI). The Impedance Cardiography (ICG) function of the C3 ICG is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a facility providing healthcare. The C3 ICG is intended for use on Adult patients that meet the limits specified below: Height: 4 ft 7 ft-6 in (122 229 cm), Weight: 67 350 lb (30 159 kg). When not in the ICG mode, the C3 ICG is intended to provide continuous ECG, heart rate, noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpOz), respiration rate, temperature and carbon dioxide (CO2) on Adult and Pediatric patients within a hospital or facility providing patient care. These are indications previously cleared under K030931. The LIFEGARD™ ICG Monitor is intended to non-invasively monitor a patient's hemodynamic parameters. The hemodynamic parameters include: Acceleration Index (ACI), Blood Pressure (built-in NIBP), Cardiac Index (CI), Cardiac Output (CO), Heart Rate (HR), Left Cardiac Work Index (LCWI), Left-ventricular Ejection Time (LVET), Pre-ejection Period (PEP), Stroke Index (SI), Stroke Volume (SV), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), Systolic Time Ratio (STR), Thoracic Fluid Content (TFC), Velocity Index (VI). The LIFEGARD™ ICG is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a facility providing healthcare. The LIFEGARD™ ICG is intended for use on Adult patients that meet the limits specified below: Height: 4 ft 7 ft-6 in (122 229 cm), Weight: 67 350 lb (30 159 kg).
Device Story
C3 ICG and LIFEGARD™ ICG are compact, battery-powered hemodynamic monitors. Inputs include ECG leads, SpO2 sensors, thermistor probes, NIBP cuffs, EtCO2 sampling, and Thoracic Electrical Bioimpedance (TEB) electrodes. Device processes physiological signals to calculate hemodynamic parameters (e.g., Cardiac Output, Stroke Volume, SVR). Output displayed on LCD and printed on 50-mm strip chart. Used in hospitals/clinics by trained healthcare personnel. Output assists clinicians in hemodynamic assessment and patient management. Benefits include non-invasive monitoring of cardiac function.
Clinical Evidence
Clinical study conducted at University of Mississippi Medical Center with 84 patients (75 readable). Compared Analogic C3 ICG to Cardiodynamics BioZ (K974725). Study verified hemodynamic monitoring performance equivalence.
Technological Characteristics
Compact, battery-powered monitors. Sensing: ECG, SpO2, thermistor, oscillometric NIBP, EtCO2, and Thoracic Electrical Bioimpedance (TEB). Connectivity: Standalone with LCD and thermal printer. Standards: IEC 60601-1, IEC 60601-1-2:2001, AAMI/ANSI EC-13, EN 864, EN 865, AAMI/ANSI SP10, IEC 60601-2-30, IEC 60601-2-49, IEC 60068 series.
Indications for Use
Indicated for adult patients (height 122-229 cm, weight 30-159 kg) for non-invasive hemodynamic monitoring via Impedance Cardiography (ICG). C3 ICG also indicated for continuous ECG, HR, NIBP, SpO2, respiration, temperature, and CO2 monitoring in adult and pediatric patients in hospital/clinical settings.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Submission Summary (Full Text)
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K041434
AUG - 6 2004
Image /page/0/Picture/2 description: The image shows the word "ANALOGIC" in a bold, sans-serif font. The letters are all capitalized and black. A registered trademark symbol is located to the right of the letter "C". A black square is located to the right of the word.
#### 510(k) Summary for Analogic Corporation C3 ICG and LIFEGARD™ ICG Hemodynamic Monitors
# Date this Summary was Prepared:
May 26, 2004
# Submitter's Name and Address:
| Submitter's Name: | Analogic Corporation |
|-----------------------|----------------------|
| Address: | 8 Centennial Drive |
| City, State, and Zip: | Peabody, MA 01960 |
| Registration Number: | 1219601 |
#### Contact Person:
| Name: | Donald J Sherratt |
|------------|-------------------------------|
| Title: | Regulatory Affairs Manager |
| Telephone: | (978) 977-3000 extension 3049 |
| Facsimile: | (978) 977-6808 |
| E-mail: | dsherratt@analogic.com |
#### Device Name:
| Proprietary or Trade Name: | C3 ICG |
|-----------------------------|---------------------------|
| Proprietary or Trade Name: | LIFEGARD™ ICG |
| Common Name: | Impedance Plethysmograph |
| Classification Name: | Plethysmograph, Impedance |
| Classification Panel: | Cardiology |
| Product Code: | DSB |
| Code of Federal Regulation: | 870.2770 |
## Predicate Device:
The legally marketed devices to which equivalence is being claimed are:
The C3 Patient Monitor cleared under K0309031, and the Cardiodynamics BioZ System cleared under Premarket Notification K974725. The Impedance Cardiography (ICG) parameter incorporated in the C3 ICG and LIFEGARD™ ICG is substantially equivalent to the Cardiodynamics BioZ System.
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KD-34
# Description of C3 ICG
The C3 ICG is a compact, lightweight device for measuring, processing, printing, and displaying information derived from six physiological measurements:
- Electrocardiogram (ECG). A three lead ECG is acquired and a waveform car. be . displayed real-time on the LCD screen or permanently recorded on the optical strip chart recorder. The design of the ECG function is derived directly from the predicate device, the C3 Patient Monitor.
- Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated from the ratio of light . transmission through the capillary bed at two wavelengths. The SpO2 subsystem uses software and firmware that is identical to that used in the predicate device, C3 Patient Monitor.
- The temperature is measured using thermistor probes for continuous temperature . measurements. Same as in the predicate device, C3 Patient Monitor.
- Blood pressure is measured non-invasively (NIBP) by the oscillometric method. Same as . in the predicate device, C3 Patient Monitor.
- End-tidal CO2 (EtCO2) This method pulls a constant sample flow of exhaled breath from . the patient, and analyzes it with a remote CO2 sensor built into the measurement system. Same as in the predicate device, C3 Patient Monitor.
- Impedance Cardiograph (ICG). This mode uses Thoracic Electrical Bioimpedance (TEB) .
- An internal thermal printer records waveforms, hemodynamic parameters and tabular . trends on a 50-mm wide strip chart.
The C3 ICG is powered by internal sealed lead-acid batteries or from the mains supply via a battery eliminator. A fully charged battery will power the monitor for two hours.
# Description of LIFEGARD™ ICG
The LIFEGARD™ ICG Patient Monitor is a compact, lightweight device for measuring, processing, storing, and displaying information derived from six physiological measurements:
- Electrocardiogram (ECG). A single lead ECG is acquired and a waveform can be . displayed real-time on the LCD screen or permanently recorded on the thermal strip chart recorder. The design of the ECG function is derived directly from the C3 Patient Monitor with ICG Parameter.
- Blood pressure is measured non-invasively (NIBP) by the oscillometric method. Same as . in the predicate device, C3 Patient Monitor.
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- A thermal printer records waveforms, digital vital signs, and tabular trends on a 50-mm . wide strip chart.
The LIFEGARD™ ICG monitor is powered by internal sealed lead-acid batteries. A fully charged battery will power the monitor for two hours.
#### Intended Use:
The purpose and function of the ICG mode of the C3 ICG is to monitor Cardiac Output through the use of Impedance Cardiography (ICG) in adult Males and Fernales.
When not being used for ICG, the C3 ICG can monitor and display continuous ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2;), respiration rate, temperature and carbon dioxide (CO2) on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics.
The purpose of the LIFEGARD™ ICG is to non invasively monitor Cardiac Output using Impedance Cardiography (ICG) on adult Males and Females and provide continuous ECG, heart rate, non-invasive blood pressure (NIBP), on adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics.
### Comparison of Technological Characteristics:
The design of the C3 ICG Monitor is a product update to the design of the C3 Patient Monitor (K030931). The technological characteristics of the C3 ICG are essentially the same as the predicate device - Cardiodynamics BioZ (K974725). Similarly, the characteristics of the LIFEGARD™ ICG are essentially the same as the predicate device - Cardiodynamics BioZ (K974725).
## Non-clinical Tests Used In Determination Of Substantial Equivalence:
The predicate device - Cardiodynamics BioZ claims compliance with IEC 601-1 and UL 2601-1 that are previous versions of IEC 60601-1 and UL 60601-1 respectively. The predicate's manufacturer has made no claims of compliance with IEC 60601-1-2 so the electromagnetic compatibility of the predicate is unknown.
The design of both the C3 ICG and the LIFEGARD™ ICG have been thoroughly validated at the unit and system level and meets all elements of their respective Requirements Specifications. This included the following non-clinical tests:
- IEC 60601-1 (including Amendments 1 & 2), an FDA recognized consensus standard for . safety of medical electrical equipment.
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- Electromagnetic Compatibility Tests in compliance with IEC 60601-1-2:2001. Emissions . limits meet Group 1 Class B.
- ECG Performance Testing According to AAMI/ANSI EC-13 (C3 ICG only when in . standard ECG mode. When in ICG Mode, ECG is non-standard single lead)
- EtCO2 Function Test According to EN 864/1996 (C3 ICG with CO2 only) .
- SpO2 Tested According to EN865, Pulse Oximeters Particular requirements: 1997 (C3 . ICG only).
- NIBP Functional Testing to AAMI/ANSI SP10, Electronic or Automated . Sphygmomanometers, 2nd Ed .: 1992 and IEC 60601-2-30
- Both new devices were tested to IEC 60601-2-49. .
- Mechanical Shock and Vibration Tests were performed in accordance with the IEC 60068 . series of standards to ensure transport does not damage the devices.
- Shipping Container Transportation Tests were performed in accordance with IEC 60068-. 2-27 to ensure that the packaging of the equipment is not adversely affected during shipping.
- Battery Cycle Testing was performed. .
- Altitude Tests were performed to ensure that operation at higher altitudes does not . adversely affect electrical safety or performance.
- Tests were performed to verify enclosure material robustness and resistance to cleaning . materials commonly used in hospitals.
Both the C3 ICG and LIFEGARD™ ICG passed the applicable tests.
# Conclusions from Non-clinical Testing
The testing of the C3 ICG and LIFEGARD™ ICG monitors demonstrates that the non-clinical performance is substantially equivalent to the predicate devices - Cardiodynamics BioZ (K974725) and C3 Patient Monitor (K030931).
Other Bench Testing has shown that the hemodynamic monitoring performance of the C3 ICG and LIFEGARD™ ICG are substantially equivalent to the Cardiodynamics BioZ monitor.
# Clinical Testing
Clinical testing was performed at the University of Mississippi Medical center where an IRB approved protocol was performed. 84 patients were sampled, 75 were readable and met Analogic's protocol (6 unreadable and 3 with abnormal EVI). Since the patients with abnormal EVI were readable, their results are included in any analysis for completeness. The study was to compare the predicate device - Cardiodynamics BioZ (K974725) with the Analogic C3 ICG. The ICG circuitry of the LIFEGARD™ ICG is essentially identical to that of the C3 ICG and bench tests have been carried out to verify that they are essentially identical when used for ICG. This meant that only one model of device was needed for the clinical study.
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Public Health Service
Image /page/4/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three lines that resemble an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2004
Analogic Corporation c/o Mr. Donald J. Sherratt Regulatory Affairs Manager 8 Centennial Drive Peabody, MA 01960
Re: K041434
K041434
Trade Name: C3 ICG and LIFEGUARD Impedance Cardiography (ICG) Monitors
Trade Name: C3 ICG and LIFEGUARD Impedance Cardiography (ICG) Monitors
Cardional C3 ICG and L Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: II (two) Product Code: DSB Dated: May 26, 2004 Received: May 28, 2004
Dear Mr. Sherratt:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Sectori > ro(x) premainer is substantially equivalent (for the indications referenced anove and have decemblical the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food Drug commerce prior in May 20, 1970, the chance with the provisions of the Federal Food, Drug, devices that have been reciassified in accounter approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approvate or exampls provisions of the Act. The You may, therefore, market the device, subject to tire genires for amual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the rect morate required.
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 If your device is classified (see above) mits existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controlis. Existing may of of 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of I ederal Regarations) our device in the Federal Register.
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Page 2 – Mr. Donald J. Sherratt
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a subscunse or equirements of the Act
that FDA has made a determination that your device of accepcies. You must that FDA has made a determination that your arres by other Federal agencies. You must or any Federal statures and regulations administered of registration and listing (21 l
ocomply with all the Act's requirements, including, but not man reguirements as set comply with all the Act S requirements, including courses on the requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as se CFR Part 807); iabeling (21 CFR Part 820); and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and 11 CFR 1000-1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Scctions 95 described in your Section 510(k)
This letter will allow you to begin marketing your device to a legal This letter will allow you to begin makemig your averal equivale of your device to a legally
premarket notification. The FDA finding of substantial equityices of your device premarket notification. The FDA Inding of substantial equives.
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
rs the latest of the many of 1610 - Alancel assements the regulation entitl If you desire specific advice for your de need on our and note the regulation entitled, the regulation entitled, the local of the contact the Office of Complance at (501) 591 107 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Pact 807.97). "Misbranding by relerence to premance noulities under the Act from the Division of Small
other general information on your responsibilities under the Act from worker (800) 63 other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-demanain html Manufacturers, International and Consulter Prossow.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil R, Ojde
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 Form (1)
510(k) Number (if known): K041434
Device Name: C3 ICG
Indications For Use:
The C3 ICG Monitor is intended to non-invasively monitor a patient's hemodynamic parameters when in the ICG mode. The hemodynamic parameters include:
| Acceleration Index (ACI) | Pre-ejection Period (PEP) |
|---------------------------------------|-------------------------------------------|
| Cardiac Index (CI) | Stroke Index (SI) |
| Cardiac Output (CO) | Stroke Volume (SV) |
| Ejection Time Ratio (ETR) | Systemic Vascular Resistance (SVR) |
| Ejection Velocity Index (EVI) | Systemic Vascular Resistance Index (SVRI) |
| Heart Rate (HR) | Systolic Time Ratio (STR) |
| Heather Index (HI) | Thoracic Fluid Content (TFC) |
| Left Cardiac Work Index (LCWI) | Thoracic Fluid Volume Index (TFI) |
| Left-ventricular Ejection Time (LVET) | Velocity Index (VI) |
The Impedance Cardiography (ICG) function of the C3 ICG is intended for use under the direct The minionalies curationer practitioner or personnel trained in its proper use within a super in on facility providing healthcare. The C3 ICG is intended for use on Adult patients that meet the limits specified below:
- > Height: 4 ft 7 ft-6 in (122 229 cm)
- > Weight: 67 350 lb (30 159 kg)
When not in the ICG mode, the C3 ICG is intended to provide continuous ECG, heart rate, noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpOz), respiration rate, temperature and carbon dioxide (CO2) on Adult and Pediatric patients within a hospital or facility providing patient care. These are indications previously cleared under K030931.
| Prescription Use<br>(Part 21 CFR 801 Subpart D | <span style="text-align:center">X</span> | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|------------------------------------------------|------------------------------------------|--------|------------------------------------------------|
|------------------------------------------------|------------------------------------------|--------|------------------------------------------------|
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
for BD2
| 510(k) Number | K041434 |
|---------------|---------|
|---------------|---------|
Analogic Corporation C3 ICG and LIFEGARD™ ICG 510(k)
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## Indications For Use Form (2)
510(k) Number (if known): K041434
Device Name: LIFEGARD™ ICG
Indications For Use:
The LIFEGARD™ ICG Monitor is intended to non-invasively monitor a patient's hemodynamic parameters. The hemodynamic parameters include:
| Acceleration Index (ACI) |
|-------------------------------------------|
| Blood Pressure (built-in NIBP) |
| Cardiac Index (CI) |
| Cardiac Output (CO) |
| Heart Rate (HR) |
| Left Cardiac Work Index (LCWI) |
| Left-ventricular Ejection Time (LVET) |
| Pre-ejection Period (PEP) |
| Stroke Index (SI) |
| Stroke Volume (SV) |
| Systemic Vascular Resistance (SVR) |
| Systemic Vascular Resistance Index (SVRI) |
| Systolic Time Ratio (STR) |
| Thoracic Fluid Content (TFC) |
| Velocity Index (VI) |
The LIFEGARD™ ICG is intended for use under the direct supervision of a licensed healtheare The Lir LOAND - TOO is michood for assessment or facility providing healthcare. practified or personner transed in the proper and h patients that meet the limits specified below:
- Height: 4 ft 7 ft-6 in (122 229 cm) A
- Weight: 67 350 lb (30 159 kg) A
| Prescription Use<br>(Part 21 CFR 801 Subpart D | X | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|------------------------------------------------|---|--------|------------------------------------------------|
|------------------------------------------------|---|--------|------------------------------------------------|
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K041434 |
|---------------|---------|
|---------------|---------|
