(455 days)
Nihon Kohden MLC-4200 Cardiac Output Computer, Nihon Kohden MLC-4100 Cardiac Output Computer
Not Found
No
The description focuses on spectrophotometry and signal processing to measure dye concentration and peak amplitudes, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is a diagnostic tool used to detect circulatory pathway abnormalities, not to treat them.
No
The device description explicitly states, "The system is not designed to produce a definitive interpretation or exhaustive evaluation of a patient's circulatory pathway. Rather, it is intended to be used as a support tool in conjunction with other clinical and diagnostic findings." This indicates it provides information to assist diagnosis, but does not itself provide a definitive diagnosis.
No
The device description explicitly details hardware components such as optical sensors, photodiodes, and a monitor, which are integral to its function of detecting and measuring ICG concentration.
Based on the provided information, the Cardiox Flow Detection System Model 99 is not an In Vitro Diagnostic (IVD).
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.
- Cardiox System Function: The Cardiox system works by transcutaneously detecting the presence and concentration of ICG dye in blood vessels at the scaphoid fossa of the ear using near infra-red spectrophotometry. This is a non-invasive method that does not involve taking a sample from the patient's body for analysis outside of the body.
- Method of Detection: The system measures the fluorescence signal of the ICG dye directly within the blood vessels, not in a sample that has been removed and processed.
Therefore, while the system provides diagnostic information about the patient's circulatory pathway, it does so through a non-invasive, in-vivo measurement rather than an in-vitro analysis of a biological sample.
N/A
Intended Use / Indications for Use
The Cardiox Flow Detection System Model 99 provides a fluorescent ICG indicator dye dilution curve for cardiac output in patients with known or suspected circulatory pathway abnormalities. The system is not designed to produce a definitive interpretation or exhaustive evaluation of a patient's circulatory pathway. Rather, it is intended to be used as a support tool in conjunction with other clinical and diagnostic findings. This device is only intended for use on patients that weigh more than 10kg.
Product codes
DXG
Device Description
The Cardiox Flow Detection System (FDS) Model 99 utilizes near infra-red (NIR) spectrophotometry to transcutaneously detect the presence and relative concentration of indocyanine green dye (ICG) in blood vessels located at the scaphoid fossa of the ear.
The indicator dye, ICG, is injected into a peripheral antecubital vein of the patient while the patient optionally blows into the ValsalvaSure™ mouthpiece. The exhalation by the patient into the mouthpiece (i.e., performing a Valsalva maneuver) is available to provide conditions that may expose abnormal blood flow. The ValsalvaSure maneuver creates a pressure differential resulting in a right-to-left flow of blood between the atria, which results in a right-to-left-shunt (RLS) through any existing Atrial Septal Defect (ASD) and/or patent foramen ovale (PFO). The RLS allows blood to flow directly from the right atrium of the left atrium of the heart without passing through the lungs. The optical sensors in the Cardiox Earpads measure the relative concentration (i.e., fluorescence signal level) of ICG in the bloodstream as a function of time. Once captured by the photodiodes, the measured fluorescence signal is transmitted to the FDS Monitor.
In a subject with a normal circulatory pathway, the ICG is injected into an antecubital vein, travels through the heart and lungs then into the arterial vasculature, and is detected at the scaphoid fossa of the ear. The magnitude of the ICG curve peak amplitude is measured and displayed by the Cardiox FDS monitor, and is referred to as the Major Curve Peak Amplitude. in a subject with an abnormality in the circulatory pathway, such as a RLS, some of the ICG dye arriving in the right atrium follows a shorter pathway between the right atrium and left atrium, instead of traveling through the anatomically longer pathway through the lungs. This fraction of ICG dye that passes through an anatomical abnormality arrives at the scaphoid fossa of the ear in advance of the main bolus of ICG dye that follows the normal circulatory pathway through the lungs. The magnitude of the ICG curve peak amplitude associated with the earlier arrival of dye is measured and displayed by the Cardiox FDS monitor, and is referred to as the Minor Curve Peak Amplitude.
The report generated by the Cardiox FDS Model 99 identifies the Major Curve and Minor Curve Peak Amplitudes.
The Cardiox™ Flow Detection System™ Model 99 consists of the following components and accessories:
- FDS Monitor, Model 99
- Cardiox Earpads
- Cardiox Headband
- Cardiox Flow Sensor Cable
Disposable Procedure Kit Components:
- Cardiox FDS™ Flowset Disposable Injection Set
- Cardiox FDS™ Mouthpiece
- Syringe without Needle 3 mL (x2)
- Syringe without Needle 5 mL
- 20 mL Syringe Luer-Lok™ Tip (x2)
- Blunt Fill Needle, 18 Gauge (x5)
- Blunt Fill Needle- Filter, 18 Gauge
- Shielded IV Catheter, 20 Gauge
- Utility Drapes
- IV Start Kit
- Akorn® IC-Green (indocyanine green for injection, USP) 25 mg vial
- Akorn® Aqueous Solvent 10mL ampule
- Hospira® 0.9% Sodium Chloride Injection
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared Spectrophotometry
Anatomical Site
Scaphoid fossa of the ear, peripheral antecubital vein (injection site)
Indicated Patient Age Range
Not Found, but only intended for use on patients that weigh more than 10kg.
Intended User / Care Setting
medical professionals
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)
The document states that "The commercially distributed Cardiox™ Flow Detection System™ conforms to the following standards:" and then lists several ISO and IEC standards related to biological evaluation, sterilization, packaging, quality management, risk management, symbols, ingress protection, electrical safety, electromagnetic compatibility, usability, laser safety, and software life cycle processes. No specific performance study results (e.g., sample size, AUC, MRMC, standalone performance, key results) are provided within the summary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nihon Kohden MLC-4200 Cardiac Output Computer, Nihon Kohden MLC-4100 Cardiac Output Computer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).
0
Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 2 of 12
Image /page/0/Picture/1 description: The image shows the word "cardiox" in a bold, sans-serif font. The "o" in "cardiox" is stylized with a curved line extending from the top right of the "o". In the top right corner of the image, there is the text "K122400 Page 1 of 11".
510(k) SUMMARY Cardiox™ Flow Detection System™, Model 99
Submitter's Name, Address, Telephone Number, Contact Person
Cardiox Corporation 4100 Horizons Drive, Suite 100 Columbus, OH 43220 Phone: (614) 791-8118 Facsimile: (614) 791-8221
Contact Person: Karen E. Matis, RAC
Date Prepared: 06/24/2013
NOV 0 5 2013
Name/Address of Sponsor:
Cardiox Corporation
- 4100 Horizons Drive, Suite 100 Columbus, OH 43220
Device Name:
Trade Name: Cardiox™ Flow Detection System™, Model 99 Common or Usual Name: Single-function, preprogrammed computer Classification Name: Single-function, preprogrammed diagnostic computer (21 CFR 870.1435)
Predicate Devices:
| Predicate Device Trade Name | Predicate Device Manufacturer |
|---|---|
| • Nihon Kohden MLC-4200 Cardiac Output Computer | Nihon Kohden |
| • Nihon Kohden MLC-4100 Cardiac Output Computer | Nihon Kohden |
Intended Use / Indications for Use:
Indication for Use:
The Cardiox Flow Detection System Model 99 provides a fluorescent ICG indicator dye dilution curve for cardiac output in patients with known or suspected circulatory pathway abnormalities. The system is not designed to produce a definitive interpretation or exhaustive evaluation of a patient's circulatory pathway. Rather, it is intended to be used as a support tool in conjunction with other clinical and diagnostic findings. This device is only intended for use on patients that weigh more than 10kg.
1
Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 3 of 12
Image /page/1/Picture/1 description: The image shows the logo for "cardiox". The logo is in black and features a stylized font. Above the logo, the text "K122-" and "Page 2 of" are visible, suggesting this image is part of a larger document or series of pages.
Intended Use:
The Cardiox™ Flow Detection System™ (FDS™) Model 99 is intended to be used by medical professionals interested in detecting ICG in the peripheral vasculature, and evaluating blood flow through the heart and circulatory system. The Cardiox FDS Model 99 provides graphical display of indicator dye dilution curves using Indocvanine Green (ICG) as the indicator dye.
Device Description:
The Cardiox Flow Detection System (FDS) Model 99 utilizes near infra-red (NIR) spectrophotometry to transcutaneously detect the presence and relative concentration of indocyanine green dye (ICG) in blood vessels located at the scaphoid fossa of the ear.
The indicator dye, ICG, is injected into a peripheral antecubital vein of the patient while the patient optionally blows into the ValsalvaSure™ mouthpiece. The exhalation by the patient into the mouthpiece (i.e., performing a Valsalva maneuver) is available to provide conditions that may expose abnormal blood flow. The ValsalvaSure maneuver creates a pressure differential resulting in a right-to-left flow of blood between the atria, which results in a right-to-left-shunt (RLS) through any existing Atrial Septal Defect (ASD) and/or patent foramen ovale (PFO). The RLS allows blood to flow directly from the right atrium of the left atrium of the heart without passing through the lungs. The optical sensors in the Cardiox Earpads measure the relative concentration (i.e., fluorescence signal level) of ICG in the bloodstream as a function of time. Once captured by the photodiodes, the measured fluorescence signal is transmitted to the FDS Monitor.
In a subject with a normal circulatory pathway, the ICG is injected into an antecubital vein, travels through the heart and lungs then into the arterial vasculature, and is detected at the scaphoid fossa of the ear. The magnitude of the ICG curve peak amplitude is measured and displayed by the Cardiox FDS monitor, and is referred to as the Major Curve Peak Amplitude. in a subject with an abnormality in the circulatory pathway, such as a RLS, some of the ICG dye arriving in the right atrium follows a shorter pathway between the right atrium and left atrium, instead of traveling through the anatomically longer pathway through the lungs. This fraction of ICG dye that passes through an anatomical abnormality arrives at the scaphoid fossa of the ear in advance of the main bolus of ICG dye that follows the normal circulatory pathway through the lungs. The magnitude of the ICG curve peak amplitude associated with the earlier arrival of dye is measured and displayed by the Cardiox FDS monitor, and is referred to as the Minor Curve Peak Amplitude.
The report generated by the Cardiox FDS Model 99 identifies the Major Curve and Minor Curve Peak Amplitudes.
2
Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 4 of 12
Image /page/2/Picture/1 description: The image shows the word "cardiox" in a bold, sans-serif font. The letters are black, and the word is slightly curved upwards. Above and to the right of the word, there is the text "K12240" and "Page 3 of 1". The text is in a smaller font than the word "cardiox".
The Cardiox™ Flow Detection System™ Model 99 consists of the following components and accessories:
| CARDIOX FDS REUSABLE SYSTEM AND ACCESSORIES |
|---|
| Cardiox Flow Detection System, Model 99 |
| Consisting of the following components and accessories: |
| • FDS Monitor, Model 99 |
| • Cardiox Earpads |
| • Cardiox Headband |
| • Cardiox Flow Sensor Cable |
| CARDIOX FDS DISPOSABLE PROCEDURE KIT COMPONENTS | |
|---|---|
| 1. | Cardiox FDS™ Flowset Disposable Injection Set |
| 2. | Cardiox FDS™ Mouthpiece |
| 3. | Syringe without Needle 3 mL (x2) |
| 4. | Syringe without Needle 5 mL |
| 5. | 20 mL Syringe Luer-Lok™ Tip (x2) |
| 6. | Blunt Fill Needle, 18 Gauge (x5) |
| 7. | Blunt Fill Needle- Filter, 18 Gauge |
| 8. | Shielded IV Catheter, 20 Gauge |
| 9. | Utility Drapes |
| 10. | IV Start Kit |
| 11. | Akorn® IC-Green (indocyanine green for injection, USP) 25 mg vial |
| 12. | Akorn® Aqueous Solvent 10mL ampule |
| 13. | Hospira® 0.9% Sodium Chloride Injection |
Technological Characteristics:
The Cardiox FDS Model 99 utilizes near-infrared (NIR) spectrophotometry to detect the presence of Indocyanine Green for Injection (ICG) dye in the peripheral vasculature. Spectrophotometry is the quantitative measurement of the reflection or transmission properties of a material as a function of wavelength.
The FDS Earpads™, including their fluorescence sensor arrays (FSA™), are used to measure and indicate the relative concentration (i.e., fluorescence signal level) of ICG dye in the bloodstream as a function of time. The Earpads contain two sets of three for a total of six coupled laser diode (LD) light sources and photodiodes. The Earpads are positioned on the surface of the subject's skin at the scaphoid fossa of each ear. When a predetermined dose of the ICG dye is injected into a peripheral antecubital vein in the human body, it is rapidly bound to plasma protein, and generates fluorescence in the NIR range (835 nm center wavelength in whole blood) when excited by light (785 nm wavelength) from the Earpads' LD light source.
3
Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 5 of 12
Image /page/3/Picture/1 description: The image shows the word "cardiox" in a bold, sans-serif font. The letters are black, and the background is white. In the upper right corner of the image, there is the text "K12240 Page 4 of 1".
The system's detector measures the time-varying intensity of emitted fluorescence photons over a predetermined time interval. The measured intensity of the emitted fluorescence photons is proportional to the concentration of the dye in the blood and can thereby provide an indicator dye-dilution curve that characterizes blood flow through the heart.
Once captured by the photodiodes, the measured fluorescence signal is transmitted from the FDS Earpads to the FDS Monitor for recording, displaying, and reporting the indicator dyedilution curves to the clinician.
Abnormal characteristics in the circulatory system present as a distortion in the measured indicator dye dilution curve and can be characterized in terms of its minor peak amplitude relative to the major peak amplitude of the indicator dye dilution curve associated with cardiac output. ICG is FDA-approved and indicated for "determining cardiac output, hepatic function and liver blood flow, and for ophthalmic angiography."
| Feature/
Component | NEW DEVICE
The CardioxTM Flow Detection
SystemTM Model 99 | PREDICATE DEVICES
Nihon Kohden America
MLC-4200 & MLC-4100 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 870.1435 | 870.1435 |
| Classification
Product Code | DXG | DXG |
| Manufacturer | Cardiox Corporation
4100 Horizons Drive
Columbus OH 43220 | Nihon Kohden (America), Inc.
530 Maple Avenue
Torrance, CA 90503 |
| Indications for
Use | The Cardiox Flow Detection System
Model 99 provides a fluorescent ICG
indicator dye dilution curve for cardiac
output in patients with known or
suspected circulatory pathway
abnormalities. The system is not
designed to produce a definitive
interpretation or exhaustive evaluation
of a patient's circulatory pathway.
Rather, it is intended to be used as a
support tool in conjunction with other | The Nihon Kohden MLC-4200/MLC-
4100 Cardiac Output Computer
provides a non-invasive measurement
and record of a dye concentration
curve for investigation of intra-cardiac
shunts and valvular regurgitation. |
| Feature/
Component | NEW DEVICE
The Cardiox™ Flow Detection
System™ Model 99
clinical and diagnostic findings. This
device is only intended for use on
patients that weigh more than 10kg. | PREDICATE DEVICES
Nihon Kohden America
MLC-4200 & MLC-4100 |
| Intended Use | The Cardiox™ Flow Detection
System™ (FDS™) Model 99 is
intended to be used by medical
professionals interested in detecting
ICG in the peripheral vasculature, and
evaluating blood flow through the heart
and circulatory system. The Cardiox
FDS Model 99 provides graphical
display of indicator dye dilution curves
using Indocyanine Green (ICG) as the
indicator dye. | The Nihon Kohden MLC-4200/MLC-
4100 constructs a curve representing
Indocyanine Green for (ICG) dye
concentration with respect to time (dye
concentration curve). The device
provides a record of the curve for
analysis of circulatory system
abnormalities. |
| Operating
Technology | Infrared Spectrophotometry | Infrared Spectrophotometry |
| Operating
Principle | Spectrophotometric ICG blood
detection and measurement | Spectrophotometric ICG blood
detection and measurement |
| Fluorescence
Media | Indocyanine Green (ICG) Dye | Indocyanine Green (ICG) Dye |
| Technological
Characteristics | The Cardiox Model 99 Flow Detection
System (FDS) is used with
Indocyanine-Green (ICG), a green dye
that temporarily binds with serum
albumin, its fluorescent agent. When a
blood vessel is irradiated with 785 nm
photons over a predetermined time
interval, this dye fluoresces, emitting
photons at wavelengths in the range of
830 to 840 nm. The system's detector
measures the time-varying intensity of
emitted fluorescence photons over a
predetermined time interval. The
measured intensity of the emitted
fluorescence photons is proportional to
the concentration of the dye in the
blood and can thereby provide an
indicator-dilution curve that | After a small amount (5mg) of
Indocyanine-Green dye is injected into
a vein, changes in its concentration are
detected at a point in the arterial
system. The dye is detected either by
a small attachment to the ear or by
cuvette through which the blood
sample is drawn at a constant speed.
Changes in the amount of dye in the
blood are measured optically by
passing light (805 and 900 nm for ear,
805 nm for cuvette) through the blood
flowing in the ear or the cuvette and
measuring the intensity of the
transmitted light with a dye sensitive
phototransistor. A dye concentration
curve is constructed by capturing the
concentration in relation to time. |
| Feature/
Component | NEW DEVICE
The Cardiox™ Flow Detection
System™ Model 99 | PREDICATE DEVICES
Nihon Kohden America
MLC-4200 & MLC-4100 |
| | characterizes blood flow through the
heart. Abnormal characteristics in the
circulatory system present as a
distortion in the measured indicator-
dilution curve and can be
characterized in terms of its minor
peak amplitude relative to the major
peak amplitude of the indicator dye-
dilution curve. ICG is FDA-approved
and indicated for "determining cardiac
output, hepatic function and liver blood
flow, and for ophthalmic angiography." | Cardiac output is automatically
computed by dividing the amount of
dye injected into the vein by the area
of the dye concentration curve.
Cardiac output is presented in four
digits with a maximum of 19.99. The
dye concentration curve is recorded for
investigation of intra-cardiac shunts
and valvular regurgitation or for
determining mean transit time and total
circulating blood volume, etc. If an
abnormality is present in the circulatory
system between the point of injection
and the sampling site, it is revealed by
a distortion of the normal pattern of the
curve. When coupled with a
Thermodilution Amplifier, cardiac
output data can be obtained via the
thermodilution method. |
| Design
Features | Single-function, preprogrammed
diagnostic computer with a modern
user-friendly touchscreen interface,
complete with an on-screen keyboard
to enter patient data for improved
usability.
Image: Cardiox Flow Detection System Model 99 | Single-function, preprogrammed
diagnostic computer
Image: Nihon Kohden America MLC-4200 & MLC-4100 |
| Dimensions
(l x w x h) | Flow Detection Monitor (10007): 10.5
in wide x 11.25 in. high x 10.5 in. deep
Earpads (20001): 93 in. long (includes
length of cable) | Main Unit (MLC-4200M): 300 mm x
300 mm x 300 mm
Earpiece (TL-410S): 16 in. diameter,
70 in. length |
| Feature/
Component | NEW DEVICE
The Cardiox™ Flow Detection
System™ Model 99 | PREDICATE DEVICES
Nihon Kohden America
MLC-4200 & MLC-4100 |
| | Headband (20002): 29 in. long x 2 in. wide
Flow Sensor Cable (20003): 72 in. long
Flowset Disposable Injection Set
(31039): 29 in. long
Mouthpiece (31035): 52.5 in. long | Cuvette (TL-430S): 450 mm x 190 mm x 190 mm
Thermodilution Amplifier (AF-410V):
300 mm x 85 mm x 300 mm |
| Power Source | Single Phase 100-240 VAC +/- 10%,
50/60 Hz +/- 1 Hz,