CARDIOX FLOW DETECTION SYSTEM
Device Facts
| Record ID | K122400 |
|---|---|
| Device Name | CARDIOX FLOW DETECTION SYSTEM |
| Applicant | Cardiox Corp. |
| Product Code | DXG · Cardiovascular |
| Decision Date | Nov 5, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1435 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
Cardiox FDS Model 99 uses near-infrared (NIR) spectrophotometry to detect indocyanine green (ICG) dye concentration in blood vessels at the scaphoid fossa of the ear. Clinician injects ICG into peripheral antecubital vein; patient may perform Valsalva maneuver via mouthpiece to induce pressure differentials, potentially revealing right-to-left shunts (e.g., ASD/PFO). Earpads contain laser diodes (785 nm) and photodiodes to measure fluorescence (835 nm) over time. Monitor displays indicator dye dilution curves, identifying Major and Minor Curve Peak Amplitudes. Minor peaks indicate abnormal circulatory pathways (e.g., shunts) where dye bypasses lungs. System serves as clinical support tool; output aids physicians in evaluating blood flow and circulatory abnormalities. Benefits include non-invasive detection of circulatory pathway distortions.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
NIR spectrophotometry; 785 nm laser diode excitation; 830-840 nm fluorescence detection. Components: FDS Monitor, Earpads, Headband, Flow Sensor Cable. Connectivity: Standalone touchscreen monitor. Sterilization: Ethylene Oxide (EO) or Gamma for disposable components. Standards: ISO 10993-1, ISO 11135-1, ISO 11607-1, ISO 13485, IEC 60601-1, IEC 60825-1 (Class I Laser).
Indications for Use
Indicated for patients >10kg with known or suspected circulatory pathway abnormalities to provide fluorescent ICG indicator dye dilution curves as a diagnostic support tool.
Regulatory Classification
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.
Predicate Devices
- Nihon Kohden MLC-4200 Cardiac Output Computer
- Nihon Kohden MLC-4100 Cardiac Output Computer
Submission Summary (Full Text)
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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.
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Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 3 of 12
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#### 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.
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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<br>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.
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Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 5 of 12
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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/<br>Component | NEW DEVICE<br>The CardioxTM Flow Detection<br>SystemTM Model 99 | PREDICATE DEVICES<br>Nihon Kohden America<br>MLC-4200 & MLC-4100 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation<br>Number | 870.1435 | 870.1435 |
| Classification<br>Product Code | DXG | DXG |
| Manufacturer | Cardiox Corporation<br>4100 Horizons Drive<br>Columbus OH 43220 | Nihon Kohden (America), Inc.<br>530 Maple Avenue<br>Torrance, CA 90503 |
| Indications for<br>Use | The Cardiox Flow Detection System<br>Model 99 provides a fluorescent ICG<br>indicator dye dilution curve for cardiac<br>output in patients with known or<br>suspected circulatory pathway<br>abnormalities. The system is not<br>designed to produce a definitive<br>interpretation or exhaustive evaluation<br>of a patient's circulatory pathway.<br>Rather, it is intended to be used as a<br>support tool in conjunction with other | The Nihon Kohden MLC-4200/MLC-<br>4100 Cardiac Output Computer<br>provides a non-invasive measurement<br>and record of a dye concentration<br>curve for investigation of intra-cardiac<br>shunts and valvular regurgitation. |
| Feature/<br>Component | NEW DEVICE<br>The Cardiox™ Flow Detection<br>System™ Model 99<br>clinical and diagnostic findings. This<br>device is only intended for use on<br>patients that weigh more than 10kg. | PREDICATE DEVICES<br>Nihon Kohden America<br>MLC-4200 & MLC-4100 |
| Intended Use | The Cardiox™ Flow Detection<br>System™ (FDS™) Model 99 is<br>intended to be used by medical<br>professionals interested in detecting<br>ICG in the peripheral vasculature, and<br>evaluating blood flow through the heart<br>and circulatory system. The Cardiox<br>FDS Model 99 provides graphical<br>display of indicator dye dilution curves<br>using Indocyanine Green (ICG) as the<br>indicator dye. | The Nihon Kohden MLC-4200/MLC-<br>4100 constructs a curve representing<br>Indocyanine Green for (ICG) dye<br>concentration with respect to time (dye<br>concentration curve). The device<br>provides a record of the curve for<br>analysis of circulatory system<br>abnormalities. |
| Operating<br>Technology | Infrared Spectrophotometry | Infrared Spectrophotometry |
| Operating<br>Principle | Spectrophotometric ICG blood<br>detection and measurement | Spectrophotometric ICG blood<br>detection and measurement |
| Fluorescence<br>Media | Indocyanine Green (ICG) Dye | Indocyanine Green (ICG) Dye |
| Technological<br>Characteristics | The Cardiox Model 99 Flow Detection<br>System (FDS) is used with<br>Indocyanine-Green (ICG), a green dye<br>that temporarily binds with serum<br>albumin, its fluorescent agent. When a<br>blood vessel is irradiated with 785 nm<br>photons over a predetermined time<br>interval, this dye fluoresces, emitting<br>photons at wavelengths in the range of<br>830 to 840 nm. The system's detector<br>measures the time-varying intensity of<br>emitted fluorescence photons over a<br>predetermined time interval. The<br>measured intensity of the emitted<br>fluorescence photons is proportional to<br>the concentration of the dye in the<br>blood and can thereby provide an<br>indicator-dilution curve that | After a small amount (5mg) of<br>Indocyanine-Green dye is injected into<br>a vein, changes in its concentration are<br>detected at a point in the arterial<br>system. The dye is detected either by<br>a small attachment to the ear or by<br>cuvette through which the blood<br>sample is drawn at a constant speed.<br>Changes in the amount of dye in the<br>blood are measured optically by<br>passing light (805 and 900 nm for ear,<br>805 nm for cuvette) through the blood<br>flowing in the ear or the cuvette and<br>measuring the intensity of the<br>transmitted light with a dye sensitive<br>phototransistor. A dye concentration<br>curve is constructed by capturing the<br>concentration in relation to time. |
| Feature/<br>Component | NEW DEVICE<br>The Cardiox™ Flow Detection<br>System™ Model 99 | PREDICATE DEVICES<br>Nihon Kohden America<br>MLC-4200 & MLC-4100 |
| | characterizes blood flow through the<br>heart. Abnormal characteristics in the<br>circulatory system present as a<br>distortion in the measured indicator-<br>dilution curve and can be<br>characterized in terms of its minor<br>peak amplitude relative to the major<br>peak amplitude of the indicator dye-<br>dilution curve. ICG is FDA-approved<br>and indicated for "determining cardiac<br>output, hepatic function and liver blood<br>flow, and for ophthalmic angiography." | Cardiac output is automatically<br>computed by dividing the amount of<br>dye injected into the vein by the area<br>of the dye concentration curve.<br>Cardiac output is presented in four<br>digits with a maximum of 19.99. The<br>dye concentration curve is recorded for<br>investigation of intra-cardiac shunts<br>and valvular regurgitation or for<br>determining mean transit time and total<br>circulating blood volume, etc. If an<br>abnormality is present in the circulatory<br>system between the point of injection<br>and the sampling site, it is revealed by<br>a distortion of the normal pattern of the<br>curve. When coupled with a<br>Thermodilution Amplifier, cardiac<br>output data can be obtained via the<br>thermodilution method. |
| Design<br>Features | Single-function, preprogrammed<br>diagnostic computer with a modern<br>user-friendly touchscreen interface,<br>complete with an on-screen keyboard<br>to enter patient data for improved<br>usability.<br>Image: Cardiox Flow Detection System Model 99 | Single-function, preprogrammed<br>diagnostic computer<br>Image: Nihon Kohden America MLC-4200 & MLC-4100 |
| Dimensions<br>(l x w x h) | Flow Detection Monitor (10007): 10.5<br>in wide x 11.25 in. high x 10.5 in. deep<br>Earpads (20001): 93 in. long (includes<br>length of cable) | Main Unit (MLC-4200M): 300 mm x<br>300 mm x 300 mm<br>Earpiece (TL-410S): 16 in. diameter,<br>70 in. length |
| Feature/<br>Component | NEW DEVICE<br>The Cardiox™ Flow Detection<br>System™ Model 99 | PREDICATE DEVICES<br>Nihon Kohden America<br>MLC-4200 & MLC-4100 |
| | Headband (20002): 29 in. long x 2 in. wide<br>Flow Sensor Cable (20003): 72 in. long<br>Flowset Disposable Injection Set<br>(31039): 29 in. long<br>Mouthpiece (31035): 52.5 in. long | Cuvette (TL-430S): 450 mm x 190 mm x 190 mm<br>Thermodilution Amplifier (AF-410V):<br>300 mm x 85 mm x 300 mm |
| Power Source | Single Phase 100-240 VAC +/- 10%,<br>50/60 Hz +/- 1 Hz, < 100 W | 100, 110, 117, 220 or 240 VAC + 10%,<br>50/60 Hz, 30VA |
| Safety Features | Class I Laser<br>Power-on and background self-tests<br>Automatic Valsalva relief mechanism<br>Audible & visual cues, indications and<br>alerts<br>Detection of external<br>component/connection status | Cuvette: patient circuit is electrically<br>isolated from the chassis, and the DC<br>motor, used for suction, is entirely<br>isolated from the AC line.<br>Alarms: Amplitude too high, area too<br>large, abnormally small cardiac output,<br>unstable baseline, pulsation<br>superimposed |
| Patient<br>Interface | Earpads<br>Image: Earpads | Earpads<br>Image: Earpads |
| | Extension Set for injection of ICG dye<br>Image: Extension Set for injection of ICG dye | Extension tube for injection of ICG dye<br>Image: Extension tube for injection of ICG dye |
| Feature/<br>Component | The Cardiox™ Flow Detection<br>System™ Model 99 | PREDICATE DEVICES<br>Nihon Kohden America<br>MLC-4200 & MLC-4100 |
| Major<br>Components | Cardiox Flow Detection Monitor<br>Cardiox Earpads<br>Cardiox Headband<br>Cardiox Flow Sensor Cable<br>Cardiox FDS Flowset Disposable<br>Injection Set, 31039<br>Cardiox ValsalvaSure™ Mouthpiece,<br>31035 | Main Unit MLC-4200M<br>Earpiece, TL-410S<br>Earpiece Control Box, JQ-410V<br>Cuvette, TL-430S<br>Thermodilution Amplifier, AF-410V |
| Convenience<br>Kit | Yes - Part No. 31039 | Yes - Part No. TL-410S |
| Invasiveness | Minimally invasive - peripheral<br>catheter | Minimally invasive - peripheral<br>catheter |
| Sterile<br>Package | Patient blood contact components<br>sterile | Patient blood contact components<br>sterile |
| Sterilization<br>Method | Extension Set - Ethylene Oxide<br>Other components - EO or Gamma | Unknown |
| Re-Use | Single Use only | Single Use only |
| User Interface | Touch screen computer monitor<br><br>Image: Cardiox user interface | Manual switches, buttons, and<br>counters; digital numeric display<br><br>Image: Predicate device display |
| Sampling | 785 nm | 805 and 900 nm |
| Feature/<br>Component | NEW DEVICE<br>The Cardiox™ Flow Detection<br>System™ Model 99 | PREDICATE DEVICES<br>Nihon Kohden America<br>MLC-4200 & MLC-4100 |
| Wavelength | | |
| Output/<br>Presentation of<br>Curves | Graphical representation of dye<br>dilution curves | Graphical representation of dye<br>dilution curves. Refer to MLC 4100<br>Operator's Manual. |
| Measuring<br>Principle | Curves are analyzed: Major and Minor<br>peaks of the curves are identified and<br>measured | Curves are analyzed:<br>Slope of curves are measured;<br>specifically downward slope |
| Dye<br>Concentration<br>Curve<br>Recording | Computer Display & Storage, with<br>optional print out | Real-time strip chart print out |
# Comparison of Technical Characteristic between Cardiox™ FDS™ Model 99 and the Predicate Devices:
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# Performance Data
The commercially distributed Cardiox™ Flow Detection System™ conforms to the following standards:
.
.
| Standard | Title |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1:2009 | Biological Evaluation of Medical Devices -- Part 1:<br>Evaluation and Testing Within a Risk Management Process |
| ISO 11135-1:2007 | Sterilization of Health Care Products -- Ethylene Oxide --<br>Part 1: Requirements for Development, Validation and<br>Routine Control of a Sterilization Process for Medical<br>Devices |
| ISO 11607-1:2009 | Packaging for Terminally Sterilized Medical Devices - Part 1:<br>Requirements for Materials, Sterile Barrier Systems and<br>Packaging Systems |
| ISO 13485:2012 | Medical Devices - Quality Management Systems -<br>Requirements for Regulatory Purposes |
| IS EN ISO 14971:2012 | Medical Devices. Application of Risk Management To<br>Medical Devices |
| IS EN ISO 15223-1:2012 | Medical Devices. Symbols to be Used With Medical Device<br>Labels, Labelling and Information to be Supplied. General<br>Requirements |
| IEC 60529, Ed 2.1:2001-02 | Degrees of Protection Provided by Enclosures (IP Code) |
| EN/ IEC 60601-1:2006 | Medical Electrical Equipment. General Requirements for<br>Basic Safety and Essential Performance |
| EN/ IEC 60601-1-2:2007 | Medical Electrical Equipment. General Requirements for<br>Basic Safety and Essential Performance -Collateral<br>Standard. Electromagnetic Compatibility - Requirements<br>and Tests |
| EN/ IEC 60601-1-6:2010 | Medical Electrical Equipment. General Requirements for<br>Basic Safety and Essential Performance-Collateral<br>Standard. Usability |
| IEC 60825-1 Ed. 2.0:2007 | Safety Of Laser Products - Part 1: Equipment Classification<br>and Requirements |
| IS EN/ IEC 62304:2006 | Medical Device Software -Software Life Cycle Processes |
| EN/ IEC 62366:2008 | Medical Devices. Application of Usability Engineering to<br>Medical Devices |
.
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#### Substantial Equivalence
The Cardiox™ Flow Detection System™ Model 99 is as safe and effective as the selected predicate devices, the Nihon Kohden MLC-4200/4100 Cardiac Output Computers. The Cardiox FDS Model 99 and the predicate devices have the same intended use and similar indications, technological characteristics and principles of operation.
The Cardiox FDS Model 99 device differs from the MLC-4200/4100 Cardiac Output Computer in that its primary function is to present and measure indicator dye dilution curves while the MLC-4200/4100 Cardiac Output Computer also presents and measures indicator dye dilution curves. it also produces a cardiac output value that captures the concentration of dye measured at the ear in relation to the dose of dye injected at the remote site.
These differences do not present any new issues of safety or effectiveness because the difference in the two technology's methods to measure the ICG dye concentration is not significant and does not have an impact on the performance of either device for its intended use.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5, 2013
Cardiox Corporation C/O Karen E. Matis, RAC, CCRA Vice President, Quality and Regulatory Affairs 4100 Horizons Drive Suite 100 Columbus, OH 43220
Re: K122400
Trade/Device Name: Cardiox® Flow Detection System™ Model 99 Regulation Number: 21 CFR 870.1435 Regulation Name: Single-function, preprogrammed diagnostic computer Regulatory Class: Class II Product Code: DXG Dated: June 25, 2013 Received: June 26, 2013
Dear Ms. Matis:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
OwePDaris-S
for
Bram D. Zuckerman Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{13}------------------------------------------------
### Indications for Use Statement
510(k) Number (if known): K122400
Device Name: Cardiox® Flow Detection System™ Model 99
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by
Owen R Faris -S
Date: 2013.11.05
16:20:37 -05'00'
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