(455 days)
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.
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 provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the Cardiox™ Flow Detection System™, Model 99. The document primarily focuses on the 510(k) summary, device description, comparison to predicate devices, and a list of standards the device conforms to. It lacks concrete performance data and study design details typically found in a clinical or performance validation study report.
Therefore, I cannot populate the requested table and answer many of the questions regarding the study that proves the device meets acceptance criteria.
However, based on the provided information, I can state the following:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision for measuring minor/major peak amplitudes) are provided in the document. The document states that the new device and predicate devices have "similar technological characteristics and principles of operation" and that "[the] 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." This suggests a reliance on equivalence to predicate devices rather than specific performance targets for the new device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The device is described as a "Single-function, preprogrammed diagnostic computer" and is not an AI-assisted system for human readers. Therefore, an MRMC comparative effectiveness study with AI assistance would not be applicable, and this information is not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as providing "a fluorescent ICG indicator dye dilution curve for cardiac output" and reports "Major Curve Peak Amplitude" and "Minor Curve Peak Amplitude." It is a diagnostic computer that processes sensor data. While it calculates values automatically, there are no specific performance metrics presented to assess its standalone accuracy or reliability in identifying specific circulatory pathway abnormalities or shunts without comparison to a recognized ground truth. The function is primarily to display and measure the dye dilution curves, which a clinician then interprets in conjunction with other clinical and diagnostic findings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
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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
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.
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Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 4 of 12
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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 99Consisting 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/Component | NEW DEVICEThe CardioxTM Flow DetectionSystemTM Model 99 | PREDICATE DEVICESNihon Kohden AmericaMLC-4200 & MLC-4100 |
|---|---|---|
| RegulationNumber | 870.1435 | 870.1435 |
| ClassificationProduct Code | DXG | DXG |
| Manufacturer | Cardiox Corporation4100 Horizons DriveColumbus OH 43220 | Nihon Kohden (America), Inc.530 Maple AvenueTorrance, CA 90503 |
| Indications forUse | The Cardiox Flow Detection SystemModel 99 provides a fluorescent ICGindicator dye dilution curve for cardiacoutput in patients with known orsuspected circulatory pathwayabnormalities. The system is notdesigned to produce a definitiveinterpretation or exhaustive evaluationof a patient's circulatory pathway.Rather, it is intended to be used as asupport tool in conjunction with other | The Nihon Kohden MLC-4200/MLC-4100 Cardiac Output Computerprovides a non-invasive measurementand record of a dye concentrationcurve for investigation of intra-cardiacshunts and valvular regurgitation. |
| Feature/Component | NEW DEVICEThe Cardiox™ Flow DetectionSystem™ Model 99clinical and diagnostic findings. Thisdevice is only intended for use onpatients that weigh more than 10kg. | PREDICATE DEVICESNihon Kohden AmericaMLC-4200 & MLC-4100 |
| Intended Use | The Cardiox™ Flow DetectionSystem™ (FDS™) Model 99 isintended to be used by medicalprofessionals interested in detectingICG in the peripheral vasculature, andevaluating blood flow through the heartand circulatory system. The CardioxFDS Model 99 provides graphicaldisplay of indicator dye dilution curvesusing Indocyanine Green (ICG) as theindicator dye. | The Nihon Kohden MLC-4200/MLC-4100 constructs a curve representingIndocyanine Green for (ICG) dyeconcentration with respect to time (dyeconcentration curve). The deviceprovides a record of the curve foranalysis of circulatory systemabnormalities. |
| OperatingTechnology | Infrared Spectrophotometry | Infrared Spectrophotometry |
| OperatingPrinciple | Spectrophotometric ICG blooddetection and measurement | Spectrophotometric ICG blooddetection and measurement |
| FluorescenceMedia | Indocyanine Green (ICG) Dye | Indocyanine Green (ICG) Dye |
| TechnologicalCharacteristics | The Cardiox Model 99 Flow DetectionSystem (FDS) is used withIndocyanine-Green (ICG), a green dyethat temporarily binds with serumalbumin, its fluorescent agent. When ablood vessel is irradiated with 785 nmphotons over a predetermined timeinterval, this dye fluoresces, emittingphotons at wavelengths in the range of830 to 840 nm. The system's detectormeasures the time-varying intensity ofemitted fluorescence photons over apredetermined time interval. Themeasured intensity of the emittedfluorescence photons is proportional tothe concentration of the dye in theblood and can thereby provide anindicator-dilution curve that | After a small amount (5mg) ofIndocyanine-Green dye is injected intoa vein, changes in its concentration aredetected at a point in the arterialsystem. The dye is detected either bya small attachment to the ear or bycuvette through which the bloodsample is drawn at a constant speed.Changes in the amount of dye in theblood are measured optically bypassing light (805 and 900 nm for ear,805 nm for cuvette) through the bloodflowing in the ear or the cuvette andmeasuring the intensity of thetransmitted light with a dye sensitivephototransistor. A dye concentrationcurve is constructed by capturing theconcentration in relation to time. |
| Feature/Component | NEW DEVICEThe Cardiox™ Flow DetectionSystem™ Model 99 | PREDICATE DEVICESNihon Kohden AmericaMLC-4200 & MLC-4100 |
| characterizes blood flow through theheart. Abnormal characteristics in thecirculatory system present as adistortion in the measured indicator-dilution curve and can becharacterized in terms of its minorpeak amplitude relative to the majorpeak amplitude of the indicator dye-dilution curve. ICG is FDA-approvedand indicated for "determining cardiacoutput, hepatic function and liver bloodflow, and for ophthalmic angiography." | Cardiac output is automaticallycomputed by dividing the amount ofdye injected into the vein by the areaof the dye concentration curve.Cardiac output is presented in fourdigits with a maximum of 19.99. Thedye concentration curve is recorded forinvestigation of intra-cardiac shuntsand valvular regurgitation or fordetermining mean transit time and totalcirculating blood volume, etc. If anabnormality is present in the circulatorysystem between the point of injectionand the sampling site, it is revealed bya distortion of the normal pattern of thecurve. When coupled with aThermodilution Amplifier, cardiacoutput data can be obtained via thethermodilution method. | |
| DesignFeatures | Single-function, preprogrammeddiagnostic computer with a modernuser-friendly touchscreen interface,complete with an on-screen keyboardto enter patient data for improvedusability.Image: Cardiox Flow Detection System Model 99 | Single-function, preprogrammeddiagnostic computerImage: Nihon Kohden America MLC-4200 & MLC-4100 |
| Dimensions(l x w x h) | Flow Detection Monitor (10007): 10.5in wide x 11.25 in. high x 10.5 in. deepEarpads (20001): 93 in. long (includeslength of cable) | Main Unit (MLC-4200M): 300 mm x300 mm x 300 mmEarpiece (TL-410S): 16 in. diameter,70 in. length |
| Feature/Component | NEW DEVICEThe Cardiox™ Flow DetectionSystem™ Model 99 | PREDICATE DEVICESNihon Kohden AmericaMLC-4200 & MLC-4100 |
| Headband (20002): 29 in. long x 2 in. wideFlow Sensor Cable (20003): 72 in. longFlowset Disposable Injection Set(31039): 29 in. longMouthpiece (31035): 52.5 in. long | Cuvette (TL-430S): 450 mm x 190 mm x 190 mmThermodilution Amplifier (AF-410V):300 mm x 85 mm x 300 mm | |
| Power Source | Single Phase 100-240 VAC +/- 10%,50/60 Hz +/- 1 Hz, < 100 W | 100, 110, 117, 220 or 240 VAC + 10%,50/60 Hz, 30VA |
| Safety Features | Class I LaserPower-on and background self-testsAutomatic Valsalva relief mechanismAudible & visual cues, indications andalertsDetection of externalcomponent/connection status | Cuvette: patient circuit is electricallyisolated from the chassis, and the DCmotor, used for suction, is entirelyisolated from the AC line.Alarms: Amplitude too high, area toolarge, abnormally small cardiac output,unstable baseline, pulsationsuperimposed |
| PatientInterface | EarpadsImage: Earpads | EarpadsImage: Earpads |
| Extension Set for injection of ICG dyeImage: Extension Set for injection of ICG dye | Extension tube for injection of ICG dyeImage: Extension tube for injection of ICG dye | |
| Feature/Component | The Cardiox™ Flow DetectionSystem™ Model 99 | PREDICATE DEVICESNihon Kohden AmericaMLC-4200 & MLC-4100 |
| MajorComponents | Cardiox Flow Detection MonitorCardiox EarpadsCardiox HeadbandCardiox Flow Sensor CableCardiox FDS Flowset DisposableInjection Set, 31039Cardiox ValsalvaSure™ Mouthpiece,31035 | Main Unit MLC-4200MEarpiece, TL-410SEarpiece Control Box, JQ-410VCuvette, TL-430SThermodilution Amplifier, AF-410V |
| ConvenienceKit | Yes - Part No. 31039 | Yes - Part No. TL-410S |
| Invasiveness | Minimally invasive - peripheralcatheter | Minimally invasive - peripheralcatheter |
| SterilePackage | Patient blood contact componentssterile | Patient blood contact componentssterile |
| SterilizationMethod | Extension Set - Ethylene OxideOther components - EO or Gamma | Unknown |
| Re-Use | Single Use only | Single Use only |
| User Interface | Touch screen computer monitorImage: Cardiox user interface | Manual switches, buttons, andcounters; digital numeric displayImage: Predicate device display |
| Sampling | 785 nm | 805 and 900 nm |
| Feature/Component | NEW DEVICEThe Cardiox™ Flow DetectionSystem™ Model 99 | PREDICATE DEVICESNihon Kohden AmericaMLC-4200 & MLC-4100 |
| Wavelength | ||
| Output/Presentation ofCurves | Graphical representation of dyedilution curves | Graphical representation of dyedilution curves. Refer to MLC 4100Operator's Manual. |
| MeasuringPrinciple | Curves are analyzed: Major and Minorpeaks of the curves are identified andmeasured | Curves are analyzed:Slope of curves are measured;specifically downward slope |
| DyeConcentrationCurveRecording | Computer Display & Storage, withoptional 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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Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 6 of 12
Image /page/4/Picture/1 description: The image shows the word "cardiox" in a stylized font. Above the word, the text "K122400" and "Page 5 of 11" are printed. The word "cardiox" is in bold black font, with a swirl design incorporated into the "o" and "x".
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Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 7 of 12
Image /page/5/Picture/1 description: The image shows the word "cardiox" in a stylized font. Above the word "cardiox" is the text "K122400" and "Page 6 of 11". The word "cardiox" is in black and the "o" in the word is stylized to look like a circle with a line through it.
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Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 8 of 12
Image /page/6/Picture/1 description: The image shows the word "cardiox" in a bold, sans-serif font. Above and to the right of the word, the text "K122400 Page 7 of 11" is printed in a smaller font. The word "cardiox" is the main focus of the image, with the other text providing context or identification.
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Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 9 of 12
Image /page/7/Picture/1 description: The image shows the word "cardiox" in a bold, sans-serif font. Above and to the right of the word, there is the text "K122400 Page 8 of 11". The word "cardiox" is the main focus of the image and is prominently displayed.
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Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 10 of 12
Image /page/8/Picture/1 description: The image shows the word "cardiox" in a bold, sans-serif font. Above and to the right of the word, the text "K122400 Page 9 of 11" is printed in a smaller font. The word "cardiox" is the main focus of the image.
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Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 11 of 12
Image /page/9/Picture/1 description: The image shows the word "cardiox" in a bold, sans-serif font. Above and to the right of the word, the text "K122400 Page 10 of 11" is visible. The word "cardiox" is the main focus of the image. The text above it appears to be a page number or document identifier.
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:Evaluation and Testing Within a Risk Management Process |
| ISO 11135-1:2007 | Sterilization of Health Care Products -- Ethylene Oxide --Part 1: Requirements for Development, Validation andRoutine Control of a Sterilization Process for MedicalDevices |
| ISO 11607-1:2009 | Packaging for Terminally Sterilized Medical Devices - Part 1:Requirements for Materials, Sterile Barrier Systems andPackaging Systems |
| ISO 13485:2012 | Medical Devices - Quality Management Systems -Requirements for Regulatory Purposes |
| IS EN ISO 14971:2012 | Medical Devices. Application of Risk Management ToMedical Devices |
| IS EN ISO 15223-1:2012 | Medical Devices. Symbols to be Used With Medical DeviceLabels, Labelling and Information to be Supplied. GeneralRequirements |
| 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 forBasic Safety and Essential Performance |
| EN/ IEC 60601-1-2:2007 | Medical Electrical Equipment. General Requirements forBasic Safety and Essential Performance -CollateralStandard. Electromagnetic Compatibility - Requirementsand Tests |
| EN/ IEC 60601-1-6:2010 | Medical Electrical Equipment. General Requirements forBasic Safety and Essential Performance-CollateralStandard. Usability |
| IEC 60825-1 Ed. 2.0:2007 | Safety Of Laser Products - Part 1: Equipment Classificationand Requirements |
| IS EN/ IEC 62304:2006 | Medical Device Software -Software Life Cycle Processes |
| EN/ IEC 62366:2008 | Medical Devices. Application of Usability Engineering toMedical Devices |
.
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Cardiox Corporation K122400/ Interactive Review REG-1001 Rev G Cardiox FDS Model 99 Page 12 of 12
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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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Image /page/11/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an emblem that features a stylized human figure with outstretched arms, representing care and protection. The emblem is composed of three curved lines that form the shape of a person.
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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Page 2 - Karen E. Matis
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
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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'
Page _ of
§ 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).