(257 days)
No
The summary describes standard physiological measurement techniques (ultrasound dilution and arterial pressure waveform analysis) and calibration methods, with no mention of AI or ML algorithms.
No
The device is intended for "diagnostic assessment of cardiovascular status and circulatory variables," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Transonic HCM102 system is intended for diagnostic assessment of cardiovascular status and circulatory variables..." and the "Device Description" section also notes it provides "diagnostic assessment of cardiovascular status."
No
The device description explicitly states it is an "apparatus based on ultrasound dilution and arterial pressure waveform analysis," indicating the presence of hardware components for data acquisition (ultrasound and pressure sensing).
Based on the provided text, the Transonic HCM102 system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The Transonic HCM102 system directly measures physiological parameters within the patient's body (cardiac output, blood pressure, heart rate, etc.) using techniques like ultrasound dilution and arterial pressure waveform analysis. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes the assessment of cardiovascular status and circulatory variables in patients, not the analysis of patient samples.
Therefore, the Transonic HCM102 system falls under the category of in vivo diagnostic devices, as it performs measurements directly within the living body.
N/A
Intended Use / Indications for Use
The Transonic HCM102 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in patients aged 1 month and older. This includes COstatus measurements by indicator dilution for quantifying patient's cardiac and volume status as well as continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation, systemic vascular resistance and related index parameters) by continuous arterial pressure waveform analysis. In this system, cardiac output (CO) value from dilution is used to calibrate the pressure wave form and assess continuous cardiac output. In addition the system also measures heart rate, systolic, diastolic pressures, mean arterial pressure and indexed parameters.
Product codes
DXG
Device Description
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic HCM102 system, which is an apparatus based on ultrasound dilution and arterial pressure waveform analysis to provide diagnostic assessment of cardiovascular status including COstatus (HCM101) measurements by indicator dilution for quantifying patient's cardiac and volume status as well as continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation, systemic vascular resistance and related index parameters) by continuous arterial pressure waveform analysis. In this system, cardiac output is first measured by COstatus (HCM101) system and this is then automatically transferred to calibrate the arterial pressure waveform to obtain continuous cardiac output (when that mode is selected). Thus cardiac output is determined both intermittently through ultrasound technique and continuously through arterial pressure waveform analysis. In addition the system also measures heart rate, systolic, and diastolic pressures and derives mean arterial pressure. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
1 month and older
Intended User / Care Setting
Not Found
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
Bench and animal testing was conducted by Transonic Systems Inc. and the test reports can be found in Section 19 of this 510(k) submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2014
Transonic Systems, Inc. Naveen Thuramalla VP, Engineering & Clinical Studies 34 Dutch Mill Rd Ithaca, New York 14850
Re: K140017
Trade/Device Name: Transonic HCM102 System Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: Class II Product Code: DXG Dated: June 17, 2014 Received: June 18, 2014
Dear Naveen Thuramalla,
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
1
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 vours.
Mude Jellm
for
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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Image /page/2/Picture/1 description: The image shows the logo for Transonic. The word "transonic" is written in blue, with the words "THE MEASURE OF" written in smaller font below the "tran" portion of the word. To the right of that text, the words "BETTER RESULTS" are written in smaller font below the "sonic" portion of the word. In the middle of the word, there is a gray symbol that looks like sound waves.
Indications for Use
510(k) Number (if known): New Submission
Device Name: Transonic HCM102 System
Indications for Use: (Prescription Device)
The Transonic HCM102 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in patients aged 1 month and older. This includes COstatus measurements by indicator dilution for quantifying patient's cardiac and volume status as well as continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation, systemic vascular resistance and related index parameters) by continuous arterial pressure waveform analysis. In this system, cardiac output (CO) value from dilution is used to calibrate the pressure wave form and assess continuous cardiac output. In addition the system also measures heart rate, systolic, diastolic pressures, mean arterial pressure and indexed parameters.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/1 description: The image shows the word "transonic" in blue, with the words "THE MEASURE OF" in gray below the left side of the word and "BETTER RESULTS." in gray below the right side of the word. In the middle of the word, there is a gray symbol that looks like sound waves.
Transonic Systems Inc. 34 Dutch Mill Rd., Ithaca, NY 14850 p: 800.353.3569 f: 607.257.7256
510(k) SUMMARY
Summary of Safety & Effectiveness
| Submitter's Name & Address: | Transonic Systems Inc
34 Dutch Mill Road,
Ithaca, NY 14850 |
| ----------------------------- | ------------------------------------------------------------------ |
|---|
- Contact Person & Telephone: Naveen Thuramalla 607-257-5300 (*326)
- Date Summary Prepared: Dec 30, 2013
Classification Name: Computer, Diagnostic, Device Name: Preprogrammed, Single-function, 21 CFR 870.1435. Product Class and Code: DXG and Class II Classification Panel: Cardiovascular Common/Usual Name: Extracorporeal, Diagnostic monitor Proprietary Name: Transonic HCM102 System
- K060898: PULSION PICCO PLUS, MODEL 8100. Predicate Devices:
K023960: LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70.
Device Description:
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic HCM102 system, which is an apparatus based on ultrasound dilution and arterial pressure waveform analysis to provide diagnostic assessment of cardiovascular status including COstatus (HCM101) measurements by indicator dilution for quantifying patient's cardiac and volume status as well as continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation, systemic vascular resistance and related index parameters) by continuous arterial pressure waveform analysis. In this system, cardiac output is first measured by COstatus (HCM101) system and this is then automatically transferred to calibrate the
4
arterial pressure waveform to obtain continuous cardiac output (when that mode is selected). Thus cardiac output is determined both intermittently through ultrasound technique and continuously through arterial pressure waveform analysis. In addition the system also measures heart rate, systolic, and diastolic pressures and derives mean arterial pressure. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.
Components:
Transonic HCM102 system consists of the following components. The below components are essentially COstatus system components with the addition of pressure transducer and connecting cable.
| Model/Part # | Description |
|---|---|
| HCM102 | Monitor (HCM101 monitor with the addition of pressure |
| capability) | |
| HCM101 | Cardiac output monitor/meter |
| HC2TP | Flow/dilution sensor pair with pump cable and pressure |
| transducer cables. | |
| HCP01 | AV Loop Pump |
| ADT2005D | Arteriovenous (AV) Loop - Tubing Set |
| ADT2005E | Arteriovenous (AV) Loop - Tubing Set |
| ADT2006E | Arteriovenous (AV) Loop - Tubing Set |
| ADT1020 | Extension Set/ Sensor Adapter Tubing |
| HCS3011 | AV Loop kit with ADT2005D AV Loop |
| HCS3021 | AV Loop kit with ADT2005E AV Loop |
| HCS3022 | AV Loop kit with ADT2006E AV Loop |
| HCS3002 | Sensor Adapter Tubing Pack with ADT1020 |
| HCS40XX | MX950 TranStar Disposable Transducer |
| (K061573) | |
| or | |
| equivalent. | |
| HCR01 | Printer |
| HFW1000 | Fluid Bag Warner |
| HCED02 | Data Transfer Module |
| HCR01 | Printer |
Substantial Equivalence:
The Transonic HCM102 System for use with patients to provide diagnostic assessment of cardiovascular status including intermittent and continuous cardiac output and associated hemodynamic parameters (such as total end diastolic blood volume, central blood volume, active circulation volume, stroke volume variation; pulse pressure variation, etc) is similar to the Pulsion Continuous Pulse Contour Cardiac Output (PiCCO Plus) System (K060898) and LiDCO plus monitor (K023960).
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Proposed device and predicate devices first measure cardiac output and other related hemodynamic parameters intermittently and then use the intermittent Cardiac output to calibrate the arterial blood pressure waveform to measure continuous cardiac output. Arterial blood pressure waveform is also analyzed to obtain other related hemodynamic parameters such as stroke volume variation and pulse pressure variation. All three systems are extracorporeal in nature and use both indicator dilution as well as arterial pressure waveform approaches. All three would require access to both arterial and central venous catheters to obtain indicator dilution and arterial pressure waveform measurements.
The difference between Pulsion PiCCO Plus system and the proposed HCM102 system is that the Pulsion system requires use of a dedicated special arterial catheter insertion into the patient, which is then connected to the Pulsion monitor for both types of measurements. However, Transonic HCM102 system works off an extracorporal AV tubing set connected between standard in-situ arterial and central venous lines (like COstatus system cleared by FDA K113821) for indicator dilution measurements and requires connecting a standard pressure transducer (such as MX950 or equivalent cleared by FDA K942377) in-line with the hospital pressure transducer for arterial pressure waveform measurements.
Pulsion system uses thermodilution and hence requires injection of cold or room temperature isotonic saline whereas Transonic HCM102 system uses ultrasound dilution and hence requires injection of body temperature isotonic saline.
The difference between LiDCPlus hemodynamic monitor and the proposed HCM102 system is that the LiDCO plus monitor uses lithium dilution, which requires injection of lithium, is used to obtain intermittent dilution cardiac output measurement and other related parameters. Transonic HCM102 system works off an extracorporal AV tubing set, which is connected between standard in-situ arterial and central venous lines (like COstatus system cleared by FDA K113821), and uses body temperature isotonic saline to obtain intermittent dilution cardiac output measurement and other related parameters.
For continuous arterial pressure waveform measurements, LiDCO Plus monitor uses the analogue arterial blood pressure trace that is slaved from the conventional blood pressure monitor to produce continuous arterial pressure waveform measurements while in case of Transonic HCM102 system a standard pressure transducer (such as MX950 or equivalent cleared by FDA K942377) is connected in-line with the hospital pressure transducer for continuous arterial pressure waveform measurements.
These differences do not raise any new issues of safety or effectiveness regarding the use of Transonic HCM102 System.
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Safety and Effectiveness:
The HCM102 is deemed to be safe and effective based on the safety testing conducted in accordance with the IEC 60601-1 standard and the electromagnetic compatibility test report.
In addition, bench and animal testing was conducted by Transonic Systems Inc. and the test reports can be found in Section 19 of this 510(k) submission. Prior to shipment, the finished product will be tested and must meet all required release specifications before distribution. The array of testing required for release includes, but are not limited to; physical testing and visual examination (in-process and finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures that ensure the product's performance parameters conform to the product design specifications. The testing instruction records for each of the individually required procedures are approved, released, distributed, and revised in accordance with document control cGMP's.