The Transonic HCM103 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in patients aged 1 month and older. The measurements include 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 stand-alone system, cardiac output (CO) value is entered from such devices as COstatus (HCM101) system or equivalent to calibrate the pressure wave form for measurement of continuous cardiac output. In addition the system also provides heart rate, systolic, diastolic pressures, mean arterial pressure and indexed parameters.

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 HCM103 system, which is an apparatus based on arterial pressure waveform analysis to provide diagnostic assessment of cardiovascular status including continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation). In this stand-alone system, calibration value is entered from such devices as COstatus (HCM101) system or equivalent. 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.

AI/ML Overview

The provided document is a 510(k) summary for the Transonic HCM103 System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, especially in terms of clinical performance metrics like sensitivity, specificity, accuracy, or diagnostic effectiveness.

Here's an analysis based on the information provided in the document, highlighting what is missing for a complete answer to your request:

A table of acceptance criteria and the reported device performance
- Not provided. The document states: "Bench studies confirmed the accuracy of the HCM103 system based on arterial pressure waveform analysis to accurately measure continuous cardiac output, stroke volume variation, pulse pressure variation, systemic vascular resistance index and other related parameters." However, it does not provide specific numerical acceptance criteria (e.g., "accuracy of +/- 10%") or the reported device performance against such criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document states "Bench studies confirmed the accuracy..." but does not mention any clinical test set, sample size, or data provenance. It explicitly states, "Animal and clinical testing was not required to support substantial equivalence."
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)
- Not applicable / Not provided. Since clinical testing was not required and no clinical test set is described, there's no mention of experts establishing ground truth for such a set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. See point 3.
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
- Not applicable. The HCM103 system is a diagnostic computer for cardiovascular status and circulatory variables. It's not an AI-assisted diagnostic tool that human readers would use to interpret images or data in a comparative effectiveness study. The document describes it as a "stand-alone system" where a CO value is "entered from such devices as COstatus (HCM101) system or equivalent to calibrate the pressure wave form."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The document describes the HCM103 system as performing measurements "by continuous arterial pressure waveform analysis" and deriving parameters. This is a standalone algorithm. The "Performance Testing" section focuses on "Bench studies confirmed the accuracy" and "software testing and electrical safety testing." There's no human-in-the-loop performance described beyond the entering of a calibration CO value.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated for the "bench studies." For a device measuring physiological parameters, the "ground truth" in bench studies would typically come from highly accurate reference instruments or simulated physiological models with known parameters. The document only mentions "Bench studies confirmed the accuracy," implying comparison to some form of established "true" values within a bench setting.
The sample size for the training set
- Not provided. The document does not describe the development or training of any machine learning model or algorithm. It refers to its analytic approach as "arterial pressure waveform analysis." If an algorithm was developed, details on its training data are not included.
How the ground truth for the training set was established
- Not provided. See point 8.

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting detailed clinical performance data against specific acceptance criteria. For the Transonic HCM103 System, the FDA determined that "Animal and clinical testing was not required to support substantial equivalence." The performance testing mentioned ("Bench studies confirmed the accuracy...") is described broadly and without specific metrics or the methodology required to answer most of your detailed questions.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 17, 2014

Transonic Systems, Inc. Naveen Thuramalla VP, Engineering and Clinical Studies 34 Dutch Mill Rd Ithaca, New York 14850

Re: K134035

Trade/Device Name: Transonic HCM 103 System Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: Class II Product Code: DXG Dated: June 18, 2013 Received: June 19, 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 your

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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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Transonic Systems Inc. 34 Dutch Mill Rd., Ithaca, NY 14850 p: 800.353.3569 f: 607.257.7256

Indications for Use

510(k) Number (if known): New Submission

Device Name: Transonic HCM103 System

Indications for Use: (Prescription Device)

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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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 Thuramalla607-257-5300 (*326)
Date Summary Prepared:	Dec 16, 2013 (Revised June 18, 2014)
Device Name:	Classification Name: Computer, Diagnostic, Pre-programmed, Single-function, 21 CFR 870.1435.Product Class and Code: DXG and Class IIClassification Panel: CardiovascularCommon/Usual Name: Extracorporeal, DiagnosticmonitorProprietary Name: Transonic HCM103 System
Predicate Devices:	K082308: MODIFICATION TO VIGILEO ARTERIALPRESSURE CARDIAC OUTPUT/OXIMETRYMONITOR; EDWARDS LIFESCIENCES, LLC
Predicate Devices:	K010049: PULSECO HEMODYNAMIC MONITORCM71, LiDCO Ltd. [K023960: LIDCOPLUSHEMODYNAMIC MONITOR SYSTEM is also similar].

Device Description:

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K134035

such devices as COstatus (HCM101) system or equivalent. 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 HCM103 system consists of the following components:

Model/Part #	Description
HCM103	Monitor
HCPR	Sensor cable with connector to mate with standard hospital pressure transducer.
HCS40XX	MX950 TranStar Disposable Transducer (K061573) or equivalent.
HCED03	Data Transfer Module

Indication for Use (Prescription Device):

The Transonic HCM103 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in neonatal, pediatric and adult patients. The measurements include 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 stand-alone system, cardiac output (CO) value is entered from such devices as COstatus (HCM101) system or equivalent to calibrate the pressure wave form for measurement of continuous cardiac output. In addition the system also provides heart rate, systolic, diastolic pressures, mean arterial pressure and indexed parameters.

Substantial Equivalence:

The Transonic HCM103 System for use with patients to provide diagnostic assessment cardiovascular status including continuous cardiac output and associated of hemodynamic parameters (such as stroke volume variation; pulse pressure variation, etc) is similar to the VIGILEO arterial pressure cardiac output (K082308) and PULSECO hemodynamic monitor (K010049) which are used to measure continuous cardiac output and related parameters using arterial pressure waveforms.

Substantial equivalence determination is based on the following information and was not based on the assessment of non-clinical performance data.

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Proposed device and predicate devices analyze the arterial pressure waveform using pre-existing arterial access in patients to continuously measure cardiac output and other related hemodynamic parameters. PulseCO software which is used with LiDCOplus hemodynamic monitor requires calibration with cardiac output measurement. HCM103 also works in the same manner. For HCM103. cardiac output measurement to calibrate the pressure waveform, which is used to measure continuous cardiac output, is entered from such systems as COstatus (HCM101).

The difference between Vigileo system and the proposed HCM103 system is that the Vigileo system requires use of FloTrac sensor, which is connected to the patient's bedside arterial pressure cable. Transonic HCM103 system requires use of any standard FDA cleared pressure transducer with suitable mating end to be placed in line with the patient's bedside arterial pressure transducer. Vigileo system in conjunction with FloTrac sensor does not require calibration whereas HCM103 system allows for calibration of pressure waveform.

The difference between PulseCO (LiDCO) monitor and the proposed HCM103 system is that the PulseCO monitor connects to the bedside blood pressure monitor whereas the HCM103 system connects to the pre-existing patient's arterial pressure transducer using any standard FDA cleared pressure transducer with mating ends.

These differences do not raise any new issues of safety or effectiveness regarding the use of Transonic HCM103 System.

Performance Testing:

Bench studies confirmed the accuracy of the HCM103 system based on arterial pressure waveform analysis to accurately measure continuous cardiac output. stroke volume variation, pulse pressure variation, systemic vascular resistance index and other related parameters.

Testing consisted of software testing and electrical safety testing according to IEC 60601-1. 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 (inprocess 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.

Animal and clinical testing was not required to support substantial equivalence.

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Safety and Effectiveness:

The successful testing demonstrates the safety and effectiveness of the HCM103 when used for the defined indications for use

Regulation Number and Section

§ 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).