The AureFlo Monitor is intended for use with Transonic Systems' HT300-Series-FT Surgical Flowmeters. These Flowmeters are intended for use with adult and pediatric patients for measurement of blood or liquid volume flow with Transonic perivascular Flowprobes on major and peripheral arteries, veins and ducts; on non-aerated synthetic vessel grafts; where surgery is medically indicated; intraoperatively, rather than in chronic implant; at intraoperative sites which admit and retain ultrasonic couplant; with minimal vessel manipulation or constriction (to avoid vessel spasm); where application does not unnecessarily lengthen surgical procedure. Measurement of blood or perfusate volume flow with sterile tubing Flowsensors on flexible tubing specific to the flowsensor (never on arteries, veins) and for non-aerated media which are transparent to ultrasound.

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 Systems AureFlo Monitoring System. The device is a versatile monitoring system to continuously measure, display, record and document absolute volume flow and other derived parameters. It is used during surgery with Transonic Flowprobes to measure and display blood flow in vessels. It can also be used with Sterile Tubing Flowsensors to measure and display flow of fluids through tubing circuits. AureFlo's flexible integrated system can be set up in a variety of configurations. A stand-alone HT300-Series flowmeter can be upgraded to work with Flow Trace® software. The system can also be set up on any operating room cart with an optional monitor stand: The display panel is an Intel® Pentium M® CPU touch-screen computer/monitor with Microsoft Windows XP®. The computer/monitor's manual can be accessed by selecting "Help" on the Windows Start Screen. FlowTrace® Software works exclusively with HT300-Series-FT Flowmeters to provide a real-time waveform display of volume flow, mean flow and Pulsatile Index (PI). During CABG surgery, connection with an ECG signal allows for an on-screen ECG display, diastolic/systolic shading of coronary graft waveforms and calculation of a D/S (diastolic/systolic) Ratio.

AI/ML Overview

The provided text describes the Transonic Systems AureFlo Monitoring System and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized safety and performance standards. However, it does not contain the level of detail typically found in a study proving a device meets specific, quantitative "acceptance criteria" related to diagnostic accuracy or clinical outcomes.

Instead, the submission primarily highlights:

Technological Characteristics Comparison with a Predicate Device: This is used to argue for substantial equivalence.
Compliance with Safety and EMC Standards: IEC 60601-1 and CISPR 11.
Bench Testing: Internal bench testing by Transonic Systems Inc. to ensure performance parameters conform to design specifications.

Given this context, I will extract and infer information where direct details are absent, making explicit that the acceptance criteria reported here are based on the information provided, which is more about regulatory compliance and engineering specifications than a traditional clinical study with accuracy metrics.

Acceptance Criteria and Device Performance Study for the Transonic Systems AureFlo Monitoring System

The Transonic Systems AureFlo Monitoring System obtained 510(k) clearance (K112657) by demonstrating substantial equivalence to a predicate device (K040228 Medi-Stim VeriQ System) and compliance with relevant safety and electromagnetic compatibility standards. The primary "acceptance criteria" for this premarket notification appear to be related to safety, electromagnetic compatibility, and the device's ability to meet its internal design specifications through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (as stated in the document)
Safety	IEC 60601-1 (Medical Electrical Equipment standard)	"The AureFlo Monitoring System is deemed to be safe and effective based on the safety testing completed by TUV Rheinland of North America, Inc., in accordance with the IEC 60601-1 Medical Electrical Equipment standard."
Electromagnetic Compatibility (EMC)	CISPR 11 standard	"This system also tested to and found to be in compliance for electromagnetic compatibility in accordance with the CISPR 11 standard."
Performance (Bench)	Conformance to product design specifications, as defined by Quality Control Test Procedure documents.	"bench testing was conducted by Transonic Systems Inc. and the validation report can be found in Section 18 of this 510(k) submission. ... The array of testing required for release includes, but are not limited to; physical testing and visual examination (in-process and finished product). ... These tests are established testing procedures that ensure the product's performance parameters conform to the product design specifications."
Technological Equivalence	Key characteristics comparable to the predicate device (Medi-Stim VeriQ System)	Detailed comparison table provided in the submission (see "Technological Characteristics Compared to Predicate Device" section for specifics like technology, channels, measured parameters, user interface, etc.). This comparison supports the claim of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify a sample size for a "test set" in the context of a clinical performance study involving patient data. The evaluation primarily relies on:

Compliance testing: For standards like IEC 60601-1 and CISPR 11. These tests typically involve simulating use conditions or testing components and the complete system in controlled environments, not a specific "patient test set."
Bench testing: Internal validation by Transonic Systems Inc. against design specifications. The document does not provide details on the sample size (e.g., number of devices tested, number of measurements taken for different flow conditions) for this bench testing, nor does it refer to data provenance in terms of country of origin or retrospective/prospective nature. It is implied that this testing was conducted in a laboratory setting by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Given that the document describes regulatory compliance testing and internal bench testing rather than a clinical study requiring an expert-adjudicated "ground truth," this information is not applicable and not provided. The "ground truth" for the performance/bench testing would be derived from calibrated measurement devices or known physical properties being assessed (e.g., known flow rates, electrical signals). For substantial equivalence, the "ground truth" is established by comparing the device's technological characteristics and intended use to those of the predicate device, which is a regulatory, not an expert-driven clinical, assessment.

4. Adjudication Method for the Test Set

As there is no clinical "test set" and thus no expert-driven adjudication described, this information is not applicable and not provided. Compliance with safety and EMC standards and internal bench testing have their own established protocols for verification and validation, which do not involve expert adjudication in the manner of medical image interpretation studies (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

No, an MRMC comparative effectiveness study involving human readers or AI assistance was not done or described in this 510(k) submission. The AureFlo Monitoring System is a blood flow measurement device, not an AI-powered diagnostic or interpretive tool that would typically undergo such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done?

No, a standalone algorithm performance study (without human-in-the-loop) was not done or described. This device is a measurement system, not a software algorithm providing diagnostic interpretations. Its "performance" is inherently tied to its physical interaction with blood vessels or tubing and its ability to accurately measure flow, which is then displayed to a human operator.

7. The Type of Ground Truth Used

For the safety, EMC, and bench testing, the "ground truth" would be established by:

Reference Standards: For electrical safety (IEC 60601-1) and EMC (CISPR 11), the ground truth is the published standard itself and the ability of the device to meet its requirements when tested by an accredited lab (TUV Rheinland of North America, Inc.).
Calibrated Measurement Equipment: For bench testing of flow measurement capabilities, the ground truth would be precise measurements from highly accurate and calibrated flow meters or known, controlled flow conditions used to verify the AureFlo system's output. The document doesn't explicitly state "calibrated equipment" but it is implicitly understood in "ensur[ing] the product's performance parameters conform to the product design specifications."

No pathology, expert consensus, or outcomes data are mentioned as ground truth for this type of device and submission.

8. The Sample Size for the Training Set

Not Applicable. The Transonic Systems AureFlo Monitoring System is a hardware-based measurement device with associated software, not a machine learning or AI algorithm that requires a "training set" of data in the typical sense. It operates based on ultrasonic transit-time principles.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no "training set" for a machine learning algorithm, there is no ground truth established for it. The device's operational principles are physics-based, not learned from data.

Summary

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DEC 2 1 2011 KI 12657 pg lof 2

Image /page/0/Picture/1 description: The image shows the logo for Transonic Systems Inc. The logo consists of a stylized graphic to the left of the company name. Below the company name is the tagline "The Flow Measurement Specialists."

510(k) SUMMARY Summary of Safety & Effectiveness

Submitter's Name & Address:	Transonic Systems, Inc.34 Dutch Mill RoadIthaca, NY 14850
Contact Person & Telephone:	David Klementowski607-257-5300
Date Summary Prepared:	September 9, 2011
Device Name:	Classification Name - Flowmeter, Blood, CardiovascularCommon/Usual Name - Blood FlowmeterProprietary Name - AureFlo Monitoring System
Predicate Device:	K040228 Medi-Stim VeriQ System

Device Description

The display panel is an Intel® Pentium M® CPU touch-screen computer/monitor with Microsoft Windows XP®. The computer/monitor's manual can be accessed by selecting "Help" on the Windows Start Screen. FlowTrace® Software works exclusively with HT300-Series-FT Flowmeters to provide a real-time waveform display of volume flow, mean flow and Pulsatile Index (PI). During CABG surgery, connection with an ECG signal allows for an on-screen ECG display, diastolic/systolic shading of coronary graft waveforms and calculation of a D/S (diastolic/systolic) Ratio.

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K112657 pg 2 of 3

Intended Use

Characteristic	Transonic Systems AureFlo Monitoring System	Medi-Stim VeriQ System
Flow measurements
> Technology	Ultrasonic Transit-time	Ultrasonic Transit-time, PW Doppler
> No. of channels	1 or 2	1, 2 or 4
> Measured parameters	Mean and pulsatile flow values
> Simulated Doppler sound	Yes
> Type of probes	Perivascular, cardiac output and tubing measurements	Perivascular, cardiac output and tubing measurements
User Interface
> Flow line zero calibration	Automatic (EEPROM)	Automatic (EEPROM)
> Controls	Touch screen	Touch screen
> Read-out	15" LCD display	19" LCD display
> Documentation	Patient database (hard disk), print-out or pdf output via external memory	Patient database (hard disk), print-out or HTML output via external memory
Technology Platform
> Hardware	Proprietary analog transit time front end with post-processing circuitry	Pentium microprocessorProprietary digital transit time front end
> Software	Windows XP	Windows XP

Technological Characteristics Compared to Predicate Device

Conclusions and Safe & Effectiveness

The AureFlo Monitoring System is deemed to be safe and effective based on the safety testing completed by TUV Rheinland of North America, Inc., in accordance with the IEC 60601-1 Medical Electrical Equipment standard. This system also tested to and found to be in compliance for electromagnetic compatibility in accordance with the CISPR 11 standard.

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K112657 Pg 3 of 3

In addition, bench testing was conducted by Transonic Systems Inc. and the validation report can be found in Section 18 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.

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

DEC 2 1 2011

Transsonic Systems, Inc. c/o Mr. David Klementowski VP, Regulatory Affairs and Quality 34 Dutch Mill Road Ithaca, NY 14850

K112657 Re:

Trade/Device Name: Transonic Systems AureFlo Monitoring System Regulation Number: 21 CFR 870.2100 Regulation Name: Flowmeter, Blood, Cardiovascular Regulatory Class: Class II Product Code: DPW Dated: December 7, 2011 Received: December 8, 2011

Dear Mr. Klementowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10. use stated in the encrosuly to regional date of the Medical Device Amendments, or to conimered province that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices mat have been results in assess and in a premarket approval application (PMA). and Cosmetic Act (71ct) that do not required to the general controls provisions of the Act. The 1 ou may, dierelore, manes of the Act include requirements for annual registration, listing of general bontrols profices in the practice, labeling, and prohibitions against misbranding and actives, good manararianing proH does not evaluate information related to contract liability aduncialion. Thease note: "ODFF" as 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 II your device is classified (boo are regulations affecting your device can be

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Page 2 - Mr. David Klementowski

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 r hat 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark Fellman 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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K112657

Indications for Use

510(k) Number (if known):

Device Name: Transonic Systems AureFlo Monitoring System

Indications For Use:

The AureFlo Monitor is intended for use with Transonic Systems' HT300-Series-FT Surgical Flowmeters. These Flowmeters are intended for use with adult and pediatric for measurement of blood or liquid volume flow with Transonic perivascular Flowprobes on major and peripheral arteries, veins and ducts; on non-aerated synthetic vessel grafts; where surgery is medically indicated; intraoperatively, rather than in chronic implant; at intraoperative sites which admit and retain ultrasonic couplant; with minimal vessel manipulation or constriction (to avoid vessel spasm); where application does not unnecessarily lengthen surgical procedure. Measurement of blood or perfusate volume flow with sterile tubing Flowsensors on flexible tubing specific to the flowsensor (never on arteries, veins) and for non-aerated media which are transparent to ultrasound.

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)

(Division Sigh-Off)
---------------------	--

Division of Cardiovascular Devices

510(k) Number	112657
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Page 1 of 1

Regulation Number and Section

§ 870.2100 Cardiovascular blood flowmeter.

(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).