The Transonic AngioFlow meter and catheter are indicated for use during angioplasty procedures to verify the flow before, during, and after treatment. The system is intended for the measurement of blood flow within a vascular bed utilizing a catheter-based sensor. This sensor system uses thermal changes induced by a bolus injection of normal saline and thermal-dilution principles to calculate blood flow.

Device Description

The Transonic Angio Flow Meter and Catheter which is intended for the measurement of blood flow within a vascular bed utilizing a catheter-based sensor. This sensor system uses thermal changes induced by a bolus injection of normal saline and thermal-dilution principles to calculate blood flow in hemodialysis grafts.

AI/ML Overview

The provided text is a 510(k) summary for the Transonic Angio Flow Meter and Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for a new device. Therefore, much of the requested information regarding acceptance criteria, specific performance studies, sample sizes, ground truth establishment, and expert qualifications is not explicitly available in the provided text.

Based on the available information, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly available in the provided text. The document states:

"All finished products are tested and must meet all required release specifications."
"The array of testing required for release includes, but is not limited to; physical testing, visual examination (in process and finished product)."
"The physical testing is defined by Quality Control Test Procedure documents. The physical testing measures values and parameters which conform to the product design specifications."

However, the specific "required release specifications" or "product design specifications" (i.e., the acceptance criteria) and the "reported device performance" against these criteria are not detailed. The document primarily focuses on the process of testing rather than the results of specific performance tests.

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 available in the provided text. The document does not describe a clinical or performance study with a dedicated test set or data provenance. The testing mentioned refers to manufacturing quality control and adherence to design specifications.

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 applicable/available. Since no specific clinical or performance study with a test set is described where ground truth was established, there's no mention of experts or their qualifications for this purpose.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable/available. As no specific test set or study is described, there is no mention of an adjudication method.

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:

This information is not applicable/available. The device is a "Thermodilution Meter and Catheter" used for measuring blood flow, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device and is not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable/available. The device is a measurement instrument, not an algorithm. Its operation inherently involves a human operator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not available. Given the nature of the device (blood flow meter), any "ground truth" for its performance would likely relate to accuracy and precision of flow measurements compared to a gold standard measurement method or known flow rates in a controlled environment. However, the document does not specify how this was established or type of data used.

8. The sample size for the training set:

This information is not applicable/available. The device is a hardware instrument, not an AI or machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established:

This information is not applicable/available, for the same reason as point 8.

Summary based on the document:

The 510(k) summary provided indicates that the Transonic Angio Flow Meter and Catheter demonstrates substantial equivalence to its predicate device (K010253, also Transonic Angio Flow Meter and Catheter) based on:

Similar intended use, device description, and indications for use.
Similar materials, form, and intended use to the previous version, with no new issues of safety or effectiveness raised by modifications.
Biocompatibility of patient-contacting materials conforming to EN Standard 30993 and/or USP class VI.
The meter component meeting applicable electrical safety requirements in accordance with the IEC 601 series of standards.
Finished products undergoing testing to meet required release specifications, including physical testing (conforming to product design specifications) and visual examination.

The document does not provide specific acceptance criteria in quantitative terms (e.g., "accuracy must be within X%"), nor does it present detailed study results with sample sizes, data provenance, ground truth establishment, or expert involvement as would be expected for a complex diagnostic or AI-driven device. It relies on the assertion of manufacturing quality control and compliance with established standards and the similarity to a legally marketed predicate device.

Summary

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DEC 1 1 2003

510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

October 22, 2003

Transonic Systems Inc. 34 Dutch Mill Road Ithaca, NY 14850 Telephone Number: (607) 257-5300 Fax: (607) 257-7256 Contact: Mark S. Alsberge

Establishment Registration Number: 1319030

Transonic Anglo Flow Meter and Catheter Product Name: Thermodilution meter and catheter Trade Name: Classification name: Cardiovascular Blood Flowmeter Cardiovascular Class II, 74 DPW 21 CRF §870.2100

SUBSTANTIAL EQUIVALENCE TO:

11 11 11 11 11 12 12 11 12 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11510 (k) Number	Name	Applicant
K010253	Transonic AngloFlow Meter and	Transonic Systems Inc.
	Catheter

Device Description:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate Cosmetic Act, Transonic Angio Flow Meter and Catheter which is intended Commerce the Transonio Anglo wwwithin a vascular bed utilizing a catheterfor the measuremont of brosses thermal changes included by a based sensor. This consor of e and thermal-dilution principles to calculate blood flow in hemodialysis grafts.

Indications for Use:

The Transonic Angio Flow Meter and Catheter indicated for use during angioplasty procedures to verify the flow before, during and after treatment. anglopasty prooodaroo to the measurement of blood flow within a vascular bed utilizing a catheter-based sensor. This sensor system uses thermal bed utilizing a outherer base injection of normal saline and thermal-dilution principles to calculate blood flow.

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KD 3342+

The Transonic Angio Flow Catheter is composed of materials that are the The Transonio Anglo Flow Sation. The patient contacting materials have been Samo type as the pro with the EN Standard 30993 and/or USP class VI and are suitable for the intended use of this product.

Biocompatibility is not applicable to the meter component of the system. The Diocompatibility is not dipindano to inolicable electrical safety requirements in accordance with the IEC 601 series of standards.

Substantial equivalence:

The Transonic Angio Flow Meter and catheters are similar in materials, form The Transonio Anglo he previous version of the Angio Flow meter and and intendod are no new issues of safety or effectiveness raised by the modifications to the Transonic Angio Flow Meter and Catheter.

Safety And Effectiveness:

All finished products are tested and must meet all required release specifications All firmshod products are rray of testing required for release includes, but is not limited to; physical testing, visual examination (in process and finished product).

The physical testing is defined by Quality Control Test Procedure documents. The prysiour tooling to usines and parameters which conform to the product design specifications.

The testing instruction records for each of the individually required procedures are rne testing instruction rocerce to d revised in accordance with document control cGMP's.

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Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion. The text is in uppercase letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 11 2003

Transonic Systems, Inc. c/o Mr. Mark S. Alsberge VP Medical and Regulatory Affairs 34 Dutch Mill Road Ithaca. NY 14850

Re: K033424

Trade Name: Thermodilution Meter and Catheter Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: DPW Dated: October 22, 2003 Received: November 12, 2003

Dear Mr. Alsberge:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Mark S. Alsberge

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 Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Elisa D. Harry 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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Page 1 of 1_

510(k) Number (if known): _ K0 33424

Device Name: _____Transonic AngioFlow Meter and Catheter

Indications for Use:

Prescription Use

The Transonic AngioFlow meter and catheter are indicated for use during angioplasty The Transons Tington for Hector and Juring, and after treatment. The system is intended procedures to verry the now ocrore, ating ,
for the measurement of blood flow within a vascular bed utilizing a catheter-based sensor. This sensor system uses thermal changes induced by a bolus injection of normal saline and thermal-dilution principles to calculate blood flow.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

tion of Cardiovascular Devices

Prescription Use
(Per 21 CFR 801.109)

510(k) Number K-033424
(Optional Format 3-10-98)

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).