ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002

K033424 · Transonic Systems, Inc. · DPW · Dec 11, 2003 · Cardiovascular

Device Facts

• Record ID: K033424
• Device Name: ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
• Applicant: Transonic Systems, Inc.
• Product Code: DPW · Cardiovascular
• Decision Date: Dec 11, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Indications for Use

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 Story

The Transonic AngioFlow Meter and Catheter is a cardiovascular blood flowmeter used during angioplasty procedures. The device utilizes a catheter-based sensor inserted into a vascular bed. The principle of operation involves the injection of a bolus of normal saline to induce thermal changes; the system applies thermal-dilution principles to these changes to calculate blood flow. The device is operated by clinicians in a clinical setting. The output, which provides quantitative blood flow measurements, is displayed to the healthcare provider to verify flow status before, during, and after angioplasty treatment, assisting in clinical decision-making regarding the procedure's efficacy.

Clinical Evidence

Bench testing only. The device underwent physical testing and visual examination in accordance with Quality Control Test Procedure documents and cGMP requirements to ensure conformance to design specifications.

Technological Characteristics

System consists of a flow meter and catheter. Patient-contacting materials comply with EN 30993 and/or USP Class VI. Electrical safety conforms to IEC 601 series standards. Operates via thermal-dilution sensing principle using saline bolus injection.

Indications for Use

Indicated for patients undergoing angioplasty procedures to verify blood flow before, during, and after treatment via catheter-based thermal-dilution measurement.

Regulatory Classification

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.

Predicate Devices

• Transonic Anglo Flow Meter and Catheter (K010253)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] 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 11<br>510 (k) Number | Name | Applicant |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|------------------------|
| K010253 | Transonic Anglo<br>Flow 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 [phone]. 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 [phone] or [phone] 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)