TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM

K080116 · Transonic Systems, Inc. · DXG · Sep 8, 2008 · Cardiovascular

Device Facts

• Record ID: K080116
• Device Name: TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
• Applicant: Transonic Systems, Inc.
• Product Code: DXG · Cardiovascular
• Decision Date: Sep 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1435
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Transonic COSTATUS System is indicated for use in patients greater than or equal to 2 years old (child, adolescent, adult) with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.

Device Story

Transonic COstatus System is a diagnostic apparatus for measuring cardiac output and hemodynamic parameters using an indicator dilution technique. It utilizes a peristaltic pump to draw a small volume of blood through an external AV-loop tubing set past sensors, then returns the blood to the patient in a closed-loop system. It is intended for use in clinical settings such as the ICU on patients with existing arterial and venous access lines. The system processes the indicator dilution data to calculate cardiac output. Healthcare providers use the output to assess cardiovascular status and inform clinical decision-making. The device benefits patients by providing hemodynamic monitoring without requiring a hemodialysis circuit.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including physical testing and visual examination, to ensure performance parameters conform to design specifications and ISO 10993 biocompatibility standards.

Technological Characteristics

System components include HCM101 cardiac output meter, HC2T sensors, ADT2005D/E AV-loop tubing sets, HCS3002 sensor tubing adaptor, HCP01 AV-loop pump, HFW1000 fluid warmer, HCR01 printer, and HCMD01 data transfer module. Materials are tested per ISO 10993. Operates via indicator dilution technique using a peristaltic pump for closed-loop blood circulation.

Indications for Use

Indicated for patients ≥ 2 years old (child, adolescent, adult) requiring diagnostic assessment of cardiovascular status, including cardiac output and hemodynamic parameters, provided they have established arterial and venous access lines.

Regulatory Classification

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.

Predicate Devices

• LiDCOplus Hemodynamic Monitor (K023960)
• Transonic Hemodialysis Monitor, Cardiac Output (Measurement) (K980906)

Submission Summary (Full Text)

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K080116

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

May 17, 2008

| Transonic Systems Inc. | |
|------------------------|---------------------------|
| 34 Dutch Mill Rd | Telephone: [phone] |
| Ithaca, NY | Fax: [phone] |

| Contact: | Mark S. Alsberge |
|----------|------------------|
|----------|------------------|

Product Name: Transonic COstatus System

Classification name: Single-Function, Preprogrammable Diagnostic Computer Circulatory System Devices Panel Class II, 74 DXG 21 CFR §870.1435

# SUBSTANTIAL EQUIVALENCE1 TO:

| 510 (k) Number | Name | Applicant |
|----------------|--------------------------------------------------------------------|------------------------|
| K023960 | LiDCOplus Hemodynamic<br>Monitor | LiDCO Limited |
| K980906 | Transonic Hemodialysis<br>Monitor, Cardiac Output<br>(Measurement) | Transonic Systems Inc. |

## 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 COstatus System which is an apparatus using an indicator dilution technique for the measurement fluid volumes. The system is a variation of the HD01 system which can measure CO during a Hemodialysis treatment. The COstatus system uses a peristaltic pump to draw a small volume of blood passed the sensors rather than using a Hemodialysis circuit. The system can thereby be used on any patient with arterial and venous access lines.

¹ The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact the from an marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent to this product or the technology used to manufacture the product.

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#### Material:

The components of the Transonic COstatus System are made of materials, which have been tested in accordance with the ISO Standard 10993 appropriate to their patient contact and therefore suitable for the intended use of this product.

This COstatus system consists of the following components;

HCM101 Cardiac output meter HC2T Sensors ADT2005D AV-Loop tubing set ADT2005E AV-Loop tubing set HCS3002 Sensor Tubing Adaptor HCP01 AV-Loop Pump HFW1000 Fluid Warmer HCR01 Printer HCMD01 Data Transfer Module

#### Substantial equivalence:

The Transonic COstatus System is similar in materials, form and intended use to the Transonic Hemodialysis Monitor, Cardiac Output HD01 system which can measure CO during a Hemodialysis treatment currently marketed by Transonic Systems Inc. cleared by the under K980906 and the LiDCOplus Hemodynamic Monitor cleared by K023960. The difference between COstatus system and the HD01 is that the COstatus system uses a peristaltic pump to draw a small volume of blood passed the sensors rather than using a Hemodialysis circuit. The system can thereby be used on any patient with arterial and venous access lines. The system can be used on patients in other clinical settings such as an ICU. The LiDCOplus Hemodynamic Monitor also uses a small peristaltic pump, but uses lithium chloride as an indicator whereas the COstatus uses saline. The LiDCOplus Hemodynamic Monitor does not return withdrawn blood to the patient, but the COstatus runs as a closed loop returning all drawn blood. These differences do not raise any new issues of safety or effectiveness regarding the Transonic COstatus System.

#### Safety and Effectiveness:

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, 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 products 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with three wavy lines below them, possibly representing water or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 8 2008

SEP 08 2008

Rockville MD 20850

Transonic Systems, Inc. c/o Mr. Mark S. Alsberge VP Medical and Regulatory Affairs 34 Dutch Mill Road Ithaca, NY 14850-9787

Re: K080116

Trade/Device Name: Transonic COStatus System Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function Preprogrammed Diagnostic Computer Regulatory Class: Class II Product Code: DXG Dated: September 4, 2008 Received: September 4, 2008

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.

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

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### Page 2 - Mr. Mark S. Alsberge

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 (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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours.

Ondley B. Bour

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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Indications for Use

510(k) Number (if known): K080116 _Transonic COSTATUS System ___________________________________________________________________________________________________________________________________________________ Device Name: Indications for Use:

The Transonic COSTATUS System is indicated for use in patients greater than or equal to 2 years old (child, adolescent, adult) with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.

Prescription Use · Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The -Counter Use NO (21 CFR 801 Subpart C)

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

Concurence of CDRH, Office of Device Evaulation (ODE)

Ashley Bra for BZ

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Numbe

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