ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711

K021874 · Abbott Laboratories · DXG · Jul 12, 2002 · Cardiovascular

Device Facts

• Record ID: K021874
• Device Name: ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
• Applicant: Abbott Laboratories
• Product Code: DXG · Cardiovascular
• Decision Date: Jul 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1435
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

It is intended for deriving and monitoring hemodynamic and cardiac parameters in patients with pre-existing central line access. It monitors cardiac output, body core temperature and blood oxygen saturation. These and other calculated hemodynamic values are displayed and may be communicated to other external monitoring systems. It is intended to be used in medical and surgical intensive care units, operating rooms, trauma and accident emergency units, coronary and intensive care units and cardiac catheterization labs.

Device Story

Desktop-sized monitor; processes signals from indwelling cardiac catheters via optical modules; measures continuous cardiac output (CCO), bolus thermal-dilution cardiac output (TDCO), blood oxygen saturation (SO2), and body core temperature. System architecture includes Interface Control Processor (ICP) and Core Control Processor (CCP) linked via serial data. Used in ICUs, ORs, and cardiac labs by clinicians to monitor hemodynamic status. Displays real-time data on monochrome CRT; supports external communication via RS-232. Provides continuous physiological data to assist clinical decision-making regarding patient hemodynamic stability.

Clinical Evidence

Bench testing only. Functional performance, software verification/validation, electrical safety, and environmental testing conducted. No clinical data presented.

Technological Characteristics

Desktop form factor; monochrome CRT display; front panel keypad. Dual-processor architecture (ICP and CCP) with serial data link. Interfaces with indwelling cardiac catheters, optical modules, and RS-232 peripherals. Performs thermal-dilution and optical oximetry signal processing. Class II device.

Indications for Use

Indicated for patients with pre-existing central line access requiring hemodynamic and cardiac parameter monitoring, including cardiac output, body core temperature, and blood oxygen saturation, in clinical settings such as ICUs, ORs, trauma units, and cardiac catheterization labs.

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

• Abbott Model 3000 Opticath Computer (SvO2/TdCO) (K853018)
• Abbott Continuous Cardiac Output System (Qvue) (K932414)

Submission Summary (Full Text)

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JUL 12 2002

K021874
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## 510(k) Summary of Safety and Effectiveness

Abbott Q2™ Plus SO2/Continuous Cardiac Output Computer

#### Submitted by:

Abbott Laboratories Hospital Products Division D-389. Bldg. J-45 200 Abbott Park Road Abbott Park, IL 60064

#### Date Prepared:

May 22, 2002

#### Contact:

Frank Pokrop Associate Director Requlatory Affairs Phone: [phone] Fax: [phone]

#### Name/Classification of Device:

Single-function, preprogrammed diagnostic computer Class II, Medical Device 21 CFR 870.1435 Product Code: DXG FDA Panel: Cardiovascular

#### Proposed Device:

Abbott Q2TM Plus SO2/Continuous Cardiac Output Computer List Number: 56711

#### Predicate Devices:

Abbott Model 3000 Opticath Computer (SvO2/TdCO), K853018 Abbott Continuous Cardiac Output System, renamed the Qvue, (CCO/TdCO), K932414

#### Proposed Device Description:

The proposed Abbott Q2™ Plus SO2/Continuous Cardiac Output Computer is based on modifications to existing Abbott devices and combines the functions into a single unit. The proposed device will be capable of measuring the following parameters:

- 1. CCO, Continuous Cardiac Output
- 2. SO2, Saturation of oxygen in the blood
- 3. Body core temperature
- 4. TDCO, Standard bolus thermal-dilution cardiac output
- 5. Calculation of other hemodynamic parameters

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## 510(k) Summary of Safety and Effectiveness

Abbott Q2™ Plus SO2/Continuous Cardiac Output Computer

### Proposed Device Description: (cont'd)

The Q2™ Plus system consists of the Q2 monitor and it is to be used with the following medical devices: an Abbott SvO%CCO catheter, Abbott Optical Module, an Oximetrix Printer and various connecting cables. Patient data is derived from an indwelling cardiac catheter.

The Q2 ™ Plus unit is the size of a desktop computer with a monochrome CRT, front panel kevpad (for user input), and various connectors for the catheter, optical module, and serial (RS-232) lines. The instrument has a single computer and various peripheral and special purpose controller boards.

The proposed instrument consists of two subsystems, the Interface Control Processor (ICP) and the Core Control Processor (CCP) which are connected by a serial data link.

#### Special Controls (Section 514)

There are no requirements or special controls under Section 514 of the Federal Food, Drug, and Cosmetic Act that are applicable to the Q2 TM Plus.

#### Intended Use:

The Abbott Q2™ Plus SO2/Continuous Cardiac Output Computer has the following indications for use.

- -It is intended for deriving and monitoring hemodynamic and cardiac parameters in patients with pre-existing central line access.
- It monitors cardiac output, body core temperature and blood oxygen saturation. - These and other calculated hemodynamic values are displayed and may be communicated to other external monitoring systems.
- It is intended to be used in medical and surgical intensive care units, operating rooms, trauma and accident emergency units, coronary and intensive care units and cardiac catheterization labs.

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## 510(k) Summary of Safety and Effectiveness

Abbott Q2™ Plus SO2/Continuous Cardiac Output Computer

### Comparative Analysis:

The Abbott Q2™ Plus SO2/Continuous Cardiac Output Computer has been demonstrated to be as safe and effective as the predicate devices for their intended use. The subject device will have the same indications for use as the predicate devices. The proposed device incorporates the functions of the predicate devices into a single unit.

### Functional/Safety Testing:

The Abbott Q2™ Plus SO2/Continuous Cardiac Output Computer has successfully underqone bench and functional testing as well as software verification and validation, electrical safety and environmental testing.

### Discussions and Conclusions from Bench Testing:

Data regarding the functional performance of the proposed Q2™ Plus has been generated and reviewed. The results of testing conducted to validate and verify the design modifications demonstrate acceptable performance of the device. These results do not raise any new issues of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ົງບໍ່ 1 ຂ 2002

Abbott Laboratories c/o Mr. Ned E. Devine, Jr. Program Manager III Entela. Inc. 3033 Madison Avenue SE Grand Rapids, MI 49548

Re: K021874

Trade Name: Abbott O2TM Plus SO2/Continuous Cardiac Output Computer Regulation Number: 21 CFR 870.1435 and 870.2700 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer and Oximeter Regulatory Class: Class II (two) Product Code: DXG and DQA Dated: June 27, 2002 Received: June 28, 2002

Dear Mr. Devine:

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. Iisting 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. Ned E. Devine, Jr.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Kastrati

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

| 510(k) Number (if known) | K021874 |
|--------------------------|--------------------------------------------------------|
| Device Name: | Abbott Q2™ Plus SO2/Continuous Cardiac Output Computer |
| Indications For Use: | |

The Abbott Q2™ Plus SO2/Continuous Cardiac Output Computer has the following indications for use:

It is intended for deriving and monitoring hemodynamic and cardiac parameters in patients with pre-existing central line access.

It monitors cardiac output, body core temperature and blood oxygen saturation. These and other calculated hemodynamic values are displayed and may be communicated to other external monitoring systems.

It is intended to be used in medical and surgical intensive care units, operating rooms, trauma and accident emergency units, coronary and intensive care units and cardiac catheterization laboratories.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use <span></span> X | OR Over-The_Counter Use |
|----------------------------------|-------------------------|
|----------------------------------|-------------------------|

(per 21 CFR 801.109)

K Qutre

(Division Sign-Off) Division of Cardiovascular and Respiratory Devic

510(k) Number K021874