LIDCORAPID V2 MONITOR

K122247 · Lidco, Ltd. · DXG · Mar 20, 2013 · Cardiovascular

Device Facts

• Record ID: K122247
• Device Name: LIDCORAPID V2 MONITOR
• Applicant: Lidco, Ltd.
• Product Code: DXG · Cardiovascular
• Decision Date: Mar 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1435
• Device Class: Class 2

Intended Use

The LiDCOrapid V2 Monitor is intended for use under the direct supervision of a ficensed healthcare practitioner or by personnel trained in its proper use for: - 1. The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients. - 2. When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation

Device Story

LiDCOrapid V2 Monitor provides hemodynamic and anesthetic depth monitoring; inputs include arterial blood pressure waveforms for cardiac output calculation and EEG signals via BIS module for anesthetic effect monitoring. Device processes arterial pressure pulse contour analysis to derive cardiac output, stroke volume, and systemic vascular resistance; EEG signals processed to provide BIS index. Used in clinical settings (ICU, OR, ER) by trained healthcare professionals. Output displayed on monitor for real-time hemodynamic and anesthetic assessment; assists clinicians in fluid management and anesthetic titration; potential benefit includes optimized hemodynamic stability and reduced incidence of awareness during anesthesia.

Clinical Evidence

Bench testing only; no clinical data provided. Performance validated through software verification and validation testing, electrical safety testing, and electromagnetic compatibility testing to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Hemodynamic monitoring via pulse contour analysis; EEG monitoring via BIS module integration. Device is a diagnostic computer (21 CFR 870.1435). Connectivity includes interface for BIS module. Software-based processing of physiological signals. Sterilization not applicable (non-invasive/external monitoring).

Indications for Use

Indicated for adult patients in ICU, operative suites, step-down units, trauma/emergency departments, and cardiac cath labs requiring hemodynamic monitoring (blood pressure, cardiac output) and/or EEG-based anesthetic depth monitoring (when connected to BIS module).

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 Monitor (K050833)
• Aspect Medical Systems BIS VISTA Monitor (K052813)

Submission Summary (Full Text)

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

March 20, 2013

LiDCO Ltd c/o Gregory Speller Quality & Regulatory Manager 16 Orsman Road London, N1 5QJ, UK

Re: K122247

Trade/Device Name: LiDCOrapid V2 Monitor Regulation Number: 21 CFR 870.1435 Regulation Name: Single-function, preprogrammed diagnostic computer Regulatory Class: II Product Code: DXG, GWO Dated: February 26, 2013 Received: February 27, 2013

Dear Mr. Speller:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, 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 may be subject to 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. Gregory Speller

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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/CDRH0ffices/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Owen P. Faris -S

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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## K122247 1/1

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: LiDCOrapid V2 Monitor

## Indications For Use:

The LiDCOrapid V2 Monitor is intended for use under the direct supervision of a ficensed healthcare practitioner or by personnel trained in its proper use for:

- 1. The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.
- 2. When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation

Locations of Use:

Suitable patients will be receiving treatment in the following areas:

Medical and Surgical Intensive Care Units

Operative Suites

Step Down / High Dependency Units

Trauma / Accident & Emergency Departments

Coronary Intensive Care Units

Cardiac Catheter Laboratories

Prescription Use __ × (Part 21CFR 801 Subpart D) AND / OR

Over-The-Counter Use (Part 21CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen P. Faris -S
2013.03.20
12:55:57 -04'00'

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