Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+

{0}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 24, 2015 Deltex Medical Limited % Neil Armstrong RA Advisor To Deltex Medical MeddiQuest Limited Quest Science Herlington House, Orton Malborne Peterborough, PE2 5XS United Kingdom Re: K150347 Trade/Device Name: Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW Dated: June 16, 2015 Received: June 22, 2015 Dear Neil Armstrong: 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. 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 {1}------------------------------------------------ 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 of medical devicerelated adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours Arthur Stei for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K150347 #### Device Name Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM #### Indications for Use (Describe) The Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM cardiac function and fluid status monitoring system is designed to provide clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters. The Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM beat-to-beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward. Type of Use (Select one or both, as applicable) | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------------------------------|-----------------------------------------------| |----------------------------------------------------------------------------------------------------------|-----------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Deltex Medical. The word "Deltex" is written in a large, bold, blue font. Below the word "Deltex" is the word "medical" written in a smaller, lighter font. The logo is simple and professional. Preparation Date: July 24, 2015 #### Owner's Name This traditional 510(k) is now submitted by: Graham Lowe Marketing & Operations Director was originally submitted as a special 510(k) by: Paul Dwane Quality and Production Director For and on behalf of the Owner: Deltex Medical Ltd Terminus Road Chichester West Sussex PO19 8TX United Kingdom Tel: 011 44 1243 523160 Fax: 011 44 1243 532534 e-mail: paul.dwane@deltexmedical.com ### Contact Person: The address and telephone number for all correspondence is: Neil R. Armstrong MeddiQuest Limited Quest Science Herlington House Orton Malborne Cambridge PE2 5XS United Kingdom UK Tel: 011 44 1733 231445 011 44 1733 233852 UK Fax: neil.armstrong@meddiquest.com e-mail: (240) 949 2477 US Tel: Or Dr Graham Lowe {4}------------------------------------------------ Marketing and Operations Director Deltex Medical Limited Terminus Road Chichester West Sussex PO19 8TX United Kingdom Tel: 011 44 1243 774837 Fax: 011 44 1243 532534 e-mail: graham.lowe@deltexmedical.com #### Classification name: Cardiovascular Blood Flowmeter 21CFR 870.2100 DPW #### Common/Usual Name: Esophageal Doppler Monitor #### Proprietary Name: Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM #### Establishment Registration Number: The device will be manufactured by: Deltex Medical Ltd Terminus Road Chichester West Sussex PO19 8TX United Kingdom Establishment Registration Number 9680933 #### Substantial Equivalence: The Deltex Medical CardioQ-EDM series are substantially equivalent in design, use and materials to the: Deltex Medical CardioQ-EDM+, 510(k) number: K132139 and Deltex Medical CardioQ-EDM, 510(k) number: K111542, only the software and related labeling has been updated to introduce a second formula to the formula and body surface area algorithms, that extends the range of volumetric calculations permits the software to recognize and select the correct formula for future additions to the probe range without further update. The software will be suitable for the Deltex Medical CardioQ-EDM Series: Deltex Medical Limited, Deltex Medical CardioQ-EDM+ - K132139 {5}------------------------------------------------ Deltex Medical Limited, Deltex Medical CardioQ-EDM - K111542 The Deltex Medical CardioQ-EDM series is made of the same materials as the Deltex Medical Limited, Deltex Medical CardioQ-EDM series - K132139 and K111542. The Deltex Medical CardioQ-EDM series is manufactured by the same processes as the Deltex Medical Limited, Deltex Medical CardioQ-EDM series - K132139 and K111542. The Deltex Medical CardioQ-EDM series is non-sterile. Modified and draft labeling for the Deltex Medical CardioQ-EDM series has been submitted. ## Description of Product: The Deltex Medical CardioQ-EDM series are medical instruments designed to monitor cardiac function and fluid status. The CardioQ-EDM series combine Doppler measurement of the blood flow (4MHz continuous wave ultrasound) with Pulse Pressure Waveform Analysis (PPWA) to monitor and quantify the blood flow in the descending thoracic aorta and hence calculate other clinically significant information. This 510(k) is submitted for clearance of a minor software change that will allow use in conjunction the KDP72 probe on additional pediatric patients K142932 of the Deltex Medical CardioQ-EDM+, K132139, and the Deltex Medical CardioQ-EDM, K111542. Only the software and related labeling has been updated to introduce a second formula and body surface area algorithms: this extends the range of volumetric calculations and a second change will permit the software to recognize future additions to the probe range and select the correct formula without further update. In all other respects the same as the predicate device. The same software will be suitable for both the Deltex Medical CardioQ-EDM+ and the Deltex Medical CardioQ-EDM (collectively referred to as the CardioQ-EDM Series). ### Intended use: The Deltex Medical CardioQ-EDM series are medical instruments designed to monitor cardiac function and fluid status, providing clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward. ### Indications for use: The Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM cardiac function and fluid status monitoring system is designed to provide clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters. The Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM beat-to-beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward. {6}------------------------------------------------ ## Additional Feature: In addition, the Deltex Medical CardioQ-EDM+ includes a function to calculate arterial blood pressure based parameters from an output slaved from a vital signs monitor. ## Testing: The changes covered in this special 510(k) do not affect the ultrasonic performance of the device or the measurement of linear data but only the identification of the probe and subsequent calculation of volumetric data. The subject device's performance in this respect is as safe and effective as the predicate devices. Testing is included to demonstrate the probe is correctly identified and the appropriate formula and Body Surface Area algorithm selected based on that identification. Code examination is also included to demonstrate that the software correctly implements the formula and algorithms and simulation testing conducted to demonstrate the values displayed match those calculated "by hand". The tests reported in the submission and the supplements demonstrate that the device is as safe, as effective, and performs as well as the predicate devices CardioQ-EDM (K111542) and CardioQ-EDM+ (K132139). Hence Deltex Medical concludes that the subject device is substantially equivalent to the predicate devices.