DOPPLEX ABILITY

{0}------------------------------------------------ Huntleigh Healthcare Limited | - | | | | T L E | G | | | T L E | G | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 510(k) Summary Dopplex Ability | | | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------| | Name & Address: | Huntleigh Healthcare Limited - Diagnostic Products Division Unit 35, Portmanmoor Road Cardiff CF24 5HN United Kingdom | | | JAN 0 3 2013 | | Telephone: | +(44) 2920 485885 | | | | | Fax: | +(44) 2920 492520 | | | | | Prepared: | 8 December 2012 | | | | | Contact: | David Moynham - Regulatory Affairs Engineer | | | | | Device Name: | Dopplex Ability | | | | | Common Name | Hydraulic, pneumatic, or photoelectric plethysmographs | | | | | Classification | Class | Product Code | Classification Regulation | | | | II | JOM | 870.2780 | | | Classification Name: | Hydraulic, pneumatic, or photoelectric plethysmographs | | | | | Predicate Device: | Vascular Assist (K002186) manufactured by Huntleigh Healthcare Limited, 35 Portmanmoor Road, Cardiff, CF24 5HN, UK | | | | | Indications for Use: | Dopplex Ability is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). | | | | | | Dopplex Ability is intended for rapid measurement of ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) in adults and pulse volume recording (PVR) / volume plethysmography. | | | | | | It is suitable for use in woundcare assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy. Dopplex Ability can be used on patients with unilateral lower limb amputation. | | | | | | | The Indications for Use of Dopplex Ability are specific to the measurement of ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) in adults and pulse volume recording (PVR) for those considered at risk of having or developing peripheral arterial disease (PAD). The Predicate device indication for use, is a broader indication "The device is used for the assessment of blood flow in veins and arteries to assist in the identification of vascular disease". Peripheral arterial disease (PAD) is a sub group of the broader indication "vascular disease". The Predicate device includes the capability of measuring ABPI / ABI and PVR. Clinical data submitted demonstrates the submission | | | Dopplex Ability FDA 510(k) Premarket Notification 3 {1}------------------------------------------------ Huntleigh Healthcare Limited = Limited = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = device to provide the performance as indicated for use by a comparison of measured indices using both devices. This supports the demonstration of its safety and effectiveness. #### Description : Dopplex Ability is intended to measure a patient's Ankle Brachial Index (ABI) and provide PVR. This is done through an automated process. The operator places the four colour coded cuffs on each of the patient's limbs as described in the instruction for use and connect to the device. When connected the operator pushes soft touch button to start measurement, the device then will automatically control the inflation / deflation of the cuffs on each limb and monitor minute variations in individual pressures to determine values to be used for the calculation of the ABI values for both the left and right hand of the patient. Dopplex Ability uses pneumo-plethysmography uses obtain physiological measurements from patient's limbs. Measurements are conducted as a single occurrence on all four limbs, eliminating any requirement to rest the patient between measurements. The test period takes approximately 3 minutes. The ABI indices are calculated using an in house algorithm. ABI values are displayed on the LCD and can also be printed. In addition, records are generated of the Pulse Volume Waveforms (PVR), which may also be displayed on the LCD and can be printed. | Model REF | Device | Features | |-----------|-----------------|----------------------------------------------| | DA100PB | Dopplex Ability | AC powered with integral printer and battery | | DA100P | Dopplex Ability | AC powered with integral printer | | DA100B | Dopplex Ability | AC powered with battery | | DA100 | Dopplex Ability | AC powered | Substantial Equivalence: Dopplex Ability is substantially equivalent to the cleared device: Vascular Assist (K002186), cleared 05/02/2001 Technologies Summary: The predicate device utilises Doppler technology to measure physiological parameters used in calculating into ABI indices. Whereas Dopplex Ability uses pneumo-plethysmography to obtain physiological parameters from patient's limbs The predicate device has been used in comparison bench testing and clinical assessment to evaluate and demonstrate the equal capability of both devices to measure ABI. Page 2 of 3 Dopplex Ability FDA 510(k) Premarket Notification {2}------------------------------------------------ Huntleigh Healthcare Limited |------------------------------------------------------------------------------------------------------------------------------------------------ Conclusion: The non clinical and clinical data detailed within submission demonstrates that the device is safe and effective and performs as well as the legally marketed Predicate device, identified in this summary. With respect to Dopplex Ability to function to measure all four limbs as a single occurrence, the submission device provides improved functionality above that of the legally marketed predicate device without addition concerns regarding safety and effectiveness. Page 3 of 3 Dopplex Ability FDA 510(k) Premarket Notification {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 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 emblem featuring three abstract shapes resembling birds in flight, rendered in black. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 JAN 0 3 2013 Huntleigh Healthcare Limited c/o Mr. David Moynham Senior Regulatory Affairs Engineer 35 Portmanmoor Road Cardiff, CF24 5HN (UK) Re: K121108 Trade/Device Name: Dopplex ability Regulation Number: 21 CFR 870.2780 Regulation Name: Hydraulic, pneumatic, or photoelectric plethysmographs Regulatory Class: Class II (two) Product Code: JOM Dated: December 10, 2012 Received: December 12, 2012 Dear Mr. David Moynham: 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. {4}------------------------------------------------ ### Page 2 - Mr. David Moynham 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/CDRH/CDRHOffices/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerelv vours. Bram D. Zuckerman Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications For Use Huntleigh Healthcare Limited Huntleigh Healthcare Limited 510(k) Number: Device Name: Dopplex Ability Indications for Use: Dopplex Ability is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). Dopplex Ability is intended for rapid measurement of ankle-brachial pressure index (ABPI) or anklebrachial index (ABI) in adults and pulse volume recording (PVR) / volume plethysmography. It is suitable for use in woundcare assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy. Dopplex Ability can be used on patients with unilateral lower limb amputation. | Prescription Use | | |-----------------------------|--------| | <b>YES</b> | AND/OR | | (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use NO (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K121108 Page 1 of 1 Huntleigh Healthcare Ltd.