PeriFlux6000

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are rendered in a dark color, creating a strong contrast against the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 5, 2016 Perimed AB Jimmy Bakker Regulatory Affairs Officer Datavägen 9A SE-175 43 Järfälla. Sweden Re: K152930 Trade/Device Name: PeriFlux 6000 Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW Dated: April 5, 2016 Received: April 13, 2016 Dear Jimmy Bakker: 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 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 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. {1}------------------------------------------------ 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 yours, Shawn W. Forrest -S 2016.05.05 23:12:25 -04'00' 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) K152930 Device Name PeriFlux 6000 #### Indications for Use (Describe) PeriFlux 6000 equipped with PF 6010 is intended for measuring micro-vascular perfusion in skin and muscle in humans. It is also intended for measuring micro-vascular perfusion in all tissues in animals for research purposes. The PF 6010 is also intended for evaluating tissue response in skin to local heating and providing temperature stabilization of skin at blood perfusion measurement. PeriFlux 6000 equipped with PF 6050 is intended for measuring the pressure cuffs, to simplify simultaneous measurements of perfusion and pressure when used in conjunction with a laser Doppler perfusion monitor. PeriFlux 6000 equipped with PF 6050 is also intended for Pulse Volume Recording (PVR) on human limbs and digits for diagnosis and evaluation of vascular disease in adults. It is not intended for use on neonates and pregnant women. PeriFlux 6000 equipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia. (Note: PeriFlux 6000 equipped with PF6040, with an intended use as in the last paragraph, was previously cleared in K131253 and is therefore not part of this submission) | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | | <span style="white-space: nowrap;"> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |--|------------------------------------------------------------------------------------------------------------------------------------| | | <span style="white-space: nowrap;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ | | <div style="display:flex; align-items:center;"> <span style="border: 1px solid black; padding: 5px;">PERIMED</span> </div> | |-----------------|----------------------------------------------------------------------------------------------------------------------------| | Document Type | Traditional 510(k) Notification | | Submission Date | 2015-10-02 | | Section-Page | 6-2/5 | | Object/Subject | | PeriFlux 6000 – 510(k) Summary ### Submitter Perimed AB Datavägen 9A SE-175 43 Järfälla, Sweden Phone: (011) 46 8 580 119 90 Fax: (011) 46 8 580 100 28 Official Correspondent: Maria Prans Liljevret Contact Person for this submission: Jimmy Bakker | | Date prepared: | 2 October 2015 | |----------|----------------|----------------| | Revised: | | 5 May 2016 | ### Device | Trade Name: | PeriFlux 6000 | |----------------------------|---------------------------------------------------------------------------------| | Common Name: | Modular multichannel system for diagnosis and<br>evaluation of vascular disease | | Classification Name: | Cardiovascular blood flowmeter | | Classification Regulation: | 870.2100 | | Product Code: | DPW | | Panel: | Cardiovascular | | Regulatory Class: | II | | Type of product: | Finished product | ## Predicate device #### Predicate device No 1 (Primary) | Trade name: | PeriFlux System 5000<br>PF 5010 LDPM Unit<br>PF 5020 Temp Unit<br>PF 5050 Pressure Unit | |------------------|-----------------------------------------------------------------------------------------| | 510(k) No: | K974285, K932068, K011899 | | Type of product: | Finished product | | Panel: | Cardiovascular | #### Predicate device No 2 | Trade name: | PeriFlux 6000 | |------------------|-------------------| | | PF 6040 LDPM Unit | | 510(k) No: | K131253 | | Type of product: | Finished product | | Panel: | Anesthesiology | {4}------------------------------------------------ Image /page/4/Figure/0 description: This image is a document header. It includes the logo for "PERIMED" on the left. The document type is listed as "Traditional 510(k) Notification", the submission date is "2015-10-02", and the section-page is "6-3/5". The object/subject is "PeriFlux 6000 - 510(k) Summary". #### Reference device No reference devices were used in this submission # Device Description The PeriFlux 6000 is a modular multichannel system that offers several tests for diagnosis and evaluation of vascular disease in one instrument. It consists of a Main Unit (PF 6001), which accommodates up to eight different function units of the same type or of different types enabling simultaneous measurements of several parameters. Currently, one type of unit –PF 6040 tcpO2/pCO2 Unit– is available for the US market. Two more units have been developed: - PF 6010 LDPM/Temp Unit ● - PF 6050 Pressure Unit The PeriFlux 6000 equipped with PF 6010 function units measures microcirculatory blood flow using Laser Doppler technology. In combination with the PF 6050 function unit to inflate blood pressure cuffs and to register the cuff pressure, it enables a range of different tests, including ankle pressure, toe pressure, skin perfusion pressure (SPP), pulse volume recording (PVR), segmental pressures, heat provocations and post-occlusive reactive hyperemia (PORH). In Laser Doppler Perfusion Monitoring, an optical fibre leads light generated by a laser to the LDPM probe tip, which rests against the tissue. The beam of light will enter the tissue and become scattered. Blood cells moving within the volume illuminated by the beam will cause the light to change frequency. This change in frequency is called a Doppler shift and it is used to calculate the blood flow in the illuminated tissue. # Indications for Use ## PF 6010 LDPM/Temp Unit PeriFlux 6000 equipped with PF 6010 is intended for measuring micro-vascular perfusion in skin and muscle in humans. It is also intended for measuring micro-vascular perfusion in all tissues in animals for research purposes. The PF 6010 is also intended for evaluating tissue response in skin to local heating and providing temperature stabilization of skin at blood perfusion measurement. # PF 6040 tcpO2/CO2 Unit PeriFlux 6000 equipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia. ## PF 6050 Pressure Unit PeriFlux 6000 equipped with PF 6050 is intended for measuring the pressure in blood pressure cuffs, to simplify simultaneous measurements of perfusion and pressure when used in conjunction with a laser Doppler perfusion monitor. PeriFlux 6000 equipped with PF 6050 is also intended for Pulse Volume Recording {5}------------------------------------------------ Image /page/5/Figure/0 description: The image shows a document with the title "Traditional 510(k) Notification". The document type is "Traditional 510(k) Notification", the submission date is "2015-10-02", and the section-page is "6-4/5". The document also includes the logo "PERIMED". PeriFlux 6000 - 510(k) Summary (PVR) on human limbs and digits for diagnosis and evaluation of vascular disease in adults. It is not intended for use on neonates and pregnant women. (Note: PeriFlux 6000 equipped with PF 6040, with an intended use as described under "PF 6040 tcpO2/CO2 Unit", was previously cleared in K131253 and is therefore not part of this submission) ## Environment of use The PeriFlux 6000 instrument is intended for professional use in a hospital environment, laboratory environment and in a hospital intensive care unit environment. ### Comparison of technological characteristics with the predicate devices There are no technological differences between the instrument approved in K131253 and the current Periflux 6000 when equipped with PF 6040 besides the ability to host the other function units. Predicate device No 2 is listed for completeness and will not be discussed further. The Periflux 6000 and the primary predicate device have Laser Doppler Perfusion Monitoring as a technological principle. It is based on measuring the Doppler shift of laser light scattered in the tissue as a measure of micro-vascular blood flow. At high level, the Periflux 6000 and the primary predicate device are based on the following same technological elements: - An infrared laser with laser class 1 (IEC 60825-1:2007, 21 CFR 1040.10 and ● 1040.11) - Measurement through optical fibre probes. ● - Temperature measurement and control in the probe possible ● - Measurement and control of pressure in blood pressure cuffs ● - Possibility to combine different function units in one device o The following technological differences exist between the PeriFlux 6000 and the primary predicate device: - Use of an SVGA display with touch screen operation ● - Up to 8 function units in one device (compared to 4 in primary predicate) ● - Laser Doppler Perfusion Monitoring and probe heating combined in one function ● unit - o Perfusion calculated from a larger frequency bandwidth. - o 6 individually controlled cuff connectors and a built-in pump. # Summary of Performance Tests #### Performance Testing - Bench Laser Doppler Perfusion Monitoring is an intricate measurement, involving more electronics and calculations than measurements of the other parameters. Also, the PF {6}------------------------------------------------ Image /page/6/Figure/0 description: The image is a document header that includes the company logo, document type, submission date, and section-page information. The company logo is "PERIMED" with a red graphic to the left. The document type is "Traditional 510(k) Notification", the submission date is "2015-10-02", and the section-page is "6-5/5". #### PeriFlux 6000 - 510(k) Summary 6010 measures over a higher frequency bandwidth than the PF 5010. We have therefore tested how the clinically relevant parameter, blood perfusion, correlates between these two systems. The tests show that the signals correlate very well between the two systems and that they can be regarded as equivalent. #### Performance Testing - Animal No performance tests on animals are submitted. #### Performance Testing - Clinical No clinical performance tests are submitted. # Conclusion The discussion of similarities and differences between the new device and the predicate device shows that the new device is similar to the predicate device in most of the relevant properties. The intended use of the devices is the same. A few differences in technological characteristics have been found and the discussion concludes that these differences do not raise different questions of safety and effectiveness, nor do they adversely affect safety and effectiveness. The PeriFlux 6000 simply follows the state of the art in standards and available technology to create a safe, effective and convenient device. Temperature and pressure are measured using the same technology and use the same type of sensors in PeriFlux 6000 as in PeriFlux System 5000 and comparative testing shows that Laser Doppler Perfusion measurements on these two systems can also be regarded as equivalent. The conclusion is that the new device PeriFlux 6000 is substantially equivalent to the predicate device PeriFlux System 5000.