AMG PMP Infant

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 10, 2021 Eurosets S.r.l. Katia Vescovini RA/QA/CQ Manager Strada Statale 12, nº 143 Medolla, Modena I-41036 Italy Re: K202510 Trade/Device Name: AMG PMP Infant Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: October 20, 2021 Received: October 25, 2021 Dear Katia Vescovini: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K202510 Device Name AMG PMP INFANT Indications for Use (Describe) The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for six hours or less with a maximum blood flow rate of 1.5 liters/minute. PATIENT POPULATION: Infants. Type of Use (Select one or both, as applicable) > 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}------------------------------------------------ # 510(k) Summary #### 1. General Information #### Submitter : EUROSETS Srl Strada Statale 12, nº 143 41036 Medolla (MO) - ITALY Tel.: +39 0535 660311 Fax +39 0535 51248 #### Establishment Registration Number: 3003752502 #### Contact: Dr. Katia Vescovini Tel.: +39 0535 660311 Email: kvescovinirequlatory@eurosets.com | Summary Preparation Date: | April 12, 2021 | |---------------------------|----------------| |---------------------------|----------------| #### 2. Name & Classification Device Name: Regulation Name: Regulation Number: Product Code: CLASS: AMG PMP INFANT Cardiopulmonary bypass oxygenator 870.4350 DTZ ll #### 3. Predicate Devices The AMG PMP INFANT device is substantially equivalent to the following devices: | Applicant | Device name | 510(k) Number | |---------------------------|---------------------------------------|-----------------------------------| | Sorin Group Italia S.r.I. | Lilliput PMP, Lilliput PMP Integrated | K151713<br>Primary predicate Dev. | | Eurosets | A.M.G. MODULE PMP NO T.P. STERILE | K141492 | #### 4. Indications for Use The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for six hours or less with a maximum blood flow rate of 1.5 liters/minute. PATIENT POPULATION: Infants. #### 5. Device Description AMG PMP INFANT is an oxygenator used to exchange gases between blood and gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery. It is composed by PMP (Polymethylpentene) hollow fiber membrane with an integrated heat exchanger. It is provided together with the accessories that are the gas line and the convenience kit. Oxygenator module, AMG PMP INFANT consist of three path, blood path, water path. These three paths, thanks to the particular configuration, allow the blood temperature control and gas exchange. The device center consists stainless steel tubes that allow the control of the temperature of the blood. The exchange of heat is between the water (with controlled temperature) that flows outside of steel tubes and the blood that flows inside the steel tubes. The device center is surrounded by an outer compartment that contains a microporous membrane of Polymethylpentene (PMP) consisting of capillary allow fibers that allows gas exchange. The air form the gas mixer rich in O2 follows the gas path: is insufflated through the gas inlet port on the top of the device, goes through microporous PMP fibers and exit from gas escape port, at the same time blood go outside the microporous fibers. The design of heat exchangers for cooling and rewarming blood in the oxygenator centers allows making a biologically inert surface capable of achieving the desired rate of heat exchange, without producing any localized overheating of the blood. {4}------------------------------------------------ # 6. Comparison with the predicate devices | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | SECONDARY PREDICATE DEVICE | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | MODEL NAME: | AMG PMP INFANT | K151713<br>Lilliput PMP | K141492<br>A.M.G. MODULE PMP NO T.P.<br>STERILE | | APPLICANT: | Eurosets S.r.l. | Sorin Group Italia S.r.l. | Eurosets S.r.l. | | | | CLASSIFICATION | | | CLASS: | II | II | II | | REGULATION<br>NUMBER: | 870.4350 | 870.4350 | 870.4350 | | PRODUCT<br>CODE | DTZ | DTZ | DTZ | | REGULATION<br>NAME: | Cardiopulmonary Bypass<br>Oxygenator | Cardiopulmonary Bypass Oxygenator | Cardiopulmonary Bypass<br>Oxygenator | | | | INTENDED USE & PATIENT POPULATION | | | INTENDED USE: | The device is indicated for<br>patients who undergo<br>cardiopulmonary bypass<br>surgery requiring<br>extracorporeal circulation for<br>six hours or less with a<br>maximum blood flow rate of<br>1.5 liters/minute. | The device is intended for use in infants<br>not exceeding 20 kg (44lb) who<br>undergo cardiopulmonary bypass<br>surgery requiring extracorporeal<br>circulation. It provides oxygenation and<br>carbon dioxide removal from venous<br>blood. The integrated heat exchanger<br>provides blood temperature control and<br>allows the use of hypothermia or aids in<br>the maintenance of normothermia<br>during surgery. The venous reservoir is<br>intended to collect blood during normal<br>operation, to always assure the proper<br>oxygenation capability of the device.<br>The device should not be used longer<br>than 6 hours. Contact with blood for<br>longer periods is not advised. | Is intended in surgical procedure<br>requiring extracorporeal gas<br>exchange support and blood<br>temperature control for periods<br>of up to 6 hours.<br>The advanced Membrane Gas<br>Exchange for extracorporeal<br>circulation is a microporous<br>hollow-fiber oxygenator with an<br>integral heat exchanger used to<br>perform cardiopulmonary bypass.<br>It includes a detachable 4.5 liter<br>blood reservoir. | | PATIENT<br>POPULATION: | Infants | Infants not exceeding 20Kg (44lbs). | Adults | | | | TECHNICAL FEATURES | | | MIN<br>BLOOD<br>FLOW: | 0,2 | / | 1l/min | | MAX<br>BLOOD<br>FLOW: | 1,5l/min | 2,3l/min | 7l/min | | KIND OF FIBER<br>OXYGENATOR: | Polymethylpentene (PMP) | Polymethylpentene (PMP) | Polymethylpentene (PMP) | | MEMBRANE<br>SURFACE<br>AREA: | 0,69m² | 0,80m² | 1,81m² | | HEAT<br>EXCAHNGER: | integrated | integrated | integrated | | HEAT EXHANGE<br>SURFACE<br>AREA: | 0,04m² | 0,02m² | 0,08m² | | STATIC<br>PRIMING<br>VOLUME: | 90ml | <140ml | 220ml | | COATING: | Phosphorylcholine | Phosphorylcholine | Phosphorylcholine | | | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | SECONDARY PREDICATE DEVICE | | MODEL NAME: | AMG PMP INFANT | K151713<br>Lilliput PMP | K141492<br>A.M.G. MODULE PMP NO T.P.<br>STERILE | | Materials | Polycarbonate (PC)<br>Polyurethane resin<br>Stainless Steel<br>Silicone<br>Polyvinyl Chloride (PVC)<br>Polypropylene (PP)<br>High Density Polyethylene<br>(HDPE)<br>Low Density Polyethylene<br>(LDPE)<br>Thermoplastic Elastomer -<br>Styrene-Ethylene-Butylene-<br>Styrene (SEBS)<br>Hydrophobic Acrylic Copolymer<br>Acrylonitrile-Butadiene-Styrene<br>(ABS)<br>PolyTetraFluoroEthylene (PTFE) | unknown | Polycarbonate (PC)<br>Polyurethane resin<br>Stainless Steel<br>Silicone<br>Polyvinyl Chloride (PVC)<br>Polypropylene (PP)<br>High Density Polyethylene (HDPE)<br>Low Density Polyethylene (LDPE)<br>Thermoplastic Elastomer -<br>Styrene-Ethylene-Butylene-<br>Styrene (SEBS)<br>Hydrophobic Acrylic Copolymer<br>Acrylonitrile-Butadiene-Styrene<br>(ABS)<br>PolyTetraFluoroEthylene (PTFE) | | OXYGENATOR CONNECTIONS | | | | | VENOUS INLET: | 1/4" (6,35mm) | 1/4" (6,35mm) | 3/8" (9,53mm) | | ARTERIAL<br>OUTLET: | 1/4" (6,35mm) | 1/4" (6,35mm) | 3/8" (9,53mm) | | GAS INLET: | 1/4" (6,35mm) | 1/4" (6,35mm) | 1/4" (6,35mm) | | STANDARDS | | | | | BIOLOGICAL<br>STANDARDS: | ISO 10993-1 Biological<br>Evaluation of Medical Devices<br>Part 1: Evaluation and Testing; | ISO 10993-1 Biological Evaluation of<br>Medical Devices Part 1: Evaluation and<br>Testing; | ISO 10993-1 Biological Evaluation<br>of Medical Devices Part 1:<br>Evaluation and Testing; | | PRODUCT<br>SPECIFIC<br>STANDARDS: | Guidance for Cardiopulmonary<br>Bypass Oxygenators 510(k)<br>Submissions; Final Guidance for<br>Industry and FDA Staff,<br>November 13, 2000;<br>ISO 7199:2016 Cardiovascular<br>implants and artificial organs -<br>Blood-gas exchangers<br>(oxygenators); | Guidance for Cardiopulmonary Bypass<br>Oxygenators 510(k) Submissions; Final<br>Guidance for Industry and FDA Staff,<br>November 13, 2000 | Guidance for Cardiopulmonary<br>Bypass Oxygenators 510(k)<br>Submissions; Final Guidance for<br>Industry and FDA Staff, November<br>13, 2000; | {5}------------------------------------------------ As can be seen from the table in the underlined parts, the Indications for Use of the AMG PMP INFANT and the predicate devices (K151713, K141492) are fundamentally the same with only some additional details provided for the predicate devices that do not affect the intended use of the subject device. ### 7. Performance Data A program of design verification and validation testing was performed according to the standards "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, November 13, 2000"; and ISO 7199:2016 "Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)" . This design verification and validation testing and includes the following tests: - Blood cell damage ● - Gas transfer rate & pressure drop ● - Blood pathway integrity ● - Heat exchanger fluid pathway integrity ● - . Gas pathway integrity - Blood volume capacity (static priming volume) . - Residual blood volume . - Blood pathway connectors (tensile strength test) ● - Gas pathway connectors integrity (tensile strength test) ● - Heat exchanger fluid pathway connectors ● {6}------------------------------------------------ - Heat exchanger performance evaluation ● #### 8. Summary Results of these performance tests allow to demonstrate that the subject device AMG PMP INFANT met the safety and performance requirements as per its indication for use and that AMG PMP INFANT subject device is substantially equivalent with the LILLIPUT PMP predicate devices, proving that the AMG PMP INFANT is as safe, as effective, and performs as well as the LILLIPUT PMP.