KIDS Arterial Filters

{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 and 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 20, 2024 Sorin Group Italia S.r.l. Martina Carlini Regulatory Affairs specialist Via Statale 12 Nord, 86 Mirandola ( Modena), IT 41037 Italy Re: K242953 Trade/Device Name: KIDS Arterial Filters Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II Product Code: DTM Dated: September 25, 2024 Received: September 25, 2024 Dear Martina Carlini: 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 (the 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 available 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. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory {2}------------------------------------------------ assistance/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, Eric E. Richardson --S)/△ for 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K242953 Device Name KIDS Arterial Filters ## Indications for Use (Describe) The device is indicated for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The device is indicated to trap and remove gaseous emboliate debris that may be introduced through the arterial line. The device is indicated for use for 6 hours or less. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"><b>Prescription Use</b></span> (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"><b>Over-The-Counter Use</b></span> (21 CFR 801 Subpart C) | | <div style="display:inline-block; margin-right:5px;"><b>☑</b></div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block; margin-right:5px;">☐</div> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Below the logo is the tagline "Health innovation that matters" in a smaller, orange font. # 510(k) Summary (in accordance with 21 CFR 807.92) 510(k) Number: K242953 | Applicant Information<br>Applicant: | SORIN GROUP ITALIA S.R.L.<br>Via Statale 12 Nord, 86<br>Mirandola, MO 41037 Italy | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Contact Person: | Martina Carlini<br>Regulatory Affairs Specialist<br>Tel: +39 0535 29811<br>e-mail: martina.carlini@livanova.com | | Application Correspondent: | SORIN GROUP ITALIA S.R.L.<br>Via Statale 12 Nord, 86<br>Mirandola, MO 41047 Italy | | Contact Person: | Martina Carlini<br>Regulatory Affairs Specialist<br>Tel: +39 0535 29811<br>e-mail: martina.carlini@livanova.com | | Date Prepared: | September 25th 2024 | #### II. Subject Device Identification | Device Trade Name: | KIDS Arterial Filters | |-----------------------|------------------------------------------------------| | Classification Name: | Filter, blood, cardiopulmonary bypass, arterial line | | Regulation Number: | 21 CFR 870.4260 | | Product Code: | DTM | | Classification: | Class II | | Classification Panel: | Cardiovascular | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for LivaNova. The logo is purple and consists of the word "LivaNova" in a sans-serif font. Below the logo is the tagline "Health innovation that matters" in a smaller, orange font. The logo is simple and modern, and the colors are eye-catching. #### lll. Predicate Device The KIDS Arterial Filters are substantially equivalent to the following cleared predicate devices. Both modified and unmodified models have fundamental scientific technology and intended use: | | 510(k) Number: | K063255 | |-------------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------| | | Device Trade Name: | D130 PH.I.S.I.O DIDECO KIDS<br>NEONATAL ARTERIAL FILTER<br>WITH 40 MICRON SCREEN<br>PHOSPHORYLCHOLINE<br>COATED | | KIDS D130<br>(neonatal) | Classification Name: | Filter, blood,<br>cardiopulmonary bypass,<br>arterial line | | | Regulation Number: | 21 CFR 870.4260 | | | Product Code: | DTM | | | Classification: | Class II | | | Classification Panel: | Cardiovascular | | | | | | | 510(k) Number: | K072308 | | | Device Trade Name: | D131 PH.I.S.I.O DIDECO KIDS<br>INFANT ARTERIAL FILTER<br>WITH 40 MICRON SCREEN<br>PHOSPHORYLCHOLINE<br>COATED | | KIDS D131<br>(Infant) | Classification Name: | Filter, blood,<br>cardiopulmonary bypass,<br>arterial line | | | Regulation Number: | 21 CFR 870.4260 | | | Product Code: | DTM | | | Classification: | Class II | #### IV. Device Description KIDS Arterial Filters are single-use, non-toxic, no pyrogenic fluid path devices and supplied sterile and individually packaged. They are devices made of plastic material (mainly PVC) and a silicon filtering net and they are recommended for use in the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bypass. These filters are used to trap and remove gaseous emboli that may be introduced through the arterial line and they can be used up to 6 hours. The KIDS Arterial Filters are the modified version of the disposables currently marketed in the D130 PH.I.S.I.O. Dideco Kids Neonatal Arterial Filter (K063255) and the D131 PH.I.S.I.O. Dideco Kids Infant Arterial Filter (K072308). ## V. ## Indications for Use The device is indicated for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The device is indicated to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device is indicated for use for 6 hours or less. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for LivaNova, a medical technology company. The logo is purple and consists of the word "LivaNova" in a sans-serif font. Below the company name is the tagline "Health innovation that matters" in a smaller, orange font. The logo is simple and modern, and the colors are eye-catching. #### VI. Summary of Technical Characteristics The KIDS Arterial Filters have the same fundamental technological characteristics, principles of operation and control mechanisms as the unmodified devices. The tubing in the purge/recirculation line made of PVC materials were changed within the modified KIDS Arterial Filters in order to remove the diethylhexyl phthalate (DEHP) used as plasticizer currently present in the device. Moreover, the silicon formulation of the valve's diaphragm in the purge/recirculation line for KIDS Arterial Filters was changed. Additionally, some technical specifications for KIDS Arterial Filters were updated and tested to better reflect the state of the art of the devices. No other design changes have been made to the devices. The devices are ethylene oxide sterilized and have a non-pyrogenic fluid path. They are for single use only. #### VII. Non-Clinical Performance Data Sorin Group Italia S.r.l. has conducted extensive verification and validation testing of the KIDS Arterial Filters, as disposables used to trap and remove qaseous emboli that may be introduced through the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The KIDS Arterial Filters comply with all the applicable voluntary standards related to Arterial Filters. The devices passed all the testing in accordance with national and international standards. #### VIII. Clinical Performance Data No clinical testing was conducted in support of the KIDS Arterial Filters, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use. The non-clinical testing summarized in this submission supports the substantial equivalence of the subject devices with the predicate devices when used according to their intended use. #### IX. Statement of Substantial Equivalence Based on equivalent intended use and technological characteristics, as well as on equivalent performance testing, the KIDS Arterial Filters can be deemed to be substantially equivalent to their predicate devices: - the unmodified KIDS D130, cleared under K063255; - - । the unmodified KIDS D131, cleared under K072308; The KIDS Arterial Filters, as designed and manufactured, do not raise new questions reqarding safety and effectiveness as compared to their predicate devices and are determined to be substantially equivalent to their predicate devices listed above.