Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);

K240934 · Spectrum Medical S.R.L. · DTZ · Mar 12, 2026 · Cardiovascular

Device Facts

Record IDK240934
Device NameQuantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);
ApplicantSpectrum Medical S.R.L.
Product CodeDTZ · Cardiovascular
Decision DateMar 12, 2026
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.4350
Device ClassClass 2
AttributesTherapeutic, Pediatric

Intended Use

Quantum Perfusion Blood Oxygenator VT160-E3 and VT200-E3 are diffusion membrane oxygenators, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The devices are limited to 6 hours of use. Devices are intended for adult patients. Quantum Perfusion Blood Oxygenator VT75-E3 is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use. Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m2 to 1 m2.

Device Story

Diffusion membrane oxygenator; oxygenates venous blood; removes carbon dioxide; measures blood pressure and temperature. Blood flows through chamber over hollow fibers (PMP); sweep gas flows inside fibers; gas exchange occurs across membrane. Embedded sensor in blood outlet measures pressure/temperature. Used in cardiac surgery; operated by perfusionist. Output provides oxygenated blood to patient; sensor data informs perfusionist of patient status during bypass. Benefits include maintenance of gas exchange and monitoring of physiological parameters during surgery.

Clinical Evidence

No clinical data included. Substantial equivalence supported by non-clinical bench testing: gas transfer performance, temperature/pressure sensor verification, mechanical blood cell damage, pressure drop, mechanical integrity, connector resistance, coating durability, air handling, EMC, and electrical safety.

Technological Characteristics

Diffusion membrane oxygenator; PMP hollow fibers; phosphorylcholine-based biocompatible coating. Materials: PMP, Tritan, Polycarbonate, silicone gel, UV adhesive, Parylene. Integrated pressure/temperature sensor. Sterilized by EtO. Connectivity: Embedded sensor for monitoring. Dimensions/flow: VT200-E3 (1-7 L/min), VT160-E3 (0.5-5 L/min), VT75-E3 (0.5-2.4 L/min).

Indications for Use

Indicated for adult patients (VT160-E3, VT200-E3) and pediatric patients with BSA 0.6-1.0 m2 (VT75-E3) undergoing cardiac surgery requiring cardiopulmonary bypass for up to 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION March 12, 2026 Spectrum Medical S.R.L. Raffaella Tommasini QA&amp;RA Director Via Di Mezzo, 23 Mirandola, MO 41037 Italy Re: K240934 Trade/Device Name: Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3) Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II Product Code: DTZ Dated: June 24, 2025 Received: June 27, 2025 Dear Raffaella Tommasini: 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} K240934 - Raffaella Tommasini Page 2 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the Medical Device File (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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K240934 - Raffaella Tommasini Page 3 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, Kathleen M. Grunder -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} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K240934 Device Name Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); Quantum Perfusion Blood Oxygenator VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT160-E3 (VT160-E3) Indications for Use (Describe) Quantum Perfusion Blood Oxygenator VT75-E3 is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use. Devices are intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m2 to 1 m2. Quantum Perfusion Blood Oxygenator VT160- E3 and VT200-E3 are a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The devices are limited to 6 hours of use. Devices are intended for adult patients. 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." {4} Spectrum Medical Spectrum Medical S.r.l. Via di Mezzo, 23 41037 Mirandola (MO) Tel: +39 0535 1803050 FAX: +39 0535 1803051 www.spectrummedical.com K240934 # 510(K) SUMMARY ## I. SUBMITTER Submitter Name: Spectrum Medical S.r.l. Submitter Address: Via di Mezzo, 23 41037 Mirandola (MO) Italy Contact Person: Raffaella Tommasini, QA&amp;RA Director – Spectrum Medical S.r.l. Phone: +39 0535 1803050 e-mail: raffaella.tommasini@spectrummedical.com Fax: +39 0535 1803051 Date Summary Prepared: March 12th, 2026 ## II. DEVICE Proprietary Name: Quantum Perfusion Blood Oxygenator VT75-E3 Quantum Perfusion Blood Oxygenator VT160-E3 Quantum Perfusion Blood Oxygenator VT200-E3 Common Name: Oxygenator Classification Name: Oxygenator, Cardiopulmonary Bypass Regulatory Class: II Product Code: DTZ Panel: Cardiovascular Devices, Office of Health Technology 2 (OHT2) / Division of Health Technology 2 B (Circulatory Support, Structural and Vascular Devices) Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 – Email: info.ITA@spectrummedical.com {5} Spectrum Medical Spectrum Medical S.r.l. Via di Mezzo, 23 41037 Mirandola (MO) Tel: +39 0535 1803050 FAX: +39 0535 1803051 www.spectrummedical.com # III. PREDICATE AND REFERENCE DEVICES ## Predicate Device Proprietary Name: Quantum Perfusion Blood Oxygenator VT160-E1 Quantum Perfusion Blood Oxygenator VT200-E1 Registered Establishment Name: Spectrum Medical s.r.l. Regulation number: 870.4350 Common Name: Oxygenator Classification Name: Oxygenator, Cardiopulmonary Bypass Regulatory Class: II Product Code: DTZ Panel: Cardiovascular Devices, Office of Health Technology 2 (OHT2) / Division of Health Technology 2 B (Circulatory Support, Structural and Vascular Devices) 510(k) Number: K203424 ## Reference Device Proprietary Name: Quantum Perfusion Blood Oxygenator VT75-E1 Registered Establishment Name: Spectrum Medical s.r.l. Regulation number: 870.4350 Common Name: Oxygenator Classification Name: Oxygenator, Cardiopulmonary Bypass Regulatory Class: II Product Code: DTZ Panel: Cardiovascular Devices, Office of Health Technology 2 (OHT2) / Division of Health Technology 2 B (Circulatory Support, Structural and Vascular Devices) 510(k) Number: K231982 Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 - Email: info.ITA@spectrummedical.com {6} Spectrum Medical Spectrum Medical S.r.l. Via di Mezzo, 23 41037 Mirandola (MO) Tel: +39 0535 1803050 FAX: +39 0535 1803051 www.spectrummedical.com ## IV. DEVICE DESCRIPTION Quantum Perfusion Blood Oxygenator (acronym VT-E) diffusion membrane devices are designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of hollow fibers membrane; while the sweep gas flows into the hollow fiber membrane. The hollow fibers are made of Polymethylpentene (PMP). In this chamber, carbon dioxide moves from the blood to the gas compartment, while oxygen enters into the red blood cells. Then, blood exits the oxygenator with the desired level of oxygen content and saturation, and carbon dioxide content. Sweep gas composition and flowrate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator. A sensor component is embedded in the Blood OUT connector of the oxygenator, to measure blood pressure and temperature during the procedure. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating. ## V. INTENDED USE / INDICATIONS FOR USE ### VT160-E3 and VT200-E3 Quantum Perfusion Blood Oxygenator VT160-E3 and VT200-E3 are diffusion membrane oxygenators, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The devices are limited to 6 hours of use. Devices are intended for adult patients. ### VT75-E3 Quantum Perfusion Blood Oxygenator VT75-E3 is diffusion membrane oxygenators, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use. Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m². Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 - Email: info.ITA@spectrummedical.com {7} Spectrum Medical Spectrum Medical S.r.l. Via di Mezzo, 23 41037 Mirandola (MO) Tel: +39 0535 1803050 FAX: +39 0535 1803051 www.spectrummedical.com VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | Device | Proposed Device – Quantum Perfusion Blood Oxygenator (VT200-E3/VT160-E3) | Proposed Device – Quantum Perfusion Blood Oxygenator (VT75-E3) | Predicate Device – Quantum Perfusion Blood Oxygenator (K203424) | Reference device – Quantum Perfusion Blood Oxygenator (K231982) | | --- | --- | --- | --- | --- | | Name | Quantum Perfusion Blood Oxygenator VT200-E3 Quantum Perfusion Blood Oxygenator VT160-E3 | Quantum Perfusion Blood Oxygenator VT75-E3 | Quantum Perfusion Blood Oxygenator VT200-E1 Quantum Perfusion Blood Oxygenator VT160-E1 | Quantum Perfusion Blood Oxygenator VT75-E1 | | 510(k) Number | K240934 | | K203424 | K231982 | | Device description | The Quantum Perfusion Blood Oxygenator (acronym VT-E) diffusion membrane device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. A sensor component is embedded in the Blood OUT connector of the oxygenator, to measure blood pressure and | The Quantum Perfusion Blood Oxygenator (acronym VT-E) diffusion membrane device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. A sensor component is embedded in the Blood OUT connector of the oxygenator, to measure blood pressure and | The Quantum Perfusion Blood Oxygenator (acronym VT-E) diffusion membrane device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with blood are treated | The Quantum Perfusion Blood Oxygenator (acronym VT-E) diffusion membrane device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with blood are | Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 - Email: info.ITA@spectrummedical.com {8} Spectrum Medical Spectrum Medical S.r.l. Via di Mezzo, 23 41037 Mirandola (MO) Tel: +39 0535 1803050 FAX: +39 0535 1803051 www.spectrummedical.com | Device | Proposed Device – Quantum Perfusion Blood Oxygenator (VT200-E3/VT160-E3) | Proposed Device – Quantum Perfusion Blood Oxygenator (VT75-E3) | Predicate Device – Quantum Perfusion Blood Oxygenator (K203424) | Reference device - Quantum Perfusion Blood Oxygenator (K231982) | | --- | --- | --- | --- | --- | | | temperature during the procedure. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating. | temperature during the procedure. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating. | with a phosphorylcholine-based biocompatible coating. | treated with a phosphorylcholine-based biocompatible coating. | | Regulation # | 870.4350 | 870.4350 | 870.4350 | 870.4350 | | Regulation Name | Cardiopulmonary Bypass Oxygenator | Cardiopulmonary Bypass Oxygenator | Cardiopulmonary Bypass Oxygenator | Cardiopulmonary Bypass Oxygenator | | Product Code | DTZ | DTZ | DTZ | DTZ | | Classification | II | II | II | II | | Indication for Use | Quantum Perfusion Blood Oxygenator VT160-E3 and VT200-E3 are diffusion membrane oxygenators, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring | Quantum Perfusion Blood Oxygenator is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass | Quantum Perfusion Blood Oxygenator VT160-E1 and VT200-E1 are diffusion membrane oxygenators, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass | Quantum Perfusion Blood Oxygenator is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass | Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 - Email: info.ITA@spectrummedical.com {9} Spectrum Medical Spectrum Medical S.r.l. Via di Mezzo, 23 41037 Mirandola (MO) Tel: +39 0535 1803050 FAX: +39 0535 1803051 www.spectrummedical.com | Device | Proposed Device – Quantum Perfusion Blood Oxygenator (VT200-E3/VT160-E3) | | Proposed Device – Quantum Perfusion Blood Oxygenator (VT75-E3) | | Predicate Device – Quantum Perfusion Blood Oxygenator (K203424) | | Reference device - Quantum Perfusion Blood Oxygenator (K231982) | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The devices are limited to 6 hours of use. | | and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use. | | cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The devices are limited to 6 hours of use. | | and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use. | | | Target population | Adult patients | | Paediatric (0,6 m² < BSA < 1m²) | | Adult patients | | Paediatric (0,6 m² < BSA < 1m²) | | | Target User | Perfusionist | | Perfusionist | | Perfusionist | | Perfusionist | | | Biocompatibility requirements | In compliance with ISO 10993 series | | In compliance with ISO 10993 series | | In compliance with ISO 10993 series | | In compliance with ISO 10993 series | | | Main Contacting Materials | Polymethylpentene Phosphorylcholine Tritan Polycarbonate Silicone-based protective gel Thermistor UV adhesive Parylene | | Polymethylpentene Phosphorylcholine Tritan Polycarbonate Silicone-based protective gel Thermistor UV adhesive Parylene | | Polymethylpentene Phosphorylcholine Tritan Polycarbonate Silicone-based protective gel Gold | | Polymethylpentene Phosphorylcholine Tritan Polycarbonate Silicone-based protective gel Thermistor UV adhesive Parylene | | | Sensor Operating Pressure Range | 0 to 800 mmHg | | 0 to 800 mmHg | | 0 to 800 mmHg | | 0 to 800 mmHg | | | Pressure Sensor Accuracy | 0 to 50 mmHg | ± (10 mmHg) | 0 to 50 mmHg | ± (10 mmHg) | 0 to 50 mmHg | ± (10 mmHg) | 0 to 50 mmHg | ± (10 mmHg) | Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 - Email: info.ITA@spectrummedical.com {10} Spectrum Medical Spectrum Medical S.r.l. Via di Mezzo, 23 41037 Mirandola (MO) Tel: +39 0535 1803050 FAX: +39 0535 1803051 www.spectrummedical.com | Device | Proposed Device – Quantum Perfusion Blood Oxygenator (VT200-E3/VT160-E3) | | Proposed Device – Quantum Perfusion Blood Oxygenator (VT75-E3) | | Predicate Device – Quantum Perfusion Blood Oxygenator (K203424) | | Reference device - Quantum Perfusion Blood Oxygenator (K231982) | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 50 to 800 mmHg | ± (8.5 mmHg + 3% of reading) | 50 to 800 mmHg | ± (8.5 mmHg + 3% of reading) | 50 to 800 mmHg | ± (8.5 mmHg + 3% of reading) | 50 to 800 mmHg | ± (8.5 mmHg + 3% of reading) | | Sensor Operating Temperature Range | 30 – 40 °C | | 30 – 40 °C | | 0 to 42 ° | | 0 to 42 °C | | | Temperature Sensor Accuracy | ± 1 °C | | ± 1 °C | | ± 1.5% | | ± 1.5% | | | Blood side Connector Type | 3/8” | | 1/4” | | 3/8” | | 1/4” | | | Blood Flow Rate [l/min] | VT200-E3: 1-7 VT160-E3: 0.5-5 | | 0.5 – 2.4 | | VT200-E1: 1-7 VT160-E1: 0.5-5 | | 0.5 – 2.4 | | | Exchange surface [m²] | VT200-E3: 1.8±0.05 VT160-E3: 1.5±0.05 | | 0.8 ± 0.05 | | VT200-E1: 1.8±0.05 VT160-E1: 1.5±0.05 | | 0.8 ± 0.05 | | | Priming Volume [ml] | VT200-E3: 185±10 VT160-E3: 145±10 | | 75 ± 5 | | VT200-E1: 185±10 VT160-E1: 145±10 | | 75 ± 5 | | | O2 Gas Transfer [mlO2/min] @ max flow rate | VT200-E3: ≥ 350 VT160-E3: ≥ 250 | | ≥ 120 | | VT200-E1: ≥ 350 VT160-E1: ≥ 250 | | ≥ 120 | | | CO2 Gas Transfer [mlCO2/min] @ max flow rate (QBlood:Qgas=1:1) | VT200-E3: ≥ 280 VT160-E3: ≥ 200 | | ≥96 | | VT200-E1: ≥ 280 VT160-E1: ≥ 200 | | ≥96 | | | Single-use | Yes | | Yes | | Yes | | Yes | | | Sterile Condition | Sterile | | Sterile | | Sterile | | Sterile | | | Sterilization Method | EtO sterilization | | EtO sterilization | | EtO sterilization | | EtO sterilization | | Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 - Email: info.ITA@spectrummedical.com {11} Spectrum Medical Spectrum Medical S.r.l. Via di Mezzo, 23 41037 Mirandola (MO) Tel: +39 0535 1803050 FAX: +39 0535 1803051 www.spectrummedical.com # VII. PERFORMANCE DATA ## NON-CLINICAL TESTING The following activities were performed to demonstrate product safety and effectiveness, considering the proposed change and related impact: - Gas transfer performance; - Temperature probe and Pressure sensor verification; - Mechanical Blood Cell Damage; - Device pressure Drop; - Mechanical Integrity; - Mechanical resistance of connectors; - Coating coverage and durability; - Air handling. Furthermore, Electromagnetic Compatibility (EMC) and Electrical Safety (ES) testing have been conducted according to applicable standards. ## ANIMAL TESTING No animal studies have been performed except for mandatory biocompatibility tests according to International Standard ISO 10993-1:2018 [Recognition Nr. 2-258] and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". ## CLINICAL TESTING No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate devices. # VIII. CONCLUSIONS Based on the indications for use, main technological characteristics and results of non-clinical testing, the Quantum Perfusion Blood Oxygenator devices, VT75-E3, VT160-E3 and VT200-E3, have been demonstrated to be appropriate for the intended use and are considered substantially equivalent to predicate and reference devices Quantum Perfusion Blood Oxygenator devices, respectively cleared by K203424 and K231982. Spectrum Medical S.r.l. - Via di Mezzo, 23 - 41037 Mirandola (MO) P.IVA/VAT 03663360364 - Email: info.ITA@spectrummedical.com
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