(435 days)
VT75-E1
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 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.
VT75-E2
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 and to measure blood pressure 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.
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.
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 flow rate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator. 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.
The provided document, K231982, is a 510(k) Premarket Notification for a medical device (Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2). This document details the device's technical specifications, intended use, and comparison to predicate devices, along with performance data regarding non-clinical testing.
However, it does not describe acceptance criteria, nor a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device. The document explicitly states:
- "No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate devices."
- "No animal studies have been performed except for mandatory biocompatibility tests according to International Standard ISO 10993-1:2018".
The performance data mentioned (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) are engineering and functional tests relevant to a blood oxygenator, not the kind of AI/ML performance metrics typically found in documents describing acceptance criteria for an AI-powered diagnostic or assistive device.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as it pertains to an AI/ML device, because this document is for a non-AI/ML medical device and does not contain such information.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 12, 2024
Qura S.r.1. % Raffaella Tommasini QA&RA Director Spectrum Medical s.r.l. Via di Mezzo, 23 Mirandola, Modena 41037 Italy
Re: K231982
Trade/Device Name: Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II Product Code: DTZ Dated: August 7, 2024 Received: August 7, 2024
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 (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/cdrb/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.
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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 mediation-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
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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,
Nicole M. Gillette -S
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
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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&RA Director – Spectrum Medical S.r.l. |
| Phone: | +39 0535 1803050 |
| e-mail: | raffaella.tommasini@spectrummedical.com |
| Fax: | +39 0535 1803051 |
| Date Summary Prepared: | December 22th, 2023 |
ll. DEVICE
| Proprietary Name: | Quantum Perfusion Blood Oxygenator VT75-E1 |
|---|---|
| Quantum Perfusion Blood Oxygenator VT75-E2 | |
| 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 (CirculatorySupport, Structural and Vascular Devices) |
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Image /page/5/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is written in blue, followed by a red line that resembles a heartbeat. The word "Medical" is written in blue after the red line.
III. PREDICATE AND REFERENCE DEVICES
| Predicate Device: | |
|---|---|
| Proprietary Name: | Medos Hilite Pediatric Oxygenator 2400 LT |
| Registered Establishment Name: | GISH BIOMEDICAL INC |
| Regulation Number: | 870.4350 |
| Common Name: | Oxygenator |
| Classification Name: | Cardiopulmonary Bypass Oxygenator |
| Regulatory Class: | II |
| Product Code: | DTZ |
| 510(k) Number: | K090450 |
Reference Device:
| Proprietary Name: | Quantum Perfusion Blood Oxygenators ECC |
|---|---|
| Registered Establishment Name: | Spectrum Medical S.r.l. |
| Regulation Number: | 870.4350 |
| Common Name: | Oxygenator |
| Classification Name: | Cardiopulmonary Bypass Oxygenator |
| Regulatory Class: | II |
| Product Code: | DTZ |
| 510(k) Number: | K203424 |
IV. 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.
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
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Image /page/6/Picture/0 description: The image shows the logo for Spectrum Medical. The text "Spectrum Medical" is written in blue font. A red line in the shape of an EKG reading is placed between the two words.
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 flow rate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator. 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 phosphorylcholinebased biocompatible coating.
INTENDED USE / INDICATIONS FOR USE V.
VT75-E1
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 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.
VT75-E2
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 and to measure blood pressure 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.
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Image /page/7/Picture/0 description: The image shows the logo for Spectrum Medical. The word "Spectrum" is in blue, followed by a red heartbeat symbol. The word "Medical" is in blue and follows the heartbeat symbol.
www.spectrummedical.com
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES VI.
| Device | Proposed Device - Quantum Perfusion BloodOxygenatorSpectrum Medical S.r.l. | Predicate Device - Medos Hilite PediatricOxygenator 2400 LTGISH BIOMEDICAL INC | Reference Device -Quantum PerfusionBlood Oxygenator ECCSpectrum MedicalS.r.l. | Device | Proposed Device - Quantum Perfusion BloodOxygenatorSpectrum Medical S.r.l. | Predicate Device - Medos Hilite PediatricOxygenator 2400 LTGISH BIOMEDICAL INC | Reference Device -Quantum PerfusionBlood Oxygenator ECCSpectrum MedicalS.r.l. |
|---|---|---|---|---|---|---|---|
| Name | Quantum Perfusion Blood Oxygenator VT75-E1Quantum Perfusion Blood Oxygenator VT75-E2 | Medos Hilite Pediatric Oxygenator 2400LT | Quantum PerfusionBlood Oxygenator ECCVT160-E1Quantum PerfusionBlood Oxygenator ECCVT160-E2Quantum PerfusionBlood Oxygenator ECCVT200-E1Quantum PerfusionBlood Oxygenator ECCVT200-E2 | contact with blood aretreated with aphosphorylcholine-based biocompatiblecoating. | |||
| 510(k) Number | K231982 | K090450 | K203424 | Regulation # | 870.4350 | 870.4350 | 870.4350 |
| Devicedescription | The Quantum Perfusion Blood Oxygenator(acronym VT-E) diffusion membrane device isdesigned to oxygenate blood and removecarbon dioxide from venous blood duringcardiac surgical procedures requiringcardiopulmonary bypass for a maximumduration of 6 hours. | The MEDOS HILITE 2400 LT Hollow FiberOxygenators consist of a hollow fibermembrane oxygenator andextracorporeal heat exchanger. TheMEDOS HILITE 2400 LT hollow fibremembrane consists of aPolymethylpentene gas plasma tight mat.The unique mat design increases theinteraction between blood and gas. | TheQuantumPerfusionBloodOxygenator ECC(acronym VT-E)diffusion membranedevice is designed tooxygenate blood andremove carbon dioxide | Regulation Name | Cardiopulmonary Bypass Oxygenator | Cardiopulmonary Bypass Oxygenator | CardiopulmonaryBypass Oxygenator |
| Device | Proposed Device - Quantum Perfusion BloodOxygenatorSpectrum Medical S.r.l. | Predicate Device – Medos Hilite PediatricOxygenator 2400 LTGISH BIOMEDICAL INC | Reference Device -Quantum PerfusionBlood Oxygenator ECCSpectrum MedicalS.r.l. | Product Code | DTZ | DTZ | DTZ |
| Blood enters the oxygenator through the bloodinlet connector, flows through a bloodchamber, touching the outer surface of hollowfibres membrane; while the sweep gas flowsinto the hollow fibre membrane. The hollowfibres are made of Polymethylpentene (PMP).In this chamber, carbon dioxide moves from theblood to the gas compartment, while oxygenenters into the red blood cells. Then, bloodexits the oxygenator with the desired level ofoxygen content and saturation, and carbondioxide content. Sweep gas composition andflow rate are used to control saturation, andoxygen and carbon dioxide content of blood atthe outlet of the oxygenator. The device is non-toxic, non-pyrogenic, sterilized by ethyleneoxide and packaged in a single box. All thedevice surfaces in contact with blood aretreated with a phosphorylcholine-basedbiocompatible coating. | creating a highly efficient bloodoxygenator. The heat exchanger consistsof a polyester non-porous hollow fiberconfigured heat exchanger as the primaryelement to affect heat exchange. Thiselement is encased by a polycarbonatehousing, which directs the blood aroundthe outside of the fibres while water flowthrough the inner lumen of the fibres andtherefore effects heat exchange whileminimizing priming volume. | from venous bloodduring cardiac surgicalprocedures requiringcardiopulmonarybypass for a maximumduration of 6 hours.Blood enters theoxygenator throughthe blood inletconnector, flowsthrough a bloodchamber, touching theouter surface of hollowfibres membrane;while the sweep gasflows into the hollowfibre membrane. Thehollow fibres are madeof Polymethylpentene(PMP). In this chamber,carbon dioxide moves from the blood to the | Classification | II | II | II | |
| Device | Proposed Device - Quantum Perfusion Blood OxygenatorSpectrum Medical S.r.l. | Predicate Device – Medos Hilite PediatricOxygenator 2400 LTGISH BIOMEDICAL INC | Reference Device -Quantum Perfusion Blood Oxygenator ECCSpectrum Medical S.r.l. | Indication forUse | VT75-E1Quantum Perfusion Blood Oxygenator VT75-E1is a diffusion membrane oxygenator, designedto oxygenate and remove carbon dioxide fromvenous blood during cardiac surgery requiringcardiopulmonary bypass and to measure bloodpressure and temperature during theprocedure. The device is limited to 6 hours touse.VT75-E2Quantum Perfusion Blood Oxygenator VT75-E2is a diffusion membrane oxygenator, designedto oxygenate and remove carbon dioxide from | The hilite 2400 LT is a hollow fibremembrane oxygenator is indicated for usein procedures requiring theextracorporeal oxygenation of and carbondioxide removal from human blood. The2400 LT is a paediatric oxygenatorsintended for use at blood flow rates of 0.5to 2.4 litres per minute for periods of up tosix hours. | VT200-E1 and VT160-E1Quantum PerfusionBlood Oxygenator ECC(VT-E1) is a diffusionmembraneoxygenator, designedto oxygenate andremove carbon dioxidefrom venous bloodduring cardiac surgeryrequiringcardiopulmonary |
| gas compartment,while oxygen entersinto the red blood cells.Then, blood exits theoxygenator with thedesired level of oxygencontent andsaturation, and carbondioxide content.Sweep gas compositionand flow rate are usedto control saturation,and oxygen and carbondioxide content ofblood at the outlet ofthe oxygenator. Thedevice is non-toxic,non-pyrogenic,sterilized by ethyleneoxide and packaged ina single box. All thedevice surfaces in |
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www.spectrummedical.com
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SpectrumMedical
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SpectrumMedical
www.spectrummedical.com
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SpectrumMedical
| Device | Proposed Device - Quantum Perfusion BloodOxygenatorSpectrum Medical S.r.l. | Predicate Device - Medos Hilite PediatricOxygenator 2400 LTGISH BIOMEDICAL INC | Reference Device -Quantum PerfusionBlood Oxygenator ECCSpectrum MedicalS.r.l. |
|---|---|---|---|
| cardiopulmonary bypass and to measure bloodpressure during the procedure. The device islimited to 6 hours of use. | blood pressure andtemperature duringthe procedure. Thedevice is limited to 6hours to use.VT200-E2 and VT160-E2Quantum PerfusionBlood Oxygenator ECC(VT-E2) is a diffusionmembraneoxygenator, designedto oxygenate andremove carbon dioxidefrom venous bloodduring cardiac surgeryrequiringcardiopulmonarybypass and to measureblood pressure duringthe procedure. Thedevice is limited to 6hours of use. | ||
| Targetpopulation | Paediatric(0.6 m² < BSA < 1 m²) | Paediatric | Adult |
| Device | Proposed Device - Quantum Perfusion BloodOxygenatorSpectrum Medical S.r.l. | Predicate Device - Medos Hilite PediatricOxygenator 2400 LTGISH BIOMEDICAL INC | Reference Device -Quantum PerfusionBlood Oxygenator ECCSpectrum MedicalS.r.l. |
| Target User | Perfusionist | Perfusionist | Perfusionist |
| Biocompatibilityrequirements | In compliance with ISO 10993 series | In compliance with ISO 10993 series | In compliance with ISO10993 series |
| Main ContactingMaterials | Fiber: Polymethylpentene | Fiber: Polymethylpentene | Fiber:Polymethylpentene |
| Sensor OperatingPressure Range | 0 to 800 mmHg | N/A | 0 to 800 mmHg |
| SensorSensitivity | 5μV/V/mmHg ± 1% | N/A | 5μV/V/mmHg ± 1% |
| Sensor Accuracy | 0 to 50 mmHg: ±1 mmHg + 1% of reading | N/A | 0 to 50 mmHg: ±1mmHg + 1% of reading |
| 50 to 800 mmHg: ±1 mmHg + 3% of reading | 50 to 800 mmHg: ±1mmHg + 3% of reading | ||
| SensorOverpressureProtection | -400 to + 6464 mmHg | N/A | -400 to + 6464 mmHg |
| Blood sideConnector Type | 1/4" (9.525mm) | 1/4" (9.525mm) | 3/8" (9.525mm) |
| Blood flow range[I/min] | 0.5 - 2.4 | 0.5 - 2.4 | 0.5 - 5 |
| Max pressuredrop @ max flowrate [mmHg] | 80 | 150 | 80 |
| Device | Proposed Device - Quantum Perfusion BloodOxygenatorSpectrum Medical S.r.l. | Predicate Device - Medos Hilite PediatricOxygenator 2400 LTGISH BIOMEDICAL INC | Reference Device -Quantum PerfusionBlood Oxygenator ECCSpectrum MedicalS.r.l. |
| Exchange surface[m²] | $0.8 \pm 0.02 \text{ m}^2$ | $0.65 \text{ m}^2$ | $1.5\pm0.05 \text{ m}^2$ |
| Priming Volume[ml] | $75 \pm 5$ | 95 | $145 \pm 10 \text{ ml}$ |
| O2 Gas Transfer[mlO2/min]@ max flow rate(QBlood:Qgas=1:1) | ≥120 | ≥120 | ≥250 |
| CO2 Gas Transfer[mlCO2/min]@ max flow rate(QBlood:Qgas=1:1) | ≥96 | ≥96 | ≥200 |
| Single-use | Yes | Yes | Yes |
| Sterile Condition | Sterile | Sterile | Sterile |
| SterilizationMethod | EtO sterilization process | EtO sterilization process | EtO sterilizationprocess |
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SpectrumMedical
www.spectrummedical.com
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SpectrumMedical
www.spectrummedical.com
Table 1 – Comparative Data with Predicate and Reference Devices
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SpectrumMedical
Spectrum Medical S.r.l. Via di Mezzo. 23 41037 Mirandola (MO) FAX: +39 0535 1803051
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. -
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 nonclinical testing, the Quantum Perfusion Blood Oxygenator devices, VT75-E1 and VT75-E2, have been demonstrated to be appropriate for the intended use and are considered substantially equivalent to predicate device, Medos Hilite Pediatric Oxygenator 2400 LT (K090450) and reference Spectrum Medical S.r.l own marketed Quantum Perfusion Blood Oxygenator ECC devices (K203424).
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
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.(b)
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.”