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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.

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.

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Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration with a maximum flow rate of 3.0 l/min.

Device is intended for pediatric patients (BSA according following characteristics: 0.6 m2 < BSA < 1m2).

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is designed to manage the temperature of blood during surgical procedures requiring cardiopulmonary bypass (CPB) for periods lasting less than 6 hours.

The device is designed to:

• keep circulating blood at a specific temperature, depending on the type of surgery being performed;
• maintain blood/patient thermoregulation during the CPB;
• rewarm blood at the conclusion of the CPB in order to restore normothermic patient condition.

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W has been designed to be powered by heater-cooler systems that use

• Water, or
• Glycol-based solution

as Heat Transfer Fluid (HTF).

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The Inspire HCR and Inspire HCR DUAL cardiotomy reservoir are a device allowing suction blood recovery during extracorporeal circulation procedures, by providing blood collection and storage.

In addition, the device supports extracorporeal system priming and defoams and filters suctioned blood. The Inspire HCR must be used up to 6 hours or less.

The Inspire HCR and Inspire HCR DUAL cardiotomy reservoirs are single-use, non-toxic, non-pyrogenic and supplied sterile in individual packs.

They are made by clear rigid shell reservoir (hard shell reservoirs), with suction/vent inlet and accessory connectors on the lid, and outlet connector on the bottom. These devices integrate a defoaming body, a filter, and a storage capacity function.

They are devices allowing suction blood recovery during extracorporeal circulation procedures, by providing blood collection and storage. In addition, they support extracorporeal system priming, they defoam and filter suctioned blood. These cardiotomy reservoirs must be used up to 6 hours or less.

The Inspire HCR and Inspire HCR DUAL cardiotomy reservoir are the modified version of the hard-shell reservoirs of the Inspire 8 and 8F hollow fiber oxygenator with integrated hardshell reservoir (Inspire HVR) (K130433) and the Inspire 8F dual hollow fiber oxygenator with integrated arterial filter and dual chamber hardshell venous/cardiotomy reservoir (Inspire HVR DUAL) (K122844).

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HORIZON AF Plus is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. HORIZON AF Plus integrated arterial filter provides additional protection against air and solid emboli.

HORIZON AF Plus is intended to be used for 6 hours or less.

The HORIZON AF PLUS System (Model number: US5300) is composed of the HORIZON ADULT OXYGENATOR with Integrated Arterial Filter Plus (A.L. One AF Plus) and the Horizon cardiotomy/venous reservoir (CVR).

The HORIZON ADULT OXYGENATOR with Integrated Arterial Filter Plus is a microporous hollow-fibre membrane oxygenator consisting of a gas exchange module with an integrated heat exchanger and an integrated 38μm arterial filter that ensures arterial blood filtration with removal of microaggregates and microemboli.

HORIZON AF PLUS also has a hard-shell cardiotomy/venous reservoir (CVR) integrated with two cardiotomy filters, designed to allow venous drainage of the patient's blood, both through the hydrostatic load (height difference between the patient and the reservoir) and the vacuum-assisted venous drainage (VAVD) technique.

HORIZON AF PLUS inner contact surfaces are coated with A.G.I.L.E. (Advanced Generation Inert Layer E.C.C.) system, based on Phosphorylcoline (PC).

The device is single use, non-pyrogenic, supplied STERILE and individually packed.
The device is individually packed and sterilized by ethylene oxide.

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The Trilly Oxygenator with Integrated Arterial Filter and Hardshell Reservoir is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.

The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit. The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.

The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is compromised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 2.5-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post-Operative Chest Drainage Procedures.

Trilly Oxygenator with Integrated Arterial Filter and Hardshell Reservoir is for use with patients when the required blood flow will not exceed 3.5 L/min and within a BSA range of 1.28 to 1.46.

Trilly Oxygenator with Integrated Arterial Filter and Hardshell Reservoir can be used in procedures lasting up to 6 hours.

The TRILLY OXYGENATOR with Integrated Arterial Filter and Hardshell Reservoir ("Trilly AF") is a microporous hollow-fibre membrane oxygenator consisting of a gas exchange module with an integrated heat exchanger and an integrated 38μm arterial filter that ensures arterial blood filtration and facilitates air removal from emboli.

The device also has a hard-shell cardiotomy/venous reservoir (CVR) that can be connected to the aspirators, designed to allow venous drainage of the patient's blood, making it both the hydrostatic load offered by the difference in height between the patient and the reservoir and the vacuum-assisted technique (VAVD).

The device hard-shell cardiotomy/venous reservoir is fitted with a pressure relief valve.

The device inner contact surfaces are coated with A.G.I.L.E. (Advanced Generation Inert Layer E.C.C.) system, based on Phosphorylcholine (PC). The A.G.I.L.E. coating doesn't have any biological activity.

The device is single use, non-pyrogenic, supplied sterile and individually packed. It is sterilized by ethylene oxide.

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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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The Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.

The Quantum Perfusion Hybrid System is a system, including a blood reservoir consisting of an hardshell and softshell reservoir. The combination of defoaming bodies and filtering media of venous/vent and cardiotomy side allows both the filtration of debris and the retention of air bubbles. Product configuration includes, together with the Hybrid System, dedicated spare parts: an adapter 1/2" – 3/8"; a spare cap set; a blood sampling set. The device is intended to be used for periods up to six hours. The Quantum Perfusion Hybrid System is a sterile device with non-pyrogenic fluid pathways, sterilized by ethylene oxide, conceived for single use only and is not to be re-sterilized by the user; the device has a declared shelf life of 2 years.

The provided text is a 510(k) summary for a medical device (Quantum Perfusion Hybrid System) and primarily focuses on proving substantial equivalence to predicate devices through non-clinical testing. It does not contain information about a study proving device performance against specific acceptance criteria for an AI/software-driven device.

Therefore, I cannot provide the requested information, as the document details a traditional medical device submission, not one related to an AI/ML component with associated performance studies (MRMC, standalone algorithm, ground truth establishment, etc.). The document explicitly states: "No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate and reference devices." and "No animal studies have been performed except for mandatory biocompatibility tests...".

The non-clinical testing mentioned is focused on general device performance for a cardiopulmonary bypass blood reservoir, such as pressure drop, mechanical resistance, air handling, and filtration efficiency, verifying it meets established engineering requirements for this type of device, which are inherent to the device's design and function rather than a set of statistical acceptance criteria that would typically be associated with an AI/ML algorithm's performance.

To answer your request, a document detailing an AI/ML device would be needed, specifically discussing its performance study, acceptance criteria, test set details, ground truth, and potentially MRMC study results.

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Model BB811 and Model BB811-NS: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

Model BB841: Oxygenator with Integrated Arterial Filter: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. Cardiotomy/Venous Reservoir: The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811), Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841), and Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Non-Sterile) (B811-NS) are collectively referred to as the Affinity Fusion Oxygenator in the summary. The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Balance Biosurface bonded to the blood contacting surface of the device. The integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

The provided text discusses the Affinity Fusion Oxygenator and its acceptance criteria, specifically focusing on the addition of an alternate hollow fiber supplier.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

Biocompatibility Testing:

*Note on "Pressure Integrity": Devices conditioned only to factors significant for leaks (per Two Proportion statistical test).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the sample sizes for the test sets (number of oxygenator units tested) for design verification or biocompatibility. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The nature of the tests (engineering performance and biocompatibility) suggests these were primarily laboratory-based prospective tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable to the type of device and testing described. The "ground truth" for a medical device like an oxygenator is established through objective performance measurements and standardized biocompatibility tests, not subjective expert assessment as would be the case for image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving subjective human interpretation (e.g., radiology reads) to resolve discrepancies. The tests described here are objective performance and safety tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is an oxygenator, not an AI-powered diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is an oxygenator, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

The ground truth for this device is based on:

• Engineering specifications and standards: For performance characteristics like O2 Transfer, CO2 Transfer, Pressure Drop, Burst, Filtration Efficiency, etc. "PASS" implies meeting predefined, objective measurable criteria.
• International standards for biocompatibility (ISO 10993-1:2018): For tests like cytotoxicity, sensitization, genotoxicity, hemocompatibility, etc. "PASS" means meeting the established safety thresholds for these biological endpoints.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device that requires a training set. The "study" described is a series of laboratory-based design verification and biocompatibility tests.

9. How the ground truth for the training set was established:

This is not applicable, as there is no training set for this type of device.

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Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541);
The AFFINITY NT Integrated CVR Membrane Oxygenator with Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Indications for Use(541B)
The Affinity NT oxygenator with Balance biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. The Affinity NT cardiotomy/venous reservoir (CVR) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine CPB procedures up to 6 hours in duration.

The Affinity NT Oxygenator with /without Balance Biosurface is a sterile membrane Oxygenator with plasma resistant fiber. It is a single-use gas exchange device with integral stainless-steel heat exchanger. Models 541 and 541B include a cardiotomy/venous reservoir.

The Luer cap 1140008-503 that is the 'subject' of this special 510(k) serve as protection of the Luer Access Port. This port can be used to prime the circuit or connect to another support device with a luer connector.

This is a 510(k) summary for a medical device change, not a study proving device meets acceptance criteria. Here's a breakdown of why and what information is provided:

This document describes a "Special 510(k) submission" for a change in a small component (a luer cap) within an already cleared medical device (Affinity NT Oxygenator). It is not a standalone study proving the device meets general acceptance criteria for a new device. The purpose of this submission is to demonstrate that the change to the luer cap does not adversely affect the safety and effectiveness of the previously cleared device, maintaining substantial equivalence to the predicate.

Therefore, most of the requested information (sample sizes, expert consensus, MRMC studies, etc.) is not applicable or not provided in the context of this specific regulatory submission.

Here's how to address the prompt based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly define acceptance criteria in a quantitative table form for the overall device's performance. Instead, it focuses on demonstrating that the change to the luer cap does not negatively impact the device's functionality. The "acceptance criteria" for this specific change are implicitly tied to maintaining the original device's performance and safety.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not explicitly stated for specific tests related to the luer cap change. The document mentions "Risk-based testing and evaluations," suggesting a sample size appropriate for these specific tests, but the number is not provided.
• Data Provenance: Not specified. Given it's a regulatory submission by Medtronic, it's presumably internal testing conducted to support the change.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a technical validation of a component change, not an evaluation requiring expert clinical interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-enabled device or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the luer cap change, the "ground truth" is established through engineering and biological testing:

• Biocompatibility: Conformance to ISO 10993-1:2018 standards, which involves specific chemical and biological tests. The "ground truth" here is the pass/fail result based on laboratory analysis against these standards, leveraged from a previous clearance (K240534) for a higher-risk product.
• Functionality: Direct measurements and observations (dimensional comparison, torque removal, pressure integrity) against established engineering specifications.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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