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510(k) Data Aggregation
(28 days)
The (X-Coated) Capiox® SX25 and SX18 Hollow Fiber Oxygenators with/without Detachable Hardshell Reservoirs are used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery for periods up to 6 hours. The integral heat exchanger is used to warm or cool blood or perfusion fluid as it flows through the device. The (detachable) hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised 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 Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement. The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass. (The X-Coating™ is a polymer coating that is applied to blood contacting surfaces of the oxygenator to reduce the adhesion of platelets to the surfaces of the device.)
The Capiox® Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line. And the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal. The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return blood to the patient for blood volume replacement. The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass. The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device. The device may be used for procedures lasting up to 6 hours.
The modified and predicate Capiox SX Oxygenator utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion. The modified and predicate Capiox SX Oxygenator has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood. With respect to the filtration of blood, the modified and predicate Capiox Hardshell Reservoir relies upon mechanical entrapment of particulates and emboli within the filter media as a means to remove those particulates from the blood. The design of the modified Capiox SX oxygenator device is unaffected by the changes being incorporated at this time. The subject of this Special 510(k) is a modification being made to the Hardshell Reservoir. The design of the Hardshell Reservoir component remains identical to the design of the original reservoir that was cleared by FDA with (K961000, K962667, K993772, and K013526) except that a positive pressure relief valve will be included in the lid of the reservoir. The intent of the relief valve is to eliminate excessive pressure that could accumulate in a reservoir during bypass procedures. The materials that are used in the construction of the CAPIOX® SX Oxygenator/Hardshell Reservoir may include, but are not limited to, nylon, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene, and X-Coating™.
The provided text describes a 510(k) summary for a modified medical device, the Capiox® SX Oxygenator and Hardshell Reservoir. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device's efficacy through extensive clinical studies against specific performance criteria.
Therefore, many of the requested categories for acceptance criteria and studies (like sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable or not provided in this type of regulatory submission. This document describes in-vitro performance evaluations for substantial equivalence, not a study to establish clinical efficacy or AI performance.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with explicit acceptance criteria and corresponding reported performance metrics in the format of a typical efficacy study. Instead, it lists performance evaluations conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" is implied to meet the expectations established by the predicate devices.
| Performance Evaluation Category | Implied Acceptance Basis |
|---|---|
| Assessment of Reservoir Pressure during Simulated Bypass Procedures | Device pressure performance during simulated bypass procedures should be equivalent to or within acceptable limits compared to the predicate device, especially with the new pressure relief valve. |
| Positive and Negative Pressure Testing of the Reservoir | The modified reservoir, including the new valve, must withstand and perform as expected under both positive and negative pressure conditions, comparable to the predicate. |
| Pressure Relief Valve performance following application of vacuum to the reservoir | The pressure relief valve must function correctly to relieve pressure when vacuum is applied, as designed. |
| Pressure Relief Valve-to-Reservoir Interface Testing | The interface between the new valve and the reservoir must be secure and functional. |
| Usability Testing | The device, with the modification, should be usable for its intended purpose without introducing new usability issues. |
| Sterilization Assessment | The device must remain sterilizable after modification. |
| Shock Drop and Vibration Testing | The device must withstand typical transportation and handling stresses; performance should be comparable to the predicate. |
| Artificial Conditioning to Shelf-Life of the product | The modification should not adversely affect the product's shelf-life under simulated aging conditions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The evaluations mentioned are primarily in-vitro tests and assessments, not typically described with "test set" sample sizes in the context of clinical data or AI model evaluation.
- Data Provenance: In-vitro performance evaluations. No information on country of origin or whether it's retrospective/prospective in a clinical sense. These are laboratory-based engineering tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a 510(k) submission for a modified medical device, not a study evaluating an AI algorithm's diagnostic performance requiring expert-established ground truth. The "ground truth" here is the expected physical and functional performance of the device based on engineering principles and comparison to predicate devices.
4. Adjudication Method for the Test Set
- Not Applicable. No human adjudication method described, as this is not a study requiring expert consensus on clinical findings or AI outputs.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is relevant for evaluating the impact of AI assistance on human reader performance for diagnostic tasks. This document describes the substantial equivalence of a physical medical device (oxygenator/reservoir), not a diagnostic AI system.
6. Standalone (Algorithm Only) Performance
- No. This is not an AI algorithm. It's a physical medical device.
7. Type of Ground Truth Used
- Engineering Specifications and Predicate Device Performance. The "ground truth" for these performance evaluations is the established engineering design specifications for the modified device and the known, acceptable performance characteristics of the predicate devices. The goal is to show the modified device performs equivalently or within acceptable parameters.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of AI for this type of device modification. The device design and materials are based on existing engineering knowledge and the predicate device's design.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set mentioned in an AI context, there's no ground truth established for it. The design of the modified device is based on internal engineering processes, regulatory requirements, and the characteristics of the predicate devices.
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(45 days)
The Capiox FX05 device is intended to be used during open heart surgical procedures to transfer oxygen and remove carbon dioxide from blood and to control the blood temperature during cardiopulmonary bypass for periods up to 6 hours. The Capiox FX05 is a Neonate/Infant oxygenator intended for use in procedures up to a maximum flow of 1.5 L/min. The patient weight and BSA should be considered upon use.
The FX05 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures.
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 Capiox FX05 device is a modification of the Capiox RX05 device that has an arterial filter integrated into the design. The design of the oxygenator device is such that it utilizes an integrated oxygenator/heat exchanger module that provides for gas transfer (blood oxygenation and carbon dioxide removal) and for blood temperature control. The RX Oxygenator/Arterial Filter device also utilizes a hardshell reservoir that is used to collect and store blood during a cardiopulmonary bypass procedure. The arterial filter contained within the oxygenator module is comprised of 32 micron PET (polyethylene terephalate) mesh material that is wrapped around the outer circumference of the oxygenator fiber bundle.
The provided document describes the Capiox® FX05 Hollow Fiber Oxygenator and Arterial Filter, a medical device intended for use during open heart surgical procedures. The submission is a 510(k) premarket notification, which means it aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing completely new safety and effectiveness. As such, the "study" described is a series of in-vitro performance evaluations comparing the new device to its predicates.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with specific numerical targets. Instead, it states that the device "exhibited performance that is deemed to be substantially equivalent to the performance of the predicate devices." This substantial equivalence is based on a series of in-vitro tests where the new device's performance was compared to the established performance of the predicate devices. The implicit acceptance criterion is that the new device's performance on these tests is comparable to or better than the predicate devices, and that any differences do not raise new issues of safety or effectiveness.
| Test Category | Reported Device Performance |
|---|---|
| Gas Transfer | Performance "deemed to be substantially equivalent to predicate devices." |
| Effects on Blood Components (Hemolysis) | Performance "deemed to be substantially equivalent to predicate devices." |
| Pressure Drop | Performance "deemed to be substantially equivalent to predicate devices." |
| Mechanical Integrity | Performance "deemed to be substantially equivalent to predicate devices." |
| Static Priming Volume | Performance "deemed to be substantially equivalent to predicate devices." |
| Heat Exchanger Performance | Performance "deemed to be substantially equivalent to predicate devices." |
| Filtration Efficiency | Performance "deemed to be substantially equivalent to predicate devices." |
| Air Handling | Performance "deemed to be substantially equivalent to predicate devices." |
| Tubing Connection Strength | Performance "deemed to be substantially equivalent to predicate devices." |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices. Substantial equivalence is demonstrated with the following in-vitro performance evaluations."
- Sample Size for Test Set: Not specified. The document repeatedly refers to "in-vitro performance evaluations" and "testing" without providing numerical sample sizes for each test (e.g., how many units were tested for pressure drop, or how many blood samples were used for hemolysis).
- Data Provenance: In-vitro laboratory testing (likely conducted by Terumo Corporation or its designated testing facilities). The country of origin for the manufacturing and submission is Japan/USA, but the specific location of the in-vitro testing is not detailed. The data is prospective in the sense that these tests were conducted specifically for this submission to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of submission. The "ground truth" for mechanical and performance characteristics of medical devices is typically established through adherence to recognized international standards and scientifically validated test methods, rather than expert consensus on a test set. The predicate devices themselves represent the "ground truth" for comparison in a 510(k) process, as they are already legally marketed and presumed safe and effective.
4. Adjudication method for the test set
Not applicable. Device performance against technical specifications and predicate device performance is typically determined through direct measurement and comparison, not adjudication by human experts in the context of this 510(k) submission.
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 device is a physical medical device (an oxygenator and filter), not an AI-powered diagnostic or decision support system. Therefore, MRMC studies and AI-assisted human reader performance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
For the in-vitro performance evaluations, the "ground truth" is established by:
- Predicate Device Performance: The primary "ground truth" for comparison is the documented and accepted performance characteristics of the predicate devices (Terumo's Capiox® RX05 Oxygenator/Reservoir K022115 and Terumo's Capiox® AF02X Arterial Filter K011804). The new device must perform comparably to these established devices.
- Accepted Industry Standards: Implied adherence to relevant industry standards for medical device testing (e.g., for blood compatibility, mechanical integrity, gas exchange efficiency).
- Biocompatibility Standards: Biocompatibility evaluation was done according to ISO 10993 guidelines, implying this standard serves as the ground truth for safety in this aspect.
8. The sample size for the training set
Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. Since there is no training set, there is no ground truth for it.
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(47 days)
The Capiox FX Hollow Fiber Oxygenator and Arterial Filter 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 comprised 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 3-liter and 4-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post Operative Chest Drainage Procedures.
The Capiox FX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min. when used with a 3 Liter Reservoir.
The Capiox FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.
The Capiox FX Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.
The Capiox FX device is a modification of the Capiox RX device that has an arterial filter integrated into the design. The design of the oxygenator device is such that it utilizes an integrated oxygenator/heat exchanger module that provides for gas transfer (blood oxygenation and carbon dioxide removal) and for blood temperature control. The RX Oxygenator/Arterial Filter device also utilizes a hardshell reservoir that is used to collect and store blood during a cardiopulmonary bypass procedure. The filter contained within the oxygenator module is comprised of 32 micron PET (polyethylene terephalate) mesh material that is wrapped around the outer circumference of the oxygenator fiber bundle. This design permits the oxygenation of blood and removal of carbon dioxide as blood passes through the fiber bundle and also facilitates blood filtration after the blood has been oxygenated. Air removal is accomplished by entrapment followed by permeation of the air into the hollow fibers of the oxygenator bundle - and subsequently is exhausted (along with carbon dioxide) via the gas outlet port. The materials used include polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™.
Acceptance Criteria and Device Performance for TERUMO CAPIOX® FX Hollow Fiber Oxygenator
The TERUMO CAPIOX® FX Hollow Fiber Oxygenator with Integrated Arterial Filter (K071494) was evaluated through a series of in-vitro performance tests to demonstrate substantial equivalence to predicate devices (Terumo's Capiox® RX15 Oxygenator/Reservoir K051997, Terumo's Capiox® RX25 Oxygenator/Reservoir K040210, and Terumo's Capiox® AF125X Arterial Filter K052205). Clinical studies were not deemed necessary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria for each test. Instead, it states that the device "exhibited performance that is deemed to be substantially equivalent to the performance of the predicate devices" based on the evaluations. The tests conducted and the general performance statements are summarized below:
| Performance Evaluation Category | Reported Device Performance |
|---|---|
| Gas Transfer | Deemed substantially equivalent to predicate devices. |
| Effects on Blood Components (Hemolysis) | Deemed substantially equivalent to predicate devices. |
| Pressure Drop | Deemed substantially equivalent to predicate devices. |
| Mechanical Integrity | Deemed substantially equivalent to predicate devices. |
| Static Priming Volume | Deemed substantially equivalent to predicate devices. |
| Heat Exchanger Performance | Deemed substantially equivalent to predicate devices. |
| Filtration Efficiency | Deemed substantially equivalent to predicate devices. |
| Air Handling | Deemed substantially equivalent to predicate devices. |
| Tubing Connection Strength | Deemed substantially equivalent to predicate devices. |
| Sterilization Conditions | Validated in accordance with AAMI guidelines to provide a SAL of 10-6. Ethylene oxide residues will not exceed maximum limits. |
| Biocompatibility | Blood contacting materials found to be biocompatible as per ISO 10993. |
| Polymer Coating (PMEA) | Evaluated in an in-vivo animal study; no adverse conditions noted. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for the independent performance evaluation tests (test set). The studies were in-vitro evaluations.
- Data Provenance: The studies were internal in-vitro performance evaluations conducted by Terumo Corporation (Ashitaka Factory), Fujinomiya City, Shizuoka Pref., Japan. The specific country of origin for the data generation is Japan. The studies are prospective in nature, as they were conducted to support the 510(k) submission for a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable. The ground truth for the in-vitro physical and biological performance tests would be established by standard engineering and biocompatibility testing methodologies, not by expert consensus in the typical sense of diagnostic accuracy studies. The equivalence is drawn against established predicate devices, implying that their performance serves as a benchmark for "ground truth" or acceptable performance in these technical domains.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human interpretation. For in-vitro engineering and biological performance tests, the results are quantitative or qualitative assessments against defined standards or predicate device performance, not subject to subjective adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating human reader performance with and without AI assistance, which is not pertinent to the in-vitro performance evaluation of this medical device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was conducted. The performance evaluations listed (Gas Transfer, Hemolysis, Pressure Drop, etc.) are all conducted on the device itself, without human intervention for direct performance measurement. These are in-vitro tests designed to assess the device's inherent functional characteristics and safety.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluations was based on:
- Engineering Standards and Specifications: For tests like Pressure Drop, Mechanical Integrity, Static Priming Volume, and Tubing Connection Strength.
- Biological Performance Benchmarks: For tests like Gas Transfer, Effects on Blood Components (Hemolysis), Filtration Efficiency, and Air Handling, the "ground truth" or acceptable performance was defined by demonstrating substantial equivalence to the performance of legally marketed predicate devices, and adherence to accepted medical device performance expectations for cardiopulmonary bypass equipment.
- Regulatory Guidelines and Recognized Standards: For Sterilization (AAMI guidelines), Biocompatibility (ISO 10993), and the safety of the PMEA coating (demonstrated through prior FDA clearances and an in-vivo animal study).
8. Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of this device's performance evaluation. The device is not an AI/ML algorithm that learns from data. Its performance is inherent to its design and materials, and it is validated through direct testing.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as #8.
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