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510(k) Data Aggregation
(435 days)
International Biophysics Corporation
The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
The FloPump 57mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Sorin Group Stöckert Centrifugal Pump Console and rotates the internal impeller using a magnetic driver. The FloPump 57mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 57mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 57mL does not have any other patient contact.
This document describes the FloPump 57mL Centrifugal Pump, a non-roller type blood pump intended for use in extracorporeal circuits for periods less than 6 hours.
Here's an analysis of the acceptance criteria and supporting studies as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific quantitative "acceptance criteria" with corresponding "reported device performance" in a structured table as might be expected for an AI/CAD device. Instead, it states that non-clinical testing was performed and the results were "Substantially equivalent to predicates" for a range of performance characteristics.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Flow curves | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Heat generation | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Prime volume | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Air handling | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Hemolysis | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Reliability | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Biocompatibility | Substantially equivalent to predicate devices | Substantially equivalent to predicates |
| Sterilization | Sterilization process results in a SAL of 10^-6 | The sterilization process results in a SAL of 10^-6 |
| Packaging durability | No signs of damage and functioned as intended following testing | No signs of damage and functioned as intended following testing |
| Shelf-life | No signs of damage and functioned as intended following testing | No signs of damage and functioned as intended following testing |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not contain any information regarding sample sizes for a standalone (test set) for clinical performance, as it explicitly states that clinical testing was not required. The testing mentioned is non-clinical, likely laboratory-based or bench testing. Therefore, there's no information on data provenance (country of origin, retrospective/prospective) related to a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical testing was required or performed, there is no information on experts establishing ground truth for a clinical test set. The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methods, and comparison against the performance of predicate devices.
4. Adjudication Method for the Test Set:
Given that no clinical testing requiring human interpretation or judgment was performed, there is no information on an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:
No MRMC comparative effectiveness study was done as clinical testing was not required for this device. This device is a mechanical pump, not an AI/CAD diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable to the FloPump 57mL Centrifugal Pump. This device is a physical, mechanical blood pump, not an algorithm or AI system. The "standalone" performance here refers to the device's functional performance on its own, which was evaluated through the non-clinical tests listed.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" was based on:
- Engineering specifications and design requirements: For parameters like priming volume, flow rates, and maximum rated pressure.
- Established test methods and standards: For sterilization (SAL of 10^-6), biocompatibility, and perhaps reliability testing.
- Performance of predicate devices: The primary method for proving substantial equivalence was demonstrating similar performance to legally marketed predicate devices for flow curves, heat generation, prime volume, air handling, hemolysis, and reliability. This implies that the accepted performance range of the predicate devices served as the "ground truth" for comparison.
8. The Sample Size for the Training Set:
Not applicable. This device is a mechanical blood pump, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As stated above, this is a mechanical device, not an AI/ML system requiring a training set.
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(345 days)
INTERNATIONAL BIOPHYSICS CORPORATION
The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or
ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
The FloPump 32mL is a single use disposable centrifugal pump has an inlet that draws blood from a patient and an outlet that pushes the blood out, where it then passes through an oxygenator and back to the patient. The pump mates with the Maquet RotaFlow console and rotates the internal impeller using a magnetic driver. The FloPump 32mL is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to the incoming blood, directing it through a spiral housing to the outflow port. The FloPump 32mL is part of the extracorporeal circuit, and is therefore in contact with the patient's blood while circulating. The FloPump 32mL does not have any other patient contact.
The provided text describes a medical device, the FloPump 32mL Centrifugal Pump, and its 510(k) summary for FDA clearance. However, it does not describe acceptance criteria and a study proving a device meets them in the context of an AI/algorithm-based medical device.
The information provided is for a physical medical device and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Therefore, I cannot extract the requested information regarding AI/algorithm performance.
Here's an analysis of why the requested information isn't present:
- No AI/Algorithm: The FloPump 32mL Centrifugal Pump is a physical device that functions to pump blood through an extracorporeal circuit. It does not employ any AI or algorithms for decision-making or analysis.
- No Diagnostic or Predictive Outputs: The device's function is mechanical (pumping blood), not diagnostic or predictive in nature. Therefore, there are no performance metrics like sensitivity, specificity, accuracy, or AUC that would be typically associated with AI/algorithm acceptance criteria.
- Focus on Substantial Equivalence: The 510(k) summary emphasizes "substantial equivalence" to predicate devices based on design, materials, specifications, and non-clinical testing (flow curves, heat generation, hemolysis, etc.).
- No Clinical Study for Performance: The document explicitly states, "Clinical testing was not required" for this device clearance. This further confirms the absence of studies designed to evaluate AI performance or human reader improvements.
Therefore, since the input document describes a physical medical device and not an AI-powered one, I cannot fulfill the request to provide acceptance criteria and study details related to AI/algorithm performance.
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(225 days)
INTERNATIONAL BIOPHYSICS CORPORATION
The International Biophysics Corporation AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment.
The International Biophysics Corporation HFCWO Vibratory Vest is comprised of a vest of synthetic polymer fabric with installed oscillating vibratory motors organized into six zones. It has three buckles and straps on the front and one over each shoulder that are used to provide the wearer with a snug and evenly-distributed fit. Additionally, there is an included charger for the batteries and a remote that is wired into the vest to adjust the intensity of the oscillation on the patient as necessary and as prescribed by a physician.
The provided text is a 510(k) summary for the International Biophysics Corporation HFCWO Vibratory Vest. This document explicitly states that no clinical or nonclinical performance data was required or submitted for this device to establish substantial equivalence with predicate devices.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided.
- Sample size used for the test set and the data provenance: No test set data exists.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment occurred.
- Adjudication method for the test set: No test set means no adjudication method.
- 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: No such study was conducted or reported. This device is a vibratory vest, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithmic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth was established for performance testing.
- The sample size for the training set: No training set was used.
- How the ground truth for the training set was established: No training set means no ground truth establishment for it.
The 510(k) summary explicitly states:
- Nonclinical Performance Data: "None required"
- Clinical Performance Data: "None required"
The conclusion is based on substantial equivalence to existing legally marketed HFCWO vests, rather than on new performance data demonstrating meeting specific acceptance criteria through a study.
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(109 days)
INTERNATIONAL BIOPHYSICS CORP.
The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen. This oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.
The IBC LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life sustaining or to be life supporting. The LifeChoice provides approximately 90% oxygen to the patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 3.0 liters per minute in increments of 1.0 liter per minute. The LifeChoice is a portable device which may be used continuously in a home, institution or travel environment. The LifeChoice uses molecular sieve pressure swing adsorption technology.
The provided text describes a 510(k) submission for the International Biophysics Corporation (IBC) LifeChoice Oxygen Concentrator. This is a medical device submission, and as such, the "acceptance criteria" and "device performance" are typically defined by demonstrating substantial equivalence to a predicate device, rather than explicit numerical performance metrics like those for an AI algorithm.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (portable oxygen concentrator), "acceptance criteria" are generally based on meeting the performance characteristics of an already legally marketed predicate device. The text does not provide a specific table of numerical acceptance criteria or detailed performance metrics. Instead, it relies on a qualitative comparison.
| Acceptance Criterion (Implied) | Reported Device Performance (IBC LifeChoice) |
|---|---|
| Substantial Equivalence to Predicate Device | "Equivalent in performance, function and principles of operation to the predicate device." "Does not create any new questions of safety and effectiveness." "Substantially equivalent to the identified predicate device, the AirSep LifeStyle Oxygen Concentrator." "No significant differences between the IBC LifeChoice and the identified predicate device." |
| Technology Use | Utilizes "well established technologies" like molecular sieve pressure swing adsorption and demand flow delivery systems. |
| Intended Use | Provides supplemental, high concentration oxygen (approx. 90%) on a demand flow basis at 1.0 to 3.0 LPM equivalent. Portable for home, institution, or travel. Not life-sustaining. |
2. Sample Size Used for the Test Set and Data Provenance
The text does not provide information about a "test set" in the context of an algorithmic evaluation. This is a medical device submission for a physical oxygen concentrator, not an AI algorithm. The evaluation relies on "Benchtop performance testing" and comparison to a predicate device. Therefore, concepts like sample size for a test set, country of origin, or retrospective/prospective data are not applicable in the way they would be for an AI study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as there is no "test set" or "ground truth" to be established by experts in the context of an AI algorithm evaluation. The device's "truth" is its physical performance and adherence to established engineering principles, benchmarked against a predicate.
4. Adjudication Method
This information is not applicable for the same reasons as above. There's no expert adjudication of image or data interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is relevant for evaluating the impact of an AI system on human reader performance (e.g., radiologists interpreting images). The IBC LifeChoice Oxygen Concentrator is a physical device, not an AI algorithm, so an MRMC study was not conducted.
6. Standalone Performance Study
Yes, in a sense. The text mentions "Benchtop performance testing" for the IBC LifeChoice. This would be considered the standalone performance evaluation for the physical device itself (i.e., how it performs in terms of oxygen concentration, flow rate, power consumption, etc., without human interaction during its operation). However, the specific results of this testing are not detailed in the provided summary, only that it demonstrated substantial equivalence.
7. Type of Ground Truth Used
The "ground truth" for this medical device's performance is ultimately derived from:
- Its engineering specifications and physical measurements (e.g., actual oxygen concentration produced, flow rates, battery life).
- The performance characteristics of the predicate device (AirSep LifeStyle Oxygen Concentrator), which serves as the established benchmark for safety and effectiveness.
- Adherence to recognized standards and regulations for oxygen concentrators.
8. Sample Size for the Training Set
This information is not applicable. The IBC LifeChoice is a physical device using established technology (molecular sieve pressure swing adsorption). It does not involve machine learning or AI that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI algorithm.
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(90 days)
INTERNATIONAL BIOPHYSICS CORP.
The International Biophysics Corporation Laser Peel system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology.
The International Biophysics Corporation Laser Peel System is an Er:YAG laser producing emission at a wavelength of 2940 nm. The laser consist of two interconnected sections: The cabinet which houses the power supply, the cooling system and the electronics, and; the umbilical cables and the hand piece, which houses the laser.
The provided text is a 510(K) Summary for the International Biophysics Corporation Laser Peel System. This document is a premarket notification to the FDA, demonstrating substantial equivalence to previously marketed devices. It is not a study that proves device performance against acceptance criteria in the manner typically understood for clinical trials or AI/software evaluations.
Therefore, many of the requested categories are not applicable to this type of regulatory submission. The document explicitly states "None Required" for both nonclinical and clinical performance data.
Here's a breakdown based on the provided text, highlighting what is (and isn't) present:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. This document is a 510(k) summary demonstrating substantial equivalence for a medical device (laser system), not a study against specific performance acceptance criteria. | Not applicable. The document states "None Required" for both nonclinical and clinical performance data, as its purpose is to show substantial equivalence to predicate devices, not novel performance metrics. |
2. Sample size used for the test set and the data provenance
Not applicable. No test set or related data provenance is mentioned as this is a 510(k) summary for a physical medical device, not a data-driven AI/software product requiring a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set or ground truth establishment by experts is mentioned.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method is mentioned.
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. No MRMC study was done. This device is a laser system, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth is not relevant for this type of regulatory submission. The submission relies on demonstrating substantial equivalence to predicate devices, not on validating performance against a ground truth.
8. The sample size for the training set
Not applicable. This device is a physical laser system, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for a training set to be established.
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(193 days)
INTERNATIONAL BIOPHYSICS CORP.
The IBC VRV is indicated for use as an intracardiac suction control valve for left ventricular venting during cardiopulmonary bypass surgery (up to six hours).
The IBC VRV Valve is a single use, disposable, vacuum and pressure relief, check valve that is intended for use during open-heart surgery for left ventricular venting. It is sometimes commonly referred to as a suction control valve for left ventricular venting. The device is designed for use in a suction line and must be used in accordance with the operating parameters of that blood recovery line. The fully assembled IBC VRV Valve is geometrically similar and clinically the same to the Omni Model RLV-2100"B" VRV valve, which is the predicate device for purposes of this 510(k) submission. The operating principles of the two devices are identical.
The differences between the IBC VRV and the predicate device are found in the material selection and specific dimensions of the component parts neither of which effects safety or effectiveness of the product. The first of these differences is the choice of polymer for molding the plastic components. The main flow through body of the IBC VRV is made of polycarbonate and the Omni RLV-2100"B" is made of ABS. The polycarbonate is clear, has higher impact resistance, greater tensile and compression strength and superior chemical. Upon review of the predicate device, we found the inability to see the interior of the device made it difficult for the user to identify the vacuum relief point. The use of polycarbonate eliminated that problem. Secondly, the straight duck bill check valve in the predicate device represents a substantial resistance to flow which contributes significantly to hemolysis. The unique curved design of the duckbill check valve in the IBC VRV substantially reduces flow resistance and hemolysis.
The provided text is a 510(k) submission for the IBC VRV Valve. The submission aims to demonstrate substantial equivalence to a predicate device, the Omni Model RLV-2100"B" VRV valve. The "acceptance criteria" and "study" described herein are focused on demonstrating this substantial equivalence through a side-by-side comparison.
Here's an analysis of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The core acceptance criteria are based on the functional equivalence of the IBC VRV to its predicate device, the Omni RLV-2100"B". The study aims to show that the IBC VRV performs as well as, or better than, the predicate device across several key performance parameters. While explicit numerical "acceptance criteria" are not given in the document (e.g., "vac_relief_rate must be > X"), the implication is that the IBC VRV's performance should be comparable to the predicate device.
| Acceptance Criteria (Implied) | Reported IBC VRV Performance | Reported Predicate Performance (Omni RLV-2100"B") |
|---|---|---|
| Vacuum Relief Rate | Measured (specific values not provided, but implied to be comparable to predicate) | Measured (specific values not provided) |
| Pressure Drop of Check Valves | Measured (specific values not provided, but implied to be comparable to predicate) | Measured (specific values not provided) |
| Hemolysis Rate | Substantially reduced compared to predicate (specific values not provided) | (Specific values not provided, but implied to be higher than IBC VRV) |
| Reverse-flow and Over-pressure Vent Functionality | Tested (implied to function similarly to predicate) | Tested (implied to function similarly to IBC VRV) |
| Biocompatibility | Non-toxic, meeting tripartite biocompatible ISO standards and FDA modified matrix of 1995. | Not directly compared in the provided text, but predicate is legally marketed. |
| Sterilization & Packaging | Same as other IBC products (bulk, non-sterile for custom packs, or sterile for single use). | Not directly compared in the provided text. |
| Functional Interchangeability | A perfusionist will "be unable to distinguish between the two valves functionally." | (Implied to be functionally indistinguishable from IBC VRV) |
Study Details
2. Sample Size for Test Set and Data Provenance:
- Sample Size:
- The text indicates the IBC VRV (sterile, 6 month aged, environmentally conditioned) was subjected to dynamic tests in a "side by side comparison" with the Omni RLV-2100"B".
- For hemolysis, the study used "fresh bovine blood at 45% hematocrit" for a simulated clinical circuit.
- Specific quantities of devices tested are not explicitly stated. It refers to "the IBC VRV" and "the Omni RLV-2100"B"" in the singular sense when describing the tests, implying at least one of each, but typically a few units would be tested.
- Data Provenance: The tests are described as dynamic tests and a simulated clinical circuit performed in a laboratory setting. There is no indication of human subject data. The use of "fresh bovine blood" suggests a laboratory study setting rather than real clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. This device is a mechanical valve, and the "ground truth" is established by physical measurement of its performance parameters (vacuum relief rate, pressure drop, hemolysis, vent function). This is not equivalent to establishing ground truth for diagnostic imaging or clinical decisions where expert consensus is needed.
4. Adjudication Method for the Test Set:
- Not applicable. As the "ground truth" is based on physical measurements, an adjudication method for expert review is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is not a diagnostic device or a system relying on human interpretation. Therefore, an MRMC study is not relevant or described.
- The text does state that a "perfusionist substituting an IBC VRV for an Omni RLV-2100"B" in his or her perfusion circuit will be unable to distinguish between the two valves functionally." This is a statement about perceived equivalence in function rather than a formal MRMC study evaluating human performance with and without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The dynamic tests performed on the IBC VRV and the predicate device are "standalone" in the sense that they measure the inherent mechanical performance of the devices themselves, without direct human intervention as part of the measured performance (though humans operate the test equipment). This is an "algorithm only" equivalent for a mechanical device.
7. The Type of Ground Truth Used:
- The ground truth is established through physical measurements and engineering tests of the device's performance parameters (vacuum relief rate, pressure drop, hemolysis rate, and vent functionality) in a simulated environment. The predicate device's performance serves as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set:
- Not applicable. This is a mechanical medical device, not a machine learning or AI-driven system. Therefore, there is no "training set" in the context of AI. The device's design is based on engineering principles and materials science.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an AI model, this question does not apply.
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(148 days)
INTERNATIONAL BIOPHYSICS CORP.
The IBC FloGard is indicated for use for the prevention of retrograde flow when used with centrifugal pumps during cardiopulmonary bypass surgery (up to six hours).
The IBC FloGard is a single-use, disposable, check valve intended for use for the prevention of retrograde flow in the arterial line when used with centrifugal pumps during open-heart surgery. The device is designed for use in the main arterial line when centrifugal pumps are used. The fully assembled IBC FloGard Valve is geometrically similar to the Quest RetroGuard valve, which is the predicate device for purposes of this 510(k) submission. The operating principles of the two devices are identical.
The differences between the IBC VRV and the predicate device are found in the material selection, specific dimensions of the component parts and the type of check valve used. The first of these differences is the choice of polymer for molding the plastic components. The main flow through body of the IBC VRV is made of polycarbonate and the Quest RetroGuard is made of clear ABS. The polycarbonate is clearer, has higher impact resistance, greater tensile and compression strength and superior chemical resistance. Secondly, the straight duck bill check valve in the predicate device, Quest RetroGuard, required an oversized body to accommodate clinical flow rates without a substantial resistance to flow. The bi-leaflet design of the check valve in the IBC FloGard valve substantially reduces the size of the flow through housing without increasing resistance to flow. This geometry substantially lowered prime volume and hemolysis.
This looks like a submission for a medical device (IBC FloGard) seeking 510(k) clearance, which means the manufacturer is trying to demonstrate that their new device is "substantially equivalent" to a legally marketed predicate device (Quest RetroGuard). The analysis primarily involves comparing performance characteristics rather than establishing de novo clinical efficacy through large-scale trials.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly substantial equivalence to the predicate device, Quest RetroGuard, particularly in key performance metrics relevant to its intended use in cardiopulmonary bypass. The document provides comparison results directly.
| Performance Metric | Acceptance Criteria (Implicit: Substantially equivalent to Quest RetroGuard) | IBC FloGard Performance (Reported) | Quest RetroGuard Performance (Reported - for comparison) |
|---|---|---|---|
| Pressure Drop (at 4 L.P.M. flow with blood at 45% hematocrit) | No substantial increase compared to predicate | (Measured - specific value not given, implied to be comparable to predicate) | (Measured - specific value not given) |
| Hemolysis (at 7 L.P.M. for 6 hours with fresh bovine blood at 45% hematocrit) | No substantial increase compared to predicate; "substantially lowered hemolysis" compared to predicate | Substantially lowered hemolysis | (Baseline for comparison) |
| Reverse-flow (at 100 mm Hg back-pressure) | Comparable to predicate | (Measured - specific value not given, implied to be comparable to predicate) | (Measured - specific value not given) |
| Pressure required to close valves in reverse direction | Comparable to predicate | (Measured - specific value not given, implied to be comparable to predicate) | (Measured - specific value not given) |
| Prime Volume | "Substantially lowered prime volume" compared to predicate | Substantially lowered prime volume | (Baseline for comparison) |
| Biocompatibility | Nontoxic, meeting ISO standards and FDA modified matrix of 1995 | Nontoxic | (Implicitly also met by predicate materials) |
| Bioburden (prior to sterilization) | "Extremely low and comparable to other 510(k) listed products manufactured by IBC" | Extremely low | (Comparable to other IBC 510(k) listed products) |
Note: For many metrics, the specific numerical values for current and predicate devices are not provided in the executive summary, only qualitative comparisons. The implicit acceptance criterion is that the IBC FloGard performs as well as or better than the Quest RetroGuard in these critical areas, demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- The study involved comparing "the IBC FloGard (sterile, 6 month aged, environmentally conditioned)" against the "Quest RetroGuard." It's not explicitly stated how many units of each device were tested for each metric (e.g., how many FloGard valves for pressure drop, how many RetroGuard valves for hemolysis). It refers to "the IBC FloGard Valve" and "the Quest RetroGuard valve" implying a representative sample, but specific numbers are absent.
- Data Provenance: The study was conducted by IBC, the manufacturer, as part of their 510(k) submission. This is retrospective in the context of device development (i.e., tests were run on finished devices to support the submission). The data is generated internally by the company for regulatory purposes. Country of origin for data generation is not specified but assumed to be the US given the submission to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This type of device clearance (510(k) for a physical medical device like a check valve) primarily relies on engineering and laboratory performance testing, not expert-established "ground truth" on diagnostic images or clinical outcomes.
- Therefore, no experts were explicitly described as establishing ground truth in the way a radiologist might for an AI diagnostic algorithm. The "ground truth" for this device's performance is derived from standardized laboratory measurements (e.g., flow rates, pressure, hemolysis assays). The "experts" involved would be the biomedical engineers and lab technicians conducting the tests, whose qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 reconciliation are typically used for establishing ground truth in clinical data (e.g., imaging studies where multiple readers interpret cases to reach a consensus).
- For this device, the "adjudication" is inherent in the reproducibility and standardization of the laboratory tests and comparison against established physical principles and the predicate device's measured performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is not relevant for this type of device (a mechanical check valve). MRMC studies evaluate the diagnostic performance of human readers, often with and without AI assistance, especially in radiology or pathology. This device is a component in a cardiopulmonary bypass circuit, not a diagnostic tool requiring human interpretation.
6. If a Standalone Performance Study was done
- Yes, a standalone performance characterization was done for the IBC FloGard, and importantly, it was conducted side-by-side with the predicate device (Quest RetroGuard). This is crucial for demonstrating substantial equivalence.
- The description details various tests:
- Pressure drop measured at 4 L.P.M.
- Hemolysis measured at 7 L.P.M. for 6 hours.
- Reverse-flow measured at 100 mm Hg back-pressure.
- Pressure required to close the valves.
- Biocompatibility, bioburden, and sterilization.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is established through:
- Direct physical measurements and laboratory assays: Pressure, flow rate, hemolysis, reverse flow, prime volume measurements.
- Compliance with recognized standards: Biocompatibility tested against "tripartite biocompatible ISO standards and the FDA modified matrix of 1995."
- Comparison to a legally marketed predicate device: The performance metrics are held against the measured performance of the Quest RetroGuard.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical component, not an AI/ML algorithm that requires a "training set." The engineering design and material selection process are not "trained" on data in the same way an algorithm is.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for a mechanical device. The design and validation are based on engineering principles, material science, and performance testing against specified requirements and predicate device characteristics.
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(78 days)
INTERNATIONAL BIOPHYSICS CORP.
The Cardiotomy Vent Valve is indicated for use to maintain a low level of vacuum in cardiotomy reservoirs.
The IBC Vent Valve is a single use, disposable, vacuum relief valve that is intended for use to maintain a low level of vacuum in reservoirs. The valve is closed until the vacuum reaches a pre-determined value in the reservoir and operates best when the pump runs at a very slow rate. The fully assembled IBC Vent Valve is basically identical to the American Omni Vent Valve, which is the predicate device for purposes of this 510(k) submission. The operating principles, performance and indications for use of the two devices are the same.
The IBC Vent Valve is manufactured in a Class 100,000 clean room. The device will be packaged and sterilized for single use. Additionally, the IBC Vent Valve will be packaged in bulk form and non-sterile for the Custom Perfusion Pack market. The materials used to manufacture the IBC Vent Valve are non-toxic and meet current ISO biocompatible tripartite standards using the FDA matrix.
A perfusionist substituting an IBC Vent Valve for an American Omni Vent Valve with his or her cardiotomy reservoir will be unable to distinguish between the two valves functionally.
This looks like a 510(k) summary for a medical device called the "IBC Vent Valve." The document states that the IBC Vent Valve is "basically identical" to a predicate device, the American Omni Vent Valve, and that a "perfusionist substituting an IBC Vent Valve for an American Omni Vent Valve with his or her cardiotomy reservoir will be unable to distinguish between the two valves functionally." This strongly suggests that the acceptance criteria for the IBC Vent Valve are tied to its functional equivalence to the American Omni Vent Valve.
However, the provided text does not contain a detailed study with specific acceptance criteria, sample sizes, expert ground truth, or statistical analysis typical of a study proving a device meets acceptance criteria. The 510(k) process often relies on demonstrating substantial equivalence to a predicate device rather than de novo clinical trials with detailed performance metrics.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional equivalence to the American Omni Vent Valve | "perfusionist ... will be unable to distinguish between the two valves functionally." |
| Operates to maintain a low level of vacuum in reservoirs | "intended for use to maintain a low level of vacuum in reservoirs" |
| Functions best when the pump runs at a very slow rate | "operates best when the pump runs at a very slow rate" |
| Closed until vacuum reaches a pre-determined value | "The valve is closed until the vacuum reaches a pre-determined value" |
| Materials are non-toxic and meet ISO biocompatible tripartite standards | "materials used ... are non-toxic and meet current ISO biocompatible tripartite standards" |
The document does not provide specific numerical acceptance criteria (e.g., vacuum level ranges, specific trigger pressures) or quantitative reported device performance measurements.
Regarding the study proving the device meets acceptance criteria, the document does not describe a formal study with the details requested. Instead, it relies on a claim of "substantial equivalence" to a predicate device.
Here's an analysis of the requested information based on the provided text:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Not provided. The document does not describe a specific "test set" or data collection for performance evaluation beyond the general statement of functional equivalence.
* The statement "A perfusionist substituting an IBC Vent Valve for an American Omni Vent Valve with his or her cardiotomy reservoir will be unable to distinguish between the two valves functionally" suggests a subjective assessment, but no details on who performed this, how many, or under what conditions are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not provided. No explicit "ground truth" establishment process or experts are detailed for device performance in the provided text. The "perfusionist" mentioned is not quantified or qualified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable/Not provided. There is no described test set or adjudication process in the provided text.
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 mechanical vacuum relief valve, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reading performance with or without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is a mechanical component. The concept of "algorithm only" performance does not apply. Its function is standalone in the sense that it operates independently once installed, but it's not a computational algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Implied functional equivalence to a predicate device. The "ground truth" seems to be the established performance and functional characteristics of the American Omni Vent Valve, which the IBC Vent Valve claims to replicate. No independent "expert consensus, pathology, or outcomes data" is described for the IBC Vent Valve's performance.
8. The sample size for the training set:
* Not applicable/Not provided. This is a mechanical device, not a machine learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
* Not applicable. As above, no training set or its ground truth establishment is relevant to this device.
In summary: The provided document is a 510(k) summary focusing on demonstrating "substantial equivalence" to a predicate device. It primarily relies on the claim that the new device is functionally identical to the previously cleared predicate. It does not detail specific, quantitative performance studies with controls, sample sizes, or expert assessments as would be typically found for novel device performance claims.
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(188 days)
INTERNATIONAL BIOPHYSICS CORP.
The IBC FloPump centrifugal blood pump is indicated for use only with the Medicus Bio-Console® to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).
The IBC FloPump centrifugal blood pump is indicated for use and is compatible with all models of the Medicus Bio-Medicus Bio-Consoles to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).
The IBC FloPump is a single use, disposable centrifugal blood pump that is intended for use during open-heart surgery. The device is designed for and limited to use with the BioMedicus BioPump Console and must be used in accordance with the operating parameters of that device. Directions for Use are included with the IBC FloPump and are the same as the BioMedicus Bio-Pump. The fully assembled IBC FloPump head is a geometric duplicate of the BioMedicus BioPump.
The IBC FloPump device is composed of a conical rotor mounted on two ball bearings on the shaft within a generally conical shaped housing. The rotor contains a sealed Strontium Ferrite ring shaped magnet. The magnet is magnetized to 1500 gauss through its thickness every 60 degrees in an alternating north-south and south-north configuration. This enables the rotor to magnetically couple to a similarly configured magnet in the BioMedicus BioPump Console such that the rotor in the IBC FloPump rotates with the magnet in the console. The rotor has two generally conical shaped components attached in close proximity to the magnet housing such that blood contained in the housing forms two generally conical flow paths. The inlet to the housing is in the top center of the housing and the outlet is located on the lower side of the housing tangent to the outer diameter of the rotor. This geometry is identical to the geometry of the predicate device, the BP80 BioMedicus BioPump Pump Head.
In use, the rotor subassembly is spun within the housing subassembly by means of the magnetic coupling to the BioMedicus BioPump Console. The blood enters the inlet by gravity and fills the housing such that the two conical flow paths are fully primed. Due to the high surface area to volume ratio of the flow paths, the cohesive force between the blood and rotor members causes the blood to spin. The blood is thereby gently accelerated to about the same angular velocity as the rotor. The resultant centrifugal force causes the blood to move in a direction tangent to the outer diameter of the rotor. The outlet from the housing is centered on the lower edge of the conical flow channels of the rotor and tangent to the outside diameter of the rotor. This dynamic energy provides the pumping power without the use of rotor vanes. The dynamics of the IBC FloPump are identical to the dynamics of the BioMedicus BioPump.
There are two technological characteristic differences between the IBC FloPump and the predicate device, the original BioMedicus BioPump. The first of these differences is the choice of polymer for molding the plastic components. The IBC FloPump plastic components are made of clear polycarbonate and the BioMedicus BioPump plastic components are made of acrylic. The polycarbonate has greater clarity and a higher impact resistance. Upon review of the predicate device, the warning to avoid contact with isopropyl alcohol was noted. The use of polycarbonate eliminated that problem. Also, polycarbonate is widely used in a large number of cardiovascular medical devices, and specifically two other brands of centrifugal blood pumps that are currently marketed. Secondly, the main shaft of the IBC FloPump is insert molded into the base of the pump assembly and the BioMedicus BioPump has a main shaft, that is assembled using various rubber seals and formed metal components held together with threads and a nut. The insert-molded shaft eliminates leakage by eliminating the potential leak path, assembly tolerances and stress points from the load-bearing portion of the assembly. This method of insert molding the shaft base has been used on another marketed centrifugal pump brand for years. These two minor technological differences do not raise any new questions concerning the safety and effectiveness of the device.
The provided text describes the IBC FloPump centrifugal blood pump and its substantial equivalence to a predicate device. However, it does not explicitly state acceptance criteria in a table format, nor does it detail a study proving the device meets specific acceptance criteria as a standalone performance study would. The information provided is primarily focused on demonstrating substantial equivalence to a previously marketed device (Medtronic Bio-Medicus, Inc. - BP-80 Bio-Pump®).
Based on the provided text, here's an analysis of the information requested:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in a table. Instead, it describes comparative performance testing and concludes substantial equivalence. The key performance metrics discussed are:
| Acceptance Criteria (Implied) | Reported Device Performance (IBC FloPump vs. Bio-Medicus Bio-Pump) |
|---|---|
| Flow Rate and Output Pressure (RPM required to generate specific flow rate and output pressure) | Insignificantly different between IBC FloPump and Bio-Medicus Bio-Pump. |
| Hemolysis (Blood trauma) | IBC data indicates lower hemolysis for IBC FloPump, but IBC states the difference is too low in either system to attribute significance. |
| Biocompatibility | Materials are biocompatible and non-toxic, in accordance with ISO 10993-1. Same materials used in other IBC products for years. |
| Sterility | Passed sterilization validation test, meets IBC SAL standard, meets sterilization residue standards (ISO 10993-7), packaging validated for 2 years. |
| Non-pyrogenic | Labeled non-pyrogenic ( |
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(569 days)
INTERNATIONAL BIOPHYSICS CORP.
The Accuflo™ Electromagnetic Flow System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. The device will function in circuits utilizing centrifugal pump heads as well as circuits utilizing roller pumps. There are no other intended uses for the device. The equivalent device, the Bioprobe, is primarily used with centrifugal pumps.
The Accuflo™ Electromagnetic Flow Monitoring System is composed of three (3) components, a monitor display unit, a transducer and a sterile flow-through probe.
The provided document is a 510(k) summary for the Accuflo™ Electromagnetic Flow Monitoring System, asserting its substantial equivalence to a predicate device, the Biomedicus Bioprobe Electromagnetic Flow System. It does not contain information about a study proving the device meets specific acceptance criteria in the manner of a clinical trial or performance study report. Instead, the "acceptance criteria" appear to be implicit in the comparison table demonstrating similarity to the predicate device. The "reported device performance" refers to the accuracy claim made for the Accuflo™ system within this comparison.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate: Bioprobe System) | Reported Device Performance (Accuflo™ System) |
|---|---|---|
| Components | 3 | 3 |
| Separate Monitor | Yes | Yes |
| Digital Display | Yes | Yes |
| Zero Offset Control | Yes | Yes |
| Electromagnetic Transducer | Yes | Yes |
| Electromagnets | 1 | 2 |
| Disposable Flow Probe | Yes | Yes |
| Construction | Insert Injection Molded | Insert Injection Molded |
| Electrodes | 3 pairs in a row | 3 in a row |
| Inside Diameter | 3/8" | 3/8" |
| Material | Polycarbonate | Polycarbonate |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Accuracy | Accurate within 300 ml | Accurate within 50 ml |
Note: The accuracy claim for the Accuflo™ system (within 50 ml) is presented as an improvement over the predicate device (within 300 ml), not as an "acceptance criterion" that was met in a separate study with a predefined threshold. The "acceptance criteria" here are inferred from the characteristics of the predicate device for demonstrating substantial equivalence.
Regarding a "study that proves the device meets the acceptance criteria":
The document does not describe a study in the traditional sense that would prove the Accuflo™ system meets its own stated accuracy of "within 50 ml" through specific testing methodologies. The accuracy claim is stated as a characteristic within the comparison table, implying it is inherent to the design and operation, potentially demonstrated through internal testing that is not detailed here.
The entire 510(k) submission itself serves as the "study" demonstrating that the Accuflo™ system is substantially equivalent to the predicate device based on design, components, materials, and intended use, with the improved accuracy noted as a difference that does not raise new questions of safety or effectiveness.
Therefore, the following information is largely not available in the provided text:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document is a 510(k) summary, not a detailed study report. It does not mention sample sizes, test sets, or data provenance for performance testing.
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 type of ground truth establishment is typically for diagnostic imaging or similar devices, not for an electromagnetic flow monitoring system where accuracy would be determined by physical measurements against a known standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to clinical or diagnostic adjudication processes, which are not relevant to the type of device described.
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 a medical imaging study type, not relevant to a flow monitoring system. The device does not involve "human readers" or "AI assistance" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly stated as a formal study. The device itself is "standalone" in its function of measuring flow, but the document doesn't describe a specific "standalone performance study" with detailed methodology.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. For a flow monitoring device, ground truth for accuracy would typically be established by in vitro testing against precisely known flow rates using calibrated equipment. This detail is not provided.
8. The sample size for the training set
- Not applicable/Not provided. This is relevant for machine learning models. The Accuflo™ system is a measurement device, not an AI/ML system.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, not relevant for this type of device.
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