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510(k) Data Aggregation
(28 days)
Occlusion Balloon Catheters are indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.
The Occlusion Balloon Catheter product line consists of two specific designs - Standard Occlusions Balloon Catheters and Berenstein™ Occlusion Balloon Catheter.
Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents.
The Occlusion Balloon Catheters are a compliant latex balloon mounted on the distal tip of a dual lumen, radiopaque catheter shaft to which two luer fittings are attached proximally. In addition to the balloon inflation lumen, the central lumen is used to pass the catheter over the guidewire as well as infusion of contrast medium, and in the case of the Berenstein™ Occlusion Balloon Catheter, coaxial delivery of small catheters or embolic agents.
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study for the provided text. The document describes a medical device, specifically an Occlusion Balloon Catheter, and its 510(k) submission to the FDA. However, the provided text does not contain explicit numerical acceptance criteria or detailed study results that would allow me to construct the specified table and answer all your questions.
The "Performance Data" section and the "Biocompatibility" and "Bench" testing sections generally state that testing was performed and that the results provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." It also concludes that the device is "substantially equivalent" to a predicate device.
Key Missing Information:
- Specific, quantifiable acceptance criteria: For example, what was the minimum tensile strength required for the proximal bond, or what was the maximum allowable balloon deflation time?
- Reported device performance values: The document states what tests were done (e.g., "Proximal Bond Tensile"), but not the results (e.g., "Proximal Bond Tensile = X N").
- Sample sizes for test sets (for specific tests): While the tests are listed, the number of units tested for each specific bench test is not provided.
- Data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details: These types of information are typically associated with performance studies for AI/ML devices or diagnostic accuracy studies, which are not described in this document for an occlusion balloon catheter. This device appears to be a physical medical instrument, not an AI/ML diagnostic tool.
Therefore, I cannot generate the table or answer questions 2, 3, 4, 5, 6, 7, 8, or 9 as the necessary information is not present in the provided text.
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(31 days)
The Occlusion Balloon Catheter is intended for temporary occlusion of large vessels.
The Occlusion Balloon Catheter is a triple lumen balloon catheter designed to temporarily occlude large vessels. The "Infusion" lumen is used to infuse contrast material through the catheter. The "Distal .035" lumen extends the length of the catheter and is used for placement over wire guides. The "Balloon" lumen is used to inflate and deflate the balloon. The Occlusion Balloon Catheter is available in one configuration. The catheter has two radiopaque marker bands on the shaft, enclosed within the balloon bonds, to help identify the location of the balloon under fluoroscopy. The balloon has a variable diameter up to a maximum of 40 mm when inflated and a catheter length of 75 cm.
Acceptance Criteria and Device Performance for Occlusion Balloon Catheter (K101877)
This document describes the acceptance criteria and the study that proves the Occlusion Balloon Catheter meets these criteria, based on the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) submission for the Occlusion Balloon Catheter (K101877) focuses on establishing substantial equivalence to a predicate device (CODA Balloon Catheter, K032869) through design and performance testing. The document lists several tests conducted but does not explicitly state numerical acceptance criteria or specific quantitative performance values for each test within the document. Instead, it concludes that the "results of these tests provide reasonable assurance that the device has been designed and tested to ensure conformance to the requirements for its intended use."
However, based on the nature of the tests listed and general device safety and effectiveness principles, we can infer the common acceptance criteria for such a device and assume the reported performance met these underlying standards.
| Test Category | Implicit Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Burst Pressure Testing | The balloon catheter must withstand specified maximum internal pressures without bursting, maintaining integrity during clinical use. | "The proposed Occlusion Balloon Catheter was subjected to... Burst Pressure Testing." (Implied: device met predefined non-bursting pressure limits) |
| Bond Strength Testing | All catheter bonds (e.g., balloon to shaft) must withstand specified forces without delamination or failure. | "The proposed Occlusion Balloon Catheter was subjected to... Bond Strength Testing." (Implied: bonds met predefined strength requirements) |
| Tensile Testing | The catheter shaft and its components must withstand specified tensile forces without breaking or permanent deformation. | "The proposed Occlusion Balloon Catheter was subjected to... Tensile Testing." (Implied: device met predefined tensile strength requirements) |
| Fatigue Testing | The device must withstand repeated inflation/deflation cycles or other relevant mechanical stresses without failure, demonstrating durability. | "The proposed Occlusion Balloon Catheter was subjected to... Fatigue Testing." (Implied: device demonstrated durability over specified cycles) |
| Sheath Compatibility Testing | The catheter must be able to be introduced and withdrawn smoothly through compatible introducer sheaths without damage to the catheter or sheath. | "The proposed Occlusion Balloon Catheter was subjected to... Sheath Compatibility Testing." (Implied: demonstrated compatibility and smooth passage) |
| Inflation/Deflation Time | The balloon must inflate and deflate within clinically acceptable timeframes for efficient temporary occlusion. | "The proposed Occlusion Balloon Catheter was subjected to... Inflation/Deflation Time." (Implied: met predefined time limits for inflation/deflation) |
| Occlusion Testing | The inflated balloon must effectively occlude the intended vessel lumen, preventing flow past the balloon. | "The proposed Occlusion Balloon Catheter was subjected to... Occlusion Testing." (Implied: successfully demonstrated effective vessel occlusion) |
| Accelerated Aged Testing | The device must maintain its functional and mechanical properties after simulating a specified shelf-life period. | "The proposed Occlusion Balloon Catheter was subjected to... Accelerated Aged Testing." (Implied: demonstrated stability over simulated shelf-life) |
| Biocompatibility Testing | The device materials must be biocompatible, not eliciting adverse biological responses (e.g., cytotoxicity, sensitization, irritation). | "The proposed Occlusion Balloon Catheter was subjected to... Biocompatibility Testing." (Implied: materials met ISO 10993 standards for biocompatibility) |
Overall Reported Performance: The document states: "The results of these tests provide reasonable assurance that the device has been designed and tested to ensure conformance to the requirements for its intended use." This indicates that all acceptance criteria were met.
2. Sample Size for Test Set and Data Provenance
The provided 510(k) submission does not explicitly state the sample sizes used for each of the performance tests (Burst Pressure, Bond Strength, Tensile, Fatigue, Sheath Compatibility, Inflation/Deflation Time, Occlusion, Accelerated Aged, and Biocompatibility Testing).
The data provenance is from Cook Incorporated, USA, as the submitter is located in Bloomington, IN, USA. The studies are described as prospective device performance tests conducted on the manufactured device.
3. Number of Experts and Qualifications for Ground Truth
This type of device submission (mechanical medical device) does not typically involve human expert adjudication for establishing "ground truth" in the same way an AI/ML-based diagnostic device would.
For mechanical performance testing, the "ground truth" is based on engineering specifications and scientific principles, verified through objective measurements and validated test methods. The "experts" involved would be the design engineers, quality control personnel, and test laboratory technicians conducting and interpreting the results according to established international and internal standards (e.g., ISO, ASTM, internal Cook specifications). Their qualifications would include engineering degrees, relevant certifications, and experience in medical device testing.
4. Adjudication Method for Test Set
As explained in point 3, no human adjudication method (like 2+1 or 3+1) was used or is applicable for this type of mechanical device performance testing. The "adjudication" is inherent in the objective measurement and comparison of test results against predefined engineering specifications and criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices (especially imaging-based AI) where human readers interpret data, and the AI's impact on their performance is evaluated. The Occlusion Balloon Catheter is a mechanical therapeutic device, not a diagnostic one.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Occlusion Balloon Catheter is a physical medical device, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this submission.
7. Type of Ground Truth Used
The ground truth used for the device's performance testing is based on:
- Engineering Specifications: Predefined performance metrics (e.g., minimum burst pressure, maximum inflation time, required tensile strength) derived from design requirements, risk analysis, and relevant standards.
- Physical Measurements: Objective data obtained from laboratory testing using calibrated equipment.
- Biocompatibility Standards: Compliance with recognized international standards for biological evaluation of medical devices (e.g., ISO 10993 series).
8. Sample Size for the Training Set
Not applicable. This submission is for a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" in the context of device development refers to iterative design, prototyping, and testing phases to refine the device, but not in the sense of a machine learning algorithm's training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated in point 8, there is no training set for this type of device submission.
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(65 days)
The Occlusion Balloon Catheter, model Venos™, is intended for a temporary occlusion of coronary sinus during a venogram, or infusion of contrast media or drug, or for possible introduction of devices into the coronary venous system.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device (Occlusion Balloon Catheter, Model Venos™). It does not contain information about acceptance criteria and a study proving the device meets those criteria.
Therefore, I cannot provide the requested information from this document. The letter only states that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not detail the specific performance metrics or studies used to demonstrate that equivalence.
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(388 days)
The SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.
The Occlusion Balloon Catheter consists of a catheter shaft with two independent lumens upon which an expandable balloon material is bonded. The "Guide Wire" lumen extends the length of the catheter and is used for placement of guide wires and injection of contrast for angiographic visualization. The "Balloon" lumen is used to inflate and deflate the balloon. Radiopaque markers at the location of the balloon provide fluoroscopic visualization of balloon placement. The outer diameter of the catheter shaft is coated with a hydrophilic polymer that reduces friction during manipulation in the vessel.
The provided text describes a 510(k) summary for the SentreHeart Occlusion Balloon Catheter. However, it does not contain specific details about acceptance criteria for performance, device performance data through a study, sample sizes for testing, ground truth establishment, or human-in-the-loop studies.
Here's a breakdown of what can be extracted and what information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified in the document) | "Functional testing was conducted to support the claim of substantial equivalence and to demonstrate the Occlusion Balloon Catheter is safe and effective for its intended use." (No specific performance metrics or thresholds are provided) |
| Biocompatibility | "Results of testing demonstrate the Occlusion Balloon Catheter is biocompatible." (No specific tests or criteria detailed) |
Missing Information: The document states that functional testing and biocompatibility testing were performed but does not quantify the acceptance criteria or the results against those criteria. It relies on a general statement of "safe and effective" and "biocompatible."
2. Sample size used for the test set and the data provenance
Missing Information: The document does not mention any specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The "functional testing" is broadly mentioned without any details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: Since no specific test set or clinical study is detailed, there is no mention of experts or how ground truth would have been established. This device is a catheter, not an AI/diagnostic imaging device where expert interpretation is typically a primary ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Missing Information: No information provided.
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
Missing Information: This is not applicable to a device like an "Occlusion Balloon Catheter." MRMC studies are typically for diagnostic imaging devices where human interpretation is involved. This is a medical device for temporary occlusion, not a diagnostic tool assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: This is not applicable. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing Information: For a medical device like this, "ground truth" would typically relate to the physical and mechanical properties of the device (e.g., balloon inflation pressure, burst pressure, material strength, biocompatibility results) and its ability to achieve its intended function (occlusion) in relevant models (in vitro, animal, or human studies, though clinical efficacy data isn't detailed here for the 510(k)). The document only generally refers to "functional testing."
8. The sample size for the training set
Missing Information: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Missing Information: Not applicable.
Summary of the Study Mentioned in the Document:
The document briefly mentions:
- "Functional testing": Conducted to support substantial equivalence and demonstrate safety and effectiveness.
- "Biocompatibility testing": Conducted for the materials used in the catheter.
Key takeaway: This 510(k) summary is for a medical device (a catheter), not a software or AI-based diagnostic tool. Therefore, many of the requested categories (like ground truth from experts, MRMC studies, training sets, algorithms) are not applicable. The document itself provides a very high-level summary of testing without specific quantitative performance data or detailed study designs. It relies on the concept of "substantial equivalence" to predicate devices rather than novel, extensive performance studies with detailed acceptance criteria for statistical clinical endpoints.
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(80 days)
Occlusion Balloon Catheters are indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.
The Occlusion Balloon Catheter product line consists of two specific designs – Standard Occlusion Balloons and Berenstein™ Occlusion Balloon Catheters.
Only the Berenstein Occlusion Balloon Catheter has been designed for coaxial delivery of small catheters or embolic agents.
The proposed devices are constructed of a dual lumen catheter shaft to which two luer fittings are attached proximately and a soft compliant balloon is mounted on the distal end of the shaft. The tubing marked BALLOON is the balloon inflation lumen. The tubing marked DISTAL is the central lumen. The central lumen is used to pass the catheter over a guidewire. This lumen can also be used for infusion of contrast medium or, in the case of the Berenstein Occlusion Balloon Catheter, coaxial delivery of small catheters or embolic agents.
As are the predicated devices, the proposed devices are provided with 1.25ml syringe. There are no changes to this accessory proposed in this submission
The provided text is related to a Special 510(k) Premarket Notification for an Occlusion Balloon Catheter. This document is a regulatory submission for a medical device and does not contain information about an AI-powered device or a study proving its performance against acceptance criteria in the context of AI.
The document discusses the device's intended use, description, biocompatibility, and substantial equivalence to predicate devices, focusing on physical characteristics and safety for a traditional medical device, not an AI algorithm.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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(90 days)
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