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The BMW Needlefree Valved Connector is designed for needlefree access to IV infusion systems for injection of fluids or aspiration of blood samples.

BMW's Needlefree Valved Connector is a rigid plastic adapter with a male luer port on the distal end for attachment to I.V. access systems (e.g., catheters). The proximal end terminates in a female luer lock fitting which may be attached to any I.V. administration set terminating in a standard male luer. The female luer is capped when napt in use to minimize the potential for contamination.

The plastic adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve is normally closed when it is not in use. The valve opens towards the I.V. access system when fluids are infused into the patient and it opens away from the I.V. access system to permit aspiration of blood samples. The valve is captured (sandwiched) between the seating surfaces of the two-piece adapter. The seating surfaces of the adapter are held in position by a bond between the proximal and distal pieces of the adapter. The connector valve is packaged in a sterile blister pack with male luer cap(s). The caps will also be packaged and sold individually.

This device is a physical medical device (Needlefree Valved Connector and Cap), not an AI/ML powered software, therefore, many of the requested categories are not applicable. The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results with acceptance criteria typical for novel devices or software.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as might be expected for an AI/ML device or a device with new performance claims. Instead, the performance is described in terms of substantial equivalence to existing predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. Given this is a physical device submission focused on substantial equivalence, the "test set" would likely refer to engineering verification and validation testing (e.g., flow rate, pressure, material compatibility, leak testing, functional cycling), rather than a clinical dataset in the AI/ML context. The document does not detail specific sample sizes for these tests or their provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/not provided. For a physical medical device like this, "ground truth" as typically defined for AI/ML (e.g., expert consensus on medical images) is not relevant. Performance is typically assessed against engineering specifications and predicate device performance.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are common in clinical studies where expert disagreement needs to be resolved for ground truth establishment. This type of submission relies on engineering testing and comparison with predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This is a physical medical device, not an AI/ML software, and therefore, an MRMC study related to human readers improving with AI assistance would not be performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on:

• Engineering Specifications: Adherence to design requirements (e.g., luer lock meeting ANSI standards).
• Functional Performance Comparison: Demonstrating that the device performs functionally identically to the predicate device (e.g., valve opening/closing as intended for infusion and aspiration).
• Safety Profile: Assurance that design differences do not introduce new safety concerns, implicitly relying on established safety profiles of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical device, not an AI/ML model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.

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BMW's multi-lumen central venous catheters have the same intended use as Bard Access Systems' Groshong long-term central venous catheters, and Bard's Hickman preamendment long-term central venous catheters.

BMW's Clampless Valved Catheter-Tunneled is designed for patients who require long-term access to the central venous system for administration of fluids including, but not limited to, hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is effective for venous access in adults, children, and infants who require intravenous therapy.

BMW Medical has developed a catheter that provides the benefits of the valve incorporated at the distal tip of the Groshong catheter on an open-ended catheter. The BMW valve is external to the central venous system and is protected inside the rigid catheter adapter.

BMW Medical, Inc.'s multi-lumen catheters are composed of extruded silicone rubber tubing which is homogeneously mixed with barium sulfate (BaSO,) prior to extrusion to impart radiopacity. The catheters vary in diameter and number of lumens to accommodate specific applications.

A silicone rubber joint permanently attaches the multi-lumen catheter tubing to the 2 or 3 legs required to access each lumen of a dual or a triple lumen catheter. A 2-piece rigid plastic adapter is attached to the proximal end of each single lumen leg. Each leg is mechanically locked onto the barbed end of the adapter with a silicone rubber sleeve. The other end of the adapter terminates in a female luer which allows for attachment of the catheter to a male luer fitting.

The adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve remains closed when the catheter is not in use. The valve opens toward the distal tip of the catheter when fluids are infused into the patient via the catheter, and it opens toward the female luer of the proximal hub during aspiration of blood samples.

The provided text is a 510(k) summary for a medical device (BMW Medical, Inc.'s Multi-Lumen Clampless Valved Catheter-Tunneled) and does not contain the information requested in your bullet points regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML device.

The document describes a physical medical device (a catheter) and its comparison to predicate devices, focusing on physical properties, materials, and basic functional performance like flow rate and leak tests. It's a premarket notification for a traditional medical device, not an AI/ML diagnostic or assistive tool.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance (for AI/ML performance): The text discusses "performance data" for the catheter's valve (reducing air embolism, bleedback, no hemolysis, low aspiration pressures) and physical properties (stiffness, elongation, radiopacity, flow rate, tensile/burst strength). However, these are for a physical device, not an AI algorithm.
• Sample sized used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone performance was done: Not applicable (for AI).
• The type of ground truth used: For the physical device, it's about physical measurements and functional characteristics against established standards or predicate devices, not "ground truth" as understood in AI/ML.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes the regulatory submission for a physical medical device (a catheter) and therefore does not contain the information you requested about acceptance criteria and studies related to an AI/ML device's performance.

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BMW's CVC Midline catheter is designed to establish peripheral venous access for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, and blood products. It is also indicated for blood specimen withdrawal.

BMW Medical has developed a midline catheter that provides the benefits of the valve incorporated at the distal tip of the Groshong PIC catheter on an open-ended midline catheter. The BMW valve is external to the central venous system and is protected inside the catheter adapter.

BMW Medical, Inc.'s midline catheters are single lumen catheters. They are composed of extruded silicone rubber tubing which is homogeneously mixed with barium sulfate (BaSO2) prior to extrusion to impart radiopacity. The catheters vary in diameter to accommodate specific patient populations.

A 2-piece plastic adapter is attached to the proximal end of each single lumen catheter. The catheter is mechanically locked onto the adapter with a silicone rubber sleeve. The other end of the adapter terminates in a female luer which allows attachment of the catheter to a male luer fitting.

The adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve remains closed when the catheter is not in use. The valve opens inward toward the distal tip of the catheter when fluids are infused into the patient via the catheter, and it opens outward toward the female luer of the proximal hub during aspiration of blood samples.

Here's a breakdown of the acceptance criteria and the study information for the BMW Medical, Inc.'s Clampless Valved Catheter-Midline (CVC-ML) as described in the provided text:

Important Note: The provided text is a 510(k) Premarket Notification summary, not a detailed study report. As such, many of the specific details usually found in a comprehensive clinical or performance study (like exact sample sizes, detailed ground truth establishment, expert qualifications, or MRMC study results) are not present in this summary. The information below reflects what can be extracted from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided text. The document refers to "test data" and "studies" but doesn't quantify the number of catheters or tests conducted for each performance characteristic.
• Data Provenance: Not specified. It's implied to be internal testing by BMW Medical, Inc. The text does not mention country of origin, nor whether the data is retrospective or prospective. Given the nature of a premarket notification for a physical device, these would almost certainly be prospective lab/bench tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It's likely that internal engineers or quality control personnel performed the tests. The "Published biocompatibility flow chart requirements" would have been established by external, recognized standards bodies, not individual experts for this specific submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not specified. The performance tests described (e.g., stiffness, flow rate, leak tests, hemolysis observation) are objective, quantitative measurements or observations that do not typically involve human adjudication in the sense of consensus on an interpretation.

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

• MRMC Study: No. This is a physical medical device (catheter), not an AI diagnostic or image interpretation system. Therefore, MRMC studies and AI assistance are not relevant to this submission.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for most performance claims appears to be:

• Predicate Device Performance: Direct comparison to the established performance characteristics of the Bard Groshong PIC catheter and the HDC V-Cath® Midline catheter. The goal is "substantial equivalence," meaning its performance is "at least as effective" or "substantially equivalent" to legally marketed predicate devices.
• Biocompatibility Standards: "Published biocompatibility flow chart requirements." These are established industry or regulatory standards.
• Direct Physical Measurement/Observation: For characteristics like hemolysis, aspiration pressures, stiffness, radiopacity, flow rate, and strength, the ground truth is derived from direct measurements and observations during bench testing.

8. The Sample Size for the Training Set

• Sample Size: Not applicable/Not specified. This device does not involve a "training set" in the context of machine learning. The reference to "test data collected" implies performance testing, not model training.

9. How the Ground Truth for the Training Set was Established

• Ground Truth Establishment: Not applicable. As this is not an AI/machine learning device, there is no "training set" or ground truth establishment relevant to that context.

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BMW's CVC-PICC is designed to establish peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.

BMW Medical, Inc.'s peripherally inserted central venous catheters are configured as long-term single lumen catheters. They are composed of extruded silicone rubber tubing which is homogeneously mixed with barium sulfate (BaSO ) prior to extrusion to impart radiopacity. The catheters vary in length and diameter to accommodate specific patient populations. A 2-piece plastic adapter is attached to the proximal end of each single lumen catheter. The catheter is mechanically locked onto the adapter with a silicone rubber sleeve. The other end of the adapter terminates in a female luer which allows attachment of the catheter to a male luer fitting. The adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve remains closed when the catheter is not in use. The valve opens inward toward the distal tip of the catheter when fluids are infused into the patient via the catheter, and it opens outward toward the proximal hub during aspiration of blood samples.

The provided text is a 510(k) Premarket Notification for a medical device and describes its equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for a novel device would. Therefore, much of the requested information regarding sample size, expert ground truth, adjudication, MRMC studies, and training sets is not applicable to this type of submission.

However, I can extract the information provided regarding performance and equivalence.

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

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

The document does not specify sample sizes for any tests, nor does it detail the provenance of the data (country, retrospective/prospective). The tests mentioned appear to be laboratory or bench tests ("performance data," "test data collected on") rather than clinical studies.

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

Not applicable. This is a 510(k) submission based on engineering and performance testing for substantial equivalence, not a study requiring expert-established ground truth for a test set.

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

Not applicable.

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 catheter, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a catheter, not an algorithm.

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

The "ground truth" for the device's performance appears to be based on established engineering standards and comparative performance against the predicate devices in various physical and functional tests. For biocompatibility, "published biocompatibility flow chart requirements" served as the standard.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning algorithm.

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

Not applicable.

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BMW's central venous catheters are designed for the administration of I.V. fluids, blood products, drugs, and parenteral nutrition solutions, as well as for blood withdrawal.

BMW Medical has developed a central venous catheter that provides the clampless valve features of the Groshong catheter on an open-ended Hickman catheter. The BMW valve is external to the central venous system and is protected inside an adapter attached to a Hickman-type catheter. This configuration provides the advantages of a normally closed three-way valve while avoiding the influences of the central venous system and continuous direct blood contact that can potentially interfere with the function of the Groshong three-way valve.

BMW Medical, Inc.'s central venous catheters are configured as long-term single lumen catheters. They are composed of extruded silicone rubber tubing which is homogeneously mixed with barium sulfate (BaSO2) prior to extrusion to impart radiopacity. The catheters vary in length and diameter, specific sizes designed for pediatric and adult populations.

A 2-piece plastic adapter is attached to the proximal end of each single lumen catheter. The catheter is mechanically locked onto the barbed end of the adapter with a silicone rubber sleeve. The other end of the adapter terminates in a female luer which allows attachment of the catheter to a male luer fitting.

The adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve remains closed when the catheter is not in use. The valve opens inward toward the distal tip of the catheter when fluids are infused into the patient via the catheter, and it opens outward toward the proximal hub during aspiration of blood samples. The valve is captured (sandwiched) between the seating surfaces of the two-piece adapter. The seating surfaces of the adapter are held in position and bonded between the proximal (female luer) and distal (barbed) pieces.

In addition to central venous catheters. BMW intends to market a surgical tunneler which is used to form a subcutaneous tunnel from the catheter exit site, in the area just below the patient's nipple, to the entrance site near the patients mid-clavicular area.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BMW Medical Inc. Clampless Valved Catheter:

Lack of Specific Acceptance Criteria and Dedicated Study:

It's important to note that the provided document is a 510(k) Summary, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove a device meets specific, pre-defined performance acceptance criteria through an independent study in the traditional sense of a clinical trial for a novel device. The document primarily relies on comparison to predicate devices and bench testing to show similar or superior performance.

Therefore, many of the requested elements (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance with specific metrics like sensitivity/specificity, and ground truth for training data) are not applicable or not explicitly detailed in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary focused on substantial equivalence through comparison, "acceptance criteria" here are implicitly linked to the performance of the predicate devices according to FDA guidance.

Details on the "Study" (Assessment of Performance Data)

The "study" referred to is primarily an assessment of performance data from bench tests comparing the BMW catheter to predicate devices, rather than a singular, large-scale, standalone study with human subjects.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document refers to "performance test results" and "comparisons." These typically involve a statistically relevant number of devices or components undergoing bench testing, but the exact N is not provided.
• Data Provenance: The tests were conducted internally by BMW Medical Inc. as part of their 510(k) submission. No country of origin for observational data is mentioned, as it primarily involves bench testing. It is inherently retrospective in the sense that the data supports a pre-existing design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not applicable / Not specified. "Ground truth" in this context would typically refer to expert consensus on clinical outcomes or image interpretations. Since this is primarily bench testing for substantial equivalence, such a concept isn't directly relevant or detailed in the submission. The "truth" is based on established engineering and medical device performance standards.

4. Adjudication Method for the Test Set

• Not applicable / None specified. Adjudication methods are typically used in clinical studies involving human interpretation or outcome assessment. This document focuses on physical and functional bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was NOT done. MRMC studies are specific to evaluating diagnostic algorithms or imaging interpretation by multiple human readers. This submission is for a physical medical device (catheter).

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

• Not applicable. This question is relevant for AI/software devices. The BMW catheter is a physical medical device; its performance is standalone in the sense that it functions physically but not "algorithm-only."

7. The Type of Ground Truth Used

• The "ground truth" for the performance comparisons was based on bench testing standards and established performance characteristics of the predicate devices (Hickman/Broviac and Groshong catheters) as outlined in the "FDA Guidance on Premarket Notification [(510(K)] Submission for Short-Term and Long-Term Intravascular Catheters."

8. The Sample Size for the Training Set

• Not applicable / Not specified. There isn't a "training set" in the context of a new algorithm. The BMW catheter's design and manufacturing processes would have been developed through R&D, but this isn't analogous to an algorithm's training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable. See point 8. The "truth" for the design would be based on engineering principles, material science, and the known characteristics of successful existing catheters.

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