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1. The ON-Q Pump is intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.
2. The ON-Q Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

The ON-Q Pump consists of an elastomeric pressure source with an integrated administration line. Fill volumes range from 50 to 770 ml. Flow rates range from 0.5 to 250 ml/hr. The administration line typically consists of fixed flow rate control tubing or orifice but may contain any of the following optional features:
• Select-A-Flow component that provides a range of flow rates that may be dialed depending on the needs of the healthcare professional.
• Bolus component (e.g. OnDemand) that provides basal and/or bolus delivery.
• Y-adapter component that may split the administration line into two or more delivery sites. The Y-adapter component may also be used to provide a combination of options (such as both the Select-A-Flow and OnDemand components) for one delivery site.
• Air and particulate eliminating filter.
The pump may be sold as a kit with additional medical devices or accessories such as the following:
• Catheter, introducer needle, Tunneler, syringe, dressing, filling extension set, carry case, E-clip, nerve block accessories, etc.

This document is a 510(k) summary for a medical device (ON-Q Pump) that describes a design change to increase its maximum fill volume. It does not provide information about acceptance criteria or a study proving that a device (specifically an AI device) meets acceptance criteria.

Therefore, I cannot answer your request based on the provided text. The questions you've asked are typically relevant for AI/ML device submissions, which involve performance metrics like sensitivity, specificity, and detailed study designs. This document is for a mechanical infusion pump and discusses substantial equivalence to a predicate device, not AI performance.

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The ON-Q Introducers are intended for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters.

The ON-Q Introducers consist of the following two components: The first component is a stainless steel shaft (trocar) with a handle or luer hub. The trocar diameter ranges from 11 to 17 GA and the length ranges from 3.25 to 12 inches. The trocar may have a sharp, beveled tip or a blunt, rounded tip. The second component is a peelable (split T-Handle) plastic sheath that is designed to fit over the trocar. The model configurations are designated as follows: Models with a blunt tip are called ON-Q Tunnelers. The sheaths may be sold separately and are single use only. Some versions of the ON-Q Tunnelers may be reusable. Models with a sharp tip are called ON-Q Introducers Needles which are single use only. The ON-Q Introducers are intended for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters.

The provided document (K063234) is a 510(k) summary for the ON-Q Introducers, a medical device. It does not contain information about studies conducted to meet specific acceptance criteria through performance metrics like sensitivity, specificity, or AUC, as would be common for diagnostic AI/ML devices.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices by meeting recognized consensus standards for device design and performance requirements. The concept of "acceptance criteria" here refers to compliance with these established standards and the safety and effectiveness profile similar to already marketed devices.

Therefore, for this particular device (ON-Q Introducers), the request for details on acceptance criteria and a study proving the device meets them needs to be interpreted within the context of a 510(k) submission for a non-AI/ML device.

Here's an analysis based on the provided text:

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

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

This information is not provided in the document. The document primarily focuses on compliance with international standards and comparison to predicate devices, rather than a clinical study with a "test set" in the context of diagnostic performance.

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

This information is not provided and is not applicable to this type of device submission. Ground truth, in the sense of expert consensus for diagnostic interpretation, is not relevant here.

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

This information is not provided and is not applicable to this type of device submission.

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

There is no indication of an MRMC study being performed. This is not an AI/ML device, and the submission is not focused on improving human reader performance.

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

This is not an AI/ML device, so a standalone algorithm performance study is not applicable and not mentioned.

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

For this type of device, ground truth relates to the physical and functional properties of the device meeting established engineering standards (e.g., sterility, material properties, luer taper dimensions, needle tubing specifications). This is assessed through laboratory testing and manufacturing controls, rather than diagnostic "ground truth." The document does not detail specific testing protocols or results in full.

8. The sample size for the training set

This information is not provided and is not applicable. The device is not an AI/ML product that would require a "training set."

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

This information is not provided and is not applicable, as there is no "training set" for this device.

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The ON-Q SilverSoaker Catheter is intended to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for perioperative and postoperative pain management. The ON-Q SilverSoaker Catheter is contraindicated for the epidural space and in neonatal populations.
The ON-Q SilverSoaker Catheter contains an antimicrobial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.

The ON-Q SilverSoaker Catheter consists of two design options:
Fenestrated Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment
Soaker Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment. This version of the ON-Q SilverSoaker Catheter contains a hollow fiber along the inner lumen of the catheter to provide even distribution of medication along the infusion segment.
This 510(k) adds an antimicrobial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.

The provided text is a 510(k) Summary for the ON-Q SilverSoaker Catheter, which is an anesthetic conduction catheter. It describes the device, its intended use, and states that it is substantially equivalent to existing devices.

However, the document does not contain any information regarding acceptance criteria or the results of a study (clinical or otherwise) proving device performance against such criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device that does not require premarket approval. It's not typically a full clinical trial where specific performance metrics are measured against pre-defined acceptance criteria with detailed statistical analysis.

Therefore, I cannot provide the requested information in the structured format because the source document does not contain it. The 510(k) summary only states:

"The ON-Q SilverSoaker Catheter is substantially equivalent to the existing ON-Q Catheter product line and predicate devices."

This is the "conclusion" of the submission, based on technology comparison, not a study demonstrating new performance criteria.

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1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
2. The 1-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia. Routes of administration may be intraoperative, perineural or percutaneous.
3. The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

The I-Flow Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. The current device has an optional Y-adapter that splits the administration line into two delivery sites. This special 510(k) proposes a multi-Y adapter that can provide 3 or more integrated administration lines for multi-site delivery.

The provided text describes a Special 510(k) submission (K052117) for a modification to the I-Flow Elastomeric Pump. This submission focuses on a design change, specifically the addition of a multi-Y adapter to allow for 3 or more integrated administration lines, as an extension of an existing product line (K040337).

Crucially, the provided document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria.

Instead, it's a declaration of substantial equivalence to a previously cleared device. The rationale is that the new multi-Y adapter utilizes the same technology as the existing unmodified design, and therefore, no new issues of safety or effectiveness are believed to arise from this change.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

Here's why and what information would typically be needed if a study were conducted:

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

• Missing Information: The document does not define any specific acceptance criteria (e.g., flow rate accuracy, pressure stability, material compatibility, bacterial ingress prevention) for the new multi-Y adapter, nor does it report any performance data.

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

• Missing Information: No test set is mentioned because no study was conducted for this specific submission to demonstrate performance against new criteria.

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)

• Missing Information: Not applicable, as no study requiring ground truth establishment was conducted for this submission. This type of information is usually relevant for studies evaluating diagnostic or AI-driven devices, not a simple accessory modification like this.

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

• Missing Information: Not applicable, as no study requiring adjudication was conducted.

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: Not applicable. This type of study is for evaluating AI performance in diagnostic imaging, which is completely unrelated to an elastomeric pump accessory.

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

• Missing Information: Not applicable. This device does not involve any algorithms.

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

• Missing Information: Not applicable, as no study requiring ground truth was conducted.

8. The sample size for the training set

• Missing Information: Not applicable. This device does not involve a training set as there is no AI/ML component.

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

• Missing Information: Not applicable, as there is no training set mentioned.

Conclusion from the provided text:

The submission K052117 is a "Special 510(k)" which indicates a modification to an already cleared device (K040337). The nature of the change (adding more "Y" splices to an existing administration line) is deemed minor enough by the submitter and the FDA to not require new performance studies. The core argument is based on technological equivalence to the predicate device, implying that the established safety and effectiveness of the original pump apply to this modified version. The FDA letter confirms the determination of "substantial equivalence" based on this premise, allowing the device to be marketed without new clinical or performance studies.

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With I-Flow Corporation's ON-Q, PainBuster and C-bloc pain management kits; and As a stand alone device to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves. Routes of administration may be intraoperative, percutaneous, perineural. The Soaker version of the I-Flow Catheter is contraindicated for the epidural space.

The I-Flow Catheter consists of three design options which can utilize infusion segments ranging from epidural to 10 inches (same as the predicate devices with the exception of the 10 inch infusion segment): Standard epidural catheter: 3 radial holes at the distal end with an approximate 0.5 inch infusion segment. Fenestrated Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment Soaker Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment. This version of the I-Flow Catheter contains a hollow fiber along the inner lumen or along the outside diameter of the distal end of the catheter to provide even distribution of medication along the infusion segment.

This document is a 510(k) summary for a medical device (I-Flow Catheter) and does not contain the information requested in your prompt regarding acceptance criteria or a study proving device performance against such criteria.

The 510(k) submission process is for demonstrating substantial equivalence to a predicate device, not for proving performance against specific acceptance criteria in a clinical study as would be seen for new technology.

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

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

What the document does indicate:

• Device: I-Flow Catheter (including Soaker Catheter, Fenestrated Catheter, Epidural Catheter, and a new 10-inch infusion segment model)
• Purpose of Submission: Special 510(k) for a new 10-inch I-Flow Catheter model.
• Basis for Approval: Substantial equivalence to already legally marketed predicate devices (I-Flow Catheter K991543, K994374, and K022869).
• Technology Comparison: The new 10-inch model "utilizes the exact same technology as the existing I-Flow Catheter product line."
• Conclusion: The new model is "substantially equivalent to the existing I-Flow Catheter product line."

In essence, this submission argues that because the new device is fundamentally the same as devices already on the market, it does not require new performance studies against specific acceptance criteria. Its performance is implicitly considered equivalent to the predicate devices.

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1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
2. The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
3. The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

The current package labeling of the I-Flow Elastomeric Pump does not reference specific types of surgeries or potential benefits. This 510(k) proposes a labeling change that would reference the specific type(s) of surgery and potential benefits that are supported by published clinical studies.

This document, K040337, is a 510(k) premarket notification for a labeling change to the I-Flow Elastomeric Pump. It is not a study that proves the device meets acceptance criteria for a new device, but rather a notification to market an existing device with updated labeling based on a review of existing clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a new device evaluation is inherently not present in this type of submission.

Here's an analysis of what information can be extracted or inferred from the provided text, and where the requested information is absent due to the nature of the submission:

1. Table of acceptance criteria and the reported device performance

This information is not applicable/provided in this 510(k) submission. A 510(k) for a labeling change based on existing studies does not typically define new acceptance criteria for the device itself or report new performance data. The core of this submission is to demonstrate that the proposed labeling changes (referencing specific types of surgeries and benefits) are supported by already published clinical studies where the device was used according to its previously cleared indications.

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

This information is not applicable/provided for a new test set in this submission. The submission refers to "published clinical studies" that support the labeling changes. Details about the sample sizes, data provenance (e.g., country of origin, retrospective/prospective nature) of these individual published studies are not provided in this 510(k) summary. These details would be found within the referenced published studies themselves.

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

This information is not applicable/provided for a new test set in this submission. Similar to point 2, the ground truth for the results of the referenced published studies would have been established within those studies. This 510(k) is a regulatory filing summarizing the existence and relevance of those studies, not establishing new ground truth for a new device test.

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

Not applicable/provided. As explained above, no new test set was established as part of this 510(k) filing.

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 submission is for an elastomeric infusion pump, not an AI-assisted diagnostic device or a system involving human readers. Therefore, an MRMC study or AI-related effectiveness is not relevant.

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

Not applicable. This submission is for an elastomeric infusion pump, not an algorithm.

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

Not applicable/provided directly by this document for a new test set. The ground truth (e.g., pain relief, decreased narcotic use) for the results of the "published clinical studies" would be defined within those studies themselves. The submission states that the labeling changes are supported by "published clinical studies in widely known and esteemed journals," implying that the outcomes and conclusions of those studies serve as the "ground truth" to support the new claims. These outcomes likely pertained to patient-reported pain levels, narcotic consumption, or other clinical measures.

8. The sample size for the training set

Not applicable. This submission is not about an AI/ML device that requires a training set. The "training" for the device's claims comes from the clinical evidence generated in the "published clinical studies," which are not referred to as a "training set" in this context.

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

Not applicable. As explained in point 8, there is no "training set" in the context of this device and submission. The "ground truth" for the claims in the new labeling is established by the findings and conclusions of the referenced "published clinical studies."

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1. The I-Flow Variable Rate Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intraarterial, subcutaneous, intramuscular and epidural.
2. The I-Flow Variable Rate Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative and postoperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.

The I-Flow Variable Rate Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. This special 510(k) proposes a labeling change to the existing device submitted under K020660 for the variable flow rate component.

The provided document K023883 is a 510(k) summary for a special 510(k) submission. This type of submission is typically used for modifications to a legally marketed device that do not raise new questions of safety and effectiveness.

In this specific case, the submission is for a labeling change to the existing I-Flow Variable Rate Elastomeric Pump (K020660) concerning its variable flow rate component. The document explicitly states: "The Variable Flow Rate Component is identical in design to the one recently cleared under K020660."

Therefore, this submission relies on the substantial equivalence to its predicate device (K020660 and K020251 for the variable flow rate component) rather than presenting new performance data from a dedicated study. As a result, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets them, as it is not a de novo submission or a new device evaluation requiring such extensive testing protocols.

Here's a breakdown of why this information is absent in this particular document:

• No new performance claims: The special 510(k) is for a labeling change and explicitly states the component is identical to a previously cleared one. This means no new performance is being claimed that would require new acceptance criteria or a new study.
• Reliance on predicate device: The basis for clearance is "substantial equivalence" to the existing I-Flow Elastomeric Pump and the variable flow rate component cleared under K020251. The performance characteristics were established and accepted during the clearance of those predicate devices.

Therefore, I cannot populate the table or answer the specific questions because the provided document does not contain a study demonstrating new device performance against new acceptance criteria.

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1. The Paragon Infusion System with Bolus is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, subcutaneous, intramuscular and epidural.
2. The Paragon Infusion System with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the Paragon Infusion System with Bolus. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market prior to May 28, 1976, or reclassified. This substantial equivalence determination is based on a review of the company's premarket notification, which would have included data and information to support this claim. However, the details of that data and the specific performance criteria used for testing are not included in this FDA clearance letter.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
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 device is an infusion system, not an AI-assisted diagnostic tool, so an MRMC study is not applicable and is not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is an infusion system, not an algorithm.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document primarily focuses on the regulatory clearance process, outlining the device's classification, product code, and indications for use. It also provides contact information for further inquiries regarding FDA regulations.

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• 1. The I-Flow Elastomeric Pump with Bolus is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, subcutaneous, intramuscular and epidural.
• 2. The I-Flow Elastomeric Pump with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/c close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.

This special 510(k) proposes a new optional component for the I-Flow Elastomeric Pump that incorporates a bolus component. The bolus component offers the additional ability to deliver fixed bolus volumes of medication at fixed time intervals instead of just a continuous infusion rate.

The provided text is a 510(k) summary for the I-Flow Elastomeric Pump with Bolus. This document does not contain the detailed acceptance criteria and study information typically found in a clinical trial report or a comprehensive device validation study.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to an existing legally marketed device (the I-Flow Elastomeric Pump without the bolus component). The key argument is that the new bolus component "utilizes the same technology for dispensing medication as the existing unmodified design," implying that the safety and effectiveness are comparable and, therefore, extensive new performance studies (as outlined in your request) are not required for this type of submission.

Therefore, I cannot provide the information requested in your numbered list directly from the provided text because it's not present. The document explicitly states:

• "Conclusion: The I-Flow Elastomeric Pump with Bolus is substantially equivalent to the existing I-Flow Elastomeric Pump."
• "Technology Comparison: The new Bolus Component utilizes the same technology for dispensing medication as the existing unmodified design."

This type of submission relies on the predicate device's established performance rather than new, extensive studies for the modified device, particularly since the modification is described as an "optional component" that adds a specific function (bolus delivery) but uses the same fundamental technology.

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• With I-Flow Corporation's PainBuster, ON-Q and Nerve Block pain management kits; and 1.
• As a stand alone device to provide continuous or intermittent delivery of local anesthetics 2. or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, percutaneous or perineural.

The Soaker Catheter has a closed end tip with multiple holes arranged radially along the lateral surface along the infusion segment at the distal end of the device. A membrane in the inner diameter of the catheter promotes even distribution along the infusion segment. This special 510(k) proposes a slight design change that has the membrane along the outside diameter of the catheter instead of the inside diameter.

The provided text is a Special 510(k) for a "Soaker Catheter" from I-Flow Corporation (K022869). This document describes a design change to an existing device, specifically moving a membrane from the inside to the outside diameter of the catheter.

Based on the nature of this submission (a Special 510(k) for a minor design change to an already cleared device), the typical detailed clinical studies and performance evaluations against specific acceptance criteria, as might be seen for a novel device or a device making substantial performance claims, are not present in this document.

Instead, the submission relies on demonstrating substantial equivalence to the predicate device (the earlier Soaker Catheter, K991543 and K994374). The justification for this substantial equivalence is that the "new Soaker Catheter utilizes the exact same technology for promoting even distribution along the infusion segment." This implies that the performance characteristics, and thus the "acceptance criteria," are inherently met by virtue of the device being functionally identical to the previously cleared version.

Therefore, many of the requested elements for a detailed study proving device meets acceptance criteria are not applicable (N/A) in this specific 510(k) summary.

Here's the breakdown of the information as requested, with explanations for why certain elements are N/A:

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

Explanation: This 510(k) is for a minor design modification where the manufacturer asserts that the fundamental technology and performance are unchanged. Therefore, explicit, quantitative acceptance criteria and a study dedicated to proving these new criteria are not typically provided in such a submission. The "acceptance" is that the device performs equivalently to its predicate, which has already been deemed safe and effective.

2. Sample size used for the test set and the data provenance

N/A. No specific test set or clinical data is presented for this Special 510(k) based on the provided text. The submission focuses on the engineering change and its lack of impact on existing performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. No ground truth establishment by experts is described in this document.

4. Adjudication method for the test set

N/A. No test set or adjudication method is described in this document.

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

N/A. This is a medical device (catheter), not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

N/A. This is a medical device (catheter), not an algorithm. Standalone performance studies in this context are not applicable.

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

N/A. No ground truth is specified or needed for this type of device modification under a Special 510(k) that claims substantial equivalence based on an identical functional principle.

8. The sample size for the training set

N/A. As this is a physical medical device and not a machine learning model, the concept of a "training set" is not applicable.

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

N/A. Not applicable, as there is no training set for a physical medical device.

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