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This device is intended for use with Flex-Neck catheters and Ash Advantage catheters in the event one of two situations described below should occur:

1. Extender Application
   In some patients, the external portion of the PD catheter may be too short for them to comfortably use. For example, obese patients may need an extender kit to be able to work with the external part of the catheter. Other patients may require the external end of the catheter to be more centrally located than it normally might be.
2. Repair Application
   If a peritoneal dialysis catheter develops a fracture in the external portion, the catheter must be trimmed to eliminate the fracture. Doing so, by definition, will shorten the catheter and may make it impractical or difficult or even unsuitable for use. Rather than replace the entire catheter, it is desirable to retain the catheter by extending the external part of the catheter with new tubing.
   In either situation, this device enables qualified medical staff to extend and/or repair the external part of an existing Flex-Neck catheter or Ash Advantage catheter by adding a 20 cm long tube to the existing and /or remaining catheter tubing.

This device consists of four components per kit, a double male connector, a catheter connector, a cap and a 20cm long silicone tube, to be assembled in an aseptic manner by qualified personnel.

1. Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set. It only mentions that "Functional testing has been performed." The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

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

This information is not provided in the document. The testing appears to be purely functional/mechanical rather than involving expert assessment of diagnostic accuracy.

4. Adjudication method for the test set:

Not applicable, as the testing described is functional/mechanical and does not involve human interpretation or adjudication.

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

Not applicable. This device is a physical medical accessory (catheter extender/repair kit), not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study related to human reader performance with or without AI is not relevant.

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

Not applicable. This is a physical device, not an algorithm. The testing described is for the device's mechanical integrity and retention, which is inherently "standalone" in that it tests the device itself.

7. The type of ground truth used:

The ground truth for the functional testing appears to be based on engineering specifications or performance standards for mechanical integrity and retention, rather than expert consensus, pathology, or outcomes data typically used for diagnostic devices.

8. The sample size for the training set:

Not applicable. This device is a physical medical accessory. There is no mention of a "training set" in the context of an algorithm or AI.

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

Not applicable. As there is no training set for an algorithm described, there is no ground truth establishment for a training set.

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The Key Tube is designed to be used to implant the Ash Advantage™ catheter. No usage change from original Ash Advantage catheter 510(k) 991042.

Stainless steel, quasi tubular (U shape) device, approximately 200 mm long and 8.0 mm diameter.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medigroup Key Tube™:

The provided document is a 510(k) summary for the Medigroup Key Tube™, which is an accessory device. The key information is presented as a demonstration of substantial equivalence to a predicate device, rather than a clinical trial proving specific performance metrics against pre-defined acceptance criteria for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

This product is not a diagnostic device, and thus does not have typical performance metrics like sensitivity, specificity, or accuracy. Its "performance" is functional, demonstrating its ability to assist in the implantation of another device (the Ash Advantage™ catheter).

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

• Sample Size: 14 catheters implanted in 13 patients.
• Data Provenance: Prospective clinical trials (Ash Advantage™ catheter clinical trials) conducted in three dialysis centers. The country of origin is not explicitly stated but is implied to be the US given the FDA submission.

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

• Experts: The document states that "All implanting doctors used the prototype version of the Key Tube™." The exact number of doctors is not specified, but it's at least three (one for each of the three dialysis centers).
• Qualifications: The document identifies them as "implanting doctors." Their specific specializations (e.g., surgeons, nephrologists performing insertions) and years of experience are not detailed, but their role implies relevant medical expertise in catheter implantation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document simply reports the clinical results as observed by the implanting doctors. Given the nature of a functional device, the success was likely determined by the operating physician's assessment during and immediately after the procedure. There is no indication of independent blinded adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC Study: This is not a diagnostic imaging device or an AI-assisted diagnostic tool, so an MRMC comparative effectiveness study is not applicable or mentioned. The device is a surgical accessory, and its effectiveness is determined by its functional role in the implantation procedure.

6. Standalone Performance Study

• Standalone Study: Yes, in a way. The "clinical trials" described for the Ash Advantage™ catheter included the observation of the prototype Key Tube™'s performance in isolation as part of its function during the implantation of the Ash Advantage™ catheter. The statement "the Key Tube™ functioned as designed" is an assessment of its standalone performance during the procedure. However, this is not a separate, dedicated standalone study with predefined metrics for only the Key Tube™; it was part of a broader study for the Ash Advantage™ catheter.

7. Type of Ground Truth Used

• Ground Truth: Clinical observation and assessment by "implanting doctors" during the surgical procedure. The "ground truth" was the successful physical placement of the catheter components as intended, as verified by the operating physicians.

8. Sample Size for the Training Set

• Training Set: Not applicable. This is a mechanical accessory device, not an AI/ML algorithm that requires a training set. The "design" of the Key Tube™ would have evolved through engineering and potentially pre-clinical testing, but not a data-driven training set in the AI sense.

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

• Not Applicable: As there is no training set in the AI/ML sense, no ground truth was established for it. The development and refinement of the Key Tube™ would have been based on engineering principles, predicate device experience, and possibly bench testing or cadaver studies, leading to the prototype used in the described clinical trials.

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The Ash Advantage™ Peritoneal Catheter is intended to provide access for passage of dialysate during chronic peritoneal dialysis (PD) such as Continuous Ambulatory Peritoneal Dialysis (CAPD). If the patient is a suitable candidate for (PD) therapy, the Ash Advantage™ Peritoneal Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Ash Advantage™ Peritoneal Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC® System of peritoneoscopic implantation enables inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.

The Ash Advantage™ Peritoneal Catheter is extruded of medical long-term implantable silicone basically identical to the existing Tenckhoff peritoneal catheters. All these peritoneal catheters include one or two Dacron® cuffs, the "deep" cuff in the abdominal musculature and the "superficial" cuff near the skin exit site of the catheter. Ingrowth of fibrous tissue over a few weeks period results in a thick fibrous plug preventing passage of bacteria around the Dacron® cuff. The coiled or straight intraperitoneal portion of the Tenckhoff catheter contains multiple 1.0 mm holes. During infusion of PD fluid, most of the flow is through the tip of the catheter. During outflow of the fluid, the soft surfaces of the peritoneum over bowel loops and omentum may be drawn to the tip; however, outflow continues through the multiple side holes. The Ash Advantage™ Peritoneal Catheter has been developed with a thin trans-abdominal tube connecting in an inverted "T" shape to a cylindrical portion which changes to longitudinal flutes (grooves) for ports, which rest against the parietal peritoneum. The Ash Advantage™ Peritoneal Catheter can be inserted via conventional surgical methods or via the Quill® Guide of the Y-TEC® peritoneoscopic system, which is used to insert the standard Tenckhoff dialysis catheters. The fixed position of the intraperitoneal portion of this catheter is designed to prevent outward migration of the deep and superficial cuffs, avoiding pericatheter hernias, pericatheter leaks, and erosion and infection of the subcutaneous cuff. Though this Ash Advantage™ Peritoneal Catheter is a novel design for peritoneal catheters used in dialysis, it actually represents a simple combination of two catheters which are currently utilized in medical practice for peritoneal access. The portion of the catheter outside the peritoneum is exactly like the Tenckhoff catheter, with deep and superficial cuffs. The fluted portion within the abdomen is exactly like a drain used to remove fluid from the peritoneum after surgery, the Blake™ Drain by Johnson & Johnson. The Ash Advantage™ Peritoneal Catheter is extruded of medical long-term implantable silicone basically identical to existing catheters and drains. The extrusions are bonded to form the inverted "T" which is then reinforced with molded silicone.

This document describes the Ash Advantage™ Peritoneal Catheter, a medical device, and its FDA 510(k) submission for substantial equivalence. The provided text, however, is a 510(k) summary and not a study report. Therefore, it does not contain the detailed acceptance criteria or a study proving the device meets those criteria in the way a clinical trial or performance study would.

Instead, the document asserts "substantial equivalence" to existing, legally marketed predicate devices. This means that for a 510(k) submission, the performance of the new device is compared to already accepted devices based on material, design, function, and intended use, rather than conducting a new, exhaustive clinical study to establish new performance metrics.

Based on the provided text, here's an analysis addressing your request, noting where information is not available in this type of document:

Analysis of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for a medical device. In this context, "acceptance criteria" are not explicitly stated as quantitative performance metrics (e.g., a specific flow rate or a success rate threshold) that the device must achieve in a dedicated study. Instead, the "acceptance criteria" implicitly revolve around demonstrating substantial equivalence to existing predicate devices.

The "performance" is implicitly demonstrated through a comparison of physical characteristics and intended use. The table below summarizes the characteristics compared, acting as the basis for the FDA's "acceptance" of substantial equivalence.

Note: The "Ash Advantage™ Peritoneal Catheter" has a novel design for its intraperitoneal portion (fluted instead of coiled/straight with side holes) which is explicitly compared to the Blake™ Drain by Johnson & Johnson, indicating a combination of features from two existing device types. The "acceptance criteria" here are that this combination does not introduce new questions of safety or effectiveness.

Study Information Breakdown

As this is a 510(k) summary focused on substantial equivalence rather than a full study report, specific details on a formal "study" with the following components are largely not provided or not applicable:

2. Sample sized used for the test set and the data provenance:

• Not Applicable/Not Provided. The document describes a comparison to predicate devices based on design and material characteristics, not a clinical test set with patient data.

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/Not Provided. Ground truth establishment for a test set is not part of this type of substantial equivalence submission.

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

• Not Applicable/Not Provided. This pertains to clinical studies often involving human interpretation of data, which is not described here.

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/Not Provided. This device is a peritoneal catheter, not an AI or imaging diagnostic device. MRMC studies are irrelevant to this product.

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

• Not Applicable/Not Provided. This device is a physical medical implant, not an algorithm.

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

• Not Applicable/Not Provided. For a 510(k) substantial equivalence, the "ground truth" is often implicitly understood as the established safety and effectiveness of the predicate devices based on their long-term use and FDA clearance. The new device is compared against these established characteristics.

8. The sample size for the training set:

• Not Applicable/Not Provided. This concept (training set) applies to AI/machine learning models, not physical medical devices in a 510(k) submission.

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

• Not Applicable/Not Provided. As with point 8, this is not relevant to a 510(k) submission for a physical medical device.

Summary of 510(k) Approach for this Device:

The FDA granted "substantial equivalence" based on:

1. Material Equivalence: The catheter is made of medical long-term implantable silicone, "basically identical to existing catheters and drains." Cuffs are Dacron® Felt, also matching predicate devices.
2. Design Comparison: While the intraperitoneal portion is "novel," it is described as "a simple combination of two catheters which are currently utilized in medical practice for peritoneal access." Specifically, the trans-abdominal portion is like a Tenckhoff catheter, and the fluted intraperitoneal portion is like the Blake™ Drain. The comparison table highlights that overall dimensions, number of cuffs, and other physical characteristics are within the range or identical to predicate devices.
3. Intended Use Equivalence: The intended use for providing access for dialysate during chronic peritoneal dialysis (PD) is identical to that of predicate peritoneal dialysis catheters.
4. No New Questions of Safety or Effectiveness: The submission implicitly argues that combining established features from existing devices does not raise new concerns about safety or effectiveness.

In essence, the "study" for this 510(k) clearance was a design and material comparison report demonstrating that the Ash Advantage™ Peritoneal Catheter is sufficiently similar to legally marketed devices to not require a full new clinical trial to prove its safety and efficacy.

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If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck™ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Flex-Neck™ PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC® System of peritoneoscopic implantation enables inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.

The current Tenckhoff peritoneal catheter is generally successful in providing peritoneal access for fluid infusion and drainage. The Flex-Neck™ PD Catheter is extruded of medical long-term implantable silicone basically identical to the existing Tenckhoff peritoneal catheters. All these peritoneal catheters include one or two Dacron® cuffs, the "deep" cuff in the abdominal musculature and the "superficial" cuff near the skin exit site of the catheter. Ingrowth of fibrous tissue over a few weeks period results in a thick fibrous plug preventing passage of bacteria around the Dacron® cuff. The coiled or straight intraperitoneal portion of the catheters contains multiple holes: 0.75mm in the Flex-Neck™ and 1.0mm in the Tenckhoff. Generally, the smaller the hole, the less likely omentum is to become trapped within the holes. During infusion of PD fluid, most of the flow is through the tip of the catheter. During outflow of the fluid, the soft surfaces of the peritoneum over bowel loops and omentum may be drawn to the tip, however, outflow continues through the multiple side holes.

The provided text, K970159, describes a 510(k) premarket notification for the Flex-Neck™ PD Catheter. This document asserts the substantial equivalence of the new device to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a study.

Therefore, the information required to populate the fields regarding acceptance criteria and a study demonstrating performance is not present in the provided text. The document is generally focused on comparing the new device's characteristics to existing devices to establish substantial equivalence for regulatory approval.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on comparing physical characteristics (material, dimensions, number of cuffs, hole diameter) to predicate devices, not performance against acceptance criteria.
2. Sample size used for the test set and the data provenance: Not mentioned, as no study demonstrating performance against acceptance criteria is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no study with a test set requiring ground truth establishment is described.
4. Adjudication method 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 is a medical device (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 is a medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no study with a test set requiring ground truth is described.
8. The sample size for the training set: Not applicable. This is a medical device, and the concept of a "training set" is not relevant here.
9. How the ground truth for the training set was established: Not applicable.

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