(88 days)
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.
| Characteristic Compared | Acceptance Criteria (Implicit from Predicate Devices) | Ash Advantage™ Peritoneal Catheter Performance (Reported) |
|---|---|---|
| Material: Catheter | Silicone (matching predicate devices) | Silicone |
| Material: Cuff | Dacron® Felt (matching predicate devices) | Dacron® Felt |
| Number of Cuffs | 1-2 (matching predicate devices) | 2 |
| Outside Diameter | 3.5 mm to 7.0 mm (matching predicate devices) | 3.5 mm to 7.0 mm |
| Inside Diameter | 2.0 mm to 5.5 mm (matching predicate devices) | 2.0 mm to 5.5 mm |
| Length [Proximal end to post distal (deep) cuff] | Variable, e.g., 29 cm to 27 cm (matching predicate devices) | Variable, 24.0 cm to 30.0 cm (trans-abdominal tube) |
| Intraperitoneal portion [from deep cuff to end] | E.g., 32.0 cm to 34.0 cm (matching predicate devices) | 30.0 cm (includes both fluted sections) |
| Radiopaque stripe | Presence of a radiopaque stripe (matching predicate devices) | Yes - Blue (color may vary) |
| Distal (deep) cuff location | Within the rectus (matching predicate devices) | Within the rectus |
| Proximal (superficial) cuff location relative to distal cuff | E.g., 5.2 cm to 6.22 cm (matching predicate devices) | 6.0 cm (standard adult) |
| Exit site direction (location), choices relative to implantation site | E.g., Caudal 60°, 0-15° straight (matching predicate devices) | Any place between lateral and caudal 30° - 90° bend |
| Intended Use | Peritoneal dialysis access (matching predicate devices) | Access for dialysate during chronic peritoneal dialysis (PD) |
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:
- 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.
- 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.
- 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.
- 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.
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.