(77 days)
The Asept Peritoneal Drainage System is indicated for periodic drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long term access of the peritoneal cavity in order to relieve symptoms such as dyspnea.
The Asept Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen. The catheler is implanted in the patient's peritoneal cavity enabling the patient to perform periodic perioneal drainage at home or hospital. The primary components of the system are the Asept indwelling Peritoneal Catheter and the Asept Drainage Kit. The proximal end of the indwelling catheter has a valve that prevents fluid or air from moving in or out of the peritoneal space until the valve is breached. The valve can be breached by the Asept Peritoneal Drainage catheter connected to wall suction or pleurovac or vacuum bottles. The Asept Peritoneal Drainage System provides patients with a convenient way to relieve malignant ascites symploms at home.
The provided text is a 510(k) summary for the "Asept Peritoneal Drainage System." It focuses on demonstrating substantial equivalence to a predicate device through in vitro testing, rather than presenting a study to prove acceptance criteria for an AI/ML powered device.
Therefore, many of the requested sections related to acceptance criteria, ground truth, expert involvement, and AI performance metrics are not applicable to this document. The device described is a physical medical device (a drainage system) and not a software algorithm that would have "acceptance criteria" in the way associated with AI/ML performance.
Here's a breakdown of what can be extracted and what is not applicable:
1. A table of acceptance criteria and the reported device performance:
Since this is a physical device submission focused on in vitro testing to demonstrate substantial equivalence, the "acceptance criteria" are implied by the standards and the performance of the predicate device. The document states:
| Acceptance Criteria (Implied by standard and predicate) | Reported Device Performance |
|---|---|
| Leakage performance (per BS EN 1618-1997) | Met |
| Flow rate performance (per BS EN 1618-1997) | Met |
| Tensile strength performance (per BS EN 1618-1997) | Met |
| Corrosion resistance (per BS EN 1618-1997) | Met |
| Biocompatibility (per ISO 10993) | Met (or identical to legally marketed devices) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not explicitly stated for each in vitro test, but implied to be sufficient for the tests mentioned by the standard BS EN 1618-1997.
- Data provenance: Not applicable. The testing was in vitro (laboratory-based) on the device itself, not on 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: This pertains to clinical studies or expert review of data, neither of which were performed. The "ground truth" for in vitro testing is defined by the physical or chemical properties measured.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: Adjudication is a process for resolving discrepancies in expert ratings or clinical outcomes, which did not occur 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: This is an AI/ML specific study type, and the device is a physical drainage system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This refers to AI/ML algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- In vitro measurements: The ground truth for the in vitro tests (leakage, flow rate, tensile strength, corrosion, biocompatibility) would be based on the established scientific and engineering principles, measurement instruments, and reference standards defined by the BS EN 1618-1997 and ISO 10993 standards.
8. The sample size for the training set:
- Not Applicable: There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable: There is no "training set" as this is not an AI/ML device.
Summary of what the document does say about meeting criteria:
The document states, "In vitro testing was performed on the Asept Peritoneal Drainage System to assure reliable design and performance in accordance with BS EN 1618-1997. Testing includes leakage, flow rate, tensile strength, and corrosion." It also mentions, "Materials used in the Asept Peritoneal Drainage System meet the requirements of ISO 10993 or Identical to legally marketed devices."
The key takeaway is that the device demonstrated safety and effectiveness through in vitro testing and comparison to legally marketed predicate devices, not through clinical trials or AI/ML performance studies.
§ 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.