(84 days)
The Aspira® Peritoneal Drainage System is indicated for intermittent drainage of recurrent and symonomalic malignant asciles. The catheter is intended for long-term access of the perionely in order is intended is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
The Aspira® Drainage Bag is indicated for use only with the Aspira® Drainage Catheter for intermittent drainage for intermittent drainage.
The Aspira® Dressing Kit is indicated for dressing of a catheter and exit site.
The Aspira® Luer/Universal Adapter is intended to provide access to the Aspira® Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacum bottle, syringe or other suction, water drainage system, glass vacuum bottle, syringe or other appropriate method.
The Aspira® Valve Assembly altaches to the Aspira® Drainage Catheter. The Aspira® Repair of the Aspira" Aspira" Drainage Catheter. The Aspira Repair Kit is for the repair of the Aspira" Drainage Catheter and replacement of the Aspira® Valve Assembly.
The Aspira* Peritoneal Drainage System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the Aspira* Peritoneal Drainage System are the Aspira* Peritoneal Drainage Catheter and the Aspira* Drainage Bag. The Aspira* Peritoneal Drainage System.
This document, outlining a Special 510(k) Premarket Notification for the Aspira® Peritoneal Drainage System, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a new device. Therefore, a direct response to all parts of your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided in the context of this regulatory document.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative "acceptance criteria" for clinical performance. Instead, it states that "Verification and validation activities were designed and performed to demonstrate that the subject Aspira® Peritoneal Drainage System met predetermined performance specifications." The general "reported device performance" is that "The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device."
The document lists several standards and guidance documents that were used to determine appropriate methods for evaluating the performance of the device. These indirectly form the basis of the "acceptance criteria" in a regulatory submission context, as compliance with these standards demonstrates safety and effectiveness.
| Acceptance Criteria (based on standards/guidance) | Reported Device Performance |
|---|---|
| Biological Evaluation (ISO 10993-1:2009, ISO 10993-7:2008, AAMI TIR 19:1998) | Met requirements (verified through testing per standards) |
| Conical Fittings (Luer) Requirements (ISO 594-1:1986, ISO-594-2:1998) | Met requirements (verified through testing per standards) |
| Sterile Drainage Catheters and Accessory Devices (EN 1617:1997, EN 1618:1997) | Met requirements (verified through testing per standards) |
| Packaging for Terminally Sterilized Medical Devices (ISO 11607-1,2:2006, ISTA -1G:2005) | Met requirements (verified through testing per standards) |
| Sterilization (Ethylene Oxide) Validation and Routine Control (BS EN 550:1994, ISO 11135-1:2007) | Met requirements (verified through testing per standards) |
| Overall safety and effectiveness (based on technological characteristics compared to predicate, and compliance with 21 CFR 820.30) | Demonstrated substantial equivalence to predicate device |
2. Sample size 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 a sample size for a clinical test set for the device performance. The listed "Safety & Performance Tests" are primarily related to bench testing and material evaluations (e.g., biocompatibility, sterility, packaging, Luer fittings), not clinical trials with human subjects. There is no mention of data provenance (country of origin, retrospective/prospective clinical 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)
This is not applicable to this document. The listed "tests" are primarily engineering, chemical, and biological evaluations against harmonized standards, which do not typically involve experts establishing clinical ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no mention of a clinical test set requiring adjudication. The document reports on in-house engineering and laboratory testing.
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 is not applicable. The device is a physical medical device (peritoneal drainage system), not an AI-powered diagnostic tool, and therefore MRMC studies or AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "tests" listed (biocompatibility, fittings, sterilization, etc.), the "ground truth" would be compliance with the specific parameters and thresholds defined within the referenced international standards (e.g., biological response within acceptable limits, fitting dimensions meeting specified tolerances, sterility assurance level achieved). These are objective measurements rather than an expert consensus on clinical findings or pathological diagnoses.
8. The sample size for the training set
This is not applicable. There is no mention of a training set as the device is not an AI/machine learning system.
9. How the ground truth for the training set was established
This is not applicable. There is no training set for this type of device.
In summary: This document is a regulatory submission demonstrating substantial equivalence for a physical medical device, not a research paper detailing a study of a novel device against clinical acceptance criteria. The "proof" of meeting acceptance criteria comes from successful completion of various bench and lab tests according to recognized international standards and guidance documents, which are used to show that the device is as safe and effective as its predicate.
§ 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.