(112 days)
The Aspira Peritoneal Drainage System 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.
•Aspira Drainage Catheter: The Aspira Dramage catheter is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieves symptoms such as dyspnea or other symptoms associated with malignant ascites.
• Aspira Drainage Bag: The Aspira Drainage Bag is indicated for use only with the Aspira Valve Assembly for internittent drainage.
•Aspira Drainage Bottle: The Aspira Drainage Bottle is indicated for use only with the Aspira Valve Assembly for intermittent drainage.
• Aspira Dressing Kit: The Aspira Dressing Kit is indicated for dressing of the drainage catheter and exit site.
•Aspira Valve Assembly / Repair Kit: The Aspira Valve Assembly is indicated for use with Aspira, PleurX® and Rocket® catheters.
• Aspira Luer Adapter: The Luer Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method. · Aspira Universal Tubing Adapter: The Universal Tubing Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe,or other appropriate method.
The Aspira Peritoneal Drainage System provides patients with a convenient method to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites at home. The primary components of the Aspira Peritoneal Drainage System are the Aspira Peritoneal Drainage Catheter, the Aspira Drainage Bag, and the Aspira Drainage Bottle.
The provided text describes the 510(k) summary for the Aspira Peritoneal Drainage System. It outlines the device's intended use, indications for use, and a comparison to a predicate device. Crucially, it lists the performance data provided in support of the substantial equivalence determination, specifically focusing on bench testing and human factors engineering/user engineering.
However, the document does not provide specific acceptance criteria or detailed results in a table format. It states generally that "The results of the testing demonstrated that the subject Aspira Peritoneal Drainage System met the predetermined acceptance criteria applicable to the safety and efficacy of the device."
Furthermore, it does not include information on:
- The sample size used for the test set or data provenance.
- The number of experts used to establish ground truth or their qualifications.
- The adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or the effect size.
- Whether a standalone algorithm performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
Therefore, based solely on the provided text, I cannot fulfill all parts of your request. The information required for a detailed description of acceptance criteria, study design, and ground truth establishment (especially related to AI/algorithm performance) is not present. The document focuses on regulatory submission for a medical device that appears to be mechanical/physical, not an AI/software as a medical device (SaMD).
If this were an AI/SaMD, the typical information regarding "acceptance criteria" would refer to performance metrics like sensitivity, specificity, AUC, F1 score, etc., and the "study" would be a clinical validation of the algorithm. The provided text, however, refers to performance tests of a physical device.
Here's what can be extracted and inferred from the text, framed as if it were a full answer, but with caveats:
Acceptance Criteria and Study for the Aspira Peritoneal Drainage System
Based on the provided 510(k) summary for the Aspira Peritoneal Drainage System, the device's acceptance criteria and performance were assessed through a series of bench testing and human factors engineering/user engineering simulations. The document states that the testing demonstrated the device met "predetermined acceptance criteria applicable to the safety and efficacy of the device," without providing specific numerical thresholds for these criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
- Note: The document lists the types of tests performed, but does not numerically define the acceptance criteria or report specific quantitative performance results for each test. The general statement is that all criteria were met.
| Test Category | Specific Test Performed | Acceptance Criteria (Not Explicitly Stated Numerically) | Reported Device Performance (General Statement) |
|---|---|---|---|
| Bench Testing | Catheter Leak Test (Negative Pressure) | No leakage at specified negative pressure. | Met predetermined criteria. (Implied: No leakage observed) |
| Tensile Strength – Valve Assembly to Catheter (Aspira Valve – Compatibility) | Withstand specified tensile force without detachment/failure. | Met predetermined criteria. (Implied: Maintained integrity) | |
| Design Validation - Insertion Forces (Aspira Valve – Compatibility) | Insertion forces within acceptable ergonomic/medical limits. | Met predetermined criteria. (Implied: Acceptable insertion forces) | |
| 1000 mL Fluid Pull Leak Test (Aspira Drainage Bottle) | No leakage during fluid pull at 1000 mL capacity. | Met predetermined criteria. (Implied: No leakage observed) | |
| Barb to Tubing Tensile (Aspira Drainage Bottle) | Withstand specified tensile force at connection points. | Met predetermined criteria. (Implied: Maintained integrity) | |
| Tubing to Connector Tensile (Aspira Drainage Bottle) | Withstand specified tensile force at connection points. | Met predetermined criteria. (Implied: Maintained integrity) | |
| Tubing Impact Resistance (Aspira Drainage Bottle) | Maintain integrity after specified impact. | Met predetermined criteria. (Implied: Resisted impact without damage) | |
| Human Factors Engineering/User Engineering | Drainage Speed Control | User able to control drainage speed as intended. | Met predetermined criteria. (Implied: Control was effective) |
| Bottle Emptying | Easy and complete emptying of the bottle. | Met predetermined criteria. (Implied: Emptying was efficient) | |
| Bottle Activation Force | Activation force within ergonomic limits. | Met predetermined criteria. (Implied: Force was appropriate) | |
| Bottle Activation Method | Activation method intuitive and effective. | Met predetermined criteria. (Implied: Method was effective) | |
| Drainage Time | Drainage time within acceptable clinical range. | Met predetermined criteria. (Implied: Drainage time was adequate) | |
| Indication of Full Flow | Clear indication of full flow for users. | Met predetermined criteria. (Implied: Indication was clear) | |
| Intuitiveness of Status | Device status easily understood by users. | Met predetermined criteria. (Implied: Status was intuitive) | |
| Handle Reseal Ability | Handle reseals effectively. | Met predetermined criteria. (Implied: Reseal was effective) | |
| Grip Comfort when Empty | Comfortable grip for users when bottle is empty. | Met predetermined criteria. (Implied: Grip was comfortable) | |
| Grip Comfort when Full | Comfortable grip for users when bottle is full. | Met predetermined criteria. (Implied: Grip was comfortable) | |
| IFU Understandability for Lay Users | Instructions for Use (IFU) easily understood by lay users. | Met predetermined criteria. (Implied: IFU was clear) | |
| Ease of Use | Overall ease of use. | Met predetermined criteria. (Implied: Device was easy to use) | |
| Vacuum Loss | No significant/unintended vacuum loss. | Met predetermined criteria. (Implied: Vacuum maintained as intended) | |
| Fluid Leak | No fluid leakage. | Met predetermined criteria. (Implied: No leakage observed) |
2. Sample Size and Data Provenance for Test Set:
- The document does not specify the sample size used for the test set (e.g., number of units tested for each bench test, number of participants for human factors).
- The data provenance (e.g., country of origin, retrospective or prospective) is not stated. Given the context of a 510(k) summary, these are likely internal company tests performed to regulatory standards, rather than clinical trial data.
3. Number of Experts and Qualifications for Ground Truth:
- This information is not provided. For physical device performance testing, "ground truth" might refer to engineering specifications or validated test methods, rather than expert interpretation of medical images. For human factors testing, "expert" might implicitly refer to human factors specialists and user testers, but their number and qualifications are not detailed.
4. Adjudication Method for Test Set:
- This information is not provided and is generally not applicable to bench or human factors testing of this nature. It is typically relevant for studies involving subjective interpretation (e.g., image reading).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was mentioned. This type of study (comparing human readers with and without AI assistance) is specific to AI/SaMD and not relevant to the physical device described.
6. Standalone Algorithm Performance Study:
- No standalone algorithm performance study was mentioned. This device is not an AI/algorithm-based product.
7. Type of Ground Truth Used:
- For the bench tests, the "ground truth" would be established engineering specifications, performance standards, and validated test methodologies. For human factors, it would be user feedback and observed performance against pre-defined usability metrics. No mention of expert consensus, pathology, or outcomes data is made for establishing ground truth in this context.
8. Sample Size for Training Set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set was Established:
- Not applicable, as there is no training set for a physical device.
§ 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.