(265 days)
The Fresenius APD Luer-Lock Adapter is intended for use with an Automated Peritoneal Dialysis cycler for the exchange of peritoneal dialysis solution. The single-use device is designed to connect any Fresenius cycler set with a Safe-Lock® connector to a peritoneal dialysis solution bag equipped with a standard luer-lock connector.
The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock® connector (e.g., Liberty® cycler, Newton IQ® cycler).
The provided document is a 510(k) summary for the Fresenius APD Luer-Lock Adapter. It describes the device, its intended use, and indicates that performance testing was conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the methodological details typically associated with studies proving a device meets acceptance criteria, particularly for AI/ML-based medical devices.
The document pertains to a physical medical device (an adapter) and its performance evaluation through standard engineering and biocompatibility tests, not an AI/ML diagnostic or prognostic algorithm. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.
Here's a breakdown of what can be extracted or inferred from the provided text, and where information is missing or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Specific Values/Thresholds) | Reported Device Performance / Evaluation |
|---|---|---|
| Biological Safety | Not specified (implied to meet relevant standards) | Material characterization and biocompatibility testing performed. |
| Sterility | Not specified (implied to meet relevant standards) | Sterility and nonpyrogenicity testing performed. |
| Nonpyrogenicity | Not specified (implied to meet relevant standards) | Sterility and nonpyrogenicity testing performed. |
| Structural Integrity | Not specified (implied to meet relevant standards) | Bond strength tensile testing performed. |
| Performance (Leak Test) | Not specified (implied to meet relevant standards) | Connector underwater leak test performed. |
| Performance (ISO 594-1 & 594-2) | ISO 594-1 and 594-2 requirements | Complete ISO 594-1 and 594-2 testing performed. |
| Functional Testing | Not specified (implied functional equivalence to predicate) | Simulated use testing performed. |
| Overall Equivalence | Performance is "substantially equivalent" to predicate. | "Based on a cumulative review of the verification testing, the performance of the APD Luer-Lock Adapter is substantially equivalent to the predicate Universal Connector..." |
Missing Information: The document states what types of tests were performed but does not provide the specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum leakage rate) or the exact numerical results obtained from these tests. It only reports that the testing "provided a sound basis for comparison" and demonstrated substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided for this Device Type: This information is typically relevant for studies evaluating the performance of diagnostic algorithms or imaging devices with clinical data. For a physical adapter, testing involves bench-top engineering tests (e.g., tensile strength, leak tests) and biocompatibility studies, not clinical "test sets" in the sense of patient data. The document does not specify the number of adapters tested for each performance criterion. Data provenance like "country of origin" or "retrospective/prospective" is also not applicable to this type of engineering and biocompatibility testing.
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 is relevant for AI/ML devices where human expert consensus often establishes ground truth for diagnosis/prognosis. For a physical adapter, "ground truth" is established by adherence to engineering specifications, physical integrity, and biological safety standards, evaluated by laboratory methods and qualified technicians/scientists, not by clinical experts reviewing cases for a diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are used in clinical studies, particularly for diagnostic accuracy, where disagreements between experts need to be resolved to establish a definitive ground truth. This concept does not apply to the performance testing of a physical medical device like an adapter.
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: MRMC studies are specifically designed to evaluate the performance of diagnostic imaging aids (often AI-powered) by comparing human reader performance with and without the aid. This is entirely irrelevant to an APD Luer-Lock adapter.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This question pertains to the performance of an AI algorithm in isolation. Since the device is a physical adapter, there is no AI algorithm to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering/Physical Standards & Biological Safety Standards: For this device, "ground truth" refers to meeting established engineering specifications for structural integrity (e.g., bond strength, leak-proof nature), functional compatibility (connecting Luer-Lock to Safe-Lock), and adherence to biological safety standards (biocompatibility, sterility, nonpyrogenicity). This is confirmed through laboratory testing against predefined criteria, not clinical outcomes or expert consensus on diagnosis.
8. The sample size for the training set
- Not Applicable: "Training set" refers to data used to train an AI/ML model. This device is a physical adapter and does not involve AI/ML.
9. How the ground truth for the training set was established
- Not Applicable: As there is no AI/ML model or training set, this question is not applicable.
Conclusion:
The provided document is a 510(k) summary for a physical medical device (an adapter). The "study" mentioned refers to a series of engineering, biological safety, and functional tests conducted to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance. The focus of these tests is on the device's physical properties, safety, and functional compatibility.
Many of the questions posed (especially those related to sample sizes for test/training sets, experts, adjudication, MRMC studies, and AI/ML performance) are highly specific to the evaluation of AI/ML-based diagnostic or prognostic medical devices and are not relevant to the type of device and submission described in this document. The document confirms that testing was done and that the device meets equivalence criteria based on those tests, but it does not provide the granular detail of a clinical trial or algorithm validation study.
§ 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.