(50 days)
stay•safe® catheter extension set with Safe-Lock, 12 inch:
The stay•safe catheter extension set with Safe-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Safe-Lock is used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stay•safe PIN technology.
stay•safe® catheter extension set with Luer-Lock, 6 inch;
stay•safe® catheter extension set with Luer-Lock, 12 inch;
and stay•safe® catheter extension set with Luer-Lock, 18 inch:
The stay•safe catheter extension set with Luer-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Luer-Lock is used to connect a PD catheter with Luer-Lock catheter adapter to PD systems that use stay•safe PIN technology.
stay•safe® to Luer-Lock Adapter, 4 inch:
The stay•safe to Luer-Lock adapter is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe to Luer-Lock adapter is used to connect a stay•safe catheter extension set to medical devices with a Luer-Lock connection.
The stay•safe® catheter extension set with Safe-Lock, 12 inch (Safe-Lock extension set) stay•safe® catheter extension set with Luer-Lock, 6 inch, stay•safe® catheter extension set with Luer-Lock, 12 inch, and stay•safe® catheter extension set with Luer-Lock, 18 inch (Luer-Lock extension sets), and stay•safe® to Luer-Lock adapter, 4 inch (Luer-Lock adapter), hereinafter collectively referred to as the "Catheter Extension Sets" are the subject devices of this 510(k).
The Safe-Lock extension set is a single-use device designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Safe-Lock extension set is provided sterile and non-pyrogenic. The Safe-Lock extension set is sterilized using ethylene oxide (EO).
The Luer-Lock extension sets are single-use devices designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Luer-Lock extension sets are provided sterile and non-pyrogenic. The Luer-Lock extension sets are sterilized using EO.
The Luer-Lock adapter is a single-use device designed to connect a stay•safe catheter extension set to a medical device with a Luer lock connector. The Luer-Lock adapter is provided sterile and non-pyrogenic. The Luer-Lock adapter is sterilized using EO.
The provided FDA 510(k) clearance letter (K250404) for Fresenius Medical Care Renal Therapies Group's stay•safe® catheter extension sets and adapter pertains to a Class II medical device (Peritoneal Dialysis System and Accessories, Product Code KDJ).
Crucially, this document details the substantial equivalence of the new device to a legally marketed predicate device (K173593), based on non-clinical performance testing and biocompatibility. It explicitly states that "No clinical studies were performed for the Catheter Extension Sets." This means the type of study typically associated with assessing an AI/Software as a Medical Device (SaMD) to meet acceptance criteria through human reader performance (like MRMC studies) or standalone algorithmic performance was not conducted because this is a physical medical device, not AI/SaMD.
Therefore, I will describe the acceptance criteria and supporting studies based on the provided document, acknowledging that they are for a physical medical device and not an AI/SaMD.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
The acceptance criteria for the stay•safe® catheter extension sets and adapter are based on demonstrating substantial equivalence to a legally marketed predicate device (K173593) in terms of safety and efficacy. This is primarily achieved through non-clinical performance testing and biocompatibility assessments, rather than clinical efficacy studies involving human patient outcomes or AI performance metrics.
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a direct "table of acceptance criteria" with specific numerical targets and performance results for each test. Instead, it lists the types of performance tests conducted to support the determination of substantial equivalence. The implication is that the new devices met the predefined specifications for each test, which would be deemed "acceptable" for equivalence.
Based on the provided text, the categories of performance testing serve as the basis for acceptance. The "Reported Device Performance" is implicitly that the device met the requirements of each test, demonstrating substantial equivalence.
| Category of Performance Criteria (Acceptance Basis for Substantial Equivalence) | Reported Device Performance (Implicitly Met) |
|---|---|
| Physical/Mechanical Performance: | |
| - Weight Verification | Met specifications |
| - Length Verification | Met specifications |
| - Clamp Occlusion | Met specifications |
| - Clamp Compression | Met specifications |
| - Visual Inspection after Challenge Condition | Passed inspection after challenge |
| - Leak Test | Passed leak test |
| - Bond/Tensile Strength | Met strength requirements |
| - Shipping and Packaging (Integrity) | Maintained integrity during shipping/packaging |
| - Tubing Verification – Dimensional | Met dimensional specifications |
| Biocompatibility (Safety): | |
| - Chemical Characterization | Acceptable profile for patient contact |
| - Cytotoxicity | Non-cytotoxic |
| - Sensitization | Non-sensitizing |
| - Irritation | Non-irritating |
| - Systemic Toxicity (acute to chronic) | Non-systemically toxic |
| - Pyrogenicity | Non-pyrogenic |
| - Genotoxicity | Non-genotoxic |
| - Hemocompatibility | Hemocompatible |
| - Carcinogenicity | Non-carcinogenic |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes (number of units tested) for each of the performance or biocompatibility tests. This information is typically detailed in the engineering test reports or biocompatibility reports submitted as part of the 510(k) package, but not in the summary letter itself.
- Data Provenance: The data originates from non-clinical laboratory testing conducted by Fresenius Medical Care Renal Therapies Group, LLC, the device manufacturer. This is by nature prospective testing, as it is performed specifically to support the 510(k) submission for the new devices. The country of origin of the data is implied to be within the US, given the submission is to the US FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: For a physical medical device cleared via substantial equivalence based on non-clinical performance and biocompatibility testing, there are no "experts" in the sense of clinicians establishing a "ground truth" for a test set in the way one would for an AI/SaMD (e.g., radiologists annotating images). The "ground truth" for these tests is defined by engineering specifications, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and established test methods. The "experts" involved are engineers and scientists responsible for designing, conducting, and interpreting these tests according to predefined protocols and standards. Their qualifications would be in relevant fields such as biomedical engineering, materials science, and toxicology.
4. Adjudication method for the test set:
- Not Applicable: As there are no human-read interpretations or clinical assessments requiring reconciliation, there is no "adjudication method" in the context of clinical expert consensus. Test results are objectively measured against predefined acceptance criteria (e.g., a leak test either passes or fails, a tensile strength measurement is or is not within specification). Any discrepancies in test results would be handled through standard quality control and engineering investigation procedures.
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:
- No, an MRMC study was not done. This type of study is specifically relevant for software/AI devices that assist human readers in diagnosing or interpreting medical images/data. The device in question is a physical catheter extension set and adapter, not an AI or imaging device. The document explicitly states: "No clinical studies were performed for the Catheter Extension Sets."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not done. This is also relevant for AI/SaMD devices. The Catheter Extension Sets do not contain any software or algorithms. The document explicitly states: "Not applicable. The Catheter Extension Sets do not contain software."
7. The type of ground truth used:
- Engineering Specifications and Standardized Test Methods: The "ground truth" for the performance tests relies on established engineering specifications, mechanical properties of materials, and successful adherence to recognized industry standards (e.g., ISO for biocompatibility testing). For instance, a "leak test" has an objective pass/fail criterion based on absence of fluid leakage under defined pressure, not a clinical interpretation. Biocompatibility results are compared against toxicological limits and biological responses as defined by ISO 10993-1.
8. The sample size for the training set:
- Not Applicable: This pertains to machine learning models. As this is a physical medical device, there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable: There is no training set for this type of device.
In summary, the FDA's clearance for the stay•safe® catheter extension sets and adapter is based on a demonstration of substantial equivalence to an existing predicate device, supported by a comprehensive battery of non-clinical performance tests and biocompatibility assessments, validating its physical and material properties for its intended use, rather than clinical efficacy studies or AI/SaMD specific evaluations.
§ 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.