(181 days)
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.
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 with Luer-Lock is used to connect a PD catheter with a Luer-Lock catheter adapter to PD systems that use stay safe PIN technology.
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 (hereinafter referred to as "Safe-Lock extension set") is a single-use device designed to connect a PD catheter to PD systems that use staysafe 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 stay safe® catheter extension sets with Luer-Lock (hereinafter referred to as "Luer-Lock extension sets") are single-use devices designed to connect a PD catheter to PD systems that use 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 stay safe® to Luer-Lock adapter (hereinafter referred to as "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 document is a 510(k) premarket notification for several medical devices: "stay safe® catheter extension set with Safe-Lock," "stay safe® catheter extension set with Luer-Lock," and "stay safe® to Luer-Lock adapter." These are accessories for peritoneal dialysis systems.
The document describes the acceptance criteria and the studies performed to demonstrate that the devices meet these criteria. However, it is important to note that the type of acceptance criteria and studies are not based on AI/ML performance, but rather on the safety and effectiveness of the physical medical devices. Therefore, many of the typical questions for AI/ML device evaluations (e.g., sample size for test/training set, expert ground truth, MRMC studies, effect size of human improvement with AI) are not applicable here.
Here's a breakdown of the requested information based on the provided text, with explanations for non-applicable points:
Acceptance Criteria and Device Performance for Physical Medical Devices
The acceptance criteria for these devices are primarily focused on their physical and biological properties to demonstrate substantial equivalence to predicate devices, ensuring safety and effectiveness for their intended use in peritoneal dialysis.
1. A table of acceptance criteria and the reported device performance
The document lists performance data categories rather than specific quantitative acceptance criteria or numerical reported performance values. The overarching acceptance criterion is demonstrating "substantial equivalence" to predicate devices, implying that the new devices perform safely and effectively for their intended use.
| Acceptance Criteria Category (Testing Performed) | Reported Device Performance Summary (as per document) |
|---|---|
| Performance Testing | |
| Tubing verification | Testing conducted to support substantial equivalence. |
| Clamp performance (where applicable) | Testing conducted to support substantial equivalence. |
| Connectology (stay safe, Safe-Lock/Luer-Lock) | Testing conducted to support substantial equivalence. |
| Package verification | Testing conducted to support substantial equivalence. |
| Engagements bond/tensile strength | Testing conducted to support substantial equivalence. |
| Device weight verification | Testing conducted to support substantial equivalence. |
| Cleaning agents compatibility | Testing conducted to support substantial equivalence. |
| Latex content verification | Testing conducted to support substantial equivalence. |
| Particulate visual inspection | Testing conducted to support substantial equivalence. |
| Shipping and packaging | Testing conducted to support substantial equivalence. |
| Maintenance of sterility | Testing conducted to support substantial equivalence. |
| ISO 594-2 (for Luer-Lock extension set/adapter) | Testing conducted to support substantial equivalence. |
| Biocompatibility Testing | |
| Simulated Use Leachables Testing | Testing conducted to support biological safety. |
| Cytotoxicity, ISO Elution Method with MEM | Testing conducted to support biological safety. |
| Sensitization, Guinea Pig Maximization | Testing conducted to support biological safety. |
| Intracutaneous Irritation | Testing conducted to support biological safety. |
| Acute Systemic Toxicity | Testing conducted to support biological safety. |
| Systemic Toxicity, Short-Term Repeated Exposure | Testing conducted to support biological safety. |
| Material-Mediated Pyrogenicity | Testing conducted to support biological safety. |
| Genotoxicity (Bacterial Review Mutation Assay, in vitro Mouse Lymphoma Gene Mutation Assay, Mouse Micronucleus in vivo Assay) | Testing conducted to support biological safety. |
| Hemocompatibility, ASTM Hemolysis (Indirect) - Extract | Testing conducted to support biological safety. |
| Toxicological risk assessment | Performed. |
| Human Factors Validation Testing | |
| Usability | Validated for safe and effective use in accordance with FDA guidance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document, as the studies are primarily about physical and biological testing of the device for manufacturing and material safety and performance, not data-driven algorithmic performance or clinical trial data. These tests would involve specific numbers of physical units of the device.
- Sample Size: Not specified for the performance and biocompatibility tests.
- Data Provenance: Not applicable in the context of AI/ML. The tests are laboratory-based and conducted on the manufactured device units.
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 as the device is a physical medical accessory, not an AI/ML algorithm requiring expert interpretation to establish ground truth for image or diagnostic data. Ground truth here refers to the validated physical and biological properties of the device, established through standardized testing methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or AI/ML evaluations to resolve disagreements among human readers or experts in establishing ground truth. For these physical devices, the "ground truth" is determined by meeting engineering and biocompatibility standards.
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. MRMC studies are specific to AI/ML devices where the performance of human readers, with and without AI assistance, is compared. This document concerns a physical medical accessory, not an AI-powered device. No human-in-the-loop study involving AI was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This refers to the performance of an AI algorithm on its own. The devices are physical medical accessories, not software algorithms.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for these physical devices is established through compliance with recognized standards and validated test methods for material properties, mechanical integrity, sterility, and biocompatibility. These involve:
- Engineering specifications and design requirements.
- ISO standards (e.g., ISO 10993-1 for biocompatibility, ISO 594-2 for Luer connections).
- Laboratory testing results (e.g., tensile strength measurements, bacterial cultures for sterility, chemical analysis for leachables).
- Demonstration of functional performance (e.g., proper connection, fluid flow).
- Toxicological risk assessment.
There is no "expert consensus" on imaging or diagnostic outcomes, nor pathology or outcomes data in the context of an AI/ML device.
8. The sample size for the training set
This is not applicable. A training set is used for machine learning models. These are physical medical devices, and the document explicitly states:
- "Software Verification and Validation Testing: Not applicable. The [device] does not contain software." (Applicable to all three device types).
9. How the ground truth for the training set was established
This is not applicable due to the reason stated in point 8.
§ 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.