(86 days)
This bag is intended for the collection of effluent during Automated Peritoneal Dialysis (APD) Therapy.
Baxter's Cycler Drainage Bag product line currently consists of a sterile 15L Cycler Drainage Bag (5C4145P). This 15 L Cycler Drainage Bag is a single use device intended for the collection of effluent during Automated Peritoneal Dialysis (APD) Therapy and can be used with Baxter's APD Sets with Cassette, Manifold Sets and Extension Sets. The purpose of this drain bag is to allow the collection of the spent effluent in the event that a patient does not have access to a drain from the location where APD therapy is performed. The basis for this submission is the addition of a non-sterile version of the 15L Cycler Drainage Bag to the current product line. The product line does not come into direct or indirect contact with the patient's body tissue. The intended use, material, design, and function of the proposed device will be the same as the currently marketed 15 L Cycler Drainage Bag.
The provided document describes a 510(k) premarket notification for a new non-sterile version of Baxter's 15L Cycler Drainage Bag (product code 5C4145NS), comparing it to the currently marketed sterile version (5C4145P) which serves as the predicate device. The primary difference is the sterility status.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance (Implied) |
|---|---|---|
| Capacity/Leak (5C4145P) | The product shall hold 16 liters of water for 24 hours without leak. | Met |
| Capacity/Leak (5C4145NS) | The product shall hold 16 liters of water for 48 hours without leak. | Met |
| Drain Line Spike/Leak | Force to spike drain line connector shall be no more than 35 lbf with no leak at 8psig for 10 seconds. | Met |
| Drain Line Spike Removal (5C4145P) | Force to remove spike connector after a 24-hour therapy shall be no less than 3 lbf. | Met |
| Drain Line Spike Removal (5C4145NS) | Force to remove spike connector after a 48-hour therapy shall be no less than 3 lbf. | Met |
| Clamp Closure Force | Manual shut-off clamp closure force on tubing lines shall be no more than 26 lbf. | Met |
| Clamp Opening Force | Manual shut-off clamps on lines shall open with a force no more than 10 lbf. | Met |
| Bioburden Measurement | The drain bag shall have less than or equal to 100 CFUs per set. | Met |
| Microbial Travel (5C4145NS) | Upper boundaries for bacterial travel distance for both ascending and descending positions at 35-39℃ after 48 hours are less than the distance required to contaminate the APD cassette. | Met (demonstrated mitigation of contamination risk) |
| Cycler System Level (5C4145NS) | For both the HomeChoice and HomeChoice Claria cyclers: Under least favorable conditions, the drain flow rate lower bound > 50ml/min. | Met |
| Spike Tip Protector Removal Force (5C4145P) | The axial force to remove the spike tip protector shall not be less than 4.5 N (1.0 lbf) or greater than 45 N (10.0 lbf). | Met |
| Pull Ring Tip Protector Removal Force (5C4145P) | The axial force to remove the pull ring tip protector shall not be less than 4.5 N (1.0 lbf) or greater than 54 N (12.0 lbf). | Met |
| Solvent Bond Leak Strength (5C4145P) | The subsystem, after being subjected to a 5 lbf pull force shall not leak when subjected to 8 psig pressure for 10 seconds. | Met |
| Connection Duration Test (5C4145P) | Drain bag and APD sets connected after 48 hours. | Met |
| Biocompatibility | Evaluation in accordance with ISO-10993 Biological Evaluation of Medical Devices Part 1, classified as "non-contact". | Biocompatibility standards met for non-contact device. |
| Sterilization (5C4145P) | Sterility Assurance Level (SAL) of 10^-6 according to ANSI/AAMI ST67:2019 and ANSI/AAMI/ISO 11135-1:2014. | Met (for sterile version; not applicable to the proposed non-sterile version) |
| Shelf Life | 5 years | Supported by aging testing. |
Note: The document states that "All results meet the acceptance criteria," therefore, the reported device performance for all listed criteria is implicitly "Met."
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample sizes for each specific test or the data provenance (e.g., country of origin) for the test sets. The tests are described as "design verification tests" conducted by Baxter Healthcare Corporation. It is implied these are internal company tests, so the data provenance would be internal to Baxter, likely in the US (where Baxter is headquartered). The studies appear to be prospective, as they were conducted to support the premarket notification for a new product configuration.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided. The tests described are largely objective engineering and microbiological performance tests (e.g., leak tests, force measurements, bioburden, microbial travel), which typically rely on predefined specifications and instrumentation rather than expert consensus on a "ground truth" in the diagnostic sense.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the tests are objective performance evaluations against established engineering and safety specifications, not subjective assessments requiring adjudication.
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. This device is a medical accessory (drainage bag), not a diagnostic imaging or AI-enabled device. Therefore, MRMC studies and AI-related effectiveness are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a medical accessory, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests outlined (Capacity/Leak, Drain Line Spike/Leak, Clamp forces, Bioburden, Microbial travel, Cycler System Level, Removal forces, Solvent Bond Leak Strength, Connection Duration) is based on engineering specifications, established industry standards (e.g., ISO, AAMI), and risk analyses. For biocompatibility, it's adherence to ISO-10993. For microbial travel, it's the lack of contamination reaching a critical point (APD cassette). These are objective, measurable criteria, not subjective human interpretations.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical accessory, not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set is involved.
§ 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.