(90 days)
The Cycler Drain Bag Set is indicated for use by patients with acute and stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The Cycler Drain Bag Set is an optional receptacle that connects to the Luer-lock end of a Cycler Set drain line in order to collect patient effluent during PD treatments. This device is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.
The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects to the drain line of a cycler set to collect patient effluent by means of gravity and the pumping action of a Peritoneal Dialysis (PD) cycler. The Drain Bag Set connects to the drain line using a standard Luer lock connection. The Drain Bag Set consists of three (3) interconnected 7-liter drain bags, each with a sampling port and an occluding clamp. The tubing lines that connect each drain bag to the drain line have a snap-disconnect tubing segment. This tubing segment allows the user to disconnect individual bags by snapping the tubing apart.
The provided document describes the acceptance criteria and performance data for the Cycler Drain Bag Set (K173363), a medical device used in peritoneal dialysis.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Conducted | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Drop Test | The drain bag shall not leak (visual inspection). Acceptance criteria from ISO 15747:2010 were applied. | Pass, results within acceptance criteria |
| Internal Pressure Test | The drain bag shall not leak (visual inspection). Acceptance criteria from ISO 15747:2010 were applied. | Pass, results within acceptance criteria |
| Hanger Holes Tensile Strength | The drain bag hanger holes shall withstand a tensile load of 15 N for 60 minutes. Acceptance criteria from ISO 15747:2010 were applied. | Pass, results within acceptance criteria |
| Film Roughness Test | The drain bag's film shall have a roughness ≤ 0.75 µm (Roughness Average). | Pass, results within acceptance criteria |
| Tensile Strength of Bonding | All bonded engagements between plastic composites shall require >10 lbf to detach. | Pass, results within acceptance criteria |
| Maintenance of Sterility testing | Acceptance criteria from ISO 11607-1:2006/(R)2010 - A1:2014 were applied. | Pass, results within acceptance criteria |
| Male Luer lock connector testing | Acceptance criteria from ISO 594-2:1998 were applied. | Pass, results within acceptance criteria |
| Drain Bag Set Capacity | The Drain Bag Set shall hold at least 24 L of water (volume ≥ 24 L). | Pass, results within acceptance criteria |
| Sampling Port Leakage Test | The sampling port shall not leak after being punctured with a 23 gauge needle one time for 15 seconds and subjected to a pressure of 20 kPa under water for 15 seconds. Acceptance criteria from ISO 15747:2010 were applied. | Pass, results within acceptance criteria |
| Snap Connector Breakage Test | The snap connector shall have a break point between 60 oz-in and 120 oz-in. | Pass, results within acceptance criteria |
| Clamp Test | No leaks past the clamp. Acceptance criteria from ISO 8638:2010 were applied. | Pass, results within acceptance criteria |
| Vibratory (ship) Testing | No tubing kinks or loose or damaged components. | Pass, results within acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test. It states "The samples" were used for various tests (e.g., sampling port leakage test) but doesn't quantify how many samples.
The data provenance is from in-house laboratory testing performed by Fresenius Medical Care. It is not externally sourced and is not described as retrospective or prospective clinical data. The tests performed are primarily engineering and material science tests according to established ISO and ASTM standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and therefore not provided in the document. The tests performed are objective, quantitative engineering and material assessments against pre-defined industry standards (e.g., ISO, ASTM). They do not involve expert interpretation or clinical ground truth determination in the way a diagnostic AI device would.
4. Adjudication Method for the Test Set
This information is not applicable. Since the tests are objective physical and performance assessments against documented standards, there is no need for an adjudication method by experts. The results are "Pass" or "Fail" based on whether the measured values meet the specified criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance
This information is not applicable. The device is a physical medical accessory (drain bag set) and does not involve AI or human reader interpretation for its function. Therefore, no MRMC comparative effectiveness study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. As mentioned, the device is a physical accessory and does not contain any algorithms or software.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests conducted is based on established international and industry standards (ISO 15747:2010, ISO 11607-1:2006/(R)2010 - A1:2014, ISO 594-2:1998, ISO 8638:2010, ASTM D4169-14) and pre-defined engineering specifications (e.g., film roughness ≤ 0.75 µm, tensile strength >10 lbf, break point between 60 oz-in and 120 oz-in, capacity ≥ 24 L). These are objective, measurable criteria.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical device, and the testing described here is for performance verification. There is no "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as 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.