(147 days)
The Liberty Cycler Sets are designed to operate with the Liberty Cycler to perform acute and chronic peritoneal dialysis.
The Cycler Sets are sterile, single-use devices designed to operate with the Liberty Cycler to perform acute and chronic peritoneal dialysis. Each Cycler Set contains a cassette portion and seven (7) fluid lines. The cassette is composed of a rigid molded plastic body covered with a flexible film (membrane). The cassette contains molded features, such as fluid channels, valve domes, and pumping chambers. There are 7 fluid lines connected to the cassette body:
- One (1) drain line (yellow clamp)
- One (1) patient connection line with two (2) stay •safe® patient connectors (blue clamp)
- Five (5) Dialysate Solution Lines (with Safe-Lock® connectors):
- One (1) heater bag (red clamp)
- One (1) last dialysate bag/'last fill option' (green clamp)
- Three (3) additional solution bags (white clamps)
The flow of peritoneal dialysate solution to and from the patient's peritoneal cavity is directed by interaction between the Liberty Cycler and the cassette.
The Fresenius Liberty Cycler Set is an accessory for the Liberty Cycler, used for acute and chronic peritoneal dialysis. The 510(k) summary provides performance data and acceptance criteria for various aspects of the device.
Here's an overview of the acceptance criteria and supporting studies:
Key Takeaways:
- No AI Component: The provided document is for a medical device accessory (cycler set) that does not contain software or electrical components, and therefore no AI. Consequently, many of the typical AI-related study components (like expert ground truth, MRMC studies, training set details) are not applicable here.
- Focus on Physical and Biocompatibility Performance: The studies conducted focus on the physical performance of the cycler set (e.g., fill/drain accuracy, structural integrity, leak tests) and its biological safety (biocompatibility).
- Comparison to Predicate Device: The primary method for proving substantial equivalence to a legally marketed predicate device (K043363) relies on demonstrating similar technological characteristics and meeting established performance and safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance | Cycler Set fill and drain accuracy | Not explicitly stated, but implies meeting functional specifications for fluid delivery and removal. | Conducted (implies meeting criteria) |
| Load to close tubing clamps test | Not explicitly stated, but implies meeting force requirements for secure clamping. | Conducted (implies meeting criteria) | |
| Load to push the stay•safe patient connector test | Not explicitly stated, but implies meeting force requirements for secure connection. | Conducted (implies meeting criteria) | |
| Compression tests on cassette ports | Implies meeting break-force limits to ensure structural integrity during use. | Conducted (implies meeting criteria) | |
| Structural Integrity | Abrasion test | Not explicitly stated, but implies resistance to wear and tear. | Conducted (implies meeting criteria) |
| Positive and negative pressure leak test (Cycler Set) | Not explicitly stated, but implies no leaks under specified pressure ranges. | Conducted (implies meeting criteria) | |
| Bond strength testing (Tensile test) | Not explicitly stated, but implies adequate strength of bonded components. | Conducted (implies meeting criteria) | |
| Positive pressure leak test (connectors/clamps) | Not explicitly stated, but implies no leaks from patient connectors and tubing clamps under pressure. | Conducted (implies meeting criteria) | |
| Film seal integrity test (Endurance test) | Not explicitly stated, but implies seals maintain integrity over device lifespan/during use. | Conducted (implies meeting criteria) | |
| Shipping and packaging test | Not explicitly stated, but implies device maintains integrity and sterility after shipping. | Conducted (implies meeting criteria) | |
| Biological Safety | Simulated use Leachables | Implies that leachable substances are within safe limits. | Conducted (implies meeting criteria) |
| Cytotoxicity, ISO Elution Method with MEM | Implies non-toxic to cells. | Conducted (implies meeting criteria) | |
| Sensitization, Guinea Pig Maximization | Implies a low risk of causing allergic sensitization. | Conducted (implies meeting criteria) | |
| Intracutaneous Irritation | Implies materials do not cause significant skin irritation. | Conducted (implies meeting criteria) | |
| Material-Mediated Pyrogenicity | Implies materials do not cause fever. | Conducted (implies meeting criteria) | |
| Hemocompatibility, ASTM Hemolysis (Indirect) Extract | Implies materials do not cause significant red blood cell lysis. | Conducted (implies meeting criteria) | |
| Other | Human Factors (HF) validation | Not explicitly stated, but implies usability and safety are validated for intended users and environments. | Conducted (implies meeting criteria) |
| Maintenance of sterility | Not explicitly stated, but implies sterility is maintained until point of use. | Conducted (implies meeting criteria) |
Note: The document generally states that testing "was conducted or leveraged to support the determination of substantial equivalence" and "implies meeting criteria" without providing specific numerical acceptance limits or raw performance results. This is common in 510(k) summaries where detailed results are part of the full submission but not always publicly accessible.
2. Sample size used for the test set and the data provenance
- The document does not specify the exact sample sizes for each test in the test set.
- The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature. However, these are performance tests and biocompatibility tests conducted on the physical device and its materials, typically under controlled laboratory conditions rather than with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a cycler set (physical accessory), not an AI/software device that generates outputs requiring expert interpretation for ground truth. Ground truth for these tests would be established by objective measurements against engineering specifications and international standards (e.g., ISO, ASTM).
4. Adjudication method for the test set
- Not applicable for the same reasons as point 3.
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 does not have an AI component and therefore no MRMC study was performed in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device does not contain a standalone algorithm.
7. The type of ground truth used
- The ground truth for the performance and structural integrity tests are quantitative engineering specifications and established material testing standards.
- For biocompatibility, the ground truth is based on established international standards (e.g., ISO 10993-1) for evaluating biological responses to medical device materials.
8. The sample size for the training set
- Not applicable. This device is a physical accessory and does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- 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.