(263 days)
These sets are used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution container.
The MiniCap Extended Life PD Transfer Set with Twist Clamp – Code 5C4482A and MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. A Transfer Set is connected to a Titanium Adapter that is at the end of an implanted peritoneal catheter. The Transfer Sets stay connected to the patient and allow for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.
This document is a 510(k) Premarket Notification from the FDA regarding Baxter Healthcare Corporation's MiniCap Extended Life PD Transfer Sets. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving that a device meets specific acceptance criteria through a study as one might conduct for a new AI/software-as-a-medical-device (SaMD) product.
Therefore, the requested information (acceptance criteria, details of a study proving device performance, sample sizes, ground truth establishment, MRMC studies, etc.) is not applicable to this type of FDA submission (510(k) for a physical medical device, specifically a transfer set for peritoneal dialysis).
Here's why and what information is provided:
Why the requested information is not applicable:
- Device Type: The "device" in question is a physical medical device (Peritoneal Dialysis Transfer Set), not an AI/software product. The typical acceptance criteria and study designs for SaMD (which would involve accuracy, sensitivity, specificity, human reader performance, etc.) do not apply here.
- Submission Type (510(k)): A 510(k) submission aims to demonstrate "substantial equivalence" to a predicate device already on the market. It does not require a full clinical trial or a study proving independent performance against specific clinical acceptance criteria in the same way a PMA (Premarket Approval) or a SaMD submission might. The focus is on showing the new device is as safe and effective as a previously cleared device, not necessarily proving new clinical benefit or performance from scratch.
- Nature of Changes: The document explicitly states the primary change is a "material change" from Dichlorobenzoyl peroxide cured silicone to platinum cured silicone for the tubing. This triggers a need to demonstrate that this material change does not negatively impact the device's fundamental function, safety, or biocompatibility.
What information is provided in the document and how it relates to device proving safety and effectiveness for a 510(k):
Instead of a "study proving the device meets acceptance criteria" in the AI/SaMD sense, the document details "non-clinical tests" and "performance data" that support the device's safety and functional equivalence after a material change.
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: While not presented in a formal table with specific numerical targets like for an AI model's operating characteristics, the document implies acceptance criteria by stating "All results meet their acceptance criteria." These criteria would be tied to the functional tests described, ensuring the device performs as intended (e.g., no leaks, proper flow rate, withstands pressure, biocompatibility).
- Reported Device Performance: Instead of performance metrics like accuracy, the "performance data" section lists the types of tests conducted:
- Visual Inspection
- Initial Pressure Test (clamp in closed position)
- Cycling (conditioning step prior to pressure tests)
- 8 psi Pressure Test Post Cycling (clamp in both open and closed position)
- 5 lb Pull of Tubing to Barb Connection
- Functionality after Iodine Exposure (over 48 hours continuous and 6 months simulated use)
- Flow Rate (after iodine exposure)
- Shelf Life
- Biocompatibility Testing: Per ISO 10993-1 and FDA Guidance: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Sub-chronic Toxicity, Genotoxicity, Implantation, Hemolysis, Extractables and Leachables (per ISO 9003-18:2020), Toxicological Evaluation (per ISO 10993-17:2002).
- No specific numerical results are provided in this summary document, only the types of tests performed and the general conclusion that "The non-clinical data supports the safety of the proposed devices and demonstrates that the proposed devices perform comparably to the predicate device that is currently marketed for the same intended use."
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Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test in this summary. For physical device testing, sample sizes are typically determined by statistical methods for device reliability, manufacturing process validation, and regulatory standards (e.g., ISO, ASTM standards for material testing, biocompatibility). These are generally much smaller than data sets for AI models.
- Data Provenance: Not applicable. These are laboratory/bench tests, not clinical data from patients or specific countries.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of AI models, refers to verified labels (e.g., disease presence/absence in an image). For a physical medical device like this, "ground truth" would be the engineering specifications and performance standards established by the manufacturer and relevant regulatory bodies. Experts involved would be engineers, material scientists, toxicologists, and quality control professionals.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This is a concept used in medical image annotation or clinical trial data interpretation by multiple readers. For physical device testing, results are typically objective (e.g., pass/fail a pressure test) and follow standardized protocols.
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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. This is a physical medical device, not an AI or imaging diagnostic device. MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For this device, the "ground truth" is defined by established engineering specifications, material properties, and performance standards expected for a product of this type. It's based on objective measurements from laboratory tests and compliance with recognized standards (e.g., ISO 10993 for biocompatibility).
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The sample size for the training set:
- Not Applicable. This is not an AI/ML model.
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How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML model.
In summary: The provided document is a regulatory letter for a 510(k) submission of a physical medical device undergoing a material change. The information required for your query predominantly applies to software/AI medical devices, particularly those involving image analysis or diagnostic support. The "study" mentioned in the document refers to a series of non-clinical functional and biocompatibility tests designed to ensure the modified physical device maintains safety and performance comparable to its predicate.
§ 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.