(41 days)
MiniCap Extended Life PD Transfer Sets: This set is used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient from the source solution container.
Locking Titanium Adapter for Peritoneal Dialysis Catheter: The Locking Titanium Adapter for Peritoneal Dialysis Catheter is intended to secure the peritoneal catheter tubing to the Baxter transfer set used during Peritoneal Dialysis therapy.
Locking Cap for Peritoneal Dialysis Catheter Adapter: This device is indicated for use in the treatment of patients receiving peritoneal dialysis therapy, to cap the Locking Titanium Adapter for Peritoneal Dialysis Catheter between Baxter Transfer Set installations.
The MiniCap Extended Life PD Transfer Sets 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 allows for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.
The Locking Titanium Adapter for Peritoneal Dialysis Catheter (Titanium Adapter) and Locking Cap for Peritoneal Dialysis Catheter (Locking Cap) are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. The Titanium Adapter is a device that is secured to the end of a peritoneal dialysis catheter and is used to connect the peritoneal dialysis catheter to the Transfer Sets. The Locking Cap is used to cap the end of the Titanium Adapter between Transfer Set installations.
This document describes the premarket notification (510(k)) for two sets of medical devices from Baxter Healthcare Corporation:
- MiniCap Extended Life PD Transfer Sets
- Locking Titanium Adapter for Peritoneal Dialysis Catheter and Locking Cap for Peritoneal Dialysis Catheter Adapter
The submission declares that these devices are substantially equivalent to legally marketed predicate devices. The majority of the information provided pertains to non-clinical performance testing and biocompatibility.
1. Acceptance Criteria and Reported Device Performance
The documents state that "All results meet their acceptance criteria, and support that the proposed device is appropriately designed for its intended use." However, specific numerical acceptance criteria and the detailed reported performance values (e.g., exact leak rates, torque values, flow rates) are not provided in the given text. Instead, the document lists the functional tests performed.
Table of Acceptance Criteria and Reported Performance (Based on provided text - specific values are not available):
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| MiniCap Extended Life PD Transfer Sets: | ||
| Leak Test Twist Clamp Closed | Not specified, implied to be "no leak" | Met acceptance criteria (implied) |
| Twist Clamp Torque to Open/Close | Not specified, implied to be within functional range | Met acceptance criteria (implied) |
| Leak Test Transfer Set to Patient Connector | Not specified, implied to be "no leak" | Met acceptance criteria (implied) |
| Patient Connector Torque On to Transfer Set | Not specified, implied to be within functional range | Met acceptance criteria (implied) |
| Patient Connector Torque Off from Transfer Set | Not specified, implied to be within functional range | Met acceptance criteria (implied) |
| MiniCap Test Attachment Torque On/Off to Transfer Set | Not specified, implied to be within functional range | Met acceptance criteria (implied) |
| Leak Test MiniCap to Transfer Set | Not specified, implied to be "no leak" | Met acceptance criteria (implied) |
| Flow Test CAPD Therapy and APD Therapy | Not specified, implied to be within functional range | Met acceptance criteria (implied) |
| Locking Titanium Adapter & Locking Cap for Peritoneal Dialysis Catheter: | ||
| Titanium Adapter/Patient Catheter Tubing Seal Test | Not specified, implied to be "no leak" | Met acceptance criteria (implied) |
| Tensile Pull Test Titanium Adapter to Patient Catheter Tubing | Not specified, implied to be above a minimum threshold | Met acceptance criteria (implied) |
| Locking Cap Removal Torque Test | Not specified, implied to be within functional range | Met acceptance criteria (implied) |
| Locking Cap Torque On Test | Not specified, implied to be within functional range | Met acceptance criteria (implied) |
| Tensile Strength Adapter Catheter to Luer End of Titanium Adapter | Not specified, implied to be above a minimum threshold | Met acceptance criteria (implied) |
| Adapter Catheter to Titanium Adapter - Torque On Test | Not specified, implied to be within functional range | Met acceptance criteria (implied) |
| Adapter Catheter to Titanium Adapter - Torque Off Test | Not specified, implied to be within functional range | Met acceptance criteria (implied) |
| Leak Test Adapter Catheter to Titanium Adapter | Not specified, implied to be "no leak" | Met acceptance criteria (implied) |
| Simulation Testing | Not specified, general functional performance | Met acceptance criteria (implied) |
| Biocompatibility (for all devices): | ||
| Cytotoxicity | Non-cytotoxic | Met acceptance criteria (implied) |
| Systemic Toxicity (Acute and Sub-chronic) | No significant systemic toxic effects | Met acceptance criteria (implied) |
| Irritation (Intracutaneous Reactivity) | Non-irritating | Met acceptance criteria (implied) |
| Sensitization | Non-sensitizing | Met acceptance criteria (implied) |
| Hemocompatibility | Biocompatible with blood components | Met acceptance criteria (implied) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the functional and biocompatibility test sets. It generically mentions "nonclinical tests." The data provenance is not specified regarding country of origin or whether it was retrospective or prospective, but as these are non-clinical (laboratory/bench) tests, typical clinical study provenance details would not apply. The tests were presumably conducted by Baxter Healthcare Corporation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the provided documentation describes non-clinical performance and biocompatibility testing of physical devices, not assessment of diagnostic accuracy or a similar task that would require expert-established ground truth.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective assessments.
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 section is not applicable. The devices are physical medical instruments (transfer sets, adapters, caps) used in peritoneal dialysis, not AI-powered diagnostic or assistive technologies. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the devices are not algorithms or AI systems.
7. The Type of Ground Truth Used
For the functional tests, the "ground truth" is established by predefined engineering specifications and performance standards for the device's operation (e.g., no leaks, specific torque values, adequate flow rates). For biocompatibility, the ground truth is established by the biological responses observed in standardized tests performed according to ISO 10993 standards. These are objective measures rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This section is not applicable as the devices are physical medical instruments, not machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set was Established
This section 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.