(83 days)
The High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) are single use caps that are intended for use with appropriate Peritoneal Dialysis (PD) products. The High Dose Cap is designed to isolate (cap off) the Easy-Lock™ connector (patient line) of the PD disposable set. The MiniCap is designed to isolate (cap off) the Easy-LockTM connector of the patient's transfer set.
The High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456) is a single use cap that is intended for use with appropriate Peritoneal Dialysis (PD) disposable products. The High Dose Cap is designed to isolate (cap off) the Easy-Lock™ connector (patient line) of the PD disposable set.
The High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) consists of the High Dose Disconnect Cap, which contains a povidone iodine impregnated polyurethane sponge, a spacer, and a MiniCap. The MiniCap also contains a povidone iodine impregnated polyurethane sponge. The povidone iodine sponge is used to disinfect the mating interface between the disconnect caps (High Dose Cap and MiniCap) and the patient connector of the PD disposable set and the patient transfer set, respectively. The High Dose Cap and the MiniCap are packaged together to conveniently allow the patient to disconnect from the peritoneal cycler therapy when desired. The spacer aids in the convenience packaging of the two caps into one product and has no other functional use. The MiniCap product is currently cleared for marketing under K895631 and is sold separately.
Similarly, the High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456) simply consists of the High Dose Disconnect Cap and a povidone iodine impregnated polyurethane sponge. The povidone iodine sponge is used to disinfect the mating interface between the disconnect cap and the patient connector of the PD disposable set.
In general, the design and materials of the subject disposable disconnect caps are similar to the Baxter predicate devices. The caps provide an integral seal to the mating part, have exterior ribs to facilitate use, and contain a iodine impregnated sponge for disinfecting purposes.
The provided text describes a 510(k) summary for the "High Dose Disconnect Cap and MiniCap with Povidone-Iodine Solution (5C4486) and High Dose Disconnect Cap with Povidone-Iodine Solution (5C4456)".
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Microbiological | "The High Dose Disconnect Cap was able to deliver the desired kill of the test organism." |
| Cap/Connector Seal | "Additionally, the cap/connector seal passed the specified pressure test." |
| Ease of Use (Torque) | "The torque to remove the cap is not greater than currently available disconnect caps." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the sample size used for any of the tests (microbiological, cap/connector seal, or ease of use).
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a 510(k) submission from Baxter Healthcare Corporation, based in McGaw Park, IL, suggesting the tests were likely conducted in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- The document describes performance/functional testing (microbiological, seal, torque). For these types of tests, "ground truth" as typically understood in AI/medical imaging contexts (e.g., expert consensus on image interpretation) is not directly applicable. The "ground truth" for these tests would be established by the defined test methods (e.g., a specific microbial reduction level, a specific pressure retention).
- Therefore, the document does not mention a number of experts or their qualifications for establishing ground truth for these specific performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- As mentioned above, the tests are performance/functional in nature, not involving interpretation by multiple human readers that would require an adjudication method.
- Therefore, the document does not describe an adjudication method.
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 device is a physical medical device (disconnect caps with povidone-iodine solution), not an AI-powered diagnostic or assistive technology.
- Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a physical device, not an algorithm.
- Therefore, a standalone algorithm performance study is not applicable and was not done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the microbiological test, the "ground truth" would be the measurable "desired kill of the test organism" as defined by a standard microbiological test method.
- For the cap/connector seal test, the "ground truth" is the "specified pressure test" passed.
- For the ease of use (torque) test, the "ground truth" is the comparison against "currently available disconnect caps."
8. The sample size for the training set:
- This device is a physical medical device; it does not involve a training set in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Since there is no training set for this physical device, this question is not applicable.
§ 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.