(190 days)
The basics of the intended use has not changed. The Maersk Medical 4L drainage bag continue to be intended for collection of fluid which is on its way away from the body. The 4L drainage bag can be used in different treatment procedures within areas as urology and dialysis, but in any case the intended use is the same. The device label will state the following: A: "Peritoned Dialysis Drainage bag" B: "Collection bag fer urine"
The general description, operation, construction and use of the Maersk Medical 4L drainage bag has not changed as a result of the modifications. The 4L drainage bag contains basically the same features as the device described in K843480 and the manufacturing process is identical. However the 4L drainage bags will hold 4000 ml. compared to 2000 ml. for the device described in K843480. On a few points features has been added to the 4L drainage bag, but they are all added to improve patient and healthcare personnel comfort.
The provided text describes a 510(k) premarket notification for a medical device, specifically a 4L drainage bag. The core of this submission is to demonstrate substantial equivalence to an existing legally marketed predicate device (K843480), rather than establishing new performance criteria through a detailed clinical study.
Therefore, the input requests for acceptance criteria, study details, and related metrics often found in a de novo or PMA submission are not directly applicable in the same way for this 510(k). The "performance data" mentioned focuses on demonstrating equivalence to the predicate, not on setting and meeting new, specific performance thresholds against a defined clinical outcome.
Here's an analysis based on the provided text, addressing the requested points where information is available or noting when it's not applicable in the context of a 510(k) for substantial equivalence:
Description of Acceptance Criteria and Study to Prove Device Meets Them
The Maersk Medical 4L drainage bag's acceptance criteria and the "study" to prove it meets them are primarily framed around demonstrating substantial equivalence to a previously cleared predicate device (K843480). This means the acceptance criteria are implicitly that the 4L drainage bag performs at least as safely and effectively as the predicate device for its intended use, despite minor modifications (increased volume and added comfort features). The "study" largely consists of functional and quality testing to support this claim of equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a 510(k) for substantial equivalence, the "acceptance criteria" are not explicitly quantitative performance metrics in the way one might see for a novel device. Instead, they relate to maintaining the functional and quality characteristics of the predicate.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Collection of fluid away from the body (urology, dialysis) remains unchanged. | The basics of the intended use have not changed. The 4L drainage bag continues to be intended for fluid collection in various medical procedures. |
| Technological Characteristics: Not adversely affected by modifications. | "The technological characteristics of the device have not been affected by these modifications." |
| Safety: Does not introduce new safety concerns (e.g., no skin/drug contact, so no biocompatibility testing needed). | "The 4L drainage bag will not come into contact with neither skin or drugs and therefore no biocompatibility test has been carried out." (Implies no new biocompatibility risk beyond the predicate). |
| Functionality & Quality: Performs equivalent to the unmodified predicate device (K843480). | "The performance data showed that the product has lives up to high quality performance demands that fully shows that the 4L drainage bag is substantially equivalent to the unmodified device." "Based on the equivalency in all the mentioned areas including functional and quality testing..." |
| Manufacturing Process: Identical to the predicate device. | "...the manufacturing process is identical." |
| Material/Design: Maintains similar features to the predicate, with added comfort features not negatively impacting core function. | "The 4L drainage bag contains basically the same features as the device described in K843480... On a few points features has been added to the 4L drainage bag, but they are all added to improve patient and healthcare personnel comfort." (Implies additions are beneficial and do not compromise existing performance). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical trial or large-scale data analysis. The "performance data" mentioned refers to functional and quality testing, which typically involves a sample of manufactured devices. The specific sample size for these engineering tests is not provided.
- Data Provenance: The testing would have been conducted by Maersk Medical A/S in Denmark (manufacturing facility location). The data is retrospective in the sense that it evaluates the modified device's performance against the established performance of the predicate device, and prospective in that the specific tests were conducted on the newly manufactured 4L bags.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable or not specified in this 510(k) submission. "Ground truth" in the context of expert consensus or clinical diagnosis is not relevant for demonstrating substantial equivalence of a drainage bag. The "ground truth" here is the established safety and effectiveness of the predicate device, as determined by the FDA during its original clearance. The "experts" involved would be the engineers and quality assurance personnel at Maersk Medical conducting the functional and quality tests.
4. Adjudication Method for the Test Set
Not applicable or not specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved. This is not the type of study presented for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are used to evaluate diagnostic systems, often AI-assisted, and are not relevant for a drainage bag that collects fluid.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a passive medical device (a drainage bag), not an algorithm or an AI-enabled system. There is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for this submission is implicitly the established safety and effectiveness profile of the predicate device (K843480). The modifications to the 4L drainage bag are demonstrated to align with this established profile through functional and quality testing. There is no clinical "ground truth" (e.g., pathology, clinical outcomes) generated for this specific submission, as it relies on the predicate's clearance.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of machine learning or AI for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth to establish for it.
§ 876.5250 Urine collector and accessories.
(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.