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Cutaneous Compression Device for Use in Hemodialysis.
This document is a 510(k) premarket notification for a medical device submitted in 1997. It describes a "Cutaneous Compression Device for Use in Hemodialysis." The purpose of a 510(k) is to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This process does not inherently require the same level of detailed performance studies or AI-specific validation metrics that would be expected for a modern AI/ML-driven device.
Therefore, many of the requested items related to AI device performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this 1997 submission for a non-AI physical medical device.
I will address the applicable sections based on the provided text.
Acceptance Criteria and Study Details for K964041 - Cutaneous Compression Device for Use in Hemodialysis
This submission is for a physical medical device (Cutaneous Compression Device) and predates the common use of AI/ML in medical devices. The "acceptance criteria" in this context refer to demonstrating substantial equivalence to predicate devices, rather than meeting specific performance metrics of an AI algorithm. Similarly, the "study" referred to is the submission itself and the comparison made, not a clinical trial involving AI performance.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a non-AI device focused on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating similarity to predicate devices in terms of safety, effectiveness, and intended use. There are no quantitative performance metrics for "device performance" in the AI sense provided in this summary.
| Acceptance Criteria Category | Description/Assessment in Submission (Implicit) |
|---|---|
| Intended Use | Same as predicate devices: Cutaneous Compression Device for Use in Hemodialysis. |
| Technological Characteristics | Implied to be similar to predicate devices, allowing for the same intended use and safety/effectiveness. No specific details provided in this excerpt. |
| Safety and Effectiveness | Demonstrated by substantial equivalence to legally marketed predicate devices (K955270, K951973). This implies that the device is as safe and effective as the predicate. |
| Performance Standards | None established for this device under Section 514 of the Federal Food, Drug, and Cosmetic Act at the time of submission. No actions taken to comply with Section 514 Performance Standards. |
| Labeling | Proposed labeling included in the submission, presumably aligning with predicate devices and regulatory requirements. |
Remaining Questions:
Most of the following questions are related to AI/ML device validation and are not applicable to this submission given its nature and date.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable: This is a pre-AI physical device submission. There is no "test set" in the context of an algorithm's performance. The "test" is the comparison to predicate devices based on design and intended use.
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)
- Not Applicable: There is no "ground truth" establishment for an algorithm's performance in this submission. The regulatory ground truth is the FDA's determination of substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: No test set or expert adjudication process for an AI algorithm's output.
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 is not an AI diagnostic or assistance tool, and therefore no MRMC study would be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable: No ground truth in the context of AI performance is used. Substantial equivalence relies on comparing the device's design, materials, and intended use to legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable: There is no AI algorithm, so no training set exists.
9. How the ground truth for the training set was established
- Not Applicable: There is no AI algorithm, so no training set or its ground truth establishment.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis 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 an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.