(16 days)
The CircuFlow 5100 Sequential Compression Device is a manual, sequential, pneumatic compression device, intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency, and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities. The device is intended for home or hospital use.
The CircuFlow 5100 is a sequential pneumatic compression device designed to apply compression to a limb. The device is composed of two components:
- Pneumatic manual pump
- Limb sleeve or garment composes of 4 chambers
The CircuFlow 5100 enables different treatment pressures (0-120mmHg) and treatment times (30 minutes to continue) that should be used according to physician prescription. When activated, air flows into chamber, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within chambers are adjustable -pressure to chamber 1 is controlled by user-adjusted regulator on the pump. Pressure in chambers 2, 3 & 4 are individually lowered according to the default factory settings. A calibrated dial gauge displays pressure in the range of 0-200 mmHg. Garments are available in 8 sizes, and custom garments are available in variations from standard sizes.
The provided text describes a 510(k) premarket notification for the CircuFlow 5100 Sequential Compression Device. This submission primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics, intended use, and performance testing, rather than detailed clinical study outcomes to prove specific acceptance criteria met by the device.
Based on the provided document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the format of a separate table with specific metrics (e.g., pressure output within X mmHg tolerance, cycle time within Y% of target) for various performance aspects. Instead, it lists various "Performance Testing" categories that were performed to assure the product meets its specifications. The specific results of these tests and the acceptance criteria they were measured against are not provided in this summary.
| Acceptance Criteria (Inferred from Test Categories) | Reported Device Performance |
|---|---|
| Electrical Safety (e.g., Dielectric Strength, Leakage Current) | "assured that the product meets its specifications" |
| Gradient Performance | "assured that the product meets its specifications" |
| Garment Performance | "assured that the product meets its specifications" |
| Pressure Performance | "assured that the product meets its specifications" |
| Tensile Strength | "assured that the product meets its specifications" |
| Material Biocompatibility (e.g., Cytotoxicity, Sensitization, Irritation) | "assured that the product meets its specifications" |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench and laboratory testing was performed," but it does not specify any sample sizes for these tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as these were likely internal lab tests on device prototypes or components. There is no indication of human subject data being used for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that the performance testing described is "Bench and laboratory testing," there is no mention of "experts" or "ground truth" being established in the context of clinical scenarios, image interpretation, or disease diagnosis. The ground truth for these tests would be the established engineering standards or internal specifications against which the device's physical and electrical performance was measured.
4. Adjudication Method for the Test Set
As the performance testing consists of bench and laboratory tests, the concept of an adjudication method (like 2+1 or 3+1 for expert review) is not applicable. The results of these tests would likely be objective measurements taken by testing personnel.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission focused on demonstrating substantial equivalence through technical characteristics and bench testing, not a clinical study involving human readers or comparative effectiveness with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device described, the CircuFlow 5100, is a sequential pneumatic compression device, a hardware medical device. There is no mention of any algorithms or AI components that would require standalone performance testing (without human-in-the-loop).
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the bench and laboratory performance tests, the "ground truth" would be the engineering specifications, established physical limits, and relevant standards (e.g., IEC 60601-1-1, ISO 10993) against which the device's performance was measured. There is no mention of ground truth based on expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Since there is no mention of any AI components or algorithms in the CircuFlow 5100, there is no training set and therefore no sample size for a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).