(77 days)
The Circul8 Pro Vascular Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to:
- · Aid in the prevention of DVT;
- · Enhance blood circulation;
- · Diminish post-operative pain and swelling;
- · Reduce wound healing time;
- · Aid in the treatment and healing of stasis dermatits, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
The Circul8 Pro Vascular Therapy System is a lightweight, portable, rechargeable battery powered prescription device. The device is intended to be used in the home or clinical setting by or under the direction of a medical professional by any patient needing venous return due to an increased risk from blood clots.
The subject device is a modification of the predicate device in K193020, which includes:
- modification of the plastic housing the electronically controlled air pump unit and solenoid valve,
- relocation of the tactile touch control switch from the front of the housing to the housing,
- introduction of LED display to replace the tricolored LED for ON, LOW BATTERY, CHARGE COMPLETED indications, and the blue LED for indicating a leak or low pressure alarm,
- removal of the micro USB port for obtaining usage (patient compliance) data,
- no longer labeling cuff as either left leg cuff or right leg cuff,
- cuffs are filled to 55 mmHg pressure
- introduces Night Mode, which minimizes light disturbances from the LEDs during patient resting times.
- increased battery life.
Both the subject device and predicate device utilize pneumatically controlled, single chamber cuffs actuated by an electronically controlled air pump unit and solenoid value of trol components are protectively housed in a plastic case that is permanently attached to the inflatable cuff.
Here's a breakdown of the acceptance criteria and the study information for the Circul8 Pro Vascular Therapy System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Physical Requirements | 1. Unit size: No smaller than 140 X 70 X 40 mm | Complies (True mean proportion, 5% margin of error, 90% CL) |
| 2. Unit weight: No more than 0.5 kg | Complies (True mean proportion, 5% margin of error, 90% CL) | |
| 3. Housing material of construction: ABS | Complies (True mean proportion, 5% margin of error, 90% CL) | |
| 4. On/Off switch location: Top side of the device | Complies (True mean proportion, 5% margin of error, 90% CL) | |
| 5. LED screen displays: "LP" for low pressure, "55mmHg" for operating pressure, " " during cycles, battery status | Complies (True mean proportion, 5% margin of error, 90% CL) | |
| 6. Device displays usage hours when powered on | Complies (True mean proportion, 5% margin of error, 90% CL) | |
| 7. Leg wrap size/shape: Identical (no distinctions between Left/Right cuffs) | Complies (True mean proportion, 5% margin of error, 90% CL) | |
| Performance Requirements | 1. Inflation pressure accuracy: 55 mmHg ± 10% | Complies (True mean proportion, 5% margin of error, 90% CL) |
| 2. Night mode: Performs as specified in software design input | Complies (True mean proportion, 5% margin of error, 90% CL) | |
| Electrical Requirements | 1. Battery: 3.7V, 1800mAh; Power Supply: 100-240 Vac, 50-60 Hz, Output: 5Vdc @ 2.0 Amp | Complies (True mean proportion, 5% margin of error, 90% CL) |
| Electrical Safety Standards | IEC 60601-1:2005+AMD1:2012+AMD2:2020 (Basic safety and essential performance) | Complies |
| IEC 60601-1-2:2014 (EMC) | Complies | |
| IEC 60601-1-11:2015+AMD1:2020 (Home healthcare environment) | Complies | |
| IEC 62133-2:2017+AMD1:2021 (Lithium systems safety) | Complies | |
| Software Verification | Conformance with FDA Guidance for Software Contained in Medical Devices | Carried out according to guidance |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Design verification test results demonstrate the true mean (average) proportion, with a 5% margin of error and at the 90% confidence level," for various physical, performance, and electrical requirements. However, the specific sample size (N number of devices or measurements) for these tests is not provided in the given text.
The document does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of design verification tests, they are typically prospective, conducted on manufactured units.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests described (measurements of size, weight, pressure, electrical characteristics, software function, and compliance with standards) are objective engineering and performance evaluations. There is no indication that expert "ground truth" was established in the clinical sense for the described verification tests.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. The tests performed are objective measurements and compliance checks against predefined specifications and standards, not evaluations requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not mentioned in the document. The Circul8 Pro Vascular Therapy System is a physical therapy device (compressible limb sleeve), not an AI-assisted diagnostic or imaging device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the Circul8 Pro Vascular Therapy System. It is a physical device, and while it has software for controlling its functions, it is not an algorithm that operates in a standalone diagnostic or interpretative capacity. Its performance is evaluated based on its physical, electrical, and functional compliance.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is based on engineering specifications, physical measurements, functional performance parameters (e.g., pressure output, battery voltage), and compliance with established electrical safety and electromagnetic compatibility international standards (IEC 60601 series, IEC 62133-2). There is no "expert consensus," "pathology," or "outcomes data" in the traditional clinical sense being used as ground truth for these design verification tests.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The device is not a machine learning or AI-based system that requires a "training set" in the context of developing an algorithm from data. The software updates mentioned are for controlling the device's functions and user interface, not for learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of machine learning for this device.
§ 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).