(88 days)
The Radial Medical Cirvo Compression System is indicated for use in:
- Preventing deep vein thrombosis (DVT)
- Enhancing blood circulation
- Diminishing post-operative pain and swelling
- Reducing wound healing time
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers
- Treatment of chronic venous insufficiency
- Reducing edema
The Cirvo Compression System is a light-weight, mobile, sequential compression device (SCD) placed around the calf that sequentially compresses the calf to augment blood flow. SCD's are used in both the hospital and home setting. most commonly to prevent deep vein thrombosis (DVT), heal venous leg ulcers (VLU) and reduce swelling. The Cirvo Compression System includes three components: the Cirvo sequential compression device, an AC charger and a smart device app.
The Cirvo compression unit generates compression cvcles using a small motor to sequentially cycle the compression unit on the calf. The Cirvo sequential compression device is placed around the lower leg using a detachable shin guard with self-aligning magnets, with the padded compression unit aligned on the calf. Proper fitting is achieved by adjusting a pair of hook and loop straps. The Cirvo compression system continuously monitors and maintains the prescribed compression therapy, records the duration of therapy session as well as compliance with the prescribed therapy. Therapy can be initiated and stopped using either the app interface on a smart device or using the capacitive touch sensor on the compression unit. Patients can track their progress with the app and can opt in to have text reminders sent to reinforce compliance with their therapy and notifications sent to their physician. All data is saved and transmitted using high-level, AES-128 encryption.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the "Cirvo Compression System," structured according to your request.
Please note: The provided document is a 510(k) summary for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed clinical efficacy trials often described in scientific publications. As such, information regarding clinical studies, AI performance metrics, ground truth establishment, and specific multi-reader multi-case studies might be limited or absent.
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the Cirvo Compression System K190976 states that "All testing met pre-established acceptance criteria." However, it does not explicitly detail the quantitative acceptance criteria for each test performed. It lists the types of tests conducted and concludes that they were successful. Therefore, the table below reflects what is implied as meeting the acceptance criteria based on the narrative.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Bench Testing | |
| Device strap tensile strength | Successfully passed |
| Device buckle to cord tensile strength | Successfully passed |
| Simulated use performance | Successfully passed |
| Reliability performance | Successfully passed |
| Packaging integrity | Successfully passed |
| Software Testing | |
| Battery power supervisor software | Compliant with FDA/IEC 62304 "moderate level of concern" |
| Mobile application client software | Compliant with FDA/IEC 62304 "moderate level of concern" |
| Signal board software | Compliant with FDA/IEC 62304 "moderate level of concern" |
| Security verification | Successfully verified |
| Electrical Safety Testing | |
| IEC 60601-1:2006 (Basic safety) | Compliant |
| IEC/EN 60601-1-2:2007 (EMC) | Compliant |
| FCC Part 15 & Part 18 | Compliant |
| Industry Canada ICES-003 Issue 5 | Compliant |
| Coexistence with intentional radiators | Successfully demonstrated |
| Therapy Parameters | |
| Pressure Delivered (40-60 mmHg) | Maintained "prescribed compression therapy" (Implied) |
| Therapy Duration Monitoring | Continuously monitored (Implied as functional) |
| Compliance with Therapy Monitoring | Continuously monitored (Implied as functional) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the "test set" in the context of clinical data. The performance testing described (bench, software, electrical safety) uses equipment and methods, but doesn't refer to a "test set" of patients or data in the way an AI/clinical study might. The data provenance is not applicable in the context of device performance testing; it's about the device itself and its components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The testing described is primarily engineering and regulatory compliance, not typically involving human expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable to the type of performance testing documented here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done or reported in this 510(k) summary. This document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and performance testing, not on comparative clinical effectiveness with or without AI assistance. The device is a "sequential compression device," not an AI diagnostic or assistive tool in the MRMC sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone physical compression system with software components. The software is part of the control system and user interface. The performance testing "without human-in-the-loop" would essentially be the bench testing and software verification, which were indeed performed. However, this is not a diagnostic algorithm in the typical sense of standalone AI performance.
7. Type of Ground Truth Used
For the engineering tests, the "ground truth" would be established by:
- Industry Standards: IEC, FCC, Industry Canada standards for electrical safety and electromagnetic compatibility.
- Design Specifications: Internal design requirements for tensile strength, pressure delivery, duration tracking, etc.
- FDA Guidance: "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" and IEC 62304 for software.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the performance testing described.
8. The Sample Size for the Training Set
This information is not applicable as the document does not describe the development of a machine learning or AI model that would require a "training set" of data in the common sense. The software is described as being developed in accordance with validation principles, but not trained on a data set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no described training set.
§ 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).