(145 days)
The Devon 51 Series Sequential Compression Device is a compression device based on sequential pneumatic Compression technique which is intended for the treatment of the following conditions:
- Lymphedema
- Venous stasis ulcers
- Venous insufficiency
- Peripheral edema
The device is intended for both home and hospital use.
The Devon 51 Sequential Compression device is a gradient compression pneumatic device used for treatment and management of venous or lymphatic disorders. The application of gradient compression is effective by increasing blood flow and encouraging extracellular fluid clearance. The system consists of a pump and a pair of four-chambered garments. The garments are available in different types and sizes. The pump provides cycles of compressed air at certain adjustable pressures and which sequentially inflates the garment from distal to proximal. When activated, air flows into the garment chambers, and the pump provides gradient pressurization to the chambers (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 until the set therapy time is reached.
The provided text describes the regulatory clearance (K172030) of the "Devon 51 Sequential Compression Device" by the FDA. The document focuses on demonstrating substantial equivalence to a predicate device ("CircuFlow 5200", K101523) rather than presenting a standalone study with acceptance criteria and a detailed analysis of device performance against those criteria in a typical clinical study format.
Therefore, much of the requested information, particularly regarding specific numerical performance metrics, sample sizes for test sets (in a clinical sense), expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not present in the provided document. The document details engineering and safety tests rather than clinical performance studies against specific clinical acceptance criteria.
However, I can extract the available information and highlight what is not present.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not present a table of specific clinical acceptance criteria with corresponding performance metrics. Instead, it lists functional and mechanical performance tests conducted to verify the device design met its requirements, and concludes that the device performed as intended and is substantially equivalent to the predicate.
| Functional Performance Test | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Devon 51 Cycle Time Test | Device operates within specified cycle times. | "The conclusions drawn from the performance tests demonstrate that the device is performing as intended..." |
| Devon 51 Reverse Pressure Test | Device prevents reverse pressure flow. | "The conclusions drawn from the performance tests demonstrate that the device is performing as intended..." |
| Devon 51 Sleeve Integrity Test | Sleeves maintain integrity under operation. | "The conclusions drawn from the performance tests demonstrate that the device is performing as intended..." |
| Devon 51 Treatment Time Test | Device operates accurately for set treatment times. | "The conclusions drawn from the performance tests demonstrate that the device is performing as intended..." |
| Devon 51 Pressure Sensor Calibration Test | Pressure sensors are accurately calibrated. | "The conclusions drawn from the performance tests demonstrate that the device is performing as intended..." |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation) | No adverse biological reactions. | Not explicitly stated for Devon 51, but stated as identical garment material and processing as predicate, which did undergo these tests. Implies acceptance via equivalence. |
| Electrical Safety (IEC 60601-1 series) | Meets relevant electrical safety standards. | Passed these tests. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Meets relevant EMC standards. | Passed these tests. |
2. Sample Size for the Test Set and Data Provenance
The document does not describe a "test set" in the context of clinical data for performance evaluation. The "tests" mentioned are engineering and safety verification tests.
- Sample Size for Test Set: Not applicable in the context of clinical or AI performance evaluation. The number of physical units tested for the functional/mechanical tests is not specified, only that "samples of the device underwent function and mechanical testing."
- Data Provenance: Not applicable, as this refers to engineering/safety tests, not clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for functional/mechanical tests is typically established by engineering specifications and objective measurements, not expert human review.
4. Adjudication Method for the Test Set
Not applicable. No human expert adjudication process is described for the engineering/safety performance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or reported. This device is a mechanical compression device, not an imaging analysis AI tool, so an MRMC study is not relevant or expected.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used
For the functional/mechanical tests, the "ground truth" would be the device's technical specifications and engineering standards it was designed to meet (e.g., specific cycle times, pressure ranges, absence of reverse flow, structural integrity). For biocompatibility, the ground truth is established by standardized biological tests.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" described in the document is a series of engineering and safety verification tests conducted on samples of the Devon 51 Sequential Compression Device. These tests included:
- Functional Performance Tests:
- Cycle Time Test (TR66.J002)
- Reverse Pressure Test (TR66.J004)
- Sleeve Integrity Test (TR66.J006)
- Treatment Time Test (TR66.J009)
- Pressure Sensor Calibration Test (TR66.J007)
The conclusion for these tests was that the device performed as intended, demonstrating that it met its functional and performance design requirements.
- Biocompatibility: The device uses the identical garment material, manufacturing process, and direct body contact method as its predicate device (CircuFlow 5200). The predicate device had previously undergone and passed biocompatibility tests (Cytotoxicity, Sensitization, Irritation) in accordance with FDA Good Laboratory Practice. Therefore, new testing was not deemed necessary for the Devon 51, establishing equivalence for biocompatibility.
- Electrical Safety and Electromagnetic Compatibility (EMC): These tests were conducted according to recognized international standards:
- IEC 60601-1:2005+C1:2006+C2:2007+A1:2012 (General requirements for basic safety and essential performance)
- IEC 60601-1-2: 2014 (EMC requirements)
- IEC 60601-1-6:2010 (Usability including IEC 62366)
- IEC 60601-1-11:2015 (Requirements for home healthcare environment)
The implication is that the device passed these tests, thereby meeting the safety and performance standards established by these regulations.
The overall conclusion reached by Devon Medical Products in their 510(k) submission is that, based on the information provided, the Devon 51 Sequential Compression Device is substantially equivalent to the predicate device (CircuFlow 5200, K101523) in terms of technology, function, operating parameters, and indication for use, and does not raise any new questions of safety or effectiveness. This substantial equivalence is the primary basis for its market clearance.
§ 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).