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The Devon 24R deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used in the home or clinical settings to:

· Aid in the prevention of DVT

• · Enhance blood circulation
• · Diminish post-operative pain and swelling
• · Reduce wound healing time

· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System."

This document focuses on the regulatory clearance process, specifically demonstrating substantial equivalence to a predicate device.

It does not contain any information about the acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, ground truth establishment, or clinical study methodologies (like MRMC studies) related to the device's efficacy or accuracy.

Therefore, I cannot fulfill your request for the information about acceptance criteria and the study proving the device meets those criteria based solely on the provided text. The document is administrative and does not detail performance testing results.

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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.

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.

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The Devon 24 deep vein thrombosis prevention system is intended to be an easy to use portable by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used in the home or clinical settings to:

• · Aid in the prevention of DVT
• · Enhance blood circulation
• · Diminish post-operative pain and swelling
• · Reduce wound healing time

· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

The Devon 24 deep vein thrombosis prevention therapy system (referred as Devon 24 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The Devon 24 system consists of a pair of pumps and sleeve assemblies.

The device will alternatively inflate and deflate the garment (sleeve) to stimulate blood flow in the extremities (muscle contraction). The device provides a 40mmHg pressure and followed by a deflation period once it reaches the desired pressure, each cycle time is 50 seconds.

This document, a 510(k) Premarket Notification for the Devon 24 Deep Vein Thrombosis Prevention Therapy System, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, many of the requested sections regarding the study design and results cannot be fully addressed from the provided text.

Based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance tests conducted, but it does not explicitly state quantitative acceptance criteria or the specific numerical results for each test. Instead, it offers a general conclusion that "The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate."

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not explicitly stated. The document mentions "samples of the device" for performance and mechanical testing, but the number of units tested is not provided.
• Data Provenance: The tests were conducted internally by Devon Medical Products (Jiangsu) Ltd. in China. The document does not specify if the data involved human subjects or was entirely bench-top testing. Given the type of tests listed, they appear to be primarily bench-top (in-vitro) engineering and functional tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not Applicable. For the engineering and functional tests performed (pressure, cycle time, alarms, battery, burst, electrical safety, software V&V), ground truth is established through measurement instruments and compliance with technical standards and specifications, not through expert human interpretation as would be the case for diagnostic imaging or clinical outcomes.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, typically in clinical studies or when human interpretation of data is required to establish a consensus ground truth. The tests described are objective engineering and functional measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. The document explicitly states: "No animal study or clinical study was conducted." MRMC studies are clinical studies involving human readers/observers.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This device is a physical medical device (intermittent pneumatic compression system), not an algorithm or AI software for diagnosis or image analysis. Its "standalone" performance refers to its functional operation as demonstrated by the engineering tests for pressure, cycle time, etc., which were reported as "performing as intended."

7. The Type of Ground Truth Used:

• Engineering Specifications and Standard Compliance. For the performance tests, the "ground truth" is defined by the device's design specifications (e.g., target pressure, cycle time) and adherence to recognized international standards for electrical safety and electromagnetic compatibility (IEC 60601 series). For biocompatibility, the ground truth was the results of previously conducted biocompatibility tests on the predicate device's materials, per FDA Good Laboratory Practice.

8. The Sample Size for the Training Set:

• Not Applicable. This information pertains to machine learning algorithms. The Devon 24 is a mechanical/electronic device, not an AI or imaging device that uses a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. See point 8.

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