(394 days)
DVT-Pro is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. DVT-Pro is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.
DVT-Pro device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients. The basic set of The Venous Assist System(DVT-PRO) consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and sleeve (cuff) for calf and foot.
The provided document is a 510(k) Summary for a medical device called "DVT-Pro," a compressible limb sleeve system used to prevent Deep Vein Thrombosis (DVT). The document outlines the device's characteristics and compares it to a predicate device (DVT-2600) to demonstrate substantial equivalence, but it does not contain information on acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML device (e.g., sensitivity, specificity, or reader studies). The "performance data" section primarily refers to safety and software validation testing, not clinical performance for its stated indications.
Therefore, I cannot provide the detailed information requested in the prompt, especially points related to:
- A table of acceptance criteria and reported device performance (in terms of clinical efficacy metrics like accuracy, sensitivity, specificity).
- Sample size used for the test set or training set for clinical performance evaluation.
- Data provenance, number of experts, adjudication methods, or ground truth types for clinical performance.
- MRMC comparative effectiveness study or standalone performance.
The document focuses on demonstrating that the DVT-Pro device is substantially equivalent to an existing device (DVT-2600) based on:
- Intended Use: Both devices are for "Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency." The DVT-Pro explicitly states it's for DVT prevention by improving blood velocity.
- Technological Characteristics Comparison (See the table on page 8-9): This table highlights similarities in mechanical and electrical specifications, such as mode of compression (sequential), pressure ranges (with slight differences in maximums for leg/foot), and general design.
- Safety and Software Validation:
- Biocompatibility testing: ISO10993-5, ISO10993-10 were performed.
- Electrical safety and performance testing: Conducted according to IEC 60601-1:2005 + CORR.1(2006) + CORR(2007).
- EMC testing: Conducted according to IEC 60601-1-2:2007.
- Software Verification and Validation Testing: Documented as per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was classified as "minor" level of concern. All test results were satisfactory.
Key Missing Information (as per your prompt):
The document does not detail any clinical performance study (e.g., to measure the device's effectiveness in preventing DVT) with specific acceptance criteria like accuracy, sensitivity, or specificity. The "performance data" discussed is related to engineering and software validation for safety and proper functioning, not clinical outcomes directly demonstrating DVT prevention efficacy against a defined ground truth.
Therefore, I cannot populate the table or answer the specific questions regarding clinical performance studies, test set/training set sizes, expert involvement, or adjudication methods, as this information is not present in the provided text.
§ 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).