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510(k) Data Aggregation
(103 days)
The B&J DVT Calf/Thigh Garments, Models 801/830 Series are designed to increase venous blood flow in at risk patients in order to help lower the risk of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
The 801/830 series of DVT calf/thigh garments are compression devices. When the devices are attached to a pump system, they provide intermittent, sequentially gradient pressure to a patient calf/thigh for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse which forces blood to move upward toward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf or thigh.
The provided document is a 510(k) Premarket Notification for a medical device (B&J DVT Calf/Thigh Garments, Models 801/830 Series). It's important to understand that a 510(k) submission generally aims to demonstrate substantial equivalence to a previously cleared predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials as would be required for a PMA (Premarket Approval).
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission refer to the non-clinical tests performed to demonstrate that the new device performs at least as well as the predicate device regarding specific physical and functional characteristics.
Here's an analysis based on the provided text for the B&J DVT Calf/Thigh Garments:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "predefined acceptance criteria" but does not explicitly list them in a table format with corresponding performance metrics. Instead, it states that "All the test results demonstrate 801 series and 830 series garments meet the requirements of its predefined acceptance criteria and intended use."
The non-clinical tests conducted are listed as:
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials are biocompatible and do not cause adverse biological reactions. | "All the test results demonstrate... garments meet the requirements of its predefined acceptance criteria." (Implied: passed biocompatibility tests) |
| Bladder burst | The inflatable bladder within the garments can withstand specified pressure without bursting. (Specific pressure value not provided) | "All the test results demonstrate... garments meet the requirements of its predefined acceptance criteria." (Implied: passed bladder burst test) |
| Leak test | The garments do not leak air when inflated, maintaining pressure effectively. (Specific leak rate criteria not provided) | "All the test results demonstrate... garments meet the requirements of its predefined acceptance criteria." (Implied: passed leak test) |
| Pressure cyclic test with B&J pneumatic pumps | The garments can withstand repeated inflation/deflation cycles at specified pressures (e.g., 40mmHg, 45/40/30mmHg) without failure. (Specific number of cycles not provided) | "All the test results demonstrate... garments meet the requirements of its predefined acceptance criteria." (Implied: passed pressure cyclic test) |
Note on Acceptance Criteria: The document implies that the acceptance criteria for these non-clinical tests were based on established standards for similar devices or performance equivalent to the predicate devices. Specific quantitative criteria (e.g., "bladder burst pressure > X mmHg", "leakage
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