(181 days)
The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation. Compression pumps of various kinds are in wide use in hospitals, clinics, patient homes, and elsewhere for treating acute and chronic fluid accumulation disorders. Complies with physician-prescribed treatment pressures.
This is an electromechanical pneumatic device that employs a compressor and precision timers, regulators, and gages to sequentially inflate a sleeve appliance that fits over the patient's extremity. This unit delivers a calibrated gradient pressure. The device is approximately 10"W x 6.75"H x 5.6"D and weighs less than 15 Ibs.
The provided text describes a medical device, the WLP Pro Lite gradient sequential compression pump, and its comparison to an existing device (K830577B) for the purpose of a 510(k) submission. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not typically a detailed study proving novel acceptance criteria for a new device's performance.
Based on the provided information, I can extract the acceptance criteria related to its functional equivalence and performance characteristics from the "non-clinical test data" section. However, the document explicitly states "clinical test data: not applicable," which means a clinical study to prove efficacy or safety against defined acceptance criteria was not conducted or provided in this summary.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Section 5.8.1) | Reported Device Performance (from Section 5.8.1) |
|---|---|
| Pressures in each individual cell reach the prescribed setting within ±5mm Hg from the panel gage reading. | Pressures in each individual cell reach the prescribed setting within ±5mm Hg from the panel gage reading. |
| Pressures in each cell reach the prescribed setting for that individual cell 10 or more seconds before the next cell is activated. | Pressures in each cell reach the prescribed setting for that individual cell 10 or more seconds before the next cell is activated. |
| Maximum pressure in the proximal cell (cell C) is reached before the end of the cycle and thus sustained. | Maximum pressure in the proximal cell (cell C) is reached before the end of the cycle and thus sustained. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the "prototype device" measurements. The measurements were taken on a "prototype device," implying a single or very limited number of units.
- Data Provenance: Not specified, but likely from internal testing by Wright Linear Pump, Inc. It is a retrospective assessment against established design parameters, not a prospective study. There is no mention of country of origin for the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for the non-clinical tests was established by comparison to a "calibrated Hg manometer," which is a standard measurement device, not expert consensus.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The test involved direct measurement against a calibrated standard, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No. The document explicitly states "clinical test data: not applicable." This device is a sequential compression pump, not an imaging or diagnostic device that would typically involve human readers interpreting output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: A form of standalone non-clinical performance was done, as described in Section 5.8.1. The device's pressure delivery and timing characteristics were measured and compared against specifications using a calibrated manometer. This is the device operating on its own, without a human in the loop for interpreting output (as might be the case for AI).
7. The Type of Ground Truth Used
- Ground Truth Type:
- For pressure accuracy: Comparison to a calibrated Hg manometer (a physical gold standard measurement tool).
- For timing (cell activation and sustained pressure): Intrinsic design specifications and observed performance.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is an electromechanical pump, not a machine learning or AI-driven system that requires a "training set" in the conventional sense. Its "design parameters" are likely derived from engineering principles and prior device models.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set." The device's operational parameters and design would have been established through engineering design, previous product iterations (as it's similar to K830577B), and adherence to general medical device standards for mechanical and pneumatic systems.
§ 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).