(177 days)
The VPULSE is intended to function as an intermittent, external compression device in extremities to prevent and reduce complications of poor circulation. This includes:
- deep vein thrombosis, .
- chronic venous insufficiency, .
- venous stasis ulcers, .
- . post-mastectomy edema and chronic lymphedema,
- reduction of edema associated with soft tissue injuries such as burns. . postoperative edema, and ligament sprains,
- localized cold thermal therapy for post-traumatic and post-surgical medical . and/or surgical conditions)
- Aids the blood flow back to the heart .
- . Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.
The VPULSE system is a device designed to function as a dual intermittent external pneumatic compression device. The intended therapies of the device are dynamic pneumatic compression therapy (DCT) in order to aid in the reduction and control of edema including lymphedema of the upper and lower extremities and venous stasis ulcers, and intermittent sequential pneumatic compression (SCT) in order to reduce the risk of the formation and prevent the occurrence of a pulmonary embolism resulting from a deep vein thrombosis (DVT) - collectively referred to as venous thromboembolism (VTE) - by aiding in the blood flow back to the heart via lower extremity limb compression.
The VPULSE system consists of a control unit, tubing set and a family of single-patient applied wraps.
The control unit contains a pneumatic pump and air reservoir for inflation of the DCT an SCT wraps, a fluid pump and user filled fluid canister for water circulation into the DCT wrap, and supporting controls to deliver and monitor the modalities. The control unit allows the patient to select and apply the treatment functions concurrently or individually.
The tubing set allows the patient to connect the wraps to the control unit and is of a length that allows treatment to be applied in a physical position comfortable for the user.
There are two (2) types of wraps given the intended treatment function of DCT and/or SCT. The DCT wraps are typically applied to an acute injury site usually the result of surgery. The SCT wraps are typically applied to the calves.
Here's a breakdown of the acceptance criteria and study information for the Cothera VPULSE, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes various performance parameters for the Cothera VPULSE and compares them to its predicate devices (Thermotek NanoTherm™ and VascuTherm™). While explicit "acceptance criteria" values are not listed as pass/fail thresholds, the comparison itself serves as the basis for demonstrating substantial equivalence. The reported performance of the device in these categories is implicitly "meets" if it is comparable to the predicate.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Cothera VPULSE Performance |
|---|---|---|
| Functional Parameters | ||
| Cycle Time | 60 seconds (Predicate) | 80 seconds |
| Inflation Time (Sequential Compression) | 30s (DVT), 20s (Edema/Lymphedema) (Predicate) | 10 seconds |
| Deflation Time (Sequential Compression) | 30s (DVT), 40s (Edema/Lymphedema) (Predicate) | 70 seconds |
| Pump Pressure Range (DVT) | 45-100 mm Hg +/- 5 mm Hg (Predicate) | 2-60 mm Hg +/- 20% |
| Pump Pressure Range (Dynamic Compression – Edema/Lymphedema) | 30 mm Hg +/- 5 mm Hg (Predicate) | 2-50 mm Hg |
| Default Pressure (DVT, Calf) | 45 mm Hg (Predicate) | 60 mm Hg |
| Default Pressure (Edema/Lymphedema) | 30 mm Hg (Predicate) | 50 mm Hg |
| Therapy Temperature Range (Cold) | 43F to 49F (Predicate) | 41F minimum, 80F maximum |
| Material/Design Features | ||
| Sterility (Wrap) | Non-Sterile (Predicate) | Non-Sterile |
| Biocompatibility | ISO 10993-1 (Predicate) | ISO 10993-1, 5, 10 |
| Single Patient Use (Wrap) | Yes (Predicate) | Yes |
| Safety Standards | ||
| General Requirements for Medical Electrical Equipment | IEC 60601-1 (Predicate) | IEC 60601-1 |
| Emissions | IEC 60601-1-1 (Predicate) | IEC 60101-1-2 (Medical Electrical Equipment: Collateral Standard) (presumably including emissions) |
| Immunity | Not explicitly listed for predicate, but generally implied by IEC 60601-1-1 | IEC 60601-1-2 (Immunity) |
Note: The document states "The Cothera VPULSE has been shown to be substantially equivalent to predicates in the above described indications, performance parameters, and safety parameters." This implies that the reported performance fell within acceptable ranges compared to the predicate device, although specific acceptance "limits" are not detailed.
2. Sample Size Used for the Test Set and Data Provenance:
The document describes specific performance tests, but it does not specify a "test set" in terms of subject data (e.g., patient records, images, or clinical outcomes). The performance data cited are for:
- Bladder fatigue
- Static burst pressure
- Thermal
- Biocompatibility
- Inflation/deflation curve analysis
- Adherence to applicable medical electrical equipment safety standards
These appear to be bench tests or engineering tests conducted on the device itself or its components. Therefore:
- Sample Size for Test Set: Not applicable in the context of clinical/patient data. The sample size for the engineering tests would refer to the number of bladders tested, devices subjected to burst pressure, etc., which is not provided.
- Data Provenance: Not applicable in the context of clinical/patient data. The provenance for bench testing would typically be the manufacturer's lab or a contracted testing facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. This device is not an AI/imaging diagnostic device that relies on expert interpretation for ground truth in a test set. The "ground truth" for the performance tests (e.g., bladder fatigue) would be the physical properties of the materials and the measured output of the device.
4. Adjudication Method for the Test Set:
Not applicable. There is no human interpretation or adjudication involved in the performance tests described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This is not an imaging or diagnostic device for which an MRMC study would typically be conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The VPULSE is a physical medical device (intermittent, external compression device) and does not involve an "algorithm" or standalone AI performance.
7. The Type of Ground Truth Used:
For the performance tests mentioned (bladder fatigue, static burst pressure, thermal, biocompatibility, inflation/deflation curve analysis), the "ground truth" is established through physical measurements and adherence to engineering/safety standards. For example:
- Bladder fatigue, static burst pressure, inflation/deflation curve analysis: Mechanical properties and performance measurements against specified design parameters or industry standards.
- Thermal: Temperature measurements against specified ranges.
- Biocompatibility: Laboratory testing according to ISO 10993 standards.
- Safety Standards (IEC 60601-1, etc.): Compliance with documented electrical and safety standards as assessed through testing.
8. The Sample Size for the Training Set:
Not applicable. The Cothera VPULSE is a physical medical device and does not utilize a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set, there is no ground truth to establish for it.
§ 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).