(190 days)
VascuEase is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting.
The VascuEase IC-1200-WH is a portable, rechargeable battery-powered, prescription device intended for home or hospital use to help prevent post-operative DVT in patients by stimulating blood flow as an aid in the prevention of DVT. The VascuEase IC-1200-WH (applicant device) provides intermittent pressure to the calf and thigh or foot through the use of inflatable garments. The cycle times and pressure are preset at the factory and cannot be changed by the user. The user interface consists of an On/Off button and two-color LED indicating operational status of the unit. The device consists of a pump. inflatable garments, and interconnection tubing. The pump air compressor is capable of no more than 80 mmHg maximum pressure and has pre-set inflate/deflate cycle times. Default pressure and timing is pre-set at the factory to 50 mmHz. with a cycle of 15 seconds on and 45 seconds off, which is consistent with the majority of indications prescribed. The garment consists of a discrete inflatable chamber, attached to the pump via interconnection tubing and Velcro. The garment is applied externally over the affected limb(s); unilateral or bilateral treatment can be applied. The garments are supplied non-sterile and are intended for single patient use.
The provided text
describes the acceptance criteria and study proving a medical device, the VascuEase IC-1200-WH, meets these criteria for FDA 510(k) clearance. This is a Class II device, specifically a "Compressible Limb Sleeve," intended for the prophylaxis of Deep Vein Thrombosis (DVT) and other circulatory benefits.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the VascuEase IC-1200-WH are based on its similarity and performance comparability to predicate devices. The document states that the device must meet "all performance specifications" and has undergone "functional testing," which "includes cycle timing and inflation pressure."
| Acceptance Criteria (Predicate-based Comparability) | Reported Device Performance (VascuEase IC-1200-WH) |
|---|---|
| Intended Use: Consistent with predicate devices for DVT prophylaxis, circulation stimulation, ulcer prevention/healing, edema reduction. | Intended Use: "VascuEase is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting." (Identical to primary predicate in core indications). |
| Principal of Operation: Intermittent Pneumatic Compression. | Principal of Operation: "Intermittent Pneumatic Compression." |
| Inflation Time: Consistent with predicate devices (e.g., 15 seconds). | Inflation Time: "15 seconds." |
| Deflation Time: Consistent with predicate devices (e.g., 45 seconds). | Deflation Time: "45 seconds." |
| Inflation Pressure: Consistent with predicate devices (e.g., 50 mmHg). | Inflation Pressure: "50 mmHg" (Pre-set at factory). |
| Cycle Times: "Results demonstrate comparable inflation cycle profiles (rise times, inflation pressures, deflation times and cycle times)" to predicate devices. | Cycle Times: "Cycle times and pressure are preset at the factory and cannot be changed by the user. ... Default pressure and timing is pre-set at the factory to 50 mmHz, with a cycle of 15 seconds on and 45 seconds off." |
| Maximum Pressure: No more than 80 mmHg. | Maximum Pressure: "The pump air compressor is capable of no more than 80 mmHg maximum pressure." |
| Aesthetic Acceptance Criteria: Met. | "In addition to aesthetic acceptance criteria, functional testing includes cycle timing and inflation pressure." (Implies aesthetic criteria were met). |
| No change in fundamental technology or intended use from predicate. | "There is no change in fundamental technology and no change in intended use from the predicate device, K133274." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" or its sample size in the context of a clinical study with patients. The performance data presented refers to internal product testing.
- Sample Size for Test Set: Not explicitly stated as a separate clinical "test set" with a specific patient count. The performance data relates to testing of the manufactured devices themselves. The document states, "Before being released every device is tested and must meet all performance specifications." This indicates an ongoing quality control process for each manufactured unit rather than a single pre-market clinical test set.
- Data Provenance: The data appears to be from internal testing by the manufacturer, Bio Compression Systems, Inc., within their typical manufacturing and quality control processes. There is no mention of country of origin for any clinical data (as there is no explicit clinical data presented). The testing described is intrinsic to the device's design and manufacturing rather than patient-derived.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since the "test set" refers to internal performance testing of the device's operational parameters (pressure, cycle times, etc.) rather than a diagnostic or clinical efficacy study requiring human expert interpretation, the concept of "ground truth" established by external experts in this context is not applicable. The measurements taken (e.g., mmHgpressure, seconds for cycle times) are objective parameters.
4. Adjudication Method for the Test Set
As the "test set" pertains to objective performance metrics of the device (e.g., pressure, timing), and not a study requiring subjective interpretation or diagnosis, an adjudication method for establishing ground truth is not applicable. The device's performance is measured against engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. The submission focuses on substantial equivalence based on technological characteristics and functional performance parameters, not on comparative clinical efficacy or how human readers (or users) improve with AI assistance. The device is a physical therapeutic device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The VascuEase IC-1200-WH is a physical medical device (pneumatic intermittent compression device), not an algorithm or software. Its performance is inherent to its mechanical and electronic function, which is tested directly. There is no AI component or algorithm that would operate "standalone."
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by the engineering specifications and design requirements of the device and its predicate. The device's function (e.g., inflation pressure of 50 mmHg, inflation time of 15 seconds) are objective, pre-defined parameters. There is no "expert consensus," "pathology," or "outcomes data" directly used to establish the ground truth for these specific performance characteristics in the sense of a diagnostic or treatment outcome study.
8. The Sample Size for the Training Set
The document does not mention a "training set." This term is typically used for machine learning or AI models. Since the VascuEase IC-1200-WH is a physical medical device, not an AI algorithm, the concept of a training set is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI or machine learning model, this question is not applicable to the VascuEase IC-1200-WH.
§ 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).