(247 days)
Veinoflow SCD system, Model LBTK-M-1 5001 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. LBTK-M-I 5001 is indicated for Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema -Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg ulcers, Venous Stasis / Venous Insufficiency.
Veinoflow SCD, Model LBTK-M-I 5001, is a pneumatic pump system that supplies compressed air to inflate garments that are attached to a patent's lower limbs. It consists of a pump controller, specially designed inflation and deflation garments for feet and legs, air supply tubes, and power line. The inflation and deflation garments have 3 types: ① thigh-calf garments, ② calf garments, and ③ foot cuffs. The system offers sequential inflation and propels the vein blood from limb to heart, therefore enhance the blood circulation. The controller can automatically detect the external garment type, and provides pressure correspondingly. The pressure value and inflatable interval time are preset and adjustable. The controller has a self test system, when there is any error, it will alarm both in visual and audio.
This document describes the Veinoflow SCD, Model LBTK-M-I 5001, an intermittent pneumatic compression device intended to prevent Deep Vein Thrombosis (DVT) by improving blood velocity. The submission is a 510(k) for a new device, seeking substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define 'acceptance criteria' in terms of success/failure rates for clinical outcomes but focuses on demonstrating substantial equivalence to a predicate device through functional and safety testing. The "reported device performance" is essentially a comparison of its technical specifications and tested safety features against recognized standards and the predicate device.
| Feature/Test | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Veinoflow SCD) |
|---|---|---|
| Intended Use | Prevent DVT, Circulation Enhancement, DVT Prophylaxis, Edema (acute/chronic), Extremity Pain (Trauma/Surgery), Leg ulcers, Venous Stasis/Insufficiency | Same as predicate device. |
| Components | Pump controller, multi-cavity thigh-calf garments, calf garments, foot cuffs, battery, air supply tubes, power line | Same as predicate device. |
| Compression Type | Thigh-calf & calf garments: Sequential, Gradient; Foot Cuffs: Uniform | Same as predicate device. |
| Compression Time | Match predicate timings | Same as predicate device (Single thigh-calf: 5.5s, Dual thigh-calf: 11s, Single calf: 4s, Dual calf: 8s, Single foot cuff: 2.5s, Dual foot cuffs: 5s). |
| Deflation Time | 2-3s | Same as predicate device (2-3s). |
| Default Inflatable Interval Time | 48s | Same as predicate device (48s). |
| Adjustable Inflatable Interval Time | 24s, 48s, 60s | Same as predicate device (24s, 48s, 60s). |
| Default Pressure (Thigh-calf & Calf Garments) | 40 mmHg | Same as predicate device (40 mmHg). |
| Default Pressure (Foot Cuffs) | 120 mmHg | 130 mmHg. Note: Although different, the submission states it can be adjusted to the same pressure as the predicate, and the adjustable range is the same. |
| Adjustable Pressure (Thigh-calf & Calf Garments) | 20-60 mmHg | 30-60mmHg. Note: Different range, but the submission states this is covered by the predicate device's adjustable pressure range. |
| Adjustable Pressure (Foot Cuffs) | 120-140 mmHg | Same as predicate device (120-140 mmHg). |
| Alarm Functionality | Cuff connection Error, Pressure Error, System Error, Power Error | No garment, Pump Error, Valve Error, Temperature Error, Software Error, System Error, High Pressure, Low Pressure, Low Battery. Note: Different/more detailed alarms, considered a safety enhancement. |
| Biocompatibility Testing | Compliance with ISO 10993-1, -5, -10 | Passed (ISO 10993-1: 2009, ISO 10993-5: 2009, ISO 10993-10: 2010). |
| Electrical Safety Testing | Compliance with IEC 60601-1 | Passed (IEC 60601-1: 2005). |
| Electromagnetic Compatibility (EMC) Testing | Compliance with IEC 60601-1-2 | Passed (IEC 60601-1-2: 2007). |
| Bench Testing (Garments/System) | Match predicate performance/safety | Passed: Pressure testing, Inflation/deflation time, Anti-stretch test of garment materials, Anti-stretch test of air chamber welding point, Air leakage test, Burst testing of garment, Bladder fatiguing test, Velcro adhesion test. The new device also has more safety testing on garments compared to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing for the device, including:
- Pressure testing
- Inflation/deflation time
- Anti-stretch test of garment materials
- Anti-stretch test of air chamber welding point
- Air leakage test
- Burst testing of garment
- Bladder fatiguing test
- Velcro adhesion evaluation test
- Biological compatibility test
- Electromagnetic compatibility test
- Electrical Safety test
The sample size for these tests is not specified in the provided text. The data provenance is also not explicitly stated as retrospective or prospective clinical data, as the study focuses on bench testing and technical comparison, not patient outcomes. The manufacturer is Dalian Labtek Science & Development Co., Ltd. from Dalian, China, so the testing likely occurred there.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. The study relies on objective technical measurements and comparisons to recognized standards and the predicate device's specifications, rather than expert consensus on a test set.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the bench testing, an adjudication method for a test set (e.g., 2+1, 3+1) is not applicable or described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (intermittent pneumatic compression system), not an AI-assisted diagnostic tool, so such a study would not be relevant.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was Done:
This question is not applicable. The device is a physical system, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is established through:
- Compliance with recognized international standards: ISO 10993 (biocompatibility) and IEC 60601 (electrical safety, EMC).
- Comparison against the predicate device's specifications and performance: The predicate device is "The Venous Assist System DVT-2600" (K112677). The new device is deemed substantially equivalent based on matching or exceeding the predicate's technical characteristics and safety features.
- Bench testing results: Demonstrating that the device meets functional and safety requirements through objective measurements (e.g., pressure, timing, material integrity).
8. The Sample Size for the Training Set:
This question is not applicable. This device is not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established:
This question is not applicable, as there is no training set mentioned for this device.
§ 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).