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510(k) Data Aggregation
(128 days)
Veinoflow SCD, LBTK-M-I 5006 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. LBTK-M-I 5006 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 5006, 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 leg garments, ② calf garments, ③ foot cuffs. The system offers sequential inflation and propels the vein blood from limb to heart, therefore enhancing the blood circulation. The controller can automatically detect the external garment type, and provides pressure correspondingly. The pressure value is 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 does not describe acceptance criteria for the performance of an AI/ML device in terms of diagnostic accuracy or clinical outcomes. Instead, it is a 510(k) summary for a medical device called "Veinoflow SCD" (Model: LBTK-M-I 5006), which is an intermittent pneumatic compression device.
The study described is focused on demonstrating substantial equivalence to a predicate device (Veinoflow SCD, Model: LBTK-M-I 5001, K123830), primarily through non-clinical testing of safety and performance characteristics. This type of regulatory submission does not typically involve the kinds of studies (e.g., multi-reader multi-case studies, standalone algorithm performance) that would be conducted for AI/ML-driven diagnostic or prognostic devices seeking to establish clinical performance.
Here's an analysis based on the provided text, addressing your questions where applicable and noting where the information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on compliance with established international standards for medical devices and demonstration that differences from the predicate device do not raise new safety or effectiveness concerns.
| Acceptance Criteria (Standard / Characteristic) | Reported Device Performance (Veinoflow SCD, Model: LBTK-M-I 5006) |
|---|---|
| Electrical Safety: Conformance to ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD) | Passed the tests of ANSI AAMI ES60601-1. Demonstrated to conform to the standard. Differences in controller dimensions and weight from predicate do not affect performance and do not raise new safety/effectiveness issues. |
| Electromagnetic Compatibility (EMC): Conformance to ANSI AAMI IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests | Passed the tests of IEC 60601-1-2. Demonstrated to conform to the standard. Differences in controller dimensions and weight from predicate do not affect performance and do not raise new safety/effectiveness issues. |
| Battery Safety: Conformance to IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems | The battery used by the proposed device has passed the test of the IEC 62133-2 standard. Difference in battery specifications (11.1V 5000mAh Lithium Ion vs. 14.8V 3100mAhr Lithium Ion for predicate) does not raise any safety or effectiveness issues as the new battery passed testing. |
| Biocompatibility (Cytotoxicity): Conformance to ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. | Demonstrated to conform to the standard. |
| Biocompatibility (Irritation and Skin Sensitization): Conformance to ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. | Demonstrated to conform to the standard. |
| Functional Equivalence: Differences in design features (e.g., controller dimensions, weight, default inflation interval, battery) must not affect the fundamental performance or indications for use, and must not raise new questions of safety or effectiveness. | Controller Dimensions/Weight: Length: 185mm; Width: 165mm; Height: 250mm; Weight: 2.5kg (vs. Predicate: Length: 240mm; Width: 140mm; Height: 263mm; Weight: 3.5kg). Conclusion: These differences don't affect performance and don't raise new safety/effectiveness issues. |
| Default Inflatable Interval Time: 60s (vs. Predicate: 48s). Conclusion: Adjustable interval times (24s, 48s, 60s) are the same for both devices, allowing user choice. This difference doesn't raise new safety/effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of AI/ML evaluation (i.e., a dataset used to evaluate diagnostic performance). The testing mentioned is for device safety and electrical performance (e.g., electrical safety, EMC, biocompatibility, battery safety) according to international standards. Therefore, information on sample size and data provenance in this context is not applicable or not provided. The provenance of the device manufacturer is China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As noted above, this device is not an AI/ML diagnostic device requiring an expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" in this context is compliance with established engineering and safety standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and the functional specifications of the device as tested against these standards. It's not a clinical ground truth for a diagnostic outcome.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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