(116 days)
WIC -2008S is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.
WIC-2008S is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.
This document describes a medical device, the Compressible Limb Therapy System WIC-2008S, which is a "Powered inflatable tube massager." The submission is for a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy through extensive clinical trials.
Therefore, the provided text does not contain information about acceptance criteria, detailed device performance metrics, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training sets was established.
The document focuses on:
- Device Description: It's a system that uses four-chamber garments for full legs and has variable duration, pressure, cycle time, and gradient settings.
- Intended Use: To treat conditions like primary lymphedema, edema following trauma and sports injuries, post-immobilization edema, venous insufficiencies, and lymphedema.
- Substantial Equivalence: The primary argument is that the WIC-2008S is substantially equivalent to a previously cleared device (WIC-2008, K102319) in terms of intended use, technological, and performance characteristics, without raising new safety or effectiveness concerns.
- Performance Characteristics (Standards Applied): Instead of reporting specific device performance against acceptance criteria, the document lists a series of national and international standards the device has conducted and applied, which are common for medical devices to ensure safety, quality, and regulatory compliance. These standards include:
- Council Directive 93/42/EEC (Medical Devices)
- IEC 980:2008 (Graphical symbols for use in labeling)
- IEC 1041:2008 (Information supplied by manufacturer)
- ISO 13485:2003 (Quality management systems)
- ISO 14155-1:2003 (Clinical investigation of medical devices for human subjects - General requirements)
- ISO 14971:2007 (Application of risk management)
- IEC 60601-1 (General requirements for safety of medical electrical equipment)
- IEC 60601-2-10 (Particular requirements for safety of nerve and muscle stimulators)
- IEC 60601-1-2 (Electromagnetic compatibility)
Conclusion:
Based on the provided text, it's not possible to populate the requested table or answer most of the questions, as this is a 510(k) submission focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria often seen for novel devices that require efficacy data.
The "performance characteristics" listed are the standards applied (bench and laboratory testing to applicable standards), not specific performance metrics like sensitivity, specificity, accuracy, or effect sizes from clinical studies. The FDA's letter explicitly states that they "have determined the device is substantially equivalent... to legally marketed predicate devices," which means they accepted the manufacturer's argument based on design, materials, and engineering testing to relevant safety standards, rather than new clinical outcome studies.
Therefore, the requested information (performance acceptance criteria, sample sizes, ground truth, expert qualifications, MRMC studies, etc.) is not present in the provided 510(k) summary.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).