(261 days)
Air compression leg massager, model:FE-7204B, is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated foot/calf and thigh in people who are in good health. The air compression leg massager simulates kneading and stroking of tissues by using air-inflatable boots.
The Air Compression Leg Massager (model: FE-7204B) is a powered inflatable tube massager intended to be an over-the counter portable tube massage system which simulates kneading and stroking of foot, calf, and thigh by the use of inflatable air compression boots. The device can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. The device is to be used by persons who are in good health. The device is non-sterile and utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump and two solenoid valves. The pump, solenoids and other components are protectively housed within the acrylonitrile butadiene styrene (ABS) plastic enclosure of the control unit. On the bottom of the control unit, there are 3 ports which include the following: . Two ports (L and R) for connecting the air compression boots (left (L) and right (R)) by the air hose which is permanently attached to the air compression boots . One port for connecting the alternating current (AC) adaptor which will convert line power into direct current (DC) power. The subject device is comprised of the following components: - Control Unit - AC Adapter (input:100-240V AC 50/60Hz 0.7A, output 12.0VDC, 2.0A) for converting line power to DC power - Connector Air Hose (connects Control Unit to the inflatable air compression boots) - Air compression boots which consist of three (3) air chambers/bladders encased inside a soft medical material.
This document describes the premarket notification (510(k)) for the Air Compression Leg Massager (model: FE-7204B). It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria for efficacy. The "acceptance criteria" discussed here are related to regulatory compliance and safety/performance standards, not clinical performance metrics.
Here is an analysis based on the provided text, structured according to your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative "acceptance criteria" in terms of clinical performance (e.g., a specific reduction in muscle aches or circulation increase percentage). Instead, acceptance is implied by adherence to recognized non-clinical standards and the demonstration of substantial equivalence to a predicate device. The "reported device performance" is largely described through its characteristics and comparison to the predicate.
| Acceptance Criterion (Implicit for Regulatory Clearance) | Reported Device Performance (Non-Clinical Compliance) |
|---|---|
| Electrical Safety: Compliance with general requirements for safety. | Met ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012. |
| Electromagnetic Compatibility (EMC): Compliance with EMC requirements. | Met IEC 60601-1-2:2014. |
| Home Healthcare Environment Safety: Compliance for devices used in home healthcare. | Met IEC 60601-1-11:2015. |
| Biocompatibility (Cytotoxicity): No in vitro cytotoxicity. | Met ISO 10993-5:2009. |
| Biocompatibility (Irritation & Skin Sensitization): No irritation or skin sensitization. | Met ISO 10993-10:2010. |
| Software Verification & Validation: Software functions correctly and safely. | Met "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices." |
| Substantial Equivalence: Device is as safe and effective as a legally marketed predicate device. | Demonstrated by comparing technological characteristics and intended use to K182668, noting differences do not raise new questions of safety or effectiveness, supported by non-clinical testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Summary for clinical test: Clinical performance is not deemed necessary." Therefore, there was no clinical test set with human subjects used to prove the device meets performance criteria. The "tests" mentioned are non-clinical, conducted on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical study requiring expert-established ground truth was performed for this 510(k) submission. The ground truth for the non-clinical tests (e.g., electrical safety, EMC) is derived from the objective standards themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study requiring adjudication of human subject data was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an air compression massager, not an AI-assisted diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests conducted, the "ground truth" is defined by the specific requirements and methodologies outlined in the referenced international standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10). The device's performance against these standards constitutes the "truth" for regulatory compliance in this context.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).