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Air Pressure Therapy System VU-IPC06 is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Device Description

Air Pressure Therapy System has a pump. The pump is connected to the dedicated cuff via the hose series, one cuff has 8 compression chambers. The pump compresses and inflates air into the chambers continuously to produce compression from the body tail end to body center and release the air after compression as one cycle process. Cycle time and pressure can be adjusted by purpose to avoid any discomfort.

Air Pressure Therapy System intermittent pneumatic compression could be used in family for improving blood circulation in treated areas, in exercise rehabilitation field for muscle relaxation before exercise and muscle rehabilitation after exercise to relieve muscle soreness.

AI/ML Overview

The provided text is a 510(k) summary for the "Air Pressure Therapy System: VU-IPC06". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of a clinical study proving its own independent performance against acceptance criteria.

The submission explicitly states:

"Performance Testing - Clinical: NOT Applicable." (Page 4)
"Performance Testing - Animal: NOT Applicable." (Page 4)

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Instead, it relies on a comparison to a predicate device (NormaTec Pulse and NormaTec Pulse Pro, K160608) to establish substantial equivalence.

The table below summarizes what could be considered acceptance criteria based on standard compliance and a comparison of the subject device's performance to its predicate. However, it's crucial to understand these are not acceptance criteria from an independent performance study of the subject device but rather a demonstration of similarity to a cleared device.

Summary of Device Comparison (No Independent Performance Study Provided)

1. Table of Acceptance Criteria and Reported Device Performance

Since no independent performance study is reported for the subject device against acceptance criteria, the table below reflects a comparison to the predicate device, which is the basis for its 510(k) clearance. The "acceptance criteria" here implicitly refer to being "as safe and effective" as the predicate.

Feature/Characteristic	Predicate Device (K160608) Performance	Subject Device (K210967) Performance	Differences/Conclusion
Indications for Use	Temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.	Temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.	Same
Pressure Range	30-110mmHg	30-110mmHg	Same
Regulation Number	21 CFR 890.5650	21 CFR 890.5650	Same
Classification Name	Massager, Powered Inflatable Tube	Massager, Powered Inflatable Tube	Same
Regulation Class	Class II	Class II	Same
Product Code	IRP	IRP	Same
Rx or OTC	OTC	OTC	Same
Mode of Compression	Sequential Gradient, Peristaltic and Pulsing	Sequential	Same (Subject device's "Mode A" is same as predicate; other modes are variations in inflation order)
Safety Feature	Button on display allows user to stop or pause therapy session at any time.	Button on display allows user to stop or pause therapy session at any time.	Same
Technology	Compressor and valve system which sequentially inflates inflatable chambers.	Compressor and valve system which sequentially inflates inflatable chambers.	Same
Treatment Time	User controlled 10 minutes to 175 minutes or continuous	1-99min	Similar; subject device's shorter maximum time is deemed not to raise adverse impact on safety/effectiveness.
Standards Compliance	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11	ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-5, ISO 10993-10	Similar (Subject device additionally lists ISO 10993-5, ISO 10993-10 for biocompatibility, which are standard for medical devices in direct contact with skin.)

Note: The differences identified (e.g., treatment time, specific modes of compression) are evaluated to ensure they do not raise adversely impact or safety and effectiveness compared to the predicate, rather than meeting specific performance thresholds for the device itself.

2. Sample Size Used for the Test Set and the Data Provenance:
Not applicable, as no clinical performance study on a test set (human subjects or patient data) was conducted or reported for the substantially equivalent device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable, as no clinical performance study was conducted.

4. Adjudication Method for the Test Set:
Not applicable, as no clinical performance study was conducted.

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 not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device (air pressure therapy system), not an algorithm or software-only device.

7. The type of ground truth used:
Not applicable, as no clinical performance study was conducted. The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the predicate device based on its prior clearance and generally accepted standards for this type of device.

8. The sample size for the training set:
Not applicable, as no algorithm training or performance study was conducted or reported.

9. How the ground truth for the training set was established:
Not applicable, as no algorithm training or performance study was conducted or reported.

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