(344 days)
Air Pressure Therapy System VU-IPC04B is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Air Pressure Therapy System has a pump. The pump is connected to the dedicated cuff via the hose series, one cuff has 6 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 the treated area, in exercise rehabilitation field for muscle relaxation before exercise and muscle rehabilitation after exercise to relieve muscle soreness.
This document is a 510(k) premarket notification for a medical device called "Air Pressure Therapy System: VU-IPC04B". The FDA has determined the device is substantially equivalent to a legally marketed predicate device, "NormaTec Pulse and NormaTec Pulse Pro (K160608)".
Based on the provided text, the device in question is a Powered Inflatable Tube Massager (Product Code IRP), which falls under Class II medical devices.
Here's an analysis of the acceptance criteria and study proving the device meets them, according to the document:
1. A table of acceptance criteria and the reported device performance:
The document directly states: "Performance testing - clinical: Not Applicable." and "Performance testing - animal: Not Applicable." This indicates that for this specific type of device and its indications for use, no clinical or animal performance studies were required by the FDA or provided by the manufacturer to demonstrate meeting acceptance criteria for its therapeutic claims (temporary relief of muscle aches/pains, increased circulation).
Instead, the substantial equivalence hinges on:
- Indications for Use: The subject device's indications for use are identical to the predicate device.
- Technological Characteristics: The core technology (compressor and valve system for sequential inflation) is the same.
- Non-clinical Performance Data: This is where the "acceptance criteria" lie in this context, focusing on safety and technical specifications rather than direct clinical efficacy.
Here's a table summarizing the relevant "performance characteristics" and acceptance based on this document:
| Acceptance Criteria (Based on comparison to Predicate Device & Applicable Standards) | Reported Device Performance (VU-IPC04B) | Meets Criteria? |
|---|---|---|
| Indications for Use (Same as predicate) | Temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. | Yes (Identical) |
| Regulation Number (Same as predicate) | 21 CFR 890.5650 | Yes (Same) |
| Classification Name (Same as predicate) | Massager, Powered Inflatable Tube | Yes (Same) |
| Regulation Class (Same as predicate) | 2 | Yes (Same) |
| Product Code (Same as predicate) | IRP | Yes (Same) |
| Rx or OTC Use (Same as predicate) | OTC | Yes (Same) |
| Pressure Range (Same as predicate) | 30-110mmHg | Yes (Same) |
| Mode of Compression (Same as predicate) | Sequential | Yes (Same) |
| Safety Feature (Same as predicate) | Power button on main unit allows user to stop therapy session at any time. | Yes (Same) |
| Technology (Same as predicate) | Compressor and valve system which sequentially inflates inflatable chambers. | Yes (Same) |
| Standard Compliance (Non-clinical safety) | Meets IEC 60601-1-11: 2015, IEC 60601-1-2: 2014, ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/R)2012, ISO 10993-5: 2009, ISO 10993-10: 2010, IEC 62133-2: 2017. | Yes |
| Treatment time (Similar to predicate without raising safety concerns) | 5-99 mins (Predicate: 10 mins to continuous / up to 175 mins) | Yes (Similar, with justification for no adverse impact) |
| Power source (Similar to predicate without raising safety concerns) | 110-240V; 50Hz/60Hz (Predicate: 100-240 VAC input) | Yes (Similar, implied no adverse impact) |
| Power consumption (Similar to predicate without raising safety concerns) | 35W (Predicate: 14W) | Yes (Similar, implied no adverse impact) |
| Dimensions/Weight (Similar to predicate without raising safety concerns) | Various (Predicate: 4"x5"x9" / 3.6 lbs) | Yes (Similar, implied no adverse impact) |
| Number of chambers (Similar to predicate without raising safety concerns) | 6 chambers (Predicate: 5 chambers) | Yes (Similar, implied no adverse impact) |
| Work modes (Similar to predicate without raising safety concerns) | Mode A (sequential), Mode B (gradual fill), Mode C (pulse), Mode D (all chambers inflate together) (Predicate: Sequential, Pulse) | Yes (Similar, with justification for no adverse impact) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No clinical or animal test set data was used for performance validation as per the document. The substantial equivalence is based on comparison to a predicate device and engineering/bench testing against recognized standards.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No expert-adjudicated test set was used for performance assessment in this 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 Pressure Therapy System, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is not an algorithm; it's a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this 510(k) relies on the established safety and effectiveness of the legally marketed predicate device (NormaTec Pulse and NormaTec Pulse Pro), combined with compliance to recognized international and national electrical, safety, and biocompatibility standards (e.g., IEC 60601 series, ISO 10993 series) through non-clinical (bench) testing. There is no "ground truth" derived from patient outcomes or expert consensus for this specific device's clinical performance, as clinical studies were deemed unnecessary for substantial equivalence.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning 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).