(134 days)
Air compression therapy system FO3002 is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Air compression therapy system FO3002 is consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.
Air compression therapy system FO3002, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas. Clothing should be worn between the device and the patient's skin.
This document is a 510(k) Premarket Notification from the FDA for an "Air compression therapy system FO3002". It demonstrates the device's substantial equivalence to a legally marketed predicate device (NormaTec Pulse and NormaTec Pulse Pro, K160608).
Based on the provided text, the device does not involve an AI algorithm or performance criteria that would require a study as described in the prompt. The "acceptance criteria" discussed are related to technical specifications and safety standards, rather than diagnostic accuracy or human performance with AI assistance.
Therefore, many of the requested sections (2-9) are not applicable to this document as it pertains to a physical medical device (an air compression therapy system) that does not incorporate AI or require assessment of its diagnostic performance through a test set and ground truth.
However, I can extract the acceptance criteria in terms of the device's characteristics and how it compares to the predicate, which serves as its "performance" in the context of this 510(k) submission.
1. A table of acceptance criteria and the reported device performance
In a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. This is primarily shown through a comparison of technological characteristics and indications for use. The "reported device performance" in this context refers to how closely the subject device's characteristics match or are explained in relation to the predicate.
| Feature/Criteria | Acceptance Criteria (Predicate: NormaTec Pulse/Pulse Pro, K160608) | Reported Device Performance (Air compression therapy system FO3002) | Discussion/Equivalence |
|---|---|---|---|
| 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 |
| Treatment Time | Stays on until the user turns it off or can be set up to turn off in a range of 10 mins to continuous / User controlled 10 minutes to 175 minutes or continuous - total time over 4 segments. | 10-60min | Similar (Subject device's range is smaller, which does not raise adverse impact on safety/effectiveness). |
| Standard Compliance | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2, ISO 10993-5, ISO 10993-10 | Similar (Subject device tested to more standards, indicating robust compliance). |
| Mode of Compression | Sequential Gradient, Peristaltic and Pulsing | Sequential (The document lists various modes for the subject device: Normal, Sequential, Double, Whole, Combined A+B, which are compared to the predicate's modes, stating A and C are the same with the predicate). | Same (with additional modes or variations whose differences don't adversely impact safety/effectiveness). |
| Power Source | 12 VDC via an IEC 60601-1 compliant power supply (100-240 VAC input) Optional Integrated rechargeable battery | Adaptor: AC 100-240V, 50/60Hz; Main unit: DC 15V, 1.5A | Similar |
| Power Consumption | 14W | 22.5VA | Similar |
| Dimensions (Main unit) | 4" x 5" x 9" | 265 x 130 x 100mm | Similar |
| Housing Materials | Molded ABS enclosure | Molded ABS enclosure | Same |
| Number of Chambers (Sleeves) | 5 or less | 6 | Similar (The additional chamber is likely an enhancement not impacting fundamental safety/effectiveness for the stated indications). |
| Safety Features | 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 |
| Intended Population/Environment | Not explicitly stated in comparison table but implied OTC/Home use. | Intended for home use. Over-The-Counter Use. | Same |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is Not Applicable (N/A). The device is an air compression therapy system, not an AI/software device that processes data for diagnostic purposes requiring a test set for performance evaluation. The submission relies on technical and safety testing to demonstrate equivalence, not clinical performance data from a patient population.
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)
N/A. No diagnostic "ground truth" or expert review of patient data was necessary for this device type.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. No test set or adjudication process as described for AI/diagnostic devices 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
N/A. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. Not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. No ground truth of this nature was established. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device, against which the subject device's technical specifications and safety profile are compared for substantial equivalence.
8. The sample size for the training set
N/A. No training set was used as this is not a machine learning/AI device.
9. How the ground truth for the training set was established
N/A. No training set or associated ground truth was established.
Summary of Study that Proves the Device Meets Acceptance Criteria:
The study that proves the device meets the "acceptance criteria" (i.e., is substantially equivalent to a legally marketed predicate) is presented as a comparative analysis of technical specifications and safety standards compliance.
- Evidence Type: The submission relies on non-clinical performance testing (compliance with electrical safety, EMC, biocompatibility standards like IEC 60601-1-11, IEC 60601-1-2, ANSI AAMI ES60601-1, ISO 10993-5, ISO 10993-10, IEC 62133-2) and a direct comparison of the subject device's features to those of the predicate device.
- Methodology: The manufacturer states "Performance Testing - Clinical" and "Performance Testing - Animal" are "Not Applicable". This indicates that no human or animal studies were conducted to prove performance for this 510(k) submission. Instead, the demonstration of substantial equivalence is built upon:
- Identical Indications for Use.
- Similar (or identical) technological characteristics: as detailed in the comparison table (e.g., pressure range, mode of compression, power source, materials, safety features). Any differences are argued not to raise new questions of safety or effectiveness.
- Compliance with recognized electrical safety and biocompatibility standards.
- Conclusion of the Study (FDA's Determination): The FDA's letter (K212169) signifies that based on the provided information, the device is considered "substantially equivalent" to predicate devices, meaning it is "as safe, as effective, and performs as well as the legally marketed predicate devices." This substantial equivalence is the ultimate "proof" required for market clearance under the 510(k) pathway for this type of device.
§ 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).