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The Aquilo Sports CCT1500 System is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The CCT1500 simulates kneading and stroking of tissues by using an inflatable garment.

Device Description

This submission is for the Aquilo Sports CCT1500 System is a powered inflatable tube massager. It is being submitted as an over the counter device. The device is indicated for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The CCT1500 simulates kneading and stroking of tissues by using an inflatable garment. The device is a Class II, type BF applied part that receives power a separately approved external IEC 60601-1 compliant power supply or integral battery pack. The CCT1500 consists of an air compressor unit with a control system, an inflatable "boot" for the leg, plastic air tubing with a proprietary connector for connecting the device to the boot. The user interface is a front panel display and buttons. The CCT1500 contains an air compressor with a system control that that allows the user to adjust the amount of air coming from the air compressor and going to the individual segments of the inflatable boot. There is no electrical contact with the user and the device does not transfer or detect energy to or from the user.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Aquilo Sports CCT1500 System, based on the provided FDA 510(k) summary:

This device is a Powered Inflatable Tube Massager (Product Code: IRP) and is classified as a Class II medical device. The 510(k) process is used to demonstrate substantial equivalence to a previously cleared predicate device, rather than proving novel safety and efficacy from scratch. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence to the predicate device through comparisons of indications for use, technological characteristics, safety features, and performance specifications.

Since this is a GHTF Class B (Class II equivalent) device and the submission focuses on substantial equivalence, the "study" is primarily a comparative analysis against a cleared predicate device, rather than a clinical trial with human subjects or a standalone AI performance study.

1. Table of Acceptance Criteria (Comparisons) and Reported Device Performance

The "acceptance criteria" for a 510(k) submission seeking substantial equivalence are met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by comparing various characteristics.

Acceptance Criteria (Comparison Point)	Aquilo Sports CCT1500 System Performance (Proposed Device)	Rapid Reboot (K182668) (Predicate Device)	NormaTec Pulse (K160608) (Reference Device - for Treatment Time)	Comment on Equivalence / Difference
Classification	Class II Device, IRP (21 CFR 890.5650)	Class II Device, IRP (21 CFR 890.5650)	N/A	Identical
Indications for Use	Temporary relief of minor muscle aches and pains; temporary increase in circulation to treated areas in healthy people. Simulates kneading and stroking with an inflatable garment.	Temporary relief of minor muscle aches and pains; temporary increase in circulation to treated areas in healthy people. Simulates kneading and stroking with an inflatable garment.	N/A	Identical
OTC or Prescription	OTC	OTC	N/A	Identical
Environment of Use	Clinics, hospital, athlete training, and home environments	Clinics, hospital, athlete training, and home environments	N/A	Identical
Compliance with Voluntary Standards	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11	IEC 60601-1, IEC 60601-1-2	N/A	CCT1500 meets home use standard (IEC 60601-1-11) in addition to the predicate's standards. This is generally seen as enhancing safety for the stated environment of use.
Mode of Operation	Sequential	Sequential/Peristaltic	N/A	No difference. "Peristaltic" and "Sequential" are stated as synonymous in this context.
Cycle Time	Between 8 sec. and 95 sec. (full cycle - including hold time) depending on device settings.	1 min 20 sec (80 seconds)	N/A	Similar. The CCT1500's range overlaps with the predicate's fixed time, and flexibility is noted as a consequence of user-programmable settings.
Hold Time	Between 4 sec. and 95 sec. depending on device settings.	Not available	N/A	Similar, as it's a configurable parameter affecting the overall cycle time.
Power	100-240 V, 50-60 Hz, 2.5A Max; Internal rechargeable battery	110 V, 60Hz	N/A	Similar. The addition of a battery is noted as not impacting efficacy and safety testing supports current standards.
Device Pressure Range	20-150mmHg	0 - 200 mmHg	N/A	The CCT1500 has a more restricted range. This difference is not presented as raising new safety or efficacy concerns.
Treatment Time	Programmable from 20-150 minutes in 5-minute intervals. Default 30 min.	User determines (10, 20, 30 min, or +10 min)	User Controlled (10 min to 175 min or continuous)	Similar. CCT1500's maximum is longer than predicate but within the reference device's range.
Garment Contact Surface Material	Nylon with a Polyurethane laminate	Nylon with a Polyurethane laminate	N/A	Same materials.
Leg Attachment	Yes	Yes	N/A	Identical in size and construction.
Number of Inflatable Appliance Segments	6	4	N/A	Similar. A difference in segment count is not considered to raise new safety/efficacy concerns for the massager function.
Weight	18.1 pounds	5.8 pounds	N/A	Similar. Weight difference attributed to battery, not raising safety/efficacy concerns.
Dimensions (W x H x D)	16" x 8.25" x 10.25"	10" x 6.5" x 5"	N/A	Similar. Proportional differences.
Housing Materials and Constructions	Molded ABS enclosure	Molded ABS enclosure	N/A	Identical.
Patient Contact	Non-conductive appliances	Non-conductive appliances	N/A	Identical.
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.	N/A	Identical.
Modes	5 modes, sequential and uniform (all segments inflated/deflated at once).	2 Modes: "A" (sequential, one at a time), "B" (sequential with sustained pressure).	N/A	Similar. Differences in specific programming modes are not presented as new substantial equivalence issues for this device type.
Accessories	One size Length: 36", Max Width: 27" (leg attachment)	X-Short: 14"x41" to X-Long: 14"x52"	N/A	CCT1500 only offers leg attachment, with one size. Predicate offers variable sizes. This is a scope difference, not a safety/efficacy concern.
SW/Firmware/Microprocessor Control	Microprocessor	Microprocessor	N/A	Identical.
Technology	Compressor and valve system which sequentially inflates cells of appliance.	Compressor and valve system which sequentially inflates cells of appliance.	N/A	Identical.

Context of the "Study" and Acceptance

The "study" in this 510(k) submission is not a traditional clinical trial or an AI/ML algorithm validation study. It is a demonstration of substantial equivalence through a detailed comparison to a legally marketed predicate device (Rapid Reboot K182668) and a reference device (NormaTec K160608 for treatment time).

The acceptance criteria are effectively met by demonstrating that:

The indications for use are identical.
The technological characteristics are sufficiently similar or that any differences do not raise new questions of safety or effectiveness.
The performance specifications are comparable or that any differences still maintain safety and effectiveness for the intended use.
The device complies with relevant recognized consensus standards.

Specific Information Not Applicable or Not Provided in this Document for a 510(k) for this type of device:

Given that this is a 510(k) for a powered inflatable tube massager and relies on substantial equivalence to a mechanically similar predicate, many of the requested items (especially those related to AI/ML or complex clinical studies) are not applicable or typically required to establish substantial equivalence for this specific type of device.

Sample size used for the test set and the data provenance: Not applicable in the context of comparative performance for this type of device. The "test" is the comparison against the predicate and compliance with standards.
Number of experts used to establish the ground truth... and qualifications: Not applicable for this type of device/submission. Ground truth for a massager is generally its mechanical function, safety, and performance within design specifications, which is verified through bench testing and standards compliance, not expert clinical interpretation of complex data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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/ML diagnostic aid.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this massager is established by its physical and mechanical performance (e.g., pressure range, cycle time, safety features) verified through bench testing and compliance with recognized electrical safety and EMC standards (ES 60601-1, IEC 60601-1-2, IEC 60601-1-11). The acceptance criteria are based on this technical performance being comparable to the predicate.
The sample size for the training set: Not applicable (not an AI/ML device).
How the ground truth for the training set was established: Not applicable (not an AI/ML device).

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