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).

Summary

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November 4, 2022

Aquilo Sports LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K223164

Trade/Device Name: Aquilo Sports CCT1500 System Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: October 06, 2022 Received: October 07, 2022

Dear Prithul Bom:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223164

Device Name Aquilo Sports CCT1500 System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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	510(k) SummaryPage 1 of 10
	K223164
Date Prepared:	November 2, 2022
Applicant	Aquilo Sports1902 Campus Pl Ste 12Louisville, KY 40299Tel - 502 290 8994
Official Contact:	John Paul Spence VP Sales and Marketing
Proprietary or Trade Name:	Aquilo Sports CCT1500 System
Common/Usual Name:	Powered Inflatable Tube Massager
Classification Name:	IRP - Massager Powered Inflatable Tube (CFR 890.5650)
Predicate Device:Reference Device:	IRP Rapid Reboot 510(k) K182668NormaTec Pulse and NormaTec Pulse Pro 510(k) K160608:

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.

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510(k) Summary Page 2 of 10

The user interface of the CCT1500 provides for starting and stopping the massage treatment, allows for adjusting time and intensity (pressure) of the treatment. The device also provides a proprietary keyed connector to the tubing which connects to the boot.

Pressure level is selectable between 20 and 150 mmHg

Indications for Use:

The Aquilo Sports CCT1500 System is indicated for the temporary relief of minor muscle aches and pains 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.

Patient Population:

Adults

Environments of Use:

Clinics, hospital, athlete training, and home environments

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510(k) Summary Page 3 of 10

Table of the Similarities and Differences of Predicate vs. Proposed Device Over The Counter Device

Model Name510(k) Number	New DeviceAquilo Sports CCT1500 System	Predicate DeviceRapid Reboot510(k) K182668	Comment
Classification	Class II Device, IRP (21CFR890.5650)	Class II Device, IRP (21CFR890.5650)	Identical
Indications for use	The Aquilo Sports CCT1500System is indicated for thetemporary relief of minor muscleaches and painsand for temporary increase incirculation to the treated areas inpeople who are in good health.The CCT1500 simulateskneading and stroking of tissuesby using an inflatable garment.	The Rapid Reboot CompressionTherapy System is indicated for thetemporary relief of minor muscleaches and pains and for temporaryincrease in circulation to the treatedareas in people who are in goodhealth. The Rapid RebootCompression Therapy Systemsimulates kneading and stroking oftissues by using an inflatablegarment.	Identical
OTC or Prescription	OTC	OTC	Identical
Environment of Use	Clinics, hospital, athletetraining, and homeenvironments	Clinics, hospital, athletetraining, and homeenvironments	Identical
Compliance with Voluntarystandards	ES 60601-1, IEC 60601-1-2,IEC 60601-1-11	IEC 60601-1, IEC 60601-1-2	The CCT1500 meetshome use standard
Mode of Operation	Sequential	Sequential/Peristaltic	No difference.Peristaltic andSequential aresynonymous

Cycle Time	Between 8 sec. and 95 sec. (full cycle - including hold time) depending on device settings*.	1 min 20 sec	Similar
Hold Time	Between 4 sec. and 95 sec. depending on device settings*.	Not available	Similar
Power	100-240 V, 50-60 Hz, 2.5A MaxInternal rechargeable battery	110 V, 60Hz	The addition of the battery does not impact the efficacy of the device. The device and battery have been tested for safety to current standards
DevicePressure range	20-150mmHg	0 - 200 mmHg	The CCT1500 has a more restricted range
Treatment Time	Treatment time programmable from 20-150 minutes in 5-minute intervals. Time default is 30 minutes	User determines therapy time. Choose from 10, 20, or 30 minutes session time, with option to add additional 10 minutes to any therapy time.	Maximum selectable time is 200 minutes which is longer that the predicate but shorter than the reference device as below
Garments contact surfaceMaterial	Nylon with a Polyurethane laminate	Nylon with a Polyurethane laminate	Same materials
Leg Attachment	Yes	Yes	Identical in size and construction
Number of Inflatable applianceSegments	6	4	Similar.
Weight	18.1 pounds	5.8 pounds	Similar. CCT1500 weighs more in part because of battery
Dimensions (W x H x D)	16" x 8.25" x 10.25"	10" x 6.5" x 5"	Similar
Housing Materials andConstructions	Molded ABS enclosure	Molded ABS enclosure	Identical
	Patient contact	Non-conductive appliances	Non-conductive appliances
Safety Features	Button on display allowsuser to stop or pausetherapy session at any time.	Button on display allowsuser to stop or pausetherapy session at any time.	Identical
Modes	5 modes, sequential and uniform(all segments inflated deflated atonce).	2 Modes: “A” mode inflates anddeflates chambers from bottom toup (distal to proximal chambers),one at a time "B" mode also inflatesfrom bottom up, but maintainspressure in lower chambers as itworks it way to the top. Then allchambers release pressure at thesame time once all chambers havesequentially inflated	Similar
Accessories	One size Length: 36"Max Width: 27"	X-Short: 14" x 41"Short: 14" x 43"Medium: 14" x 45"Long: 14" x 48"X-Long: 14" x 52"	CCT1500 only offersleg attachment
SW/Firmware/MicroprocessorControl	Microprocessor	Microprocessor	Identical
Technology	Compressor and valvesystem which sequentiallyinflates cells of appliance	Compressor and valvesystem which sequentiallyinflates cells of appliance	Identical

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510(k) Summary Page 4 of 10

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510(k) Summary

Page 5 of 10

*The cycle time and hold time of the device are contings programmed by the user. These times will fluctuate within the described range depending on the user's input for the pressure, and compression mode settings. For example, using only one compression chamber at a low pressure will result in cycle and hold times on the range, while using all six chambers at a high pressure will result

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510(k) Summary Page 6 of 10

in cycle and hold times at the upper end of the range. Additionally, the hold time will be different chambers in the compression boot during sequential compression mode 1, compression chamber 1 at the foot will inflate and maintain the target pressure while the rest of the boot inflates, meaning the hold time in chamized (up to 95 seconds), while the hold time in chamber 6 will be minimized (4 seconds).

Reference Device: NormaTec Pulse and NormaTec Pulse Pro 510(k) K160608:

The NormaTec Pulse and NormaTec Pulse Pro are used as a reference device for "Treatment Time". The subject device has a treatment time of 20-150 minute intervals. Time default is 30 minutes while the reference device is user controlled 10 minutes to 175 minutes or continuous. As the reference device includes a continuous treatment that the subject device range is within the reference.

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510(k) Summary Page 7 of 10

Substantial Equivalence Discussion

In the above tables we have compared the CCT1500 to the predicate for equivalence of: Indications -

These indications are identical to the predicate device.

Design, Technology and Principle of Operation - The CCT15000 is equivalent in design and features when compared to the predicate and has identical technology

Performance and Specifications – The CCT1500 has equivalent specifications of performance when compared to the predicate device. This includes cycle time and hold time.

Compliance with standards - The CCT1500 is compliance with IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2 which is identical to the predicate devices.

Patient Population -

The CCT1500 and predicate are indicated for adults

Environment of Use -

The CCT1500 environments are identical to the predicate

Differences –

There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns.

Performance Testing

Bench:

The device has been tested to ensure that it all requirements have been met, this includes:

. Testing of all controls
Testing of all indicators .
Testing of performance .

The device has also been tested to the requirements of the following standards:

AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment part 1: general requirements for basic safety and essential performance
IEC 60601-1-2: 2014, Collateral standard: Electromagnetic Disturbances -● Requirements and Tests

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510(k) Summary Page 8 of 10

IEC 60601-1-11: 2015, Collateral standard: requirements for medical . electrical equipment and medical electrical systems used in the home healthcare environment

Animal:

No animal testing was performed

Clinical:

No clinical testing was performed

Differences -

There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns.

Substantial Equivalence Rationale

The CCT1500 is viewed as similar to the predicate device because:

Indications - are identical to the predicate

Prescriptive - The CCT1500 is over the counter and same as the identified predicate.

Design, Technology and Principle of Operation - The CCT1500 has equivalent design and features when compared to the predicate and has the identical technology.

Performance and Specifications – The CCT1500 has equivalent specifications of performance when compared to the predicate.

Compliance with standards - The CCT1500 declares compliance with IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2 which is identical to the predicate.

Environment of Use - Identical to the predicate.

Features - The CCT1500 has equivalent features when compared to the predicate device

Conclusion

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510(k) Summary Page 9 of 10

The CCT1500 is similar to the predicate in: indications for use, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. Minor differences as detailed in the substantial equivalence table above do not raise questions of safety and effectiveness. Therefore, subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).