The Aria sequential circulator is a programmable sequential, pneumatic compression device intended for use by medical professionals and patients at home, for the treatment of the following conditions:

Chronic edema
Lymphedema
Venous insufficiency
Wound healing

Device Description

The Aria system consists of two main components: A flow generator and a garment. The garment is to be wrapped around the limb, providing a comfortable fit. The garment has seven (7) chambers that are filled with air by the flow generator to provide compression on the extremity. The Aria system uses a compressand-release massage action, similar to the predicate, in order to stimulate lymphatic vessels in the treated area and encourage fluid clearance.

The Aria system retains similar hardware and performance features of the predicate device. Key features include flow generator, valves, A/C plug pack, lower limb garment, tubing, no-LCD User Interface and ON/OFF button. The Aria System contains a microprocessor-controlled flow generator/blower system that generates pressure from 0-45 mmHG to provide for effective treatment of the conditions described in the IFU.

The Aria flow generator has no control settings and delivers one pre-programmed therapy mode.

AI/ML Overview

This document describes the Inova Labs Aria System, a programmable sequential, pneumatic compression device. It is intended for the treatment of chronic edema, lymphedema, venous insufficiency, and wound healing. The submission is a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which the device performance is reported with specific numerical targets. Instead, it describes "bench testing" which included performance comparisons to a predicate device. The results of this testing are stated to "demonstrate that the Aria system raises no new safety or effectiveness concerns and is substantially equivalent to the predicate device."

Here's a summary of the characteristics compared with the predicate device (Entre Model PD08-U, K143185):

Characteristic	Predicate Device (Entre Model PD08-U, K143185)	New Device (Aria System)	Performance Statement (as implied from "Substantial Equivalence")
Intended Use	Treatment of Chronic edema, Lymphedema, Venous insufficiency, Wound healing	Treatment of Chronic edema, Lymphedema, Venous insufficiency, Wound healing	Same intended use
Pressure Range	0-45 mmHG (at 'moderate' setting)	0-45 mmHG	Similar pressure range
Cycle Time	65 seconds	56 seconds	Similar cycle time (minor difference)
Total Therapy Time	Approx. 60 minutes	Approx. 60 minutes	Same total therapy time
Modes of Operation	Sequential gradient compression therapy	Sequential gradient compression therapy	Same mode of operation
System Components	Flow generator, Valves, Tubing, Garment	Flow generator, Valves, Tubing, Garment	Similar system components
Flow Generator Operating System	Microcontroller	Microcontroller	Same operating system
Garment Air Chambers	8	7	Similar (minor difference, 7 vs 8)
Tubing Length	2m length	1.8m length	Similar (minor difference)
User Interface	On/Off Button, Pressure Low/Med/High Button, Start Therapy/Pause	On/Off (Start/Stop Therapy) Button	Simplified UI on Aria System
Connectivity	None	Bluetooth classic to allow export of system data to a paired app	New feature on Aria System
Motor Type	Compressor	Brush-less low voltage DC	Different motor type
Power Supply	100-240V, 50-60Hz	100-240V, 50-60Hz	Same power supply
Weight	2.5lb	0.65lb	Significantly lighter Aria System
Dimensions H x W x D (inches)	11 x 6 x 8	Flow generator unit: 2 x 3.3 x 5.3	Smaller Aria System
Tested Standards (electrical safety, EMC, usability, home medical, biocompatibility)	IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, (ISO 10993-1 not referenced in 510(k) summary)	IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-6, ISO 10993-1	Both adhere to relevant standards, Aria includes ISO 10993-1

The "bench testing" areas mentioned for the Aria System were:

Pressure stability
Sleeve burst test
Sleeve leakage test
Sleeve integrity test
Pressure accuracy test
Chamber filling cycle time testing
Total therapy time

The report generally states that the Aria system "met the Aria System Specification when compared to the predicate device" for these tests, implying that the performance was either equivalent or acceptable relative to the predicate. Specific numerical values for acceptance criteria or detailed results are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical bench testing. There is no "test set" in the context of patient data described for evaluating device performance. The testing involved physical device units. The provenance of the device units used for bench testing (e.g., country of manufacture) is not specified.

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)

This question is not applicable as there was no clinical test set requiring expert ground truth establishment. The evaluation was based on bench testing against engineering specifications and comparison to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as there was no clinical test set requiring adjudication.

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

This question is not applicable. The Aria System is a pneumatic compression device, not an AI-assisted diagnostic or interpretative device that would involve human "readers." No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. The Aria System itself is a standalone medical device (hardware) that delivers therapy; it's not an algorithm whose performance needs to be assessed independently. While it contains a microprocessor and potentially firmware/software for control, the evaluation focuses on the overall device's physical and functional performance through bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing, the "ground truth" or reference for evaluating performance was based on engineering specifications for the Aria System and the performance characteristics of the legally marketed predicate device (Entre Model PD08-U, K143185). For example, pressure accuracy would be compared to a calibrated standard.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a "training set" of data for learning.

9. How the ground truth for the training set was established

This question is not applicable as there was no training set.

Summary

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April 3, 2020

Inova Labs % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street. Ste. 444 Ludlum, Florida 33155-3708

Re: K200564

Trade/Device Name: Aria System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: March 3, 2020 Received: March 4, 2020

Dear Rafael Aguila:

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 Actinclude 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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-devices/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 (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,

Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K200564

Device Name

Aria™ System

Indications for Use (Describe)

Chronic edema
Lymphedema
Venous insufficiency

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

Wound healing

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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K200564

InovaLabs

510(k) Summary Inova Labs Aria System

Date Prepared	April 3, 2020
Submitter	Inova Labs7581 Convoy Court, San Diego CA 92111
Official Contact	Reuben LawsonRegulatory Affairs Consultantreuben.lawson@gmail.com
Product Codes	JOW
Class	Class II
Classification Reference	21 CFR 870.5800
Common/Usual Name	Sleeve, Limb, Compressible
Proprietary Name	Aria
Predicate Device(s)	Tactile Systems Technology Inc, Entre Model PD08-U (K143185)
Reason for submission	New Device

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Indication for Use

· Chronic edema
· Lymphedema
· Venous insufficiency
· Wound healing

Device Description

The Aria flow generator has no control settings and delivers one pre-programmed therapy mode.

Characteristics between predicate and new device

Characteristic	Predicate Device Entre Model PD08-U (K143185)	New device: Aria System
Indication for use	The entré System is intended for use by medicalprofessionals and patients who are undermedical supervision, for thetreatment of the following conditions:• Chronic edema• Lymphedema• Venous insufficiency• Wound healing	The Aria sequential circulator is a programmablesequential, pneumatic compression deviceintended for use by medical professionals andpatients at home, for the treatment of thefollowing conditions:• Chronic edema• Lymphedema• Venous insufficiency• Wound healing
Pressure range	0-45 mmHG (at 'moderate' setting)	0-45 mmHG
Cycle Time	65 seconds	56 seconds
Total Therapy Time	Approx. 60 minutes	Approx. 60 minutes
Modes of operation	Sequential gradient compression therapy	Sequential gradient compression therapy
System Components	• Flow generator	• Flow generator
	• Valves	• Valves
	• Tubing	• Tubing
	• Garment	• Garment
Flow Generatoroperating system	Microcontroller	Microcontroller
Garment AirChambers	8	7

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Characteristic	Predicate Device Entre Model PD08-U (K143185)	New device Aria System
Tubing	Entre Tubing (2m length)	Aria tubing (1.8m length)
User Interface	On/Off ButtonPressure Low/Med/High ButtonStart Therapy/Pause	On/Off (Start/Stop Therapy) Button
Connectivity	None	Bluetooth classic to allow export of system datato a paired app.
Motor type	Compressor	Brush-less low voltage DC
Power supply	100-240V, 50-60Hz	100-240V, 50-60Hz
Weight	2.5lb	0.65lb
Dimensions H x W x D(inches)	11 x 6 x 8	Flow generator unit:2 x 3.3 x 5.3
IEC 60601-1 (electricalsafety)	Yes	Yes
IEC 60601-1-2 (EMC)	Yes	Yes
IEC 60601-1-6(Usability)	Yes	Yes
IEC 60601-1-11(Home medical)	Yes	Yes
ISO 10993-1	Not referenced in 510(k) summary	Yes

InovaLabs

Substantial Equivalence

The new device has the following similarities to the previously cleared predicate devices.

Same intended use A
Similar operating principle
Similar technology

As a result of the Risk Analysis review and design input requirements. non-clinical verification activities were performed on the Aria System. The results demonstrate that the Aria system raises no new safety or effectiveness concerns and is substantially equivalent to the predicate device. The Aria System complies with the applicable requirements referenced in the FDA guidance documents:

FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices A (May 11, 2005)
FDA Guidance for Industry and FDA Staff Design Considerations for Devices Intended for Home A Use- Document Issued on: Nov 24, 2014
FDA Guidance for Industry and FDA Staff Radio Frequency Wireless Technology in Medical Devices - Document Issued on: August 14, 2013

Non-Clinical Testing:

Side-by-Side bench testing was performed to verify that the Aria System met the Aria System Specification when compared to the predicate device.

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InovaLabs

The bench testing included performance comparisons to the predicate device and covered:

Pressure stability A
Sleeve burst test A
Sleeve leakage test A
Sleeve integrity test A
A Pressure accuracy test
A Chamber filling cycle time testing
Total therapy time »

The Aria system has been tested to appropriate standards and other applicable requirements:

IEC 60601-1:2005 A1:2015 Ed. 3.1, Medical electrical equipment Part 1: General requirements for safety Medical electrical equipment - General requirements for basic safety and essential performance
IEC 60601-1-2:2013 Ed. 4.0 Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11:2015 Ed 2.0 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
FDA guidance on software development for medical devices
ISO 10993-1 Biological evaluation of medical devices
IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Clinical Testing:

As with the predicate system, clinical testing was not conducted for Aria system. The technology used in JOW devices is well known and understood. Bench testing against recognized consensus standards, is sufficient to demonstrate no new risk.

Conclusion

The Aria System is substantially equivalent the predicate device Entre PD08-U (K143185) and is as safe and as effective as the predicate device.

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).