(30 days)
Not Found
No
The description mentions a microprocessor-controlled flow generator with a single pre-programmed therapy mode and no control settings. There is no mention of AI, ML, or any adaptive or learning capabilities.
Yes
The device is intended for the treatment of various medical conditions such as chronic edema, lymphedema, venous insufficiency, and wound healing, indicating its therapeutic purpose.
No
The device is described as a sequential circulator providing compression therapy, which is a treatment, not a diagnostic, function. Its purpose is to treat conditions like edema and lymphedema by encouraging fluid clearance.
No
The device description explicitly details hardware components such as a flow generator, garment, valves, A/C plug pack, tubing, and an ON/OFF button. It also mentions a microprocessor-controlled flow generator/blower system. This indicates it is a physical medical device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
- Aria System Function: The Aria sequential circulator is a physical therapy device that applies external compression to a limb. It does not analyze any biological samples from the patient.
- Intended Use: The intended use clearly states it's for the "treatment" of conditions like edema, lymphedema, venous insufficiency, and wound healing through physical compression.
- Device Description: The description focuses on the mechanical components (flow generator, garment, chambers, pressure) and its function of applying compression.
The Aria system is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
JOW
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 compress-and-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found (implied limbs for compression)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and patients at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The bench testing included performance comparisons to the predicate device and covered:
- Pressure stability
- Sleeve burst test
- Sleeve leakage test
- Sleeve integrity test
- Pressure accuracy test
- Chamber filling cycle time testing
- Total therapy time
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Tactile Systems Technology Inc, Entre Model PD08-U (K143185)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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
1
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)
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
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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InovaLabs
510(k) Summary Inova Labs Aria System
| Date Prepared | April 3, 2020 |
|---|---|
| Submitter | Inova Labs |
| 7581 Convoy Court, San Diego CA 92111 | |
| Official Contact | Reuben Lawson |
| Regulatory Affairs Consultant | |
| reuben.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
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.
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 medical | |
| professionals and patients who are under | ||
| medical supervision, for the | ||
| treatment of the following conditions: | ||
| • Chronic edema | ||
| • Lymphedema | ||
| • Venous insufficiency | ||
| • Wound healing | 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 | ||
| 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 Generator | ||
| operating system | Microcontroller | Microcontroller |
| Garment Air | ||
| Chambers | 8 | 7 |
5
| 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 Button | |
| Pressure Low/Med/High Button | ||
| Start Therapy/Pause | On/Off (Start/Stop Therapy) Button | |
| Connectivity | None | Bluetooth classic to allow export of system data |
| to 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 (electrical | ||
| safety) | 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.