ARTAIRA Arterial Compression Device (AACD01)

K240499 · Airos Medical, Inc. · JOW · Oct 11, 2024 · Cardiovascular

Device Facts

• Record ID: K240499
• Device Name: ARTAIRA Arterial Compression Device (AACD01)
• Applicant: Airos Medical, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Oct 11, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ARTAIRA Arterial Compression Device's is an intermittent pneumatic compression device intended for treatment of patients with the following conditions: - Intermittent claudication - Rest pain - Diabetic Foot - Ischemic neuritis - Arterial ulcers - Gangrene - Poor runoff.

Device Story

Intermittent pneumatic compression device; increases lower extremity blood flow/circulation. System comprises hard casing with air pump, valves, and reservoir; connects via tubing to compression garments (left/right leg) featuring foot/ankle and calf air chambers. Device software controls pneumatic pressure delivery in timed, cyclical bursts. Intended for home use per physician prescription. User interface includes color LCD displaying pressure and countdown timer; LED indicators for device state and errors. Benefits patient by providing mechanical compression therapy to manage arterial conditions.

Clinical Evidence

Bench testing only. Performance testing included user interface/error indicator testing, noise testing, compression sequence timing accuracy, pressure accuracy, therapy time accuracy, garment integrity, and air leakage testing.

Technological Characteristics

Intermittent pneumatic compression system; hard casing with air pump, valves, and reservoir. Biocompatible compression garments with dual air chambers (foot/ankle and calf). Color LCD display; LED status/error indicators. Standards: ISO 14971:2019, ISO 10993-1:2018, ISTA 3A:2018, ES 60601-1, IEC 60601-1-2, IEC 61000-3-2, IEC 61000-3-3, IEC 60601-1-6, IEC 60601-1-11.

Indications for Use

Indicated for patients with intermittent claudication, rest pain, diabetic foot, ischemic neuritis, arterial ulcers, gangrene, or poor runoff.

Regulatory Classification

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.

Predicate Devices

• ArtAssist Device (K131146)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

October 11, 2024

AIROS Medical, Inc. Darren Behuniak Vice President, Operations and Marketing 2501 Monroe Blvd., Suite 1200 Audubon, Pennsylvania 19403

Re: K240499

Trade/Device Name: ARTAIRA Arterial Compression Device (AACD01) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: September 16, 2024 Received: September 17, 2024

Dear Darren Behuniak:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

{1}------------------------------------------------

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

{2}------------------------------------------------

Sincerely,

# Nicole M. Gillette -S

Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural, and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known) K240499

#### Device Name

ARTAIRA Arterial Compression Device

Indications for Use (Describe)

The ARTAIRA Arterial Compression Device's is an intermittent pneumatic compression device intended for treatment of patients with the following conditions:

- · Intermittent claudication
- · Rest pain
- Diabetic Foot
- · Ischemic neuritis
- · Arterial ulcers
- · Gangrene
- Poor runoff.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for AIROS Medical. The logo consists of a hexagon with a green "A" inside, followed by the text "AIROS" in a simple, sans-serif font. Below "AIROS" is the word "MEDICAL" in a smaller font size.

### 510(k) Summary

September 9, 2024

### Submitter:

AIROS Medical, Inc. 2501 Monroe Blvd, Suite 1200 Audubon, PA 19403

## Contact Person:

Darren Behuniak, VP Operations & Marketing Email: dbehuniak(@airosmedical.com Phone: [phone]

#### Common Classification & Proprietary Names

Trade Name: ARTAIRA Arterial Compression Device

#### Classification

| Classification Name | 21 CFR Regulation | Product Code | Class |
|-----------------------------|-------------------|--------------|-------|
| Compressible Limb<br>Sleeve | 870.5800 | JOW | II |

#### Predicate Device

The ARTAIRA Arterial Compression Device is substantially equivalent to the predicate device, the ArtAssist Device.

| | Predicate ArtAssist Device |
|--------------------------|----------------------------|
| 510(k) | K131146 |
| 21 CFR Regulation Number | 870.5800 |
| Product Code | JOW |
| Classification | II |

#### Device Description

The AIROS ARTAIRA Arterial Compression Device is an intermittent pneumatic compression device intended to increase blood flow and increase circulation in the lower extremities by providing timed compression to the foot/ankle and calf. The device consists of a hard casing with an air pump, a set of air valves, an air reservoir controlled by the device software to deliver a rapid burst of pneumatic pressure to the treatment area. The device connects through air tubing to a pair of compression garments (left and right leg), each with two air chambers: one on the underfoot (Foot/Ankle chamber) and one on the calf area (Calf Chamber). The device can either be used with one garment or two garments. The system is intended to be used primarily at home settings according to a physician-prescribed therapy.

www.airosmedical.com 1.866.991.6956

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for AIROS Medical. The logo consists of a hexagon with the letter A inside of it on the left, and the word "AIROS" above the word "MEDICAL" on the right. The hexagon is gray, the letter A is green, and the words "AIROS MEDICAL" are gray.

# Indication for Use

The ARTAIRA Arterial Compression Device is an intermittent pneumatic compression device intended for treatment of patients with the following conditions:

- Intermittent claudication
- Rest pain ●
- Diabetic Foot
- Ischemic neuritis ●
- Arterial ulcers
- Gangrene ●
- Poor runoff. ●

### Technological Characteristics

The manufacturer believes that the technological characteristics of the ARTAIRA are substantially equivalent to those of the predicate device. The ARTAIRA has the same pressure setting, as well as the same compression and non-compression timing sequences. Both devices are used with associated compression garments that feature air chambers in both the foot/ankle area and the underfoot. The garments can be used on one limb or two and the material is biocompatible. The device and grarment system provides cyclical air compression sequences intended to increase blood flow to the lower extremities.

The ARTAIRA also features a large color LCD screen that can be easily viewed by the user. The LCD screen displays pressure as well as a countdown timer so the user knows how much therapy time is left in the treatment session. Additional device features include LED lights to indicate device states and multiple error indicators that are triggered in the event of an error with the device.

#### Functional Performance Testing

Testing was performed and to ensure that the system meets its specifications. The functional performance testing includes the following tests:

- User Interface & Error Indicator Testing
- Noise Testing
- Compression Sequence Timing Accuracy Testing ●
- Pressure Accuracy Testing ●
- Therapy Time Accuracy Testing ●
- Garment Integrity Testing
- Air Leakage Testing

#### Standards

www.airosmedical.com 1.866.991.6956

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for AIROS Medical. The logo consists of a hexagon with a green letter A inside, followed by the text "AIROS" in gray, with the word "MEDICAL" underneath in a smaller font. The logo is clean and modern, with a focus on the company name.

- ISO 14971:2019 Medical Devices - Application of Risk Management to Medical Devices
- ISO 10993-1 2018 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process
- ISTA 3A:2018 Packaged Products for Parcel Delivery System Shipment ●
- ES 60601-1: 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 -● Medical electrical equipment- Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2: 2014 + AMD1:2020 CSV - Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral Standard: Electromagnetic disturbances- Requirements and tests
- IEC 61000-3-2: 2018 A1: 2020 EMC Part 3-2: Limits Limits for harmonic current . emissions (Equipment input current 16A per phase)
- IEC 61000-3-3: 2013 A1: 2017 EMC - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems for equipment with rated current ≤ 16 A per phase and not subject to conditional connections
- IEC 60601-1-6: 2010/AMD1: 2013 Medical electrical equipment- Part 1-6: General requirements for basic safety and essential performance- Collateral Standard: Usability
- IEC 60601-1-11: 2015 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

# Statement of Substantial Equivalence

The ARTAIRA is substantially equivalent in technology, function, operating parameters, and indications to the ArtAssist predicate device There are no new risks introduced with the ARTAIRA.

## Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, AIROS Medical, Inc., believes that the ARTAIRA is substantially equivalent to the predicate device.