The AIROS 8 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:

· Lymphedema
Venous stasis ulcers
· Venous insufficiency
· Peripheral edema
The device is safe for both home and hospital use,

Device Description

The AIROS 8 Sequential Compression Device is a gradient pneumatic compression device. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow and encourages extracellular fluid clearance.
The AIROS 8 system consists of the device and 8-chambered garments. The device provides cycles of compressed air at certain adjustable pressures, and sequentially inflates the garments from distal to proximal. The pressure at each chamber can be individually adjusted to accommodate different therapy needs.

AI/ML Overview

Here's an analysis of the provided text regarding the AIROS 8 Sequential Compression Device, focusing on acceptance criteria and study data:

Based on the provided 510(k) summary for the AIROS 8 Sequential Compression Device, the document does not contain the detailed information typically found in an AI/ML-based medical device submission regarding acceptance criteria, performance metrics, and study details (like sample size for test/training sets, expert qualifications, ground truth establishment, or clinical outcome studies).

The AIROS 8 device is a physical medical device (a sequential compression device) and its 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (CircuFlow 5208) based on technological characteristics and functional performance testing, rather than AI/ML algorithm performance.

Therefore, I cannot populate the requested table and answer many of the specific questions as they are designed for AI/ML device assessment. The provided text describes a traditional medical device submission.

However, I can extract the acceptance criteria and performance testing described for this type of physical device:

Acceptance Criteria and Reported Device Performance (for a physical medical device)

1. A table of acceptance criteria and the reported device performance

The document does not present quantitative acceptance criteria or specific numerical performance results in a table format. Instead, it states that "Testing was performed and to ensure that the system meets its specifications" and lists the types of functional performance tests conducted. The conclusion is that the device is "substantially equivalent" to the predicate.

Interpretation for a physical device: The acceptance criteria for these tests would likely be "passes" or "meets specification" for each functional test, implying the device performed as intended and comparably to the predicate. Specific numerical targets for pressure accuracy, cycle time, noise, etc., would be in the full submission, but are not in this summary.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Alarm Testing: Alarms function correctly.	Testing performed; system meets specifications.
LED/LCD Testing: Displays function correctly.	Testing performed; system meets specifications.
Cycle Time Testing: Cycles occur within specified times.	Testing performed; system meets specifications.
Pressure Accuracy Testing: Pressure output is accurate within specified tolerances.	Testing performed; system meets specifications.
Therapy Time Testing: Therapy duration is accurate.	Testing performed; system meets specifications.
Therapeutic Performance Testing: Device delivers intended therapy.	Testing performed; system meets specifications.
Garment Integrity Testing: Garments maintain integrity under use.	Testing performed; system meets specifications.
Pull Testing: Components withstand specified pull forces.	Testing performed; system meets specifications.
Transportation Testing: Device withstands transport conditions.	Testing performed; system meets specifications.
Garment Printing Testing: Printing is durable and legible.	Testing performed; system meets specifications.
Button Life Testing: Buttons endure specified number of actuations.	Testing performed; system meets specifications.
Noise Testing: Operating noise is within specified limits.	Testing performed; system meets specifications.
Visual Appearance Testing: Device meets aesthetic and manufacturing standards.	Testing performed; system meets specifications.

Study Details (as inferable for a physical medical device)

The following points are mostly not applicable (N/A) in the context of this 510(k) summary for a physical compression device, as they are typically relevant to AI/ML or diagnostic device studies. The "study" here is primarily functional performance and electrical safety testing.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. For functional testing of a physical device, this would typically involve testing a representative sample of manufactured units (e.g., a few devices from a production batch).
Data Provenance: Not specified, but generally refers to in-house laboratory testing of the manufactured device.
Retrospective/Prospective: N/A. This is functional testing, not a clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. Ground truth as understood in AI/ML (e.g., disease presence/absence determined by experts) is not relevant for the functional testing of a pneumatic compression device. Testing relies on engineering specifications and measurement equipment.

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

N/A. Adjudication is not applicable for functional engineering tests.

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

N/A. This device is not an AI/ML diagnostic or assistive tool for human readers.

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

N/A. This device does not have an AI algorithm. Its "performance" is its mechanical and electrical function.

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

N/A. The "ground truth" for the listed functional tests would be engineering specifications, direct measurements, and established quality control protocols for pressure, time, electrical safety, etc.

8. The sample size for the training set

N/A. This concept is for AI/ML models. No training set is mentioned as this is not an AI/ML device.

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

N/A. Not applicable, as there is no training set for an AI/ML model for this device.

Summary

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

June 22, 2018

AIROS Medical, Inc. Darren Behuniak VP Operations & Marketing 2501 Monroe Blvd., Suite 1200 Audubon, Pennsylvania 19403

Re: K172779

Trade/Device Name: AIROS 8 Sequential Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: May 10, 2018 Received: May 11, 2018

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 (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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

M.A. Willemsen

for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K172779

Device Name AIROS 8 Sequential Compression Device

Indications for Use (Describe)

The AIROS 8 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:

· Lymphedema
Venous stasis ulcers
· Venous insufficiency
· Peripheral edema

The device is safe for both home and hospital use,

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)

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FORM FDA 3881 (7/17)

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510(K) SUMMARY

Submitter: AIROS Medical, Inc.

Contact Person:

Darren Behuniak, VP Operations & Marketing 2501 Monroe Blvd, Suite 1200 Audubon, PA 19403 Phone: 866-991-6956

Common Classification & Proprietary Names:

Trade Name: AIROS 8 Sequential Compression Device Common Names: Sequential Compression Device

Date Prepared:

May 9, 2018

Classification

The classification name, 21 CFR Part and Paragraph number, product code and classification of the AIROS 8 Sequential Compression Device.

Classification Name	21 CFRSection	ProductCode	Class
Compressible LimbSleeve	870.5800	JOW	II

Predicate Device:

The AIROS 8 Sequential Compression Device is substantially equivalent to the following.

Predicate Device	Manufacturer	510(k)#
CircuFlow 5208	Devon Medical, Inc.	K123647

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Device Description

The AIROS 8 system consists of the device and 8-chambered garments. The device provides cycles of compressed air at certain adjustable pressures, and sequentially inflates the garments from distal to proximal. The pressure at each chamber can be individually adjusted to accommodate different therapy needs.

Intended Use:

The AIROS 8 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:

o Lymphedema
Venous stasis ulcers ●
Venous insufficiency ●
o Peripheral edema

The device is safe for both home and hospital use.

Technological Characteristics:

The manufacturer believes that the technological characteristics of the AIROS 8 are substantially similar to those of the predicate device.

The AIROS 8 has similar components to its predicate device and has similar operating principles. The digitally-controlled device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, and like the predicate, pressure is applied cyclically for a specified period of time, according to the physician's prescription.

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Functional Performance Testing

Testing was performed and to ensure that the system meets its specifications. The manufacturer believes that the technological characteristics of the AIROS 8 are substantially equivalent to those of the predicate device. The functional performance testing includes the following tests:

Test Description
Alarm Testing
LED/LCD Testing
Cycle Time Testing
Pressure Accuracy Testing
Therapy Time Testing
Therapeutic Performance Testing
Garment Integrity Testing
Pull Testing
Transportation Testing
Garment Printing Testing
Button Life Testing
Noise Testing
Visual Appearance Testing

Standards

The AIROS 8 conforms to the following standards:

IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1:2006/A1:2013 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment -- Part 1-2: Medical Electrical Equipment Part ● 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
ANSI/AAMI ES60601-1:2006/A1:2012 Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
ISO 10993-5 Biological evaluation of medical devices Part 1: Biological evaluation of o medical devices -- Part 5: Tests for in vitro cytotoxicity

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ISO 10993-10 Biological evaluation of medical devices -- Part 10:Tests for irritation and delayed-type hypersensitivity
IEC 61000-3-2 Electromagnetic compatibility (EMC) Part 3-2: Limits Limits for ● harmonic current emissions (equipment input current < 16 A per phase)
IEC 61000-3-3 Electromagnetic compatibility (EMC) Part 3-3: Limits Limitation of o 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 connection
CAN/CSA-C22.2 No. 60601-1:14 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance (Adopted IEC 60601-1:2005, third edition, 2005-12, including amendment 1:2012, with Canadian deviations)

Statement of Substantial Equivalence

The AIROS 8 is substantially equivalent in technology, function, operating parameters, and indicated use to the predicate device that is currently commercially available and in distribution. The system does not raise any new risks when compared to the predicate product.

Conclusions

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 AIROS 8 is substantially equivalent to 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).