The AIROS 6 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 6 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 6 system consists of the device and 6-chambered garments. The device provides cycles of compressed air and sequentially inflates the garments from distal to proximal.

AI/ML Overview

The provided text is a 510(k) summary for the AIROS 6 Sequential Compression Device. This type of FDA submission is for demonstrating substantial equivalence to a predicate device, primarily through performance testing and adherence to standards, rather than clinical efficacy studies often associated with AI/ML-based devices.

Therefore, the document does not contain specific details regarding:

Acceptance criteria and reported device performance related to a diagnostic or AI/ML-based task. The performance tests listed are functional and safety tests for a pneumatic compression device, not accuracy metrics for a diagnostic algorithm.
Sample sizes for a test set or data provenance (e.g., country of origin, retrospective/prospective). The testing described is for engineering validation of the physical device.
Number of experts and their qualifications for ground truth establishment. Ground truth as defined for diagnostic AI/ML models is not applicable here.
Adjudication method for a test set. Not applicable.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to this device.
Standalone (algorithm-only) performance. The device is a physical pneumatic compression system, not an algorithm.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.). Not applicable.
Sample size for the training set or how ground truth for the training set was established. This device does not involve machine learning or a "training set" in the context of AI.

Based on the provided text, here is what can be extracted regarding the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission:

The "acceptance criteria" in this context are the successful completion of various functional and safety performance tests, and compliance with recognized medical device standards, to demonstrate that the AIROS 6 Sequential Compression Device operates as intended and is safe. The "study" refers to the conducted functional performance testing.

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

The document lists "Functional Performance Testing" that was performed to "ensure that the system meets its specifications." While the specific numerical acceptance criteria (e.g., "pressure accuracy within +/- X mmHg") are not detailed, the implication is that the device met these criteria for each test.

Acceptance Criterion (Test Description)	Reported Device Performance
Alarm Testing	Met (Implied by submission)
LED/LCD Testing	Met (Implied by submission)
Cycle Time Testing	Met (Implied by submission)
Pressure Accuracy Testing	Met (Implied by submission)
Therapy Time Testing	Met (Implied by submission)
Therapeutic Performance Testing	Met (Implied by submission)
Garment Integrity Testing	Met (Implied by submission)
Pull Testing	Met (Implied by submission)
Transportation Testing	Met (Implied by submission)
Garment Printing Testing	Met (Implied by submission)
Button Life Testing	Met (Implied by submission)
Noise Testing	Met (Implied by submission)
Visual Appearance Testing	Met (Implied by submission)

Notes:

The phrase "Testing was performed and to ensure that the system meets its specifications" and the conclusion "AIROS Medical, Inc., believes that the AIROS 6 is substantially equivalent to the predicate device" implicitly state that the device met the acceptance criteria for these tests. The specific quantitative results are not in this summary but would be in the more detailed submission.
Additionally, compliance with the listed consensus standards (IEC 60601-1, ISO 10993, IEC 61000, ANSI/AAMI ES60601-1, CAN/CSA-C22.2 No. 60601-1) also represents a set of acceptance criteria regarding safety and essential performance.

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

This information is not provided in the 510(k) summary. These details would typically be found in the full test reports submitted to the FDA, not in the public summary. For functional performance tests, a "sample size" often refers to the number of devices or components tested. Data provenance (country, retrospective/prospective) is not relevant for this type of mechanical device testing.

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 concept is not applicable to the testing described for this device. Ground truth in the context of diagnostic performance (e.g., image interpretation) is not relevant here. The "ground truth" for these functional tests would be the established engineering specifications and physical measurements.

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

This concept is not applicable to the testing described for this device. Adjudication methods are used in diagnostic studies to resolve reader discrepancies.

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:

No. This type of study is for evaluating AI-assisted diagnostic performance, which is not relevant to this pneumatic compression device.

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

No. This device is a physical medical device, not an algorithm, so a "standalone" algorithmic performance evaluation is not applicable.

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

This concept is not applicable in the context of this device's functional and safety testing. The "ground truth" for the performance characteristics (e.g., pressure output, cycle time) is based on engineering specifications and direct physical measurement calibrated against known standards.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable. As there is no training set, there is no ground truth to establish for it in this context.

Summary

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June 22, 2018

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

Re: K172770

Trade/Device Name: AIROS 6 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 mediation-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.G. Hillemann
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

지

Indications for Use

510(k) Number (if known)

K172770

Device Name AIROS 6 Sequential Compression Device

Indications for Use (Describe)

The AIROS 6 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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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 6 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 6 Sequential Compression Device.

Classification Name	21 CFRSection	ProductCode	Class
Compressible LimbSleeve	870.5800	JOW	II

Predicate Device:

The AIROS 6 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 6 system consists of the device and 6-chambered garments. The device provides cycles of compressed air and sequentially inflates the garments from distal to proximal.

Intended Use:

The AIROS 6 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.

Technological Characteristics:

The manufacturer believes that the technological characteristics of the AIROS 6 are substantially similar to those of the predicate device.

The AIROS 6 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 6 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 6 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 ● 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 6 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 6 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).