(30 days)
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.
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.
The provided FDA 510(k) summary for the AIROS 6 Sequential Compression Device does not include a study proving device performance against detailed acceptance criteria in the manner typically seen for AI/ML-based diagnostic devices. This document is for a Class II medical device (compressible limb sleeve), which is a mechanical device, not an AI or imaging diagnostic tool. Therefore, the questions related to AI/ML specific aspects (such as AI assistance, human-in-the-loop, training/test set details, expert ground truth, effect size, etc.) are not applicable to this submission.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (AIROS 6 Sequential Compression Device K172770 from the same manufacturer) through functional performance testing and adherence to relevant standards.
Here's an analysis based on the provided text, primarily addressing the "functional performance testing" section:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "functional performance testing" categories but does not provide specific numerical acceptance criteria or detailed reported performance values. It states: "Testing was performed and to ensure that the system meets its specifications." This implies that the device did meet its internal specifications, but these specs are not detailed in the public 510(k) summary.
| Test Description | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Alarm Testing | Alarms function correctly per specifications. | Meets specifications (passed). |
| LED/LCD Testing | LEDs/LCDs function correctly per specifications. | Meets specifications (passed). |
| Cycle Time Testing | Cycle times are accurate per specifications. | Meets specifications (passed). |
| Pressure Accuracy Testing | Pressure output is accurate per specifications. | Meets specifications (passed). |
| Therapy Time Testing | Therapy duration is accurate per specifications. | Meets specifications (passed). |
| Therapeutic Performance Testing | Device performs intended therapeutic function. | Meets specifications (passed). |
| Garment Integrity Testing | Garments maintain integrity under normal use. | Meets specifications (passed). |
| Pull Testing | Connections/components withstand specified pull forces. | Meets specifications (passed). |
| Garment Printing Testing | Garment markings/printing are durable and legible. | Meets specifications (passed). |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the testing involves the physical device and garments, not a dataset in the context of AI/ML. The "test set" would be the manufactured devices and accompanying garments. The provenance would be the manufacturing site of AIROS Medical, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. "Ground truth" in this context refers to the device's functional specifications, which are established by the manufacturer through engineering design and regulatory requirements, not by external experts adjudicating data.
4. Adjudication Method for the Test Set
Not applicable. The testing appears to be functional and engineering validation, not consensus-based adjudication of interpretations of clinical data.
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
Not applicable. This device is a mechanical sequential compression device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no AI algorithm in this device.
7. The Type of Ground Truth Used
The ground truth is the device's design specifications and functional requirements as established by the manufacturer and validated through engineering tests.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
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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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
K193069
AIROS Medical, Inc. Darren Behuniak Vice President, Operations and Marketing 2501 Monroe Blvd. Suite 1200 Audubon, Pennsylvania 19403
Re: K193069
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: November 1, 2019 Received: November 4, 2019
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. 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 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
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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 mediation-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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Indications for Use
510(k) Number (if known) K193069
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)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/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 thin, sans-serif font. Below "AIROS" is the word "MEDICAL" in a smaller, sans-serif font.
510(k) SUMMARY
November 1, 2019
Submitter:
AIROS Medical, Inc. 2501 Monroe Blvd, Suite 1200 Audubon, PA 19403
Contact Person:
Darren Behuniak, VP Operations & Marketing Email: dbehuniak@airosmedical.com Phone: 866-991-6956
Common Classification & Proprietary Names:
Trade Name: AIROS 6 Sequential Compression Device Common Names: Sequential Compression Device
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)# |
|---|---|---|
| AIROS 6 Sequential Compression Device | AIROS Medical, Inc. | K172770 |
www.airosmedical.com 1.866.991.6956
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Image /page/4/Picture/0 description: The image shows the logo for AIROS Medical. The logo consists of a hexagon shape with a green "A" inside, and the words "AIROS" and "MEDICAL" to the right of the hexagon. The word "AIROS" is in a larger font than the word "MEDICAL".
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.
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.
ww.airosmedical.com 866.991.6956
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Image /page/5/Picture/0 description: The image contains 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.
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 |
| Garment Printing Testing |
Standards
The AIROS 6 conforms to the following standards:
- ISO 14971: 2007 Medical Devices – Application of Risk Management to Medical Devices
- ISO 10993-5 Biological evaluation of medical devices Part 1: Biological evaluation of ● medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices --Part 10:Tests for irritation and ● delayed-type hypersensitivity
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.
w.airosmedical.com
§ 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).