(57 days)
The AIROS 8P 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.
AIROS 8P Sequential Compression Device is a pneumatic compression device used for treatment and management of venous or lymphatic disorders. The application of compression is effective by increasing blood flow and encouraging extracellular fluid clearance. The device consists of the mechanical device that is used to set the treatment options and supplies cycles of air to the compression garments. There are three primary treatment modes, Gradient Mode, Pressure Mode, and Peristaltic Mode. The air is supplied at adjustable pressures and sequences and inflates the compression garments from the distal to proximal areas of the body. The compression garments are supplied in various sizes for the upper and lower extremity areas of the body.
The provided text is a 510(k) premarket notification for the AIROS 8P Sequential Compression Device. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving that a device meets specific performance acceptance criteria for a novel AI/ML algorithm.
Therefore, the requested information regarding acceptance criteria for an AI/ML device, its performance, sample sizes for test and training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document.
This document describes a medical device (a pneumatic compression device) and its functional performance testing (e.g., Error Indicator Testing, Noise Testing, Cycle Time Accuracy, Pressure Time Accuracy, Therapeutic Performance, Therapy Time Accuracy, Garment Integrity). These tests ensure the hardware and software functionality, and compliance with electrical and safety standards, but do not involve an AI/ML algorithm that requires a dedicated clinical or imaging study with a ground truth established by experts.
Here's why the specific questions cannot be answered from the provided text:
- No AI/ML Component: The AIROS 8P Sequential Compression Device is a physical medical device that applies pneumatic compression. The "AIROS" in the name refers to the company, not Artificial Intelligence. The description of the device's operation ("digitally controlled device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve") confirms it's a mechanical device with digital controls, not an AI/ML algorithm that interprets data or images.
- Substantial Equivalence Focus: The entire premise of this 510(k) submission is to demonstrate that the AIROS 8P is "substantially equivalent" to already legally marketed predicate devices (AIROS 8 Sequential Compression Device and Mego Afek Lympha Press Optimal). This type of submission does not typically involve clinical trials or performance studies that would establish acceptance criteria for a novel AI/ML algorithm's accuracy, sensitivity, or specificity.
- Functional Performance Testing: The "Functional Performance Testing" listed (Error Indicator Testing, Noise Testing, Cycle Time Accuracy, etc.) pertains to the engineering and operational parameters of the physical device, not an AI algorithm's diagnostic or predictive performance.
In summary, the provided document does not contain information about acceptance criteria or a study for an AI/ML device because the AIROS 8P Sequential Compression Device is not described as an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo 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.
December 9, 2022
AIROS Medical, Inc Darren Behuniak Vice President, Operations and Marketing 2501 Monroe Blvd. Suite 1200 Audubon, Pennsylvania 19403
Re: K223193
Trade/Device Name: AIROS 8P Sequential Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: October 12, 2022 Received: October 13, 2022
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
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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) 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-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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Eric E. Richardson -5 D2022.12.09 16:00:05 -05'00'
Nicole Gillette for 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
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Indications for Use
510(k) Number (if known) K223193
Device Name
AIROS 8P Sequential Compression Device
Indications for Use (Describe)
The AIROS 8P 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/1 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
October 12, 2022
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 8P Sequential Compression Device Common Name: Sequential Compression Device
Classification
| Classification Name | 21 CFR Regulation | Product Code | Class |
|---|---|---|---|
| Compressible LimbSleeve | 870.5800 | JOW | II |
Primary Predicate Device and Reference Device
The AIROS 8P Sequential Compression Device is substantially equivalent to the primary predicate. AIROS 8 Sequential Device, and the reference device, Mego Afek Lympha Press Optimal.
| Primary Predicate | Reference Device | |
|---|---|---|
| AIROS 8 Sequential | Mego Afek Lympha Press | |
| Compression Device | Optimal | |
| 510(k) | K193068 | K182003 |
| 21 CFR Regulation Number | 870.5800 | 870.5800 |
| Product Code | JOW | JOW |
| Classification | II | II |
Device Description
AIROS 8P Sequential Compression Device is a pneumatic compression device used for treatment and management of venous or lymphatic disorders. The application of compression is effective by increasing blood flow and encouraging extracellular fluid clearance. The device consists of the mechanical device that is used to set the treatment options and supplies cycles of air to the compression garments. There are three primary treatment modes, Gradient Mode, Pressure Mode, and Peristaltic Mode. The air is supplied at adjustable pressures and sequences and inflates the compression garments from the distal to proximal areas of the body. The
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Image /page/4/Picture/0 description: The image shows the logo for AIROS Medical. The logo consists of a gray hexagon with a green "A" inside of it on the left, and the text "AIROS" in gray on the right. Below the word "AIROS" is the word "MEDICAL" in a smaller font, also in gray.
compression garments are supplied in various sizes for the upper and lower extremity areas of the body.
Indication for Use
The AIROS 8P 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 8P are substantially equivalent to those of the primary predicate device and reference device. The AIROS 8P has similar components to its primary predicate and reference devices and has similar operating principles to the primary predicate and reference devices. 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 primary predicate and reference devices, pressure is applied cyclically for a specified period of time, according to the physician's prescription. Three primary operating modes, Gradient, Pressure, and Peristaltic are available to the user and multiple size garments are available for the upper extremities, and trunk of the body. The AIROS 8P is identical to the AIROS 8 except for minor component changes that do not affect safety and efficacy of the device and the addition of new models of compression garments. The addition of the Peristaltic Mode is substantially equivalent to the reference device, the Mego Afek Lympha Press Optimal.
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 8P are substantially equivalent to those of the primary predicate and reference devices. The functional performance testing includes the following tests:
- Error Indicator Testing ●
- Noise Testing
- Cycle Time Accuracy
- Pressure Time Accuracy ●
- Therapeutic Performance ●
- Therapy Time Accuracy
- Garment Integrity
www.airosmedical.com 1.866.991.6956
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Image /page/5/Picture/0 description: The image shows the logo for AIROS Medical. The logo consists of a hexagon with a stylized "A" inside, and the words "AIROS MEDICAL" to the right of the hexagon. The hexagon is gray, the "A" is green, and the words "AIROS MEDICAL" are gray.
Standards
- ISO 14971:2019 Medical Devices Application of Risk Management to Medical . Devices
- 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 AIROS 8P is substantially equivalent in technology, function, operating parameters, and indications to the AIROS 8 primary predicate device and the Lympha Press Optimal reference device. There are no new risks introduced with the AIROS 8P.
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 AIROS 8P is substantially equivalent to the primary predicate device and the reference device.
§ 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).