(57 days)
No
The description focuses on pneumatic compression mechanics and treatment modes, with no mention of AI/ML terms or capabilities.
Yes
The device is described as "intended for treatment of patients with the following conditions: Lymphedema, Venous stasis ulcers, Venous insufficiency, Peripheral edema," and it "utilizes gradient pneumatic compression, which is intended for treatment of patients." These statements clearly indicate a therapeutic purpose.
No
The device is described as a treatment device for conditions like lymphedema and venous ulcers, focusing on applying compression to increase blood flow and clear fluid, rather than on diagnosing these conditions.
No
The device description explicitly states it consists of a "mechanical device" and "compression garments," indicating it is a hardware-based pneumatic compression device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The AIROS 6P Sequential Compression Device is a therapeutic device. It applies external pneumatic compression to the body to treat conditions like lymphedema and venous insufficiency. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for the "treatment of patients with the following conditions," which is a therapeutic purpose, not a diagnostic one.
Therefore, based on the provided information, the AIROS 6P Sequential Compression Device is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AIROS 6P 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
Product codes
JOW
Device Description
AIROS 6P 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 two primary treatment modes, Gradient 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremities, lower extremities, and trunk of the body.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is safe for both home and hospital use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 6P 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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December 9, 2022
AIROS Medical, Inc Darren Behuniak Vice President, Operations and Marketing 2501 Monroe Blvd. Suite 1200 Audubon, Pennsylvania 19403
Re: K223195
Trade/Device Name: AIROS 6P 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.
1
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) 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 --S 2022.12.09 16:20:07 -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) K223195
Device Name
AIROS 6P Sequential Compression Device
Indications for Use (Describe)
The AIROS 6P 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 is a logo for AIROS Medical. The logo consists of a gray hexagon with a green letter "A" inside of it. To the right of the hexagon is the word "AIROS" in gray, with the word "MEDICAL" underneath it in a smaller font.
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 6P Sequential Compression Device Common Name: Sequential Compression Device
Classification
| Classification Name | 21 CFR Regulation | Product Code | Class |
|---|---|---|---|
| Compressible Limb | |||
| Sleeve | 870.5800 | JOW | II |
Primary Predicate Device and Reference Device
The AIROS 6P Sequential Compression Device is substantially equivalent to the primary predicate. AIROS 6 Sequential Device, and the reference device, Mego Afek Lympha Press Optimal.
| Primary Predicate | Reference Device | |
|---|---|---|
| AIROS 6 Sequential | ||
| Compression Device | Mego Afek Lympha Press | |
| Optimal | ||
| 510(k) | K193069 | K182003 |
| 21 CFR Regulation Number | 870.5800 | 870.5800 |
| Product Code | JOW | JOW |
| Classification | II | II |
Device Description
AIROS 6P 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 two primary treatment modes, Gradient Mode and Peristaltic Mode. The air is supplied at adjustable pressures and sequences and inflates the
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 gray hexagon with a green letter A inside of it. To the right of the hexagon is the word "AIROS" in gray, with the word "MEDICAL" underneath it.
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.
Indication for Use
The AIROS 6P 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 6P are substantially equivalent to those of the primary predicate and reference devices. The AIROS 6P has the same therapy modes as the AIROS 6 predicate with the exception that the AIROS 6P also includes the Peristaltic mode which is substantially equivalent to the reference device, Mego Afek Lympha Press Optimal. There have also been some component changes with the 60 that do not affect safety or efficacy of the device. The digitally controlled device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeves, and like the primary predicate and reference devices, pressure is applied cyclically for a specified period of time, according to the physician's prescription. Two primary operating modes, Gradient and Peristaltic are available to the user and multiple size garments are available for the upper extremities, lower extremities, and trunk of the body.
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 6P 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
Standards
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 the letter A inside, and the words "AIROS MEDICAL" to the right of the hexagon. The hexagon is gray, the letter A is green, and the words "AIROS MEDICAL" are gray.
- 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 AIROS 6P is substantially equivalent in technology, function, operating parameters, and indications to the AIROS 6P primary predicate device and the Lympha Press Optimal reference device. There are no new risks introduced with the AIROS 6P.
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 6P is substantially equivalent to the primary predicate and reference devices.