(281 days)
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No
The document describes a standard pneumatic compression device and its functional testing, with no mention of AI or ML technologies. The name "AIROS" appears to be a brand name, not an indicator of AI functionality.
Yes
The device is described as "intended for treatment of patients with the following conditions" and "used for treatment and management of venous or lymphatic disorders." This indicates a therapeutic purpose.
No
The device description and intended use clearly state that the AIROS 6 is a treatment device, utilized for conditions such as lymphedema, venous stasis ulcers, and peripheral edema, by applying gradient pneumatic compression. There is no mention of it being used to diagnose conditions.
No
The device description explicitly states that the system consists of a "device" and "6-chambered garments," which are hardware components. The performance studies also include testing of hardware aspects like pressure accuracy, garment integrity, and button life.
Based on the provided information, the AIROS 6 Sequential Compression Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of conditions like lymphedema, venous stasis ulcers, venous insufficiency, and peripheral edema. IVD devices are used to diagnose or monitor conditions by examining samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a pneumatic compression device that applies external pressure to the limbs. This is a therapeutic mechanism, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information.
Therefore, the AIROS 6 Sequential Compression Device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
safe for both home and hospital use.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 6 are substantially equivalent to those of the predicate device. The functional performance testing includes the following tests:
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "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: 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.
1
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 CFR
Section | Product
Code | Class |
|-----------------------------|-------------------|-----------------|-------|
| Compressible Limb
Sleeve | 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 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.
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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