(94 days)
Prophylaxis for Deep Vein Thrombosis (DVT) for use in a clinical setting or in the home.
The Aircast VenaFlow Elite System is a prescription only, intermittent pneumatic compression device designed to apply rapid inflation with graduated sequential compression to a patient's calf, thigh or foot for the purpose of assisting blood flow in the veins. This rapid inflation and graduated, sequential compression device accelerates venous velocity and enhances fibrinolysis.
The Aircast VenaFlow Elite System provides two different modes for inflation. The system defaults to Standard Operation which inflates the cuffs one leg at a time, alternating between the two legs once every 30 seconds. The cuffs inflate within less than 0.5 seconds. The system has an alternate S Mode which inflates both cuffs at the same time, once every 60 seconds. The cuffs inflate in approximately 10 seconds.
The Aircast VenaFlow Elite System provides the user with an option of battery operation in addition to operation from the mains power. The Aircast VenaFlow Elite System is easy to use and provides the user with several cuff type options: calf, thigh and foot as well as combined compression of any combination of two cuffs.
The Aircast VenaFlow Elite System is available in two configurations. The CLINICAL configuration is for medical facilities and offers the full range of accessories including cuffs, varying tube lengths, optional battery and replacement kits. The HOME configuration is for home use and is provided with simplified patient instructions and offers a specific set of accessories limited to calf cuffs and tubing.
The provided document is a 510(k) summary for a medical device (Aircast VenaFlow Elite System). It describes the device, its intended use, and indicates that performance data was collected. However, it does not contain specific acceptance criteria or details of a study that proves the device meets those criteria in a quantitative sense as typically expected for diagnostic or AI-based devices.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory purposes, specifically after a device modification. The performance data mentioned relates to risk assessment, usability, and electrical safety, not clinical efficacy or diagnostic accuracy with specific metrics like sensitivity, specificity, or AUC.
Therefore, many of the requested sections about acceptance criteria, study sample sizes, ground truth, expert involvement, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it describes a different type of evaluation.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in a quantitative table format suitable for performance metrics like sensitivity, specificity, or predictive values. The document states:
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Failure Modes and Effects Analysis (FMEA) | "adequately assess the risks of the device. Known and potential hazards... were evaluated for risk and the severity of the failure effects to the user and probability of occurrence were categorized." |
| Human Factors and Usability | "validated the usability of the Aircast VenaFlow Elite System in the home environment." "substantiates the acceptability of the risks identified during the risk assessment activities." |
| Electrical Safety | "meets Electrical Safety testing according to IEC 60601-1" |
| Electromagnetic Compatibility (EMC) | "meets Electromagnetic Compatibility according to IEC 60601-1-2" |
2. Sample size 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 document. The FMEA and usability studies are mentioned but no specifics on participant numbers or data collection methods (retrospective/prospective) are given.
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 information is not provided. The usability study would likely have involved user participants, but they are not described as "experts" establishing a clinical "ground truth" for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
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:
This type of study is not applicable and was not done. The Aircast VenaFlow Elite System is an intermittent pneumatic compression device, not an AI-based diagnostic tool. Therefore, there are no "human readers" to improve with "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device, not an algorithm, and its performance is inherently human-in-the-loop (the patient and potentially caregivers/clinicians).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the safety and usability tests mentioned:
- FMEA: Ground truth would be established by risk assessment methodologies and potentially known failure modes of similar devices or components.
- Human Factors and Usability Study: Ground truth would be established by observation of user interaction, user feedback, and comparison against established usability heuristics or safety standards.
- Electrical Safety & EMC: Ground truth is defined by compliance with the referenced IEC standards (IEC 60601-1 and IEC 60601-1-2).
8. The sample size for the training set:
This is not applicable as this is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
This is not applicable.
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Special 510(k): Device Modification Aircast VenaFlow Elite System
Image /page/0/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The globe is black and white and has a circular shape with curved lines inside. The text "DJO" is in large, bold, sans-serif letters, and the text "GLOBAL" is in smaller, sans-serif letters below it. There is a trademark symbol after the O in DJO.
JUN 2 0 2013
Aircast® VenaFlow® Elite System 510{k) Number K 130722
March 15, 2013
510(k) Summary
Applicants Name: · DJO, LLC 1430 Decision Street Vista, Ca 92081
Contact Person: Lorri Trotter Regulatory Affairs Specialist Phone: 760-734-3049 Fax: 760-734-5544 Email: lorri.trotter@djoglobal.com
Date Prepared:
Trade Name:
Common/Usual Name: Compressible Limb Sleeve Device
Classification Name: Sleeve, Limb, Compressible (21 CFR 870.5800, Product Code JOW)
Aircast VenaFlow Elite System
Regulatory Class: Class II
Predicate Device(s): Aircast VenaFlow Elite System (K122499)
Device Description: The Aircast VenaFlow Elite System is a prescription only, intermittent pneumatic compression device designed to apply rapid inflation with graduated sequential compression to a patient's calf, thigh or foot for the purpose of assisting blood flow in the veins. This rapid inflation and graduated, sequential compression device accelerates venous velocity and enhances fibrinolysis.
The Aircast VenaFlow Elite System provides two different modes for inflation. The system defaults to Standard Operation which inflates the cuffs one leg at a time, alternating between the two legs once every 30 seconds. The cuffs inflate within less than 0.5 seconds. The system has an alternate S Mode which inflates both cuffs at the same time, once every 60 seconds.
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Special 510(k): Device Modification Aircast VenaFlow Elite System
.
Image /page/1/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The word "DJO" is in a larger, bolder font than the word "GLOBAL", and the letters are slightly slanted to the right. The globe is a black circle with two white lines running through it.
The cuffs inflate in approximately 10 seconds.
| The Aircast VenaFlow Elite System provides the user with anoption of battery operation in addition to operation from themains power. The Aircast VenaFlow Elite System is easy to useand provides the user with several cuff type options: calf, thighand foot as well as combined compression of any combinationof two cuffs. | |
|---|---|
| The Aircast VenaFlow Elite System is available in twoconfigurations. The CLINICAL configuration is for medicalfacilities and offers the full range of accessories including cuffs,varying tube lengths, optional battery and replacementkits. The HOME configuration is for home use and is providedwith simplified patient instructions and offers a specific set ofaccessories limited to calf cuffs and tubing. | |
| Intended Use: | The Aircast VenaFlow Elite System is an intermittent pneumaticcompression device that is intended to apply intermittentapplication of pressure to a patient's calf, thigh or foot for thepurpose of assisting blood in the veins. The Aircast VenaFlowElite System is a prescription device for use in a clinical settingor in the home. |
| Technological Characteristics: | The modified device has the same technologicalcharacteristics as compared to predicate device AircastVenaFlow Elite System (K122499) |
| Performance Data: | A Failure Modes and Effects Analysis (FMEA) was created toadequately assess the risks of the device. Known andpotential hazards for operation of the Aircast VenaFlow EliteSystem were evaluated for risk and the severity of the failureeffects to the user and probability of occurrence werecategorized. |
| A Human Factors and Usability Study was conducted tovalidate the usability of the Aircast VenaFlow Elite System inthe home environment. The result of the Human Factors andUsability Study substantiates the acceptability of the risksidentified during the risk assessment activities. | |
| The modified device meets Electrical Safety testing according |
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心
Special 510(k): Device Modification Aircast VenaFlow Elite System
Image /page/2/Picture/2 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO" and "GLOBAL" on the right. The globe is black and white and has a curved design. The text is in a sans-serif font, with "DJO" in a larger size than "GLOBAL".
to IEC 60601-1 and Electromagnetic Compatibility according to IEC 60601-1-2.
.
Conclusion:
Based on the performance testing and the supporting documentation, it can be concluded that the Aircast VenaFlow Elite System is safe, effective and substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2013
DJO, LLC Lorri Trotter 1430 Decision Street Vista, CA 92081-8553
Re: K130722
Trade/Device Name: Aircast VenaFlow Elite System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: April 18, 2013 Received: April 23, 2013
Dear Lorri Trotter:
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 (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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Page 2 - Lorri Trotter
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman -S
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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Indications for Use
510(k) Number (if known):__K130722
Device Name: Aircast VenaFlow Elite System
Indications For Use:
Prophylaxis for Deep Vein Thrombosis (DVT) for use in a clinical setting or in the home.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Bram D. Zuckerman -S |
|---|
| 2013.06.20 08:08:58 |
| -04'00' |
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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).