(94 days)
Not Found
No
The description details a mechanical intermittent pneumatic compression device with different modes and power options. There is no mention of AI, ML, or any data processing that would suggest such technology is incorporated.
No.
The device is used for prophylaxis of DVT, meaning it prevents a condition rather than treating an existing one.
No
Explanation: The device is intended for prophylaxis of Deep Vein Thrombosis (DVT) by assisting blood flow using pneumatic compression, not for diagnosing medical conditions.
No
The device description explicitly states it is an "intermittent pneumatic compression device" and mentions hardware components like cuffs, tubing, and a battery, indicating it is a physical device with software control, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Prophylaxis for Deep Vein Thrombosis (DVT) for use in a clinical setting or in the home." This describes a therapeutic or preventative action applied directly to the patient's body.
- Device Description: The device is an "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 is a physical intervention applied externally to the patient.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, in order to provide information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. The description of the Aircast VenaFlow Elite System does not involve the examination of any specimens from the human body.
Therefore, the Aircast VenaFlow Elite System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aircast VenaFlow Elite System is an intermittent pneumatic compression device that is intended to apply intermittent application of pressure to a patient's calf, thigh or foot for the purpose of assisting blood in the veins. The Aircast VenaFlow Elite System is a prescription device for use in a clinical setting or in the home.
Prophylaxis for Deep Vein Thrombosis (DVT) for use in a clinical setting or in the home.
Product codes (comma separated list FDA assigned to the subject device)
JOW
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's calf, thigh or foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical setting or in the home
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)
A Failure Modes and Effects Analysis (FMEA) was created to adequately assess the risks of the device. Known and potential hazards for operation of the Aircast VenaFlow Elite System were evaluated for risk and the severity of the failure effects to the user and probability of occurrence were categorized.
A Human Factors and Usability Study was conducted to validate the usability of the Aircast VenaFlow Elite System in the home environment. The result of the Human Factors and Usability Study substantiates the acceptability of the risks identified during the risk assessment activities.
The modified device meets Electrical Safety testing according to IEC 60601-1 and Electromagnetic Compatibility according to IEC 60601-1-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Aircast VenaFlow Elite System (K122499)
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.
Not Found
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).
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).
0
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.
1
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 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. |
| Intended Use: | The Aircast VenaFlow Elite System is an intermittent pneumatic
compression device that is intended to apply intermittent
application of pressure to a patient's calf, thigh or foot for the
purpose of assisting blood in the veins. The Aircast VenaFlow
Elite System is a prescription device for use in a clinical setting
or in the home. |
| Technological Characteristics: | The modified device has the same technological
characteristics as compared to predicate device Aircast
VenaFlow Elite System (K122499) |
| Performance Data: | A Failure Modes and Effects Analysis (FMEA) was created to
adequately assess the risks of the device. Known and
potential hazards for operation of the Aircast VenaFlow Elite
System were evaluated for risk and the severity of the failure
effects to the user and probability of occurrence were
categorized. |
| | A Human Factors and Usability Study was conducted to
validate the usability of the Aircast VenaFlow Elite System in
the home environment. The result of the Human Factors and
Usability Study substantiates the acceptability of the risks
identified during the risk assessment activities. |
| | The modified device meets Electrical Safety testing according |
2
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another, with flowing lines suggesting movement or care.
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.
4
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
5
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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