(29 days)
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No
The summary describes a mechanical pneumatic compression device and does not mention any AI or ML capabilities.
Yes
The device is indicated as a prophylaxis for deep vein thrombosis (DVT) and assists blood flow in the veins, which are therapeutic actions.
No
The device is described as a prophylactic device for deep vein thrombosis (DVT) and is intended for assisting blood flow, not for diagnosing a condition.
No
The device description explicitly states it is an "intermittent pneumatic compression device" and mentions hardware components like battery operation, mains power, and cuff types (calf, thigh, foot). This indicates it is a physical device with software control, not a software-only medical device.
Based on the provided information, the Aircast VenaFlow Elite System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the prophylaxis of deep vein thrombosis (DVT) by applying external pressure to assist blood flow in veins. This is a therapeutic and preventative action on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an intermittent pneumatic compression device that applies pressure to the patient's limbs. This is a physical intervention, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Aircast VenaFlow Elite System does not fit this description.
N/A
Intended Use / Indications for Use
The Aircast VenaFlow Elite System is indicated as a prophylaxis for deep vein thrombosis (DVT).
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 flow in the veins.
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 design 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 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 provided the user with several cuff type options: calf, thigh and foot as well as combined compression of any combination of two cuffs.
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
calf, thigh or foot
Indicated Patient Age Range
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Intended User / Care Setting
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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)
Safety and performance testing including bench testing and clinical comparison between the previously cleared Aircast VenaFlow System and the modified device (e.g., Aircast VenaFlow Elite System) demonstrates that the modified system is substantially equivalent to the previously cleared device (predicate) and does not raise any new safety or effectiveness issues.
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.
Aircast VenaFlow System
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 for DJO. The logo is in black and white, and it features the letters "DJO" in a bold, sans-serif font. There is a curved line above and below the letters. The logo is simple and modern.
Section 8: 510(k) Summary
Aircast® VenaFlow® Elite System 510(k) Number Key 1700
JUL - 9 2009
Applicant's Name:
DJO, LLC 1430 Decision Street Vista, CA 92081
Contact Person:
Christine Otis Senior Regulatory Affairs Specialist Phone: 760-734-3504 Fax: 760-734-5544 E-mail: christine.otis@djoglobal.com
Trade Name:
Aircast VenaFlow Elite System
Classification Name:
Compressible Limb Sleeve
Classification:
Compressible Limb Sleeves have been classified as Class II, 74J--OW. Regulation number 21 CFR 870.5800, Cardiovascular Devices.
Device Description:
The Aircast VenaFlow Elite System is a prescription only, intermittent pneumatic compression device design 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 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 provided the user with several cuff type options: calf, thigh and foot as well as combined compression of any combination of two cuffs.
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Image /page/1/Picture/0 description: The image shows the logo for DJO. The logo is in black and white, and the letters "DJO" are written in a bold, sans-serif font. There are curved lines above and below the letters. The logo is simple and modern.
Indications for Use:
The Aircast VenaFlow Elite System is indicated as a prophylaxis for deep vein thrombosis (DVT).
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 flow in the veins.
Contraindications:
The VenaFlow Elite System should not be used by persons with known or suspected deep vein thrombosis, severe congestive heart failure, pulmonary edema, thrombophlebitis, severe arteriosclerosis or active infection. Do not use on extremities which are not sensitive to pain, where cuff will interfere with gangrene, on patients with vein ligation or recent skin grafts, or extreme deformity of the leg. Do no use the VenaFlow Elite System where increased venous or lymphatic return is undesirable.
Substantial Equivalence:
The modified Aircast VenaFlow System (e.g., Elite) is substantially equivalent in all aspects (technological characteristics, modes of operation, performance characteristics, intended use, etc. to the previously cleared Aircast VenaFlow System. The modified system provides an optional battery operation configuration.
The pressure profile of the new Aircast VenaFlow Elite System is similar to the previously cleared Aircast VenaFlow System. Additionally, the energy type and design and software modifications were verified through bench testing and validated through clinical analysis that was performed on healthy volunteers.
Test results demonstrate that the new Aircast VenaFlow Elite System performs according to its predetermined specifications in a safe and effective manner.
Performance Data:
Safety and performance testing including bench testing and clinical comparison between the previously cleared Aircast VenaFlow System and the modified device (e.g., Aircast VenaFlow Elite System) demonstrates that the modified system is substantially equivalent to the previously cleared device (predicate) and does not raise any new safety or effectiveness issues.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 2009
DJO, LLC c/o Ms. Christine Otis Senior Regulatory Affairs Specialist 1430 Decision Street Vista, CA 92081
K091700 Re:
Aircast VenaFlow Elite System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: June 5, 2009 Received: June 10, 2009
Dear Ms. Otis:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 -- Ms. Christine Otis
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dvina R. Berliner
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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
K091700 510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________
Prophylaxis for Deep Vein Thrombosis (DVT) Indications for Use: ____
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (Part 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)
sumer R. Vclune
(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices
510(k) Number K091700