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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the Aircast VenaFlow Elite System and focuses on demonstrating its substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria in a typical standalone performance evaluation.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, expert-established ground truth, sample sizes for test/training sets, and MRMC studies is not available in the provided document. The document primarily focuses on regulatory approval through substantial equivalence.

Here's what can be extracted based on the information given, and where information is missing:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence):

Acceptance Criteria (Implied)	Reported Device Performance
Technological Characteristics similar to predicate	"similar to the previously cleared Aircast VenaFlow System"
Modes of Operation similar to predicate	"similar to the previously cleared Aircast VenaFlow System"
Performance Characteristics similar to predicate	"similar to the previously cleared Aircast VenaFlow System"
Intended Use similar to predicate	"similar to the previously cleared Aircast VenaFlow System"
Pressure Profile similar to predicate	"The pressure profile of the new Aircast VenaFlow Elite System is similar to the previously cleared Aircast VenaFlow System."
Safety and Effectiveness equivalent to predicate	"Test results demonstrate that the new Aircast VenaFlow Elite System performs according to its predetermined specifications in a safe and effective manner.""demonstrates that the modified system is substantially equivalent to the previously cleared device (predicate) and does not raise any new safety or effectiveness issues."
Functionality with optional battery operation (new feature)	"verified through bench testing and validated through clinical analysis"
Energy type and design modifications verified and validated	"verified through bench testing and validated through clinical analysis"
Software modifications verified and validated	"verified through bench testing and validated through clinical analysis"

Details on the Study (or lack thereof, as per the 510(k) process):

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "clinical analysis that was performed on healthy volunteers" but does not give a number for participants.
- Data Provenance: The document does not specify the country of origin of the data. It indicates the study was "prospective" to some extent as it involved "healthy volunteers."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. This type of information is typically for studies evaluating diagnostic or predictive algorithms against an expert-established truth. This submission focuses on demonstrating engineering equivalence and clinical performance (e.g., pressure profiles, blood flow assistance) compared to an existing device. The "ground truth" here is the performance of the predicate device and the physiological effects observed in healthy volunteers.
Adjudication method for the test set:
- Not Applicable / Not Provided. Adjudication methods (like 2+1, 3+1) are relevant for studies where subjective expert interpretation is being formalized for ground truth. This is not the case here.
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:
- No. This device is an intermittent pneumatic compression system for DVT prophylaxis. It is a physical device, not an AI-powered diagnostic or assistive tool, so an MRMC study is not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device. The "standalone" performance would be its functional operation in delivering compression, which was verified through "bench testing" and "clinical analysis."
The type of ground truth used:
- For the "clinical analysis": The "ground truth" was likely physiological measurements (e.g., venous velocity, pressure readings) in healthy volunteers, compared against the established performance of the predicate Aircast VenaFlow System, to ensure similar therapeutic effect and safety.
The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. Since there is no training set, this question is not relevant.

Summary of the Study per the Document:

The "study" referenced in the 510(k) submission is primarily a comparative engineering and clinical performance assessment against a predicate device, rather than a standalone clinical trial establishing new efficacy. The key components mentioned are:

Bench Testing: To verify energy type, design, and software modifications.
Clinical Analysis: Performed on "healthy volunteers" to validate the device's performance, likely by measuring its impact on blood flow or other physiological parameters. This analysis also compared the modified device to the previously cleared Aircast VenaFlow System.
Purpose: To demonstrate "substantial equivalence" to the predicate, ensuring the new device performs "according to its predetermined specifications in a safe and effective manner" and "does not raise any new safety or effectiveness issues."

Summary

{0}------------------------------------------------

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:

{1}------------------------------------------------

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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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

Image /page/3/Picture/5 description: The image shows a black and white drawing of a symbol or character. The symbol is abstract and appears to be handwritten, with curved lines and a tail-like extension at the bottom. The lines are thick and bold, creating a distinct shape against the white background.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

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

Regulation Number and Section

§ 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).