(216 days)
Not Found
No
The device description details a microchip controller board that regulates pressure and compression time on a set cycle, which is a deterministic process, not indicative of AI/ML. There is no mention of AI, ML, or related terms in the provided text.
Yes
The device is described as assisting in the relief of various medical conditions such as fatigue, venous congestion, edema, and prevention of Deep Vein Thrombosis, indicating its use for therapeutic purposes.
No
The device is described as a portable compression system intended to assist in the relief of conditions like fatigue, venous congestion, and edema, and for the prevention of Deep Vein Thrombosis. It operates by physically compressing the legs to enhance venous return, rather than by diagnosing medical conditions.
No
The device description clearly states it consists of a battery-operated compression pump and an inflatable leg wrap, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The TravelAir Portable Compression System is a physical device that applies external pressure to the lower limbs. It does not analyze any biological samples.
- Intended Use: The intended use is to provide physical relief and prevention of conditions related to blood circulation in the legs, not to diagnose or monitor a disease through laboratory analysis.
Therefore, the description clearly indicates a therapeutic or preventative physical device, not an IVD.
N/A
Intended Use / Indications for Use
The TravelAir Portable Compression System is intended to assist in the relief of the following:
Fatigue in the lower limbs
Venous congestion in the lower legs
Edema in the lower legs
Edema in the lower legs post injury or trauma
Prevention of Deep Vein Thrombosis
The TravelAir Portable Compression System is designed to provide intermittent compression of the lower legs to enhance venous return toward the heart. This venous enhancement is meant to relieve aches and fatigue in the legs brought on by long periods of immobility and reduce edema or swelling after sports injury or minor trauma.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The Dynamic Air, Inc. TravelAir Portable Compression System consists of a battery operated compression pump connected to an inflatable leg wrap. The compression pump is connected to the leg wrap by plastic tubing connected by CPC quick connectors at the pump and at the tubing /wrap junction.
The leg wrap consists of a Polyvinyl chloride (PVC) air bladder encapsulated inside a VelFoam material; the color of the outer covering material is white. The VelFoam material is adhered to the PVC air bladder. The wrap is provided clean, non-sterile packaged in pairs for use.
The compression pump consists of a medical grade micro pump which delivers preset pressures to the leg wraps. The micro pump is controlled by a microchip controller board which regulates pressure and compression time on a set cycle.
The compression pump inflates and deflates the leg wraps in a preset sequence intermittently compressing the soft tissue of the legs. This compression forces blood to move toward the heart and enhances venous return from the lower legs. After compression the wraps deflate and allow the veins and capillaries to refill. The cycle then repeats until the unit is deactivated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs (legs)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench testing performed by Dynamic Air has show that the leg wraps are substantially equivalent in performance to the predicate devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing and side by side comparisons were done with predicate devices to assure equivalence in performance.
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.
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
510k Summary July 2, 2002
FEB 1 9 2003
TravelAir Portable Compression System
In accordance with 21 CFR 807.92 this summary is submitted by:
I. Name of Submitter
Dynamic Air Incorporated 3485 BankHead Highway Atlanta, GA 30331
Contact: Brent Knight ERN: 232094
II Device Name and Classification
Proprietary Name: TravelAir Portable Compression System Common or Usual Name: Compressible Limb Sleeve Classification: Class II: IRP 890.5650
III Predicate Device
The TravelAir Portable Compression System is substantially equivalent to devices currently in commercial distribution by the following company:
Wizair (K002287) Medical Compression Systems' 117 Ahuzah Street Ra'ananna, IS 43373 DVT275 (K915638) Talley Medical Group Progressive Medical Technology, Inc 815 Terminal Road
IV. Description of Device
Lansing, MI 48906
The Dynamic Air, Inc. TravelAir Portable Compression System consists of a battery operated compression pump connected to an inflatable leg wrap. The compression pump is connected to the leg wrap by plastic tubing connected by CPC quick connectors at the pump and at the tubing /wrap junction.
The leg wrap consists of a Polyvinyl chloride (PVC) air bladder encapsulated inside a VelFoam material; the color of the outer covering material is white. The VelFoam material is adhered to the PVC air bladder. The wrap is provided clean, non-sterile packaged in pairs for use.
The compression pump consists of a medical grade micro pump which delivers preset pressures to the leg wraps. The micro pump is controlled by a microchip controller board which regulates pressure and compression time on a set cycle.
1
The compression pump inflates and deflates the leg wraps in a preset sequence intermittently compressing the soft tissue of the legs. This compression forces blood to move toward the heart and enhances venous return from the lower legs. After compression the wraps deflate and allow the veins and capillaries to refill. The cycle then repeats until the unit is deactivated.
V Intended Use and Contraindications
The TravelAir Portable Compression System is intended to assist in the relief of the following:
Fatigue in the lower limbs Venous congestion in the lower legs Edema in the lower legs Edema in the lower legs post injury or trauma
Prevention of Deep Vein Thrombosis
Contraindications For Use of the TravelAir Portable Compression System
Acute pulmonary edema Acute congestive heart failure Acute diagnosis of DVT Acute infection of the limb to be compressed Open wounds of the limb to be compressed
VI Technical Characteristics
The TravelAir Portable Compression System is similar in to the predicate device in its operation characteristics. The material in the leg wrap is similar in make up to the predicate devices. The mode of operation and delivery of therapy is similar.
Bench testing performed by Dynamic Air has show that the leg wraps are substantially equivalent in performance to the predicate devices.
VII Performance Standards
There are no performance standards for this class of medical device (class II). Bench testing and side by side comparisons were done with predicate devices to assure equivalence in performance.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them, resembling a stylized caduceus without the snake.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2003
Dynamic Air, Inc. c/o Mr. Brent Knight Vice President Products 3495 Bankhead Highway, Suite A Atlanta, GA 30331
Re: K022340
Trade Name: TravelAir Portable Compression System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: November 9, 2002 Received: November 21, 2002
Dear Mr. Knight:
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 - Mr. Brent Knight
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
KelaTM
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510 (k) Number
K02234D
Device Name
TravelAir Portable Compression System
Indications forUse
The TravelAir Portable Compression System is designed to provide intermittent compression of the lower legs to enhance venous return toward the heart. This venous enhancement is meant to relieve aches and fatigue in the legs brought on by long periods of immobility and reduce edema or swelling after sports injury or minor trauma.
Contraindications for this Device Would Include:
Acute congestive heart failure Acute pulmonary edema Existing Deep Vein Thrombosis Acute infection of the leg to be compressed Presence of skin ulceration on area to be compressed
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE
ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
| Division of Cardiovascular, Respitory, |
| And Neurological Devices |
| 510(k) K022340 |
Prescription Use
(per 21 CFR 801.109)
Over The Counter Use