(28 days)
Not Found
Not Found
No
The description focuses on pneumatic compression and sequential pressure application, with no mention of adaptive algorithms, learning, or data-driven decision making that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended for preventing Deep Vein Thrombosis (DVT), enhancing blood circulation, diminishing post-operative pain and swelling, reducing wound-healing time, and treating various venous and arterial conditions. These are all therapeutic applications.
No
The device is a prescriptive, pneumatic compression device designed for therapeutic purposes (preventing DVT, enhancing blood circulation, reducing pain/swelling, etc.), not for diagnosing conditions.
No
The device description explicitly mentions a "control unit," "pneumatic compression device," "battery operation," and "cuffs," indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, the WizAir DVT™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The WizAir DVT™ is a physical device that applies pneumatic compression to the lower limbs.
- The intended use and device description clearly state that the WizAir DVT™ is a prescriptive, pneumatic compression device used for physical therapy and circulation enhancement. It does not involve the analysis of biological samples.
Therefore, the WizAir DVT™ falls under the category of a therapeutic or physical medicine device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.
The WizAir DVT™ is intended for use in:
- . Preventing Deep Vein Thrombosis (DVT).
- Enhancing blood circulation.
- Diminishing post-operative pain and swelling.
- Reducing wound-healing time.
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers.
- Treatment of chronic venous insufficiency.
- Reducing edema.
Product codes
JOW
Device Description
The WizAir DVT™ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the WizAir DVT™ is light and compact, thus making it a portable ambulant system. The WizAir DVT™ provides the user with an option of battery operation in addition to the operation from the mains option. The WizAir DVT™ is easy to use and provides the user with several treatment options: compression of the foot -- single or double (either regular foot or foot booster), compression of the calf - single or double, compression of the Thigh -- single or double, and combined compression of any combination of two cuffs.
The foot compression program is sequential intermittent pressure pulse application to a single celled foot cuff. The calf and thigh compression program is a sequential intermittent gradient application of a pressure to a three-celled calf cuff.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs (lower limb, foot, calf, thigh)
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
Description of the test set: clinical analysis that was performed on healthy volunteers.
Summary of Performance Data: Testing results showed that the Foot Booster performs according to its specifications in safe and effective manner. A series of safety and performance testing including bench testing and clinical comparison between the Foot Booster cuff of the WizAir DVT™ and its predicate device demonstrated that the modified WizAir DVT™ System is substantially equivalent to its predicate devices without raising new safety and/or effectiveness issues
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: bench testing and clinical comparison.
Key results: Testing results showed that the Foot Booster performs according to its specifications in safe and effective manner.
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.
Not Found
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
1023573
NOV 2 1 2002
510(K) SUMMARY
WizAir DVT™M
510(k) Number K_______________________________________________________________________________________________________________________________________________________________
Applicant's Name:
Medical Compression Systems (DBN) Ltd. 2 Ha-Ilan Street, P.O. Box 75 Or-Akiva 30600, Israel Tel: +972 (4) 6266630 Fax: +972 (4) 6266640 mcs@mcsmed.com
Contact Person:
Arava Hacohen Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9- 7718130 Fax: 972-9-7718131
Trade Name:
WizAir DVT™
Classification Name:
Compressible Limb Sleeve
Classification:
Class II; Product Code JOW; Regulation No. 870.5800.
1
Device Description:
The WizAir DVT™ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the WizAir DVT™ is light and compact, thus making it a portable ambulant system. The WizAir DVT™ provides the user with an option of battery operation in addition to the operation from the mains option. The WizAir DVT™ is easy to use and provides the user with several treatment options: compression of the foot -- single or double (either regular foot or foot booster), compression of the calf - single or double, compression of the Thigh -- single or double, and combined compression of any combination of two cuffs.
The foot compression program is sequential intermittent pressure pulse application to a single celled foot cuff. The calf and thigh compression program is a sequential intermittent gradient application of a pressure to a three-celled calf cuff.
Indications:
The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.
The WizAir DVT™ is intended for use in:
- Preventing Deep Vein Thrombosis (DVT).
- Enhancing blood circulation.
- Diminishing post-operative pain and swelling.
- Reducing wound-healing time. .
- Treatment and assistance in healing: stasis dermatitis; ● venous stasis ulcers; arterial and diabetic leg ulcers.
- Treatment of chronic venous insufficiency.
- Reducing edema.
Contraindications:
The WizAir™ system should not be used in the following cases: fresh pre-existing DVT, pulmonary embolism, leg gangrene, recent skin graft, acute thrombophlebitis and in medical situations where increased venous and lymphatic return is undesirable
2
Substantial Equivalence: Statement
The modified WizAir DVT™ System is substantially equivalent in all aspects. e.g., technological characteristics, modes of operation, performance characteristics, intended use, etc., to the commercially available WizAir DVT™. The modified WizAir DVT™ System includes an additional cuff -- the Foot Booster cuff for faster inflation of the cell.
The pressure profile of the new cuff is similar to that of the A-V Impulse System. Moreover, the additional cuff and software modification were verified through bench testing and validated through clinical analysis that was performed on healthy volunteers.
Testing results showed that the Foot Booster performs according to its specifications in safe and effective manner.
Performance Data:
A series of safety and performance testing including bench testing and clinical comparison between the Foot Booster cuff of the WizAir DVT™ and its predicate device demonstrated that the modified WizAir DVT™ System is substantially equivalent to its predicate devices without raising new safety and/or effectiveness issues
3
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The words "HUMAN SERVICES - USA" are arranged in a circular fashion around the top of the design, and the word "DEPARTMENT" is written vertically along the left side of the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2002
Medical Compression Systems (D.B.N.) Ltd. c/o Mr. Arava Hacohen Project Manager Push-med Ltd. 117 Ahuzah St. Ra'ananna 43373 ISRAEL
Re: K023573 Trade Name: WizAir DVT™ Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II (two) Product Code: JOW Dated: October 21, 2002 Received: October 24, 2002
Dear Mr. Hacohen:
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.
4
Page 2 – Mr. Arava Hacohen
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Dna Xlumberfu
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): __
WizAir DVT™ Device Name:
Indications for Use:
The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.
The WizAir DVT™ is intended for use in:
- . Preventing Deep Vein Thrombosis (DVT).
- Enhancing blood circulation.
- Diminishing post-operative pain and swelling.
- Reducing wound-healing time.
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers.
- Treatment of chronic venous insufficiency.
- Reducing edema.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Division of C Respiratory Devices
510(k) Nu K023573
510(k) Number 11/20/02
Prescription Use (Per 21 CFR 801.109)
Over the Counter U
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