AVIAFIT

{0}------------------------------------------------ K111720 pg 1 of 3 ## SECTION 5 - 510(K) SUMMARY SEP 1 6 2011 # AVIAFIT™ DEVICE 510(k) Number K____________ ## Applicant's Name: | Company name: | FlowMedic Ltd. | |---------------|--------------------------| | Address: | 15 Alon Hatavor St. | | | Industrial Area Caesarea | | | Caesarea, 38900 | | | ISRAEL | | Tel.: | +972 (4) 627-5559 | | Fax: | +972 (4) 627-5560 | | E-mail: | info@flowmedic.com | ## Contact Person: | Contact Name: | Ahava Stein | |---------------|----------------------------------------------------------| | Company: | A. Stein – Regulatory Affairs Consulting | | Address: | 20 Hata'as St. (P.O.B. 124)<br>Kfar Saba 44425<br>ISRAEL | | Tel.: | +972 (9) 7670002 | | Fax.: | +972 (9) 7668534 | | E-mail: | asteinra@netvision.net.il | ## Date Prepared: Date: June 12, 2011 ## Name of the device: AviaFit™ Device ## Trade or proprietary name, if applicable: AviaFit™ Device ## Common or usual name: Compressible Limb Sleeve б {1}------------------------------------------------ #### Establishment Registration No .: 3005003051 #### Classification Name: Compressible Limb Sleeve (21 CFR 870.5800, Product Code JOW) #### Classification: FDA has classified Compressible Limb Sleeve devices as Class II devices (product code JOW), which are reviewed by the Cardiovascular Devices Panel. 11720 g 208 3 #### Predicate Device: The AviaFit™ Device is substantially equivalent to the originally cleared AviaFit™ Device (also manufactured by FlowMedic Ltd. and the subject of 510(k) document no. K071744) and the DVTcare CA5 device (manufactured by Doctor's Orders Inc. and the subject of 510(k) document no. K061125). #### Device Description: The FlowMedic AviaFit™ is a battery operated portable device integrating a patented mechanical intermittent compression technology to improve blood circulation in the lower limbs and reduce the risk of deep vein thrombosis, edema and leg discomfort during limited mobility conditions. The device is comprised of an actuator and is externally mounted on the calf. The anatomical concave shaped control unit is connected to the leg strap and applied to the calf. Using an innovative low power consumption mechanism, the system tugs and releases the leg strap placed around the calf muscle, thus exerting intermittent cycles of external pressure build-up on the tissue, and a subsequent release, thus aiding venous return. Strap tug and release are controlled by a system of gears, springs, a motor and integrated microprocessor contained in the plastic control unit. The device mimics the muscle activity during walking by acting sequentially in cycles of an active interval of exerting pressure on the muscle, thus augmenting blood flow. followed by a loose state for a period of time, allowing blood flow to return to the limb. #### Intended Use / Indication for Use: The AviaFit™ Device is intended for use to help prevent the onset of DVT in patients by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to aid in the prevention of DVT, enhance blood circulation, diminish post-operative pain and 7 {2}------------------------------------------------ KWI720 pg 3 of 3 swelling, reduce wound healing time, and aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs. #### Comparison of Technological Characteristics with the predicate device: The technological characteristics of the AviaFit™ device are similar to the technological characteristics of the predicate devices including mechanism of action (e.g., compression to simulate muscle contraction), pressure range of compression time and cycle time, treatment site, indicators, power requirements, etc. #### Non-Clinical Performance Data and Performance Standards The performance tests performed on the original, cleared and identical AviaFit™ device verified that the operating characteristics and performance of the device are in accordance with its specifications. #### Clinical Performance Tests: Not Applicable. #### Conclusions Drawn from Non-Clinical and Clinical Tests: The non-clinical tests demonstrated that the AviaFit™ device meets its design and performance specifications. #### Substantial Equivalence: The AviaFit™ device has the same intended use as the DVTcare CA5 device. Furthermore, the AviaFit™ device has the same technological characteristics, (i.e., same mechanism of action, and similar design and specifications) as the originally cleared AviaFit™ device and the DVTcare CA5 predicate device. The differences in the new device do not raise new issues of safety or effectiveness. In conclusion, the modified AviaFit™ device is substantially equivalent to the predicate devices and therefore, may be cleared for marketing in the United States. 8 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 FlowMedic Ltd. c/o Ms. Ahava Stein Regulatory Affairs Consulting 15 Alon Hatavor Street Industrial Arca Caesarea Caesarea, 38900 ISRAEL CFP 16 2001 Re: K111720 AviaFit™ Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 14, 2011 Received: June 20, 2011 Dear Ms. Stein: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(ty promation health (for the indications referenced above and have determined the device is substantials; interstate for use stated in the enclosure) to legally marketed predical devices marketed in interstate for use stated in the encrosity manatiment date of the Medical Device Americal Food. Drug commerce prof to May 20, 1977, the enatified in accordance with the Federal Frod. Drug. devices that have been reclassified in accordance with the provisions of PMA N devices that nave been recuired in accordance who a premarket approval applications (PMA). and Cosmetic Act (Act) that do not require approval of a previsions of the Act, The and Cosmetic Act (Act) that to not require approvince in controls provisions of the Act. The Act. The Act. The You may, meretore, market the device, solojost to magines for annual registration, listing of the and general controls provisions of the Fee mondov rounds on and probibitions against links and devices, good mandracturing practice, acomig and information related to contract frability adulteration. Please note: CDRT does not evaluate mombe truthful and not misleading. {4}------------------------------------------------ #### Page 2 - Ms. Ahava Stein 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 of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket nonification" (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/Resourcesfor You/Industry/default.htm. Sincerely yours, LL Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### SECTION 4 - INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K11172Ø Device Name: AviaFit™ Device #### Indications for use: The AviaFit 110 Device is intended for use to help prevent the onset of DVT in patients by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to aid in the prevention of DVT, enhance blood circulation, diminish postoperative pain and swelling, reduce wound healing time, and aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs. Prescription Use (Per 21 C.F.R. 801 Subpart D) OR Over-The-Counter Use (Optional Format Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) . 5 (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K111720