ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare

{0}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Medical Compressions System (DBN) Ltd. Adely Levy RA & QA General Manager 12 Ha'ilan Street, PO Box 75 Or - Akiva, Israel 30600 Re: K151377 Trade/Device Name: ActiveCare+S.F.T .; ActiveCare+S.F.T. Homecare; ActiveCare+DTx ; ActiveCare+DTx Homecare Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 19, 2015 Received: May 22, 2015 Dear Adely Levy: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 {1}------------------------------------------------ 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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, M. A. Hillebrenner for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): K151377 Device Name: ActiveCare+S.F.T. 8 and ActiveCare+DTx® Systems The ActiveCare+S.F.T.® and ActiveCare+DTx® Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by healthcare professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised, such as during and after major orthopedic surgery procedures e.g total joint (hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment and can be provided directly to the patient for home use. These devices are indicated for use in: - . Preventing Deep Vein Thrombosis (DVT) - Diminishing post-operative pain and swelling - Reducing wound healing time - Patients at risk for deep vein thrombosis (DVT) and related pulmonary embolism (PE) ● (Venous Thromboembolism (VTE)) - Treatment of venous stasis ● - Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers - Enhancing blood circulation - Treatment of chronic venous insufficiency ● - Reducing edema ● The ActiveCare+S.F.T. and ActiveCare+DTx® Systems are intended to provide external compression in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow. In addition, the ActiveCare+DTx® System can detect hemodynamic changes in venous blood flow. | Prescription Use _X_ | AND/OR | Over-The-Counter Use _ | |-------------------------------|--------|-------------------------------| | (Per 21 C.F.R. 801 Subpart D) | | (Per 21 C.F.R. 807 Subpart C) | (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of of 1 {3}------------------------------------------------ #### 510(K) SUMMARY 5. Medical Compression Systems (DBN) Ltd's ActiveCare+S.F.T.® and ActiveCare+DTx® Systems Date Prepared: May 18, 2015 | Submitter and Manufacturer | Contact Person | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Medical Compression Systems (DBN) Ltd.<br>12 Ha'ilan Street, PO Box 75<br>Or Akiva 30600, Israel<br>Tel: +972 (4) 6266630<br>Fax: +972 (4) 6266640<br>E-mail: adely@mcsmed.com<br><br>Manufacturer Registration Number: 9616558 | Adely Levy<br>12 Ha'ilan Street, P.O. Box 75<br>Or Akiva 30600, Israel<br>Telephone:+972 (4) 6266630<br>Fax: +972 (4) 6266640<br>E-mail: adely@mcsmed.com | #### Name of Device | Trade Names: | ActiveCare+S.F.T.® and ActiveCare+DTx® Systems<br>ActiveCare+S.F.T.® HomeCare and ActiveCare+DTx® HomeCar | |----------------------|-----------------------------------------------------------------------------------------------------------| | Common Names: | Pneumatic Compression System | | Classification Name: | Compressible Limb Sleeve | ### Device Classification/FDA Reviewing Branch The Division of Cardiovascular Devices has classified Compressible Limb Sleeves as Class II devices pursuant to 21 C.F.R. § 870.5800 (JOW). #### Predicate Device Information | Predicate Device Name | 510(k) | Manufacturer | |-------------------------------------------------|---------|-----------------------------| | ActiveCare+S.F.T. and<br>ActiveCare+DTx Systems | K142728 | Medical Compression Systems | #### Intended Use/Indications The ActiveCare+S.F.T. and ActiveCare+DTx Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by healthcare professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised such as during and after major orthopedic surgery procedures e.g total joint {4}------------------------------------------------ (hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment, and can be provided directly to the patient for home use. These devices are indicated for use in: - Preventing Deep Vein Thrombosis (DVT) - Diminishing post-operative pain and swelling ● - Reducing wound healing time ● - Patients at risk for deep vein thrombosis (DVT) and related pulmonary embolism (PE) . (Venous Thromboembolism (VTE)) - Treatment of venous stasis - Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and ● diabetic leg ulcers - Enhancing blood circulation - Treatment of chronic venous insufficiency ● - Reducing edema The ActiveCare+S.F.T. and ActiveCare+DTx Systems are intended to provide external compression in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow. In addition, the ActiveCare+DTx System can detect hemodynamic changes in venous blood flow. #### Device Description/Technological Characteristics The ActiveCare+S.F.T. and ActiveCare+DTx Systems are prescriptive, portable, sequential, intermittent pneumatic compression devices designed to apply sequential compression to the lower limb. The systems include a rechargeable battery powered option (in addition to an AC/DC adapter) allowing full patient mobility and ease of use. The control units of the Systems provide the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the thigh - single or double, and combined compression of any combination of two sleeves. The foot compression program is an intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve. The ActiveCare+S.F.T. and ActiveCare+DTx Systems are intended to provide continuous monitoring of each patient's venous phasic blood flow on a real time basis so that the timing of external compression is in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow. In addition, the ActiveCare+DTx System can detect hemodynamic changes that may be indicative of the development of a venous blood flow obstruction event in the treated patient's limbs. The ActiveCare+DTx is not a diagnostic tool. {5}------------------------------------------------ ## Performance Data A Human Factors and Usability Study was conducted to validate usability of the ActiveCare Systems for Direct to Home use. The results substantiated the acceptability of the risks identified during the risk assessment activities. Additional Testing/Reports referenced in support of this submission includes: Electrical Safety, Electromagnetic Compatibility, Usability/Environmental, Software Validation, Internal testing and Risk Analysis. #### Substantial Equivalence The ActiveCare+S.F.T. and ActiveCare+DTx Systems are substantially equivalent in intended use and technological characteristics to the commercially available Medical Compression Systems ActiveCare+S.F.T. and ActiveCare+DTx Systems, previously cleared under K142728, and raises no new safety or effectiveness issues.