DVTCARE CA5

{0}------------------------------------------------ Section VIII ## VIII.A 510(k) Summary MAY 0 2 2013 510(k) Number K130174 #### Date: Mar 11 2013 #### Submitter: Ossur Americas Inc. 27051 Towne Centre Drive Foothill Ranch, CA 92610 Phone: 949-268-3185 Establishment Registration Number: 3003764610 #### Contact Person: Ubaldo Anaya Quality Assurance Manager #### Device name and classification: Trade Name / Model: DVTCare CA5 Common or usual name: Compressible Limb Sleeve Device Classification Name: Compressible Limb Sleeve Class: II Product Code: JOW Regulation Number: 21 CFR 870.5800 #### Predicate Devices: - i. DVTCare CA5, Doctors Orders (K061125), Acquired by Ossur Americas - TriplePlay-VT Vascular Therapy System TPVT-01, Wildcat Medical Inc (K103187) ii. #### Device Description: The subject 'DVTCare CA5' is a light weight, portable, prescriptive device intended to aid in prevention of Deep Vein Thrombosis (DVT) by helping to stimulate blood flow in the legs. This functionality is accomplished through the use of electronically controlled pump unit delivering a set amount of air to the leg cuffs that, in turn, compresses the calf(s) to aid blood flow out of the lower extremities. The pump control unit components are protectively housed in a plastic shell except the outer membrane switch (needed for user interface), 2 locking, plastic quick disconnects for air tube connection, and an external power supply input jack. The device is provided with non-serviceable battery to allow user portability, and an external power supply for mains connection. {1}------------------------------------------------ During device operation, the pump unit provides air to the cuff through flexible plastic tubing, inflating it to a specified pressure (set by user or healthcare provider), to compress the lower limb, thus aiding venous return. Air pressure and delivery are monitored by a pressure transducer and integrated system software contained in the plastic control unit. Immediately after the pressure transducer detects that the cuff has achieved the set pressure, the cuff deflates to ambient pressure. This allows the blood flow to return to the limb. The device software ensures the cycle time is a minimum of 60 seconds (the is the length of time for one complete cycle on one cuff including fill time, exhaust, and relaxation time). This is done to prevent excessive stimulation of the limb. #### Intended Use / Indications for Use: The subject DVTcare CA5 is intended to be a portable system that is prescribed by healthcare professionals 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 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. #### Technological Characteristics and comparison with predicates: The intended use of the subject 'DVTCare CA5' is same as the intended use of the predicates DVTCare CA5 (K061125) and TriplePlay-VT (K103187). The fundamental technology of the proposed device is also same as that of the predicates. A comparison of the main characteristics and features of these devices is provided as follows: | | DVTCare CA5 | DVTCare CA5 | TriplePlay-VT Vascular<br>Therapy System, TPVT-<br>01 | | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device<br>(Ossur Americas, Inc.) | Predicate K061125<br>(Össur Americas) | Predicate K103187<br>(Wildcat Medical Inc.) | | | Characteristics<br>/ Features | | | | | | Application | Non-invasive / external | Non-invasive / external | Non-invasive / external | | | Portability | Portable, ambulant | Portable, ambulant | Portable, ambulant | | | Basis of<br>operation | Aids venous return by<br>using cyclic, intermittent,<br>pneumatic pressure<br>application (inflation<br>followed by deflation) to<br>compress the lower<br>limb(s). | Aids venous return by<br>using cyclic, intermittent,<br>pneumatic pressure<br>application (inflation<br>followed by deflation) to<br>compress the lower<br>limb(s). | Aids venous return by<br>using cyclic, intermittent,<br>pneumatic pressure<br>application (inflation<br>followed by deflation) to<br>compress the lower<br>limb(s). | | | | DVTCare CA5 | DVTCare CA5 | TriplePlay-VT Vascular<br>Therapy System, TPVT-<br>01 | | | Characteristics<br>/ Features | Subject Device<br>(Ossur Americas, Inc.) | Predicate K061125<br>(Össur Americas) | Predicate K103187<br>(Wildcat Medical Inc.) | | | Location of<br>treatment<br>application | Lower limb(s) (Calf) | Lower limb(s) (Calf) | Lower limb(s) (Calf) | | | System<br>management | Electronic,<br>microprocessor controlled | Electronic,<br>microprocessor controlled | Electronic,<br>microprocessor controlled | | | Treatment<br>delivery | Uses electronic<br>microprocessor and<br>pneumatics to inflate and<br>deflate bladder cuffs to<br>achieve compression<br>therapy | Uses electronic<br>microprocessor and<br>pneumatics to inflate and<br>deflate bladder cuffs to<br>achieve compression<br>therapy | Uses electronic<br>microprocessor and<br>pneumatics to inflate and<br>deflate bladder cuffs to<br>achieve compression<br>therapy | | | Pressure Source | Micropump controlled by<br>electronic processor | Micropump controlled by<br>electronic processor | Micropump controlled by<br>electronic processor | | | Outlet ports | Two | Two | Three | | | Outlet valves | Two 2-way valves with<br>one vent valve | One three-way valve with<br>two vent valves | Three 3-way valves | | | Operating<br>Modes | • 'Single leg' mode<br>• 'Double leg' mode | • 'Single leg' mode<br>• 'Double leg' mode | • Leg 1<br>• Leg 2<br>• Auxiliary<br>• Leg 1+auxiliary<br>• Leg 2+auxiliary | | | Working<br>Pressure | Single and double leg<br>modes are preset at<br>50mmHg; and adjustable<br>by user between 20-<br>50mmHg, | Single and double leg<br>modes are preset at<br>40mmHg; and adjustable<br>by user between 20-<br>40mmHg. | Leg 1 and Leg 2 modes<br>are preset at 50mmHg;<br>and adjustable between<br>20-65mmHg<br><br>Auxiliary modes are<br>preset at 35mmHg; and<br>adjustable between 20-<br>50mmHg. | | | | Note: The Healthcare<br>Provider can adjust<br>pressure range from 20-<br>65mmHg for both modes,<br>if so prescribed. | Note: The Healthcare<br>Provider can adjust<br>pressure range from 20-<br>65mmHg for both modes,<br>if so prescribed. | | | | Inflation time | 10 seconds | 10 seconds | Not Specified | | | | DVTCare CA5 | DVTCare CA5 | TriplePlay-VT Vascular<br>Therapy System, TPVT-<br>01 | | | | Subject Device<br>(Ossur Americas, Inc.) | Predicate K061125<br>(Össur Americas) | Predicate K103187<br>(Wildcat Medical Inc.) | | | Characteristics<br>/ Features | Hold Time | 2 seconds | 0 second | 3.5 seconds<br>(approximately)<br>Note: Although the<br>TriplePlay-VT user<br>manual does not specify<br>the 'hold-time'; in-house<br>testing by Ossur showed<br>the hold-time as 3.5<br>seconds (approximately) | | | Cycle time<br>(One inflation<br>and deflation<br>per limb) | Preset at 60 seconds,<br>Adjustable between 60-75<br>seconds | Preset at 60 seconds,<br>Adjustable between 60<br>and 75 seconds. | Preset at 60 seconds.<br>Adjustable between 60-70<br>seconds | | | System<br>diagnostics | Audible and visual alarms<br>prompt recognition of<br>system faults | Audible and visual alarms<br>prompt recognition of<br>system faults | Audible and visual alarms<br>prompt recognition of<br>system faults | | | Battery<br>Specifications | 7.4V, 1.8Ah, Li-Po<br>rechargeable battery | 6V, 1.8Ah, Ni-MH<br>rechargeable battery | 6V, 2.0 Ah, Ni-MH<br>rechargeable battery | | | Power<br>Requirement | Rechargeable battery<br>and/or 110VAC | Rechargeable battery<br>and/or 110VAC | Rechargeable battery<br>and/or 110VAC | | | Air delivery<br>from pump to<br>cuff bladder | Via flexible plastic (PVC)<br>tube(s) terminated with<br>quick disconnect CPC<br>fittings | Via flexible plastic (PVC)<br>tube(s) terminated with<br>quick disconnect CPC<br>fittings | Via flexible plastic air<br>tubes with locking / quick<br>disconnect air ports | | | Leg cuffs<br>(garments)<br>material | PVC bladder covered with<br>brushed Nylon | PVC bladder covered with<br>brushed Nylon | PVC bladder encased in a<br>soft, non-woven medical<br>fabric made from<br>common sponge material | | | Leg cuff Sterile<br>/ Not Sterile | Clean / non sterile | Clean / non sterile | Clean / non sterile | | | Leg cuff usage | Single patient use | Single patient use | Single patient use | {2}------------------------------------------------ {3}------------------------------------------------ Like the predicates, the subject device uses intermittent, pneumatic compression to simulate muscle contractions in the legs aiding the return of venous flow. The compression is achieved by air delivery, through flexible plastic tubing that are terminated with CPC quick lock connectors, to inflatable cuffs/bladders that are wrapped around the limb(s) to transmit the pneumatic force to the leg. The air delivery is controlled by a microprocessor controlled pump and valve system. The specifications of the proposed device (such as working pressure, cycle {4}------------------------------------------------ time and hold-time) are also comparable to the identified predicates. Like the predicates, the proposed 'DVTCare CA5' includes audible and visual alarms for system monitoring and fault recognition. Like the predicates, the proposed device also incorporates rechargeable batteries enabling the unit to be portable; and is offered with an external power supply for connection to mains supply (for normal operation and battery recharging). The difference in type of battery between the subject device (Li-PO battery) and the predicate devices (Ni-MH battery), different configuration of outlet valves and slight difference in appearance do not raise any new concerns of safety or effectiveness. #### Non-Clinical Testing The 'DVTCare CA5' has been subjected to extensive in-house bench testing for design. software and performance validation. Moreover, the device was also evaluated by third party test laboratories for compliance to Electrical safety (IEC/UL/CAN60601-1) and Electromagnetic Compatibility (IEC 60601-1-2) and Environmental testing. Being a portable unit, the DVTCare CA5 was also tested to standard MIL-STD 810D, section 514.3-1 for Vibration integrity. The results from these non-clinical tests demonstrated that the proposed DVTCare CA5 meets design. safety and performance requirements; and does not raise any new concerns of safety and effectiveness. | Design Change | Validation Document | |---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Upgrade from NiMH batteries to Lithium Ion batteries. | DVT Charge Parameters and Verification Report<br>Globtek battery UN38 3 TEST REPORT<br>EC DECLARATION EN62133 battery<br>Software Functions Verification Report highlighted<br>CA5 System Safety Testing Report<br>CA5 System EMC test report<br>CA5 Shelf Life Test<br>CA5 PCB Verification Report | | Changes in the external power supply. | UL REPORT GTM21089<br>Software Functions Verification Report highlighted<br>CA5 System Safety Testing Report<br>CA5 System EMC test report | | The single 3-way outlet valve with two vent valves has been replaced by two 2-way fill valves with one common vent valve. | Software Functions Verification Report highlighted<br>CA5 System Safety Testing Report | | Case material changed from ABS to ASA-PC. | CA5 System Safety Testing Report<br>V0 material trans test 110512<br>CA5 Crush Test | | Software has been modified to provide control for the Lithium Ion battery. | Software Functional Requirements highlighted | The list of Design Changes and the corresponding Validation Documents are listed below. The location of each Test Report can be found in this in the Cover Letter, Section IV.B. {5}------------------------------------------------ | Default pressure setting for both 'single-<br>leg' and 'double-leg' modes has changed<br>from 40mmHg to 50mmHg. | Software Functions Verification Report<br>highlighted | |-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | The hold-time specification for both<br>modes has changed from 0 seconds to 2<br>seconds before deflation. | Software Functional Requirements highlighted<br>Software Functions Verification Report<br>highlighted<br>CA5 Predicate Testing | | Self-diagnostic feature added to verify<br>proper operation every half hour during<br>use. | Software Functional Requirements highlighted<br>Software Functions Verification Report<br>highlighted | | Resettable Compliance Counter added for<br>provider use to record number of hours<br>use by each patient. | Software Functional Requirements highlighted<br>Software Functions Verification Report<br>highlighted | #### Conclusion: Based on validation testing, compliance to voluntary standards and non-clinical bench testing information provided in the submission; the proposed 'DVTCare CA5' is substantially equivalent to the predicate devices, and does not raise any new concerns of safety of effectiveness. Therefore, the proposed device is substantially equivalent to the referenced predicate devices. {6}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 2, 2013 Ossur Americas Inc. c/o Mr. Ubaldo Anaya Quality Assurance Manager 27051 Towne Center Drive Foothill Ranch, CA 92610 Re: K130174 Trade/Device Name: DVTCare CA5 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: March 14, 2013 Received: March 15, 2013 Dear Mr. Anaya: 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. {7}------------------------------------------------ #### Page 2 - Mr. Mark Job 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 (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.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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 notification" (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 vours. ## Bram D. Zuckerman Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ### Section VII #### VII.C Indications for Use 510(k) Number (if known): K130174 Device Name: DVTCare CA5 #### Indications for Use: The DVTCare CA5 is intended to be a portable system that is prescribed by healthcare professionals 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 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 (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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) # Bram D. Zuckerman 2013.05.02 16:33 VII.C - 1