Ezvena IPC, Ezvena SQS

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a seal on the left and the FDA acronym with the full name of the agency on the right. The seal features a stylized depiction of human services, while the text part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text. January 29, 2020 Eezcare Medical Corp % John Gillespy President FDA 510K Consultants, LLC 1100 Del Lago Cir, STE 104 Palm Beach Gardens, Florida 33410 Re: K191937 Trade/Device Name: Ezvena IPC, Ezvena SOS Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: December 20, 2019 Received: December 30, 2019 Dear John Gillespy: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm_identifies_combination product submissions. 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191937 Device Name EzVena IPC, EzVena SQS #### Indications for Use (Describe) To apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Section 5 – 510(k) Summary | 1. 510(k) Submitter: | Eezcare Medical Corp<br>No 3-1, Minquan St, New Taipei City 236<br>Taipei, Tu-Cheng District, Taiwan 23679<br>Phone: 757-224-0177<br>Email: michelle.mitchell@eezcare.com.tw | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. Company Contact: | Michelle C Mitchell | | 3. Date of Submission: | July 8, 2019 | | 4. 510(k) Preparer: | John F. Gillespy, MBA<br>FDA 510k Consulting, LLC<br>Palm Beach Gardens, FL 33410<br>Phone: 386-243-4332<br>Email: john@fda510kconsultants.com | | 5. Device Classification: | Trade name: EzVena IPC, EzVena SQS<br>Common name: DVT Pump System<br>Device: Sleeve, Limb, Compressible<br>Class: II<br>Product Code: JOW | | 6. Predicate: | Applicant: Getinge (Suzhou) Co, Ltd<br>Device: Flowtron ACS900<br>510(k) Number: K143438 | - 7. Device Description... EzVena IPC and EzVena SQS ("EzVena") is a deep vein thrombosis (DVT) pump system intended for performing non-invasive, intermittent compression of the lower limbs (see Figure 1). The system is used to squeeze blood from the deep veins, which displaces proximally. On deflation of the cuff, the veins refill, and the intermittent nature of the system ensures periodic flow of blood through the deep veins, helping to prevent venous stasis and the formation of blood clots. The basic technology has proven effective across many scientific studies since its introduction in the 1970s. System components include a mains-powered, pneumatic pump with touch-input control panel Image /page/3/Picture/6 description: The image shows an EzVena Pump and Air Hoses (IPC). The pump is white and blue, and it has a screen with buttons on the front. There are two gray air hoses connected to the pump, and an orange power cord is visible in the background. The pump is sitting on a gray surface. {4}------------------------------------------------ and microprocessor circuit; connecting air hoses; and foot, calf, and calf/thigh garments, or cuffs. The pump intermittently releases compressed air through the tubing into inflating and deflating bladders within cuffs that are wrapped separately around the patient's left and right lower limbs. Compression is uniform in the IPC model and graded sequential in the SQS model (see Table 1). The system alternates between left and right cuffs in EzVena IPC and inflates both garments simultaneously in EzVena SQS. | Site of Compression | EzVena IPC | EzVena SQS | |---------------------|---------------------|-------------------------| | Foot | Uniform (1 Bladder) | Uniform (1 Bladder) | | Calf | Uniform (1 Bladder) | Sequential (3 Bladders) | | Calf/Thigh | Uniform (1 Bladder) | Sequential (3 Bladders) | Table 1 - Uniform Vs Sequential Compression Graded sequential compression (in SQS) is accomplished through the use of three bladders in calf and calf/thigh garments (by contrast, IPC cuffs and all foot garments contain but one bladder) (see Table 2). The distal bladder is inflated first, and at the highest pressure; then the central and proximal bladders are inflated in turn at steppeddown pressures. In case of power failure, the pump has battery backup. ## Table 2 - Compression Differentiation | Factor | EzVena IPC | EzVena SQS | |-----------------------|------------------------|------------------------| | Site of Compression | Foot, Calf, Calf/Thigh | Foot, Calf, Calf/Thigh | | Type of Compression | Uniform | Graded Sequential | | Extent of Compression | Noncircumferential | Noncircumferential | EzVena may be operated only by acute-care personnel authorized and trained to treat DVT. The device is intended for patients at risk for the medical condition. The system is portable, and it includes a bed mount for secure placement at the foot of the patient's bed. The garments, which come in three sizes (S/M/L), contact the patient. The pump and air hoses are reusable and cleaned before each use. The garments are for patient single use. - 8. Mechanism of Action... Intermittent compression of air inflates and deflates cuffs, ensuring blood flow in the deep veins. - 9. Indications For Use... To apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis. The device is intended for prescription use only. - 10. Comparison To Predicate and Reference Devices... See Table 3 on the following pages. {5}------------------------------------------------ | Characteristics | Subject Device | Predicate Device | SE Comparison | |-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | EzVena IPC & EzVena SQS | Flowtron ACS900 | NA | | Manufacturer | Eezcare Medical Corp | Getinge (Suzhou) Co, Ltd | NA | | 510k Number | Applied For | K143438 | NA | | Device Photo<br>(Pump/Air Hoses) | Image: EzVena IPC & EzVena SQS Pump/Air Hoses | Image: Flowtron ACS900 Pump/Air Hoses | SE | | Device Photo<br>(Calf/Thigh Garment) | Image: EzVena IPC & EzVena SQS Calf/Thigh Garment | Image: Flowtron ACS900 Calf/Thigh Garment | SE | | Regulation # | 870.5800 | 870.5800 | SE | | Product Code | JOW | JOW | SE | | Common Description | DVT Pump System | DVT Pump System | SE | | Indication For Use | To apply intermittent<br>pneumatic compression to<br>the lower limbs to help<br>prevent deep vein<br>thrombosis. | To help prevent deep vein<br>thrombosis. | SE | | Target Population | At risk for DVT | At risk for DVT | SE | | Anatomical Site | Foot/Calf/Thigh | Foot/Calf/Thigh | SE | | Rx/OTC/Both | Rx Only | Rx Only | SE | | Physical Characteristics--Overall | | | | | System Description | Portable DVT pump,<br>connecting L&R air hoses,<br>& compressible limb<br>sleeves (garments or<br>cuffs) | Portable DVT pump,<br>connecting L&R air hoses,<br>& compressible limb<br>sleeves (garments or<br>cuffs) | SE | | Design Concept | Pneumatic pump supplies<br>compressed air to inflate<br>compression garments<br>attached to patient limbs | Pneumatic pump supplies<br>compressed air to inflate<br>compression garments<br>attached to patient limbs | SE | | Physical Characteristics--Compression Garment | | | | | Garment Styles | Foot, Calf, Calf/Thigh | Foot, Calf, Calf/Thigh | SE | | Garment Sizes | IPC--Foot (Univ/L), Calf (S/<br>M/L), Calf/Thigh (S/M/L);<br>SQS--Foot (Univ/L), Calf<br>(S/M/L), Calf/Thigh<br>(S/M/L) | Uniform--Foot (Reg, L),<br>Calf (Std, L), Calf/Thigh<br>(Std, L, XL);<br>Sequential--Calf (Reg, L,<br>XL), Thigh (Reg),<br>Calf/Thigh (L) | SE--Both devices offer<br>uniform compression in<br>single-bladder garments<br>designed for foot, calf,<br>and thigh; both also offer<br>sequential compression in | | Number of Air<br>Chambers (Bladders) | IPC--1 (foot, calf,<br>calf/thigh);<br>SQS--1 (foot), 3 (calf,<br>calf/thigh) | Uniform--1 (foot, calf,<br>calf/thigh);<br>Sequential--3 (calf,<br>calf/thigh) | triple-bladder garments<br>for calf and thigh. | | Compression--<br>Uniform | All 1-chamber garments<br>(IPC + SQS foot) | All 1-chamber garments<br>(Uniform) | | | Compression--<br>Sequential | All 3-chamber garments<br>(SQS calf + thigh), with<br>sequence from distal to<br>proximal bladders | All 3-chamber garments<br>(sequential), with<br>sequence from distal to<br>proximal bladders | | | Compression<br>Sequence (each cycle) | IPC--Inflate L&R<br>alternating (30 sec each,<br>60 total), uniform<br>compression;<br>SQS--Inflate L&R together<br>(60 sec total), sequential<br>compression from bottom<br>up | Inflate L&R alternating<br>(foot 30 sec each, 60 total;<br>calf or calf/thigh 60 sec<br>each, 120 total; foot+calf<br>or calf/thigh, 30 sec foot<br>2X then 60 sec calf or<br>calf/thigh, 120 total) | SE--Both provide<br>alternating L&R inflation<br>for 1 or 2 minutes per<br>complete cycle. Subject<br>also compresses both L&R<br>at same time for<br>sequential; difference<br>does not raise new issue<br>of S&E. | | Cycle Length | 60 sec | 60 sec (foot) or 120 sec<br>(calf or calf/thigh) | | | Mode of Operation | Continuous | Continuous | SE | | Pressure Range | Foot--130 $\pm$ 5mmHg;<br>Calf/Thigh--Uniform<br>40 $\pm$ 5mmHg, Sequential<br>45/40/30 $\pm$ 5mmHg | Foot--130 $\pm$ 10mmHg;<br>Calf/Thigh--Uniform<br>40 $\pm$ 5mmHg, Sequential<br>45 $\pm$ 5mmHg | SE--Subject steps pressure<br>down during sequential;<br>difference not raise new<br>issue of S&E (and in fact is<br>considered preferable<br>method). | # Table 3 - Comparison Table {6}------------------------------------------------ ## Physical Characteristics--DVT Pump | Dimensions (mm) | 190L x 203W x 194H | 230L x 228W x 190H | SE--minor difference | |---------------------------------------|-------------------------------------------------|------------------------------------------------------|------------------------------------------------| | Weight | 2.5Kg (5.5lb) | 4.1Kg (9.0lb) | SE--minor difference | | Energy Source (Mains | 100~240V (60/50Hz) | 100~230V (60/50Hz) | SE--minor difference | | Energy Consumption | IPC: <18W; SQS: <23W | 15W | SE--minor difference | | Battery | Li-ion 2600mAh, 14.8V | NiMH 4000mAh, 13.8V | SE--Battery passed ES<br>testing | | Ingress Protection | IP22 | IP23 (IEC 529) | SE--minor difference | | Control Panel | TFT-LCD 4.3" color; 3.3V;<br>480 RGB x 272 dots | LCD 3" black; 70 x 35 dots | SE--minor difference | | Integrated Bed Mount | Yes | Yes | SE | | Garment Material<br>(Patient Contact) | Nylon brush fabric | Polyester knit-blush with<br>TPU laminated + PU foam | SE--Garment passed<br>biocompatibility testing | | Case Material | ABS plastic | ABS plastic | SE | | Components & Accessories | | | | | Components | Pump, air hoses, garments | Pump, air hoses, garments | SE | | Accessories | User manual | User manual | SE | {7}------------------------------------------------ #### S&E Testing | Biocompatibility<br>(Garment) | ISO 10993-1:2009<br>ISO 10993-5:2009<br>ISO 10993-10:2010 | Not provided | SE (tested to recog std) | |-------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------| | Software Validation | SW V&V IEC 62304:2006;<br>EN 62366:2008 | Not provided | SE (tested to recog std) | | Risk Management | ISO 14971:2007 | Not provided | SE (tested to recog std) | | Electrical Safety | IEC 60601-1:2012 | AAMI/ANSI ES60601-<br>1:2005/R:2012 + A1:2012 | SE (tested to recog std) | | EMC | IEC 60601-1-2:2014 | IEC 60601-1-2:2007 | SE (tested to recog std) | | Mechanical Safety | Pump SW/HW<br>functionality; Garments<br>pressure cyclic test | Pump SW/HW function-<br>ality; Garments pressure<br>cyclic test | SE | | Reprocessing | Pump & Air Hose--clean<br>before each use;<br>Garment--single patient<br>use (discarded) | Pump & Air Hose--clean<br>before each use;<br>Garment--single patient<br>use (discarded) | SE | ## Summary of Similarities and Differences The subject and predicate devices share the same: - Intended use – apply intermittent pneumatic compression to lower limbs - Indications for use to help prevent deep vein thrombosis (DVT) ● - System design portable pump, air hoses, compression garments ● - Garment styles – foot, calf, and thigh - Compression methods – uniform and sequential - # of air chambers – 1 (uniform compression) and 3 (sequential compression) - Energy sources – mains power and battery backup - Materials – ABS plastic (pump case) and biocompatible fabric (garments) - . Reusability – of pump and air tubing, while garments are for single-patient use Tables 4 and 5 highlight the similarities in compression methods and other factors: ### Table 4 - Uniform Vs Sequential Compression | | EzVena IPC & | EzVena SQS & | |---------------------|----------------------|-------------------------| | Site of Compression | ACS900 Uniform Mode | ACS900 Sequential Mode | | Foot | Uniform (1 Bladder) | Uniform (1 Bladder) | | Calf | Uniform (1 Bladder) | Sequential (3 Bladders) | | Calf/Thigh | Uniform (2 Bladders) | Sequential (3 Bladders) | {8}------------------------------------------------ | | EzVena IPC & | EzVena SQS & | |-----------------------|------------------------|------------------------| | Factor | ACS900 Uniform Mode | ACS900 Sequential Mode | | Site of Compression | Foot, Calf, Calf/Thigh | Foot, Calf, Calf/Thigh | | Type of Compression | Uniform | Sequential | | Extent of Compression | Noncircumferential | Noncircumferential | ## Table 5 - Compression Differentiation Minor differences between EzVena (subject) and Flowtron ACS900 (predicate) include: - Compression cycle lengths - both offer 60-second cycles except that the predicate increases cycle length to 120 seconds for cycles that include calf or thigh; since application is continuous over long time periods (days and weeks, not hours or minutes), this difference is immaterial. - Pressure ranges – both increase bladder air pressure to 130 mmHg for foot treatment, 40mmHg for uniform compression of calf and thigh, and start at 45mmHg for sequential compression of calf and thigh; the subject then steps down sequential pressure for calf or thigh to 40 and 35 mmHg in the second and third bladders, respectively (while the predicate continues to reach 45mmHg in the second and third bladders). Both DVT treatment options-continuous 45 mmHg and step-down to 35mmHg-are common in the industry. - Compression sequence – both devices alternatively inflate left and right cuffs during uniform compression treatments; the predicate continues to inflate left and right on a rotating basis for sequential compression, while the subject device chooses to inflate both sides in tandem. Either option is common in the industry. None of the differences noted above raise new issues of safety and effectiveness. - 11. Non-Clinical Testing... EzVena passed the following non-clinical tests, all of which were performed to current FDA-recognized standards, except as noted: - Biocompatibility... ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 ● - Electrical Safety... IEC 60601-1:2012 - EMC... IEC 60601-1-2:2014 ● - Usability Engineering... EN 62366-1:2008 (not to recognized standard) ● - Software Life Cycle ... IEC 62304:2006 - Risk Management... ISO 14971:2007 - Symbols Used With Labels... ISO 15223-1:2012 Clinical testing was not deemed necessary. - 12. Patient-Contacting Materials... The only EzVena component that comes into contact with patients is the compression garment fabric which covers the patient's lower limbs. The garment material is polyester knit-blush with thermoplastic polyurethane (TPU) laminated + polyurethane foam. {9}------------------------------------------------ According to ISO 10993-1, the garment is a surface device in contact with intact skin. Biological evaluation was performed in accordance with ISO 10993-1:2009 and FDA's guidance document, "Use of International Standard ISO 10993" (2016), and test results showed the material is biocompatible. - 13. Software Verification and Validation... Software verification and validation testing were conducted in line with the requirements of FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005). The software for this device was considered as a "moderate level of concern" and software verification and validation reports have been included in this submission. - 14. Cybersecurity... EzVena is in compliance with FDA's guidance, "Management of Cybersecurity in Medical Devices" (2014). The device is not capable of connecting (wirelessly or hard-wired) to another device, to the Internet or other network, or to portable media (e.g. USB or CD). - 15. Substantial Equivalence... Many of the features and technical characteristics of EzVena IPC and EzVena SQS are identical to those of the Flowtron ACS900 predicate device, and where there are differences, such differences do not raise new issues of safety and effectiveness and do not have an impact on the safety or effectiveness of the subject device. EzVena IPC and EzVena SQS successfully followed the pathway to Substantial Equivalence in the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications" (2014). The steps are summarized below: - . The predicate device is legally marketed and was found substantially equivalent through 510(k) premarket submission. - . The subject and predicate devices have the same intended use. - . Technological differences between the subject and predicate were evaluated; none of the differences raised different issues of safety and effectiveness. - . The following methods for evaluation of the effects of different characteristics on safety and effectiveness were deemed acceptable-testing for biocompatibility, electrical safety, EMC, usability engineering, and mechanical performance; software verification and validation and life cycle documentation; and risk management assessment. Evaluation methods were conducted to FDArecognized standards. - . Data from these tests demonstrated equivalence and support the indications for use. In summary, all necessary testing has been performed and the results support the conclusion that EzVena IPC and EzVena SQS is substantially equivalent to the legally marketed predicate, Flowtron ACS900, based on both (a) comparison of intended use, materials, technology, and design and (b) testing to FDA-recognized standards, and the device thus does not raise any new concerns of safety or effectiveness. {10}------------------------------------------------ Based on the information contained within this submission, it is concluded that EzVena IPC and EzVena SQS is substantially equivalent to the identified predicate device and warrants clearance for marketing activities.