Ezlymph, Ezlymph M

{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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. February 11, 2021 Eezcare Medical Corp % John Gillespy President FDA 510k Consultants, LLC 1100 Del Lago Cir, Ste 104 Palm Beach Gardens, Florida 33410 Re: K193662 Trade/Device Name: Ezlymph, Ezlymph M Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: January 7, 2021 Received: January 11, 2021 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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 Advice (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) K193662 Device Name EzLymph and EzLymph M | Indications for Use (Describe) | |--------------------------------| |--------------------------------| EzLymph and EzLymph M are intended to treat lymphedema. Type of Use (Select one or both, as applicable): | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| #### 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: | December 29, 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:<br>Common name:<br>Device:<br>Class:<br>Product Code: | EzLymph, EzLymph M<br>Lymphedema Pump System<br>Sleeve, Limb, Compressible<br>II<br>JOW | | | | 6. Predicate: | Applicant:<br>Device:<br>510(k) Number: | ArjoHuntleigh AB (Sweden)<br>Hydroven 3 Pump, Hydroven FPR<br>Pump, Hydroven Garments<br>K910188 | | | | Reference: | Applicant:<br>Device:<br>510(k) Number: | Tactile Medical<br>Flexitouch System<br>K170216 | | - 7. Device Description... EzLymph and EzLymph M is a pump system intended to apply intermittent pneumatic compression (IPC) to arms and legs to relieve the discomfort of lymphedema (see image of device in Figure 1 below). The device helps move the flow of lymphatic and venous fluid throughout the extremities by stimulating muscles within the affected extremity. This action mimics natural muscle contractions, improves circulation, and moves excess fluid back to the circulatory system so edema can be eliminated from the body. System components include (a) a mains-powered, portable pneumatic pump with a pressure-control knob and on/off switch (the device contains no control panel or microprocessor circuit); (b) connecting air hoses; and (c) compression garments attached {4}------------------------------------------------ to patient limbs. In addition, garment inserts allow increase in circumference of arm and leg garments. The pump intermittently releases compressed air through the tubing into inflating and deflating bladders within cuffs that are wrapped separately around the patient's upper and lower limbs (full arm, full leg, and half leg). EzLymph and EzLymph M is intended for home use under the care of personnel authorized and trained to treat lymphedema. The device is intended for patients at risk for the medical condition. The system is portable. - 8. Mechanism of Action... Intermittent pneumatic compression of air inflates and deflates cuffs attached to affected extremities. - 9. Indications For Use... Intended to treat lymphedema. The device is intended for prescription use only. Image /page/4/Picture/6 description: The image shows an EzLymph pump and garments. The pump is white with a blue panel and a timer dial. The garments are gray with orange trim and have tubes attached to them. The garments appear to be for legs. # 10. Comparison To Predicate & Reference Devices The subject and predicate devices share the same: - Intended use – To apply intermittent pneumatic compression to arms and legs to relieve the discomfort of lymphedema. - Indications for use – To treat lymphedema (the predicate also claims other indications, as noted in Table 5). - System design - Portable pump, air hoses, compression garments. - Number of models – Two. - Garment styles - Arm, leg. - Compression methods – Uniform, sequential. - Compression cycle lengths - 180 seconds. - Air chambers - Single chamber, multiple chamber. - Multiple garments – Both devices allow treatment with 2 garments. - Mode of operation - Continuous. - Energy sources - Mains power. - Materials – ABS plastic (pump case) and biocompatible fabric (garments). - Reusability – Reusable pump and air tubing; garments are single-patient use. {5}------------------------------------------------ Minor differences between the subject and predicate devices include: - Number of compression chambers – While both offer single- and multiple-chamber models, for the latter the subject provides 4 chambers compared to the predicate's 3 chambers. - Compression cycle sequence – Both offer 180-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. The reference device demonstrates substantial equivalence for one physical characteristic, pressure range, for EzLymph. | Characteristics | Subject Device | Predicate Device¹ | SE Comparison | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | Device Name | EzLymph, EzLymph M | Hydroven 3 Pump,<br>Hydroven FPR Pump,<br>Hydroven Garments | NA | | Manufacturer | Ezcare Medical Corp<br>(Taiwan) | ArjoHuntleigh AB<br>(Sweden) | NA | | Estab Registration # | 3003801933 | 3007420694 | NA | | 510k Number | Applied For | K910188 | NA | | Device Photo (Pump<br>& Air Hoses) | Image: EzLymph pump and air hoses | Image: Hydroven 3 pump and air hoses | SE--both portable pumps | | Device Photo<br>(Calf/Thigh<br>Garment) | Image: EzLymph calf/thigh garment | Image: Hydroven calf/thigh garment | SE--same basic design | | Class | II | II | SE | | Regulation # | 870.5800 | 870.5800 | SE | | Product Code | JOW | JOW | SE | | Common Description | Lymphedema Pump | Lymphedema Pump | SE | | Medical Specialty | Cardiovascular | Cardiovascular | SE | | Submission Type | 510(k) | 510(k) | SE | | Intended Use | To apply intermittent<br>pneumatic compression to<br>arms and legs to relieve the<br>discomfort of lymphedema. | To apply intermittent<br>pneumatic compression to<br>arms and legs to treat<br>conditions listed in IFU. | SE--subject intended use is<br>subset of predicate's | | Indication For Use | EzLymph & EzLymph M are<br>intended to treat<br>lymphedema. | Intermittent Pneumatic<br>Compression (IPC) is effective<br>in treatment of following<br>clinical conditions, when<br>combined with an<br>individualized monitoring<br>program: Edema (dependent<br>& traumatic), Lymphedema,<br>(primary and secondary),<br>Chronic venous insufficiency,<br>Post phlebotic syndrome,<br>and Acute & chronic wounds<br>including venous leg ulcers &<br>post-surgical wounds. IPC<br>may also be beneficial in<br>management of: Fixed flexion<br>deformity, Arthritic<br>conditions, Lower limb pain<br>due to trauma or surgery,<br>and Lipedema. Selection<br>should be based upon a<br>holistic assessment of<br>patients' individual care<br>needs. | SE--subject intended use<br>(and IFU) is subset of<br>predicate's | | Target Population | Sufferers of lymphedema | Sufferers of lymphedema<br>or other clinical conditions<br>listed in IFU | SE--subject intended use is<br>subset of predicate's | | Anatomical Site | Arm/Leg | Arm/Leg | SE | | Where Used | Home | Home | SE | | Rx/OTC/Both | Rx Only | Rx Only | SE | | Physical Characteristics -- Overall | | | | | System Description | Portable pump, connecting<br>air hoses, & compressible<br>limb sleeves | Portable pump,<br>connecting air hoses, &<br>compressible limb sleeves | SE | | Working Principle | 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 | | | | | | | Garment Styles | Full Arm, Half Leg, Full Leg | Full Arm, Half Leg, Full Leg | SE | | Garment Sizes | EzLymph--Arm (S,M), Leg<br>(Half,S,M,L);<br>EzLymph M--Arm (S,M), Leg<br>(Half,S,M,L) | Hydroven 3-- Single-<br>Chamber Arm (4 lengths),<br>Leg (6 lengths); Triple-<br>Chamber Arm (2 lengths),<br>Leg (6 lengths);<br>Hydroven FPR (all triple-<br>chamber)--Arm (2<br>lengths), Leg (6 lengths). | SE--both offer multiple<br>arm and leg sizes | | Garment Inserts | Allow increase in<br>circumference of arm and<br>leg garments. | Allow increase in<br>circumference of arm and<br>leg garments. | SE | | Number of Air<br>Chambers (Bladders) | EzLymph--1 (arm, leg) and 4<br>connected bags (arm, leg);<br>EzLymph M--4 independent<br>bags (arm, leg) | Hydroven 3--1 (arm, leg) &<br>3 connected bags (arm,leg);<br>Hydroven FPR -- 3 indepen-<br>dent bags (arm, leg). | SE--minor difference in<br>number of chambers | | Compression --<br>Uniform | EzLymph (1 & 4-chamber<br>garments) -- Inflate 90 sec,<br>then deflate 90 sec. Cycle<br>time 180 sec. | Hydroven 3 (1-chamber<br>garments) -- Inflate 90 sec,<br>then deflate 90 sec. Cycle<br>time 180 sec. | SE | | Compression --<br>Sequential | EzLymph M (4-chamber)--<br>Inflate sequentially from<br>distal (120, 90, 60, & 30 sec<br>respectively), with 10%<br>pressure decrease with<br>each subsequent chamber<br>moving up garment. Then<br>deflate from proximal (60<br>sec). Cycle time 180 sec. | Hydroven 3 & FPR (3-<br>chamber) -- Inflate<br>sequentially from distal<br>(114, 76, & 38 sec). Then<br>deflate from proximal (66<br>sec). Cycle time 180 sec. | SE--minor difference in<br>number of chambers | | Multiple Garments | 2 garments can be used by<br>alternating for every 90 sec.<br>Cycle time is 180 sec<br>(EzLymph only). | 2 garments can be used by<br>alternating for every 90<br>sec. Cycle time is 180 sec<br>(Hydroven 3 only). | SE | | Mode of Operation | Continuous | Continuous | SE | | Pressure Range | EzLymph: 30-75 mmHg +/-<br>10%<br>EzLymph M: 30-90 mmHg<br>+/- 10% | Predicate: 30-100 mmHg<br>+/- 5%<br>Reference: 30-75 mmHg | EzLymph: SE--minor<br>difference w/reference<br>EzLymph M: SE--minor<br>difference w/predicate | | Physical Characteristics -- Pump | | | | | Dimensions (mm) | 280L x 140W x 70H | 270L x 150W x 105H<br>(Hydroven 3) or 130H<br>(FPR) | SE--minor difference | | Weight | 1.7 kg (3.75lb) | 2.4 kg (5.3 lb) | SE--minor difference | | Energy Source<br>(Mains) | AC 100V-230V (60/50 Hz) | AC 120V (60 Hz) | SE--minor difference | | Fuse Rating | 1A 250V/T1A 250V | F500 mAH 250V | SE--minor difference | ## Table 5 - Comparison Table ¹ Comparison data for the reference device, Flexitouch (K170216), is shown in "Pressure Range" characteristic on Page 5.0-5. {6}------------------------------------------------ {7}------------------------------------------------ ## Physical Characteristics--Compression Garment {8}------------------------------------------------ | Ingress Protection | IP21 | IPX0 | SE--minor difference | |---------------------------------------|----------------------------------|--------------------------|------------------------------------------------| | Control Panel | Mechanical | Not provided | SE | | Operating Temp | 5C to 40C | 10C to 40C | SE--minor difference | | Storage/Transport | -20C to 70C | -20C to 50C | SE--minor difference | | Relative Humidity | <93% RH non-condensing | 30%-75% (non-condensing) | SE--minor difference | | Garment Material<br>(Patient Contact) | Nylon fabric with TPU<br>coating | Not provided | SE--subject 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 | ## Non-Clinical Testing EzLymph and EzLymph M passed the following non-clinical tests, all of which were performed to current FDA-recognized standards: - Electrical Safety... IEC 60601-1:2005, Mod - EMC... IEC 60601-1-2:2014 - Usability Engineering... IEC 62366-1:2015 - Risk Management... ISO 14971:2007 - Home Healthcare... IEC 60601-1-11:2015 The device passed pump functionality testing and garments pressure cyclic testing. ## Cybersecurity EzLymph and EzLymph M 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). #### Substantial Equivalence EzLymph and EzLymph M 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 electrical safety, {9}------------------------------------------------ EMC, usability engineering, home healthcare, and mechanical performance; and risk management assessment. Evaluation methods were conducted to FDArecognized standards where applicable. - 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 EzLymph and EzLymph M is substantially equivalent to the legally marketed predicate, Hydroven, 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 concerns of safety or effectiveness. Based on the information contained within this submission, the applicant concludes that EzLymph and EzLymph M is substantially equivalent to the identified predicate device and warrants clearance for marketing activities.