Plexus

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 27, 2019 Alleva Medical (D.G.) Ltd Max Choi CEO Suite M-Q, 12th Floor, Kings Wing Plaza 2, 1 On Kwan Street Hong Kong, Hk Re: K191107 Trade/Device Name: Plexus RP100 Disposable Portable Deep Vein Thrombosis Prevention Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: July 29, 2019 Received: July 31, 2019 Dear Max Choi: 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. {1}------------------------------------------------ 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) 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 medical devices and radiation-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) K191107 Device Name Plexus RP100 Disposable Portable Deep Vein Thrombosis Prevention Device Indications for Use (Describe) The Plexus RP00 Disposable Portable Deep Vein Thrombosis (DVT) Prevention Device is intended to be used in either home or clinical settings for: - · Aiding the prevention of DVT onset - · Enhancing blood circulation in the lower extremities - · Diminishing post-operative pain and swelling - · Reducing wound healing time, and - · Serving as a prophylaxis for DVT for stationary or bedridden individuals · Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Alleva Medical LTD. The logo features a stylized letter "A" in blue, followed by the company name in a sans-serif font. Below the company name is the address: Suite M-Q, 12th Floor, Kings Wing Plaza 2, 1 On Kwan St. Shek Mun, Shatin, N.T., Hong Kong, along with the phone number +852 3166 7200, fax number +852 2355 7663, and website www.allevamedical.com. ### 510(k) Summary ### Summary Preparation Date: April 10, 2019 ### Submitter Alleva Medical Ltd Suite M-Q, 12th Floor, Kings Wing Plaza 2 1 On Kwan Street, Shek Mun, Shatin New Territories, Hong Kong ### Contact Person Mr. Max Choi Chief Executive Officer Phone: +852-3166-7239 Fax: +852-2355-7663 Email: max@allevamedical.com ### Device Name Device Name: Portable Deep Vein Thrombosis Prevention Device Proprietary Trade Name: Plexus RP100 Common Name: Compressible Limb Sleeve Device ### Product Classification Product Classification: Compressible Lim Sleeve, 21 CFR 870.5800 Product Code: JOW Device Class: II ### Predicate Device: Cirona 6300 DVT Prevention Device, Devon Medical Products, K151189 ### Device Description The Plexus RP100 Portable Deep Vein Thrombosis ("DVT") Prevention Device is an electronic device that helps to prevent the onset of deep vein thrombosis by stimulating blood flow and increasing venous flow velocity. Each RP100 DVT Prevention Device consists of a pump body and a pressure sleeve with internal air bladder. When turned on, the air bladder inside the sleeve will be automatically inflated to a pre-set level, thereby providing intermittent pressure to the calf. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo and contact information for Alleva Medical LTD. The logo features a stylized letter A in blue. The text includes the company name, address (Suite M-Q, 12th Floor, Kings Wing Plaza 2, 1 On Kwan St. Shek Mun, Shatin, N.T., Hong Kong), telephone number (+852 3166 7200), fax number (+852 2355 7663), and website address (www.allevamedical.com). The commercial saleable package will consist of two pump units with their sleeves, one for each leg. The unit operates by inflating the air bladder until the pressure reaches 50mmHg. After reaching this pressure level, the unit will automatically deflate for 50 seconds to complete one cycle. Therapy could persist as long as the patient needs or is instructed by their physician. When the therapy ends, the patient simply would turn off the device by the press of a power button. ## Indications for Use The Plexus RP100 Portable DVT Prevention Device is intended to be used by patients 21 years of age or older, in either home or clinical settings for: - Aiding the prevention of DVT onset ● - . Enhancing blood circulation in the lower extremities - . Diminishing post-operative pain and swelling - Reducing wound healing time - Serving as a prophylaxis for DVT for stationary or bedridden individuals - . Aiding in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs ## Summary of Technological Characteristics Both the Plexus RP100 and predicate device, Cirona 6300 (K151189), share the same operating principles whereby each unit provides intermittent compression and inflation is supplied by a miniature air pump and deflation is managed by the pressure relief valve. Both devices utilize a microprocessor to deliver 50mmHg of pressurized air to the bladders in the sleeve garment for a predefined period of time. Further, both devices have similar usability, in that they both utilize a single button to initiate device use and utilize Velcro in securing the device to the lower limb. Both pump casings are constructed of hard ABS plastic to provide structural protection to the internal components and the sleeves are made of soft, non-woven materials with the bladders made of Polyurethane films. Both devices are also powered by an internal rechargeable battery. ## Summary of Non-Clinical Testing The following non-clinical testing has been completed to demonstrate that the Plexus RP100 device is performing as intended and has performance characteristics that are substantially equivalent to the listed predicate device. | Standards and Regulations Applied | Results | |--------------------------------------------|---------| | ISO10993-5:2009 In-Vitro Cytotoxicity | Passed | | ISO10993-10:2010 Intracutaneous Reactivity | Passed | ## Biocompatibility Testing {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo and contact information for Alleva Medical LTD. The logo features a stylized letter A in blue. The text includes the company's address, which is Suite M-Q, 12th Floor, Kings Wing Plaza 2, 1 On Kwan St. Shek Mun, Shatin, N.T., Hong Kong, as well as their phone number +852 3166 7200, fax number +852 2355 7663, and website www.allevamedical.com. | ISO10993-10: 2010 Skin Sensitization | Passed | |--------------------------------------|--------| |--------------------------------------|--------| ### Electromagnetic Compatibility and Electrical Safety Testing | Standards and Regulations Applied | Results | |--------------------------------------------------------------------------|---------| | IEC 60601-1:2005 (Third Edition) + A1:2012(or IEC 60601-1: 2012 reprint) | Passed | | IEC 60601-1-2:2014 | Passed | ### Functional Performance Testing | Test Items | Results | |-----------------------------|-------------------------| | Battery charging time test | Design requirements met | | Sleeve leakage test | Design requirements met | | Pressure accuracy test | Design requirements met | | Inflation time test | Design requirements met | | Deflation time test | Design requirements met | | Battery operating life test | Design requirements met | | Sleeve integrity test | Design requirements met | | Total worklife test | Design requirements met | ## Software Verification and Validation Software verification and validation activities were completed and there were no unresolved anomalies. The software was considered a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the user. ## Summary of Clinical Testings No clinical testing was performed to support the claim of substantial equivalence to the Cirona 6300 device. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo and contact information for Alleva Medical LTD. The logo features a stylized letter A in blue. Below the logo is the company name, address (Suite M-Q, 12th Floor, Kings Wing Plaza 2, 1 On Kwan St. Shek Mun, Shatin, N.T., Hong Kong), telephone number (+852 3166 7200), fax number (+852 2355 7663), and website (www.allevamedical.com). # Summary of Substantial Equivalence | Characteristics | Subject Device | Predicate Device | Comparison | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Alleva Medical (D.G) Ltd | Ascent Healthcare, LLC, DBA<br>Devon Medical Products | - | | 510(k) Number | N/A | K151189 | - | | Class | II | II | Equivalent | | Product Name | Disposable Deep Vein<br>Thrombosis Prevention<br>Device | Disposable Deep Vein<br>Thrombosis Prevention<br>Device | - | | Product Code | JOW | JOW | Equivalent | | Regulation Number | 21 CFR 870.5800 | 21 CFR 870.5800 | Equivalent | | Intended Use | • Aiding the prevention of<br>DVT onset<br>• Enhancing blood<br>circulation in the lower<br>extremities<br>• Diminishing post-<br>operative pain and<br>swelling<br>• Reducing wound healing<br>time<br>• Serving as a prophylaxis<br>for DVT for stationary or<br>bedridden individuals<br>• Aid in the treatment of:<br>stasis dermatitis, venous<br>stasis ulcers, arterial and<br>diabetic leg ulcers,<br>chronic venous<br>insufficiency and<br>reduction of edema in<br>the lower limbs | • Aid in the prevention of<br>DVT<br>• Enhance blood circulation<br>• Diminish post-operative<br>pain and swelling<br>• Reduce wound healing<br>time<br>• Aid in the treatment of:<br>stasis dermatitis, venous<br>stasis ulcers, arterial and<br>diabetic leg ulcers, chronic<br>venous insufficiency and<br>reduction of edema in the<br>lower limbs<br>• Serve as a prophylaxis for<br>DVT by persons expecting<br>to be stationary for long<br>periods of time | Equivalent | | Use Settings | Home, hospital, surgery<br>center | Home, hospital, surgery<br>center | Equivalent | | Portability | Portable | Portable | Equivalent | | Principles of<br>operation | Air pump supplying<br>pressure to the air bladder<br>on the pressure garment.<br>Air pressure is relieved<br>through an open air valve | Air pump supplying<br>pressure to the air bladder<br>on the pressure garment.<br>Air pressure is relieved<br>through an open air valve | Equivalent | | Location of treatment | Lower limbs/calves | Lower limb/calves | Equivalent | | Pressure source | Miniature air pump | Miniature air pump | Equivalent | | Therapy Mode | One | One | Equivalent | | Compression<br>pressure level | 50mmHg | 50mmHg | Equivalent | | Cycle pattern | Inflation to target pressure,<br>then 50 seconds rest period | Inflation to target pressure,<br>then 50 seconds rest period | Equivalent | | Sterility | Clean/non-sterile | Clean/non-sterile | Equivalent | | Source of power | Lithium Battery 3.7V<br>2600mAh | Lithium Battery 3.7V<br>1350mAh | RP100/Plexus has a<br>higher battery<br>capacity, otherwise<br>equivalent | | Power supply | AC Input: 100~240V,<br>AC50/60Hz, 500mA Max;<br>DC output 5V 2A (2 Plugs) | AC Input: 100~240V,<br>AC50/60Hz, 500mA Max;<br>DC output 5V 2A (2 Plugs) | Equivalent | | Sleeve material | Soft non-woven fabric | Soft non-woven fabric | Equivalent | | Pump housing<br>material | Hard Plastic (ABS) | Hard Plastic (ABS) | Equivalent | | Sleeve orientation | Left and right sleeves are<br>different. Indicated on<br>sleeve. | Left and right sleeves are<br>different. Indicated on<br>sleeve | Equivalent | | LED indicator | Yes<br>(Blue & Yellow) | Yes<br>(Yellow) | Equivalent in both<br>having a LED<br>indicator; (Plexus<br>has two colors to<br>provide visual aid on<br>power and alarm<br>status) | | Alarm<br>communications | Audible and Visual | Audible and Visual | Equivalent: only<br>different in color<br>and duration of the<br>alarm | | Alarm modes | Pressure error, low battery<br>error, charging error | Pressure error, low battery<br>error, charging error | Equivalent | | Operating time | 16 hours continuous for a<br>single charge | 8 hours continuous for a<br>single charge | Equivalent;<br>RP100/Plexus has a<br>longer operating<br>time | | Storage | -25-70°C, | -25-70°C, | Equivalent | | Requirements | <93% relative humidity (RH) | <93% relative humidity (RH) | | | Operating<br>requirements | +5°C to 40°C<br>(41°F to 104°F),<br>15%-93% RH | +5°C to 40°C<br>(41°F to 104°F),<br>15%-93% RH | Equivalent | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a company logo for Alleva Medical LTD. The logo includes the company name and address. The address is Suite M-Q, 12th Floor, Kings Wing Plaza 2, 1 On Kwan St. Shek Mun, Shatin, N.T., Hong Kong. The phone number is +852 3166 7200, the fax number is +852 2355 7663, and the website is www.allevamedical.com. ## Conclusions The Plexus RP100 device has the same intended use and performance characteristics as the predicate device. The results of non-clinical testing demonstrate that the device met all performance requirements and that the subject device is substantially equivalent to the predicate device.