WoundExpress

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September 3, 2021 Huntleigh Healthcare Ltd Steve Monks ORE Director 35 Portmanmoor Road Cardiff, CF24 5HN United Kingdom Re: K211200 Trade/Device Name: WoundExpress Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: July 30, 2021 Received: August 5, 2021 Dear Steve Monks: 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). 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Sincerely, for Nicole Gillette Acting 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) K211200 Device Name WoundExpress Indications for Use (Describe) WoundExpress aids in the treatment of the following clinical conditions: - Chronic wounds including leg ulcers (venous leg ulcers and mixed aetiology leg ulcers) - The management of lower limb pain | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ # K211200 page 1 of 7 # 510(k) Summary WoundExpress | Name & Address: | Huntleigh Healthcare Limited<br>Unit 35, Portmanmoor Road<br>Cardiff<br>CF24 5HN<br>United Kingdom | |-----------------|----------------------------------------------------------------------------------------------------| | Telephone: | +44 (0)2920 485885 | | Fax: | +44 (0)2920 492520 | | Prepared: | 14th April 2021 | | Contact: | Steve Monks | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for HUNTLEIGH. The text is in a dark blue color. Below the main text, there is a smaller line of text that reads "A MEMBER OF THE ARJO FAMILY". #### 5.1 Device Information | Device Trade Name: | WoundExpress | |-----------------------------|----------------------------| | Regulation Name: | Compressible Limb Sleeve | | Regulation Number: | 21 CFR 870.5800 | | Product Code: | JOW | | Device Classification Name: | Sleeve, Limb, Compressible | | Regulatory Class: | II | | Review Panel: | Cardiovascular | #### 5.2 Predicate Device Information | Predicate Devices: | ActiveCare+SFT System (K110159) manufactured by<br>Medical Compression Systems (DBN) Ltd. | | |-----------------------------|-------------------------------------------------------------------------------------------|--| | | VenaPro Vascular Therapy System (K193020)<br>manufactured by Innovamed Health, LLC. | | | Regulation Name: | Compressible Limb Sleeve | | | Regulation Number: | 21 CFR 870.5800 | | | Product Code: | JOW | | | Device Classification Name: | Sleeve, Limb, Compressible | | | Regulatory Class: | II | | | Review Panel: | Cardiovascular | | | | The predicate devices have not been subject to a<br>design-related recall. | | #### 5.3 Indications for Use WoundExpress aids in the treatment of the following clinical Indications for Use: conditions: - Chronic wounds including leg ulcers (venous leg . ulcers and mixed aetiology leg ulcers) - The management of lower limb pain. ● #### 5.4 Description Description : The WoundExpress Therapy Device is an intermittent pneumatic compression system consisting of a pump unit and a thigh garment, interconnected by a detachable three chamber tube set. It is a non-invasive mechanical system designed to enhance blood and lymph flow as a therapy to manage the clinical condition listed above. {5}------------------------------------------------ The pump is a portable, ac mains powered device, that produces a pre-set pneumatic therapy cycle delivered through a 3 port output connector, which is connected to a three chamber garment that is applied to the patient thigh. The pump operates on a 4 minute automatically timed gradient pressure sequence, consisting of a 2 minute venous emptying phase and a 2 minute rest phase. The venous emptying phase consists of six 20 second compression cycles, while no compression takes place during the rest phase. Each 20 second compression cycle is characterised by overlapping synchronous inflations and deflations of the distal (lower), central (middle) and proximal (upper) chambers. - Models Wound Express Pump: WE100P Wound Express Garment: WE100G ### Comparison of Technological Characteristics with Predicate 5.5 Device Intermittent Pneumatic Compression is the technological principle for both the subject and predicate device. The system comprises of a pump and garment. | Technological<br>Element | ActiveCare+SFT<br>System<br>(K110159) | VenoPro Vascular<br>Therapy System<br>(K193020) | WoundExpress | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | Basis of<br>operation | Enhances blood flow<br>using intermittent<br>pneumatic<br>compression<br>application (inflation<br>followed by deflation) | Aids venous return by<br>using cyclic<br>intermittent pneumatic<br>compression<br>application (inflation<br>followed by deflation) | Aids venous return by<br>using cyclic intermittent<br>pneumatic compression<br>application (inflation<br>followed by deflation) | | Application | Non-invasive /<br>external | Non-invasive /<br>external | Non-invasive / external | | Number of<br>Chambers in<br>garment | 3 | 1 | 3 | | Cycle Time | 8 seconds<br>compression followed<br>by 36-56 seconds of<br>rest. | 10 seconds<br>compression followed<br>by 50 seconds of rest. | 20 second compression<br>cycles (x6), followed by<br>120 seconds rest. | | Material | Brushed Nylon | PVC coated with soft,<br>non-latex woven | Brushed Loop Woven<br>Nylon | {6}------------------------------------------------ | | | medical fabric. | Polyurethane Foam<br>100% Nylon textured<br>binding | |----------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | | | | Polyurethane Film | | Pressure range | 50mmHg ± 10% when<br>applied to the thigh.<br>130mmHg ± 10%<br>when applied to the<br>foot. | Fixed at 50mmHg | Fixed at 60mmHg ±<br>5mmHg | | Power Source | 7.2 VDC (NiMH<br>rechargeable<br>batteries) | 3.7v rechargeable<br>battery | Mains powered | | Size | 135 x 135 x 60mm | 131 x 66 x 37mm | 270 x 130 x 150mm | | Indicators | ON/OFF Indicator -<br>Green light<br>Attention Indicator -<br>Airway obstruction /<br>air leakage / low<br>battery / no treatment<br>mode | Blue & tri-colour<br>indicator.<br>Blue LED - leak or<br>low pressure alarm<br>Tri-colour LED – On,<br>low battery, charging,<br>charge completed. | Power Status, Rest and<br>Off / Normal Operating<br>Range / Error Refer to<br>Service | Review of differences: - Number of chambers The subject device has 3 0 chambers along with the ActiveCare+SFT predicate. All devices use intermittent pneumatic compression to inflate and deflate the chambers to help stimulate blood flow. This difference does not affect safety or efficacy. - Cycle time The subject device operates on 20 . second compression cycles (x6), followed by 120 seconds rest, whereas the predicates operate on a 10 second compression followed by 50 seconds rest and 8 seconds compression followed by 36-56 seconds of rest. All include a compression stage and a rest period. For the subject device, the cycle time has been optimised specifically for leg ulcers, whereas the predicate device has a much broader indications for use. This difference does not affect safety or efficacy. - o Garment Material - The difference in garment material does not affect, safety or effectiveness of the subject device. The materials used in the subject device are identical to materials used in an already marketed device (K172103). This difference is insignificant. - Pressure Range The pressure for the subject device . is fixed at 60mmHg, whereas the predicates are fixed at 50mmHg (when applied to the thigh for the ActiveCare+SFT). The subject device's pressure is only slightly higher and has been tested to prove its {7}------------------------------------------------ safety and effectiveness. This difference is insignificant. - . Power Source - The subject device is mains operated, whereas the predicate devices are battery operated. The subject device is compliant to the electrical safety standard IEC 60601-1. This difference does not affect safety or effectiveness. - Size- The subject device is bigger than the predicate . devices. This difference has no bearing on functionality, safety or efficacy of the subject device. This difference is insignificant. - Indicators The subject device uses a pressure . gauge display whereas the predicate devices used LED lights. This difference does not affect safety of effectiveness. #### 5.6 Substantial Equivalence Substantial The WoundExpress is substantially equivalent to the cleared Equivalence: predicate devices ActiveCare+SFT System and VenaPro Vascular Therapy System. The WoundExpress has equivalent performance to the ActiveCare+SFT System and VenaPro Vascular Therapy System. #### Performance Data 5.7 Testing to demonstrate substantial equivalence included: | Testing Conducted | Discussion | |----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility Testing<br>-Cytotoxicity<br>-Sensitization<br>-Irritation | The biocompatibility evaluation of<br>the device was conducted in<br>accordance with ISO 10993-<br>1:2009 Biological evaluation of<br>medical devices - Part 1:<br>Evaluation and testing within a<br>risk management process. The<br>Wound Express garments are<br>surface devices (intact skin<br>contact) designed to be used on<br>patients for prolonged duration<br>(cumulative duration of 24 hours<br>to 30 days). | | Electronic Hardware<br>Testing | Testing provides verification of the<br>Wound Express's two PCB<br>assemblies including logic supply<br>(and with ripple voltage), reset<br>pulse, operating frequency, min | | | ON-time, optp-triac drive, zero-<br>crossing voltage, triac switch off,<br>optical sensor and hardware timer. | | Mechanical Testing | Testing provides verification of<br>mechanical performance including<br>general, physical, environment,<br>packaging and durability.<br><br>Testing also confirmed Basic Safety<br>and Essential Performance are<br>maintained in accordance with IEC<br>60601-1-11:2015. | | Functional Testing | Testing provides verification that<br>the Wound Express pump and<br>garment system works as intended<br>as fulfils the requirements of the<br>technical specifications. | | Performance Testing | The WoundExpress has undergone<br>a validation study to ensure the<br>device can achieve its intended<br>use. The validation concluded the<br>device is fit for purpose and the<br>clinical benefits of the device<br>outweighs the overall residual risk. | | Electrical Safety Testing | Electrical safety testing was<br>conducted on the product by a<br>third party laboratory, UL. Testing<br>confirms device complies with IEC<br>60601-1:2005 + A1:2012. | | EMC Testing | EMC testing was conducted on<br>the product by a third party<br>laboratory. Testing confirms<br>device complies with EN 60601-1-<br>2:2015. | | Environmental<br>Performance Testing | Testing provides verification of the<br>non-operational shock and<br>vibration. | {8}------------------------------------------------ ### 5.8 Technologies Summary Technologies The WoundExpress uses similar technology to the {9}------------------------------------------------ | Summary: | predicate devices; ActiveCare+SFT System and VenaPro Vascular Therapy System. All aid venous return by using cyclic intermittent pneumatic compression application (inflation followed by deflation). The application of the WoundExpress is the same as the ActiveCare+SFT System predicate device as the garments for both can be applied to the thigh. The subject device is indicated for adults with chronic wounds including leg ulcers and therefore the garment is applied to the thigh, away from the wound site making it more comfortable and easily tolerated by the patient. | |----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The WoundExpress subject device delivers pressure fixed at 60mmHg ±5mmHg, which is adjusted and calibrated at the factory, to simplify the operation by the patient. This pressure is only slightly higher than the predicate devices. | | | The WoundExpress cycle time is 20 second compression cycles (x6), followed by 120 seconds rest. This cycle time is optimised to deliver the best treatment therapy for chronic wounds including leg ulcers. | | 5.9 | Conclusion | Conclusion: The data detailed within this submission demonstrates that the WoundExpress is as safe and effective as the predicate devices ActiveCare+SFT System and VenaPro Vascular Therapy System and performs as well as the predicate devices identified in this summary, which is currently marketed for the same intended use. The device hardware, mechanical and functional verification demonstrates that it should perform as intended in the specified user conditions.