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. 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.

AI/ML Overview

The provided document is an FDA 510(k) Premarket Notification for the WoundExpress device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and efficacy through extensive clinical studies with specific performance acceptance criteria like those seen for novel drug or high-risk medical device approvals.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for a new and complex AI/software-as-a-medical-device (SaMD) or drug study.

Specifically:

There is no table of acceptance criteria and reported device performance as the performance data section focuses on engineering verification and validation testing (biocompatibility, electrical safety, mechanical, functional, etc.) to ensure the device performs as intended and is safe, rather than clinical performance against specific metrics like sensitivity/specificity for a diagnostic AI.
No sample size used for a test set (clinical data), data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance are described because this is a physical medical device (compressible limb sleeve), not an AI algorithm. Its performance is related to its mechanical and physiological function, not diagnostic accuracy based on image analysis or similar AI tasks.
There is no notion of "ground truth" establishment for a test set or training set in the context of AI. The "validation study" mentioned in the Performance Data section is likely a non-clinical/engineering validation to ensure the device meets its design specifications and intended use, not a clinical trial establishing ground truth for AI model training or evaluation.
No sample size for a training set is applicable as this is not an AI/ML device.

The document states:

"The WoundExpress has undergone a validation study to ensure the device can achieve its intended use. The validation concluded the device is fit for purpose and the clinical benefits of the device outweighs the overall residual risk." (Page 7)
Under "Performance Data," various types of engineering and safety testing are listed: Biocompatibility, Electronic Hardware Testing, Mechanical Testing, Functional Testing, Performance Testing (general validation as above), Electrical Safety Testing, EMC Testing, Environmental Performance Testing. These are standard tests for physical medical devices to demonstrate safety and proper function, not clinical efficacy or diagnostic accuracy.

In summary, the provided FDA 510(k) notification for the WoundExpress device does not offer the kind of detailed information about acceptance criteria and clinical study performance (especially related to AI/ML or diagnostic accuracy) that your questions are looking for. This is because the device is a physical, mechanical system (compressible limb sleeve) cleared under the substantial equivalence pathway, which relies on demonstrating similarity to existing devices and adequate non-clinical testing, rather than novel clinical performance metrics.

Summary

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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). 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

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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,

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

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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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K211200 page 1 of 7

510(k) Summary WoundExpress

Name & Address:	Huntleigh Healthcare LimitedUnit 35, Portmanmoor RoadCardiffCF24 5HNUnited Kingdom
Telephone:	+44 (0)2920 485885
Fax:	+44 (0)2920 492520
Prepared:	14th April 2021
Contact:	Steve Monks

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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 byMedical Compression Systems (DBN) Ltd.
	VenaPro Vascular Therapy System (K193020)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 adesign-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 :

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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.

TechnologicalElement	ActiveCare+SFTSystem(K110159)	VenoPro VascularTherapy System(K193020)	WoundExpress
Basis ofoperation	Enhances blood flowusing intermittentpneumaticcompressionapplication (inflationfollowed by deflation)	Aids venous return byusing cyclicintermittent pneumaticcompressionapplication (inflationfollowed by deflation)	Aids venous return byusing cyclic intermittentpneumatic compressionapplication (inflationfollowed by deflation)
Application	Non-invasive /external	Non-invasive /external	Non-invasive / external
Number ofChambers ingarment	3	1	3
Cycle Time	8 secondscompression followedby 36-56 seconds ofrest.	10 secondscompression followedby 50 seconds of rest.	20 second compressioncycles (x6), followed by120 seconds rest.
Material	Brushed Nylon	PVC coated with soft,non-latex woven	Brushed Loop WovenNylon

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		medical fabric.	Polyurethane Foam100% Nylon texturedbinding
			Polyurethane Film
Pressure range	50mmHg ± 10% whenapplied to the thigh.130mmHg ± 10%when applied to thefoot.	Fixed at 50mmHg	Fixed at 60mmHg ±5mmHg
Power Source	7.2 VDC (NiMHrechargeablebatteries)	3.7v rechargeablebattery	Mains powered
Size	135 x 135 x 60mm	131 x 66 x 37mm	270 x 130 x 150mm
Indicators	ON/OFF Indicator -Green lightAttention Indicator -Airway obstruction /air leakage / lowbattery / no treatmentmode	Blue & tri-colourindicator.Blue LED - leak orlow pressure alarmTri-colour LED – On,low battery, charging,charge completed.	Power Status, Rest andOff / Normal OperatingRange / Error Refer toService

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

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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-Cytotoxicity-Sensitization-Irritation	The biocompatibility evaluation ofthe device was conducted inaccordance with ISO 10993-1:2009 Biological evaluation ofmedical devices - Part 1:Evaluation and testing within arisk management process. TheWound Express garments aresurface devices (intact skincontact) designed to be used onpatients for prolonged duration(cumulative duration of 24 hoursto 30 days).
Electronic HardwareTesting	Testing provides verification of theWound Express's two PCBassemblies including logic supply(and with ripple voltage), resetpulse, operating frequency, min
	ON-time, optp-triac drive, zero-crossing voltage, triac switch off,optical sensor and hardware timer.
Mechanical Testing	Testing provides verification ofmechanical performance includinggeneral, physical, environment,packaging and durability.Testing also confirmed Basic Safetyand Essential Performance aremaintained in accordance with IEC60601-1-11:2015.
Functional Testing	Testing provides verification thatthe Wound Express pump andgarment system works as intendedas fulfils the requirements of thetechnical specifications.
Performance Testing	The WoundExpress has undergonea validation study to ensure thedevice can achieve its intendeduse. The validation concluded thedevice is fit for purpose and theclinical benefits of the deviceoutweighs the overall residual risk.
Electrical Safety Testing	Electrical safety testing wasconducted on the product by athird party laboratory, UL. Testingconfirms device complies with IEC60601-1:2005 + A1:2012.
EMC Testing	EMC testing was conducted onthe product by a third partylaboratory. Testing confirmsdevice complies with EN 60601-1-2:2015.
EnvironmentalPerformance Testing	Testing provides verification of thenon-operational shock andvibration.

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5.8 Technologies Summary

Technologies

The WoundExpress uses similar technology to the

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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.

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).