The PulseFlowDF™ is designed to enhance blood circulation in the venules and arterioles in patients with diabetic foot ulcers of the lower extremities.

PulseFlowDF is intended for patients in the home who would benefit from increased blood flow to:

· Treat and assist healing of cutaneous ulceration (wounds)
· Reduce wound healing time
· Enhance arterial circulation (blood flow)
· Prevent venous stasis (slowing of blood flow)
· Reduce compartmental pressures
· Reduce edema (swelling)
· Reduce post-operative pain and swelling
Reduce the need for anticoagulant medications (medications that thin the blood) and
· Prevent Deep Venous Thrombosis (DVT) (blood clots in the deep veins).

Device Description

PulseFlowDF is an off-loading boot with a built in air bladder in the insole for intermittent plantar compression therapy. One active boot and one matched height inactive boot is provided. PulseFlowDF is designed to protect a diabetic wound during healing by (1) stimulating blood flow to the wound (and throughout the foot and leg) by means of cyclic inflation of an air bladder under the arch of the foot (primary action), (2) providing a protective cover for the wound which is bandaged and shielded inside the boot) and (3) stabilizing the foot and lower leg with an "off-loading design" that holds the foot and lower leg in a fixed position to reduce pressure on the sole of the foot (secondary action). PulseFlowDF allows the user to walk and move while wearing the boot. PulseFlowDF is worn for up to 10 to 15 hours per day for 12 weeks, after which time it can be converted to standard footwear.

AI/ML Overview

The FDA 510(k) summary for the PulseFlowDF device mentions several performance tests but does not explicitly define acceptance criteria prior to reporting results. Instead, it describes the outcome of these tests, generally stating "pass" or "statistically significantly improved" to indicate that performance objectives were met.

Here's an attempt to extract the implied acceptance criteria and reported performance based on the provided text, along with other requested study details:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Implied Acceptance Criteria (Based on reported outcome)	Reported Device Performance
Electrical Safety Testing (IEC 60601-1)	Compliance with IEC 60601-1 standards (Pass)	"Test results were a pass."
Electromagnetic Safety (International EMC standards)	Compliance with International Electromagnetic Compatibility standards (Pass)	"Test results were a pass."
Manufacturing validation (Pressure relief valve)	All components (e.g., pressure relief valve) function as required.	"In-process manufacturing validation is performed to ensure that all components function as required."
Lithium Battery testing (IEC 62133:2012)	Compliance with IEC 62133:2012 for the 7.4V nominal voltage rechargeable lithium battery pack, 950mAh rated capacity.	"The... battery pack... is compliant with the requirements of IEC 62133:2012."
Pressure mapping testing (Off-loading properties)	Verification of the off-loading properties.	"Verification of the off-loading properties of PulseFlowDF was demonstrated in bench testing."
Bench Performance testing (Disabling at 1000 hours)	Device disables at 1000 hours.	"Bench performance testing was performed to verify that the PulseFlow device disables at 1000 hours..."
Bench Performance testing (Inflation/Deflation specifications)	Inflation and deflation specifications are achieved.	"...that the inflation and deflation specifications are achieved..."
Bench Performance testing (Inflation pressure)	Inflation pressure specifications are reliably achieved.	"...and that the inflation pressure specifications are reliably achieved."
Bench testing (Pressure relief valve/Bladder structure)	Pressure relief valve functions as intended, and bladder structure/material withstands sudden large forces.	"Bench testing was conducted to demonstrate that the pressure relief valve functions as intended and that the bladder structure and material can withstand a sudden large force being exerted on the bladder."
Simulated Use testing (Mechanical integrity)	Integrity of mechanical components withstands anticipated forces/pressure for 12 weeks for a simulated 400lb body weight without failure.	"Bench performance testing was performed to validate that the integrity of the mechanical components can withstand the anticipated forces and pressure throughout the 12-week operating period for a simulated 400lb body weight without failure of the mechanical components."
Software Verification and Validation (Firmware)	Firmware is verified and validated to monitor compliance with wear time.	"V&V testing was performed for the firmware in PulseFlowDF, which is used to monitor compliance with wear time."
Summative Usability Testing	No safety issues occur, and essential tasks are performed, particularly with face-to-face training.	"The usability validation study revealed that no safety issues occurred while using PulseFlowDF, performance of essential tasks was demonstrated, particularly with face-to-face training in suitable patients, as planned."
Measurement of Blood Flow	Venous blood flow in the calf and microvascular perfusion of the foot are statistically significantly improved during use.	"venous blood flow in the calf and microvascular perfusion of the foot were statistically significantly improved during use of PulseFlowDF, as measured using a Near-Infrared Spectroscopic technique (blood flow in the calf) and a Doppler flowmeter (microvascular perfusion of the foot), confirming the efficacy of PulseFlowDF's intermittent compression to improve blood flow."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set:
- Summative Usability Testing: 10 diabetic patients (under treatment for active or healed diabetic foot ulcers) and 2 healthcare professionals.
- Measurement of Blood Flow Study: 8 volunteer subjects.
Data Provenance: The document does not specify the country of origin for the clinical or usability studies. The manufacturing company is located in the UK. The studies appear to be prospective as they describe specific tests and measurements performed with the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Experts for Usability Testing: Two (2) healthcare professionals were involved in the summative usability testing. Their specific qualifications (e.g., specialty, years of experience) are not specified in the provided text.
Experts for Blood Flow Study: No information is provided regarding experts establishing ground truth for the blood flow measurements. The measurements were taken using Near-Infrared Spectroscopic technique and a Doppler flowmeter, implying objective measurements rather than expert interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not mention any adjudication method for establishing ground truth in any of the described tests. The tests appear to rely on objective measures (e.g., electronic sensors, quantitative blood flow measurements) or direct observation during usability testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (a compressible limb sleeve) and not an AI-driven diagnostic or interpretative tool that would typically involve human readers or AI assistance in a clinical setting.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the PulseFlowDF is a physical medical device, not an algorithm, and its performance inherently involves interaction with a human (the patient). The firmware monitors wear time, but there's no "algorithm-only" performance in the sense of a diagnostic AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For Blood Flow Measurement: The ground truth for the efficacy claim (improved blood flow) was established using objective physiological measurements from a Near-Infrared Spectroscopic technique (for calf blood flow) and a Doppler flowmeter (for microvascular perfusion).
For Usability Testing: Ground truth related to usability was established through direct observation that "no safety issues occurred" and "performance of essential tasks was demonstrated," likely based on predefined criteria and user feedback.
Other Bench/Safety Tests: Ground truth was based on compliance with established engineering and safety standards (e.g., IEC 60601-1, IEC 62133:2012) and pre-defined performance specifications (e.g., disabling at 1000 hours, inflation pressure).

8. The sample size for the training set

The document does not mention any "training set." This term is typically used for machine learning or AI models. The studies described are for a physical medical device and involve performance verification and validation rather than model training.

9. How the ground truth for the training set was established

This question is not applicable as there is no mention of a training set for this device.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 16, 2015

PulseFlow Technologies % Diane Horwitz Regulatory Consultant Mandell Horwitz Consultants 2995 Steven Martin Dr. Fairfax, Virginia 22031

Re: K150806

Trade/Device Name: PulseFlowDF Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: November 11, 2015 Received: November 13, 2015

Dear Diane Horwitz:

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. 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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand

for

for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150806

Device Name PulseFlowDF™

Indications for Use (Describe)

The PulseFlowDF™ is designed to enhance blood circulation in the venules and arterioles in patients with diabetic foot ulcers of the lower extremities.

PulseFlowDF is intended for patients in the home who would benefit from increased blood flow to:

· Treat and assist healing of cutaneous ulceration (wounds)
· Reduce wound healing time
· Enhance arterial circulation (blood flow)
· Prevent venous stasis (slowing of blood flow)
· Reduce compartmental pressures
· Reduce edema (swelling)
· Reduce post-operative pain and swelling
Reduce the need for anticoagulant medications (medications that thin the blood) and
· Prevent Deep Venous Thrombosis (DVT) (blood clots in the deep veins).

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for PulseFlow Technologies. The word "PulseFlow" is written in a combination of light blue and gray colors. Below "PulseFlow" is the word "Technologies" in light blue. To the right of the word "Flow" is a light blue line graph that resembles a pulse.

510(k) Summary

Submitter'sinformation	PulseFlow TechnologiesMidshires House, Midshires Business Park, Smeaton CloseAylesbury, UK HP19 8HLContact Name: Les LindsayTelephone: +44 1296 678596
Device/classificationname	Device Name: PulseFlowDF, K150806510(k) Number:K150806Device Class:Class IIClassification Number: 21 CFR 870.5800Classification Name:Compressible limb sleeveProduct Code:JOWClassification Panel:Cardiovascular
PredicateDevice	Cowboy XV, marketed as PlexiPulse, K981311
DeviceDescription	PulseFlowDF is an off-loading boot with a built in air bladder in the insole forintermittent plantar compression therapy. One active boot and one matchedheight inactive boot is provided. PulseFlowDF is designed to protect a diabeticwound during healing by (1) stimulating blood flow to the wound (andthroughout the foot and leg) by means of cyclic inflation of an air bladderunder the arch of the foot (primary action), (2) providing a protective cover forthe wound which is bandaged and shielded inside the boot) and (3) stabilizingthe foot and lower leg with an "off-loading design" that holds the foot andlower leg in a fixed position to reduce pressure on the sole of the foot(secondary action). PulseFlowDF allows the user to walk and move whilewearing the boot. PulseFlowDF is worn for up to 10 to 15 hours per day for 12weeks, after which time it can be converted to standard footwear.
Intended Use	The PulseFlowDF is designed to enhance blood circulation in the venules andarterioles in patients with diabetic foot ulcers of the lower extremities.PulseFlowDF is intended for patients in the home who would benefit fromincreased blood flow to:Treat and assist healing of cutaneous ulceration (wounds) Reduce wound healing time Enhance arterial circulation (blood flow) Prevent venous stasis (slowing of blood flow) Reduce compartmental pressures Reduce edema (swelling) Reduce post-operative pain and swelling Reduce the need for anticoagulant medications (medications that thin the blood) and Prevent Deep Venous Thrombosis (DVT) (blood clots in the deep veins)

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Image /page/4/Picture/0 description: The image is a logo for PulseFlow Technologies. The word "PulseFlow" is written in a combination of light blue and gray colors. Below "PulseFlow" is the word "Technologies" in light blue. To the right of the word "PulseFlow" is a light blue graphic that resembles a pulse.

	NEW DEVICEPulseFlowDF, K150806	PREDICATE DEVICEPlexiPulse, K981311	Same or Different
Intended Use	See above	Identical	Same
DeviceDescription	Foot and lower leg held inposition using a shinsupport and offloading bootto redistribute pressureacross the foot; bootcontains inbuilt air bladderand inflation mechanism forpressure against plantarvenous plexus	Pump connected throughtubing to inflatable footwraps	Similar. Foot is compressedwith inflatable bladder.
Mode ofAction	Generates pneumaticpressure using an internalpump and promotes bloodflow via intermittent plantarcompression.Redistributes pressureevenly across sole of footduring gait cycle to avoidpressure hot spots thatleading to tissue damage/delayed wound healing	Generates pneumaticpressure using an externalpump and promotes bloodflow via intermittent plantarcompression	Same and Different. The newdevice has the same activepumping mechanism for thesame purpose.The new device has theadditional functionality ofbeing an off-loading boot thathelps re-distribute pressure onthe sole of the foot.The new device allows the userto be mobile during treatment.Differences have been shownto result in increased bloodflow to the foot and to beusable by the subject.
Components	Boot, Off-loader, Motor,Battery charger, Mini-USBcable (Professional Use),CD with Downloadprogram (Professional Use)	PlexiPulse pump, foot wrap,Tubing and tube connector,Power cord	Different. Components of newdevice have been demonstratedto achieve their intendedpurpose.
Energy Source	Lithium Battery	Electrical (A/C PowerSupply)110 VAC, 60 Hz, 0.25 A	Different. Power source hasbeen demonstrated to achieveits intended purpose.
SoftwareControlled	Firmware for compliancedata download and to stoppump after 1000 treatmenthours	Unknown extent ofsoftware regulation	Similar; both have been V&Vtested.
Size of Unit	Boot-shaped and sized	Inflatable wrap around footPump 12" x Depth 7" xHeight 11"	Different. Boot shape allowssubject to be mobile.
Max. PressureGeneration	160mm HgFixed pressure	160 ±15 mm Hg (140 to180 mmHg), Adjustable	Same
Duration ofPulse	Inflation cycle every 20sec.duration 2 sec, Fixedduration	Inflation cycle every 20sec.duration 2 sec, Adjustable(20 to 60 sec)	Same

SUBSTANTIAL EQUIVALENCE COMPARISON

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Image /page/5/Picture/0 description: The image shows the logo for PulseFlow Technologies. The word "Pulse" is in a light blue color, while the word "Flow" is in gray. Below the two words is the word "Technologies" in a smaller font and in light blue. To the right of the words is a light blue line that resembles a heart rate monitor.

PerformanceData	Performance testing was conducted to ensure that user requirements andspecifications were met, and to ensure that any differences betweenPulseFlowDF and the predicate would not affect safety or effectiveness.Performance testing included the following:Electrical Safety Testing: Electrical safety was tested according to IEC 60601-1.Test results were a pass.
	Electromagnetic Safety: PulseFlowDF was tested to the requirements ofInternational Electromagnetic Compatibility standards, with respect to radiofrequency emissions and radio frequency susceptibility. Test results were a pass.
	Manufacturing validation including pressure relief valve testing: In-processmanufacturing validation is performed to ensure that all components function asrequired.
	Lithium Battery testing: The 7.4V nominal voltage rechargeable lithium batterypack, 950mAh rated capacity, is compliant with the requirements of IEC 62133:2012.
	Pressure mapping testing: Verification of the off-loading properties ofPulseFlowDF was demonstrated in bench testing.
	Bench Performance testing: Bench performance testing was performed to verifythat the PulseFlow device disables at 1000 hours, that the inflation and deflationspecifications are achieved, and that the inflation pressure specifications arereliably achieved.
	Bench testing was conducted to demonstrate that the pressure relief valvefunctions as intended and that the bladder structure and material can withstand asudden large force being exerted on the bladder.
	Simulated Use testing: Bench performance testing was performed to validatethat the integrity of the mechanical components can withstand the anticipatedforces and pressure throughout the 12-week operating period for a simulated400lb body weight without failure of the mechanical components.
	Software Verification and Validation: V&V testing was performed for thefirmware in PulseFlowDF, which is used to monitor compliance with wear time.Summative Usability Testing: A summative usability test was performed in ten(10) diabetic patients under treatment for active or healed diabetic foot ulcers andtwo (2) healthcare professionals. The usability validation study revealed that nosafety issues occurred while using PulseFlowDF, performance of essential taskswas demonstrated, particularly with face-to-face training in suitable patients, asplanned.
	Measurement of Blood Flow: In a validation study with eight (8) volunteersubjects, venous blood flow in the calf and microvascular perfusion of the footwere statistically significantly improved during use of PulseFlowDF, asmeasured using a Near-Infrared Spectroscopic technique (blood flow in the calf)and a Doppler flowmeter (microvascular perfusion of the foot), confirming theefficacy of PulseFlowDF's intermittent compression to improve blood flow
Conclusions	Based on the documentation presented in this 510(k) it has been demonstratedthat PulseFlowDF is substantially equivalent to the predicate device for itsintended use.

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).