(265 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical functions, with no mention of AI/ML algorithms for data analysis, decision-making, or personalized therapy. The software mentioned is for compliance monitoring, not AI/ML.
Yes
The device is intended to treat and assist healing of wounds, enhance circulation, reduce edema, and prevent DVT, all of which are therapeutic actions.
No
The device is designed to treat and enhance blood circulation, not to diagnose a condition. Its applications are therapeutic (e.g., treating ulcers, reducing pain) and preventative (e.g., preventing DVT), not diagnostic.
No
The device description clearly states it is an "off-loading boot with a built in air bladder in the insole for intermittent plantar compression therapy." This indicates a physical hardware component (the boot and air bladder) is central to the device's function, not just software.
Based on the provided information, the PulseFlowDF™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- PulseFlowDF™ Function: The PulseFlowDF™ is a physical device (an off-loading boot with an air bladder) that applies intermittent compression to the foot and lower leg. Its intended use is to enhance blood circulation and aid in the healing of diabetic foot ulcers. It does not analyze any biological specimens.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics. It is a therapeutic device that directly interacts with the patient's body to achieve its intended effect.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities, foot, leg, calf
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients in the home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to ensure that user requirements and specifications were met, and to ensure that any differences between PulseFlowDF 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 of International Electromagnetic Compatibility standards, with respect to radio frequency emissions and radio frequency susceptibility. Test results were a pass.
Manufacturing validation including pressure relief valve testing: In-process manufacturing validation is performed to ensure that all components function as required.
Lithium Battery testing: The 7.4V nominal voltage rechargeable lithium battery pack, 950mAh rated capacity, is compliant with the requirements of IEC 62133: 2012.
Pressure mapping testing: Verification of the off-loading properties of PulseFlowDF was demonstrated in bench testing.
Bench Performance testing: Bench performance testing was performed to verify that the PulseFlow device disables at 1000 hours, that the inflation and deflation specifications are achieved, and that the inflation pressure specifications are reliably achieved.
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: 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: V&V testing was performed for the firmware 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 and two (2) healthcare professionals. 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: In a validation study with eight (8) volunteer subjects, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
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's
information | PulseFlow Technologies
Midshires House, Midshires Business Park, Smeaton Close
Aylesbury, UK HP19 8HL
Contact Name: Les Lindsay
Telephone: +44 1296 678596 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/
classification
name | Device Name: PulseFlowDF, K150806
510(k) Number:
K150806
Device Class:
Class II
Classification Number: 21 CFR 870.5800
Classification Name:
Compressible limb sleeve
Product Code:
JOW
Classification Panel:
Cardiovascular |
| Predicate
Device | Cowboy XV, marketed as PlexiPulse, K981311 |
| 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. |
| Intended Use | 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) |
4
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 DEVICE
PulseFlowDF, K150806 | PREDICATE DEVICE
PlexiPulse, K981311 | Same or Different |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | See above | Identical | Same |
| Device
Description | Foot and lower leg held in
position using a shin
support and offloading boot
to redistribute pressure
across the foot; boot
contains inbuilt air bladder
and inflation mechanism for
pressure against plantar
venous plexus | Pump connected through
tubing to inflatable foot
wraps | Similar. Foot is compressed
with inflatable bladder. |
| Mode of
Action | Generates pneumatic
pressure using an internal
pump and promotes blood
flow via intermittent plantar
compression.
Redistributes pressure
evenly across sole of foot
during gait cycle to avoid
pressure hot spots that
leading to tissue damage/
delayed wound healing | Generates pneumatic
pressure using an external
pump and promotes blood
flow via intermittent plantar
compression | Same and Different. The new
device has the same active
pumping mechanism for the
same purpose.
The new device has the
additional functionality of
being an off-loading boot that
helps re-distribute pressure on
the sole of the foot.
The new device allows the user
to be mobile during treatment.
Differences have been shown
to result in increased blood
flow to the foot and to be
usable by the subject. |
| Components | Boot, Off-loader, Motor,
Battery charger, Mini-USB
cable (Professional Use),
CD with Download
program (Professional Use) | PlexiPulse pump, foot wrap,
Tubing and tube connector,
Power cord | Different. Components of new
device have been demonstrated
to achieve their intended
purpose. |
| Energy Source | Lithium Battery | Electrical (A/C Power
Supply)
110 VAC, 60 Hz, 0.25 A | Different. Power source has
been demonstrated to achieve
its intended purpose. |
| Software
Controlled | Firmware for compliance
data download and to stop
pump after 1000 treatment
hours | Unknown extent of
software regulation | Similar; both have been V&V
tested. |
| Size of Unit | Boot-shaped and sized | Inflatable wrap around foot
Pump 12" x Depth 7" x
Height 11" | Different. Boot shape allows
subject to be mobile. |
| Max. Pressure
Generation | 160mm Hg
Fixed pressure | 160 ±15 mm Hg (140 to
180 mmHg), Adjustable | Same |
| Duration of
Pulse | Inflation cycle every 20sec.
duration 2 sec, Fixed
duration | Inflation cycle every 20sec.
duration 2 sec, Adjustable
(20 to 60 sec) | Same |
SUBSTANTIAL EQUIVALENCE COMPARISON
5
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.
| Performance
Data | Performance testing was conducted to ensure that user requirements and
specifications were met, and to ensure that any differences between
PulseFlowDF 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 of
International Electromagnetic Compatibility standards, with respect to radio
frequency emissions and radio frequency susceptibility. Test results were a pass. |
| | Manufacturing validation including pressure relief valve testing: In-process
manufacturing validation is performed to ensure that all components function as
required. |
| | Lithium Battery testing: The 7.4V nominal voltage rechargeable lithium battery
pack, 950mAh rated capacity, is compliant with the requirements of IEC 62133:
2012. |
| | Pressure mapping testing: Verification of the off-loading properties of
PulseFlowDF was demonstrated in bench testing. |
| | Bench Performance testing: Bench performance testing was performed to verify
that the PulseFlow device disables at 1000 hours, that the inflation and deflation
specifications are achieved, and that the inflation pressure specifications are
reliably achieved. |
| | 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: 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: V&V testing was performed for the
firmware 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 and
two (2) healthcare professionals. 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: In a validation study with eight (8) volunteer
subjects, 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 |
| Conclusions | Based on the documentation presented in this 510(k) it has been demonstrated
that PulseFlowDF is substantially equivalent to the predicate device for its
intended use. |