(198 days)
No
The description focuses on the mechanical and physiological principles of external counter-pulsation and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the "treatment of chronic stable angina" and "to provide improvement in vasodilation, increased blood flow," which are therapeutic applications.
No
Explanation: The device description states it is a mechanical device used for treatment, specifically to improve blood flow to the heart and reduce ventricular workload. Its intended use is for treating chronic angina and improving vasodilation/blood flow in healthy patients. It does not mention diagnosing conditions.
No
The device description explicitly states it is a "mechanical device" and lists several hardware components including a main unit, computer monitor, keyboard, flexible tubes, fabric cuffs with inflatable balloons, EKG wires, and SpO2 sensors. It also mentions utilizing cleared hardware components like cables and sensors.
Based on the provided information, the Pure Flow External Counter-Pulsaion device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Pure Flow Function: The Pure Flow device is a mechanical device that applies external pressure to the extremities to influence blood flow within the body. It works by physically manipulating the circulatory system.
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens. Its function is entirely external and mechanical.
Therefore, the Pure Flow device falls under the category of a therapeutic or physiological support device, not an IVD.
N/A
Intended Use / Indications for Use
The Pure Flow External Counter-Pulsation device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased blood flow. It is intended for use under the oversight of a healthcare professional.
Product codes
DRN
Device Description
The Pure Flow External Counter-Pulsation device is a mechanical device used to increase aortic pressure during early native heart diastole to augment myocardial perfusion, and to decrease aortic pressure during early native heart systole to reduce ventricular workload and vascular afterload.
The PureFlow consists of a main unit, and applied parts (computer monitor, keyboard, flexible tubes which connect to fabric cuffs, inside each cuff is an inflatable plastic balloon), EKG wires, and SpO2 sensors.
PureFlow works on the basis of external counter pulsation. The pressure is created by inflating a series of cuffs (similar to blood-pressure cuffs) that squeeze the extremities (calf's, thighs, buttocks) forcing blood back up to the heart on each heart cycle. This process ultimately restores (by force) sufficient blood flow to parts of the heart that is lacking oxygen. The treatment process generally spans for a period of 1 hour each day for a period of 35 total treatments. ECP Treatment is proven to develop existing pathways of oxygenated blood back to the heart muscle. In other words, External Counterpulsation Therapy restores pathways for adequate & necessary blood flow back to heart through vessels that already exist.
The device also utilizes the following cleared components: Cable/Lead wire (ECG/EKG, SpO2, and Invasive Blood Pressure): K120010 LNCS/M-LNCS Oximetry Sensor: K101896
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
It is intended for use under the oversight of a healthcare professional.
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)
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing
Shelf-Life Testing
Shelf-life was calculated to be three years, based on information provided by the manufacturer estimated use conditions.
Pressure Control Timing Measurement Test
The device was evaluated for synchronization of therapy with the appropriate phase of cardiac cycle or functionality of alarms per the special control in 21 CFR 870.5225. The reference standard used was JIS T0601-2-204: Particular requirements for the basic safety and essential performance of pneumatic compression equipment. Timer accuracy should be within +/- 5% of the set value. Three models were tested, and each met the pass criteria.
Pressure Accuracy Test
Pressure was set for each device, and the actual pressure was measured to check if accuracy is verified. Referenced standard used was JIS T 0601-2-204 Particular requirements for the basic safety and essential performance of pneumatic compression equipment 201.12.1. Pressure must be +/- 20% from the set pressure value. Three models were tested, and each met the pass criteria.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device, and was found to comply with IEC 60601-1 and 60601-1-2.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was determined to be of "moderate" level of concern.
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
§ 870.5225 External counter-pulsating device.
(a)
Identification. An external counter-pulsating device is a noninvasive, prescription device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle.(b)
Classification. (1) Class II (special controls) when the device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. The special controls for this device are:(i) Nonclinical performance evaluation of the device must demonstrate a reasonable assurance of safety and effectiveness for applied pressure, synchronization of therapy with the appropriate phase of the cardiac cycle, and functionality of alarms during a device malfunction or an abnormal patient condition;
(ii) Reliabilities of the mechanical and electrical systems must be established through bench testing under simulated use conditions and matched by appropriate maintenance schedules;
(iii) Software design and verification and validation must be appropriately documented;
(iv) The skin-contacting components of the device must be demonstrated to be biocompatible;
(v) Appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device; and
(vi) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) for the following intended uses: Unstable angina pectoris; acute myocardial infarction; cardiogenic shock; congestive heart failure; postoperative treatment of patients who have undergone coronary artery bypass surgery; peripheral arterial disease associated with ischemic ulcers rest pain or claudication, threatened gangrene, insufficient blood supply at an amputation site, persisting ischemia after embolectomy or bypass surgery, and/or pre- and post-arterial reconstruction to improve runoff; diabetes complicated by peripheral arterial disease or other conditions possibly related to arterial insufficiency including nocturnal leg cramps and/or necrobiosis diabeticorum; venous diseases, including prophylaxis of deep vein thrombophlebitis, edema (e.g., chronic lymphedema) and/or induration (e.g., stasis dermatitis) associated with chronic venous stasis, venous stasis ulcers, and/or thrombophlebitis; athletic injuries, including Charley horses, pulled muscles and/or edematous muscles; necrotizing cellulitis.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before March 31, 2014, for any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any external counter-pulsating device, with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other external counter-pulsating device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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May 30, 2018
Xtreem Pulse, LLC % Rhonda Alexander Sr. Director, Regulatory & Leadership Development IUVO Consulting, LLC 1820 Perla Drive Virginia Beach, Virginia 23456
Re: K173483
Trade/Device Name: Pure Flow External Counter-Pulsation Device Regulation Number: 21 CFR 870.5225 Regulation Name: External Counter-Pulsating Device Regulatory Class: Class II Product Code: DRN Dated: April 16, 2018 Received: April 20, 2018
Dear Rhonda Alexander:
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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. 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) K173483
Device Name
PureFlow External Counter-Pulsation Device
Indications for Use (Describe)
The Pure Flow External Counter-Pulsation device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased blood flow. It is intended for use under the oversight of a healthcare professional.
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
510(k) Summary K173483
1. SUBMITTER
XTREEM PULSE LLC Andrew Barile, CEO 353 W. 29 ST. SUITE 3 NEW YORK, NY 10001 UNITED STATES
Contact Person: Rhonda Alexander, MS, MPA Sr. Director, Regulatory & Leadership Development IUVO Consulting, LLC (757) 582-4337 ralexander@iuvoconsulting.com
Date Prepared: 22 May 2018
II. DEVICE
| Name of Subject Device: | Pure Flow External Counter-Pulsation Device |
|---|---|
| Classification Name: | External Counter-Pulsation Device |
| Regulatory Class: | Class 2 |
| Product Code: | DRN |
III. PREDICATE DEVICE
Renew™ NCP-5 External Counterpulsation System (K152115) Renew Group Ptc Ltd.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Pure Flow External Counter-Pulsation device is a mechanical device used to increase aortic pressure during early native heart diastole to augment myocardial perfusion, and to decrease aortic pressure during early native heart systole to reduce ventricular workload and vascular afterload.
The PureFlow consists of a main unit, and applied parts (computer monitor, keyboard, flexible tubes which connect to fabric cuffs, inside each cuff is an inflatable plastic balloon), EKG wires, and SpO2 sensors.
PureFlow works on the basis of external counter pulsation. The pressure is created by inflating a series of cuffs (similar to blood-pressure cuffs) that squeeze the extremities (calf's, thighs, buttocks) forcing blood back up to the heart on each heart cycle. This process ultimately restores (by force) sufficient
4
blood flow to parts of the heart that is lacking oxygen. The treatment process generally spans for a period of 1 hour each day for a period of 35 total treatments. ECP Treatment is proven to develop existing pathways of oxygenated blood back to the heart muscle. In other words, External Counterpulsation Therapy restores pathways for adequate & necessary blood flow back to heart through vessels that already exist.
The device also utilizes the following cleared components: Cable/Lead wire (ECG/EKG, SpO2, and Invasive Blood Pressure): K120010 LNCS/M-LNCS Oximetry Sensor: K101896
V. INDICATIONS FOR USE
The Pure Flow External Counter-Pulsation device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased VO2, and increased blood flow. It is intended for use under the oversight of a healthcare professional.
VI. SUMMARY OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
At a high level, the subject and predicate devices are based on the following same technological elements:
| CHARACTERISTICS | PREDICATE DEVICE | SUBJECT DEVICE | CONCLUSION |
|---|---|---|---|
| RENEW NCP-5 (K152115) | PureFlow | ||
| Intended Use | Stable and Unstable Angina, Congestive | ||
| Heart Failure, cardiogenic shock, and | |||
| acute myocardial infarction, increase in | |||
| circulation, increase VO2. In addition, it | |||
| is intended for use in healthy patients | |||
| to provide improvement in | |||
| vasodilation, increased VO2, and | |||
| increased blood flow. It is intended for | |||
| use under the oversight of a healthcare | |||
| professional. | Stable and Unstable Angina, | ||
| Congestive Heart Failure, | |||
| cardiogenic shock, and acute | |||
| myocardial infarction, increase in | |||
| circulation, increase VO2. In | |||
| addition, it is intended for use in | |||
| healthy patients to provide | |||
| improvement in vasodilation, | |||
| increased VO2, and increased | |||
| blood flow. It is intended for use | |||
| under the oversight of a healthcare | |||
| professional. | SAME | ||
| Classification Name | |||
| Mechanism of | |||
| operation | Counter-Pulsating, External | Counter-Pulsating, External | SAME |
| Triggering Mechanism | T-Wave trigger for inflation and P- | ||
| Wave deflation timing | T-Wave trigger for inflation and P- | ||
| Wave deflation timing | SAME | ||
| Microprocessor | Windows Based | Windows Based | SAME |
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| Emergency System
| power-down | Red-Emergency Stop Button | Red-Emergency Stop Button | SAME |
|---|---|---|---|
| Maximum pressure | |||
| used for | |||
| treatment/Timer | |||
| Settings | 6.0 PSI | ||
| Timer- 1-60 minutes | |||
| (10 minute increments) | 4.0 PSI | ||
| Timer: 1-60 minutes | |||
| (Single minute increments) | DIFFERENT | ||
| Cuff system | Nylon fabric cuffs, three parts, calf, | ||
| thigh and buttocks. | Nylon fabric cuffs, three parts, calf, | ||
| thigh and buttocks. | SAME | ||
| Major components | Base Unit, Air-Tubes, EKC, SPO2, EKG | ||
| and three Cuffs | Base Unit, Air-Tubes, EKC, SPO2, | ||
| EKG and three Cuffs | SAME | ||
| Voltage /HZ/ Wattage | 100-240V/ 50/60HZ | 100-240 V 50/60HZ | SAME |
| Dimension/Weight | 1930mm (L) x 718mm (W) x 927mm (H) | ||
| 102KG | 1250mmX700mmX 500mm | ||
| 120KG | SAME | ||
| Major components | Base Unit, Air-Tubes, EKC, SPO2, EKG | ||
| and three cuffs | Base Unit, Air-Tubes, EKC, SPO2, | ||
| EKG and three nylon and cotton | |||
| cuffs | SAME | ||
| Operating | |||
| Environment | Temperature: 16° to 30° ( 60.8° F to 86 | ||
| ° F) | |||
| Humidity: 30% to 70% RH | |||
| (non-condensing) | |||
| Barometric Pressure: 80kPA to 100kPA | Temperature: 10° to 30° ( 50 °F- 86 | ||
| °F) | |||
| Humidity: 30% to 75% RH | |||
| (non-condensing) | |||
| Barometric Pressure: 80kPA to | |||
| 100kPA | SAME | ||
| Electrical Safety and | |||
| EMC Safety Testing | Passed IEC 60601 | Passed IEC 60601 | SAME |
| Biocompatibility Testing | ISO 10993 | NONE | DIFFERENT |
There are no differences between the subject device and the predicate device with respect to indications and intended use. Electrical safety and EMC testing was performed per IEC 60601 on the subject device. The device passed the testing, just as the predicate device did. Thus, in electrical safety and EMC testing, the devices are equivalent.
The difference in the length of the device is only a design preference. Renew has decided to incorporate a built in treatment bed. The core dimension of the machine are the same. The additional length of the unit is due to the extension of the bed components, which have no therapeutic or functional effect on the treatment. Our device can be wheeled bedside to the patient who can lie comfortably on specialized beds if required.
6
The increased weight of PureFlow, as compared to the predicate, is due to the materials used for the shell of the housing of the unit. It weighs approximately 18kg more but this has no direct effect on the clinical application.
No biocompatibility testing was conducted on PureFlow, as none of its components or parts are intended to touch the skin. The cuffs of the device are intended to be used on top of clothing. The device will only use 510(k) cleared ECG electrodes and pulse oximeters.
VII. NON-CLINICAL TESTING
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing
Shelf-Life Testing
Shelf-life was calculated to be three years, based on information provided by the manufacturer estimated use conditions.
Pressure Control Timing Measurement Test
The device was evaluated for synchronization of therapy with the appropriate phase of cardiac cycle or functionality of alarms per the special control in 21 CFR 870.5225. The reference standard used was JIS T0601-2-204: Particular requirements for the basic safety and essential performance of pneumatic compression equipment. Timer accuracy should be within +/- 5% of the set value. Three models were tested, and each met the pass criteria.
Pressure Accuracy Test
Pressure was set for each device, and the actual pressure was measured to check if accuracy is verified. Referenced standard used was JIS T 0601-2-204 Particular requirements for the basic safety and essential performance of pneumatic compression equipment 201.12.1. Pressure must be +/- 20% from the set pressure value. Three models were tested, and each met the pass criteria.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device, and was found to comply with IEC 60601-1 and 60601-1-2.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was determined to be of "moderate" level of concern.
VIII. CLINICAL TESTING
Clinical data were not required in this submission to support a finding of substantial equivalence.
IX. CONCLUSIONS
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We conclude that the information provided in this submission are sufficient to demonstrate that the Pure Flow External Counter-Pulsation Device is substantially equivalent to the predicate device which is currently marketed for the same intended use.