Renew NCP-5 External Counterpulsation System

K152115 · Stage 2 Innovations · DRN · Dec 17, 2015 · Cardiovascular

Device Facts

• Record ID: K152115
• Device Name: Renew NCP-5 External Counterpulsation System
• Applicant: Stage 2 Innovations
• Product Code: DRN · Cardiovascular
• Decision Date: Dec 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5225
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Renew NCP-5 External Counterpulsation System is intented 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.

Device Story

Renew NCP-5 is an external counterpulsation (ECP) system; used in clinical settings under healthcare professional oversight. Device consists of a main unit, laptop PC, switch panel, foldable bed, and three pairs of air cuffs. System monitors heart cycle; sequentially inflates and deflates cuffs on calves, thighs, and buttocks in synchrony with cardiac rhythm. Sequential compression of vascular beds increases venous return and diastolic pressure; enhances coronary perfusion and peripheral blood flow. Benefits include improved vasodilation and increased blood flow in healthy patients; symptom relief for refractory angina patients. Healthcare providers use the system to deliver non-invasive circulatory support.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 for patient-contacting materials. Electrical safety and EMC testing performed per IEC 60601. Software and firmware validated per FDA guidance. Literature review provided to support the indication for use in healthy patients.

Technological Characteristics

Microprocessor-controlled pneumatic system. Components: switch panel, laptop PC, foldable treatment bed, main unit, and air cuffs. Sensing/actuation: sequential inflation/deflation of air cuffs synchronized with heart cycle. Electrical safety/EMC per IEC 60601. Biocompatibility per ISO 10993.

Indications for Use

Indicated for patients with chronic stable angina refractory to optimal medical therapy without revascularization options, and for healthy patients to improve vasodilation and increase blood flow.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ACS Model NCP-2 External Counterpulsation Device (K042413)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES-USA

Public Health Service

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

December 17, 2015

Renew Group Pte Ltd. % Janice Hogan Regulatory Counsel Hogan Lovells US, LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K152115

Trade/Device Name: Renew™ NCP-5 External Counterpulsation System Regulation Number: 21 CFR 870.5225 Regulation Name: External Counter-Pulsating Device Regulatory Class: Class II Product Code: DRN Dated: November 23, 2015 Received: November 24, 2015

Dear Janice Hogan:

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 801); medical device reporting (reporting of medical device

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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.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely vours.

M. G. Hilleman

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

#### K152115

Device Name

Renew™ NCP-5 External Counterpulsation System

Indications for Use (Describe)

The Renew NCP-5 External Counterpulsation System is intented 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)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) SUMMARY

# Renew™ NCP-5 External Counterpulsation System

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Jonathan Helfgott, Renew Group Pte Ltd. 7811 Montrose Rd. Rockville, MD 20854 732 -754-2073 Date Prepared: December 15, 2015

### Name of Device

Renew™ NCP-5 External Counterpulsation System

## Common/ Classification Name

Device, Counter-pulsating, External, 21 CFR 870.5225, Class II Product code: DRN

### Primary Predicate Device

ACS Model NCP-2 External Counterpulsation Device (K042413)

### Indications for Use

The Renew NCP-5 External Counterpulsation System 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.

### Technological Characteristics

The Renew"" NCP-5 External Counterpulsation System (ECS) is comprised of the following major components, a switch panel, laptop PC computer, a foldable treatment bed, main unit, and a set of patient cuffs. The device is a microprocessor-controlled system that sequentially inflates then deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks in synchrony with the heart cycle to achieve the desired therapy.

### Performance Data

Cytotoxicity, irritation, and sensitization testing per ISO 10993 was performed to evaluate the biocompatibility of the patient contacting materials. Electrical safety and EMC compatibility testing per IEC 60601 was performed to ensure appropriate electrical performance. The

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software and firmware used in the system was validated per FDA's guidance document. In all instances, the NCP-5 system functioned as intended. In addition, a literature review regarding the use of external counterpulsation in healthy patients was provided to support this additional indication.

# Substantial Equivalence

The NCP-5 system has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. Thus, the NCP-5 system is substantially equivalent to the predicate device.

# Conclusions

The NCP-5 system is substantially equivalent to the predicate NCP-2 device.