(14 days)
The intended use of the ScottCare Genesis ECP device is to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.
The "Genesis" is a non-invasive medical device for performing external, sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks to achieve the desired therapy. The microprocessor's primary function is to serve as an R-wave detector, calculate the R-wave rate (heart rate), and deliver triggering signals to actuate valves that allow the cuffs to be filled during the diastolic period and then emptied prior to systole. The secondary function of the microprocessor is to output, through a serial port, information necessary for displaying patient treatment data on a video monitor. This data allows a trained operator to finetune the inflation/deflation signals to optimize a patient's diastolic augmentation. The cuffs are snugly wrapped around the patient's calves, thighs, and buttocks to allow compression of vascular beds in these body areas. To prevent skin irritation the patient is typically dressed in tight fitting, stretchable treatment pants prior to being fitted with the cuffs. As diastole begins, the cuffs inflate sequentially proceeding from the calves, to the thighs, to the buttocks, with the inflation sequence taking a total of approximately 200ms. The inflation sequence generates and drives an arterial counter pulsation wave creating an increase in coronary perfusion pressure and coronary blood flow. The compression sequence also increases venous return, which increases stroke volume and cardiac output. At the end of diastole, and just before the next QRS complex, the cuffs are evacuated simultaneously over a period of approximately 120ms. The course of treatment is typically 35 1-hour treatments administered 5 days a week. The device automatically stops compression of the cuffs and releases all pressure in the cuffs upon completion of the pre-set treatment timer. The system consists of two major assemblies: 1) the patient bed that houses the electronic pneumatic controls / valves, compressor / vacuum pump and associated power supplies and 2) the operator's console that consists of an all-in-one computer/monitor, computer peripherals (keyboard and pointing device) and a control panel.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for the "ScottCare Genesis ECP Device," primarily focused on demonstrating substantial equivalence to a predicate device.
It lists:
- Device Description: How the ECP device works.
- Indications for Use: The medical conditions the device is intended to treat.
- Substantial Equivalence Comparison: A table comparing features of the new "Genesis" model with the predicate device "NCP-1 Counter Pulsation Device."
- Conclusion: States that testing (without details on specific acceptance criteria or results) demonstrated the device functioned as designed and complied with IEC60601 safety and EMC requirements. It concludes substantial equivalence to the predicate device.
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Image /page/0/Picture/0 description: The image shows the word "ScottCare" in a stylized font. There is a line that runs underneath the word, and it resembles an EKG readout. The line has a peak in the middle, which is directly under the space between the two words. The image is in black and white.
800 243.9412 phone 216.267.6129 fax www.scottcare.com web
510(K) SUMMARY
(SPECIAL CONSIDERATION)
MAY 2 9 2008
This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92
| The assigned 510(k) number is | K081359 |
|---|---|
| Date: | April 18, 2008 |
| Submitted by: | ScottCare CorporationRegistration No: 15277154791 West 150 th StreetCleveland, OH 44135 |
| Contact Person: | Mr. Ronald J. Clines216-362-0550 # 113216-264-6129 Faxrclines@scottcare.com |
| Manufacturing Site: | ScottCare CorporationRegistration No: 10632684897 W. Waters Ave, Suite JTampa, Florida 33634 |
| Trade Name: | ScottCare Genesis ECP Device |
| Common Name: | External Counter Pulsation (ECP) device |
| Classification: | 870.5225External counter-pulsating device, |
| Product Code: | DRN |
| Legally Marketed Predicate Device(s): | Model NCP-1 Counter Pulsation DeviceK023016, December 12, 2002 |
| 2-0001 |
દર
TeleRehab®
ROLINN
Page 1 of 4
NICORE
Telemetry
Diagnostic Cardiology
External Counterpulsation
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Image /page/1/Picture/0 description: The image shows the word "ScottCare" in a stylized font. Above the "t" in ScottCare is a line that resembles an EKG reading. Below the word ScottCare is another line that resembles an EKG reading.
800.243.9412 phone 216.267.6129 fax www.scottcare.com web
Device Description:
The "Genesis" is a non-invasive medical device for performing external, sequential counterpulsation. It is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks to achieve the desired therapy. The microprocessor's primary function is to serve as an R-wave detector, calculate the R-wave rate (heart rate), and deliver triggering signals to actuate valves that allow the cuffs to be filled during the diastolic period and then emptied prior to systole. The secondary function of the microprocessor is to output, through a serial port, information necessary for displaying patient treatment data on a video monitor. This data allows a trained operator to finetune the inflation/deflation signals to optimize a patient's diastolic augmentation. The cuffs are snugly wrapped around the patient's calves, thighs, and buttocks to allow compression of vascular beds in these body areas. To prevent skin irritation the patient is typically dressed in tight fitting, stretchable treatment pants prior to being fitted with the cuffs. As diastole begins, the cuffs inflate sequentially proceeding from the calves, to the thighs, to the buttocks, with the inflation sequence taking a total of approximately 200ms. The inflation sequence generates and drives an arterial counter pulsation wave creating an increase in coronary perfusion pressure and coronary blood flow. The compression sequence also increases venous return, which increases stroke volume and cardiac output. At the end of diastole, and just before the next QRS complex, the cuffs are evacuated simultaneously over a period of approximately 120ms. The course of treatment is typically 35 1-hour treatments administered 5 days a week. The device automatically stops compression of the cuffs and releases all pressure in the cuffs upon completion of the pre-set treatment timer.
The system consists of two major assemblies: 1) the patient bed that houses the electronic pneumatic controls / valves, compressor / vacuum pump and associated power supplies and 2) the operator's console that consists of an all-in-one computer/monitor, computer peripherals (keyboard and pointing device) and a control panel.
Indications for Use:
The ScottCare Genesis ECP is a non-invasive external counterpulsation (ECP) device indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardioqenic shock and acute myocardial infarction.
2-0002
Page 2 of 4
TeleRehab® Telemetry
ROTANN
NICORE™
Diagnostic Cardiology
External Counterpulsation
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Image /page/2/Picture/0 description: The image shows the word "ScottCare" in a stylized font. Above the "i" in ScottCare is a line that resembles a heartbeat. Below the word ScottCare is a line that also resembles a heartbeat.
800.243.9412 phone 216.267.6129 fax www.scottcare.com web
Substantial Equivalence:
| Features | The Modified Genesis Model | Predicate DeviceNCP-1 |
|---|---|---|
| 510(k) Number | TBD | K023016 |
| Date Cleared | TBD | 12/12/2002 |
| Intended Use | The intended use of the ScottCare Genesisdevice is to provide external counterpulsation(ECP) therapy, and is indicated for use in thetreatment of stable or unstable angina pectoris,congestive heart failure, cardiogenic shock,and acute myocardial infarction. | The intended use of the NCP-1 device is toprovide external counterpulsation (ECP)therapy, and is indicated for use in thetreatment of stable or unstable angina pectoris,congestive heart failure, cardiogenic shock, andacute myocardial infarction. |
| Bed Enclosure | Aluminum panels / welded | Furniture grade compressed wood / fasteners &glue |
| Pump | Integral compressor / vacuum220VAC 15A 60Hz (UL listed)50Hz Option (UL Listed) | Integral compressor / vacuum120VAC, 30A, 60Hz |
| nflate / Deflate Valve | 6 per bed, Voltage controlled24VDC | 6 per bed, Voltage controlled24VDC |
| Emergency relief valve | 3 per bed, Normally open, voltage controlled24VDC | 3 per bed, Normally open, voltage controlled110VAC |
| Vacuum Tank Relief Valve | 1 per bed, Voltage controlled24VDC | 1 per bed, Voltage controlled24VDC |
| Air Valve Type | Magnetic bobbin, Normally Closed, spring | Magnetic bobbin, Normally Closed, spring |
| Pressure Tank Relief | Mechanical Type Calibrated at 8PSI | Mechanical Type Calibrated at 8PSI |
| Power Supply | (2) Switching Medical GradeLocated in bed base | (2) Step down transformerLocated in the Operator's Console cabinet |
| Bed Function Control | Xilog Z-80 CPU integrated on motherboard | Xilog Z-80 CPU integrated on motherboard |
| Data Display Device | Flat Panel LCD Computer Display | CRT Display |
| Panel Control Type | Membrane style, momentary, panel type | Non-sealed, latching pushbutton, panel type |
| Operator's Console | Floor standing pole type W/casters | Metal enclosure, floor type W/casters |
Page 3 of 4
2-0003
TeleRehab®
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NICORE External Counterpulsation
Telemetry
.
Diagnostic Cardiology
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Image /page/3/Picture/0 description: The image shows the word "ScottCare" in a stylized font. A graphic resembling an electrocardiogram (ECG) tracing is incorporated into the design, with a sharp peak positioned above the "tt" in "ScottCare." The ECG line extends horizontally beneath the word, adding a medical or healthcare-related visual element to the logo.
800.243.9412 phone 216.267.6129 fax www.scottcare.com web
As the above chart demonstrates, the Genesis model ECP bed is substantially equivalent to the NCP-1 ECP bed that was cleared on December 12, 2002. Basic control functions remain unchanged and there are no significant technological changes to the device. The changes are predominantly cosmetic in nature and include:
- Changing from a CRT display screen to a flat panel LCD computer type display. .
- . Elimination of the large roll-around control console (that housed the CRT display) and utilize a pole style, roll around to mount the all-in-one computer /LCD display and control panel.
- Changing the construction of the bed base from compressed wood to aluminum ● and present a smaller overall footprint.
- Changing the control panel switches from latching, push-button style to a . momentary, membrane style. To support this change a minor software (firmware) change was required.
- Provision for 50Hz operation where required. .
- Simplification of the internal power supply to use switching, medical grade power . supplies instead of discrete step down / rectification.
- Emergency relief valves (normally open) were changed to operate at 24V DC . instead of at 120V AC. The control mechanism, construction and overall action of the valves remain unchanged. Lower voltage valve standardizes the control voltage within the device to a safer, 24V DC level.
The intended use of the modified device, as described in its labeling, has not changed as a result of these modifications. No technologically significant changes have occurred.
Conclusion:
Appropriate testing was conducted in accordance with established design control procedures. Testing demonstrated that the device functioned as designed and that the device was in compliance with IEC60601 Medical Device Safety and EMC testing requirements. The modified device, which is to be marketed as the "ScottCare Genesis" ECP Treatment device, is substantially equivalent to the predicate device.
2-0004
Page 4 of 4
NICORE External Counterpulsation
TeleRehab
Image /page/3/Picture/18 description: The image contains the logo for "ROZINN" in a stylized font with a trademark symbol. Below the logo, the text "Diagnostic Cardiology" is present. The text is in a simple, sans-serif font and is smaller than the logo.
Telemetry
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Food and Drug Administration
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2008
ScottCare Corporation Ronald J. Clines Manager Regulatory/Quality 4791 West 150th Street Cleveland, OH 44135
Re: K081359
Trade/Device Name: ScottCare Genesis External Counter Pulsation (ECP) Device Regulation Number: 21 CFR 870.5225 Regulation Name: External counter-pulsation device Regulatory Class: Class III (three) Product Code: DRN Dated: April 30, 2008 Received: May 15, 2008
Dear Mr. Clines:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Ronald J. Clincs
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
R. Vahmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use
| 510(k) Number (if known): | K081359 |
|---|---|
| --------------------------- | --------- |
Device Name: ScottCare Genesis External Counterpulsation Device
Indications for Use:
The intended use of the ScottCare Genesis ECP device is to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.
Prescription Use -(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Holmes
2-0005
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K081359
Page 1 of
§ 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.