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.
Device Story
Genesis ECP is non-invasive microprocessor-controlled system for external, sequential counterpulsation therapy. Device uses three pairs of air cuffs wrapped around patient calves, thighs, and buttocks. Microprocessor detects R-wave from ECG input, calculates heart rate, and triggers pneumatic valves to inflate cuffs sequentially during diastole (approx. 200ms) and evacuate simultaneously before systole (approx. 120ms). Inflation increases coronary perfusion pressure, coronary blood flow, and venous return; improves stroke volume and cardiac output. System comprises patient bed with pneumatic controls/valves/pump and operator console with all-in-one computer/monitor. Trained operator uses display to fine-tune inflation/deflation signals. Treatment typically 35 1-hour sessions, 5 days/week. Device automatically stops compression upon timer completion. Used in clinical settings.
Clinical Evidence
Bench testing only. Device performance verified through design control procedures, confirming functionality as designed and compliance with IEC60601 medical device safety and EMC standards.
Technological Characteristics
Microprocessor-controlled pneumatic system. Materials: aluminum bed base. Energy: 220VAC/50Hz or 120VAC/60Hz. Sensing: R-wave detection (ECG). Actuation: 6 magnetic bobbin valves per bed (24V DC). Connectivity: serial port for display data. Form factor: patient bed with floor-standing pole console. Software: firmware-based control.
Indications for Use
Indicated for patients with stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, or acute myocardial infarction.
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.
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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 Corporation<br>Registration No: 1527715<br>4791 West 150 <sup>th</sup> Street<br>Cleveland, OH 44135 |
| Contact Person: | Mr. Ronald J. Clines<br>216-362-0550 # 113<br>216-264-6129 Fax<br>rclines@scottcare.com |
| Manufacturing Site: | ScottCare Corporation<br>Registration No: 1063268<br>4897 W. Waters Ave, Suite J<br>Tampa, Florida 33634 |
| Trade Name: | ScottCare Genesis ECP Device |
| Common Name: | External Counter Pulsation (ECP) device |
| Classification: | 870.5225<br>External counter-pulsating device, |
| Product Code: | DRN |
| Legally Marketed Predicate Device(s): | Model NCP-1 Counter Pulsation Device<br>K023016, December 12, 2002 |
| | 2-0001 |
## દર
TeleRehab®
ROLINN
Page 1 of 4
NICORE
Telemetry
Diagnostic Cardiology
External Counterpulsation
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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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800.243.9412 phone 216.267.6129 fax www.scottcare.com web
## Substantial Equivalence:
| Features | The Modified Genesis Model | Predicate Device<br>NCP-1 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBD | K023016 |
| Date Cleared | TBD | 12/12/2002 |
| Intended Use | The intended use of the ScottCare Genesis<br>device is to provide external counterpulsation<br>(ECP) therapy, and is indicated for use in the<br>treatment of stable or unstable angina pectoris,<br>congestive heart failure, cardiogenic shock,<br>and acute myocardial infarction. | The intended use of the NCP-1 device is to<br>provide external counterpulsation (ECP)<br>therapy, and is indicated for use in the<br>treatment of stable or unstable angina pectoris,<br>congestive heart failure, cardiogenic shock, and<br>acute myocardial infarction. |
| Bed Enclosure | Aluminum panels / welded | Furniture grade compressed wood / fasteners &<br>glue |
| Pump | Integral compressor / vacuum<br>220VAC 15A 60Hz (UL listed)<br>50Hz Option (UL Listed) | Integral compressor / vacuum<br>120VAC, 30A, 60Hz |
| nflate / Deflate Valve | 6 per bed, Voltage controlled<br>24VDC | 6 per bed, Voltage controlled<br>24VDC |
| Emergency relief valve | 3 per bed, Normally open, voltage controlled<br>24VDC | 3 per bed, Normally open, voltage controlled<br>110VAC |
| Vacuum Tank Relief Valve | 1 per bed, Voltage controlled<br>24VDC | 1 per bed, Voltage controlled<br>24VDC |
| 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 Grade<br>Located in bed base | (2) Step down transformer<br>Located 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
{3}------------------------------------------------
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
{4}------------------------------------------------
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.
{5}------------------------------------------------
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
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
