VASC-ALERT

K042566 · Vasc-Alert, Inc. · MQS · Nov 8, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K042566
• Device Name: VASC-ALERT
• Applicant: Vasc-Alert, Inc.
• Product Code: MQS · Gastroenterology, Urology
• Decision Date: Nov 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

Vasc-Alert vascular data analysis software is intended for use by Healthcare professionals in a non-critical care setting for assessment of access site stenosis in patients with grafts and fistulas. It is to be used with data generated from hemodialysis machines.

Device Story

Vasc-Alert is software for monitoring hemodialysis access site patency. It ingests routine hemodialysis machine data (pressure, flow rate); applies the Vascular Access Pressure Ratio (VAPR) algorithm to calculate values per treatment session; stores results in a database. The system identifies significant patterns—specifically three consecutive high VAPR readings—to trigger alerts. Reports are generated and sent to clinical staff to indicate potential stenosis. Used in dialysis centers by medical staff to proactively monitor patients, facilitate early intervention, and prevent access site closure.

Clinical Evidence

No clinical data provided. The device relies on the previously published Vascular Access Pressure Ratio (VAPR) algorithm for data analysis.

Technological Characteristics

Software-based data analysis system. Operates via internet-based data input module. Components include data recording/parsing, VAPR calculation, pattern identification, report generation, and database storage. No specific hardware materials or energy sources defined as it is a software-only device.

Indications for Use

Indicated for healthcare professionals to assess access site stenosis in hemodialysis patients with grafts and fistulas in non-critical care settings.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• Vasc-Alert (K030456)

Submission Summary (Full Text)

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# 510(K) SUMMARY

NOV - 8 2004

### Submitter's Name

Vasc-Alert L.L.C. 1807 W. Sunnyside Ave. Suite 301 Chicago, IL 60640

# Contact Person

| John Kennedy, President | |
|-------------------------|----------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| E-Mail: | [e-mail] |

# Date of preparation of this summary: September 15, 2004

#### General Information

| age of the contract and consistence of the consistent of the consistent of<br>Proprietary Name | Free with the country of the maint and commend of the country of the country of the county of the county of<br>Vasc-Alert: Vascular Data Analysis for Access Site Monitoring<br>and the production of the subscribed on the production of the comments of the comments of the first | | |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| been a manufacturer a market in the state of the subscribed on the | Common / Usual Name Hemodialysis access site patency monitoring software<br>A subscription and states and second and commend and commend and the comments of the comments of | | |
| The production of the program station of the commend the street and the status and | System, Hemodialysis, Access Recirculation Monitoring | | |
| Classification Name | ad would and the country of the country and concern and the more of the successful and | | |
| page of the complex were a series and security of the section and any and | Vasc-Alert (K030456) | | |
| Equivalent Devices | Production of Arman Annual Property Comments of Children Comments of Children | | |

# Device Description

Vasc-Alert is a software program for alerting dialysis center personnel of an increased risk of access site vace institutional hemodialysis patients. Vasc-Alert utilizes measurements routinely collected during a dialysis treatment by the hemodialysis machine, such as pressure and flow rate, and applies a previously published algorithm called the Vascular Access Pressure Ratio (VAPR) test to these measurements. The average VAPR test result for each treatment session is stored in a Vasc-Alert database. If a patient has a high reading in three consecutive dialysis sessions, a report is issued to the medical staff indicating that the patient should be examined more closely for the onset of stenosis. Hemodialysis center personnel can use the report as a tool to proactively monitor for incipient stenosis and prompt proactive intervention to avoid site closure.

Vasc-Alert comprises five main components or modules:

- A module for recording, transferring and parsing data collected by dialysis center machines. I
- A module for calculating the VAPR values from treatment data. .
- A module for identifying significant patterns in the calculated VAPR data that will prompt an 트 alert (i.e., 3 high readings in a row for a patient).
- A module for generating reports and sending these out to center personnel. l
- An internet-based data input module. 이

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2004

Mr. John B. Kennedy President Vasc-Alert, LLC 1807 W. Sunnyside Avenue, Suite 301 CHICAGO IL 60640

Re: K042566 Trade/Device Name: Vasc-Alert Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 MQS Dated: September 17, 2004 Received: September 21, 2004

Dear Mr. Kennedy:

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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I levice 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); 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.

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmadsmam.html

Sincerely vours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known) K042566
(Note: original submission for Vasc-Alert was K030456)

Vasc-Alert Device Name:

#### Indications for Use:

Vasc-Alert vascular data analysis software is intended for use by Healthcare professionals in a non-Vasc-Afert vascular data analysis software is nave access site stenosis in patients with grafts and critical care setting for assessment of mercasse money is to be used with data generated from hemodialysis machines.

(Please do not WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

NancyC brogdon
Division Sign-Off

Division of Repro and Radiological Device

510(k) Number

Prescription Use
(Per 21 CFR 801.109)