VASC-ALERT

K030456 · Vasc-Alert, LLC · KOC · Jul 11, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030456
• Device Name: VASC-ALERT
• Applicant: Vasc-Alert, LLC
• Product Code: KOC · Gastroenterology, Urology
• Decision Date: Jul 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Vasc-Alert vascular data analysis software is intended for use by Healthcare professionals in a noncritical care setting for assessment of increased risk of access site stenosis in patients with grafts, as an aid for vascular access site management. The software is to be used with data generated from hemodialysis machines manufactured by Fresenius and Cobe/Gambro.

Device Story

Vasc-Alert is software for monitoring hemodialysis access site patency. It ingests pressure and flow rate data routinely collected by Fresenius and Cobe/Gambro hemodialysis machines. The software applies the Vascular Access Pressure Ratio (VAPR) algorithm to these inputs to calculate VAPR values for each treatment session. These values are stored in a database. The system identifies patterns of three consecutive high VAPR readings and generates reports for medical staff. Used in dialysis centers by healthcare professionals, the output serves as a clinical decision support tool to prompt closer examination for incipient stenosis and proactive intervention. By identifying patients at risk, the device aims to prevent access site closure.

Clinical Evidence

No formal clinical trial data provided. Substantial equivalence supported by side-by-side testing comparing Vasc-Alert to predicate devices. Results indicated Vasc-Alert identified more patients at risk than predicates, with the majority of these patients developing access site complications within 3 months, validating the device's ability to indicate developing stenosis.

Technological Characteristics

Software-based analysis system. Inputs: pressure and flow rate data from hemodialysis machines. Algorithm: Vascular Access Pressure Ratio (VAPR) test. Connectivity: Internet-based data input module. Components: data recording/parsing module, VAPR calculation module, pattern identification module, report generation module.

Indications for Use

Indicated for patients with grafts undergoing hemodialysis to assess increased risk of access site stenosis. Intended for use by healthcare professionals in noncritical 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

• Transonic HD01 Hemodialysis Monitor (K960817 and K980906)
• Medisystems Access Alert (K002372)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUL 1 1 2003

# K030456 PAGE 1 OF 2 510(K) Summary

# 510(K) SUMMARY

#### 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: December 30, 2002

# General Information

| Proprietary Name | Vasc-Alert: Vascular Data Analysis for Access Site Monitoring |
|---------------------|----------------------------------------------------------------------------------------------------------|
| Common / Usual Name | Hemodialysis access site patency monitoring software |
| Classification Name | System, Hemodialysis, Access Recirculation Monitoring |
| Equivalent Devices | The Transonic HD01 Hemodialysis Monitor (K960817 and K980906)<br>and Medisystems Access Alert (K002372). |

# Device Description

Vasc-Alert is a software program for alerting dialysis center personnel of an increased risk of access site stenosis for individual 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:

- 해 A module for recording, transferring and parsing data collected by dialysis center machines.
- A module for calculating the VAPR values from treatment data. 특
- A module for identifying significant patterns in the calculated VAPR data that will prompt an alert (i.e., 3 high readings in a row for a patient).

{1}------------------------------------------------

K030456
PAGE 2 OF 2

510(K) Summary

- A module for generating reports and sending these out to center personnel. 트
- An internet-based data input module. I

### Intended Use

Vasc-Alert vascular data analysis software is intended for use by Healthcare professionals in a noncritical care setting for assessment of increased risk of access site stenosis in patients with grafts, as an aid for vascular access site management. The software is to be used with data generated from hemodialysis machines manufactured by Fresenius and Cobe/Gambro.

### Substantial Equivalence Comparison

The Vasc-Alert device is substantially equivalent to both the Transonic Flow Monitor and the Access Alert product because it has the same intended use (detection of the buildup of stenosis in the access site), and has proven in side-by-side testing that they can detect the same 'at risk' patients. The devices cited as equivalent also use essentially the same technology in their analysis (pressure and flow). Access Alert uses the same physical measurements as an indication of stenosis (pressure measurement). The Transonic Flow Monitor measures flow, which is directly related to pressure of Bernoulli's Principle. While Vasc-Alert identified more patients at risk than the other technologies, the majority of these patients did in fact develop complications in their access sites within 3 months, proving that Vasc-Alert can be used as an indication of stenosis developing in the access site.

### Safety and Effectiveness

The system is considered to be a MINOR risk for users and patients because:

- T it does not control a life supporting or life-sustaining device,
- it does not control the delivery of potentially harmful energy, 비
- 트 it does not control treatment delivery,
- it does not provide diagnostic information on which treatment or therapy is based, such that if I misapplied it could result in serious injury or death,
- I it does not perform vital signs monitoring.

As a practical matter, the reports generated by Vasc-Alert merely prompt medical staff to examine the patient more closely to confirm the degree of stenosis present and its location. Such an examination is common practice prior to any intervention.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1 2003

Mr. John Kennedy President Vasc-Alert L.L.C. 1807 W. Sunnyside Suite 301 CHICAGO IL 60640

Re: K030456

Trade/Device Name: Vasc-Alert Regulation Number: 21 CFR \$876.5820 Regulation Name: Hemodialysis systems and accessories Regulatory Class: II Product Code: 78 KOC Dated: June 13, 2003 Received: June 16, 2003

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 (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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

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

{4}------------------------------------------------

# INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known): K030456

Device Name: Vasc-Alert

Indications for Use:

Vasc-Alert vascular data analysis software is intended for use by Healthcare professionals in a noncritical care setting for assessment of increased risk of access site stenosis in patients, as an aid for vascular access site management. The software is to be used with data generated from hemodialysis machines manufactured by Fresenius and Cobe/Gambro.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Prescription Use* ✓

David A. Lynn

(Division Sign-Off) n of Reproductive. Al