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.

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:

A module for recording, transferring and parsing data collected by dialysis center machines.
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 alert (i.e., 3 high readings in a row for a patient).
A module for generating reports and sending these out to center personnel.
An internet-based data input module.

AI/ML Overview

The provided text does not contain specific acceptance criteria, reported device performance metrics, or details about a study designed to prove the device meets these criteria. The document is a 510(k) summary for the Vasc-Alert device, primarily focusing on its description, intended use, and substantial equivalence to predicate devices, rather than a detailed performance study report.

However, based on the narrative, we can infer some aspects and highlight what information is missing:

Inferred Information:

The core function of Vasc-Alert is to identify an "increased risk of access site stenosis" when a patient has a "high reading in three consecutive dialysis sessions" based on the Vascular Access Pressure Ratio (VAPR) test. The "study" mentioned isn't a formalized clinical trial with defined endpoints and acceptance criteria, but rather a "side-by-side testing" for substantial equivalence.

Here's an attempt to structure the information based on your request, noting significant gaps:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Inferred from Substantial Equivalence Claim)
Identify patients at risk of stenosis.	Vasc-Alert "identified more patients at risk than the other technologies."
Patients identified as 'at risk' by Vasc-Alert develop complications within a reasonable timeframe (e.g., 3 months).	"the majority of these patients [identified by Vasc-Alert as at risk] 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."
Similar intended use to predicate devices (detection of stenosis buildup).	Vasc-Alert has "the same intended use (detection of the buildup of stenosis in the access site)."
Uses similar technology/measurements as predicate devices (pressure and flow).	"uses essentially the same technology in their analysis (pressure and flow)."

Missing Information:

Specific quantitative acceptance criteria: There are no defined thresholds for sensitivity, specificity, positive predictive value, negative predictive value, or accuracy for identifying "at risk" patients or predicting complications.
Detailed performance metrics: Beyond the qualitative statements, no numerical data (e.g., exact percentages of patients identified, or precise proportion of those who developed complications) is provided.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document only refers to "side-by-side testing" without providing the number of patients or dialysis sessions included.

Data Provenance: Not specified. It doesn't mention the country of origin, whether the data was retrospective or prospective, or from how many centers.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Number of Experts: Not specified.

Qualifications of Experts: Not specified. The phrase "medical staff" is used when referring to who examines the patient after an alert, but it's unclear if these or other experts were involved in establishing the ground truth for the "side-by-side testing."

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. There is no information about how the "complications" were confirmed or how ground truth was established for the "side-by-side testing."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not reported. The device is software that generates alerts, and the text describes its standalone performance and comparison to other technologies, not a human-AI comparison.

Effect Size: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: Yes, a standalone (algorithm only) performance was implicitly reported as the "side-by-side testing" where Vasc-Alert identified patients at risk and predicted complications within 3 months. The software's ability to trigger an alert based on VAPR readings in three consecutive sessions constitutes its standalone performance.

Missing Information: Quantitative results for this standalone performance (e.g., sensitivity, specificity, predictive values).

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used for performance inference was outcomes data, specifically whether "complications in their access sites" developed within 3 months after Vasc-Alert identified them as "at risk." This implies clinical diagnosis of stenosis or related complications.

8. Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document describes the algorithm as "a previously published algorithm called the Vascular Access Pressure Ratio (VAPR) test," implying the algorithm itself was developed or validated prior to this submission, but does not provide details on Vasc-Alert's specific training set if any machine learning was involved (which is unlikely given the description of a fixed algorithm).

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not specified. Since the VAPR algorithm is stated to be "previously published," the details of its development and the establishment of ground truth for its initial formulation are outside the scope of this 510(k) summary. No specific training data or ground truth establishment for Vasc-Alert's software implementation is detailed.

Summary

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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:	(773) 334-8177
Fax:	(773) 334-8187
E-Mail:	jkennedy@openchannelsoftware.com

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)and Medisystems Access Alert (K002372).

Device Description

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).

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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.

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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.

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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 the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known): K030456

Device Name: Vasc-Alert

Indications for Use:

(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

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
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.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.