(48 days)
No
The device description explicitly states that it applies a "previously published algorithm called the Vascular Access Pressure Ratio (VAPR) test" and identifies patterns based on a fixed rule (3 high readings in a row). There is no mention of learning from data or adapting its behavior, which are hallmarks of AI/ML.
No
The device is a software program that analyzes data from hemodialysis machines to alert healthcare professionals to an increased risk of access site stenosis. It does not directly provide therapy or interact with the patient's body for a therapeutic purpose. Its role is diagnostic/alerting, guiding proactive intervention, but not performing the intervention itself.
Yes
The device is described as software that assesses the risk of access site stenosis and issues a report indicating that the patient should be examined more closely for the onset of stenosis, which is a diagnostic function.
Yes
The device description explicitly states that Vasc-Alert is a "software program" and details its components as "modules" for data processing, calculation, pattern identification, reporting, and data input. It relies on data from hemodialysis machines but does not include any hardware components itself.
Based on the provided information, Vasc-Alert is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use states that the software is for "assessment of mercasse money is to be used with data generated from hemodialysis machines." While the wording is a bit unclear ("mercasse money"), the core function is to analyze data generated from a medical device (hemodialysis machine) to assess a patient's condition (risk of access site stenosis).
- Device Description: The description explicitly states that Vasc-Alert "utilizes measurements routinely collected during a dialysis treatment by the hemodialysis machine, such as pressure and flow rate." These measurements are biological data collected from the patient during a medical procedure.
- Function: The software analyzes this data to identify patterns (high VAPR readings) that indicate an increased risk of a medical condition (stenosis). This analysis of biological data to provide information about a patient's health status is a key characteristic of an IVD.
While the software itself doesn't directly interact with biological samples in vitro, it processes and analyzes data derived from a medical procedure that involves the patient's blood (hemodialysis). The analysis of this data provides diagnostic information about the patient's vascular access.
Therefore, Vasc-Alert fits the definition of an IVD because it is a device intended for use in the examination of specimens derived from the human body (in this case, data derived from the hemodialysis process involving the patient's blood) to provide information for diagnostic purposes.
N/A
Intended Use / 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.
Product codes
78 MQS
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals in a critical care setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Vasc-Alert (K030456)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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: | (773) 334-8177 |
| Fax: | (773) 334-8187 |
| E-Mail: | jkennedy@openchannelsoftware.com |
Date of preparation of this summary: September 15, 2004
General Information
| age of the contract and consistence of the consistent of the consistent of
Proprietary Name | Free with the country of the maint and commend of the country of the country of the county of the county of
Vasc-Alert: Vascular Data Analysis for Access Site Monitoring
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
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
1
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.
2
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 (800) 638-2041 or (301) 443-6597 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
3
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)