FLOSTAT VASCULAR REPORT GENERATOR (VRG) by BIOMEDIX, INC.

The BioMedix, Inc. Flostat Vascular Report Generator is a device for the use to display the outputs from three strip chart recorder based peripheral vascular diagnostic instruments on a PC printer. In essence, this is changing one printer for another. This generic device can bu used to input a signal from any device into a is intended soley for use in conjunction with computer but Blood pressures, displayed peripheral diagnostic instruments. digitally, may be recorded with the original cuffs provided by the original manufacturer. No change in equipment or technique is warranted.

The three target devices are the Imex Corp. 3000 Series, 301 The Life Sciences Corp./HealthWatch PVR Series Series, and All these incorporate analog or digital pen diagnostic devices. strip chart recorders to display the output waveforms. The sole use of the VRG is to display the waveforms on the PC printer. une lowest resolution dot matrix printer with 90x90 dots per inch(and certainly much higher resolution laser printers) has a much higher resolution than the relatively meager 100 Hz bandwidth that an analog pen recorder can provide. No alterations in the clinical instructions, indications, methodologies, or outcomes will occur. The VRG is simply connected to an analog output path on the target The VRG is then connected(via a high ESD rated RS-232 device. driver) to the computer. The waveforms are brought into the computer and the opportunity is provided for printing to a printer. The intended use of the VRG-Vascular Diagnostic Unit tandem is the the original intended use of the original vascular same diagnostic unit(ie. peripheral vascular studies).

The BMX Vascular Report Generator passes the output information of a peripheral vascular deviceto a computer and then onto a printer. All ourputs of a peripheral vascular device, throuhg the VRG, can displayed, including data that can be shown as a spectrum analysis. The Vascular Report Generator does not change the output of a peripheral vascular devicebut only allows the computer to display the informan: in various forms .

Device Description

The BioMedix, Inc. Flostat Vascular Report Generator is a device for the use to display the outputs from three strip chart recorder based peripheral vascular diagnostic instruments on a PC printer.

AI/ML Overview

The provided documentation, a 510(k) submission for the Flostat Vascular Report Generator (VRG), focuses on demonstrating substantial equivalence to existing devices rather than presenting a detailed study with acceptance criteria and device performance metrics in the typical sense of a clinical trial for diagnostic accuracy.

The core argument for the VRG's acceptance revolves around its function as a printer substitute and its ability to display outputs from existing peripheral vascular diagnostic instruments. The "acceptance criteria" can therefore be inferred as the VRG's ability to accurately and without degradation convert and display the data from the listed diagnostic devices on a PC printer, mirroring the output of the original strip chart recorders.

Here's an attempt to extract the requested information based on the provided text, recognizing that much of it is not explicitly stated in a typical study report format:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Accurate Display of Waveforms: The VRG must accurately display waveforms from target peripheral vascular diagnostic instruments (Imex 3000 Series, Imex 301 Series, Life Sciences Corp./HealthWatch PVR Series) on a PC printer.	The VRG "is changing one printer for another." "The sole use of the VRG is to display the waveforms on the PC printer.""The waveforms are brought into the computer and the opportunity is provided for printing to a printer.""The BMX Vascular Report Generator passes the output information of a peripheral vascular device to a computer and then onto a printer.""All outputs of a peripheral vascular device, through the VRG, can be displayed."
Preservation of Resolution: The display resolution on a PC printer (even low-res dot matrix) must be equal to or better than the original strip chart recorder.	"The lowest resolution dot matrix printer with 90x90 dots per inch (and certainly much higher resolution laser printers) has a much higher resolution than the relatively meager 100 Hz bandwidth that an analog pen recorder can provide."
No Alteration of Clinical Instructions, Indications, Methodologies, or Outcomes: The VRG should not introduce any changes to the existing clinical use of the diagnostic instruments.	"No alterations in the clinical instructions, indications, methodologies, or outcomes will occur.""The intended use of the VRG-Vascular Diagnostic Unit tandem is the same as the original intended use of the original vascular diagnostic unit (ie. peripheral vascular studies).""The Vascular Report Generator does not change the output of a peripheral vascular device but only allows the computer to display the information in various forms."
No Change in Equipment or Technique for Blood Pressure Recording (if applicable to original device): If the original device recorded blood pressures, the VRG's use should not necessitate changes in cuffs or technique.	"Blood pressures, displayed digitally, may be recorded with the original cuffs provided by the original manufacturer. No change in equipment or technique is warranted."

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

Sample Size: Not explicitly stated. The submission refers to "the three target devices are the Imex Corp. 3000 Series, 301 The Life Sciences Corp./HealthWatch PVR Series Series, and All these incorporate analog or digital pen diagnostic devices." This implies testing (or at least compatibility assessment) across these three models. However, the number of cases or patients tested with the VRG is not provided.
Data Provenance: Not specified. It's likely an internal company assessment given the nature of a 510(k) submission, not a broad clinical study. The location of BioMedix, Inc. is Camden, N.J., USA, so the underlying data would presumably be from the US, but this is not explicitly stated for the "test set" (if one even existed in a formal sense). It is retrospective in the sense that it relies on the established performance of existing devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. Given the nature of the device (a report generator/printer interface), the "ground truth" would likely be the direct, original output from the strip chart recorders of the peripheral vascular diagnostic instruments themselves. It's unlikely that external medical experts were formally used to establish ground truth for the display accuracy of the VRG.

4. Adjudication Method for the Test Set

Not applicable/Not provided. There's no indication of independent adjudication or a formal adjudication process. The assessment appears to be a technical verification that the VRG can correctly transmit and display the data.

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

No, an MRMC study was not done. The VRG is not an AI diagnostic tool and does not involve human readers interpreting its output in a comparative effectiveness study against a baseline. Its function is to display data, not interpret it.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in a conceptual sense. The "performance" of the VRG is its ability to transmit and print data accurately, independently of human interpretation of that data. The statement "The Vascular Report Generator does not change the output of a peripheral vascular device but only allows the computer to display the information" indicates a standalone function of data conveyance. The device is not making diagnostic decisions; it is reflecting the output of other diagnostic devices.

7. Type of Ground Truth Used

The "ground truth" implicitly referred to is the output waveform/data directly from the original manufacturer's peripheral vascular diagnostic instruments operating via their original strip chart recorders. The VRG's performance is gauged against its ability to faithfully reproduce this known output on a different medium (PC printer).

8. Sample Size for the Training Set

Not applicable/Not provided. The VRG is described as a "generic device" that can "input a signal from any device." This strongly suggests it's a hardware/software interface designed to work with any analog output pathway or specific digital signals, not a machine learning model that requires a "training set" in the conventional sense. Its "training" would be its engineering design to correctly interpret and display signals, not a data-driven learning process.

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

Not applicable/Not provided, as there is no "training set" for an AI or machine learning model. The ground truth for its engineering design would be the specifications and expected output characteristics of the analog and digital signals from the target peripheral vascular devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 1997

David Lerner Sr. Engineer BioMedix, Inc. P.O. Box 1419 Camden, N.J. 08105 Re:

K973857 Flostat Vascular Report Generator (VRG) Dated: September 22, 1997 Received: October 9, 1997 Regulatory Class: II 21 CFR 892.1540/Procode 90 JAF

Dear Mr. Lerner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K973857 510(k) : Jumber (if known): VASCULAR REPORT CENERATOR LOSTAT Device Name:

Indications For Use:

(PLE \SE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

and Radiological Devices 510(k) Number

Prescripti ›› Use (Per 21 C!JR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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Intended Use.

Regulation Number and Section

§ 892.1540 Nonfetal ultrasonic monitor.

(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.