PHYSIOLOG, SERIES 95000

K013032 · Camtronics, Ltd. · DQK · Jun 4, 2002 · Cardiovascular

Device Facts

• Record ID: K013032
• Device Name: PHYSIOLOG, SERIES 95000
• Applicant: Camtronics, Ltd.
• Product Code: DQK · Cardiovascular
• Decision Date: Jun 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

VERICIS Physiolog monitors, measures, and/or records physiologic data and patient images from a patient undergoing a cardiac catheterization procedure. VERICIS Physiolog is intended for use in hospital cardiac catheterization laboratories.

Device Story

VERICIS Physiolog is a PC-based cardiac catheterization lab physiologic data recording system; operates on Windows 2000. Inputs include 12-lead EKG, respiratory rate, invasive pressures, NIPB, and SpO2. System performs automated hemodynamic analysis including systolic/diastolic/mean pressures, valve area, resistance, shunt, and flow calculations; provides automatic beat selection and time-stamped event logging. Used by clinicians in hospital cardiac cath labs; interfaces with digital imaging systems and hospital information systems (HIS). Output displayed on CRT color monitor; assists physicians in real-time clinical decision-making during catheterization procedures by providing hemodynamic data and procedure documentation.

Clinical Evidence

No clinical data. Bench testing only. Software validated using physiologic simulators to test R-wave detection, pressure/valve analysis, hemodynamic calculations, and data entry restrictions. System integrity and report generation functions were verified through simulated case creation.

Technological Characteristics

PC-based off-the-shelf hardware; Windows 2000 OS. Inputs: 12-lead EKG, respiratory rate, 4 invasive pressure channels, NIPB, SpO2. Connectivity: HIS interface, digital imaging system interface. User interface: keyboard and mouse. Display: CRT color monitor. Patient isolation and leakage current testing performed per unit.

Indications for Use

Indicated for patients undergoing cardiac catheterization procedures in hospital settings for monitoring, measurement, and recording of physiologic data and images.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Witt Biomedical Series IV Physiomonitoring System (K950436)
• Witt Biomedical Central Station Monitoring System (K973474)

Submission Summary (Full Text)

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K013032

## JUN 0 4 2002

## 510(k) Summary

Date prepared: May 31, 2002 Name of contact person: Scott Pease Device trade name: VERICIS Physiolog Common name: Cardiac Cath Lab Physiologic Data Recording System Classification name: Predicate substantially equivalent devices: K950436 Witt Biomedical Series IV Physiomonitoring System Device description and intended use: VERICIS Physiolog monitors, measures, and/or records physiologic data and patient images from a patient undergoing a cardiac catheterization procedure. VERICIS Physiolog is intended for use in hospital cardiac catheterization laboratories.

Predicate device specifications comparison:

| Feature | Camtronics<br>VERICIS Physiolog | Witt Biomedical Central Station<br>Monitoring System K973474 and Series |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| | | IV Physiomonitoring System K950436 |
| Signals transduced | 12-lead EKG (heart rate) | 12-lead EKG (heart rate) |
| | Respiratory rate | Respiratory rate |
| | 4 invasive pressures | Invasive pressures |
| | NIPB/SpO2 | NIPB/SpO2 |
| Cardiac output | Yes | Yes |
| Display screens | CRT color monitor | CRT color monitor |
| HIS Interface | Yes, optional | Yes, optional |
| Digital Imaging System Interface | Yes | Yes |
| Computer system | PC-based off-the-shelf hardware;<br>Windows 2000 | PC-based off-the-shelf hardware, Windows |
| User interface | Keyboard, mouse | Keyboard, mouse |
| Automated hemodynamic data<br>analysis functions | Continuous systolic, diastolic, and<br>mean pressure, wedge, end diastolic<br>pressure.<br>Gradients by pullback or differential<br>pressure. Valve area calculations.<br>Automatic beat selection. Resistance,<br>shunt, and flow calculations. Assumed<br>oxygen consumption.<br>AJI calculations may be displayed for<br>verification or edit. | Instantaneous hemodynamic results and on-<br>line QCA |
| Automatic time stamped log of<br>catheterization events and<br>procedures | Menu selection from customized<br>protocols, automatic entries, and free<br>text. Correlated by time to waveform<br>recordings and measurements. Also<br>menu selections for emergency<br>protocols and medications. | Same |

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Page 2 Camtronics VERICIS Physiolog 510(k) Summary May 29, 2002

Performance data: The VERICIS Physiolog software was tested using physiologic simulators. Various types of ECG aberrations, rates, amplitudes, and deviations were used for validation of R-Wave detection for the rate meter and timing measurements related to pressure analysis. Multiple pressures were simulated under various conditions to validate the pressure and valves. Multiple oxygen saturations were entered to validate hemodynamic calculations. Multiple erroneous and/or incongruous entries were made in data entry locations to validate data entry restrictions. Multiple cases were created to validate data integrity. All command buttons were tested for their appropriate response. Multiple reports were generated to validate the report generation functions. The software responded appropriately in the tests described. After assembly is completed, each unit undergoes final product testing. Patient isolation and leakage current tests are to be performed on each unit prior to packaging for shipment.

Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device.

Substantial equivalence summary: The Camtronics VERICIS Physiolog System is a comparable type and substantially equivalent to a legally marketed predicate device. The intended use of the Camtronics VERICIS Physiolog System is the same as that of the predicate device "Series IV Physiomonitoring System" marketed by Witt Biomedical. No new safety or effectiveness issues are raised with the Camtronics VERICIS Physiolog System. The subject device has substantially equivalent technological characteristics, features, materials, modes of operation, and intended uses as a legally marketed predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 0 4 2002

Camtronics Medical Systems c/o Mr. Scott J. Pease Director, Quality Assurance and Regulatory Affairs 900 Walnut Ridge Drive P.O. Box 950 Hartland. WI 53029

Re: K013032

Trade Name: Vericis Physiolog Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DOK Dated: March 27, 2002 Received: March 29, 2002

Dear Mr. Pease:

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 such 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.

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Page 2 - Mr. Scott J. Pease

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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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). 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 vours.

QabTuk

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Ver/ 3 - 4/24/96 | |
|---------------------------|----------------------------|
| Applicant: | Camtronics Medical Systems |
| 510(k) Number (if known): | K013032 |
| Device Name: | VERICIS Physiolog |
| | Page 1 of 1 |

Indications For Use:

VERICIS Physiolog monitors, measures, and/or records physiologic data and patient images from a patient undergoing a cardiac catheterization procedure. VERICIS Physiolog is intended for use in hospital cardiac catheterization laboratories.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division of Cardiovascular & Respiratory Devices | |
|--------------------------------------------------|-------------------------------------------------------------------------------------|
| 510(k) Number | K013032 |
| | (Per 21 CFR 801.109) Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) |

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