(267 days)
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.
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.
Here's an analysis of the acceptance criteria and study information for the VERICIS Physiolog device, based on the provided text:
Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria or a direct comparison of its performance against those criteria in a table format. Instead, it describes a functional validation process. The "Predicate device specifications comparison" table, while comparing features, does not represent acceptance criteria met by the device under test.
However, based on the performance data section, we can infer the implicit acceptance criteria were that the device functioned appropriately for the specific tests performed.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Accurate R-Wave detection for rate meter and timing measurements | Responded appropriately to various ECG aberrations, rates, amplitudes, and deviations |
| Accurate pressure and valve measurements under various conditions | Responded appropriately to multiple pressure simulations |
| Accurate hemodynamic calculations based on oxygen saturation input | Responded appropriately to multiple oxygen saturation entries |
| Proper validation of data entry restrictions (error handling) | Responded appropriately to multiple erroneous and/or incongruous entries |
| Maintenance of data integrity across cases | Responded appropriately when multiple cases were created |
| Correct response of all command buttons | Responded appropriately when all command buttons were tested |
| Correct generation of various reports | Responded appropriately when multiple reports were generated |
| Compliance with patient isolation and leakage current standards (post-assembly) | Performed on each unit prior to packaging for shipment |
Study Details:
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Sample Size Used for Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a number of patients or cases. The testing involved "various types of ECG aberrations," "multiple pressures," "multiple oxygen saturations," "multiple erroneous and/or incongruous entries," and "multiple cases." This suggests a varied test suite but no specific count of simulated data points or cases.
- Data Provenance: The data was generated using physiologic simulators. This indicates that the data was synthetic/simulated, not derived from human patients. The country of origin is not applicable as it was simulated data. It was retrospective in the sense that the simulated scenarios were pre-defined for testing.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The ground truth for the simulated data points (e.g., correct R-wave detection for a given simulated ECG, correct pressure calculation for a given simulated pressure waveform) would be inherent in the design of the physiologic simulators and the expected output of the device. There's no mention of human experts establishing ground truth for these simulated scenarios.
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Adjudication Method for the Test Set:
- Not applicable. Since the ground truth was based on simulator output and expected device behavior, human adjudication of results against a separate expert consensus was not performed or mentioned.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study assesses human reader performance, often with and without AI assistance. The testing described for VERICIS Physiolog exclusively focuses on the device's standalone functional performance with simulated data and does not involve human readers or clinical efficacy studies.
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Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Yes. The described "Performance data" section details testing of the VERICIS Physiolog software and system in a standalone capacity using physiologic simulators. The device's "appropriate response" to various simulated conditions was assessed as purely algorithmic and system function.
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Type of Ground Truth Used:
- Simulated data ground truth / Expected algorithmic output: The ground truth for the performance tests was based on the known, expected output of a properly functioning physiologic data recording system given the inputs from the physiologic simulators. This is not expert consensus, pathology, or outcomes data.
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Sample Size for the Training Set:
- Not applicable. The document does not describe the use of machine learning or AI models that would require a distinct training set. The device appears to be a rule-based system for monitoring, measuring, and recording physiologic data.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as no training set for a machine learning model is mentioned.
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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 | CamtronicsVERICIS Physiolog | Witt Biomedical Central StationMonitoring 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;Windows 2000 | PC-based off-the-shelf hardware, Windows |
| User interface | Keyboard, mouse | Keyboard, mouse |
| Automated hemodynamic dataanalysis functions | Continuous systolic, diastolic, andmean pressure, wedge, end diastolicpressure.Gradients by pullback or differentialpressure. Valve area calculations.Automatic beat selection. Resistance,shunt, and flow calculations. Assumedoxygen consumption.AJI calculations may be displayed forverification or edit. | Instantaneous hemodynamic results and on-line QCA |
| Automatic time stamped log ofcatheterization events andprocedures | Menu selection from customizedprotocols, automatic entries, and freetext. Correlated by time to waveformrecordings and measurements. Alsomenu selections for emergencyprotocols 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 (301) 594-4646. 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). 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 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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§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).