(253 days)
Not Found
Unknown
The summary mentions "Software collects and analyzes data, summarizes results and suggests possible implications of abnormalities observed." and "suggest interpretive statements based on the results of the analysis". While this could potentially involve AI/ML for interpretation and suggestions, the summary does not explicitly state the use of AI, ML, DNN, or provide details about training/test sets, which are common indicators of AI/ML in medical devices. Therefore, it's not possible to definitively confirm or deny the presence of AI/ML based on this information alone.
No.
The primary purpose of this device is to collect and analyze physiological data during exercise stress tests, which is for diagnostic and monitoring purposes rather than direct therapeutic intervention.
Yes
The device is used for exercise tests to collect and analyze gas exchange and pulse rate information and suggest interpretive statements based on the results, indicating its role in diagnosis.
No
The device description explicitly lists multiple hardware components (flow sensor, gas analyzers, pulse oximeter, analog/digital converter, personal computer) that are part of the system, in addition to the software.
Based on the provided information, the ORCA System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ORCA System function: The ORCA System measures gas exchange and extracts pulse rate information during exercise stress testing. This involves analyzing exhaled air and potentially integrating with ECG data, which are measurements taken from the body during a physiological process, not tests performed on samples taken from the body.
- Intended Use: The intended use clearly states "exercise tests where the collection and analysis of gas exchange and extraction of pulse rate information from ECG during exercise stress testing is needed." This describes a physiological monitoring and analysis system, not a diagnostic test performed on a sample.
- Device Description: The description details components that measure and analyze exhaled air flow and content, and a pulse oximeter. These are all devices that interact with the body or its outputs directly during a test, not devices that analyze samples.
Therefore, the ORCA System falls under the category of a physiological monitoring and analysis device used during exercise stress testing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ORCA System is indicated for use in exercise tests where the collection and analysis of gas exchange and extraction of pulse rate information from ECG during exercise stress testing is needed. Further, the device will suggest interpretive statements based on the results of the analysis and the reasons for the test termination. The intended patients are adults and children and the intended environment of use is indoors.
Product codes (comma separated list FDA assigned to the subject device)
BZM, BTY
Device Description
The ORCA Cardiopulmonary Exercise Testing System is a self-contained unit designed to provide patient respiratory gas exchange data during exercise stress testing. The system consists of components which measure the flow of exhaled air, and analyze the oxygen and carbon dioxide content of the exhaled air. A transcutaneous pulse oximeter reports heart rate and oxygen content of the arterial blood. Instruments are interfaced to a Pentium-based personal computer through a 16 channel, 12 bit analog/digital converter. As an option, information can be integrated with electrocardiographic information provided by external EKG equipment (EKG equipment is not provided with the ORCA system). Software collects and analyzes data, summarizes results and suggests possible implications of abnormalities observed.
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
Adults and children
Intended User / Care Setting
Pulmonologists, Cardiologists and Sports Medicine physicians / Cardiology, Pulmonary and Sports Medicine clinics and physician offices; Hospitals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1900 Diagnostic pulmonary-function interpretation calculator.
(a)
Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.(b)
Classification. Class II (performance standards).
0
JUL 21 1998
Attachment 2
510(k) Summary ORCA Cardiopulmonary Exercise Testing System ORCA Diagnostics Corporation July 18, 1998
| Product Name: | Current Trade Name: ORCA Cardiopulmonary Exercise Testing
System.TM |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Generic Name: | Cardiopulmonary exercise or stress
testing equipment |
| Classification Name: | Calculator, pulmonary function interpreter; 21 CFR 868.1900,
classification code BZM and Calculator, predicted values,
pulmonary. Function, 21 CFR 868.1890, code BTY, both
designated as Class II devices |
| Contact Person: | Sheila W. Pickering Ph.D.
P.O. Box 1951
Los Altos, California 94123
Telephone/Fax 650 969 6114 |
A. Legally Marketed Predicate Device
The ORCA Cardiopulmonary Exercise Testing System is substantially equivalent to the MedGraphics Exercise Consult (K923209) manufactured by Medical Graphics, Inc, and the Vmax 229 Series, Pulmonary/metabolic System (K942211) manufactured by Sensormedics, Inc., which are both hardware and software devices. The ORCA device is substantially equivalent to the predicate devices with regard to device features and specifications, as well as intended use. All devices are cardiopulmonary exercise/stress evaluation systems with similar operating requirements. The application is based on standard clinical procedures.
B. Device Description
The ORCA Cardiopulmonary Exercise Testing System is a self-contained unit designed to provide patient respiratory gas exchange data during exercise stress testing. The system consists of components which measure the flow of exhaled air, and analyze the oxygen and carbon dioxide content of the exhaled air. A transcutaneous pulse oximeter reports heart rate and oxygen content of the arterial blood. Instruments are interfaced to a Pentium-based personal computer through a 16 channel, 12 bit analog/digital converter. As an option, information can be integrated with electrocardiographic information provided by external EKG equipment (EKG equipment is not provided with the ORCA system). Software collects and analyzes data, summarizes results and suggests possible implications of abnormalities observed.
1
C. Intended Use
C. Intented Coo of gas exchange and extraction of pulse rate information from ECG during exercise stress testing is needed. Further, the device will suggest interpretive statements based on the tesults of the analysis and the reasons for the test termination. The intended patients are results of the unalysis and the intended environment of use is indoors. The ORCA System Product Manual provides warnings and precautions regarding intended use, detailed information on system operation, and further information on interpretive features.
D. Substantial Equivalence
The following tables show the basis for substantial equivalence
| Predicate Devices | Submission Device | ||
|---|---|---|---|
| Product Name | Medgraphics CPX/D | ||
| K923209 | Sensormedics Vmax 229 | ||
| K942211 | ORCA Diagnostics | ||
| Intended Use* | Collection and analysis of | ||
| gas exchange and extraction | |||
| of pulse rate from ECG | |||
| during stress testing | Collection and analysis of | ||
| gas exchange and extraction | |||
| of pulse rate from ECG | |||
| during stress testing | Collection and analysis | ||
| of gas exchange and | |||
| extraction of pulse rate | |||
| from ECG during stress | |||
| testing | |||
| Intended | |||
| Users | Pulmonologists, | ||
| Cardiologists and Sports | |||
| Medicine physicians | Pulmonologists, | ||
| Cardiologists and Sports | |||
| Medicine physicians | Pulmonologists, | ||
| Cardiologists and | |||
| Sports Medicine | |||
| physicians | |||
| Intended | |||
| Population | Not specified in labeling | Not specified in labeling | Adults and children |
| referred for stress | |||
| testing | |||
| Site of Use | Cardiology, Pulmonary and | ||
| Sports Medicine clinics and | |||
| physician offices; Hospitals | Cardiology, Pulmonary and | ||
| Sports Medicine clinics and | |||
| physician offices; Hospitals | Cardiology, Pulmonary | ||
| and Sports Medicine | |||
| clinics and physician | |||
| offices; Hospitals | |||
| Measurements | Expired concentration of | ||
| O2 and CO2, expired air | |||
| flow, O2 saturation, pulse | |||
| rate | Expired concentration of | ||
| O2 and CO2, expired air | |||
| flow, O2 saturation, pulse | |||
| rate | Expired concentration | ||
| of O2 and CO2, expired | |||
| air flow, O2 saturation, | |||
| pulse rate | |||
| Patient | |||
| Interfaces | ECG electrodes, disposable | ||
| pneumotach, pulse | |||
| oximeter | ECG electrodes, disposable | ||
| pneumotach, pulse | |||
| oximeter | ECG electrodes, | ||
| disposable | |||
| pneumotach, pulse | |||
| oximeter | |||
| Accessories | Integrated gas calibrator | Integrated gas calibrator | Integrated gas |
| calibrator |
Substantial Equivalence Comparison Table
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the head, body, and tail feathers. The logo is simple and recognizable, and it is often used on official documents and websites related to health and human services in the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ORCA Diagnostics, Inc. c/o Sheila W. Pickering, Ph.D. P.O. Box 1951 Los Altos, CA 94019
Re: K974200 ORCA Cardiopulmonary Exercise Testing System Requlatory Class: II (two) Product Code: 73 BZM Dated: June 24, 1998 Received: June 26, 1998
Dear Dr. Pickering:
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 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, Druq, and Cosmetic Act (Act). 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 reqistration, 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 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 requirements, 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Sheila W. Pickering, Ph.D.
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 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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,
Thomas J. Callshan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
FDA Submission Cover Sheet
510(k) Number (if known): K974200
Device Name: ORCA Cardiopulmonary Exercise Testing System
Indications For Use:
The ORCA System is indicated for use in exercise tests where the collection and analysis of gas exchange and extraction of pulse rate information from ECG during exercise stress testing is needed. Further, the device will suggest interpretive statements based on the results of the analysis and the reasons for the test termination. The intended patients are adults and children and the intended environment of use is indoors.
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Concurrence Of CDRH, Office Of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21CFR 801)