(160 days)
Not Found
No
The summary describes a system for acquiring, calculating, and transmitting physiological data using standard modules (NIBP, SP02). There is no mention of AI, ML, or any learning algorithms used for data processing or analysis. The performance testing focuses on equivalence to predicate devices using simulated data, not on the performance of a learning model.
No
The device is used for the "acquisition, calculation, and transmission of physiological parameters" and functions as an accessory for gathering and transmitting data, rather than directly treating a condition.
Yes
The device acquires, calculates, and transmits physiological parameters (blood pressure, blood oxygen saturation, and heart rate), which are measurements used to inform a diagnosis or monitor a patient's condition.
No
The device description explicitly states the device is made up of a metal enclosure with compartments for hardware modules (non-invasive blood pressure, SP02, pass-through modules) and contains a power supply. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Quinton Vital Statistics System (Q-Cath Accessory) is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is the acquisition, calculation, and transmission of physiological parameters (blood pressure, blood oxygen saturation, heart rate) during cardiac cath procedures. These are measurements taken directly from the patient's body, not from samples of bodily fluids or tissues in vitro (outside the body).
- Device Description: The description details modules for non-invasive blood pressure and SpO2, which are applied externally to the patient. It also mentions "pass-through" connections for external devices, but the core function is acquiring physiological data from the patient.
- Performance Studies: The performance studies involve comparing measurements taken by the device and predicate devices from simulators that mimic physiological outputs (blood pressure, heart rate, SpO2). This further reinforces that the device is measuring physiological parameters directly or via simulation of those parameters, not analyzing samples in vitro.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The Quinton Vital Statistics System does not perform this function.
N/A
Intended Use / Indications for Use
The intended use of the Quinton Vital Statistics System (Q-Cath Accessory) is the acquisition, calculation, and transmission of physiological parameters as diastolic and systolic blood pressure, blood oxygen saturation levels, and heart rate to the Quinton Q-Cath during cardiac cath procedures.
Product codes (comma separated list FDA assigned to the subject device)
73 DQA
Device Description
The Vital Statistics System (VSS) is an accessory to the Quinton Q-Cath catheterization analysis system. The purpose of the VSS is to acquire, calculate, and transmit physiological data as blood pressure (acquired noninvasively), blood oxygen saturation data, and heart rate to the Q-Cath during cardiac cath procedures. Additionally, the VSS has 'pass-through' input and output connections for the purposes of acquiring and transmitting low voltage signal data to the Q-Cath from external devices and from the Q-Cath Signal Conditioning System component. Set-up of the VSS modules occurs at the Q-Cath via software controls.
The VSS is made up of a 3" x 20" x 12" metal enclosure that has compartments for insertion of the non-invasive blood pressure module, SP02 module, and two pass-through modules. A power supply within the device is capable of converting line voltage to regulated low voltage needed by the modules. The VSS weighs 35 Ibs when all modules are in place within the VSS.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
The performance testing included both adult and neonate modes.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Performance testing was an equivalence study comparing blood pressure measurements and heart rate obtained by the VSS NIBP module with blood pressure measurements and heart rate obtained by the predicate device, the Colin BP-508 NIBP monitor, over both adult and neonate modes. Randomized simulated oscillometric NIBP and HR outputs over the specified range of both the NIBP module and the predicate device were obtained from a NIBP simulator. The test was conducted by the VSS NIBP module taking blood pressure and heart rate measurements from the simulator for a certain number of randomized samples. This was then repeated for the predicate device at the same blood pressure levels and heart rate. The number of randomized blood pressure, heart rate samples chosen were such that a meaningful statistical analysis and conclusion could be reached.
The SP02 performance testing was conducted in a similar fashion. Randomized simulated SP02 and HR outputs over the specified range of both the SP02 module and the Nellcor N-180 Pulse Oximeter were obtained from a SP02 simulator. The test was conducted by the VSS SP02 module taking SP02 data and heart rate measurements from the simulator for a certain number of randomized samples. This was then repeated for the predicate device at the same SP02 levels and heart rate. The number of randomized blood pressure, heart rate samples chosen were such that a meaningful statistical analysis and conclusion could be reached.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was an equivalence study comparing blood pressure measurements and heart rate obtained by the VSS NIBP module with blood pressure measurements and heart rate obtained by the predicate device, the Colin BP-508 NIBP monitor, over both adult and neonate modes.
The SP02 performance testing was conducted in a similar fashion comparing the SP02 module and the Nellcor N-180 Pulse Oximeter.
Key result: It was formulated that both modules would be considered subtantially equivalent to their respective predicate devices if it could be shown at the 0.05 confidence level that the mean percentage difference between each pair of measurements taken by the devices being compared is less than 5%.
Using a +/- 5% equivalence region, the study results showed the following:
- The VSS NIBP module operating in adult mode can be regarded as equivalent to the Colin BP-508 at the 95% confidence level (e.g., 0.05 significance level);
- The VSS NIBP module operating in neonate mode can be regarded as equivalent to the Colin BP-508 at the 95% confidence level; and
- The VSS SP02 module can be regarded as equivalent to the Nellcor N-180 pulse oximeter at the 95% confidence level.
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).
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§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
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510(k) SUMMARY
MAY 2 1 1997
| Submitter's Name: | Quinton Instrument Company |
|---|---|
| Submitter's Address: | 3303 Monte Villa Parkway |
| Bothell, Washington 98021-8906 | |
| Submitter's Phone Number: | (US) 206-402-2000 |
| Submitter's Fax Number: | (US) 206-402-2017 |
| Contact Person: | Matt Hedlund |
| Date Summary Prepared: | April 11, 1997 |
A. Device Name and Classification
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- Device Trade Name: Vital Statistics System (Q-Cath Accessory)
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Device Common Name: Physiological Monitoring and Analysis System
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Device Classification Names 870.2700 Oximeter 870.1130 Noninvasive Blood Pressure Measurement System
B. Predicate Device
The legally marketed device to which we claim equivalence is the Nellcor Puritan Bennett N-180 Pulse Oximeter and the Colin Medical Instrument BP-508 Patient Monitor (PILOT model No. 9200) . The 510(k) numbers for these devices are K913695 and K922668, respectively.
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C. Device Description
The Vital Statistics System (VSS) is an accessory to the Quinton Q-Cath catheterization analysis system. The purpose of the VSS is to acquire, calculate, and transmit physiological data as blood pressure (acquired noninvasively), blood oxygen saturation data, and heart rate to the Q-Cath during cardiac cath procedures. Additionally, the VSS has 'pass-through' input and output connections for the purposes of acquiring and transmitting low voltage signal data to the Q-Cath from external devices and from the Q-Cath Signal Conditioning System component. Set-up of the VSS modules occurs at the Q-Cath via software controls.
The VSS is made up of a 3" x 20" x 12" metal enclosure that has compartments for insertion of the non-invasive blood pressure module, SP02 module, and two pass-through modules. A power supply within the device is capable of converting line voltage to regulated low voltage needed by the modules. The VSS weighs 35 Ibs when all modules are in place within the VSS.
D. Intended Use of Device
The intended use of the Quinton Vital Statistics System (Q-Cath Accessory) is the acquisition, calculation, and transmission of physiological parameters as diastolic and systolic blood pressure. blood oxygen saturation levels, and heart rate to the Quinton Q-Cath during cardiac cath procedures.
E. Summary of Technological Characteristics Compared with the Predicate Device
The NIBP and SP02 modules are manufactured by Nellcor Puritan Bennett and Colin Medical, respectively. These modules are modifications of the devices that are used as the predicate devices in this 510k notification, as referenced in Section B, supra. The SP02 module acquires, calculates, and transmits oximetry and heart rate data as the Nellcor N-180. The SP02 and heart rate measurement system in the module and in the N-180 are 'equivalent' within certain statistical parameters. [See 'Performance Test and Conclusions' in Section F, infra.] Differences between the Nellcor N-180 and the VSS SP02 module are that the N-180 is a self-contained unit having controls, alarms, and a display. For the VSS module these features are contained on the Q-Cath. The VSS NIBP module acquires, calculates, and transmits diastolic and systolic blood pressure and heart rate data, as the Colin BP-508. The blood pressure and heart rate measurement system in the module and in the BP-508 are 'equivalent' within certain statistical parameters. [See 'Performance Test and Conclusions' in Section F, infra.] Differences between the Colin BP-508 and
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E. Summary of Technological Characteristics Compared with the Predicate Device (Continued)
the VSS NIBP module are that the BP-506 is a self-contained unit having controls, alarms, and a display. For the VSS NIBP module these features are contained on the Q-Cath. Additionally, the BP-508 has measurement and recording capability covering ECG, invasive blood pressure, SP02, tonometry blood pressure, and C02. These features are not on the VSS NIBP module.
F. Performance Testing and Conclusions
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- Performance Testing
Performance testing was an equivalence study comparing blood pressure measurements and heart rate obtained by the VSS NIBP module with blood pressure measurements and heart rate obtained by the predicate device, the Colin BP-508 NIBP monitor, over both adult and neonate modes. Randomized simulated oscillometric NIBP and HR outputs over the specified range of both the NIBP module and the predicate device were obtained from a NIBP simulator. The test was conducted by the VSS NIBP module taking blood pressure and heart rate measurements from the simulator for a certain number of randomized samples. This was then repeated for the predicate device at the same blood pressure levels and heart rate. The number of randomized blood pressure, heart rate samples chosen were such that a meaningful statistical analysis and conclusion could be reached.
- Performance Testing
The SP02 performance testing was conducted in a similar fashion. Randomized simulated SP02 and HR outputs over the specified range of both the SP02 module and the Nellcor N-180 Pulse Oximeter were obtained from a SP02 simulator. The test was conducted by the VSS SP02 module taking SP02 data and heart rate measurements from the simulator for a certain number of randomized samples. This was then repeated for the predicate device at the same SP02 levels and heart rate. The number of randomized blood pressure, heart rate samples chosen were such that a meaningful statistical analysis and conclusion could be reached.
It was formulated that both modules would be considered subtantially equivalent to their respective predicate devices if it could be shown at the 0.05 confidence level that the mean percentage difference between each pair of measurements taken by the devices being compared is less than 5%.
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F. Performance Testing and Conclusions (Continued)
2) Conclusions
Using a +/- 5% equivalence region, the study results showed the following:
- The VSS NIBP module operating in adult mode can be regarded as . equivalent to the Colin BP-508 at the 95% confidence level (e.g., 0.05 significance level);
- The VSS NIBP module operating in neonate mode can be regarded as . equivalent to the Colin BP-508 at the 95% confidence level; and
- The VSS SP02 module can be regarded as equivalent to the Nellcor N-180 . pulse oximeter at the 95% confidence level.
都能
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 1997
Mr. Matt Hedlund Quinton Instrument Company 3303 Monte Villa Parkway Bothell, Washington 98021-8906
Re : K964978 Vital Statistics System (Q-Cath Accessory) Requlatory Class: II (two) Product Code: 73 DQA Dated: April 15, 1997 Received: April 17, 1997
Dear Mr. Hedlund:
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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 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 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 device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (CMP) regulation (21 CFR Part 820) and that, through perioding GMP 2 inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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 - Mr. Matt Hedlund
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) 594-4646. 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" (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. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K96 4978 510 K Number (if known):
Device Name: Vital Statistics System (Q-Cath Accessory)
Indications For Use:
The intended use of the Quinton Vital Statistics System (Q-Cath Accessory) is the acquisition, calculation, and transmission of physiological parameters as diastoic and systolic blood pressure, blood oxygen saturation levels, and heart rate to the Quinton Q-Cath during cardiac cath procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-OH) Division of Cardiovascular, Respiratory, and Neurological Devices
K964978 510(k) Number
Prescription Use_ X Per 21 CFR 801.109) ·
OR
Over-The-Counter Use
000012
(Optional Format 1-2-96)
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