(28 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or training/test sets for algorithms. The device description and intended use focus on standard oximetry measurements.
No.
The device measures oxygen saturation to assess oxygen delivery, which is diagnostic information, not a therapy or treatment.
Yes
The device measures oxygen saturation to assess oxygen delivery, which is a diagnostic function used to evaluate a patient's physiological state.
No
The device description explicitly mentions an "optional CeVox™ oximetry module connected to a compatible PulsioFlex oximetry probe," indicating the presence of hardware components (module and probe) in addition to any potential software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes measuring oxygen saturation to assess oxygen delivery in adults. This is a measurement taken directly from the patient's body (likely through a probe on the skin or potentially a more invasive probe, though the description doesn't specify the exact probe type beyond "compatible PulsioFlex oximetry probe").
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. The description of the PulsioFlex system does not mention analyzing any such specimens. It describes a monitoring system that measures physiological parameters directly from the patient.
- Anatomical Site: While not explicitly stated, the nature of oximetry suggests a measurement taken from a specific anatomical site on the patient.
Therefore, the PulsioFlex Monitoring System with Optional CeVox ™ Accessories, as described, functions as a patient monitoring device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
With the optional CeVox™ oximetry module connected to a compatible PulsioFlex oximetry probe, PulsioFlex measures oxygen saturation to assess oxygen delivery in adults.
Product codes
74 DXG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
Prescription Use
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SO2: Accuracy +/- 2% (Valid from 40-99%)
SvO2: Accuracy +/- 2% (Valid from 40-99%)
ScvO2: Accuracy +/- 2% (Valid from 40-99%)
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.
Not Found
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-GG09 Silver Spring, MD 20993-0002
Pulsion Medical Systems, Inc. c/o Dr. Jamie Sulley US Agent 1511 Essex Road Westbrook, CT 06498
SEP 22 2011
Re: KI12448
RT.12440
Trade/Device Name: PulsioFiex, Model Number PC4000 Regulatory Number: 21 CFR 870,1435 Regulatory Number. 21 CFR 070.11199
Regulation Name: Single-function, Preprogrammed Diagnostic Computer Regulatory Class: II (two) Product Code: 74 DXG Dated: August 19, 2017 Received: August 25, 2011
Dear Dr. Sulley:
We have reviewed your Section 510(k) premarket notification of intent to market the undicati We have reviewed your Section 510(A) premater is substantially equivalent (for the indications
referenced above and have determined the device is subscan devices in interstat referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to legally manced province device Amendments, or to
commerce prior to May 28, 1976, the enactment and the Federal Food. Drug. commerce prof to May 28, 1976, the enactinent with the provisions of the Federal Food, Drug, devices that have been reclassment approval of a proval approval application (PMA).
and Cosmetic Act (Act) that do not require approval sonvelions of the Act. The and Cosmetic Act (Act) that do not require approven controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, soojed to the gening misting of the gol
general controls provisions of the Act include requires arginst mistvanding and general controls provisions of the Act mendo requirements.
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).) ff your device is classified (sec above) mitor regulations affecting your device can be
it may be subject to additional controls. Extran it may be subject to additional controls. Existing major 10 and 10 addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898 - Regiter found in the Code of Tederal Regarations) This device in the Federal Register,
1
Page 2 - Dr. Jamie Sulley
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
-Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix B
Indications for Use Statement
510(k) Number (if known):
Device Name: PulsioFlex Monitoring System with Optional CeVox ™ Accessories
Indications for Use:
With the optional CeVox™ oximetry module connected to a compatible PulsioFlex oximetry probe, PulsioFlex measures oxygen saturation to assess oxygen delivery in adults.
The following tabular shows the parameters measured by the PulsioFlex monitor and its specifications:
| Label | Unit | Lower Limit | Upper Limit | Accuracy* | Remark |
|---|---|---|---|---|---|
| SO2 | % | 1 | 99 | $\pm$ 2% | Valid from 40-99% |
| SvO2 | % | 1 | 99 | $\pm$ 2% | Valid from 40-99% |
| ScvO2 | % | 1 | 99 | $\pm$ 2% | Valid from 40-99% |
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) ·
/
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number
Page 1 of 1
(Posted November 13, 2003)