(28 days)
With the optional CeVox™ oximetry module connected to a compatible PulsioFlex oximetry probe, PulsioFlex measures oxygen saturation to assess oxygen delivery in adults.
PulsioFlex Monitoring System with Optional CeVox ™ Accessories
The provided text is a 510(k) premarket notification and does not contain detailed information about a study proving the device meets acceptance criteria. It mainly focuses on regulatory approval. Therefore, I cannot extract complete information for all the requested sections.
However, I can extract the acceptance criteria for oxygen saturation measurements from the "Indications for Use Statement" and state that no study details are provided in this document.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Label | Unit | Lower Limit | Upper Limit | Acceptance Criteria (Accuracy) | Reported Device Performance |
|---|---|---|---|---|---|
| SO2 | % | 1 | 99 | $\pm$ 2% (Valid from 40-99%) | Not reported in this document |
| SvO2 | % | 1 | 99 | $\pm$ 2% (Valid from 40-99%) | Not reported in this document |
| ScvO2 | % | 1 | 99 | $\pm$ 2% (Valid from 40-99%) | Not reported in this document |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable as this is not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is a standalone device measuring oxygen saturation. The document doesn't provide performance data from any study, standalone or otherwise.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not provided in this document. For oximetry, typically a co-oximeter is used as the reference standard (ground truth).
8. The sample size for the training set
Not applicable as this device is not described as having a training set (e.g., it is not an AI/ML model being trained).
9. How the ground truth for the training set was established
Not applicable.
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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,
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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)
§ 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).