(16 days)
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Not Found
No
The description focuses on standard physiological monitoring techniques (pulse contour analysis, thermodilution, oximetry) and calculations based on measured parameters. There is no mention of AI or ML.
No.
The device is described as a monitoring system that measures and determines various physiological variables without any indication of providing treatment or therapy.
Yes
The device is intended for "determination and monitoring of cardiopulmonary and circulatory variables," and measures parameters like oxygen saturation, cardiac output, heart rate, and pressures, which are used to assess physiological states and aid in diagnosis.
No
The device description explicitly mentions a "PULSION PulsioFlex Monitoring System with optional PiCCO Module" and an "optional CeVox oximetry module connected to a compatible oximetry probe." These are hardware components used for measurement and monitoring, indicating the device is not software-only.
Based on the provided information, the PULSION PulsioFlex Monitoring System with optional PiCCO Module is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the PulsioFlex system focuses on measuring and monitoring physiological variables directly from the patient (cardiopulmonary and circulatory variables, oxygen saturation, heart rate, blood pressure, fluid volumes). It does not mention analyzing blood, urine, tissue, or other bodily fluids outside the body.
- The measurements are taken in vivo. The techniques described, such as pulse contour analysis, thermodilution, and oximetry, are applied to the patient directly.
Therefore, the PulsioFlex Monitoring System is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PulsioFlex Monitoring System measures heart rate, systolic, and diastolic and derives mean arterial and central venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PulsioFlex monitor presents the derived parameters indexed to body surface area.
Product codes
74 DXG
Device Description
The PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PulsioFlex Monitoring System measures heart rate, systolic, and diastolic and derives mean arterial and central venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PulsioFlex monitor presents the derived parameters indexed to body surface area.
Mentions image processing
Not Found
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 and pediatrics
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings forming a protective shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 2012
Pulsion Medical Systems, Inc. c/o Dr. Jamie Sulley , US Agent 1511 Essex Road Westbrook, CT 06498
Re: K122121
Trade/Device Name: PulsioFlex Monitoring System with PiCCO Module Regulatory Number: 21 CFR 870.1435 Regulation Name: Single-function, Preprogrammed Diagnostic Computer Regulatory Class: II (two) Product Code: 74 DXG Dated: July 12, 2012 Received: July 17, 2012
Dear Dr. Sulley:
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 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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If 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.htm 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
2
PULSION
Medical Systems
Appendix B
Indications for Use Statement
510(k) Number (if known):
Device Name: PulsioFlex Monitoring System with PiCCO Module
Indications for Use:
The PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PulsioFlex Monitoring System measures heart rate, systolic, and diastolic and derives mean arterial and central venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PulsioFlex monitor presents the derived parameters indexed to body surface area.
The following tabular shows the parameters measured by the PulsioFlex Monitoring System with PiCCO Module and CeVox Accessories and their specifications:
| Label | Unit | Lower
Limit | Upper
Limit | Accuracy* | Remark |
|-------|-------|----------------|----------------|-------------------------------|-------------------------|
| CO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Valid over a full range |
| GEDV | ml | 40 | 4800 | Coefficient of variation ≤ 3% | Valid over a full range |
| EVLW | ml | 10 | 5000 | Coefficient of variation ≤6% | Valid over a full range |
| PCCO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Valid over a full range |
| SV | ml | 1 | 250 | Coefficient of variation ≤ 2% | Valid over a full range |
| SO2 | % | 1 | 99 | +2% | Valid from 40-99% |
| SvO2 | % | 1 | 99 | +2% | Valid from 40-99% |
| ScvO2 | % | 1 | 99 | +2% | Valid from 40-99% |
- Statistical evaluation based on random examination of actual production output
| 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)
Page 1 of 1
f CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
12 July, 2012
510(k) Nt