(366 days)
Not Found
No
The summary describes a microprocessor-based instrument that performs calculations based on physiological measurements and thermodilution analysis. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is described as an instrument for "determination and monitoring of cardiopulmonary and circulatory variables," which indicates it is a diagnostic and monitoring tool, not a device that directly administers therapy or performs a therapeutic function.
Yes
The device is intended for "determination and monitoring of cardiopulmonary and circulatory variables," and it "measures oxygen saturation," "cardiac output," "heart rate," "systolic, and diastolic and derives mean arterial venous pressure," and "intravascular and extravascular fluid volumes." These are all measurements used to assess a patient's physiological state, which is the definition of a diagnostic device.
No
The device description explicitly states it is a "microprocessor-based instrument" and mentions connecting "optional CeVOX™ optical module and probe," indicating it includes hardware components beyond just software.
Based on the provided text, the PULSION PiCCO-2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The description of the PULSION PiCCO-2 clearly states it is used for determining and monitoring cardiopulmonary and circulatory variables in vivo (within the body). It measures parameters like cardiac output, heart rate, blood pressure, and fluid volumes directly from the patient.
- The optional CeVOX™ module measures oxygen saturation, which is also a measurement taken directly from the patient's blood in vivo via a probe.
The device is a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The PULSION PICCO-2 is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVOX™ oximetry module connected to a compatible oximetry probe, the PiCCO-2 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 thermodilution technique. In addition, the PiCCO-2 measures heart rate, systolic, and diastolic and derives mean arterial 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 PiCCO-2 monitor presents the derived parameters indexed to body surface area.
Product codes (comma separated list FDA assigned to the subject device)
DXG
Device Description
The PULSION PiCCO-2 is a microprocessor-based instrument intended for the determination and monitoring of cardiopulmonary and circulatory variables. When the optional CeVOX™ optical module and probe are connected to the PiCCO-2, the monitor measures oxygen samuation in adults or pediatrics. In addition, the PiCCO-2 measures heart rate, systelic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO-2 presents the derived parameters indexed to body surface area.
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 pediatrics
Intended User / Care Setting
Not Found
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)
Functional/SafetyTesting:
The PULSION PiCCO-2 with optional CeVOX™ accessories has successfully undergone functional testing demonstrating equivalence to the predicate devices. The subject and predicate devices are similar in design, principle of operation, materials of construction, intended use, labeling and manufacturing processes. In vivo non-clinical testing, sterilization validation and biocompatibility testing was conducted. Results of all non-clinical testing met associated acceptance criteria and did not raise new issues of safety and/or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Label | Unit | Lower limit | Upper limit | Accuracy* | Remark |
|---|---|---|---|---|---|
| CO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Valid over full range |
| GEDV | ml | 40 | 4800 | Coefficient of variation ≤ 3% | Valid over full range |
| ITBV | ml | 50 | 6000 | Coefficient of variation ≤ 3% | Valid over full range |
| EVLW | ml | 10 | 5000 | Coefficient of variation ≤ 6% | Valid over full range |
| PCCO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Valid over full range |
| SV | ml | 1 | 250 | Coefficient of variation ≤ 2% | Valid over 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
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
§ 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
Pulsion Medical Systems AG K091786 Pulsion PiCCO-2 with Optional CeVox Accessories
JUN 1882010
Image /page/0/Picture/3 description: The image shows the words "PULSION" and "Medical Systems" stacked on top of each other. The word "PULSION" is in a larger, bolder font than the words "Medical Systems". The words are black and the background is white. The image appears to be a logo or branding for a medical company.
Section 3.0
510(k) Summary or Statement
| Preparation Date: | May 24, 2010 |
|---|---|
| Applicant/Sponsor: | Pulsion Medical Systems AG |
| 20 Joseph-Wild-Strasse | |
| Munich, Germany | |
| 81829 | |
| Contact Person: | Christoph Manegold, Director Research and Development |
| Phone: 214-557-8730 | |
| Fax: +49 89 459 914 18 | |
| Trade name: | PULSION PICCO-2 with Optional CeVOX™ Accessories |
| Common Name: | • Computer, Diagnositic, Pre-programmed |
| Classification Name: | • Single-function, preprogrammed diagnostic computer |
| (21 CFR 870.1435) | |
| Device Product Code: | • DXG |
| Legally Marketed Devices to Which Substantial Equivalence Is Claimed: | |
| PULSION PICCO-2, MODEL 8500 | K072735 |
| VIGILEO ARTERIAL PRESSURE CARDIAC | |
| OUTPUT/OXIMETRY MONITOR | K062134 |
| EDWARDS LIFESCIENCES LLC PRESEP AND | |
| PEDIASAT OXIMETRY CATHETERS | K053609 |
May, 2010
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0
CeVOX™ Accessories to PICCO-2
Page 3-1
1
Device Description:
The PULSION PiCCO-2 is a microprocessor-based instrument intended for the determination and monitoring of cardiopulmonary and circulatory variables. When the optional CeVOX™ optical module and probe are connected to the PiCCO-2, the monitor measures oxygen samuation in adults or pediatrics. In addition, the PiCCO-2 measures heart rate, systelic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO-2 presents the derived parameters indexed to body surface area.
Indications for Use:
The PULSION PiCCO-2 is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVOX™ oximery module connected to an oximetry probe, the PiCCO-2 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 PiCCO-2 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 PiCCO-2 monitor presents the derived parameters indexed to body surface area.
Comparative Analysis:
The PULSION PiCCO-2 with optional CeVOX™ accessories has been demonstrated to be as safe and effective as the predicate devices for its intended use.
Functional/SafetyTesting:
The PULSION PiCCO-2 with optional CeVOX™ accessories has successfully undergone functional testing demonstrating equivalence to the predicate devices. The subject and predicate devices are similar in design, principle of operation, materials of construction, intended use, labeling and manufacturing processes. In vivo non-clinical testing, sterilization validation and biocompatibility testing was conducted. Results of all non-clinical testing met associated acceptance criteria and did not raise new issues of safety and/or effectiveness.
Conclusion:
The PULSION PiCCO-2 with optional CeVOX™ accessories are substantially equivalent to the predicate devices.
May, 2010
CeVOX™ Accessories to PiCCO-2
Page 3-2
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread, with three lines extending from the eagle's body. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Orug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 8 2010
Pulsion Medical Systems Ag C/O Dr. Jamie Sulley, President Triangulum Consulting Services, Inc. 7220 Sparhawk Rd. Wake Forest, North Carolina 27587
Re: K091786
Trade/Device Name: PULSION PiCCO-2 with Optional CeVOX Accessories Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function Pre-Programmed Diagnostic Computer Regulatory Class: Class II Product Code: DXG Dated: May 15, 2010 Received: May 25, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling, must be truthful and not misleading.
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.
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
3
Page 2 - Dr. Jamie Sulley
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 (2) 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/ucm 115809.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
2
Enclosure
4
Medical Systems
Section 1.0
Indications for Use Statement
510(k) Number (If known): K091786
Device Name: Pulsion PiCCO-2 with Optional CeVOX™ Accessories
Indications for Use:
The PULSION PICCO-2 is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVOX™ oximetry module connected to a compatible oximetry probe, the PiCCO-2 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 thermodilution technique. In addition, the PiCCO-2 measures heart rate, systolic, and diastolic and derives mean arterial 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 PiCCO-2 monitor presents the derived parameters indexed to body surface area.
The following tabular shows the parameters measured by the PICCO2 patient monitor and their specifications:
| Label | Unit | Lower limit | Upper limit | Accuracy* | Remark |
|---|---|---|---|---|---|
| CO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Valid over full range |
| GEDV | ml | 40 | 4800 | Coefficient of variation ≤ 3% | Valid over full range |
| ITBV | ml | 50 | 6000 | Coefficient of variation ≤ 3% | Valid over full range |
| EVLW | ml | 10 | 5000 | Coefficient of variation ≤ 6% | Valid over full range |
| PCCO | l/min | 0.25 | 25 | Coefficient of variation ≤ 2% | Valid over full range |
| SV | ml | 1 | 250 | Coefficient of variation ≤ 2% | Valid over 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
May, 2010
ARYTH Arcessaries to t
Page 1-1
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(Division Sign-
510(k) Number K091786