(90 days)
No
The document describes a hardware device for physiological monitoring and does not mention any software or algorithms that would suggest the use of AI/ML.
No
This device is described as a monitoring system (measurement of cardiac output, arterial blood pressure, arterial pulse contour analysis) for cardiovascular and circulatory volume status, not for providing therapy.
Yes
The device is intended for "measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis" and is "indicated in patients where cardiovascular and circulatory volume status monitoring is necessary." These functions clearly establish it as a diagnostic device used to assess a patient's physiological status.
No
The device description explicitly mentions physical components like a catheter, pressure monitoring kit, injectate in-line sensor, and housing, along with changes to their design, materials, and dimensions. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for monitoring physiological parameters within the patient (cardiac output, arterial blood pressure, circulatory volume status). This is a direct measurement of bodily functions, not an analysis of samples taken from the body.
- Device Description: The device is a catheter and monitoring kit, designed to be inserted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a disease or condition based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device directly measures physiological parameters in vivo.
N/A
Intended Use / Indications for Use
The PULSION Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the PULSION PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The PULSION PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, medical, cardiac, and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
Product codes
74 KRB
Device Description
Pulsion Pulsiocath PiCCO Monitoring Kit, Injectate Sensor Temperature Housing PV 4046. The Pulsion PV4046 Injectate Sensor component of the PULSION Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor. The primary modifications are changes to the injectate in-line sensor design, materials, and dimensions. Corresponding dimensional changes have been made to the housing to accommodate additional components and their positioning within the housing resulting from the change.
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
Not Found
Intended User / Care Setting
patients in surgical, medical, cardiac, and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
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)
Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device. Testing involved safety testing from the risk analysis, including laboratory studies for performance, mechanical properties, and biocompatibility. Acceptance criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1915 Thermodilution probe.
(a)
Identification. A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.(b)
Classification. Class II (performance standards).
0
MAY 2 3 2002
510(k) Summary KO20587
This summary of 510(k) safety and,effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.
| Submitter of this
premarket notification | Pulsion Medical Systems, AG
C/O James M. Delaney
EXPERTech Associates, Inc.
100 Main Street, Ste 120
Concord, MA 01742
Phone 978.371.0066
Fax 978.371.1676
e-mail: jdelaney@fdahelp.com | |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Date of summary | January 29, 2002 | |
| Device name | Pulsion Pulsiocath PiCCO Monitoring Kit, Injectate Sensor Temperature
Housing PV 4046 | |
| Common name | Injectate in-line sensor | |
| Classification names | Regulation Number | Classification Name |
| | §870.1915 | Probe, Thermodilution |
| Predicate Devices | The modified device is substantially equivalent to the device previously
cleared under K991886. | |
| Modifications | The primary modifications are changes to the injectate in-line sensor design,
materials, and dimensions. Corresponding dimensional changes have been
made to the housing to accommodate additional components and their
positioning within the housing resulting from the change. | |
| Intended Use | The modified device has the same intended use as previously cleared in
K991886. The PV4046 injectate in-line sensor is a component of a
prescription use accessory package to the Pulsion PiCCO Cardiac Output
System. The accessory package was cleared with the following Indications
for Use:
The PULSION Pulsiocath Thermodilution Catheter and Pressure
Monitoring Kit with Injectate In-Line Sensor are intended for use with the
PULSION PiCCO Cardiac Output System for the measurement of cardiac
output by the thermodilution method, measurement of arterial blood
pressure, and for cardiac output determination by arterial pulse contour
analysis. The PULSION PiCCO Cardiac Output System with
Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line
Sensor is indicated in patients where cardiovascular and circulatory volume
status monitoring is necessary. Such as patients in surgical, medical,
cardiac, and burn specialty units as well as other specialty units where
cardiovascular monitoring is desired and patients undergoing surgical | |
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KOZO587
p.2/2
interventions of such magnitude that cardiovascular monitoring is necessary.
Technological characteristics
Testing
The modified device has the same technological characteristics as the legally marketed predicate devices.
Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device. Testing involved safety testing from the risk analysis, including laboratory studies for performance, mechanical properties, and biocompatibility. Acceptance criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
Public Health Service
MAY 23 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pulsion Medical Systems, Inc. c/o Mr. James M. Delaney EXPERTECH Associates, Inc. 100 Main Street. Suite 120 Concord, MA 01742
Re: K020587
Pulsion Pulsiocath PiCCO Regulation Number: 870.1915 Regulation Name: Thermodilution Probe Regulatory Class: Class II (two) Product Code: 74 KRB Dated: February 19, 2002 Received: February 22, 2002
Dear Mr. Delaney:
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 such 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
3
Page 2 - Mr. James M. Delaney
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Elias Mallis
Image /page/3/Picture/6 description: The image contains a handwritten word that appears to be "for". The writing is cursive and the letters are connected. The "f" is a loop that extends above the other letters, and the "r" has a small curve at the end.
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3.1 ODE Indications Statement
Indications for. Use Statement
| 510(k) Number
| (if known) | K 02 0587 |
|---|---|
| Device Name | The Pulsion PV4046 Injectate Sensor component of the |
| PULSION Pulsiocath Thermodilution Catheter and Pressure | |
| Monitoring Kit with Injectate In-Line Sensor | |
| Indications for Use | The PULSION Pulsiocath Thermodilution Catheter and Pressure |
| Monitoring Kit with Injectate In-Line Sensor are intended for use | |
| with the PULSION PiCCO Cardiac Output System for the | |
| measurement of cardiac output by the thermodilution method, | |
| measurement of arterial blood pressure, and for cardiac output | |
| determination by arterial pulse contour analysis. The PULSION | |
| PiCCO Cardiac Output System with Thermodilution Catheter and | |
| Pressure Monitoring Kit with Injectate In-Line Sensor is indicated | |
| in patients where cardiovascular and circulatory volume status | |
| monitoring is necessary. Such as patients in surgical, medical, | |
| cardiac, and burn specialty units as well as other specialty units | |
| where cardiovascular monitoring is desired and patients | |
| undergoing surgical interventions of such magnitude that | |
| cardiovascular monitoring is necessary. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elias Mallis
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_KO20597
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
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