(28 days)
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No
The summary describes a device for measuring cardiac output and arterial blood pressure using thermodilution and pulse contour analysis, which are established physiological monitoring techniques. There is no mention of AI, ML, or any related concepts in the provided text.
No.
The device is described as being used for measurement and monitoring, which are diagnostic purposes, not therapeutic ones.
Yes
The device is described as measuring cardiac output and arterial blood pressure, and is indicated for monitoring cardiovascular and circulatory volume status, which are all diagnostic functions.
No
The device description explicitly mentions a "Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor," which are hardware components. The system also includes a "Pulsion PiCCO Cardiac Output System," which is a hardware system. Therefore, this is not a software-only medical device.
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 the measurement of cardiac output and arterial blood pressure in patients. This involves direct interaction with the patient's circulatory system.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) outside of the body to detect diseases, conditions, or infections.
The Pulsion Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit is a device used for in vivo monitoring (monitoring within the living body), not in vitro testing.
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, 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
KRB
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
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Indicated Patient Age Range
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 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
Image /page/0/Picture/1 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 an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2007
Pulsion Medical Systems AG c/o Dr. Jamie Sulley President Triangulum Consulting Services, Inc. 7220 Sparhawk Rd. Wake Forest, NC 27587
Re: K072364
Pulsion Pulsiocath Thermodilution Catheters and Accessories Regulation Number: 21 CFR 870.1915 Regulation Name: Thermodilution Probe Regulatory Class: Class II Product Code: KRB Dated: August 20, 2007 Received: August 22, 2007
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 Amendmouts, or to devices that have been reclassified in accordance with the provisions of the Federal Foold, Dr u 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 1.01 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, TDA movie 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 mcan 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); 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 logal/y 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), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may bitain 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) 633-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely yours.
R. bacher
\ Dr. Bram Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
| 510(k) Number (if known): | K072364 |
|---|---|
| --------------------------- | --------- |
Pulsion Pulsiocath Thermodilution Catheters and Accessories Device Name:
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, 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.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susna R. behner
(Printed)
(Division Sinn-Off) Division J. Cardiovascular Devices
510(k) Number K072364
Pulsion Medical Systems, AG Pulsion Pulsiocath Thermodilution Catheters and Accessories
August 2007 Page 17