(344 days)
Not Found
No
The summary describes a thermodilution catheter and pressure monitoring kit used with a cardiac output system, focusing on physical measurements and analysis methods like thermodilution and pulse contour analysis. There is no mention of AI or ML in the intended use, device description, or other sections.
No
The device is described as a diagnostic tool for monitoring cardiovascular and circulatory volume status, not for treating a condition.
Yes
The intended use explicitly states the device is 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," which are all diagnostic activities.
No
The device description explicitly states it includes a catheter, guidewire, needle, and monitoring kit with an in-line injectate sensor, which are all hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the device as being used in vivo (within the patient's body) for measuring physiological parameters like cardiac output and blood pressure. IVDs are used in vitro (outside the body) to examine specimens derived from the human body.
- Device Description: The device description confirms it's a catheter and monitoring kit used in conjunction with a system to measure parameters in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on specimens outside the body, which are hallmarks of IVDs.
Therefore, this device is a medical device used for in vivo monitoring, not an IVD.
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 monitorinq is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
Product codes (comma separated list FDA assigned to the subject device)
74 KRB
Device Description
The PULSION Pulsiocath Thermodilution Catheter with J-Guidewire and needle, and a monitoring kit including an in-line injectate sensor used as accessories to the Pulsion Continuous Pulse Contour Cardiac Output System (PiCCO). The common names are thermodilution catheter, J-Guidewire and needle pressure monitoring kit/disposable pressure transducer, and in-line injectate sensor.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K810124, K810675, K892941, K842352, K841788
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
§ 870.1915 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
K991886
MAY 11 2000
10.0 510(k) Summary.
510 (k) Summary
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.
- The submitter of this premarket notification is:
Ulf Borg PULSION US 8911 Sedgley Drive Wilmington NC 28412 Tel .: (910) 452-7386 Fax .: (910) 793-9479
This summary was prepared on May 13, 1999.
- The name of this device is the PULSION Pulsiocath Thermodilution Catheter with J-Guidewire and needle , and a monitoring kit including an in-line injectate sensor used as accessories to the Pulsion Continuous Pulse Contour Cardiac Output System (PiCCO). The common names are thermodilution catheter, J-Guidewire and needle pressure monitoring kit/disposable pressure transducer, and in-line injectate sensor. Classification names are as follows:
| REGULATION
| NUMBER | CLASSIFICATION NAME |
|---|---|
| 870.1240 | Flow-directed catheter |
| 870.1330 | Catheter guidewire and |
| accesssories | |
| 870.2850 | Extravascular blood |
| pressure transducer | |
| 870.1915 | Thermodilution probe |
- The Pulsion Pulsiocath Thermodilution Catheter and introducer accessories are substantially equivalent to the Baxter Swan-Ganz® VIP™ Thermodilution Catheter marketed pursuant to K810124, and the Arrow International Radial (Femoral) Artery Catheterization Set marketed under K810675. The Pulsion in-line injectate sensor is substantially equivalent to that marketed by Spectramed under K892941. The Pulsion Pressure Monitoring Kit and Disposable Pressure Transducer are substantially equivalent to those sold by Utah Medical pursuant to K842352 and K841788, respectively.
1
-
When coupled with the Pulsion Continuous Pulse Contour Cardiac Output System (PiCCO), the above device accessories, in connection with a central venous catheter, operate to measure and display cardiac output parameters.
-
The device has the same intended use as the legally marketed predicate devices.
-
The technological characteristics are the same or similar to those found with the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 11 2000
Mr. Ulf Borg Pulsion Medical Systems, Inc. 8911 Sedgley Drive Wilmington, NC 28412
Re: K991886 n Sioo Pulsion I . Requlatory Class: II (two) Product Code: 74 KRB Dated: May 3, 2000 Received: May 4, 2000
Dear Mr. Borg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is che devros foreivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encrobare, co regally may 28, 1976, the enactment date of the Incelbeate oommondents, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control enc general ochersi 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 II your dovies is cli (Premarket Approval), it may be subject to such controld, or Claub -----------------------------------------------------------------------------------------------------------------------------------------add Exonar Collections of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set with the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS General legarden on on Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in assumptions. Furrate co comparish further announcements regaratory wour device in the Federal Register. Please note: this concerning your action int notification submission does not affect any response to your pht have under sections 531 through 542 of the Act
3
Page 2 - Mr. Ulf Borg
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described This lecter will allow you co boyin manufactor of substantial in your SIU(K) premarket notreasing marketed predicate device equivalence of your device of a region and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advice 105 jirionally 809.10 for in vitro regulation (21 cris fure over and the Office of Compliance at Additionally, for questions on the promotion and (301) 594-4648. (301) 394-4646. Addrefonally) 202 quesect the Office of Compliance at
advertising of your device, please contact letice entitled Also, please note the regulation entitled, (301) 594-4639. (21CB 991 1037 - REEEE notification" (21CFR 807.97) -"Misbranding by reference to promazion in the Act may Other general information of Small Manufacturers Assistance at its Internet be obtained from the British or (301) 443–6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Brim E. Atwer
James E. Dillard III
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page
510(k) Number (if known):
PULSION Pulsiocath Thermodilution Catheter, with Device Name: Pressure Monitoring Kit and 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 monitorinq 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)
Brim E. Hansen
Division of Cardiovascular. Respirato 510(k) Nun
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)