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.

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). 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.

AI/ML Overview

The provided document is a 510(k) summary for the PULSION Pulsiocath Thermodilution Catheter with J-Guidewire and needle, and a monitoring kit including an in-line injectate sensor. This submission is for market clearance based on substantial equivalence to predicate devices, not for a de novo device requiring extensive clinical trials and performance evaluation against predefined acceptance criteria. Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets them.

Specifically:

A table of acceptance criteria and the reported device performance: Not present. The document focuses on demonstrating substantial equivalence to existing devices.
Sample sized used for the test set and the data provenance: Not applicable as a performance study against acceptance criteria is not described. The document pertains to substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a medical catheter and sensor system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The submission is based on the premise that the device has the "same intended use" and "technological characteristics are the same or similar" to legally marketed predicate devices. Performance is thus inferred through equivalence, rather than a new study against specific performance criteria.

Summary

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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:

REGULATIONNUMBER	CLASSIFICATION NAME
870.1240	Flow-directed catheter
870.1330	Catheter guidewire andaccesssories
870.2850	Extravascular bloodpressure 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.

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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.

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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

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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

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Page

510(k) Number (if known):

PULSION Pulsiocath Thermodilution Catheter, with Device Name: Pressure Monitoring Kit and Injectate In-Line Sensor

Indications for Use:

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).