(90 days)
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.
The Pulsion Pulsiocath PiCCO Monitoring Kit, Injectate Sensor Temperature Housing PV 4046 is an 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.
The provided text describes a 510(k) summary for the Pulsion Pulsiocath PiCCO Monitoring Kit, Injectate Sensor Temperature Housing PV 4046. Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Based on Predicate Device Specifications) | Reported Device Performance (Summary) |
|---|---|
| Substantial equivalence to the predicate device cleared under K991886 in terms of performance and reliability characteristics. | "Test results showed substantial equivalence." |
| Safety (from risk analysis) | Verification and validation testing included safety testing from risk analysis. |
| Performance (laboratory studies) | Verification and validation testing included laboratory studies for performance. |
| Mechanical properties (laboratory studies) | Verification and validation testing included laboratory studies for mechanical properties. |
| Biocompatibility (laboratory studies) | Verification and validation testing included laboratory studies for biocompatibility. |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated in the provided text. The text only mentions "laboratory studies."
- Data provenance: Not explicitly stated. The studies were conducted by the manufacturer, Pulsion Medical Systems, AG, but the country of origin of the data is not specified. The studies were likely prospective to verify and validate the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the text. The device is a physical medical device (injectate in-line sensor) for measuring cardiac output, not an AI/software device that typically relies on expert-established ground truth from image or medical record interpretation.
4. Adjudication method for the test set
This information is not applicable/provided as the device's performance is based on physical and functional characteristics verified through laboratory studies, not on interpretations that would require adjudication.
5. 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
This is not applicable. This is a physical medical device, not an AI medical device that involves human readers or interpretation of data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device, not an algorithm, so "standalone performance" in the context of AI is not relevant.
7. The type of ground truth used
The ground truth for the performance of this device would be established by objective measurements of the injectate in-line sensor's functionality, accuracy, mechanical integrity, and biocompatibility in laboratory settings, compared against established engineering and medical device specifications, which were based on the predicate device. It is not an "expert consensus, pathology, or outcomes data" type of ground truth in the context of diagnostic AI.
8. The sample size for the training set
This information is not applicable/provided. The device is a physical medical device, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable/provided as there is no "training set" for this physical medical device.
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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 thispremarket notification | Pulsion Medical Systems, AGC/O James M. DelaneyEXPERTech Associates, Inc.100 Main Street, Ste 120Concord, MA 01742Phone 978.371.0066Fax 978.371.1676e-mail: jdelaney@fdahelp.com | |
|---|---|---|
| Date of summary | January 29, 2002 | |
| Device name | Pulsion Pulsiocath PiCCO Monitoring Kit, Injectate Sensor TemperatureHousing 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 previouslycleared under K991886. | |
| Modifications | The primary modifications are changes to the injectate in-line sensor design,materials, and dimensions. Corresponding dimensional changes have beenmade to the housing to accommodate additional components and theirpositioning within the housing resulting from the change. | |
| Intended Use | The modified device has the same intended use as previously cleared inK991886. The PV4046 injectate in-line sensor is a component of aprescription use accessory package to the Pulsion PiCCO Cardiac OutputSystem. The accessory package was cleared with the following Indicationsfor Use:The PULSION Pulsiocath Thermodilution Catheter and PressureMonitoring Kit with Injectate In-Line Sensor are intended for use with thePULSION PiCCO Cardiac Output System for the measurement of cardiacoutput by the thermodilution method, measurement of arterial bloodpressure, and for cardiac output determination by arterial pulse contouranalysis. The PULSION PiCCO Cardiac Output System withThermodilution Catheter and Pressure Monitoring Kit with Injectate In-LineSensor is indicated in patients where cardiovascular and circulatory volumestatus monitoring is necessary. Such as patients in surgical, medical,cardiac, and burn specialty units as well as other specialty units wherecardiovascular monitoring is desired and patients undergoing surgical |
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KOZO587
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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.
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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 & 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
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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
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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 thePULSION Pulsiocath Thermodilution Catheter and PressureMonitoring Kit with Injectate In-Line Sensor |
| Indications for Use | The PULSION Pulsiocath Thermodilution Catheter and PressureMonitoring Kit with Injectate In-Line Sensor are intended for usewith the PULSION PiCCO Cardiac Output System for themeasurement of cardiac output by the thermodilution method,measurement of arterial blood pressure, and for cardiac outputdetermination by arterial pulse contour analysis. The PULSIONPiCCO Cardiac Output System with Thermodilution Catheter andPressure Monitoring Kit with Injectate In-Line Sensor is indicatedin patients where cardiovascular and circulatory volume statusmonitoring is necessary. Such as patients in surgical, medical,cardiac, and burn specialty units as well as other specialty unitswhere cardiovascular monitoring is desired and patientsundergoing surgical interventions of such magnitude thatcardiovascular 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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§ 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).