(59 days)
Not Found
No
The description focuses on standard physiological measurement techniques (thermodilution, pulse contour analysis) and mentions "Pulsion algorithms" which are likely deterministic calculations based on these techniques, not AI/ML. There is no mention of AI, ML, or related concepts like training/test sets.
No.
The device is intended for determination and monitoring of cardiopulmonary and circulatory variables; it does not directly treat a condition.
Yes
The device is described as determining and monitoring various cardiopulmonary and circulatory variables, including cardiac output, arterial pressure, and fluid volumes, which are used to assess a patient's physiological state.
No
The device description explicitly states that the Infinity PICCO Pod is an "optional accessory" that "acquires cardiac output thermal and invasive blood pressure data from Pulsion Medical transducers and sends this data to the Draeger patient monitors." This indicates the device includes hardware components (the pod itself and the ability to acquire data from transducers), not just software.
Based on the provided information, the Draeger Infinity PICCO Pod is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The Draeger Infinity PICCO Pod directly measures and monitors physiological variables within the patient's body (cardiopulmonary and circulatory variables, arterial pressure, fluid volumes) using techniques like pulse contour analysis and thermodilution. It acquires data from transducers placed on or in the patient.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens (blood, tissue, etc.) outside of the body.
The device is a patient monitoring accessory that uses invasive and non-invasive techniques to gather real-time physiological data from the patient. This falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Draeger Infinity PICCO Pod is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the Infinity PICCO Pod measures systolic, diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the monitor to which, the PICCO Pod is connected, presents the derived parameters indexed to body surface area.
Product codes
DXG
Device Description
The Infinity PICCO Pod is an optional accessory to Draeger Medical Systems' Infinity patient monitoring series (Delta, Delta XL, and Kappa) that provides for determination and monitoring of cardiopulmonary and circulatory variables.
The Infinity PICCO Pod acquires cardiac output thermal and invasive blood pressure data from Pulsion Medical transducers and sends this data to the Draeger patient monitors. The Draeger patient monitors contain Pulsion algorithms which are run on this data to calculate a number of cardiopulmonary and circulatory variables.
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)
Extensive bench testing has been performed to insure that the hardware of the Infinity PICCO Pod is equivalent to the hardware of the Pulsion PiCCO Plus.
Extensive bench testing has been performed to insure that the software as implemented in the Infinity PICCO Pod is equivalent to that of the Pulsion PiCCO Plus.
Extensive simulator based testing has been performed to insure that the Infinity PICCO Pod as a complete device is equivalent to that of the Pulsion PiCCO Plus as a complete device.
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
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for Dräger medical. The word "Dräger" is in bold, while the word "medical" is in a thinner font. Below the logo, it says "A Dräger and Siemens Company" in a smaller font.
K073//3
Page 1 of 3
JAN
- 3 2008
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, 21 CFR 807.87, 21 CFR 807.92, Format for Traditional and Abbreviated 510(k) s.
- Name of Submitter, Contact Person and Date Summary Prepared:
| Name: | Draeger Medical Systems, Inc. |
|---|---|
| Address: | 6 Tech Dr Andover MA 01810 |
| Phone: | |
| Fax: | 978.379.8124 |
| 978.379.8330 |
Official Contact: Genci Omari, Regulatory Affairs Manager
Date of Preparation: 18 October 2007
- Device Trade Name and Common Name:
Trade Name:
Infinity PICCO Pod
21 CFR 870.1435
Common/Usual Name: Single-function, preprogrammed diagnostic computer
Classification:
-
- Product Code: DXG
Device Class: Class II
- Product Code: DXG
Legally Marketed Equivalent Device Names: 4.
Substantial equivalence is claimed to the Pulsion PICCO Plus System 510(k) K060898
COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810 Tel: 978-379-8124 Fax: 978-379-8330
1
Image /page/1/Picture/1 description: The image shows the logo for Dräger medical. The word "Dräger" is in a bold, sans-serif font, with an umlaut over the "a". The word "medical" is in a thinner, sans-serif font. Below the logo, in a smaller font, is the text "A Dräger and Siemens Company".
tage and Element Comp
Page 2 of 3
న్. Performance Standards: None
- Description of the Device: The Infinity PICCO Pod is an optional accessory 6. to Draeger Medical Systems' Infinity patient monitoring series (Delta, Delta XL, and Kappa) that provides for determination and monitoring of cardiopulmonary and circulatory variables.
The Infinity PICCO Pod acquires cardiac output thermal and invasive blood pressure data from Pulsion Medical transducers and sends this data to the Draeger patient monitors. The Draeger patient monitors contain Pulsion algorithms which are run on this data to calculate a number of cardiopulmonary and circulatory variables.
7. Intended Use of the Device:
The Infinity PICCO Pod is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PICCO Pod measures systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO Plus presents the derived parameters indexed to body surface area.
8. Comparison of technological characteristics with Predicate Devices:
The Draeger Infinity PICCO Pod uses the same algorithms as its predicate, the Pulsion PiCCO Plus. The Pulsion PiCCO plus integrates all functionality into one device, where the Infinity PICCO Pod is a separate pod for signal acquisition from the patient, the data from the pod is sent to the Drager patient monitor for algorithm processing and display.
9. Discussion of Non-clinical Studies:
Extensive bench testing has been performed to insure that the hardware of the Infinity PICCO Pod is equivalent to the hardware of the Pulsion PiCCO Plus.
Extensive bench testing has been performed to insure that the software as implemented in the Infinity PICCO Pod is equivalent to that of the Pulsion PiCCO Plus.
Extensive simulator based testing has been performed to insure that the Infinity PICCO Pod as a complete device is equivalent to that of the Pulsion PiCCO Plus as a complete device.
COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810 Tel: 978-379-8124 Fax: 978-379-8330
2
Image /page/2/Picture/1 description: The image shows the logo for Dräger medical. The text "Dräger" is in a bold, sans-serif font, with an umlaut over the "a". The text "medical" is in a thinner, sans-serif font. Below the logo is the text "A Dräger and Siemens Company" in a smaller font.
Page 3 of 3
10. Conclusion:
The Infinity PICCO Pod is as safe and effective as its predicate, the Pulsion PiCCO Plus, and it provides a convenient means to continuously monitor a variety of circulatory parameters.
COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810 Tel: 978-379-8124 Fax: 978-379-8330
3
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines that curve and flow together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 3 2008
Dräger Medical Systems, Inc. c/o Mr. Genci Omari Regulatory Affairs Manager 6 Tech Drive Andover, MA 01810
Re: K073113
Infinity PiCCO Pod, Model MS16734 Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function Preprogrammed Diagnostic Computer Regulatory Class: Class II (two) Product Code: DXG Dated: October 18, 2007 Received: November 5, 2007
Dear Mr. Omari:
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.
4
Page 2 - Mr. Genci Omari
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 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 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), 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 obtain 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) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blymmuma for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
510(k) Number (if known): KO73113
Device Name: Infinity PICCO Pod
Indications for Use:
The Draeger Infinity PICCO Pod is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the Infinity PICCO Pod measures systolic, diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the monitor to which, the PICCO Pod is connected, presents the derived parameters indexed to body surface area.
Prescription Use_ く (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhimma
ular Devices
COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA - 01810 Tel: 978-379-8124 Fax: 978-379-8330