Siemens INFINITY etCO2 is indicated for use in the adult, pediatric and neonatal populations, in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode is not intended for use in the neonatal patient population). In conjunction with the SC 7000 / SC 9000XL monitors, visual and audible alarms will be produced if any of these parameters vary beyond preset limits, and timed or alarm recordings will be produced.

Device Description

The INFINITY etCO2 Pod is an addition to Siemens SC8000/SC7000/SC9000XL INFINITY modular bedside monitoring series. When connected to an INFINITY modular bedside monitor the etCO2 pod will measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate.

AI/ML Overview

Here's the breakdown of the acceptance criteria and the study information based on the provided text, recognizing that this is a 510(k) summary for a medical device (Siemens INFINITY etCO2 Pod), and its primary intent is to demonstrate substantial equivalence to predicate devices rather than providing a detailed clinical study report. Therefore, some information expected in a full clinical study might be limited or inferred.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state "acceptance criteria" in a quantified, pass/fail manner. It focuses on demonstrating equivalence to predicate devices and lists the device's measuring capabilities and range. The "reported device performance" is essentially the device's specifications, which are presented as similar to or improved upon the predicate devices.

Metric/Parameter	Acceptance Criteria (Inferred from Similarities/Improvements)	Reported Device Performance
Intended Use	To measure EtCO2, iCO2, and respiration rate in mainstream & side-stream modes (side-stream not for neonatal). Alarms for out-of-limit parameters, timed/alarm recordings. (Must match predicate's core function)	Measures EtCO2, iCO2, and respiration rate in mainstream & side-stream modes (side-stream not for neonatal). Alarms for out-of-limit parameters, timed/alarm recordings.
Intended Population	Adult/Pediatric/Neonatal	Adult/Pediatric/Neonatal
Intended Environment	Healthcare environment by healthcare professionals	Healthcare environment by healthcare professionals
Displayed Parameters	EtCO2, iCO2, Respiration rate (RRc). (Must be at least functional equivalent to predicate without spirometry/pulse oximetry)	EtCO2, iCO2, Respiration rate (RRc)
Display Scales	Comparable to predicate (0-40, 0-80 mmHg) with potential for improvement/flexibility	0-40, 0-60, 0-80, 0-100 mmHg (More display flexibility than Siemens predicate)
Measuring Method	Dual-wavelength, non-dispersive infrared (Must be identical to predicate)	Dual-wavelength, non-dispersive infrared
Measuring Capabilities	Mainstream and Sidestream	Mainstream and Sidestream
Measuring Range	0 to 99 mmHg CO2 partial pressure (Siemens predicate) or 0 to 100 mmHg partial pressure (Novametrix predicate). A CO2 ≥ 100 is out of range.	0 to 100 mmHg CO2 partial pressure
Averaging	Breath, 10s, 20s (Siemens predicate) or Breath, 10s, 20s, Instantaneous (Novametrix predicate). Must be at least equivalent.	Breath, 10s, 20s, Instantaneous (Improvement over Siemens predicate)

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Assessment of non-clinical performance data for equivalence: Section T" and "Assessment of clinical performance data for equivalence: Section V." However, it does not provide details on the specific sample size, data provenance, or whether the data was retrospective or prospective for any test set. The 510(k) summary focuses on demonstrating substantial equivalence, and often, extensive clinical trials with detailed data are not explicitly summarized in this front-end document if equivalence can be shown through other means (e.g., bench testing, comparison to predicate specifications).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The nature of the device (etCO2 measurement) suggests that "ground truth" would likely be established through validated reference devices or methods, rather than expert interpretation of images or other subjective data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the type of measurement, adjudication by expert consensus is unlikely to be the primary method for ground truth, which is typically based on objective measurements.

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 document is for a basic medical device (etCO2 monitor) from 1999, which is not an AI-powered diagnostic tool. Therefore, an MRMC study or any assessment of human performance improvement with AI assistance is not applicable and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is a device that directly measures physiological parameters (CO2 concentration and respiration rate). Its performance is inherently standalone in the sense that the device itself produces the measurement. There is no separate "algorithm only" performance reported in the context of interpretation that would require human-in-the-loop comparison. Its performance would be assessed against a reference standard to demonstrate accuracy. The document implies that "non-clinical performance data" and "clinical performance data" were reviewed for equivalence, but without details.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, for a device measuring end-tidal carbon dioxide and respiration rate, the ground truth would typically be established using:

Reference Standard Devices: Highly accurate and calibrated gas analyzers or capnographs known to be reliable.
Controlled Gas Mixtures: Precisely known concentrations of CO2 to test accuracy across the measuring range.
Physiological Reference: For respiration rate, potentially a spirometer or other validated method.

It is highly unlikely to involve expert consensus or pathology in the way it would for imaging diagnostics.

8. The Sample Size for the Training Set

This information is not provided in the document. This is not an AI/machine learning device that typically involves a distinct "training set." The development of such a device relies on engineering principles, sensor calibration, and physiological modeling, not data-driven model training in the modern AI sense.

9. How the Ground Truth for the Training Set was Established

As this is not an AI/machine learning device, the concept of a "training set" and establishing ground truth for it in that context is not applicable. The device's underlying principles are based on established physics (dual-wavelength, non-dispersive infrared measurement) and engineering, likely validated through bench testing and, potentially, in-vivo testing against standard methods, but not through a "training set" of patient data for algorithm learning.

Summary

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510(k) SUMMARY

as required per 807.92(c)

1. Submitters Name, Address:

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: June 11, 1999

Trade Name, Common Name and Classification Name: 2.

A. Trade Name: Siemens INFINITY etCO2 Pod

Common Name, Classification Name, Class and Regulation Number: B.

Common Name	ClassificationNumber	Class	Regulation Number
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	73CCK	II	868.1400

Predicate Device Identification: 3.

Siemens SC9000 etCO2 Module 510(k) K954632

Novametrix CO2SMO Plus 510(k) K963380

4. Device Description:

ડ. Intended Use:

The intended use of Siemens INFINITY etCO2 pod is to measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in both mainstream and side-stream measurement modes (side-stream is not intended for use in the neonatal population). In conjunction with an INFINITY modular bedside monitor, visual and audible alarms will be produced if any of these parameters vary beyond preset limits, and timed or alarm recordings will be produced.

-

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)

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6. Table of Device Similarities and differences to predicate device

Predicate Device	Predicate Device	Applicant	Explanation ofDifferences
Manufacturer	Siemens Medical SystemsSC9000 etCO2 Module	Novametrix Medical SystemsCO2SMO Plus	Siemens Medical SystemsINFINITY etCO2 Pod
510(k) Number	K954632	K963380	To be assigned
Intended Use	To measure end tidal carbon dioxide,inspired carbon dioxide, andrespiration rate in both mainstreamand side-stream measurement modes(side-stream is not intended for use inthe neonatal population). Inconjunction with the SC9000, visualand audible alarms will be producedif any of these parameters varybeyond preset limits, and timed oralarm recordings will be produced.	To provide spirometric, carbondioxide and pulse oximetrymonitoring	To measure end tidal carbon dioxide,inspired carbon dioxide, and respiration ratein both mainstream and side-streammeasurement modes (side-stream is notintended for use in the neonatalpopulation). In conjunction with the SC7000 / SC 8000 / SC 9000XL monitors,visual and audible alarms will be producedif any of these parameters vary beyondpreset limits, and timed or alarm recordingswill be produced.	Siemens etCO2 pod doesnot measure or displayspirometry or pulseoximetry
Intended Population	Adult/Pediatric	Adult/Pediatric/Neonatal	Adult/Pediatric/Neonatal
IntendedEnvironment	A healthcare environment byhealthcare professionals	Same	Same
Measuring Capabilities
Displayed parameters	EtCO2, iCO2, Respiration rate (RRc)	Spirometry, Pulse oximetry,EtCO2, iCO2, Respiration rate(RRc)	EtCO2, iCO2, Respiration rate (RRc)	Siemens etCO2 pod doesnot measure or displayspirometry or pulseoximetry
Display Scales	0-40, 0-80 mmHg	0-50, 0-75, 0-100 mmHg	0-40, 0-60, 0-80, 0-100 mmHg	More display flexibility
Measuring method	Dual-wavelength, non-dispersiveinfrared	Same	Same
Measuringcapabilities	Mainstream and Sidestream	Same	Same
Measuring range	0 to 99 mmHg CO2 partial pressure	0 to 100 mmHg partial pressure	0 to 100 mmHg CO2 partial pressure	*A CO2 ≥ 100 isconsidered out of range
Averaging	Breath, 10s, 20s	Breath, 10s, 20s, Instantaneous	Breath, 10s, 20s, Instantaneous	Improvement

COMPANY CONFIDENTIAL

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Assessment of non-clinical performance data for equivalence: Section T

1. Assessment of clinical performance data for equivalence: Section V
1. Biocompatability: Not applicable
1. Sterilization: Not applicable
1. Standards and Guidances: EN 864: 1996 IEC 60601-1

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2000

Mr. David Simard Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923

Re: K992116 Siemens INFINITY etCO2 Pod Regulatory Class: II (two) Product Code: 73 CCK October 15, 1999 Dated: Received: October 15, 1999

Dear Mr. Simard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David Simard

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

feamothw. Wutoduca fro,

elia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): _

Device Name: Siemens INFINITY etCO2 Pod

Indications for Use:

MRI Compatibility Statement: The Siemens INFINITY etCO2 Pod is not intended for use in a MRI magnetic field.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

to AW. Watscher

Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K9921116

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).