The INFINITY Modular monitors are capable of monitoring: Heart rate, Respiration rate, Invasive pressure, Non-invasive pressure, Arrhythmia, Temperature, Cardiac output, Arterial oxygen saturation, Pulse rate, Apnea, ST Segment Analysis, 12-Lead ST Segment Analysis, tcp02/tcpC02, EEG signals, FiO2. The Scio and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors. With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The monitors can interface with specific third party devices via a MIB protocol converter.

Device Description

Siemens INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The SCIO module samples breathing gases from adults and pediatrics. SCIO continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents: halothane, isoflurane, enflurane, sevoflurane, and desflurane in any mixture. When SCIO is connected to an INFINITY Modular monitor it communicates real time and derived gas information to the monitor for display.

AI/ML Overview

This 510(k) premarket notification for the INFINITY Modular Monitors with SCIO module focuses on substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria for a new AI/software-as-a-medical-device (SaMD) product. Therefore, many of the requested categories related to AI/SaMD performance studies and ground truth establishment are not applicable.

The document primarily demonstrates that the new device, which continuously measures various breathing gases and anesthetic agents, has the same intended use and technological characteristics as legally marketed predicate devices.

Here's the breakdown of the information that can be extracted from the provided text, and where specific requested details are not applicable:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the 510(k) summary. The summary states "Assessment of non-clinical performance data for equivalence: Substantially equivalent (Section S)" and "Assessment of clinical performance data for equivalence: Substantially equivalent (Section U)". This indicates that performance data was reviewed to establish equivalence to predicate devices, but the specific acceptance criteria and detailed performance metrics are not included in this summary document. For a traditional medical device like a patient monitor, acceptance criteria would typically involve accuracy, precision, response time, alarm functionality, and other physiological measurement parameters compared to established standards or a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The 510(k) summary refers to "non-clinical performance data" and "clinical performance data" but does not detail the specifics of any test sets, sample sizes, or data provenance.

3. 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)

This information is not applicable/not provided. For a device like a physiological monitor measuring gas concentrations, ground truth would typically be established by highly accurate reference measurement devices, not by human experts. The 510(k) summary does not describe a study involving expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication methods are typically relevant for studies where human interpretation (e.g., image reading) contributes to ground truth establishment, which is not the case for this type of device.

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 information is not applicable/not provided. This is not an AI/SaMD product that assists human readers. It's a physiological monitor.

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

This information is not applicable/not provided. The device is a physiological monitor, not an algorithm being tested in a standalone capacity separate from the human operator. Its function is to provide direct measurements and alarms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not explicitly stated, but for a device measuring gas concentrations, the ground truth would typically be established by highly accurate laboratory-grade gas analyzers or calibrated reference standards.

8. The sample size for the training set

This information is not applicable/not provided. This is a physiological monitor, not a machine learning or AI device that requires a "training set" in the conventional sense. Its functionality relies on sensing and processing physical signals based on established scientific principles.

9. How the ground truth for the training set was established

This information is not applicable/not provided for the same reasons as point 8.

Summary

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NOV 2 5 2003

510(k) Notification INFINITY Modular Monitors (SC 7000, SC 8000, SC 9000XL) with SCIO

510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

KO31340 Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco April 23, 2003 Date submission was prepared:

Trade Name, Common Name and Classification Name:

A. Trade Name:

INFINITY Modular Monitors (SC 7000 / SC 9000XL / SC 8000) with SCIO

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

Common Name	Product Code	Class	Regulation Number
Monitor, Physiological, Patient (withArrhythmia Detection or Alarms)	MHX	III	21 CFR 870.1025

Legally Marketed Device Identification:

INFINITY SC 8000 Monitor, 510(k) K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, 510(k) K003243/K982730/ K980882

Predicate Device Identification:

K022889	INFINITY Modular Monitors
K012139	Vamos Anesthetic Gas Monitor

Other relevant submissions

K965062	SC 9000 / SC 9015 Multigas and Multigas+ Modules
K012016	SC 8000 with Advanced Communication Option II
K980882	SC 7000 / SC 9000XL Modular Monitors
K003243	INFINITY Modular Monitors (SC 7K, 8K, 9KXL)
K990563	SC 8000 with Advanced Communication Option
K983632	SC 8000 Bedside Monitor

Device Description:

Page 1 of 2 COMPANY CONFIDENTIAL Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Tel: (978) 907-7500 Danvers, MA 01923 Fax: (978) 750-6879

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Intended Use:

The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. This device will connect to a Siemens R50 Bedside recorder, either directly or via the INFINITY Network.

Assessment of non-clinical performance data for equivalence: Substantially equivalent (Section S)

Assessment of clinical performance data for equivalence: Substantially equivalent (Section U)

Biocompatibility: Section M

Sterilization: Not applicable

Standards and Guidance: Section R

Page 2 of 2

COMPANY CONFIDENTIAL

Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: (978) 907-7500 Fax: (978) 750-6879

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 25 2003

Ms. Penelope H. Greco Regulatory Submissions Manager Siemens Medical Solutions USA, Incorporated 16 Electronics Avenue Danvers, MA 01923

Re: K031340

Trade/Device Name: INFINITY Monitors (SC 7000/SC 900XL) with SCIO Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor, (W/ Arrhythmia Detection or Alarms) Regulatory Class: III Product Code: MHX Dated: August 29, 2003 Received: September 2, 2003

Dear Ms. Greco:

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 vour 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.

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Page 2 – Ms. Penelope H. Greco

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 (OS) 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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Susa Qum
Chiu Lin, Ph.D.

Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KO31340

Device Name:

Indications for Use:

The INFINITY Modular monitors are capable of monitoring:

Heart rate ●
Respiration rate ●
Invasive pressure
Non-invasive pressure ●
Arrhythmia .
Temperature .
. Cardiac output
Arterial oxygen saturation ●
Pulse rate .
. Apnea
ST Segment Analysis .
12-Lead ST Segment Analysis .
tcp02/tcpC02 .
EEG signals ●
FiO2 ●

The Scio and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.

With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored.

The monitors can interface with specific third party devices via a MIB protocol converter.

The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The devices are intended to be used on Adult, Pediatric and Neonatal patients, with the exception of the parameter Cardiac Output, ST Segment Analysis, etCO2 sidestream, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

MRI Compatibility Statement:

The INFINITY Modular Monitors are not compatible 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	✓	OR	Over-The-Counter Use_
(Per 21 CFR 801.109)
	E. Zintch 11/25/03 (Optional Format 1-2-96) (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number 109/5

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.