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. With the MultiGas and MultiGas+ modules the monitors are capable of measuring respiration rate, Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen (MultiGas+ only), average inspired Oxygen (MultiGas only), inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide. 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 an 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 populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, 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.

Device Description

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. These devices will connect to a Siemens R50 Bedside recorder, either directly or via the INFINITY Network. The primary modification implemented with the release of software version VF3 is support for the INFINITY Microstream pod, an etCO2 pod that utilizes Oridion's Microstream technology. This technology utilizes a sidestream sampling flowrate appropriate for neonates. The VF3 software release also includes the support of additional pulse oximeter sensors.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Siemens INFINITY Modular Monitors). It describes modifications to the device and asserts substantial equivalence to a legally marketed predicate device.

It does not contain information on acceptance criteria, a specific study proving the device meets acceptance criteria, or performance metrics typically associated with AI/algorithm-based devices.

The document discusses:

Device: Siemens INFINITY Modular Monitors (SC 7000 / SC 9000XL / SC 8000)
Modifications: Support for the INFINITY Microstream pod (etCO2) and additional pulse oximeter sensors with VF3 software release.
Claim: The modifications have not altered the basic fundamental technology, and testing indicated no new issues relative to safety and efficacy.
Regulatory Status: Substantial equivalence to predicate devices (K983632, K990563, K003243, K982730, K980882).

Therefore, I cannot provide the requested information as it is not present in the given text.

The prompt asks for details about an "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based device. The provided FDA 510(k) summary is for hardware and software updates to a patient vital signs monitor, not an AI/algorithm device. The assessment mentioned ("Assessment of non-clinical performance data for equivalence: See Section J") would refer to traditional medical device testing (e.g., electrical safety, EMC, functional verification) to ensure the updated device performs as intended and is safe, similar to the predicate device. It does not involve the types of studies or performance metrics relevant to AI models, such as sensitivity, specificity, F1-score, AUC, etc., which would be compared against a ground truth established by experts.

To reiterate, the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, training set ground truth establishment) is not found in the provided 510(k) summary because it describes a different type of medical device submission than one for an AI/ML algorithm.

Summary

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AUG 1 9 2003

Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text is oriented diagonally, starting from the bottom left and moving towards the upper right. The characters are written in a simple, somewhat crude style, with varying stroke thicknesses. The text appears to be "K031433".

SIEMENS INFINITY Modular Monitors with VF3 Modifications

510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

Special 510(k) Notification

Siemens Medical Solutions USA, 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 Date submission was prepared: May 2, 2003

Trade Name, Common Name and Classification Name:

A. Trade Name:
Siemens INFINITY Modular Monitors (SC 7000 / SC 9000XL / SC 8000)
B. Common Name, Classification Name, Class and Regulation Number:

Common Name	Product Code	Class	Regulation Number
Monitor, Physiological, Patient (with arrhythmia detection or alarms)	MHX	III	21 CFR 870.1025
Arrhythmia detector & Alarm	74DSI	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

Description of Modification:

The primary modification implemented with the release of software version VF3 is support for the INFINITY Microstream pod, an etCO2 pod that utilizes Oridion's Microstream technology. This technology utilizes a sidestream sampling flowrate appropriate for neonates.

The VF3 software release also includes the support of additional pulse oximeter sensors.

The modifications implemented with the release of VF3 software have not altered the basic fundamental technology of the INFINITY Modular Monitors. Testing with VF3 software and the INFINITY Microstream pod, as well as the additional sensor support indicate no new issues relative to safety and efficacy.

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Special 510(k) Notification SIEMENS INFINITY Modular Monitors with VF3 Modifications

Intended Use:

Assessment of non-clinical performance data for equivalence: See Section J

Assessment of clinical performance data for equivalence: See Section J

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances: See Section J

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 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 a stylized image of three wavy lines, which are meant to represent the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2003

Ms. Penelope H. Greco Regulatory Submissions Manager Siemens Medical Solution USA, Incorporated Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, Massachusetts 01923

Re: K031433

Trade/Device Name: Siemens Infinity Modular Monitors (SC 7000/ SC 9000XL SC 8000) Regulation Number: 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: III Product Code: MHX, DSI, DQA, CCK Dated: August 13, 2003 Received: August 14, 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. 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 (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 (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 yours

Jason Runoes

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_K03 |433

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 ●

signature

510(k) Number: K031433

K031433

With the MultiGas and MultiGas+ modules the monitors are capable of measuring respiration rate, Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen (MultiGas+ only), average inspired Oxygen (MultiGas only), inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide.

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 an 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 populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, 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)

ﻠ Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.