The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, 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 Arrhythmia which is not intended for the neonatal population.

Device Description

The INFINITY SC 6002XL is an addition to Siemens INFINITY patient monitoring series that has combined the technologies of two predicate devices: the INFINITY SC 600X and the INFINITY SC 7000. Like the SC 600X the INFINITY SC 6002XL is a compact, configured monitor whose small size allows for ease of portability. Modifications have been made to the SC 600X software to make it more analogous to the SC 7000 platform. The front panel display is similar in design to the SC 7000 for a more uniform look to the INFINITY product line. In addition to A/B clinical performance tests that compared the new INFINITY SC 6002XL to the SC 7000, in-house verification and validation tests were performed. All tests confirmed that the new INFINITY SC 6002XL is as safe and effective as the predicate devices.

AI/ML Overview

The provided text is a 510(k) Notification for the Siemens INFINITY SC 6002XL Portable Patient Monitor. This type of submission is for medical devices to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new safety and efficacy. Therefore, the document primarily focuses on comparing the new device against existing ones.

As such, detailed acceptance criteria and a study proving the device meets them in the way modern clinical trials would are not present in this type of submission. This document highlights that "in-house verification and validation tests were performed" and "All tests confirmed that the new INFINITY SC 6002XL is as safe and effective as the predicate devices." However, it does not provide the specific metrics, methodologies, or results of these tests in detail.

Thus, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated based on the document:

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

This information is not explicitly provided in the 510(k) summary. The document states that "in-house verification and validation tests were performed" and "All tests confirmed that the new INFINITY SC 6002XL is as safe and effective as the predicate devices." This implies that the acceptance criteria were likely based on matching the performance of the predicate devices for each monitored parameter (Heart Rate, Respiration Rate, Invasive Pressure, Non-Invasive Pressure, Arrhythmia, Temperature, Arterial oxygen saturation, Pulse Rate, (central) Apnea, and end-tidal CO2). However, specific numerical acceptance thresholds or detailed performance metrics are not given.

2. Sample size used for the test set and the data provenance:

This information is not provided. The document mentions "A/B clinical performance tests" and "in-house verification and validation tests" but gives no details on sample size, data source (country), or whether it was retrospective or prospective.

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.

4. Adjudication method for the test set:

This information is not provided.

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 irrelevant for a patient monitor and certainly not mentioned. Patient monitors like this do not involve "human readers" or "AI assistance" in the way an imaging diagnostic device might.

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

The device is a patient monitor, which inherently operates in a standalone manner by continuously measuring and displaying physiological parameters. The "algorithm only" aspect would refer to the internal signal processing of the monitor. The document confirms that "in-house verification and validation tests were performed," which would include testing the accuracy and reliability of these internal algorithms. However, a separate "standalone" study in the context of an AI algorithm is not applicable here given the device's function as a physiological monitor.

7. The type of ground truth used:

This information is not provided. For a patient monitor, ground truth would typically be established using validated reference measurement devices or established clinical standards for each physiological parameter.

8. The sample size for the training set:

This information is not provided. For a device like this, there isn't a "training set" in the machine learning sense. The device's algorithms are developed through engineering and validated against known physiological signals and simulated conditions.

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

This information is not provided. As noted above, the concept of a "training set" with established ground truth as in machine learning is not directly applicable to this type of device development as described in the 510(k) notice.

Summary

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510(k) Notification INFINITY SC 6002XL Portable Patient Monitor

K993974

510(k) SUMMARY

as required per 807.92(c)

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: November 23, 1999

Trade Name, Common Name and Classification Name:

A. Trade Name: Siemens INFINITY SC 6002XL Portable Patient Monitor

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

Common Name	ClassificationNumber	Class	Regulation Number
Cardiac Monitor	74DRT	II	21 CFR 870.2300
Pulse Rate Monitor	74BWS	II	21 CFR 870.2300
Pulse Oximeter	74DQA	II	21 CFR 870.2700
Breathing Frequency Monitor	73BZQ	II	21 CFR 868.2375
Clinical Electronic Thermometer	80BWX	II	21 CFR 880.2910
Indwelling Blood Pressure Monitor	74CAA	II	21 CFR 870.1110
Noninvasive Blood Pressure Monitor	74DXN	II	21 CFR 870.1130
Heart Rate Monitor, Neonatal	74FLO	II	21 CFR 870.2300
Ventilatory Effort Monitor (Apnea Detector)	73FLS	II	21 CFR 868.2375
Monitor Blood Pressure, Neonatal, Invasive	74FLP	II	21 CFR 870.1110
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	73CCK	II	21 CFR 868.1400
Arrhythmia Detector & Alarm System	74DSI	III	21 CFR 870.1025
Monitor, Physiological, Patient (with arrhythmiadetection or alarms)	MHX	III	21 CFR 870.1025

Predicate Device Identification:

K980882	SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor
K982730	SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor
K944350	SC 6000 / SC 6000P
K962404	SC 6000 / SC 6000P Neonatal
K955743	SC 6000 / SC 6000P w/Arrhythmia
Other relevant submissions
K983980	MVWS INFINITY Telemetry System Additional Arrhythmia Calls
K955059	SC3000 MULTIVIEW WorkStation and Remote Display
K992116	INFINITY etCO2 Pod

-

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

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

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510(k) Notification INFINITY SC 6002XL Portable Patient Monitor

Device Description:

Intended Use:

The intended use of the SC 6002XL is substantially equivalent to that of the predicate devices in that it monitors heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea, and end-tidal carbon dioxide. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to Siemens R50 recorders, either directly or via the INFINITY network.

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

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

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidance: Section S

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

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

{2}------------------------------------------------

Manufacturer	Legally Marketed DeviceSC 600XSiemens Medical Systems	Legally Marketed DeviceSC 7000Same	Modified DeviceINFINITY SC 6002XLSame	Explanation of Differences
Intended Use	The intended use of this device is tomeasure heart rate, respiration rate,invasive pressure, non-invasivepressure, arrhythmia (adult),temperature, arterial oxygensaturation, pulse rate, and (central)apnea. This device will producevisual and audible alarms if any ofthese parameters vary beyond presetlimits and produce timed or alarmrecordings. This device will connectto the Siemens SIRENET or Infinity(Olympus) network	The intended use of this device is tomonitor heart rate, respiration rate,invasive pressure, non-invasivepressure, arrhythmia, temperature,arterial oxygen saturation and pulserate, cardiac output, central apnea,end-tidal carbon dioxide, STsegment analysis, 12-Lead STsegment analysis, andtranscutaneous oxygen &transcutaneous carbon dioxide. Thisdevice will produce visual andaudible alarms if any of theseparameters vary beyond preset limitsand produce timed or alarmrecordings. This device will connectto Siemens R50 recorder, eitherdirectly or via the INFINITYnetwork.	The intended use of this device is tomonitor heart rate, respiration rate,invasive pressure, non-invasivepressure, arrhythmia, temperature,arterial oxygen saturation and pulse rate,central apnea, end-tidal carbon dioxide.This device will produce visual andaudible alarms if any of theseparameters vary beyond preset limitsand produce timed or alarm recordings.This device will connect to SiemensR50 recorders, either directly or via theINFINITY network.	ST segment analysis, 12-lead STsegment analysis, transctaneousoxygen & transcutaneous carbondioxide, and cardiac output are notavailable.
IntendedPopulation	Adult/Pediatric/Neonatal	Same	Same
IntendedEnvironment	In a healthcare environment wherepatient care is provided byhealthcare professionals.	Same	Same
Display type	Color TFT, 6" diagonal	Color TFT, 10.4" diagonal	Color TFT, 6.7" diagonal	New mechanical design
Weight	2.9 kg (6.63 lb) with battery	7.2 kg (15.9 lbs) with battery	3.42 kg (7.54 lb) with lead-acid battery3.22 kg (7.10 lb) with lithium-ionbattery	New mechanical design
Dimensions (H xW x D)	189 x 225 x 131 mm(7.4 x 8.9 x 5.2 in.)	224 x 330 x 190 mm(8.8 x 13.0 x 7.5 inches)	196 x 223 x 134 mm(7.7 x 9.8 x 5.3 inches)	New mechanical design

Table of Device Similarities and differences to legally marketed device

COMPANY CONFIDENTIAL

Siemens Medical Systems, 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/3/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the edge of the logo. In the center of the logo is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2000

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

Re: K993974 INFINITY SC 6002XL Portable Patient Monitor Regulatory Class: III (three) Product Code: 74 MHX, MSX Dated: November 23, 1999 November 24, 1999 Received:

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 leqally 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 against 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 requlation (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,

Zita for
Written

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

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Siemens INFINITY SC 6002XL Portable Patient Monitor Device Name:

Indications for Use:

This device is capable of monitoring:

Heart Rate .
Respiration Rate ●
Invasive Pressure .
Non-Invasive Pressure ●
Arrhythmia ●
Temperature .
Arterial oxygen saturation .
Pulse rate .
(central) apnea .
end-tidal CO2 .

The devices are intended to be used on Adult. Pediatric and Neonatal populations, with the exception of Arrhythmia which is not intended for the neonatal population.

MRI Compatibility Statement:

The Siemens INFINITY SC 6002XL is 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 (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

2/22/00

(Division Sign-Off) Division of Cardiovascu = Respiratory, and Neurological Devices

510(k) Number.

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.