Respiration rate
Inspired and expired Carbon Dioxide (CO2)
Inspired and expired Oxygen (MultiGas+TM only)
Average inspired Oxygen (MultiGas™ only)
Inspired and expired gas concentrations of Enflurane, Isoflurane, Desflurane, Desflurane, Sevollurane, and Nitrous Oxide.

The SC 7000 and SC 9000XL can interface with third party devices.

The devices are intended to be used in the environment where patient care is provided by Healtheare. 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 and ST Segment Analysis which are intended for use in the adult and pediatric populations only; and Arrhythmia which is intended for use in the adult population only.

Device Description

The SC 7000 and SC 9000XL modular bedside monitors are enhanced versions of the SC 9000 (predicate device - original submission K946306) and use the same front panel display and user interface as the SC 9000. In addition, the SC 9000 docking station is compatible with the SC 7000 and SC 9000XL for power and communication capabilities.

The SC 7000 (mid-level monitor) and the SC 9000XL (high-end monitor) are additions to the Siemens INFINITY Modular Portable Bedside Monitoring Series. Both the SC7000 and SC 9000 XL utilize the same electronics and software, but with different base configurations and available options.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving device performance for the Siemens SC7000 and SC9000XL INFINITY Modular Bedside Monitors.

The document is a 510(k) notification and summary, which primarily establishes substantial equivalence to a predicate device (Siemens SC9000). It focuses on:

Device Description: Explains that the SC7000 and SC9000XL are enhanced versions of the SC9000 and share electronics/software.
Intended Use: Lists the physiological parameters the devices are intended to measure and alarm functions.
Predicate Device Identification: Specifies the Siemens SC9000 as the predicate.
Table of Device Similarities and Differences: Compares the new devices to the predicate in terms of manufacturer, intended use, population, environment, display, waveforms, and various measurement capabilities, noting mostly "Same."
Assessment of non-clinical and clinical performance data for equivalence: The document refers to Sections U and V for this assessment but does not include the content of these sections.
FDA Letter: Confirms substantial equivalence but does not detail performance studies.
Indications for Use: Reiterates the parameters monitored and populations.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: This level of detail regarding specific performance metrics and their acceptance thresholds, along with the device's actual measured performance, is not present.
Sample sizes used for the test set and the data provenance: No information on test set sample sizes or data origin is provided.
Number of experts used to establish the ground truth for the test set and their qualifications: No mention of experts or ground truth establishment for a test set.
Adjudication method for the test set: Not discussed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No mention of such a study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not discussed, as this device does not appear to be an AI/algorithm-only device in the context usually implied by this question. It's a physiological monitor.
The type of ground truth used: Not specified.
The sample size for the training set: Not applicable for a traditional physiological monitor without AI/machine learning training sets in the modern sense.
How the ground truth for the training set was established: Not applicable.

The document focuses on establishing substantial equivalence to a legally marketed predicate device, which is a different regulatory pathway than providing detailed performance studies for novel AI/algorithm-driven devices with specific acceptance criteria. For physiological monitors like these, compliance is typically demonstrated through engineering testing, adherence to recognized standards, and comparison of specifications to the predicate device, rather than the types of clinical studies you've outlined for AI.

Summary

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Image /page/0/Picture/1 description: The image shows the alphanumeric string "K980882" on the top line. The second line shows the alphanumeric string "P 1/3". The text appears to be handwritten with a dark pen or marker on a white background.

510(k) NOTIFICATION 510(k) NOTIFICATION

SIEMENS SC7000 and SC9000XL INFINITY Modular BedsideMonitors

510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

Siemens Medical Systems, Inc. Stement Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Fax: (978) 750 00:dent: David Simard, Director David Juality Assurance & Regulatory Affairs Contact person for this submission: Jacqueline Emery Contact person for this ents entruary 27, 1998

Trade Name, Common Name and Classification Name:

A. Trade Name:
Trade Name:
Siemens SC7000 & SC9000 XL INFINITY Modular Bedside Monitor Series
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
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
Arrhythmia detector & Alarm	74DSI	III	21 CFR 870.1025
Medical Cathode-Ray Tube Display	74DXJ	II	21 CFR 870.2450
ST Segment Monitor with Alarm	74MLD	III	21 CFR 870.1025
Non-indwelling Blood Pressure Monitor	74DXN	II	21 CFR 870.1130
End-tidal Carbon-Dioxide Monitor	73CCK	II	21 CFR 868.1400

Predicate Device Identification:

licate Device Identification:
Siemens SC9000/SC9015 Patient Monitoring System, original 510(k) submission K946306.

ﻧﺴﻤﺎ

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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510(k) NOTIFICATION SIEMENS SC7000 and SC9000XL INFINITY Modular BedsideMonitors

Device Description:

Intended Use:

The intended use of the SC 7000 and SC 9000XL Bedside Monitoring Series is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, cardiac output, central apnea, and ST segment analysis. 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 a Siemens R50 Bedside Recorder, either directly or via the Infinity network.

COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronies Avenue Danvers, MA 01923 USA

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

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K980882
P3/3

510(k) NOTIFICATION 510(K) NOTTITICATION

SIEMENS SC7000 and SC9000XL INFINITY Modular Bedside Monitors

	Substantial Equivalent Device	ApplicantSiemens Medical Systems
	Siemens SC9000	Siemens SC 7000	Siemens SC9000 XL
Manufacturer	Siemens	Same	Same
510(k) Number	K946306 (original submission)	To be assigned	Same
Intended Use	The intended use of this deviceis to measure heart rate,respiration rate, invasivepressure, non-invasive pressure,arrhythmia, temperature, cardiacoutput, arterial oxygensaturation, pulse rate, cardiacoutput, end-tidal carbon dioxide,(central) apnea, and ST SegmentAnalysis. This device willproduce visual and aural alarmsif any of these parameters varybeyond preset limits and producetimed or alarm recordings. Thisdevice will connect to a SiemensR50 Bedside recorder, eitherdirectly or via the InfinityNetwork.	Same	Same
Intended Population	Adult/Pediatric/Neonatal	Same	Same
Intended Environment	In a healthcare environmentwhere patient care is providedby healthcare professionals.	Same	Same
Display type	Color TFT, 10.4"	Same	Same
Waveforms	Up to 8	Same	Same
Arrhythmia Detection	BasicEnhanced Optional	Same	Same
Modular	Yes	Same	Same
Networking	Standard	Same	Same
NBP	Oscillometric	Same	Same
MIB	Compatible	Same	Same
MultiGas	Compatible	Same	Same
ST	3/7/8 leads	Same	Same
IBP	Up to 8 channels	Same	Same

Table of Device Similarities and differences to predicate device

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

Assessment of clinical performance data for equivalence: See Section V

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances: See Section W

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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IIIN

Ms. Penelope H. Cameron Regulatory Submissions Manager Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923

K980882 Re: Siemens SC 7000/SC 9000XL INFINITY Modular Bedside Monitors Requlatory Class: III (three) Product Code: DSI Dated: March 4, 1998 Received: March 9, 1998

Dear Ms. Cameron:

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 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 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 regulation may result in regulatory 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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Psge 2 - Mr. Joel C. Kent

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/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. 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):

Siemens SC 7000 and SC 9000 XL INFINITY Modular Bedside Monitors Device Name:

Indications for Use:

The SC 7000 and SC 9000XL INFINITY Modular Bedside monitors are capable of monitoring:

Heart rate t
Respiration rate .
. Invasive pressure
Non-invasive pressure 후
. Arrhythmia
Temperature .
Cardiac output .
Arterial oxygen saturation .
Pulse rate ♥
End-tidal carbon dioxide .
(central) apnea ♥
ST segment analysis .

With the MultiGas™ and MultiGas+™ modules the SC 7000 and SC 9000XL are capable of measuring:

Respiration rate .
Inspired and expired Carbon Dioxide (CO2) .
Inspired and expired Oxygen (MultiGas+TM only) .
Average inspired Oxygen (MultiGas™ only) .
Inspired and expired gas concentrations of Enflurane, Isoflurane, Desflurane, Desflurane, Sevollurane, ● and Nitrous Oxide.

The SC 7000 and SC 9000XL can interface with third party devices.

MRI Compatibility Statement:

The Siemens SC 7000 and SC 9000XL INFINITY Modular Bedside 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
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format

(Optional Format 1-2-96)

Division Sign-Off) ivision of Cardiovascular, Respiratory, and Neurological D

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.