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, Halothane, Isoflurane, Desflurane, Sevoflurane, . 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 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 and ST Segment Analysis which are intended for use in the adult and pediatric populations only; Arrhythmia which is intended for use in the adult population only; and Transcutaneous Oxygen which is intended for use in the neonatal population when the patient is not under gas anesthesia.

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

The provided text describes the Siemens SC7000 and SC9000XL INFINITY Modular Bedside Monitors and their intended use, but it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria.

The document is a 510(k) summary, which is typically a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. While it lists various monitoring capabilities and specifications, it does not detail performance metrics, study designs, or results that would demonstrate the device meets specific acceptance criteria.

Therefore, many of the requested sections about acceptance criteria and study details cannot be answered from the provided text.

Here's what can be extracted based on the information given, with explicit notes where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The document lists the types of parameters the monitors are capable of measuring (e.g., heart rate, respiration rate, invasive pressure, etc.), but it does not specify performance metrics (e.g., accuracy, precision, response time, false alarm rates) or compare them against predefined acceptance criteria.

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

Not provided. The document does not describe any specific test set or clinical study data.

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

Not provided. The document does not describe any test set or ground truth establishment process.

4. Adjudication Method for the Test Set

Not provided. The document does not describe any test set or adjudication process.

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

Not applicable. The document describes a medical device (patient monitor), not an AI algorithm for diagnostic imaging or interpretation by human readers. Therefore, an MRMC study or AI assistance is not relevant to the information provided.

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

Not applicable. The device is a patient monitor, which by its nature is an "algorithm only" type of device in terms of measuring and displaying parameters. However, the document does not contain details of standalone performance studies for its various algorithms (e.g., arrhythmia detection, ST segment analysis). It relies on substantial equivalence to a predicate device.

7. The Type of Ground Truth Used

Not provided. As no specific performance studies are detailed, the type of ground truth is not mentioned.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is a hardware and software system for patient monitoring, not a machine learning model that undergoes "training" in the conventional sense for AI. If there were internal algorithm development or validation, the sample sizes for such activities are not mentioned.

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

Not applicable/Not provided (see #8).

Summary of Device and Regulatory Status:

Device Name: Siemens SC7000 and SC9000XL INFINITY Modular Bedside Monitors
Predicate Device: Siemens SC9000/SC9015 Patient Monitoring System (K946306)
Regulatory Pathway: 510(k) premarket notification to establish substantial equivalence.
Date of Submission: August 13, 1998
FDA Clearance Date: August 24, 1998
Intended Use: To monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, cardiac output, central apnea, end-tidal carbon dioxide, ST segment analysis, 12-Lead ST Segment Analysis, and transcutaneous oxygen & transcutaneous carbon dioxide. Also includes measurement of various gas concentrations with add-on modules. The device provides visual and audible alarms.
Intended Population: Adult, Pediatric, and Neonatal (with specific parameter restrictions for different populations).
Intended Environment: Healthcare environment where patient care is provided by healthcare professionals.
Evidence for Equivalence: The document indicates an "Assessment of non-clinical performance data for equivalence: See Section U" and "Assessment of clinical performance data for equivalence: See Section V". However, these sections are not provided in the given text, so the specific details of the data reviewed by the FDA for substantial equivalence are missing. The primary argument in the provided text for equivalence is the similarity in manufacturer, intended use, population, environment, display, waveforms, arrhythmia detection, modularity, networking, NBP, MIB, MultiGas, ST, and IBP features to the predicate device.

Summary

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

AUG 24 1998

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: Jacqueline Emerv Date submission was prepared: August 13, 1998

Trade Name, Common Name and Classification Name:

A. 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
Monitor, Carbon-Dioxide, Cutaneous	73LKD	II	21 CFR 868.2480
Monitor, Oxygen, Cutaneous, for infants not under gasanesthesia	73KLK	II	21 CFR 868.2500

Predicate Device Identification:

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

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)

{1}------------------------------------------------

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 monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, cardiac output, central apnea, end-tidal carbon dioxide, ST segment analysis, 12-Lead ST Segment Analysis, and transcutaneous oxygen & transcutaneous 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 a Siemens R50 Bedside Recorder, either directly or via the Infinity network.

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)

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

	able of Device Similarities and differences to predicate device	Applicant
	Substantial Equivalent Device	Siemens Medical Systems
	Siemens SC9000	Siemens SC 7000	Siemens SC9000 XL
Manufacturer	Siemens	Same	Same
510(k) Number	K946306 (original submission)	To be assigned
Intended Use	The intended use of the SC 7000and SC 9000XL BedsideMonitoring Series is to monitorheart rate, respiration rate,invasive pressure, non-invasivepressure, arrhythmia,temperature, arterial oxygensaturation and pulse rate, cardiacoutput, central apnea, end-tidalcarbon dioxide, ST segmentanalysis, 12-Lead ST SegmentAnalysis, and transcutaneousoxygen & transcutaneous carbondioxide. This device willproduce visual and audiblealarms if any of these parametersvary beyond preset limits andproduce timed or alarmrecordings. This device willconnect to a Siemens R50Bedside Recorder, either directlyor via the Infinity network.	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	3/7/8/12 leads	Same	Same
IBP	Up to 8 channels	Same	Same

f Device Similarities and differences to predicate device i Tabl

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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles a stylized human figure in profile, repeated three times. The figures are connected and appear to be facing the same direction.

AUG 2 4 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Simard, Director Quality Assurance and Regulatory Affairs Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923

Re: K982730 Siemens SC 7000 and SC 9000XL Bedside Monitors Requlatory Class: III (three) Product Code: DSI Dated: July 13, 1998 Received: July 16, 1998

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 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 regulatory 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 requlations.

{4}------------------------------------------------

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 Also, device, please contact the Office of Compliance at (301) 594-4639. please note the requlation entitled, ?Misbranding by reference to premarket notification? (21CFR 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,
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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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 .
Respiration rate .
Invasive pressure .
Non-invasive pressure .
Arrhythmia ●
. Temperature
Cardiac output .
Arterial oxygen saturation .
Pulse rate .
End-tidal carbon dioxide .
(central) apnea
ST Segment Analysis .
12-Lead ST Segment Analysis .
Transcutaneous Oxygen and Transcutaneous Carbon Dioxide (tpO2/CO2) .

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, Halothane, Isoflurane, Desflurane, Sevoflurane, . 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)
		Stuart Portnoy for DBT	8-18-98
Prescription Use
(Per 21 CFR 801.109)	(Division Sign-Off) OR
	Division of Cardiovascular, Respiratory,
	and Neurological Devices
	510(k) Number	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.