The device is 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 device is 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 tcpO2/CO2 which is to be used in the neonatal population only.

Device Description

The SC 8000 bedside monitor is a modified version of the SC 7000/SC 9000XL INFINITY Modular Bedside Monitors (K982730). The SC 8000 supports all SC 7000 software based options and offers all of the standard I/O connections of the SC 7000 plus interface plate. The hardware has been reengineered as a unit without a display that allows customers the option of providing their own medical-grade display.

AI/ML Overview

The Siemens SC 8000 Bedside Monitor is a modified version of the SC 7000/SC 9000XL INFINITY Modular Bedside Monitors. This device is intended to monitor various physiological parameters and produce alarms if these parameters vary beyond preset limits.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria or provide a table of performance data for the SC 8000 Bedside Monitor. The document focuses on establishing substantial equivalence to a predicate device (Siemens SC 7000/SC9000 XL INFINITY Modular Bedside Monitors, K982730) rather than presenting a detailed performance study with defined acceptance criteria for the new device.

The "Intended Use" section lists the parameters the device is capable of monitoring, but it does not specify performance metrics (e.g., accuracy, sensitivity, specificity, or error margins) for these parameters.

Therefore, I cannot generate the requested table of acceptance criteria and reported device performance from the provided text.

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

The document states, "Assessment of non-clinical performance data for equivalence: See Section L" and "Assessment of clinical performance data for equivalence: Not applicable." This indicates that clinical performance data was not considered applicable for demonstrating equivalence.

Since no clinical performance study for the SC 8000 is described, there is no information on sample size, test set, or data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

As no clinical performance study is described as applicable for the SC 8000, there is no information on the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method

Given that no clinical performance study or ground truth establishment for the SC 8000 is described, there is no information on an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document states, "Assessment of clinical performance data for equivalence: Not applicable." This clearly indicates that a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or considered necessary for this submission. Therefore, there is no information on the effect size of human readers with vs. without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The document does not describe any standalone algorithm performance studies for the SC 8000. The focus is on the device's functional capabilities and its equivalence to a predicate device, not on the performance of a specific embedded algorithm in isolation. Therefore, no standalone performance study is explicitly mentioned.

7. Type of Ground Truth Used

As clinical performance data was deemed "Not applicable" for this submission, the document does not specify the type of ground truth used for evaluating the SC 8000's performance. The equivalence relies on the predicate device's established performance and the changes being non-substantive from a clinical perspective.

8. Sample Size for the Training Set

The document does not describe the development or training of any algorithms for the SC 8000. It refers to the device as a "modified version" of existing monitors. Therefore, there is no information regarding the sample size for a training set.

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

Since no training set is described (as per point 8), there is no information on how the ground truth for a training set was established.

Summary

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510(k) SUMMARY

6 1998 NOW

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: October 9, 1998

Trade Name, Common Name and Classification Name:

A. Trade Name: Siemens SC 8000 Bedside 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
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
Monitor, Carbon-Dioxide, Cutaneous	73LKD	II	21 CFR 868.2480
Monitor, Oxygen, Cutaneous, for infant not under gasanesthesia	73KLK	II	21 CFR 868.2500

Legally Marketed Device Identification:

Siemens SC 7000/SC9000 XL INFINITY Modular Bedside Monitors, 510(k) submission K982730.

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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Description of Modification:

Intended Use:

The intended use of the SC 8000 Bedside Monitor is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation, pulse rate, (central) apnea, cardiac output, ST Segment Analysis, 12-lead ST Segment Analysis, and transcutaneous partial pressure of oxygen and 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.

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

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances: See Declaration of Conformity, Section P-1

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 NOV

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

K983632 Re : Siemens SC 8000 Bedside Monitor Trade Name: Requlatory Class: III Product Code: 74 DSI Dated: October 14, 1998 Received: October 15, 1998

Dear Ms. Greco:

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, Druq, 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, qood 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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 - Ms. Penelope H. Greco

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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510(k) Number (if known):_

Device Name:

Indications for Use:

The SC 8000 Bedside monitor is capable of monitoring:

. Heart rate
Respiration rate .
Invasive pressure .
Non-invasive pressure .
Arrhythmia ●
Temperature .
Cardiac output .
Arterial oxygen saturation .
. Pulse rate
(central) apnea ●
ST segment analysis .
12-Lead ST Segment Analysis ●
tcpO2/CO2 .

MRI Compatibility Statement:

The Siemens SC 8000 Bedside Monitor 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)

N. Deelutelli

sion Sion-Off Division of Cardiovascular, Respiratory, and Neurological Devi 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.