The INFINITY SC 8000 monitor is intended for multi-parameter patient monitoring. The device will r no INT I 1 1 50 0000 months if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. This device will connect to a Siemens R50 Bedside recorder, either directly or via the INFINITY Network.

The INFINITY SC 8000 Monitor is 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 monitor is 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 monitor can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode

With the INFINITY etCO2 + Respiratory Mechanics Pod the monitor can provide spirometric and carbon dioxide monitoring.

The monitor can interface with specific third party devices via an MIB protocol converter.

Device Description

The SC 8000 Advanced Communication Option II is equivalent to that submitted in K990563 in that it can process and display, from external devices:
MultiGas and MultiGas+ modules (K965062)
Surgical Display Controller (K970348)
Medical Information BUS Protocol Converter (MIB and MIB II) (K970368, K973222, K99166, K003248, and K010640)

A modification has been implemented in the SC 8000 Advanced Communication Option II to accommodate RJ45 connectors for interfacing to the MIB II Protocol Converter (K010640). The MIB II Protocol Converter supports the new IEEE 1073.3.2-2000, Standard for Medical Communications -Transport Profile - irDA Based - Cable Connected.

AI/ML Overview

The provided document is a 510(k) summary for a modification to the Siemens INFINITY SC 8000 monitor, specifically its Advanced Communication Option II to accommodate RJ45 connectors for interfacing with the MIB II Protocol Converter. This submission does not contain details about acceptance criteria, study methodologies, or performance data in the way that would typically be found for a medical device that makes a diagnostic or therapeutic claim based on novel algorithms or complex data analysis.

The device in question, the Siemens Medical Information Bus (MIB II) Protocol Converter (and its integration into the monitor), falls under the classification of a "Monitor, Physiological, Patient (with arrhythmia detection or alarms)" and "Arrhythmia detector & Alarm." The purpose of this 510(k) is to demonstrate substantial equivalence to previously cleared devices for a modification to the communication option, not to prove the primary clinical performance of the physiological monitoring functions themselves.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this document because they are not applicable to the scope of this particular 510(k) submission, which focuses on an interface modification. The primary "study" mentioned is the assessment of "non-clinical performance data for equivalence."

Based on the provided text, here is what can be extracted and what cannot:

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

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this submission appear to be demonstrating equivalence to previously cleared devices for the communication interface. The relevant standard mentioned is IEEE 1073.3.2-2000.
Reported Device Performance: No specific clinical performance metrics (e.g., accuracy of arrhythmia detection) are reported for this modification. The document states "Assessment of non-clinical performance data for equivalence" was performed, which implies testing related to the communication functionality (e.g., data integrity, transmission speed, protocol compliance).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. As this is a modification to a communication interface, it's likely that the "test set" would involve a range of communication scenarios or data types, rather than a patient-based sample size.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. This information is typically relevant for studies evaluating diagnostic accuracy or clinical effectiveness, which is not the primary focus of this submission for an interface modification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified.

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

No. This type of study is not relevant to a communication interface modification.

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

Not applicable/Not specified, as the device is a protocol converter and part of a larger monitoring system intended for use by healthcare professionals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not specified. The "ground truth" for this modification would likely be compliance with the IEEE 1073.3.2-2000 standard and successful, reliable data transmission and reception from external devices.

8. The sample size for the training set

Not applicable. This device is not described as involving machine learning or AI models that would require a 'training set.'

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The document broadly refers to "Assessment of non-clinical performance data for equivalence" (Section J). This indicates that the study focused on demonstrating that the modified communication option maintains the established safety and effectiveness of the predicate devices. The key aspect of this modification is to accommodate RJ45 connectors and support the new IEEE 1073.3.2-2000 standard for medical communications. Therefore, the "study" likely involved:

Verification of Protocol Compliance: Testing to ensure the MIB II Protocol Converter correctly implements and adheres to the IEEE 1073.3.2-2000 standard.
Data Integrity Testing: Verification that physiological data transmitted through the new RJ45 interface and protocol converter is accurate, complete, and free from corruption as it passes between the connected external devices and the INFINITY SC 8000 monitor.
Functional Testing: Ensuring that the monitor can still process and display data from the listed external modules (MultiGas/MultiGas+, Surgical Display Controller, etc.) via the new interface, similar to its predicate.
Electrical and Mechanical Safety: Given the hardware modification (RJ45 connectors), testing would likely include electrical safety and mechanical compatibility assessments to ensure no new hazards are introduced.

The "acceptance criteria" for this type of submission are typically met by demonstrating that the device modification does not alter the fundamental safety and effectiveness of the predicate device and complies with relevant recognized standards (in this case, IEEE 1073.3.2-2000). The document states "Assessment of non-clinical performance data for equivalence" was done, implying these types of tests were performed to satisfy the FDA's requirements for substantial equivalence for this specific modification. However, no specific results, methods, or details of these non-clinical tests are provided in this summary.

Summary

{0}------------------------------------------------

510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

JUL 2 0 2001

P. 1/2

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director, QA/RA Contact person for this submission: Penelope H. Greco Date submission was prepared: June 26, 2001

Trade Name, Common Name and Classification Name:

A. Trade Name:

Siemens Medical Information Bus (MIB II) Protocol Converter 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:

Siemens SC 8000 K983632 SC 8000 w/Advanced Communication Option, K990563 Siemens INFINITY MIB II Protocol Converter, K010640

Description of Modification:

The SC 8000 Advanced Communication Option II is equivalent to that submitted in K990563 in that it The SC 6000 Authuned Communication of can process and display, from external devices:

MultiGas and MultiGas+ modules (K965062) Surgical Display Controller (K970348) Medical Information BUS Protocol Converter (MIB and MIB II) (K970368, K973222, K99166, K003248, and K010640)

Intended Use:

COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.Electromedical Systems Group. PCS	16 Electronics AvenueDanvers, MA 01923	Tel: (978) 907-7500Fax: (978) 750-6879

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

Assessment of non-clinical performance data for equivalence:_Section J

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances:

1073.3.2 - 2000 IEEE Standard for Medical Communications Transport Profile - IrDA Based - Cable Connected

2

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}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the left and top of the emblem in a circular fashion. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2001

Ms. Penelone H. Greco Regulatory Submissions Manager Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923

Re: K012016

Trade Name: INFINITY SC 8000 with Advanced Communications Option II Regulation Number: 21 CFR 870.1025 Regulatory Class: III (three) Product Code: 74 MHX Dated: June 26, 2001 Received: June 28, 2001

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 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 control provisions of the Act. The general control 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 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

{3}------------------------------------------------

Page 2 - Ms. Penelope H. Greco

Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow you to ovegn mansoning your device of your device to a legally marketed notification. The PDA midning of substantal vour 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 If you desire specific as no room in devices), please contact the Office of Compliance at additionally 807.10 for m This allestions on the promotion and advertising of your device, (201) 594-4649. Truuntonally, 10. quice at (301) 594-4639. Also, please note the regulation 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 . Information on your responsionnities and research or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Ken Miller

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_KO120 كا 20120)

Device Name: INFINITY SC 8000 Monitor_ Indications for Use:

The INFINITY SC 8000 Monitor is 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 etCO2 the monitor can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode

With the INFINITY etCO2 + Respiratory Mechanics Pod the monitor can provide spirometric and carbon dioxide monitoring.

The monitor can interface with specific third party devices via an MIB protocol converter.

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 parameler Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediarric populations only; Arrhylhmia which is not intended for use in neonatal mode; 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 SC 8000 Monitor is not compatible for use in a MRI magnetic field.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use
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Division of Cardiovascular & Respiratory Devices (Optional Format 1-2-96)

510(k) Number	12012016
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Page 1 of 1

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.