The Siemens SC9000/SC9015 MULTIGas "" and MULTIGas+"" Modules are indicated for adult and pediatric patient populations in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that these devices are required to measure any one or more of the following parameters:

. Respiration rate
inspired and expired Carbon Dioxide (CO3) .
inspired and expired Oxygen (MULTIGas+ only) 9
average inspired Oxygen (MULTIGas only)
inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, . Sevoflurane, and Nitrous Oxide

Device Description

There are two multi gas modules being submitted as part of this 510(K) Notification: the MULTIGas™ (MGM) and the MULTIGas+ "" (MGM+). Both modules are free standing units that perform sidestream measurements of respiratory gases (CQ2, N3O, and O2) and anesthetic gases. Both modules automatically identify and report measurement data to the SC9000/SC9015 Bedside Monitor for display.

The MULTIGas™ and MULTIGas+ ™ modules differ only in the way they measure O2. The basic MULTIGas Module measures O2 using a galvanic cell, and calculates average inspiratory values for O2 (labeled iO2). The MULTIGas+ incorporates a faster-responding paramagnetic sensor that provides both inspired and expired O2 measurements (iO2 and etO2).

The enhanced software (version VB1.1) is compatible with previously sold versions of the monitor. A retrofit will be offered to the owners of units with previous software versions.

AI/ML Overview

The Siemens SC9000/SC9015 MULTIGas™ and MULTIGas+™ Modules are gas and anesthetic agent monitoring devices. The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device, the Hewlett-Packard model M1026A Anesthesia Gas Module, rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics of the new device itself.

Based on the provided document, the device itself is a measurement module that internally uses the Andros Inc Model 4700 MGM Multi Gas Module. The submission argues for equivalence based on the shared internal measurement component and similar principles of operation. Therefore, the "acceptance criteria" and "reported device performance" in this context refer to the demonstrated substantial equivalence to the predicate device, especially regarding its operational principles and intended use.

Here's an attempt to extract and present the information as requested, though it's important to note the limitations due to the nature of a 510(k) submission for substantial equivalence.

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for the performance of the Siemens device are not detailed as they might be for a novel device. Instead, the "acceptance criteria" are implied by the similarity to the predicate device. The "reported device performance" is essentially the statement of shared internal components and measuring methods.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Siemens MULTIGas™/MULTIGas+™)
Similar Core Measurement Technology: The predicate device uses an internal module for gas measurement. The Siemens device should utilize the same or an equivalent technology.	Meets Criteria: Both the Siemens MULTIGas™ Modules and the HP M1026A Anesthesia Gas module employ, internally, the Andros Inc Model 4700 MGM Multi Gas Module as the means for measuring the various gases.
Similar Principle of Operation: The gas measurement methods should be consistent with the predicate device.	Meets Criteria: The principle of operation for both the predicate and the Siemens device is "Non-dispersive Infra Red". The measuring method is "sidestream".
Similar Displayed Parameters: The types of gases and related parameters measured and displayed should be comparable.	Meets Criteria: Both devices display "CO2, N2O, Respiration Rate, Anesthetic Agents." The Siemens device further specifies: "Respiration rate, inspired and expired Carbon Dioxide (CO3), 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." While the predicate doesn't list all individual anesthetic agents, "Anesthetic Agents" implies a similar functionality. The MULTIGas+ adds expired O2, which is a stated difference but still within the scope of gas analysis.
Similar Intended Use: The target patient population and environments should be consistent.	Meets Criteria: The Siemens device is intended for "adult and pediatric patient populations in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that these devices are required to measure any one or more of the following parameters: Respiration rate, inspired and expired Carbon Dioxide (CO3), 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." The predicate's intended population was "Not stated in literature," but the 510(k) process accepts a well-defined intended use for the new device if it aligns with general clinical practice for similar devices.
Acceptable Performance (Non-clinical Data): Non-clinical data, such as bench testing or engineering specifications, should support the device's functionality.	Meets Criteria: Section "8. Assessment of non-clinical performance data for equivalence" states: "Both the Siemens MULTIGas™ Modules and the HP M1026A Anesthesia Gas module employ, internally, the Andros Inc Model 4700 MGM Multi Gas Module as the means for measuring the various gases." This is the primary non-clinical basis for equivalence. No other specific quantitative performance data (e.g., accuracy, precision tests) are provided in this summary.

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

The document explicitly states: "9. Assessment of clinical performance data for equivalence: Not applicable".
This indicates that no dedicated clinical test set data was used or presented for the Siemens MULTIGas™ and MULTIGas+™ modules to demonstrate their performance against pre-defined acceptance criteria, beyond the equivalence claimed by using the same internal measurement component as a previously cleared device. Therefore:

Sample size for test set: Not applicable (no separate clinical test set data provided).
Data provenance: Not applicable.

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, as no separate clinical test set data was presented. Ground truth determination would be relevant for a clinical study comparing device performance to a referent standard.

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

Not applicable, as no separate clinical test set was used requiring adjudication.

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. This device is a measurement module for physiological gases, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this submission.

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

The primary basis for this 510(k) is the assertion that the core measurement component (Andros Inc Model 4700 MGM Multi Gas Module) is the same as that used in a predicate device. This implies that the standalone performance of this internal module was considered adequate as part of the predicate device's clearance. However, no specific standalone performance metrics (e.g., accuracy, bias, limits of agreement) for the Siemens device itself are provided in this 510(k) summary. The submission relies on the "substantial equivalence" of the components rather than new standalone performance testing specific to the Siemens branding.

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

Not applicable, as no new clinical performance data was presented. For gas analyzers, ground truth would typically be established by highly accurate laboratory-grade gas standards or alternative validated measurement techniques. The reliance on the shared internal component implies that such ground truth was used in the assessment of the Andros Inc Model 4700 MGM during its own development or the predicate device's clearance.

8. The sample size for the training set

Not applicable. This device is a hardware-based gas analyzer, not an algorithm that requires a "training set" in the context of machine learning.

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

Not applicable, as it's not an algorithm requiring a training set.

Summary

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K 96 50 60

JUN - 4 1997

510 (K) Notification 510 (K) Notification

Siemens SC9000/ SC9015 MULTIGas ™ and MULTIGas+ ™ Modules

510(k) SUMMARY

as required per 807.92(c)

2: Submitters Name, Address:

Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (508) 750-7500 Fax: (508) 777-3398 Fax. (306) 771-55376
Official Correspondent: David Simard, Director Quality Assurance and Regulatory Affairs Contact person for this submission: Jacqueline E. M. Emery Date submission was prepared: December 9, 1996

3: Trade Name, Common Name and Classification Name:

A. Trade Name: Siemens SC9000/ SC9015 Series MULTIGas ™ Module Siemens SC9000/SC9015 Series MULTIGas+ ™ Module

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

Common Name	Classification Number	Class	Regulation Number
Cardiac monitor	74DRT	II	21 CFR 870.2300
Arrhythmia detector& Alarm System	74DSI	III	21 CFR 870.1025
Breathing frequencymonitor	73BZQ	II	21 CFR 868.2375
Pulse rate monitor	74BWS	II	21 CFR 870.2300
Non-indwelling bloodpressure monitor	74DXN	II	21 CFR 870.1130
Clinical electronic thermometer	80BWX	II	21 CFR 880.2910
Pulse Oximeter	74DQA	II	21 CFR 870.2700
Cardiac Output Monitor	74KFN	II	21 CFR 870.1435
end-tidal Carbon-Dioxide Monitor	73CCK	II	21 CFR 868.1400
Indwelling Blood Pressure Monitor	74CAA	II	21 CFR 870.1110
Indwelling bloodpressure 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

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)

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510 (K) Notification Siemens SC9000/ SC9015 MULTIGas ™ and MULTIGas+ *™ Modules

Multi Gas Monitor
Analyzer, Gas, Carbon Dioxide,Gaseous	73CCK	II	21CFR868.1400
Analyzer, Gas, Enflurane Gaseous	73CBQ	II	21CFR868.1500
Analyzer, Gas, Halothane, Gaseous	73CBS	II	21CFR868.1620
Analyzer, Gas, Nitrous Oxide,Gaseous	73CBR	II	21CFR868.1700
Analyzer, Gas, Oxygen, Gaseous	73CCL	II	21CFR868.1720

4: Predicate Device Identification:

The MULTIGas modules use the same hardware, provided by the same OEM manufacturer, as the Hewlett-Packard model M1026A Anesthesia Gas Module Gas Module, cleared under 510(K) number K951127.

The SC900/9015 Bedside Monitor System (510 (K) number K946306) provides the display and user interface capabilities for the MULTIGas "" modules.

5. Device Description

The enhanced software (version VB1.1) is compatible with previously sold versions of the monitor. A retrofit will be offered to the owners of units with previous software versions.

6. Intended Use:

The intended use of the Siemens SC9000/ SC9015 MULTIGas ™ Module is to measure inspiratory and expiratory carbon dioxide, inspiratory oxygen, inspiratory and expiratory Nitrous Oxide and anesthetic agents. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce recordings. This device will connect to either the Siemens SIRENET or Infinity (Olympus) network.

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD) 大學二十

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Table of device similarities and differences to predicate device

	Substantial EquivalenceHewlett PackardModel M1026A Anesthesia GasModule	SC 9000/9015 Series MULTIGAS™and MULTIGAS+™ Modules
Manufacturer	Hewlett-Packard	Siemens Medical Systems -Electromedical Group
510K Number	K951127	New
Intended Population	Not stated in literature	Adult and Pediatric
Module/Stand-Alone Monitor	Module: Communicates onlywith HP Anesthesia ComponentMonitoring System	Module: Communicates onlywith Siemens SC9000/9015Bedside Monitors
Displayed Parameters	CO2, N2O, Respiration Rate,Anesthetic Agents	Same
Principle of Operation	Non-dispersive Infra Red	Same
Measuring Methods	sidestream	Same
Waveform Display	Inspired and expiredconcentrations (in %) pluswaveform and trend data	Same
Dimensions HxWxD (mm/in)	80x370x439 / 3.5x14.5x17.3	146x183x451 / 5.7x7.2/17.8
Weight kg / lb	8.2 / 18	7.3 / 16.0

Assesment of non-clinical performance data for equivalence: Both the Siemens MULTIGas™ Modules and the HP M1026A Anesthesia Gas module employ, internally, the Andros Inc Model 4700 MGM Multi Gas Module as the means for measuring the various gases.
Assesment of clinical performance data for equivalence: Not applicable
Biocompatability: Not applicable
Sterilization: Not applicable

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol with three branches, representing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 1997

Ms. Jacqueline E. M. Emery Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, Massachusetts 01923

Re: ¸ K965062 Siemens SC9000/SC9015 MULTIGas™ and MULTIGas+™ Modules Regulatory Class: III (three) Product Code: 74 DSI Dated: March 25, 1997 Received: March 27, 1997

Dear Ms. Emery:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 - Ms. Jacqueline E. M. Emery

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, "Misbrandinq 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,

D. Thomas J. Callahon

Thomas J. Callahan, Ph. D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Indicated Use Statement

. Respiration rate
inspired and expired Carbon Dioxide (CO3) .
inspired and expired Oxygen (MULTIGas+ only) 9
average inspired Oxygen (MULTIGas only) �
inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, . Sevoflurane, and Nitrous Oxide

MRI Compatibility Statement:

The Siemens SC9000/9015 MULTIGas tm and MULTIGas+ tm modules are not intended for use in an MRI magnetic field

Picscription hie

für Z1 CFR 801.109

PCRND Sig

(Division Sign-Off)
Division of Cardiova
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510(k) Number

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PCRND Sign-off

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number
Over-the-Counter via

Company Confidential

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)

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.