The S/5 FM with L-FICU04 or L-FICU04A software is indicated for monitoring of hemodynamics (including arrhythmia and ST-segment analysis) and respiratory status of all hospital patients.

Extension module N-FCREC (option N-FCREC or N-FC) is indicated for monitoring CO2 and respiration rate of all hospital patients. CO2 measurements are indicated for patients weighing over 5kg (11lbs).

The S/5 FM Monitor and N-F(C)(REC) Extension Module are indicated for use by qualified medical personnel only.

Device Description

The S/5™ FM Monitor with L-FICU04(A) software is a patient monitor, which measures and displays patient physiological parameters in hospital environments. The S/5™ FM uses two types of plug-in measurement modules: Extension module N-F(C)(REC) with CO2 or Recorder option, or both, and Patient side Module E-PSM(P), that measures ECG, impedance respiration , invasive and non-invasive blood pressures, pulse oximetry and temperature. The E-PSM(P) is the subject of a separate 510(k). The miniC unit of the N-FC(REC) Extension module, included in this 510(k) submission, is a side stream gas analyzer. It monitors the Carbon dioxide (CO2) inhaled and exhaled by the patient, by measuring the absorption of CO2 at 4.2-4.3 micrometer using narrow band IR filters. It can also monitor the respiration rate as the frequency of peak (end tidal) CO2 measurements per minute. All concentrations are measured and displayed breath by breath. The MiniC unit of the Extension module is equipped with the mini D-fend water separation system. There are two software options available for the S/5 FM: L-FICU04 and L-FICU04A. The L-FICU04A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to the L-FICU04. Commonly, the software is collectively referred to as L-FICU04(A). The E-PSM(P) and N-F(C)(REC) Modules placed in the S/5 FM are automatically recognized by the monitor. Monitoring can begin when patient cables are connected to the module plug-in jacks. The modules perform parameter measurement and minor data processing. The S/5™ FM displays measured parameters in the form of numeric values, waveforms and trends on the screen. Audible and visual alarms are used to indicate patient status. The priority profile of an alarm depends on the parameter. The L-FICU04(A) software performs some module-related tasks like arrhythmia analysis, ST value calculation, heart rate calculation, impedance and respiration rate calculation. All the module communication is also handled in the main software. The S/5™ FM is operated by command board keys. Typically pressing a key results in a pop up menu appearing on the screen. Selections can then be made easily from the menu using a unique ergonomically designed pointing device on the keyboard called a ComWheel™. In addition of the standard command board there is an optional type of keyboard, a hand-held Remote controller (REMCO), which is directly connected to the S/5™ FM via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. The Recorder is a thermal array printer with which you can print from one to three traces and numerical information with a selectable speed. The S/5™ FM Monitor can be in a stand-alone or networked configuration. If networked, measurement data (parameter-associated numbers, waveforms or trends and patient care documentation) is sent to the network for central viewing of the network, monitor-to-monitor viewing, or for archiving. Software I .- FICU04 and L-FICU04A include support for wireless LAN communication between the monitor and S/5 Central station. The networking can thus be hardwired or wireless.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for the Datex-Ohmeda S/5™ FM monitor. It aims to demonstrate substantial equivalence to previously cleared devices, rather than proving a new device's efficacy through a comprehensive clinical study with acceptance criteria and a detailed study design. Therefore, much of the requested information regarding acceptance criteria, specific study design elements (sample size, ground truth establishment, expert qualifications, MRMC studies, standalone performance), is not provided because this type of submission focuses on regulatory compliance through comparison to existing predicates.

However, based on the provided text, we can extract the general approach to showing safety and effectiveness by demonstrating compliance with recognized standards and similarity to predicate devices.

Here's an attempt to answer your questions based on the available information:

1. Table of acceptance criteria and the reported device performance

The document does not present a table of specific quantitative acceptance criteria or device performance in the manner typically seen for a new clinical efficacy study. Instead, the acceptance criteria are implicitly compliance with established safety and performance standards and demonstration of substantial equivalence to predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance
Compliance with mandatory and voluntary safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-27, ISO 9918, etc.)	"Datex-Ohmeda S/5™ FM with L-FICU04 and L-FICU04A Software and N-FCREC Module complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested through validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made: [list of 19 standards provided]." (Page 3)
Substantial equivalence to predicate devices in terms of: - General construction - Indications for use - Intended use - User interface - Alarms - Manufacturing processes - Safety and effectiveness - Specific functionalities (arrhythmia analysis, CO2 measurement, recorder option)	"The Datex-Ohmeda S/5™ FM with L- FICU04 and L- FICU04A software is substantially equivalent to the predicate Datex-Ohmeda S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A software (K022740), as indicated by the similarities discussed below." (Page 2) "The general construction, indications for use and intended use of the S/5™ FM Monitor are almost the same as for the predicate device (K022740)." (Page 2) "The arrhythmia analysis functionality of the S/5TM FM with L-FICU04A is identical to the functionality of the predicate device..." (Page 2) "The CO2 measurement of the N-FC(REC) is based on the CO2 measurement of the predicate M-miniC module (K023454)." (Page 2) "The S/5™ FM Monitor and its predicate device both have the same basic user interface and alarms. They are manufactured using the same processes, and have the same safety and effectiveness, as indicated by the thorough and successful testing of the FM Monitor, documented in this submission." (Page 2)
No new questions of safety and effectiveness compared to the predicate device.	"The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5™ FM with L-FICU04 and L-FICU04A Software and N-FCREC Module as compared to the predicate device." (Page 3)

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 does not detail a "test set" in the context of a clinical study with patient data. The "testing" referred to is primarily nonclinical verification and validation of specifications and compliance with standards. Therefore, specific sample sizes for clinical data, country of origin, or retrospective/prospective nature are not provided.

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 this is a 510(k) submission based on substantial equivalence and compliance with engineering/safety standards, there is no mention of experts establishing ground truth for a clinical "test set."

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

Not applicable. No clinical "test set" requiring adjudication by experts is described.

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 is not an AI/CAD device, and no MRMC study is mentioned. The device is a patient monitor, and its safety and effectiveness are established by comparison to predicate devices and compliance with standards, not by an MRMC study.

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

The device is a patient monitor designed for use by qualified medical personnel, continuously monitoring physiological parameters. While it performs automated measurements and calculations (like arrhythmia analysis, ST value calculation, heart rate calculation, impedance and respiration rate calculation), its "performance" is inherently tied to being used by and displaying information for a human operator. Therefore, a standalone "algorithm only" performance, isolated from the human-in-the-loop, is not described in this context. The document states: "The S/5 FM Monitor and N-F(C)(REC) Extension Module are indicated for use by qualified medical personnel only." (Page 2)

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

For the nonclinical testing and validation mentioned, the "ground truth" would be the engineering specifications and the requirements of the applicable standards. For example, the accuracy of CO2 measurement would be validated against calibrated gas mixtures, and electrical safety against the requirements of IEC 60601-1. There is no mention of clinical ground truth (like pathology or outcomes data) in this summary, as it's not a clinical efficacy study for a new therapeutic or diagnostic claim.

8. The sample size for the training set

Not applicable. This document describes a patient monitor, not an AI/machine learning algorithm that requires a "training set" of data.

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

Not applicable. As no training set for an AI/ML algorithm is mentioned, the method for establishing its ground truth is also not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence appears to be 'K043276'. The characters are written in a bold, slightly irregular style, giving them a hand-drawn appearance. The contrast between the characters and the background is high, making them easily readable.

Page 1 of 4

DEC 2 3 2004

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5™ FM with L-FICU04 and L-FICU04A Software and N-FCREC Module

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

COMPANY NAME/ADDRESS/PHONE/FAX:

Datex-Ohmeda 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344

NAME OF CONTACT:

Mr. Joel Kent

DATE:

November 23, 2004

DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-FCREC Module

COMMON NAME:

Patient Monitor

CLASSIFICATION NAME:

The following Class II classifications appear applicable:

MHX	Monitor, Physiological,Patient (With Arrhythmia Detection or Alarm)	870.1025
MLD	Monitor, ST segment with Alarm	870.1025
CCK	Analyzer, gas, carbon-dioxide, gaseous-phase	868.1400
The following Class I classifications appear applicable:
DSF	Paper Chart Recorder	870.2810

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NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The Datex-Ohmeda S/5TM FM with L- FICU04 and L- FICU04A software is substantially equivalent to the predicate Datex-Ohmeda S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A software (K022740). The N-F(C)(REC) Extension module used with the FM Monitor allows measuring CO2 (module versions N-FC and N-FCREC) and printing on a recorder chart (module versions N-FREC and N-FCREC). The CO2 measurement of the N-FC(REC) is based on the CO2 measurement of the predicate M-miniC module (K023454). The recorder option is based on the predicate M-REC module, originally cleared in the Datex AS/3 AM Monitor (K933285) and the Datex AS/3 Compact Monitor (K933156) submissions.

DEVICE DESCRIPTION as required by 807.92(a)(4)

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INTENDED USE as required by 807.92(a)(5)

Intended use:

The S/5™ FM with L-FICU04 and L-FICU04A and N-FCREC Module are intended for multiparameter patient monitoring.

Indications for use:

The S/5 FM with L-FICU04 or L-FICU04A software is indicated for monitoring of . hemodynamics (including arrhythmia and ST-segment analysis) and respiratory status of all hospital patients.

Extension module N-FCREC (option N-FCREC or N-FC) is indicated for monitoring CO2 and respiration rate of all hospital patients. CO2 measurements are indicated for patients weighing over 5kg (11lbs).

The S/5 FM Monitor and N-F(C)(REC) Extension Module are indicated for use by qualified medical personnel only.

SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The Datex-Ohmeda S/5™ FM with L- FICU04 and L- FICU04A software is substantially equivalent to the predicate Datex-Ohmeda S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A software (K022740), as indicated by the similarities discussed below.

The S/5™ FM Monitor is a modular multiparameter patient monitor providing connections to measurement modules, in a similar way as the predicate device. The general construction, indications for use and intended use of the S/5™ FM Monitor are almost the same as for the predicate device (K022740).

The basic model of the monitor is the S/5™ FM with L-FICU04 software. When equipped with extended bedside arrhythmia analysis capability, the monitor is called S/5™ FM with L-FICU04A. The arrhythmia analysis functionality of the S/5TM FM with L-FICU04A is identical to the functionality of the predicate device S/5™ Compact Critical Care Monitor with L-CICU02A software (K022740).

The N-F(C)(REC) Extension module used with the FM Monitor allows measuring CO2 (module versions N-FC and N-FCREC) and printing on a recorder chart (module versions N-FREC and N-FCREC). The CO2 measurement of the N-FC(REC) is based on the CO2 measurement of the predicate M-miniC module (K023454). The recorder option is based on the predicate M-REC module, originally cleared in the Datex AS/3 AM Monitor (K933285) and the Datex AS/3 Compact Monitor (K933156) submissions.

The S/5™ FM Monitor and its predicate device both have the same basic user interface and alarms. They are manufactured using the same processes, and have the same safety and effectiveness, as indicated by the thorough and successful testing of the FM Monitor, documented in this submission.

Based on the above and a detailed analysis in other documentation included in this 510(k) notification and attachments, it is evident that the main features and indications for use of the S/5™ FM Monitor with I - L-FICU04 and L- L-FICU04A software are substantially equivalent in safety and effectiveness compared to the predicate.

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SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-FCREC Module complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested through validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made:

IEC 60601-1:1988+ Amdt .: 1:1991 + Amdt. 2:1995
EN 60601-1: 1990 + A1:1993+A2:1995+A13:1996
CAN/CSA-C22.2 No.601.1-M90 +S1:1994+Amdt. 2:1998
UL 2601-1:1997
. IEC 60601-2-27:1994/EN 60601-2-27:1994
· . IEC 60601-2-30:1999/EN 60601-2-30:2000
IEC 60601-2-34:2000/EN 60601-2-34:2000
IEC 60601-2-49:2001/EN 60601-2-49:2001
ISO 9919:1992/EN865:1997
. EN 1060-1:1995/EN 1060-3:1997
EN 12470-4:2000
ISO 9918:1993 / EN 864:1996
. IEC/EN 60601-1-2: 2001
. . IEC/EN 60601-1-4: 1996+A1:1999
. ANSI/AAMI ES-1:1993
. ANSI/AAMI EC57:1998
. ANSI/AAMI EC11:1991
. ANSI/AAMI EC13:2002
IEC 60068-2 (Mech stress tests, Temp and Humidity tests). .

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5™ FM with L-FICU04 and L-FICU04A Software and N-FCREC Module as compared to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2004

Datex Ohmeda c/o Mr. Joel C. Kent Quality and Regulatory Affairs Manager 86 Pilgrim Road Needham, MA 02492

Re: K043276

K043270
Trade Name: Datex-Ohmeda S/5™ FM with L-FICU04 and L-FICU04A Software and Extension module N-FCREC

Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Monitor Regulatory Class: Class II (two) Product Code: MHX Dated: November 24, 2004

Received: November 26, 2004

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(t) premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative) to regard cate of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Device All Producti commente prior to May 20, 1976, the enaordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Cosment Act (71ct) that to nor requestly subject to the general controls provisions of the Act. The I ou may, merciolo, manel and include requirements for annual registration, listing of general controls provisions of the ree, labeling, and prohibitions against misbranding and t adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is crassified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major and contribution may oc subject to sueritudions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.

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Page 2 - Mr. Joel C. Kent

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Bermuda for

Bram D. Zuckerman, M.D. Director Division fo Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K043276

Device Name: Datex-Ohmeda S/5™ FM with L-FICU04 and L-FICU04A Software and Extension module N-FCREC

Indications for Use:

The S/5 FM with L-FICU04 or L-FICU04A software is indicated for monitoring of hemodynamics (including arrhythmia and ST-segment analysis) and respiratory status of all hospital patients.

Extension module N-FCREC (option N-FCREC or N-FC) is indicated for monitoring CO2 and respiration rate of all hospital patients. CO2 measurements are indicated for patients weighing over 5kg (11lbs).

The S/5 FM Monitor and N-F(C)(REC) Extension Module are indicated for use by qualified medical personnel only.

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.H. Simmons

(Division Sign-OH)
Division of Cardiovascular Devices
510(k) Number K043274

Page __ of ___________________________________________________________________________________________________________________________________________________________________

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.