The Datex-Ohmeda S/5 PSM module (consisting of E-PSM and E-PSMP modules) and accessories are indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including ST-segment and arrhythmia), Impedance respiration, NIBP, Temperature, SpO2 (including monitoring during conditions of clinical patient motion), and invasive blood pressure.

Impedance Respiration measurement is indicated for patients ages 3 and up.

The NIBP measurement is indicated for patients who weigh 5kg (11 lb.) and up.

The device is indicated for use by qualified medical personnel only.

Device Description

The Datex-Ohmeda S/5 PSM Module, (consisting of E-PSM and E-PSMP modules) and accessories is a hemodynamic multiparameter module which is able to measure ECG, two Invasive blood pressures, SpO2, two Temperatures, Non-invasive blood pressure and Impedance Respiration. The module is compatible with the Datex-Ohmeda S/5 FM monitor with L-FICU04...00 and L-FICU04A..00 which has a separate 510(k).

There are 2 different model variants of the module:
E-PSMP: (includes all possible parameters) NIBP, ECG, SpO2, 2T, 2inv. press.,Resp
E-PSM: (does not include invasive pressures) NIBP, FCG, SpO2, 2*T, Resp.

E-PSMP is a hemodynamic plug-in parameter module including the NIBP measurement, 12-lead ECG with the Impedance Respiration measurement, SpO2 with the plethysmographic waveform, two invasive pressure measurements (PL and P2) and two temperature measurements (T1 and T2). This module can be used in the FM modular monitor.

The monitor displays waveforms and measurement readings, and handles the trending and alarm management. The monitor software handles the ECG (including arrhythmia detection) and the Impedance Respiration measurement. The modules measure signals and send them to the monitor. The NIBP, SpO2, Temperature and Invasive Pressure algorithms are in the module. There are two available options of the module: E-PSMP with invasive pressures P1 and P2 and E-PSM without invasive pressures. There are two parameter circuit boards inside the E-PSMP module for Panel A and Panel B. Each processing board has a microcontroller with software.

AI/ML Overview

The provided text describes a medical device, the Datex-Ohmeda S/5 PSM Module, and its compliance with various safety standards. However, it does not contain information about specific acceptance criteria for a device's performance (e.g., sensitivity, specificity, accuracy targets), nor does it describe a study conducted to demonstrate that the device meets such criteria.

The document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria, as this information is not present in the provided text.

The document primarily provides organizational information, device description, intended use, indications for use, and a list of safety standards with which the device complies. It states that "The device has been validated and verifications. Verifications. Verification of compliance with the following mandatory and voluntary standards has been made," followed by a list of standards. This indicates that non-clinical testing was performed to demonstrate compliance with these standards, but the specifics of how the device performed against criteria within these standards are not detailed in this summary.

To answer your specific questions:

A table of acceptance criteria and the reported device performance: Not provided in the text.
Sample size used for the test set and the data provenance: Not provided in the text. The document refers to "nonclinical testing" and compliance with standards, but no details of test sets, sample sizes, or data provenance are given.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided, as detailed performance studies with ground truth establishment are not described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: Not provided. The summary is focused on substantial equivalence based on technical characteristics and compliance with standards, not comparative effectiveness with human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. The device is a physiological monitor, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided.
The sample size for the training set: Not applicable/Not provided, as it's a physiological monitor, not an AI algorithm that typically has a training set.
How the ground truth for the training set was established: Not applicable/Not provided.

Summary

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FEB 1 8 2005

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Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5 PSM Module, (consisting of E-PSM and E-PSM and E-PSMP

Datex-Ohmeda S/5 PSM Module, (consisting of E-PSM and E-PSMP
PS PSM Module, Consisting of Leassesseries modules) and accessories

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: December 21, 2004

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

TRADE NAME:

Datex-Olımeda S/5 PSM Module, (consisting of E-PSM and E-PSMP modules) and accessories

COMMON NAME:

Multiparameter Hemodynamic Module

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
DSK	Blood pressure computer	870.1110
DRQ	Transducer signal amplifier and conditioner	870.2060
DQA	Oximeter	870.2700
DPZ	Ear Oximeter	870.2710
DRT	Cardiac Monitor (including cardiotachometer and rate alarm)	870.2300
DPS	Electrocardiograph	870.2340
DXN	Non-invasive blood pressure measurement system	870.1130
111	Clinical Electronic Thermometer	880.2910

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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/5 PSM Module, (consisting of E-PSM and E-PSMP modules) and I he Datex-Offineda 3:51 BM Modate, (confessional effectiveness to the legally marketed accessoriesis substantially oqur arest N..01 Module (K041772)

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

The Datex-Ohmeda S/5 PSM Module, (consisting of E-PSM and E-PSMP modules) and The Datex-Onlineda $77 Fort Module, (ventions) (ventions which is able to measure ECG, two accessories is a nemocyllante inditipatible.com invasive blood pressure and Impedance invasive blood pressures, SpOZ, (wo Temperatures, is the same as the predicate, Datex-Ohmeda Respliation. The michaed use for the modified as tor use are also the same.
M-PRESTN. 01 module and accessories (K041772). The indications for use of model possible M-F KESTN..VI Inodule and decessories (18) 11) 11 the predicate. The Datex-Ohmeda PSM There has bectif no change to the basic tocalled is a hemodynamic multiparameter module which is able to measure ECG, two Invasive blood pressures, SpO2, two Temperatures, Nonwhich is able to measure LCG, two invasive blood press.- Ohmeda E-PSM(1) module can
invasive blood pressure and Impedance Respiration. The Datex-Ohmedia HTCHAA mvasoe blood pressure and mipedated Acopitation - with main software S/5 FM with L-FICU04...00 and L-FICU04A..00 which has a separate 510(k).

There are 2 different model variants of the module:

r nere are 2 unnetons moossible parameters) NIBP, ECG, SpO2, 2T, 2inv. press.,Resp E-PSM: (docs not include invasive pressures) NIBP, FCG, SpO2, 2*T, Resp.

be used in the ? W thounar monnor.
The monitor displays waveforms and measurement readings, and handles the trending and alarm The monitor usplays waveromis and moud arrhythmia detection) and the Impedance Respiration management. The Hoo (vitor software. The modules measure signals and send them to the monitor. The NIBP, SpO2, Temperature and Invasive Pressure algorithms are in the module. There are two available options of the module: E-PSMP with invasive pressures P1 and P2 and E-There are two available options of the mourameter circuit boards inside the E-PSMP module for I Sive without I Panel B. Each processing board has a microcontroller with software.

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

Intended use:

The Datex-Ohmeda S/5 PSM Module, (consisting of E-PSM and E-PSMP modules) and accessories is intended for monitoring hemodynamic parameters of hospitalized patients.

Indications for use:

multanons for use:
The Datex-Ohmeda S/5 PSM Module, (consisting of E-PSM and E-PSMP modules) and The Dates Onlineda 0/3 1 Or monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including ST-segment and arrhythmia), Inconee respiration, NIBP, Temperature, SpO2 (including monitoring during conditions of clinical patient motion), and invasive blood pressure.

Impedance Respiration measurement is indicated for patients ages 3 and up..

The NIBP measurement is indicated for patients who weigh 5kg (11 lbs.) and up.

The device is indicated for use by qualified medical personnel only.

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

The Datex-Ohmeda E-PSM Module is substantially equivalent in safety and effectiveness The Datex-Onlineda E-L SM Module is sacctainment StRESTN..01 Module (K041772). to the legally marketed (predicato) Daten Gilliarities compared to the predicate M-PRESTN..01 (K041772):

§ identical intended use and indications for use
S identical fundamental scientific technology
$ use the same operating principle
identical ECG connector ಳು
§ identical arrhythmia and ST analysis
& have the same safety and effectiveness
S have the same user interface at the monitor and alarms
§ are manufactured using the same processes

The main differences between the new E-PSMP and the predicate M-PRESTN. 01 (K041772) is primarily due to fact that the new E-PSM module has the following changes: § new shape and size and thus differing mechanics

S new GE-type NIBP, invBP, Temperature and SpO2 module connectors
S dynamic module addressing in the module-to-monitor communication

Bascd on the analysis and other documentation included in this 510(k) notification and Dasca on the unatyon and other wain features and indications for use of Datex-Ohmeda Eattacinnents it is evident mail the main lent to the predicate Datex-Ohmeda M-PRESTN..01 Module (K041772).

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

Datex-Ohmeda S/5 F-PSMP and E-PSM Module and accessories complies with the safety standards below and is therefore safe and effective for the intended use. The device has been standards betwn and is therealidation and verifications. Verifications. Verification of compliance with the following mandatory and voluntary standards has been made:

FDA regulation 21 CFR 898.12
IFC 60601-1:1988 + Amendments: A1:1991, ,A2:1995, .
IEC 60601-1-2:2001 . ·
IFC 60601-1-4:1996 + A1 1999 · .
: ANSI/AAMI ES1 (1993) .
CAN/CSA C22.2 No. 601-1-M90 + S1 (1994)+Amdt2:1998 : .
: IEC 60601-2-27 (1994) .
: IEC 60601-2-30 (1999) .
IEC 60601-2-34 (2000) . ・
IFC 60601-2-49:2001 .
EN 12470-4:2000 .
ISO 9919 (1994) / EN 865:1997 . ・
UL 2601-1 : 1997

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CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the The summary above shows that mere are no new questions of accorpared to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

FEB 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K043551

K043531
Trade Name: Datex-Ohmeda S/5 PSM Module, (consisting of E-PSM and E-PSMP modules) and accessories Regulation Number: 21 CFR 870.1025 Regulation Number. 21 CFR 676.1025
Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: II (two) Product Code: MHX Dated: December 22, 2005 Received: December 23 2005

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(tr) premainted in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intersuate for use stated in the enclosure) to regarly mancess province Americal Device American Food. Drug commerce prior to May 26, 1976, the encordance with the provisions of the Federal Food, Drug. devices that have been reclassified in accordance was a premarket approval application (PMA). and Cosment Act (Act) that do not require appent of the general controls provisions of the Act. The Act. The You may, therefore, market the device, basjon to the see annual registration, listing of general Controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (sec above) into exist on a subs regulations affecting your device can
may be subject to such additional controls. Existing major regulations FD may be subject to such additional controller Entrolise of the 21, Parts 800 to 898. In addition, FDA may be found in the Cour of Pouch oncerning your device in the Federal Register.

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Page 2 - Mr. Joel Kent

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substanted of the requirements of the Act
that FDA has made a determination that your device and other requirements of the Act that FDA has made a determination in an your development was a sencies. You must
or any Federal statutes and regulations administered by other Federation and Jisti or any Federal statutes and regulations administration of engistration and listing (21
comply with all the Act's requirements, including, but not arguirements as set comply with all the Act s requirements, incriance, varias requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Patl on ); good niannatoan; gand if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicab forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (Sections 35 described in your Section 510(k)
This letter will allow you to begin marketing your device to a legal This letter will allow you to begin marketing your article equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The PDA Inding of substantial equivales by the subsition of this, 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
rs of the may of the may on any and 1400 - Alless and the regulation entitl If you desire specific advice for your de need on one note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the regulation contact the Office of Compliance at (210) 277 - 1777 Part 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFF) Part 807.97) you may obtain. " Misbranding by reletelice to premarket noutification of the Act may be obtained from the Other general miormation on your responsional 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,

B. Himma for
E. E. Jones, M.D.

Bram D. Zuckerman, M.D. Director Division of 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): _K04355 )

Device Name: Datex-Ohmeda S/5 PSM Module, (consisting of E-PSM and E-PSMP modules) and accessories

Indications for Use:

Impedance Respiration measurement is indicated for patients ages 3 and up.

The NIBP measurement is indicated for patients who weigh 5kg (11 lb.) and up.

The device is indicated for use by qualified medical personnel only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumimer

Sian-Off f Cardiovascular Devices 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.