The Datex-Ohmeda PRESTN model family E-PRESTN is intended to be used with Datex-Ohmeda modular monitors for monitoring hemodynamic parameters of hospitalized patients.

Indications for use:

The Datex-Ohmeda E-PRESTN module family (including E-PRESTN, E-RESTN, E-PRETN, E-PP, E-PT,a nd E-P modules) and accessories is 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 patient's 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 E-PRESTN module family 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 Datex-Ohmeda E-PRESTN module can be used with the following Datex-Ohmeda modular monitors.

S/5 Anesthesia Monitor(AM) with main software L-ANE05(A)..00 or newer version

S/5 Compact Anesthesia Monitor (CAM), with main software L-CANE05(A) or newer version

S/5 Critical Care Monitor (CCM) with main software L-ICU05(A) or newer version

S/5 Compact Critical Care Monitor (CCCM), with main software L-CICU05(A) or newer version

There are 6 different model variants of the module:

E-PRESTN: (includes all possible parameters) NIBP, ECG, SpO2, 2T, 2inv. press.,Resp

E-RESTN: (does not include invasive pressures) NIBP, ECG, SpO2, 2*T, Resp

E-PRETN: (does not include SpO2) NIBP, ECG, 2T, 2inv. press.,Resp.

E-PP: Two invasive pressure measurement channels

E-PT: One invasive pressure measurement channel, dual temperature measurement channel One invasive pressure measurement channel E-P:

The letters in the module name stand for:

P= Invasive Pressure

R= Impedance Respiration

E= 12-Lead ECG

S= Pulse Oximetry

T= Temperature

N=NIBP, Non-Invasive Blood Pressure

In the remainder of this document," E-PRESTN module family" is used to denote all six modules, "E-PRESTN" is used as a collective name for the double-width E-PRESTN, E RESTN, and E-PRETN modules, and the respecitve module names "E-PP", "E-PT" or "E-P" (or "E-PT/E-P") are used for the single-width modules.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a physiological patient monitor. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data with acceptance criteria for device performance. Therefore, the document does not contain the detailed information necessary to fully answer all aspects of your request as typically found in a clinical study report for new device performance claims.

Specifically, there is no mention of:

A table of acceptance criteria and reported device performance in the format requested. The document references compliance with various IEC, ANSI, CSA, and ISO standards as part of non-clinical testing for validation and verification of specifications. However, specific performance metrics and acceptance thresholds are not detailed in this summary.
Sample sizes used for a test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, or details on ground truth establishment for a test set. This is because the submission emphasizes technological equivalence and compliance with established standards rather than new clinical performance claims requiring such detailed validation.
Training set sample size or how ground truth for a training set was established.

Instead, the document states:

"The Datex-Ohmeda PRESTN Module (Model family E-PRESTN, including E-PRESTN, E-RESTN, E-PRETN, E-PP and E-PT/E-P) and accessories have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications."

The standards listed are primarily for electrical safety, electromagnetic compatibility, and specific medical device functionalities (e.g., ECG, patient monitors, blood pressure, oximeters, thermometers). Compliance with these standards implies that the device meets their specified performance and safety requirements.

However, based on the information provided, here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document primarily refers to compliance with various international and national standards for medical devices. Compliance with these standards serves as the "acceptance criteria" for the non-clinical performance and safety aspects. No specific performance metrics (e.g., accuracy, sensitivity, specificity) with associated acceptance thresholds are reported for comparison in this summary.

2. Sample size used for the test set and the data provenance

Not explicitly stated for a clinical test set. The submission focuses on non-clinical testing (validation and verification of specifications) against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/mentioned. Ground truth establishment for a test set is not described as part of this 510(k) submission.

4. Adjudication method for the test set

Not applicable/mentioned.

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 physiological monitor, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies for human reader improvement. The "arrhythmia and ST detection and analysis algorithm" is described as having identical functionality to the predicate, implying no new AI-driven improvement study was conducted.

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

The device itself is a standalone monitor. Its performance is assessed through compliance with standards. The summary does not detail specific "algorithm-only" performance metrics in the way one might expect for a new diagnostic algorithm.

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

Not explicitly stated for a clinical performance study. For hardware and software components, ground truth would typically refer to calibrated reference instruments or established physical/electrical benchmarks used during validation and verification processes.

8. The sample size for the training set

Not applicable/mentioned. This is a physiological monitor, not a machine learning model that requires a "training set" in the typical sense of AI development.

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

Not applicable/mentioned.

Summary of Nonclinical Testing and Conclusion from the Document:

Study: The device underwent "thorough testing through validation and verification of specifications" against a list of international and national standards. These standards cover aspects such as electrical safety, electromagnetic compatibility, and performance requirements for specific physiological measurements (ECG, blood pressure, SpO2, temperature).
Acceptance Criteria (Implied): Compliance with the following standards:
- FDA regulation 21 CFR 898.12
- IEC 60601-1:1988 + Amendments: A1:1991, A2:1995
- IEC 60601-1-2:2001
- IEC 60601-1-4:1996 + AI 1999
- ANSI/AAMI ES1 (1993)
- CAN/CSA C22.2 No. 601-1-M90 + S1 (1994)+Amdt2:1998
- IEC 60601-2-27 (1994) (Electrocardiographic monitoring equipment)
- IEC 60601-2-30 (1999) (Automated non-invasive sphygmomanometers)
- IEC 60601-2-34 (2000) (Invasive blood pressure monitoring equipment)
- IEC 60601-2-49:2001 (Multi-function patient monitoring equipment)
- EN 12470-4:2000 (Clinical thermometers - Part 4: Electrical thermometers for continuous measurement)
- ISO 9919 (1994) / EN 865:1997 (Pulse oximeters - Particular requirements for safety and essential performance)
- UL 2601-1 : 1997
Reported Device Performance: The document states that the device "has been thoroughly tested through validation and verification of specifications" and concludes that "there are no new questions of safety and effectiveness... as compared to the predicate device." This implies that the device met the requirements of all listed standards. Specific numerical performance data (e.g., accuracy ranges for NIBP, SpO2, temperature, ECG bandwidth) are not provided in this summary but would be detailed in the full validation and verification reports submitted to the FDA.

Summary

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2006 FEB 3

Page 1 of 4

217

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda PRESTN Module (Model family E-PRESTN, including E-PRESTN, E-RESTN,E-PRETN, E-PP,and E-PT/E-P) and accessories

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

COMPANY NAME/ADDRESS/PHONE/FAX:

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

NAME OF CONTACT:

Mr. Joel Kent

DATE:

May 1, 2005

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

TRADE NAME:

Datex-Ohmeda PRESTN Module (Model family E-PRESTN, including E-PRESTN, E-RESTN, E-PRETN, E-PP and E-PT/E-P) and accessories.

COMMON NAME:

Multiparameter Hemodynamic Module (E-PRESTN, E-RESTN,E-PRETN) Invasive Pressure Measurement Module (E-PP, E-P) Invasive Pressure Temp Hemodynamic Module (E-PT)

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CLASSIFICATION NAME:

The following Class II classifications appear applicable:

Product Code	Classification Name	CFR Section
MHX	Monitor, Physiological, Patient (With Arrhythmia Detection or Alarm)	870.1025
MLD	Monitor, ST segment with Alarm	870.1025
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
FLL	Clinical Electronic Thermometer	880.2910
DSK	Blood pressure computer	870.1110
DRQ	Transducer signal amplifier and conditioner	870.2060

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™ E-PRESTN Module family is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-PRESTN..01 Module (K041772).).

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

The Datex-Ohmeda E-PRESTN module can be used with the following Datex-Ohmeda modular monitors.

S/5 Anesthesia Monitor(AM) with main software L-ANE05(A)..00 or newer version

S/5 Compact Anesthesia Monitor (CAM), with main software L-CANE05(A) or newer version

S/5 Critical Care Monitor (CCM) with main software L-ICU05(A) or newer version

S/5 Compact Critical Care Monitor (CCCM), with main software L-CICU05(A) or newer version

There are 6 different model variants of the module:

E-PRESTN: (includes all possible parameters) NIBP, ECG, SpO2, 2T, 2inv. press.,Resp

E-RESTN: (does not include invasive pressures) NIBP, ECG, SpO2, 2*T, Resp

E-PRETN: (does not include SpO2) NIBP, ECG, 2T, 2inv. press.,Resp.

E-PP: Two invasive pressure measurement channels

E-PT: One invasive pressure measurement channel, dual temperature measurement channel One invasive pressure measurement channel E-P:

The letters in the module name stand for:

P= Invasive Pressure

R= Impedance Respiration

E= 12-Lead ECG

S= Pulse Oximetry

T= Temperature

N=NIBP, Non-Invasive Blood Pressure

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

Intended use:

The Datex-Ohmeda PRESTN model family E-PRESTN is intended to be used with Datex-Ohmeda modular monitors for monitoring hemodynamic parameters of hospitalized patients.

Indications for use:

The device is 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™ E-PRESTN Module family is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-PRESTN..01 Module (K041772).).

The E-PRESTN module has the following similarities compared to the predicate M-PRESTN..01 (K041772):

identical intended use and indications for use ●
identical fundamental scientific technology .
. use the same operating principle
identical ECG connector .
have the same safety and effectiveness .
the Customer and parameter specifications are basically the same (four minor . modifications)
. have the same user interface at the monitor and alarms
are manufactured using the same processes .

The main differences between the new E-PRESTN and the predicate M-PRESTN..01 (K041772) is primarily due to the fact that the new E-PRESTN module has the following changes:

. New color, shape, and size and thus differing mechanics
. The front panel and labeling have changed
. New GE-type NIBP, invBP, Temperature and SpO2 module connectors
Dynamic module addressing in the module-to-monitor communication .
. Minor enhancements to module software
Minor modifications to the electronic measurement boards .
The arrhythmia and ST detection and analysis algorithm in the monitor software . supporting the E-PRESTN modules have changed. The functionality is identical, the same arrhythmias are detected and alarms are initiated for them in a identical manner.
. The single-width hemodynamic pressure and temperature modules E-PP, E-PT, and E-P have been added to the E-PRESTN Module family.

Based on the analysis and other documentation included in this 510(k) notification and attachments it is evident that the main features and indications for use of Datex-Ohmeda E-

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PRESTN Module family are substantially equivalent 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 PRESTN Module (Model family E-PRESTN, including E-PRESTN, E-RESTN, E-PRETN, E-PP and E-PT/E-P) and accessories have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.

FDA regulation 21 CFR 898.12 .
IEC 60601-1:1988 + Amendments: A1:1991, ,A2:1995, .
IEC 60601-1-2:2001 .
IEC 60601-1-4:1996 + AI 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) .
. IEC 60601-2-49:2001
EN 12470-4:2000 .
ISO 9919 (1994) / EN 865:1997 ●
· UL 2601-1 : 1997

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda PRESTN Module (Model family E-PRESTN, including E-PRESTN, E-RESTN, E-PRETN, E-PP and E-PT/E-P) and accessories as compared to the predicate device.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 2006

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

Re: K051217

Trade Name: Datex-Ohmeda S/5 E-PRESTN Module Family, including E-PRESTN, E-RESTN, E-PRETN, E-PP, and E-PT/E modules Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: January 06, 2006 Received: January 06, 2006

Dear Mr. Kent,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements 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 Please be advised that FDA s issuation of a bucosains with other requirements of the Act
that FDA has made a determination that your device complies with other may that FDA has made a decemmation that your as read by other Federal agencies. You music or any Federal Statutes and regulations adminitives but not limited to: registration and listing comply with all the Act STequirements, morading proctice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing proctice description (21 CFR Part 807), laoching (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regardatin (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections on r device as described in your becise to 10(k) I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally premarket notification. The PDA inding of substance of a lovice 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 If you desire spectific advice for your active of our and one one one one the regulation entitled,
contact the Office of Compliance at (240) 276-0210. Also, please note of Colliact the Office of Compilance an (21 the Part 807.97). You may obtain Misolanding by reference to premainters withing the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oolisan http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blymmmofor

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): ____________________________________________________________________________________________________________________________________________________

Device Name: Datex-Ohmeda PRESTN Module (Model family E-PRESTN, including E-PRESTN, E-RESTN,E-PRETN, E-PP and E-PT/E-P) and accessories.

Indications for Use:

The Datex-Ohmeda E-PRESTN module family (including E-PRESTN, E-RESTN, E-PRETN, E-PP, E-PT, and E-P modules) and accessories is indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including STsegment 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.

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)

Bettmann

Division Sign-Off)

■ivision of Cardiovascular Devices

10(k) Number K05017

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.