The Datex-Ohmeda PRESTN module , M-PRESTN is intended to be used with Datex-Ohmeda modular monitors for monitoring hemodynamic parameters of hospitalized patients.
The Datex-Ohmeda PRESTN module (model family M-PRESTN) 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 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 PRESTN module (model family M-PRESTN) 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Datex-Ohmeda PRESTN Module (Model family M-PRESTN) and its accessories. This submission focuses on establishing substantial equivalence to a predicate device, rather than performing a de novo study with strict acceptance criteria based on novel performance metrics. Therefore, the information provided does not align with a typical acceptance criteria and study structure for a new device's performance claims.

Here's a breakdown of why this submission differs from what your request implies, and what can be extracted from the provided text:

Lack of Traditional Acceptance Criteria and Performance Study:

The document is a 510(k) summary, aiming to demonstrate that the new device (Datex-Ohmeda PRESTN Module) is "substantially equivalent" to an already legally marketed predicate device (Datex-Ohmeda M-NE12STPR Module). This means the focus is on showing that the new device is as safe and effective as the predicate, not necessarily that it meets specific, predefined performance thresholds for a novel function.

Instead of defining explicit acceptance criteria and then proving the device meets them through a dedicated performance study, the submission relies on:

Comparison to a Predicate Device: Stating similarities in intended use, indications for use, fundamental scientific technology, operating principles, safety and effectiveness, user interface, and manufacturing processes.
Compliance with Standards: Listing adherence to various mandatory and voluntary safety and performance standards (e.g., IEC, ANSI/AAMI, UL).
Validation and Verifications: General statement about thorough testing through validation and verifications, but no specific study details are provided.
Minor Changes Justification: Explaining that changes (e.g., new boards, software modifications, new cables, NIBP cuff) do not affect safety and effectiveness.

Specific Points from your Request and their Application to the Document:

Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in a quantitative, measurable table as one would expect for a novel device performance study. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device and compliance with relevant standards.
- Reported Device Performance: No specific numerical performance metrics are reported from a dedicated study. Instead, the document claims "the same safety and effectiveness" as the predicate device. The only specific performance change mentioned is a "New SpO2 calibration range: 70 to 100%," which is a specification adjustment rather than a performance outcome from a study.
Sample Size used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document refers to "thoroughly tested through validation and verifications" but doesn't detail the subjects or cases used for these tests.
- Data Provenance: Not specified. Given the nature of a 510(k) for a device with "no change to the basic technology from the predicate," it's highly likely that testing involved bench testing, simulated environments, and potentially limited clinical validation to confirm functionality and compliance with standards rather than a large-scale clinical trial to establish new performance. The mention of "clinical motion in the M-PRESTN module uses the same algorithm as the predicate M-OSAT module (K011670)" suggests leveraging prior evidence for that specific aspect.
Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. The context is not a diagnostic device where expert ground truth is typically established (e.g., image interpretation). This is a vital signs monitor, where "ground truth" would likely refer to direct physical measurements or comparison to established reference devices/methods, rather than subjective expert consensus.
Adjudication Method for the Test Set:
- Not Applicable. See point 3. This concept is not relevant for the type of device and study described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not a diagnostic imaging device or a device where human interpretation is a primary component being evaluated. Therefore, an MRMC study comparing human readers with and without AI assistance is not described or relevant.
Standalone (Algorithm Only) Performance Study:
- Implicitly Yes, but not detailed. The device is a monitor, and its internal algorithms (e.g., for ECG, NIBP, SpO2) operate in a "standalone" fashion as part of the total system. The compliance with standards like IEC 60601-2-27 (for ECG), IEC 60601-2-30 (for NIBP), ISO 9919 (for pulse oximeters) implies that the algorithms and hardware meet predefined performance metrics, but specific study details are not provided. The phrase "The software has been modified accordingly to accommodate the new hardware" indicates algorithmic changes were part of the update.
Type of Ground Truth Used:
- Objective Measurements/Reference Standards. For a physiological monitor, ground truth would be established through highly accurate reference instruments for parameters like blood pressure, SpO2, and temperature, or standardized test signals for ECG and respiration. The document states "Verification of compliance with the following mandatory and voluntary standards has been made," which implies comparison against established criteria specified within those standards.
Sample Size for the Training Set:
- Not Applicable / Not Specified. This device is not presenting as an AI/Machine Learning diagnostic algorithm that requires a "training set" in the conventional sense. The "software has been modified accordingly to accommodate the new hardware," but this refers to system programming and control, not typically a data-driven model training. If any "training" occurred, it would be calibration and tuning against known physiological signals or simulated data according to the listed standards.
How Ground Truth for the Training Set Was Established:
- Not Applicable. As above, the concept of a training set and its ground truth in the context of machine learning is not discussed in this 510(k) submission for a vital signs monitor.

Summary based on the Provided Text (No formal table possible due to lack of explicit criteria and performance numbers):

The Datex-Ohmeda PRESTN Module (Model family M-PRESTN) and accessories demonstrated acceptance by achieving substantial equivalence to the predicate Datex-Ohmeda M-NE12STPR Module (K993608) and in one specific aspect (SpO2 clinical motion) to the predicate M-OSAT module (K011670).

The study that "proves" the device meets acceptance criteria primarily consists of:

Nonclinical Verification and Validation Tests: These tests confirmed compliance with a comprehensive list of national and international safety and performance standards (e.g., IEC 60601-series, ANSI/AAMI, UL, ISO). This indicates the device's components and overall system performance were evaluated against established engineering and medical device standards.
Risk Analysis Redo: Ensuring that none of the changes introduced in the new device adversely affected its safety and effectiveness.

Key takeaway: This document represents a regulatory submission for a device modification, focusing on upholding existing safety and effectiveness benchmarks rather than introducing and validating entirely new performance claims with dedicated clinical efficacy studies with predefined acceptance criteria.

Summary

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870.1130

880.2910

Image /page/0/Picture/1 description: The image is a logo that features a stylized letter "D" inside of a circle. The circle is black, and the "D" is white. There is a small black square in the upper right corner of the circle. The logo is simple and modern.

JUN 2 5 2003

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda PRESTN Module, (Model family M-PRESTN) 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:

June 7, 2003

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

TRADE NAME:

Datex-Ohmeda PRESTN Module, (Model family M-PRESTN) and accessories

COMMON NAME:

Multiparameter Hemodynamic Module

CLASSIFICATION NAME:

DXN

FLL

The following Class III classifications appear applicable:

Non-invasive blood pressure measurement system

Clinical Electronic Thermometer

MHXMLD	Monitor, Physiological, Patient (With Arrhythmia Detection or Alarm) 870.1025Monitor, ST segment with Alarm	870.1025
The following Class II classifications appear applicable:
DSK	Blood pressure computer	870.1110
DRO	Transducer signal amplifier and conditioner	870.2060
DOA	Oximeter	870.2700
DPZ	Ear Oximeter	870.2710
DRT	Cardiac Monitor (including cardiotachometer and rate alarm)	870.2300
Disc	Electrocardiograph	870 2340

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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 M-PRESTN Module is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-NE12STPR Module (K993608).

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

The intended use for the modified device is the same as the predicate, Datex-Ohmeda M-NE12STPR family module and accessories (K993608). The indications for use are also the same with the clarification for SPO2 use also during clinical motion conditions. There has been no change to the basic technology from the predicate.

The Datex-Ohmeda M-PRESTN module can be used with the following Datex-Ohmeda modular monitors which already have separate 510(k) clearances:

S/5 Anesthesia Monitor(AM), with main softwares L-ANE01(A)..00 or newer version S/5 Compact Anesthesia Monitor (CAM), with main softwares S-00A05/06..00 rev. 10.9 or newer version, L-00A07/08..00 rev. 10.9 or newer version

S/5 Critical Care Monitor (CCM), with main softwares S-00C01/02.00 rev. 10.5 or newer version S/5 Compact Critical Care Monitor (CCCM), with main softwares S-00C03/04.00 rev. 10.9 or newer version

There are 3 different model variants of the module: M-PRESTN: (includes all possible parameters) NIBP, ECG, SpO2, 2T, 2inv. press.,Resp M-RESTN: (does not include invasive pressures) NIBP, ECG, SpO2, 2T, Resp M-PRETN: (does not include SpO2) NIBP, ECG, 2T, 2*inv. press.,Resp. 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

For the purpose of this 510(k) "M-PRESTN" will be used to denote all models since it includes all the parameters.

The fundamental scientific technology is identical to the predicate device. However, all measurement boards and their software have been changed to allow state of the art solid state technology on all boards, including low power low voltage operation amplifier technology and new state of the art low power microcontroller technology. The boards have also been improved to fulfill the latest standard requirements including the requirements of the latest EMC standards, (IEC 60601-1-2:2001). The software has been modified accordingly to accommodate the new hardware. The front panel and its labelling has been changed because the ECG connector was made smaller.

There are new ECG cables, made for the new smaller connector. We also introduce a NIBP thigh cuff, and disposable NIBP adult cuffs as an answer to customer feedback.

There are minor changes in the customer specifications (e.g. New SpO2 calibration range: 70 to 100%) to reflect the proposed standards and customer needs.

The risk analysis has been redone to make sure none of the changes has effected the safety and effectiveness of the device.

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There are minor changes in the customer specifications (e.g. New SpO2 calibration range: 70 to 100%) to reflect the proposed standards and customer needs.

The risk analysis has been redone to make sure none of the changes has effected the safety and effectiveness of the device.

Changes to the labeling include an instruction for use sheet, revised User's Manual and Brochure.

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

Intended use:

The Datex-Ohmeda PRESTN module , M-PRESTN is intended to be used with Datex-Ohmeda modular monitors for monitoring hemodynamic parameters of hospitalized patients. Indications for use:

The Datex-Ohmeda PRESTN module (model family M-PRESTN) 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 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.

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

The Datex-Ohmeda M-PRESTN Module is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-NE12STPR Module (K993608).

The redesigned M-PRESTN module has the following similarities compared to the predicate M-NE12STPR (K993608):

identical intended use and indications for use, only clinical motion added to SpO2 ● measurement. Clinical motion in the M-PRESTN module uses the same algorithm as the predicate M-OSAT module (K011670).
identical fundamental scientific technology
use the same operating principle
have the same safety and effectiveness ●
have the same user interface and alarms
are manufactured using the same processes

The main differences between the new M-PRESTN and the predicate M-NE12STPR (K993608) is primarily due to fact that the new M-PRESTN module has the following new parts:

a new ECGR measurement board
a new NIBP measurement board
a new STP measurement board ●
. a new ECG patient connector

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 M-PRESTN Module are substantially equivalent to the predicate Datex-Ohmeda M-NE12STPR Module (K993608). For SpO2 clinical motion 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 M-PRESTN Module are substantially equivalent to the predicate Datex-Ohmeda M-OSAT Module (K011670).

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

Datex-Ohmeda PRESTN Module, (Model family M-PRESTN) and accessories 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 verifications. Verifications. Verification of compliance with the following mandatory and voluntary standards has been made:

. Performance standard for electrode lead wires and patient cables, FDA regulation 21 CFR.898.12
ANSI/AAMI ES1-1993 .
. IEC60601-1:1988, Amendment 1: 1991, Amendment 2: 1995
EN 60601-1:1990 +A1:1993 +A2:1995 +A12:1993 .
UL 2601-1:1997 .
CAN/CSA-C22.2 No 601.1-M90 + Supplement +S1:1994+Amdt2:1998 .
IEC 60601-1-2: 2001 .
IEC 60601-1-4 .
IEC60601-2-27:1994 /EN60601-2-27:1994 .
. 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: 1994 .
. EN 865:1997
. AAMI EC11-1991
AAMI EC13-2002 .
AAMI EC57:1998 .
. AAMI SP10-1992/AAMI SP10-2002
EN 12470-4 .

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda PRESTN Module, (Model family M-PRESTN) and accessories as compared to the predicate device.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2003

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

Re: K031781

Trade Name: Datex-Ohmeda PRESTN Module, (Model family M-PRESTN) and accessoreis Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: MHX Dated: June 8, 2003 Received: June 10, 2003

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 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 (301) 594-4646. 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.

KadetTule

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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Page 1 of 1

510(k) Number (if known): K031781

Device Name: Datex-Ohmeda PRESTN Module (Model family M-PRESTN) and accessories

Indications For Use:

The Datex-Ohmeda PRESTN module (model family M-PRESTN) 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 aged 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	X
OR	Over-The-Counter Use(Optional Format 1-2-96)
(Division Sign-Off)Division of Cardiovascular Devices
510(k) Number	K031781

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.