The Datex-Ohmeda S/5™ Nellcor Compatible Saturation Module, E-NSAT, and accessories are indicated for monitoring arterial oxygen saturation of hospitalized patients. The device is indicated for use by qualified medical personnel only.

Device Description

The Datex-Ohmeda S'57M E-NSAT module is a single-width plug-in parameter module for a Datex-Ohmeda S 5 modular monitoring system. E-NSAT is used for monitoring arterial oxygen saturation of hospitalized patients. The E-NSAT module provides continuous non-invasive measurement of the pulse rate and oxygen saturation. Visual and auditory alarms are given for high/low pulse rate and high/low saturation values. The user can adjust the alarm limits. The E-NSAT module is designed using the Nelleor pulse oximetry technology. The real-time pulse oximetry signal is displayed without any scale. The calculated Sp()2 value and pulse rate can be shown in a separate numberfield, or beside the pulse oximetry signal. The parameters can be trended and the trends can be printed with the Recorder module in the momitor or with a separate laser printer.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for a medical device, the Datex-Ohmeda S/5™ Nellcor Compatible Saturation Module, E-NSAT. This document focuses on demonstrating substantial equivalence to a predicate device based on technical and functional similarities, rather than presenting a detailed clinical study with acceptance criteria and performance metrics for a novel AI device.

Therefore, most of the requested information regarding acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, ground truth establishment for AI training/testing, and expert qualifications for ground truth cannot be extracted from this document, as it describes a traditional medical device submission and not an AI/ML device.

However, I can provide what is available or inferable:

1. A table of acceptance criteria and the reported device performance

The document does not detail specific acceptance criteria for performance metrics (e.g., accuracy, precision) in a tabular format, nor does it report specific performance values for the E-NSAT module against such criteria. Instead, it states that the device has been "thoroughly tested through validation and verification of specifications" and assessed against various medical device standards. The key assertion is "The Customer and parameter specifications are the same" as the predicate device, implying that the performance targets are identical to the predicate.

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

Not applicable. This document does not describe a clinical study with a test set of data in the context of AI/ML evaluation. The primary validation appears to be non-clinical, focusing on compliance with standards and equivalence to a predicate device.

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. This document does not describe establishing ground truth for a test set in the context of an AI/ML device.

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

Not applicable. This document does not describe a test set or adjudication method.

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 document describes a pulse oximeter, not an AI-assisted diagnostic tool that would typically undergo an MRMC study.

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

Not applicable. This device is a measurement module, and its performance is inherent in its design and operation; it's not an algorithm that functions without human interaction in its use context. "Standalone performance" in the AI/ML context doesn't apply here. The device itself is "standalone" in its measurement function, but that's a different concept.

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

Not applicable. Ground truth, in the context of evaluating a diagnostic AI device, is not mentioned in this document. The device's performance is likely evaluated against established standards for pulse oximetry measurements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and thus there is no "training set."

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

Not applicable. There is no training set mentioned for this device.

Summary of available information related to performance/validation from the document:

While the document doesn't fit the AI/ML framework of your questions, it does describe the validation process for a traditional medical device:

Validation Method: The device has been "thoroughly tested through validation and verification of specifications" against a comprehensive list of international and national standards, including IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 9919 (pulse oximeters for medical use safety requirements), and EN 865 (pulse oximeters particular requirements). FDA guidance documents for premarket notifications and software were also considered.
Equivalence Basis: The primary "proof" that the device meets acceptance criteria (implicit, as being safe and effective) is its substantial equivalence to a legally marketed predicate device (Datex-Ohmeda M-NSAT Module K020479). This equivalence is based on:
- Identical intended use and indications for use.
- Same operating principle and fundamental scientific technology.
- Compatibility with the same monitor software and user interface.
- Identical customer and parameter specifications.
- Same safety and effectiveness profile.
- Same manufacturing processes.
Key Change and Its Clearance: The main difference is an updated Nellcor OEM Pulse Oximetry electronic measurement board (MP100 instead of MP404). Crucially, the document states: "The MP100 is an enhanced version of the MP404, and has been previously cleared with the Sandman Express (K040113)." This prior clearance of the core measurement technology likely significantly contributes to the non-clinical validation reliance.

Summary

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OCT 1 3 2005

KOS2753

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/57M Nellcor Compatible Saturation Module, E-NSAT 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:

September 28, 2005

DIATICE NAME as required by 807.92(a)(21

TRADE NAME

Datex-Ohmeda S/5™ Nellcor Compauble Saturation Module, E-NSAT and accessories

COMMON NAME:

Pulse Oximeter

CLASSIFICATION NAME:

The following Class II classification appears applicable:

Product Code	Classification Name	CFR Section
DQA	Oximeter	870.2700
DPZ	Ear Oximeter	870.2710

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 5781 Nellcor Compatible Saturation Module, F-NSAT is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M NSAT Module (K020479).

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

The Datex-Ohmeda Nelleor Compatible Saturation Module, E-NSAT can be used with the following Datex-Ohmeda modular monitors:

S/5TM Anesthesia Monitor (AM) with main software S-STD94(A) or S ARK94(A) or . newer
S/5TM Compact Anesthesia Monitor (CAM) with main S-STD94(A) or S ARK 94(A) or . newer
S/5TM Critical Care Monitor (CCM) with main software S-ICU97(A) or newer. .
S/5TM Compact Critical Care Monitor (CCCM) with main software S-IC U97(A) or . newer.

The E-NSAT module provides continuous non-invasive measurement of the pulse rate and oxygen saturation. Visual and auditory alarms are given for high/low pulse rate and high/low saturation values. The user can adjust the alarm limits.

The E-NSAT module is designed using the Nelleor pulse oximetry technology. The real-time pulse oximetry signal is displayed without any scale. The calculated Sp()2 value and pulse rate can be shown in a separate numberfield, or beside the pulse oximetry signal. The parameters can be trended and the trends can be printed with the Recorder module in the momitor or with a separate laser printer.

The accessories are all new for E-NSAT. The accessories are manufactured and tested by Nellcor Puritan Bennet Inc. and distributed by GE Healthcare.

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

Intended Use:

The Datex-Ohmeda S/5™ Nelleor Compatible Saturation Module. E-NSAT is intended for use with the Dates-Ohmeda modular multiparameter patient monitoring arterial oxygen saturation of hospitalized patients.

Indication for use:

The Datex-Ohmeda S 50% Nellcor Compatible Saturation Module, E-NSAT, and accessories are indicated for monitoring arterial oxygen saturation of hospitalized patients. 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™ Nelleor Compatible Saturation Module, F-NSAT is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M NSAT Module (K020479).

The E-NSAT module has the following similarities compared to the predicate M-NSAT (K()20479):

Identical intended use and indications for use .
. Use the same operating principle
The same fundamental scientific technology .
Can be used with the same pulse oximetry -specific monitor software. (Have the same t user interface at the monitor)

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The Customer and parameter specifications are the same .
Have the same safety and effectiveness .
Are manufactured using the same processes .

The main differences between the new E-NSAT and the predicate M-NSAT (K020479) is primarily due to fact that the new E-NSAT module has the following changes

New color, shape, and size and thus differing mechanies .
The front panel and labeling have changed .
The Nellcor OEM Pulse Oximetry electronic measurement board with software, provided . by Nelleor Puritan Bennet Inc has changed from MP404 to MP100. The MP100 is an enhanced version of the MP404, and has been previously cleared with the Sandman Express (K040113).
The Datex-Ohmeda Interface board connecting the measurement board to the monitor . have been revised to accommodate the changes to the electronic measurement board
The E-NSAT connector coding differs to allow use of the accessories specified by . Nellcor for the MP100 board
. The accessories (provided by Nellcor) have changed

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 the Datex-Ohmeda S/5™ Nellcor Compatible Saturation Module, E-NSAT are substantially equivalent to the predicate Datex-Ohmeda M-NSAT Module (K020479).

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

The Datex-Ohmeda S:500 Nelleor Compatible Saturation Module, F:-NSAT and accessories has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.

COUNCH. DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices .
FDA:DCRND Reviewer Guidance for Premarket Notification Submissions, November 1993 .
1EC 60601-1:1988 + Amdt. 2:1991 + Andt. 2:1995 (Part 1: General requirements for safety) .
EN 60601-1:1990+ A1:1993 + A13:1996 + A2:1995 (identical to IE:C60601-1:1988 + Amdt. . 1:1991 + Anidt. 2:1995)
CAN/CSA C22.2 No. 601.1-M90 + S1:1994 (Canadian deviations to IFC 60601-1:1988 + . Andt. 1:1991) + S2:1998 (=IFC Andt 2:1995)
UI, 2601-1, October 24, 1997 (U.S. deviations to IEC 60601-1:1988 + Amdt. . 2:1995)
IEC 60601-1-2:2001 (Electromagnetic compatibility Requirements and tests) .
1EC 60601-1-4:2000 (Programmable medical systems) .
ISO 9919 (1994) Pulse oximeters for medical use safety requirements .
EN 865 (1997) Pulse oximeters Particular requirements .
AAMI ES1-1993 (Safe current limits for electromedical apparatus) .
FDA-ODE Guidance for Content of Premarket Submission for Software Contained in Medical . Devices. (May 11, 2005)

CONCLUSION.

The summary above shows that the Datex-Ohmeda S:57M Nelleor Compatible Saturation Module, I :- NSAT is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M NSAT Module (K020479).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The graphic is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, framing the graphic element.

001 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joel Kent Manager, Quality and Regulatory Affairs GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492

Re: K052755

Trade/Device Name: Datex-Ohmeda S/5™ Nellcor Compatible Saturation Module, E-NSAT and accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: September 29, 2005 Received: October 3, 2005

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. 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) 276-0120. 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/industry/support/index.html.

Sincerely vours,

Chris Liu, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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 S/5™ Nellcor Compatible Saturation Module, E-NSAT and accessories.

Indications for use:

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)

signature

Bivision Sign-Off) sion Sign-Om)
ion of Anesthesiology, General Hospital, Division of Anesthoolarda Devices

510(k) Number: K052755

Page __ of __

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).