K Number

Device Name

DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT

Manufacturer

GE HEALTHCARE

Date Cleared

2005-10-13

(13 days)

Product Code

DQA DPZ

Regulation Number

870.2700

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K020479

Reference Devices

K040113

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on standard pulse oximetry technology and basic signal processing, with no mention of AI or ML algorithms for data analysis, interpretation, or prediction.

Therapeutic

No.
The device is used for monitoring arterial oxygen saturation and pulse rate, providing information rather than directly treating a condition.

Diagnostic

Yes

This device monitors arterial oxygen saturation and pulse rate, providing continuous non-invasive measurement and alarms for values outside of a set range. This real-time data collection and display of physiological parameters for evaluation by medical personnel constitutes diagnostic functionality.

SaMD (Software as a Medical Device)

The device description clearly states it is a "single-width plug-in parameter module" for a monitoring system, indicating it is a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, the Datex-Ohmeda S/5™ Nellcor Compatible Saturation Module, E-NSAT, is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for "monitoring arterial oxygen saturation of hospitalized patients." This describes a device that measures a physiological parameter directly from the patient's body, not from a sample of bodily fluid or tissue in vitro (outside the body).
Device Description: The description details a device that uses pulse oximetry technology to continuously and non-invasively measure pulse rate and oxygen saturation. This is a direct measurement from the patient, not an analysis of a sample.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents, which are hallmarks of IVD devices.

Therefore, the E-NSAT module is a patient monitoring device, specifically a pulse oximeter module, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Indications for use:
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.

Product codes (comma separated list FDA assigned to the subject device)

DQA, DPZ

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified medical personnel / hospitalized patients

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K020479

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K040113

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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).

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 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)

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)

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).

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.

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

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

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