The Datex-Ohmeda S/5™ E-MEM module is indicated for storing patient related physiological data, discrete record keeping events, and menu configurations in removable flash memory cards. The device is indicated for use by qualified medical personnel only.

Device Description

The Datex-Ohmeda Memory module, E-MEM is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda S/STM Memory module, E-MEM can be used with the following Datex-Ohmeda S/5™ modular monitors: S/5 Anesthesia Monitor(AM) with main software S-STD95, S-ARK95 or newer version S/5 Critical Care Monitor (CCM) with main software S-ICU97 or newer version. The Datex-Ohmeda S/5™ Memory Module, E-MEM, is an data storage module for the S/5 family anesthesia monitors. It is used for storing patient related physiological data, discrete record keeping events, menu configurations and user defined monitor configurations in removable PCMCIA compatible flash memory cards. The E-MEM has two card slots; one for patient data (MemCard Data) and the other for anesthesia record keeping configurations and monitoring modes. (MemCard Menu).

AI/ML Overview

This document pertains to a 510(k) premarket notification for the Datex-Ohmeda S/5™ E-MEM module. It is a memory module for medical monitors and its acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (Datex-Ohmeda M-MEM Module, K945234), rather than specific performance metrics evaluated through a clinical study. As such, many of the requested categories related to clinical study design and performance will not be applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Test Performed	Reported Device Performance (Summary)
Substantial Equivalence to Predicate	Functional Equivalence:	Met: Identical intended use, indications for use, fundamental scientific technology, operating principle, user interface, alarms, customer/parameter specifications, safety/effectiveness, and manufacturing processes compared to the predicate device (M-MEM, K945234).
	Safety Standards Compliance:	Met: Assessed against and complies with relevant international and national safety standards for medical electrical equipment, including: - COUNCIL DIRECTIVE 93/42/EEC - FDA/DCRND Reviewer Guidance for Premarket Notification Submissions - IEC 60601-1 (General requirements for safety) - EN 60601-1 - CAN/CSA C22.2 No. 601.1-M90 - UL 2601-1 - IEC 60601-1-2 (Electromagnetic compatibility) - FDA/ODE Guidance for Content of Premarket Submission for Software Contained in Medical Devices.
	Verification and Validation:	Met: The device has been "thoroughly tested through validation and verification of specifications." (Specific details of these tests are not provided in the summary, but implied to be sufficient for demonstrating compliance with standards and equivalence.)
Minor Differences Impact Assessment:	Differences in Aesthetics/Mechanics:	Deemed Non-Impactful: New color, shape, size, front panel/labeling changes. These are mechanical/aesthetic and do not affect functional equivalence.
	Minor Improvements to Electronics/Software:	Deemed Non-Impactful: Minor improvements to the electronic board and module software. These are presented as enhancements that do not alter the fundamental safety or effectiveness.
	PC Card Software Updating:	Deemed Non-Impactful: Added support for module software updating via PC card in one slot. This is an added feature that improves serviceability.
	Changed PCMCIA Card Type:	Deemed Non-Impactful: Changed type of PCMCIA cards used. This is a component change that does not affect the core function or safety.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a non-clinical substantial equivalence assessment and verification/validation testing against established medical device standards and the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable in the context of a 510(k) for a data storage module of this nature. The "test set" here refers to the device itself and its components undergoing engineering verification and validation against specified requirements and standards. It's not a clinical data set in the traditional sense.
Data Provenance: Not applicable. The "data" evaluated is the device's design, engineering specifications, test results from internal verification and validation, and comparison to the predicate device. There is no mention of patient data being used for the substantial equivalence claim itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts: Not explicitly stated. The "ground truth" for a medical device like this is primarily derived from established engineering principles, international and national medical device standards (e.g., IEC 60601-1), and the performance of the legally marketed predicate device. Experts involved would be internal R&D, quality assurance, regulatory affairs personnel at GE Healthcare, and potentially independent testing labs for specific standard compliance. Their qualifications would be in medical device engineering, safety, and regulatory compliance, but not in clinical specialties like radiology for image interpretation.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. This wasn't a study involving human interpretation or subjective assessment that would require an adjudication process. Compliance was assessed against objective standards and technical specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic or screening devices where human readers interpret patient data (e.g., medical images) with and without AI assistance. The E-MEM module is a data storage device, not a diagnostic or interpretive tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Standalone Performance Study: No, a standalone performance study in the context of an "algorithm only" was not done. While the device has "module software," its function is data storage and system integration, not complex algorithmic analysis requiring a "standalone" performance evaluation separate from the hardware. Its performance is tied to the reliable storage and retrieval of data according to specifications.

7. The Type of Ground Truth Used:

Type of Ground Truth: The "ground truth" for this submission is based on:
- Engineering Specifications: The defined requirements for the module's performance, reliability, and functionality.
- Regulatory Standards: Compliance with established international and national medical device safety and performance standards (e.g., IEC 60601-1, EMC standards).
- Predicate Device Performance: The established safety and effectiveness of the legally marketed Datex-Ohmeda M-MEM Module (K945234), which serves as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. The "module software" would have been developed and tested using standard software engineering practices.

9. How the Ground Truth for the Training Set Was Established:

How Ground Truth for Training Set Was Established: Not applicable. As it's not an AI/ML device, there isn't a "training set" or "ground truth" for training in the traditional sense. Software validation would ensure the software performs according to its design specifications.

Summary

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K0 52756

Page 1 of 3

NOV - 1 2005

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5TM E-MEM module

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

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

TRADE NAME:

The Datex-Ohmeda S/5TM E-MEM module

COMMON NAME:

Memory Module

CLASSIFICATION NAME:

The following Class II classification appears applicable:

Product Code	Classification Name	CFR Section
MHX	Monitor, physiological, patient(with arrhythmia detection or alarms)	870.1025

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™ Memory Module, E-MEM is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-MEM Module (K945234).

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

S/5 Anesthesia Monitor(AM) with main software S-STD95, S-ARK95 or newer version S/5 Critical Care Monitor (CCM) with main software S-ICU97 or newer version

The Datex-Ohmeda S/5™ Memory Module, E-MEM, is an data storage module for the S/5 family anesthesia monitors. It is used for storing patient related physiological data, discrete record keeping events, menu configurations and user defined monitor configurations in removable PCMCIA compatible flash memory cards. The E-MEM has two card slots; one for patient data (MemCard Data) and the other for anesthesia record keeping configurations and monitoring modes. (MemCard Menu).

The Memory Module, E-MEM, can be utilized in the following ways:

. as a backup media for patient related physiological and record keeping data
. as a local menu server for the monitor it is connected to
a memory card with newly recorded patient data can be moved to a new monitor together t . with the patient, thus enabling continuous data collection

for storing user defined monitor configurations and transporting them to other monitors . The presence of a memory card is indicated by a card specific symbol on the moritor display.

INTENDED USE as required by 807,92(a)(5)

Intended Use:

. '

The Datex-Ohmeda S/5™ E-MEM module is intended to be used with a Datex-Ohmeda modular monitor for storing patient related physiological data, discrete record keeping events and menu configurations in removable flash memory cards.

Indications for use:

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

The Datex-Ohmeda S/5TM Memory Module, E-MEM is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-MEM Module (KN45234). The E-MEM module has the following similarities compared to the predicate M-MEM module (K945234):

identical intended use and indications for use .
identical fundamental scientific technology �
the same (improved) electronic board
. same (improved) module software
. use the same operating principle
. have the same user interface at the monitor and alarms (can be used with the same monitor software)
. the Customer and parameter specifications are the same
. have the same safety and effectiveness
. are manufactured using the same processes

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The main differences between the new E-MEM module and the predicate M-MEM module (K945234) is primarily due to fact that the new E-MEM module has the following changes:

New color, shape, and size and thus differing mechanics .
. The front panel and labeling have changed
Minor improvements to the electronic board .
Minor improvements to the module software ◆
Added Support for module software updating via PC card (PCMCIA) in one of the two . card slots of the module without opening the module case
. Changed type of PCMCIA cards used with the Memory module

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/5M Memory Module, E-MEM are substantially equivalent to the predicate Datex-Ohmeda -M-MEM module (K945234).

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

The Datex-Ohmeda S/5™ Memory Module, E-MEM has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices ◆
FDA/DCRND Reviewer Guidance for Premarket Notification Submissions, November 1993 .
. IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety)
EN 60601-1:1990+ A1:1993 + A13:1996 + A2:1995 (identical to IEC60601-1:1988 + Amdt. . 1:1991 + Amdt. 2:1995)
CAN/CSA C22.2 No. 601.1-M90 + S1:1994 (Canadian deviations to IEC 60601-1:1988 + t Amdt. 1:1991) + S2:1998 (=IEC Amdt 2:1995)
. UL 2601-1, October 24, 1997 (U.S. deviations to IEC 60601-1:1988 + Amdt. 1:1991+ Amdt. 2:1995)
. IEC 60601-1-2:2001 (Electromagnetic compatibility - Requirements and tests)
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/5™ Memory Module, E-MEM is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-MEM Module (K945234).

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DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 2005

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

Re: K052756

Trade Name: Datex-Ohmeda S/5TM E-MEM Module Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: September 29, 2005 Received: September 30, 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. 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 (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 yours,

Blummina for

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 S/5™ Memory Module, E-MEM

Indications for use:

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)

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Blumuma
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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.