The Masimo Compatible Saturation Module, E-MASIMO, and accessories are indicated for monitoring arterial oxygen saturation and pulse rate of hospitalized patients. The device is indicated for use by qualified medical personnel only.

Device Description

The Masimo Compatible Saturation Module, E-MASIMO, is a single-width plug-in parameter module for a S/5 Modular Monitoring system. The Masimo Compatible Saturation Module, E-MASIMO is used for measuring noninvasive arterial oxygen saturation (SpO2) and pulse rate of hospitalized patients. The SpO2 measurement is based on light transillumination and is made optically with an infrared light and a red light sources and a photosensitive detector. The SpO2 value and pulse rate are calculated based on the signals, which are measured with the photosensitive detector in the SpO2 sensor.

The Masimo Compatible Saturation Module, E-MASIMO consists of an electronic measurement board based on MasimoSET® technology (OEM from Masimo Inc.), an interface board and connector flex board designed by GE Healthcare Finland Oy (former Datex-Ohmeda Div) for connecting the Masimo measurement board to a Datex-Ohmeda S/5 modular monitor.

AI/ML Overview

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device for a Masimo Compatible Saturation Module (E-MASIMO), rather than presenting a study to prove the device meets specific performance acceptance criteria through clinical trials or extensive validation. The submission primarily relies on a comparative approach, asserting that the new device is as safe and effective as its predicate. Therefore, much of the requested information regarding acceptance criteria, study sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-based diagnostic devices, is not explicitly available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria and a detailed table of device performance against these criteria are not provided in this 510(k) summary. The submission states that the device "complies with the voluntary standards as detailed in Section 4.2 Specific Standards and Guidance of this submission," but these standards and their specific requirements are not included in the provided text.

The conclusion states: "The results of these tests and analysis demonstrated that the Masimo Compatible Saturation Module, E-MASIMO is as safe, as effective, and performs as well as the predicate device." This is a general statement of equivalence, not a report of specific performance metrics against pre-defined acceptance criteria.

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

The document does not specify any sample size for a test set or data provenance (e.g., country of origin, retrospective or prospective) for performance evaluation. The "Test Summary" lists various quality assurance measures (risk analysis, requirements reviews, design reviews, subsystem verification, integration testing, final acceptance testing, performance testing, safety testing, environmental testing), but these appear to be related to engineering and manufacturing quality rather than specific clinical performance validation studies with defined test sets.

Given the nature of the device (a saturation module based on existing MasimoSET® technology integrated into GE Healthcare monitors), the performance is likely assumed to be inherited from the proven MasimoSET® technology and the predicate device, with the primary focus of this submission being the integration and compatibility.

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

Not applicable and not mentioned. This type of information is typically required for diagnostic devices where human expert interpretation is the gold standard. For a pulse oximeter module, the "ground truth" for SpO2 measurements would typically be derived from co-oximetry, not expert visual assessment. However, no such detailed clinical study is described here.

4. Adjudication Method for the Test Set

Not applicable and not mentioned. As there's no described test set requiring human interpretation, no adjudication method would be in place.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done or described. This type of study is relevant for imaging or diagnostic tools where human readers interpret results, sometimes with AI assistance. The E-MASIMO is a measurement device (pulse oximeter module), not an interpretative diagnostic system.

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

The device itself is a standalone module designed to run an algorithm (MasimoSET® technology) for SpO2 and pulse rate measurement. Therefore, its performance is inherently a "standalone" or "algorithm only" performance within the context of hardware integration. However, the document does not present a specific standalone performance study in terms of accuracy metrics against reference standards. It relies on the equivalence to the predicate device and the underlying MasimoSET® technology.

7. The Type of Ground Truth Used

Not explicitly stated for any formal clinical validation study. For pulse oximetry, the gold standard (ground truth) for oxygen saturation is typically arterial blood gas analysis with co-oximetry. However, this 510(k) summary is not detailing a de novo clinical validation study against such a ground truth. It assumes the underlying MasimoSET® technology has already established its accuracy, and the focus is on the integration and compatibility.

8. The Sample Size for the Training Set

Not applicable and not mentioned. This device is not an AI/ML system that requires a "training set" in the conventional sense of machine learning algorithms. It is a hardware module incorporating a pre-existing signal processing technology (MasimoSET®).

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

Not applicable and not mentioned for the same reasons as above.

Summary

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Kosi870

510(k) Summary of Safety and Effectiveness

Date:	June 30, 2008 JUL 31 2008
Submitter:	GE Healthcare Finland Oy.Kuortaneenkatu 2Helsinki, FinlandFIN-00510
Contact Person:	John PendergastRegulatory Affairs SpecialistGE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USAPhone: 2506Fax: 362-2585E-mail: john.pendergast@med.ge.com
Secondary ContactPerson:	Joel KentRegulatory Affairs Program ManagerGE Medical Systems Information TechnologiesPhone: (781) 449-8685Fax: (781) 433-1344E-mail: joel.kent@med.ge.com
Device Trade Name:	Masimo Compatible Saturation Module, E-MASIMO
Common /Usual Name:	Pulse Oximeter
Classification Names:	21 CFR 870.2700 Oximeter (DQA)21 CFR 870.2710 Ear Oximeter (DPZ)
Predicate Devices:	K052755 Datex-Ohmeda S/5™ Nellcor Compatible Saturation Module,E-NSAT and accessories
Device Description:	The Masimo Compatible Saturation Module, E-MASIMO, is a single-width plug-in parameter module for a S/5 Modular Monitoring system.The Masimo Compatible Saturation Module, E-MASIMO is used formeasuring noninvasive arterial oxygen saturation (SpO2) and pulserate of hospitalized patients.The SpO2 measurement is based on light transillumination and ismade optically with an infrared light and a red light sources and aphotosensitive detector. The SpO2 value and pulse rate are calculatedbased on the signals, which are measured with the photosensitivedetector in the SpO2 sensor.

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The Masimo Compatible Saturation Module, E-MASIMO was designed to work with the GE Healthcare modular monitoring platforms. Currently it can be used in the following four monitor platforms:

· GE Datex-Ohmeda S/5* Anesthesia Monitor
· GE Datex-Ohmeda S/5* Compact Anesthesia Monitor
· GE Datex-Ohmeda S/5* Critical Care Monitor
· GE Datex-Ohmeda S/5* Compact Critical Care Monitor

*Note: GE Datex-Ohmeda S/5 is the brand name. The older versions of S/5 monitor platforms were designated AS/3 for anesthesia models and CS/3 for critical care models instead of the current designator S/5, and can also use the Masimo Compatible Soturation Module, E-MASIMO.

The Masimo Compatible Saturation Module, E-MASIMO is compatible with the above monitors that run software versions:

· S-STD94 or S-ARK94 or newer
· S-ANE97 or newer
S-ICU97 or newer

Note: For reference the latest 510(k) clearances of the above listed monitors/software are as follows

· Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE05 AND L-ANE05A with 8-module monitor frame F-CU8 or the 5-module monitor frame F-CU5(P): K051400
Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05 and L-CANEO5A Software with frame F-CM1: K061185
· Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU05 and L-CICU05A with frame F-CMC1: K071020
Datex-Ohmeda S/5 Critical Care Monitor with L-ICU05 and L-1CU05A software, with 8-module monitor frame F-CU8 or the 5-module monitor frame F-CU5(b) : K071889

The Masimo Compatible Saturation Module, E-MASIMO uses Masimo SpO2 accessories including interconnect cable 2027263-002 (manufactured by Masimo Inc. and distributed by GE Healthcare) and interconnect cables 2017002-001, and 2017002-003 manufactured by GE Healthcare Information Technologies. All accessories have been

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previously cleared. See Section 6.7, Table 3.

Indications for Use: The Masimo Compatible Saturation Module, E-MASIMO, and accessories are indicated for monitoring arterial oxygen saturation and pulse rate of hospitalized patients. The device is indicated for use by qualified medical personnel only.

Technology:

The Masimo Compatible Saturation Module, E-MASIMO employs the same functional scientific technology as its predicate device.

Test Summary:

The subject of this 510(k) is a modification for the Datex-Ohmeda S/5™ Nellcor Compatible Saturation Module, E-NSAT. The Masimo Compatible Saturation Module, E-MASIMO complies with the voluntary standards as detailed in Section 4.2 Specific Standards and Guidance of this submission. The following quality assurance measures were applied to the development of the Masimo Compatible Saturation Module, E-MASIMO:

. Risk Analysis
. Reguirements Reviews
Design Reviews
Subsystem Verification .
. Integration testing (System verification)
. Final acceptance testing (Validation)
. Performance testing
Safety testing .
Environmental testing .

Conclusion:

The results of these tests and analysis demonstrated that the Masimo Compatible Saturation Module, E-MASIMO is as safe, as effective, and performs as well as the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three distinct legs or supports. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 31 2008

GE Healthcare Finland Oy C/O Mr. John Pendergast Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, Wisconsin 53223

Re: K081870

Trade/Device Name: Masimo Compatible Saturation Module, E-MASIMO and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 30, 2008 Received: July 1, 2008

Dear Mr. Pendergast:

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. Pendergast

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 Ccnter for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

MH Nomulo Lerdmiz
foren

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: Masimo Compatible Saturation Module, E-MASIMO and accessories

Indications for Use:

Prescription Use _ x 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

. 7. h

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081870

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).