The LNCS oximetry sensors are intended for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The SPO2.COM oximetry sensors are intended for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The LNCS Sensors are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

The SPO2.COM Sensors are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatic, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Device Description

The LNCS Oximery Sensors are fully compatible disposable sensors for use with Masimo SET compatible pulse oximeter monitors and also with Nellcor compatible pulse oximeter monitors. There is no change in design to the sensors. The only change is to add that the sensors can be sterilized by Ethylene Oxide.

The SPO2.COM Oximetry Sensors are fully compatible disposable sensors for use with Nellcor compatible pulse oximeter monitors. There is no change in design to the sensors. The only change is to add that the sensors can be sterilized by Ethylene Oxide.

AI/ML Overview

The provided 510(k) summary (K060143) describes LNCS and SPO2.COM Oximetry Sensors. The submission is for a modification to existing, legally marketed sensors to add clearance for Ethylene Oxide (EtO) sterilization. This is explicitly stated in the "Device Description" sections for both types of sensors: "There is no change in design to the sensors. The only change is to add that the sensors can be sterilized by Ethylene Oxide."

Therefore, the performance testing described is focused on demonstrating that EtO sterilization does not negatively impact the performance of the sensors, and that the sensors remain "substantially equivalent" to their non-EtO sterilized counterparts. This is a crucial distinction, as the study is not intended to establish the foundational accuracy or performance of the oximetry technology itself, but rather to confirm the safety and effectiveness after a new sterilization method is applied.

Given this context, the request for "acceptance criteria," "reported device performance," and details about the "study that proves the device meets the acceptance criteria" must be interpreted in relation to the impact of EtO sterilization. The original oximeter performance, including accuracy, would have been established and reviewed in the predicate device submissions (K033298, K041815, K051212).

Here's an analysis based on the provided text, acknowledging the specific nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for EtO Sterilization)	Reported Device Performance (Post-EtO)
Maintain equivalency to predicate devices in:	"The LNCS and SPO2.COM sensors are substantially equivalent to the LNCS and SPO2.COM sensors before and after Ethylene Oxide Sterilization."
- Intended Use	Confirmed to be identical to predicate devices.
- Design	Confirmed to be identical to predicate devices (no design change).
- Principles of Operation	Confirmed to be identical to predicate devices.
- Materials	Confirmed to be identical to predicate devices.
- Performance (e.g., accuracy)	"The accuracy of the LNCS and SPO2.COM oximetry sensors is equivalent to those of the predicate devices."
- Safety and Effectiveness	"The results of the performance data demonstrate that the LNCS and SPO2.COM oximetry sensors are as safe and effective than the legally marketed predicate devices."

Study Description:

The study conducted was a Performance Testing that included:

Ethylene Oxide Sterilization Testing: This would typically involve validating the sterilization cycle to ensure sterility assurance levels (SAL) are met, and then testing the functional performance of sensors that have undergone this sterilization process.
In-house laboratory testing: This would involve a battery of tests to confirm that the sensors still meet all functional, material, and electrical specifications after EtO sterilization. This could include tests for mechanical integrity, response time, electrical performance, and critically, oximetry accuracy when subjected to known SpO2 levels (often through testing with blood gas analyzers or calibrated simulators) to ensure the sterilization process has not degraded the sensor's ability to accurately measure SpO2.

The key outcome reported is that the performance data demonstrate that the LNCS and SPO2.COM sensors are substantially equivalent to the LNCS and SPO2.COM sensors before and after Ethylene Oxide Sterilization. This confirms that the sterilization process did not negatively impact the device's ability to meet its established performance.

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

The 510(k) summary does not explicitly state the sample size used for the Ethylene Oxide Sterilization Testing or the in-house laboratory testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective data) for these specific tests.

It is common for 510(k) summaries, especially for modifications to predicate devices, to summarize performance testing results rather than providing granular detail on sample sizes, as these details are typically found in the full 510(k) submission document.

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

This information is not provided in the 510(k) summary. Given that the testing primarily involved "Ethylene Oxide Sterilization Testing and in-house laboratory testing," the ground truth would likely be established through objective laboratory measurements and validated sterilization processes, rather than expert human interpretation in a clinical context.

4. Adjudication Method for the Test Set

This information is not provided. As mentioned above, the nature of the testing (sterilization and lab performance) suggests that adjudication by human experts in the traditional sense (e.g., 2+1 reading consensus for images) would not be applicable.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, nor would it be relevant for this type of device modification. This submission relates to pulse oximetry sensors and their sterilization, not an AI-powered diagnostic or interpretive device that would assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/not provided. The device is a medical sensor, not an algorithm, and operates as a standalone measurement device providing data to a pulse oximeter monitor.

7. The Type of Ground Truth Used

For the Ethylene Oxide Sterilization Testing and in-house laboratory testing, the ground truth would be based on:

Sterility Assurance Level (SAL) validation: Demonstrating that the sterilization process achieves a predefined probability of a non-sterile unit.
Physical and electronic measurements: Using calibrated equipment to assess the mechanical integrity, electrical characteristics, and functional performance (e.g., accuracy against a reference oximeter or blood gas analyzer, simulated SpO2 values) of the sensors after sterilization.
Material compatibility testing: Ensuring that the materials of the sensor are not degraded or altered by the EtO process, which could affect performance or biocompatibility.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device does not use machine learning or AI that would require a "training set."

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

This information is not applicable/not provided, as there is no training set for this device.

Summary

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510(k) SUMMARY

Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K060143'. The characters are written in a handwritten style, with varying stroke thicknesses. The overall impression is that of a label or identifier.

Image /page/0/Picture/2 description: The image shows the logo for Masimo, a medical technology company. Below the logo is the company's address, which is 40 Parker, Irvine, CA 92618. The image also includes the company's phone number, which is 949-297-7000, and fax number, which is 949-297-7001.

JUN 16 2006

Submitted by:	Masimo Corporation40 ParkerIrvine, CA 92618949-297-7000FAX 949-297-7001
Company Contact:	James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance
Date Summary Prepared:	January 17, 2006
Trade Name	LNCS and SPO2.com Oximetry Sensors
Common Name	Oximeter Sensor
Classification Name and Product Code:	Oximeter (74DQA) (870.2700)
Substantially Equivalent Devices:	SPO2.COM A, P, I, N, RS-I Pulse Oximeter Sensors 510(k) Number - K033298LNCS Oximetry Sensors - K041815LNCS Oximetry Sensors - K051212

Device Description

Intended Use

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510(k) SUMMARY

Technology Comparison

The LNCS and SPO2.COM oximetry sensors are equivalent in intended use, design, principles of operation, materials, and performance to predicate sensors and operate on identical principles of non-invasive optical assessment of tissue oxygenation using emitters and detectors.

The LNCS oximetry sensors are designed, and manufactured for full compatibility with Masimo SET and Masimo SET compatible pulse oximeters and Nellcor compatible pulse oximeter monitors. The LNCS oximetry sensors are constructed of exact materials and components as used in the predicate devices.

The SPO2.COM oximetry sensors are designed, configured, and manufactured for full compatibility with Nellcor compatible pulse oximeter monitors. The SPO2.COM oximetry sensors are constructed of exact materials and components as used in the predicate devices.

The accuracy of the LNCS and SPO2.COM oximetry sensors is equivalent to those of the predicate devices.

Performance Testing

Performance data include results from Ethylene Oxide Sterilization Testing and in-house laboratory testing.

The performance data demonstrate that the LNCS and SPO2.COM sensors are substantially equivalent to the LNCS and SPO2.COM sensors before and after Ethylene Oxide Sterilization.

Conclusion

The results of the performance data demonstrate that the LNCS and SPO2.COM oximetry sensors are as safe and effective than the legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes forming its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Public Health Service

JUN 16 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James J. Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 40 Parker Irvine, California 92618

Re: K060143

Trade/Device Name: LNCS and SPO2.COM Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: June 9, 2006 Received: June 12, 2006

Dear Mr. Cronin:

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. Cronin

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 (OS) 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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):

LNCS and SPO2.COM Sensors Device Name:

Indications For Use:

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C) 011

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign-Off)
ton of Anesthesiology, General Hospital,
Cion Control Dental Dovinn

AA6

Number: K066/73

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).