The neonatal/adult Oxisensor, model N-25, is Indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing less than 3 kg or more than 40 kg.

The reprocessed ClearMedical/Nellcor N-25 Oxisensor is intended as a single patient use O₂ transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of neonatal and adult patients. The N-25 oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.

Device Description

The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturation and pulse rate. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information.

The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.

AI/ML Overview

The provided document is a 510(k) summary for the ClearMedical/Nellcor Oxisensor II, Neonatal/Adult O2 Transducer, Model N-25, which is a reprocessed single-use device. This document primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a performance study with explicit acceptance criteria for a new device's performance. Therefore, much of the requested information regarding acceptance criteria, study design, and specific performance metrics for the device itself is not explicitly detailed in this type of submission.

However, I can extract information related to the basis for establishing substantial equivalence, which serves as the "study" proving the device meets its regulatory acceptance criteria (i.e., substantial equivalence to a legally marketed predicate device).

Here's an analysis based on the provided text, addressing the points where information is available or inferable:

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

Since this is a 510(k) submission for a reprocessed device, the "acceptance criteria" are primarily framed around demonstrating substantial equivalence to the predicate device. The performance data presented is comparative, showing that the reprocessed device performs equivalently to the original. Explicit numerical acceptance criteria for clinical performance are not provided in this summary.

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance
Technological Characteristics:
Form and design similarity	"In form, the predicate device and the ClearMedical/Nellcor Oxisensor are substantially equivalent."
Optical components (2 LEDs, 1 photodiode)	"The predicate device and the ClearMedical/Nellcor Oxisensor contain three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector."
Laminated envelope with adhesive bandage	"Both the LEDs and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient, which serves to align the optical sensors and retain the sensor to a patient digit or foot."
Sensor cable and connector	"Attached to the laminated envelope is a sensor cable, which terminates in a molded PVC connector element that connects to the oximeter."
Performance Indicators:
Functionality in optical sensitivity of diodes	"Demonstrated equality in safety and performance" for "functionality in optical sensitivity of the optical diodes."
Continuity of sensor numbers	"Demonstrated equality in safety and performance" for "continuity of sensor numbers."
Comparative non-invasive Co-Oximetry and Oximetry data	"Demonstrated equality in safety and performance" for "comparative non-invasive Co-Oximetry and Oximetry data."
Infection control methodology	"Demonstrated equality in safety and performance" for "infection control methodology."
Fit/attachment and connector function	"Demonstrated equality in safety and performance" for "fit/attachment and connector function."
Overall Safety and Performance:
Substantial equivalence in safety and performance	"For all established indicators of substantial equivalence, the ClearMedical devices demonstrated equality in safety and performance." and "we believe that in all relevant safety and performance indicators the ClearMedical/Nellcor Oxisensor demonstrates substantial equivalence to the Nellcor Oxisensor predicate devices."

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

The summary states that "specific bench and non-invasive clinical testing" was performed. However, it does not specify:

The exact sample size for the test set (number of patients or reprocessed devices tested).
The country of origin of the data.
Whether the study was retrospective or prospective.

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)

This information is not provided in the summary. For an oximeter, "ground truth" for oxygen saturation is typically established by arterial blood gas analysis (Co-Oximetry), not by expert consensus. The summary mentions "comparative non-invasive Co-Oximetry and Oximetry data," suggesting a comparison against a more accurate measurement method (Co-Oximetry), which would serve as the ground truth. However, details on how this was conducted or expert involvement in establishing ground truth are not present.

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

This information is not provided in the summary. Given the nature of oximetry, it's unlikely a multi-reader adjudication method would be directly relevant to the core SpO2 measurement, which tends to be an objective numerical value.

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

An MRMC study is not applicable here. This device is an oximeter transducer, an accessory device, not an AI-powered diagnostic tool requiring human interpretation. The "study" focuses on the equivalence of the reprocessed hardware's performance.

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

The device itself is a transducer, a hardware component that, in conjunction with an oximeter system, acquires data. It's not an algorithm that operates "standalone" in the way AI algorithms are evaluated. The "performance" refers to the sensor's ability to accurately transmit patient-modified signals to the oximeter, and thus its accuracy in contributing to SpO2 and pulse rate determination. The evaluation would have been of the device in its intended use, effectively "standalone" from human interpretation of raw signals, but in conjunction with the oximeter system.

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

The summary mentions "comparative non-invasive Co-Oximetry and Oximetry data." This strongly suggests that Co-Oximetry (a more accurate, usually invasive, measurement of arterial oxygen saturation) was used as the ground truth for evaluating the accuracy of the reprocessed oxisensor in contributing to SpO2 determination.

8. The sample size for the training set

This information is not relevant or provided as there is no "training set" in the context of this traditional medical device (a reprocessed oximeter transducer). The device is not an AI algorithm that learns from data.

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

Not applicable, as there is no training set for this type of device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2004 NOV

Clear Medical, Inc. c/o Wayne Pong Quality Team Leader 1776 136th Place NE Bellevue, WA 98005

Re: K012609 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: NLF Dated: August 8, 2001 Received: August 13, 2001

Dear Mr. Pong:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on July 3, 2002. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.

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Page 2 - Mr. Wayne Pong

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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.

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices 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/dsma/dsmamain.html.

Sincerely yours,

Qve

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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Statement of Indications for Use

510(K) NUMBER (IF KNOWN): __________________________________________________________________________________________________________________________________________________

ClearMedical/Nellcor Oxisensor II, · DEVICE NAME:

Neonatal/Adult O2 Transducer, Part No. N-25

INDICATIONS FOR USE:

(Please do not write below this line-continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ] (Per 21 CFR 801.109)

OR Over-The-Counter-Use__

Orvision Sign-C T vision of Dental, Infection Control, Coneral Hospital Devi KO12609 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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K012649 - Trade/Bevice Name List

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Clear Medical/Nellcor Oxisensor II, Neonatal/Adult O2 Transducer, Model N-25

And And Production

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3 2002 JUL

510(k) Summary K 012609

Submitter's name and Address:	ClearMedical, Inc.1776 - 136th Place NEBellevue, WA 98005Ph (425) 401-1414Fax (425) 401-1515
FDA Registration Number:	3017110
Contact Person:	Richard RadfordDirector of Research and Product Development
Date Summary Prepared:	August 8, 2001
Trade or Proprietary Name:	ClearMedical/Nellcor Oxisensor II,Neonatal/Adult O2 Transducer, Part N-25
Common Name:	Oxisensor
Classification:	Oximeter (per 21 CFR 870.2700) / DQA

Equivalent Device

The reprocessed ClearMedical/Nellcor Oxisensor II, Neonatal/Adult O₂ Transducer, Part N-25, is substantially equivalent to the Nellcor Oxisensor II™ Neonatal/Adult O2 , Part N-25 This determination has been reached based on an evaluation and analysis of the predicate device's technical and promotional labeling and specific bench and non-invasive clinical testing. For all established indicators of substantial equivalence, the ClearMedical devices demonstrated equality in safety and performance.

Device Description

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510(k) Summary (Cont'd)

Intended Use of the Oxisensor

Technological Characteristics of ClearMedical/Nellcor Oxisensor Compared with the Nellcor Oxisensor

The predicate device and the ClearMedical/Nellcor Oxisensor contain three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and photodiode are contained within a leminated envelope with an adhesive bandage for attachment to a patient, which serves to align the optical sensors and retain the sensor to a patient digit or foot. Attached to the laminated envelope is a sensor cable, which terminates in a molded PVC connector element that connects to the oximeter. In form, the predicate device and the ClearMedical/Nellcor Oxisensor are substantially equivalent.

Other technological indicators of substantial equivalence were identified and included functionality in optical sensitivity of the optical diodes, continuity of sensor numbers comparative non-invasive Co-Oximetry and Oximetry data, infection control methodology, fit/attachment and connector function.

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Summary of the ClearMedical/Nellcor Oxisensor Performance

Based on an assessment of bench tests and clinical and/or non-clinical performance data, we believe that in all relevant safety and performance indicators the ClearMedical/Nellcor Oxisensor demonstrates substantial equivalence to the Nellcor Oxisensor predicate devices.

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).