The pediatric Oxisensor, model D-20, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg.

The reprocessed ClearMedical/Nellcor D-20 Oxisensor is intended as a single patient use O 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 pediatric patients. The D-20 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 saturering 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 LED's 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

Here's a breakdown of the acceptance criteria and study information based on the provided text, categorized as you requested. Please note that the document is a 510(k) summary, which often provides general statements of equivalence rather than a full, detailed study report. Therefore, some information, especially regarding specific statistical outcomes or detailed methodologies, might be inferred or not explicitly present.

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

The document doesn't explicitly state quantitative acceptance criteria in a pass/fail format with exact numerical targets for all aspects. Instead, it emphasizes substantial equivalence to the predicate device in terms of safety and performance. The performance is reported as meeting this substantial equivalence.

Acceptance Criterion (Inferred from substantial equivalence)	Reported Device Performance
Functionality in optical sensitivity of the optical diodes	ClearMedical devices demonstrated "equality in safety and performance" when compared to the predicate device. Assumed to be met as part of "Technological Characteristics of ClearMedical/Nellcor Oxisensor Compared with the Nellcor Oxisensor."
Continuity of sensor circuitry	ClearMedical devices demonstrated "equality in safety and performance" when compared to the predicate device. Assumed to be met as part of "Technological Characteristics of ClearMedical/Nellcor Oxisensor Compared with the Nellcor Oxisensor."
Comparative non-invasive Co-Oximetry and Oximetry data (SpO2 and Pulse Rate accuracy)	ClearMedical devices demonstrated "equality in safety and performance" based on "specific bench and non-invasive clinical testing." This implies that the reprocessed device's SpO2 and pulse rate measurements were comparable to the predicate device and within acceptable clinical ranges. The device is intended for "determination of functional oxygen saturation and pulse rate."
Infection control methodology	ClearMedical devices demonstrated "equality in safety and performance." Given it's a reprocessed single-use device, this would involve validation of the reprocessing method to ensure sterility and prevent cross-contamination.
Fit/attachment	ClearMedical devices demonstrated "equality in safety and performance." The sensor uses an "adhesive bandage for attachment to a patient" and serves "to align the optical sensors and retain the sensor to a patient digit." This implies the reprocessed device fits as intended.
Connector function	ClearMedical devices demonstrated "equality in safety and performance." The sensor terminates in a "molded PVC connector element that connects to the oximeter." This implies the reprocessed device's connector is compatible and functions correctly with the oximeter.
Overall safety and performance	"For all established indicators of substantial equivalence, the ClearMedical devices demonstrated equality in safety and performance." The device is intended for "non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function" in a hospital environment for patients weighing between 10 and 50 kg.

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

Sample size for test set: Not explicitly stated. The document refers to "specific bench and non-invasive clinical testing" but does not provide details on the number of subjects or cases included in these tests.
Data provenance: Not explicitly stated. Clinical testing implies prospective data collection, but the location (country of origin) is not mentioned.

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 document. For oximeters, ground truth for SpO2 is typically established via arterial blood gas (Co-Oximetry) measurements, but the specifics of how this was performed (number of experts, their qualifications, or who performed the reference measurements) are not detailed.

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

This information is not provided in the document. Adjudication methods are more common in studies involving subjective interpretation (e.g., radiology reads). For objective measurements like oximetry, statistical comparison to a reference standard is typically used rather than adjudication.

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

This is not applicable (N/A). The device is an oximeter sensor, which provides objective physiological measurements (SpO2 and pulse rate) and does not involve human "readers" interpreting images or data that could be augmented by AI. The device functions as a transducer for an oximeter system.

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

This is not applicable (N/A). The device itself is a sensor (hardware component), not an algorithm. Its performance is measured in conjunction with an oximeter system. The "algorithm" here would be inherent in the oximeter's processing of the sensor's signals, not a standalone AI application. The document describes the sensor's function as "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."

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

The document mentions "Comparative non-invasive Co-Oximetry and Oximetry data." For oximeters, the gold standard for measuring arterial oxygen saturation is arterial blood gas analysis (Co-Oximetry). Therefore, it is highly likely that this was the type of ground truth used for the "non-invasive clinical testing" to validate SpO2 accuracy. Pulse rate ground truth would typically come from an ECG or manual palpation.

8. The sample size for the training set

This information is not provided and is likely not relevant in the context of this device. The device is a reprocessed hardware sensor. Its "performance" is based on its physical and electrical properties, and its ability to produce signals comparable to the predicate device. It is not an AI/ML algorithm that requires a distinct "training set" in the conventional sense. The "training" here would be the quality control and reprocessing procedures, and the "validation" would be the bench and clinical testing described.

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

This is not applicable (N/A) for the reasons stated in point 8. There is no "training set" in the AI/ML context for this hardware device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines representing human profiles.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2004

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

Re: K012622 - 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 (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.

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 vou 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 vours.

Clare

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, O2 Transducer, Part No. D-20 DEVICE NAME:

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 __

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K012622

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K012622 – Trade/Device Name List

Clear Medical/Nellcor Oxisensor II, O2 Transducer, Model D-20

the submit and the state of the same of the states

1222

: 201

: .

. .

· .

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|< 012622 510(k) Summary

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, PediatricO₂ Transducer, Part D-20
Common Name:	Oxisensor
Classification:	Oximeter (per 21 CFR 870.2700) / DQA

Equivalent Device

The reprocessed ClearMedical/Nellcor Oxisensor II, Pediatric O₂Transducer, Part D-20, is substantially equivalent to Nellcor Oxisensor II™ Pediatric വു, Part D-20. This detemination has been reached based on an evaluation and analysis of the predicated witce'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 (LED's) that serve as light sources and one photodiode that acts as a light detector. Both the LED's and photodiode are contained within a Invinated i 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. Attached to the laminated envelope is a sensor cable, which terminates in a molded PVC connector element that connects to the 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 circuity, 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

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).