The reprocessed AllFit Oximetry sensor, OXY-AFR, is a single-patient-use, adhesive sensor for short-term or long-term monitoring of functional oxygen saturation and pulse rate. The device is indicated for use by qualified medical personnel only.

Device Description

This OXY-AFR sensor has a sensor head, consisting of a red LED and two infrared LEDS mounting on a leadframe, wired to a detector with a 1 meter cable and custom "happisnap" connector. There are two optical windows where the LED light is transmitted between the detector and LEDS. These components are packaged in a heat sealed package. The OXY-AFR is identical to the OXY-AF sensor with the exception of the new patient window adhesive. The ICU, a FR Sensor is for use in small adult and pediatric patients in the hospital, ICU, anesthesia, respiratory therapy, and during transport.

The Datex-Ohmeda OXY-AFR Sensor has the following differences when compared to the Datex-Ohmeda OXY-AF predicate device. The OXY-AFR sensor is a reprocessed OXY-AF sensor During reprocessing the used OXY-AF sensor is tested, cleaned, inspected and decontaminated. After decontamination new patient adhesive is installed over the optical windows and the reprocessed sensor is repacked with new removable tape. The OXY-AFR Sensor and the predicate OXY-AF SENSOR have the same performance specifications. The changes in the labels and instructions for use were made to add the reprocessed part numbers and name of the new device to the IFU. No changes in the warnings, cautions or contraindications have been made

AI/ML Overview

The provided text describes the Datex-Ohmeda OXY-AFR Sensor, a reprocessed pulse oximetry sensor, and its substantial equivalence to a predicate device (Datex-Ohmeda OXY-AF SENSOR, K040831). The submission focuses on demonstrating that the reprocessed sensor maintains the safety and effectiveness of the original device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for performance metrics like accuracy, sensitivity, or specificity in the way one might expect for a novel AI device. Instead, the core acceptance criterion is substantial equivalence to the predicate device. This means the reprocessed device must perform equivalently to the original.

Performance Metric/Acceptance Criterion	Reported Device Performance
Substantial Equivalence	The Datex-Ohmeda OXY-AFR Sensor is stated to be substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda OXY-AF SENSOR (K040831). This is supported by claims of identical indicated use, fundamental scientific technology, operating principle, and manufacturing processes.
Performance Specifications	The OXY-AFR Sensor and the predicate OXY-AF SENSOR are stated to have the same performance specifications.
Decontamination Process Validation	The decontamination process validation was reportedly conducted, and a report is included, implying it met necessary criteria to ensure safety for reprocessing.
Biocompatibility	Biocompatibility summary and testing reports are included, indicating the reprocessed device's materials (especially the new adhesive) are biocompatible.
Safety Testing	Safety testing report is included.
Accuracy Testing	Accuracy testing is included.

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

The document does not specify a sample size for a "test set" in the context of a typical AI/ML study (i.e., a dataset used for performance evaluation of an algorithm on unseen data). The testing mentioned (Verification and Validation data, safety testing, and accuracy testing) refers to engineering/device-level performance validation rather than AI model evaluation.

Sample Size: Not specified for a "test set" in the AI/ML sense.
Data Provenance: Not applicable as this is a device reprocessing submission, not an AI/ML study with data provenance. The context implies testing was done on the physical reprocessed sensors.

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 document. Ground truth as typically understood in AI/ML (e.g., expert labels on images) is not relevant to this submission, which is about the substantial equivalence of a medical device (pulse oximeter sensor). The "ground truth" for this type of device would be established through direct physiological measurement or comparison to a gold standard during accuracy testing.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given this is not an AI/ML study with a reader study component.

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 information is not provided and is not applicable. This submission is for a reprocessed pulse oximetry sensor, which is a hardware device for physiological measurement, not an AI diagnostic tool that assists human readers.

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

This information is not provided and is not applicable. The device is a reprocessed pulse oximetry sensor, not a standalone algorithm. Its performance is inherent to the physical sensor and its components.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document mentions "Accuracy testing" and "Verification and Validation data." For a pulse oximeter, the ground truth for accuracy testing would typically involve:

Physiological measurements: Comparing SpO2 readings to arterial blood gas measurements (co-oximetry) in human subjects or animal models under controlled desaturation conditions.
Reference standards: Using a calibrated reference oximeter or a phantom for certain functional tests.

The document does not explicitly detail the specific ground truth method, but it would be based on these types of direct physiological or metrological comparisons, not expert consensus on images or pathology.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. This is not an AI/ML study involving a "training set."

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

This information is not provided and is not applicable. This is not an AI/ML study involving a "training set."

Summary

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K042891

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JUN 2 9 2005

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda OXY-AFR Sensor

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

COMPANY NAME/ADDRESS/PHONE/FAX:

Datex-Ohmeda, Inc 1315 W Century Dr Louisville, Colorado 80021 USA FDA Registration No. 1719176. Tel: 303-666-7001 Fax: 303-665-9176

NAME OF CONTACT:

Mr. Joel Kent Datex-Ohmeda 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344

DATE:

October 17, 2004

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

TRADE NAME:

Datex-Ohmeda OXY-AFR Sensor

COMMON NAME:

Reprocessed Pulse Oximetry Sensor

CLASSIFICATION NAME:

The following Class II classifications appear applicable:

73 NLF (Reprocessed) Oximeter 21 CFR 870.2700

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NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The Datex-Ohmeda OXY-AFR Sensor is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda OXY-AF SENSOR (K021265).

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

INTENDED USE as required by 807.92(a)(5)

Intended use:

The reprocessed AllFit Oximetry sensor, OXY-AFR, is a single-patient-use, adhesive sensor for short-term or long-term monitoring of functional oxygen saturation and pulse rate

Indications for use:

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

The Datex-Ohmeda OXY-AFR Sensor is substantially equivalent in safety and Fffectiveness to the legally marketed (predicate) Datex-Ohmeda OXY-AF SENSOR (K040831).

The Datex-Ohmeda OXY-AFR Sensor has the following similarities to the Datex-Ohmeda OXY-AF SENSOR predicate device:

-have the same indicated use

-have the same fundamental scientific technology and use the same operating principle -are manufactured using the same processes

-constructed of identical materials except for the patient window adhesive which is equivalent to the original window adhesive

The Datex-Ohmeda OXY-AFR Sensor has the following differences when compared to the Datex-Ohmeda OXY-AF SENSOR predicate device:

-The OXY-AFR sensor is a reprocessed OXY-AF sensor

-The patient window adhesives are different but equivalent.

In summary, the Datex-Ohmeda OXY-AFR Sensor, described in this submission is substantially equivalent to the predicate OXY-AF SENSOR (K040831).

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

Datex-Ohmeda OXY-AFR Sensors are normally used and installed by a trained nurse or doctor. Necessary precautions and warnings are stated on the instructions for use. The Verification and Validation data, safety testing report and Accuracy testing is included.

The decontamination process validation was conducted and this report is included.

Biocompatibility summary and testing reports are included as well.

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda OXY-AFR Sensor as compared to the predicate device.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol.

SEP - 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042891

Trade/Device Name: Datex-Ohmeda OXY-AFR Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: May 17, 2005 Received: May 18, 2005

Dear Mr. Kent:

This letter corrects our substantially equivalent letter of June 29, 2005

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 (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 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. 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 continue 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/dsma/dsmamain.html

Sincerely yours,

Clive, Ph.D.

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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List of Models: Datex Ohmeda Reprocessed Sensors

Datex Ohmeda OxyTip+ OXY-AFR

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Datex-Ohmeda OXY-AFR Sensor

Indications for Use:

Over-The-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aingulion

on Siyn-Off) (Di-Divin of Anesthesiology, General Hospital, Infection Collast, Deman De vices

510(k) Number _

Page _ of _

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).