SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in soft pad with a clear window. The sensor cable is terminated in a connector that couples with the corresponding monitor.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Tenacore Holdings, Inc. SpO2 Sensor:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
SpO2 Accuracy (ARMS)	Acceptability within ±3%
Pulse Rate Accuracy	Verified (claimed to be equivalent to predicate device)

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

The exact sample size for the clinical hypoxia studies is not explicitly stated in the provided text.

Data Provenance: Clinical hypoxia studies were conducted in an independent research lab. The data is prospective as it involved conducting new studies. The country of origin is not specified, but given the submission to the FDA, it is likely the studies were conducted in the US or in a manner compliant with US regulatory standards.

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

The document does not specify the number of experts used to establish ground truth or their qualifications.
The ground truth for SpO2 accuracy was established by comparing the subject sensors to arterial blood samples analyzed on a laboratory co-oximeter. This implies the co-oximeter itself provides the "ground truth," rather than human experts interpreting results.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. The comparison was directly against objective measurements from a laboratory co-oximeter for SpO2 and likely a reference standard for pulse rate.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret images. For an SpO2 sensor, the performance is measured against objective physiological parameters.

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

Yes, a standalone performance assessment was done. The performance data explicitly states, "Subject sensors were compared to arterial blood samples analyzed on a laboratory co-oximeter and found to be equivalent to predicate device accuracy claims." This indicates the device's accuracy was assessed directly without human interpretation influencing the measurement.

7. The Type of Ground Truth Used

SpO2 Accuracy Ground Truth: Achieved by arterial blood samples analyzed on a laboratory co-oximeter. This is an objective, gold-standard physiological measurement.
Pulse Rate Accuracy Ground Truth: The text states, "Bench testing was performed to verify pulse rate accuracy." While not explicitly stated, this would typically involve comparing the device's pulse rate reading against a known, highly accurate reference standard (e.g., an ECG or a precision pulse generator).

8. The Sample Size for the Training Set

The provided document does not mention a training set or its sample size. This is typical for a medical device like an SpO2 sensor where performance is based on physical principles and calibration, not a machine learning algorithm that requires extensive data for training.

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

As no training set is mentioned (or generally applicable to this type of device), this question is not applicable.

Summary

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K053420

510(k) Summary

Submitter Information Tenacore Holdings, Inc 647 E. Young Street Santa Ana, CA 92705

NOV 15 2006

Contact Brand Caso, QA Director

Ph: 714-444-4643

Fx: 714-549-7835

Date Prepared November 1, 2005

Product Name SpO2 Sensor (accessory to pulse oximeter)

Predicate Device K973970, K002223

Product Description

Intended Use

SpO2 Sensors are indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

	Tenacore Model	Epic SPo2 FingerSensor	Medical CablesSpo2 Finger Probes
Intended use	Continuous SPO2monitoring	Same	Same
Patient population(weight range)
Anatomical sites	Finger	Finger	Finger
Patient use/reuse	Reuse	Same	Same
Sterility	Non-sterile	Same	Same
Description ofpatient attachment	Finger clip	Same	Same

Comparison to Predicate Device

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Connector design	Various; modular ormolded	Same	Same
Cable structure	Multi-conductor,shielded, PVC jacket	Same	Same
Cable length	3-12 ft	Same	Same
LED wavelength	660/895 nm660/940 nm	Same	Same
Photodiode activearea	3 mm2, 8mm2	Same	Same
Accuracy (Arms)	Acceptability within ±3%	Same	Same

Performance Data & Conclusions

Performance testing was conducted during clinical hypoxia studies conducted in an independent research lab. Subject sensors were compared to arterial blood samples analyzed on a laboratory co-oximeter and found to be equivalent to predicate device accuracy claims. Bench testing was performed to verify pulse rate accuracy.

Biocompatibility, electrical safety, and EMC testing was also performed to demonstrate conformance with established industry standards.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brand Caso Quality Assurance Director Tenacore Holdings, Incorporated 647 E. Young Street Santa Ana, California 92705

NOV 15 2006

Re: K053420

Trade/Device Name: SpO2 Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: November 8, 2006 Received: November 8, 2006

Dear Mr. Caso:

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. Caso

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

Snyite Y. Michauoms.

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: SpO2 Sensors

Indications for Use:

Accessory to pulse oximeter for the purpose of continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

Prescription Use _ XX (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Wholly Held for Ann Graham

hesiology. General Hospital.

Number: K05 3420

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).