The Flexi-Site SpO2 Ear Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing > 30 kg.

Device Description

The Flexi-Site SpO2 Sensor is an electro-optical sensor that functions 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 a durable silicone casing. The sensor cable is terminated in a Hypertronics style connector.

AI/ML Overview

Here is an analysis of the provided text regarding the acceptance criteria and the study that proves the Flexi-Site SpO2 Ear Sensor meets those criteria:

Device Acceptance Criteria and Performance

Acceptance Criteria	Reported Device Performance
Accuracy (Ams) for SpO2	3.84% across the range of 70%-100% SaO2

While the document explicitly states the "Accuracy (Ams) for the Flexi-Site was 3.84% across the range of 70%-100% SaO2", it does not provide a pre-defined acceptance criterion for this metric. The listed value of 3.84% is simply the result obtained from the performance testing. In a typical regulatory submission, there would be a target accuracy value (e.g., "Accuracy Ams shall be less than 4%"). However, based on the provided text, the 3.84% value implicitly met the FDA's unstated or assumed requirements for substantial equivalence to the predicate devices.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "clinical hypoxia studies," but does not provide the number of subjects or data points included in these studies.
- Data Provenance: The studies were "clinical hypoxia studies conducted in an independent research lab." While the country of origin is not specified, clinical hypoxia studies typically involve human subjects whose oxygen levels are carefully controlled. The phrasing "clinical hypoxia studies" implies a prospective study design where data was collected specifically for this purpose.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth was established by laboratory co-oximetry, not by expert consensus.
- Qualifications of Experts: Not applicable.
Adjudication method for the test set:
- Adjudication Method: Not applicable. The ground truth was established by direct comparison to arterial blood samples analyzed on a laboratory co-oximeter, a gold standard measurement, which does not typically involve expert adjudication in the same way imaging or subjective diagnostic tasks might.
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:
- MRMC Study: No. This device is an SpO2 sensor, which provides automated measurements, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.
- Effect Size: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, implicitly. The performance data presented (Accuracy Ams of 3.84%) refers to the device's measurement accuracy compared to a reference standard, without any explicit mention of human interpretation or intervention in the measurement process itself. The SpO2 sensor is an automated measurement device.
The type of ground truth used:
- Ground Truth Type: Arterial blood samples analyzed on a laboratory co-oximeter. This is considered a gold standard for blood oxygen saturation measurement.
The sample size for the training set:
- Sample Size: Not applicable. As an electro-optical sensor, the device's operation is based on established physical principles for light absorption by hemoglobin. It's not a machine learning or AI device that requires a training set in the conventional sense. Its "training" is in its design and calibration, not in learning from a large dataset.
How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable, as no training set was used in the machine learning sense. The device's fundamental operating principles and calibration would be based on well-understood physiological and optical science.

Summary

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OCT 1 7 2001

K012333

Appendix C
Page 1 of 2

510(k) Summary

Submitter Information:

Epic Medical Equipment Services, Inc. 1800 E. 10th Street, Suite 300 Plano, TX 75074

Contact:

Krista Oakes Vice President, Regulatory Affairs and Quality Assurance Telephone: (972) 801-9854 Fax: (972) 801-9859

Date Prepared:

September 12, 2001

Product Name:

Common Name: SpO2 Ear Sensor (accessory to ear oximeter) Trade Name(s): Flexi-Site SpO2 Ear Sensor

Predicate Device:

This product is substantially equivalent to the original Flexi-Site sensor, marketed under K964055, the Flexi-Site ear sensor marketed under K010718, and the Ohmeda 6051-0000-115 sensor marketed under K850494. Accuracy is equivalent to the Nellcor Dura-Y ear sensor, marketed under K944760.

Description:

Intended Use:

The Flexi-Site SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

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Comparison to Predicate Device:

The Flexi-Site SpO2 Sensor uses the same theory and principle of operation as the predicate device. The design is equivalent to the original Flexi-Site, with the addition of a filter and an ear clip accessory to facilitate use on the ear.

Performance Data & Conclusions:

Performance testing was conducted during clinical hypoxia studies conducted in an independent research lab. The Flexi-Site was compared to arterial blood samples analyzed on a laboratory co-oximeter. Accuracy (Ams) for the Flexi-Site was 3.84% across the range of 70%-100% SaO2

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2001

Ms. Krista Oakes Epic Medical Equipment Services 1800 10th Street Suite 300 Plano, TX 75074

Re: K012333

Flexi-Site SpO2 Ear Sensor Regulation Number: 870.2710 Regulation Name: Impedance Plethysmograph Regulatory Class: III (three) Product Code: 73 DPZ Dated: September 13, 2001 Received: September 17, 2001

Dear Mr. Oakes:

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.

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

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Page 2 - Ms. Krista Oakes

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix B Page 1 of 1

Statement of Indications For Use

510(k) # KOIZ333 Device Name: Flexi-Site SpO2 Ear Sensor

Indications for Use:

The Flexi-Site SpO2 Ear Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in patients weighing > 30 kg.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Division of Cardiovascular & Respiratory Devices
510(k) Number R012333

Regulation Number and Section

§ 870.2710 Ear oximeter.

(a)
Identification. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.(b)
Classification. Class II (performance standards).