The ViOptix Intra.Ox™ Handheld Tissue Oximeter is a sterile, cordless, batterypowered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device uses spatially-resolved optical measurements at four wavelengths. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the built-in screen. The ViOptix Intra.Ox™ Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that can tolerate bodily fluids and other liquids such as disinfectants and marking materials.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Intra.Ox™ Handheld Tissue Oximeter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Device: Intra.Ox™ Handheld Tissue Oximeter (Subject Device)
Predicate Device: T.Ox (formerly ODISsey) Tissue Oximeter

Acceptance Criterion (Bench Test)	Reported Device Performance (Bench Test)
Correlation coefficient > 0.9 for absorption coefficients measured in liquid phantoms for each of the four wavelengths.	The Intra.Ox™ devices were found to measure absorption coefficients with a high degree of correlation to actual absorption coefficients in liquid phantoms prepared with Intralipid and swine whole blood. The correlation coefficient was greater than 0.9 for each of the four wavelengths used in the devices.
Limits of agreement between Intra.Ox™ and predicate device (T.Ox) StO2% measurements to be less than ±10 percentage points over three full-scale blood desaturations.	Over three full-scale (complete oxygenation to complete deoxygenation) blood desaturations, three different Intra.Ox™ devices as compared to two T.Ox devices showed combined limits of agreement of +8.49 and -7.50 percentage points. (This meets the criterion as both are within ±10 percentage points).
Acceptance Criterion (Clinical Study)	Reported Device Performance (Clinical Study)
Not explicitly stated as a numeric criterion in the document. The aim was to demonstrate "excellent agreement in shape of the ischemic events" and "good agreement considering the physiological variances inherent between measurement sites," and that "Intra.Ox™ and T.Ox measure similar ranges of StO2 values for both healthy and compromised tissue."	There was excellent agreement in shape of the ischemic events between the Intra.Ox™ and T.Ox devices. A direct comparison with paired data showed good agreement considering the physiological variances inherent between measurement sites. The mean baseline value of 68% and mean desaturation dynamic range of 30 percentage points agrees well with literature-reported values of skin and muscle transient ischemia. Importantly, the Intra.Ox™ and T.Ox measure similar ranges of StO2 values for both healthy and compromised tissue, thus validating substantial equivalence.

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

Bench Tests: The sample size for the test set is not explicitly stated in terms of number of data points or phantom measurements. However, it mentions "three different Intra.Ox™ devices as compared to two T.Ox devices" for the agreement test, and "liquid phantoms prepared with Intralipid and swine whole blood" for the correlation test.
Clinical Study: Data from 11 subjects were analyzed.
Data Provenance (Clinical Study): The data was collected from healthy human volunteers. The country of origin is not explicitly stated, but the submission is to the US FDA, implying data collected under US regulatory standards or from a region that complies with such standards for submission. The study appears to be prospective as it involved measuring patients during "transient ischemic events."

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

The document does not mention the use of experts to establish ground truth for the test set in either the bench or clinical studies. The ground truth for the bench tests was derived from known absorption coefficients in liquid phantoms and the performance of the predicate device. For the clinical study, the ground truth was the physiological changes observed in human volunteers and the measurements from the predicate device.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

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

No, an MRMC comparative effectiveness study was not done. This device is a direct measurement device (tissue oximeter), not an AI-powered diagnostic tool requiring human interpretation. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

Yes, a standalone performance assessment was done. The entire performance testing described (both bench and clinical) evaluates the device's ability to measure StO2 independently. The clinical study compares the subject device's readings with those of the predicate device, but it doesn't involve human-in-the-loop interpretation of the device's output. The device itself provides the StO2 estimate.

7. The Type of Ground Truth Used

Bench Tests: The ground truth for absorption coefficients was established using known values from prepared liquid phantoms. For the comparative performance with the predicate, the predicate device (T.Ox) served as a reference point for "truth" in its StO2 measurements.
Clinical Study: The ground truth was essentially the physiological states of the human volunteers during induced transient ischemia, as measured by both the subject and predicate devices, and compared against "literature-reported values of skin and muscle transient ischemia." The predicate device (T.Ox) also served as a comparative ground truth.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its sample size. This type of device (a biophysical measurement instrument) typically relies on validated physical principles and calibration, rather than machine learning models that require distinct training and test sets in the same way an AI diagnostic algorithm would. The development and internal calibration would implicitly use various data, but it's not defined as a "training set" in the context of this submission.

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

As a dedicated "training set" is not explicitly defined, the method for establishing its ground truth is also not specified. The underlying principles and calibration would be based on established physics and chemistry (e.g., spectroscopy of light absorption by oxygenated and deoxygenated hemoglobin), likely validated through laboratory experiments with known concentrations and conditions.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central graphic. The graphic depicts a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

September 12, 2014

Vioptix Inc. c/o Mr. Greg Holland Regulatory Specialist 3722 Ave. Sausalito Irvine, CA 92606 US

Re: K133983

Trade/Device Name: Intra. Ox Handheld Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter, Tissue Saturation Regulatory Class: Class II Product Code: MUD Dated: August 5, 2014 Received: August 7, 2014

Dear Mr. Greg Holland:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part

803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htmfor the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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K133983 Page 1 of 1

Indications for Use Statement

Indications for Use

510(k) Number (if known): ______________________

Device Name: Intra.Ox™ Handheld Tissue Oximeter

Indications for Use:

The Intra.Ox™ Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue.

The Intra.Ox™ Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.

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

Page 1 of 1

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510(k) Summary

Image /page/3/Picture/2 description: The image shows the logo for ViOptix. The logo consists of the word "ViOptix" in blue font, with the "V" and "i" in a larger, bolder font than the rest of the word. To the right of the word is a green checkmark symbol, with a green circle inside the top part of the checkmark.

47224 Mission Falls Court · Fremont, CA 94539 Office: (510)226-5860 · Fax: (510)226-5864

Submitter's Name	ViOptix, Inc.
Address	47224 Mission Falls Ct., Fremont, CA 94539
Contact at ViOptix	Mark Lonsinger
Telephone	510-360-7506
Fax	510-226-5864
Email	info@vioptix.com
Date the Summary was prepared: December 20, 2013

Information regarding Application Correspondent:

Official Correspondent	Greg Holland
Address	3722 Ave. SausalitoIrvine, CA 92606
Telephone	949-262-0411
Email	greg@regulatoryspecialists.com

Information regarding the device classification:

Trade Name:	Intra.Ox™ Handheld Tissue Oximeter
Common Name:	Tissue Oximeter
Classification regulation:	21 CFR 870.2700
Classification regulation name:	Oximeter
Product code:	MUD
Device Class:	II

Information regarding the legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

510(k) Reference # Device Name 510(k) Holder

K042657 ODISsey Tissue Oximeter ViOptix

Description of the Device:

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measurements at four wavelengths. The device performs measurements on the م patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the built-in screen. The ViOptix Intra.Ox™ Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that can tolerate bodily fluids and other liquids such as disinfectants and marking materials.

Indications for Use:

The Intra.Ox™ Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue.

The Intra.Ox™ Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.

Intended Use:

The Intra.Ox™ Handheld Tissue Oximeter has the same intended use as the predicate, the T.Ox.

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Technological Characteristics:

Parameter	Subject Device:Intra.OxTM	Predicate Device:T.Ox (formerly known asODISsey)
510K number	This submission	K042657
Manufacturer	ViOptix, Inc.	ViOptix, Inc.
Intended Use
Indications for Use	The Intra.OxTM HandheldTissue Oximeter isintended to non-invasivelyestimate the percentoxygen saturation (StO2)in a volume of tissue.The Intra.OxTM HandheldTissue Oximeter isindicated for use inmonitoring patients duringcirculatory or perfusionexaminations.	The ViOptix ODISseyTissue Oximeter isintended to non-invasivelyestimate the percentoxygen saturation (StO2) ina volume of tissue. This isperformed in medicalenvironments includingphysician offices, hospitals,ambulatory care andEmergency MedicalServices.The ODISsey TissueOximeter is indicated foruse in monitoring patientsduring circulatory orperfusion examinations ofskeletal muscle or whenthere is a suspicion ofcompromised circulation.
MeasuredParameters	Tissue oxygen saturation(% StO2)	Tissue oxygen saturation(% StO2) and trend graph
Operating Principle	Spectrophotometricoximetry	Spectrophotometricoximetry
Energy Delivered	Near-infrared lightSource: LED chipsWavelengths: 760, 810,850, 900 nm	Near-infrared lightSource: laser diodesWavelengths: 690, 830 nm
Single Patient Use?	Yes, integrated sensorand control unit is singlepatient use disposable.	Sensor is single patientuse disposable. Controlunit is reusable.
Power Source	Battery poweredBattery type: 4 Lithium AABattery voltage: 6 V total	Mains powered withbattery backupBattery type: 3-cell Lithiumion
Parameter	Subject Device:Intra.Ox™	Predicate Device:T.Ox (formerly known asODISsey)
Measurement Range	1-99% StO₂	1-99% StO₂

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Performance Testing

Bench Tests

The Intra.Ox™ devices were found to measure absorption coefficients with a high degree of correlation to actual absorption coefficients in liquid phantoms prepared with Intralipid and swine whole blood. The correlation coefficient was greater than 0.9 for each of the four wavelengths used in the devices.

The Intra.Ox™ devices were shown to agree well with the predicate device in StO2% measurements. Over three full-scale (complete oxygenation to complete deoxygenation) blood desaturations, three different Intra.Ox™ devices as compared to two T.Ox devices showed combined limits of agreement of +8.49 and -7.50 percentage points. The acceptance criterion required the limits of agreement to be less than ±10 percentage points. Therefore, the Intra.Ox™ is demonstrated to be substantially equivalent to the T.Ox in estimating StO2%.

Clinical Study

Performance was determined by measuring tissue oxygen saturation (StO2) with both devices during transient ischemic events on healthy human volunteers that temporarily mimics compromised tissue. Data from 11 subjects, who were nearevenly distributed over age, gender, and skin color as determined by the Fitzpatrick skin type, were analyzed.

There was excellent agreement in shape of the ischemic events between the Intra. Ox™ and T.Ox devices. A direct comparison with paired data showed good agreement considering the physiological variances inherent between measurement sites.

The mean baseline value of 68% and mean desaturation dynamic range of 30 percentage points agrees well with literature-reported values of skin and muscle transient ischemia.

Importantly, the Intra.Ox™ and T.Ox measure similar ranges of StO2 values for both healthy and compromised tissue, thus validating substantial equivalence.

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K133983 Page 5 of 5

Image /page/7/Figure/1 description: The image is a boxplot comparing Intra.Ox and T.Ox in healthy and compromised conditions. The y-axis represents StO2% ranging from 0 to 100. The boxplot shows the median, 25%-75% range, and 9%-91% range for each condition. The plot indicates that both Intra.Ox and T.Ox have higher StO2% values in healthy conditions compared to compromised conditions.

Conclusion

The Intra.Ox™ Handheld Tissue Oximeter has the predicate device identified above, has the same intended use as the predicate, has similar technology that does not raise new types of questions of safety or effectiveness, and performance data shows that this device provides reasonable assurance of safety and effectiveness to demonstrate substantial equivalence.

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).