The ViOptix Intra.Ox" Handheld Tissue Oximeter is a sterile, cordless, battery-powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device uses spatially resolved optical measurements at five 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 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.

ViOptix has made modifications to the cleared Intra.Ox Handheld Tissue Oximeter (K133983) to optimize the design and improve manufacturability. The modified device shares the same indication for use and the same technological characteristics as the cleared device, including principle of operation, StO2 measured parameters, accuracy and range, energy delivered and power source.

AI/ML Overview

The provided text does not contain detailed information on acceptance criteria or a study designed to explicitly prove the device meets those criteria in a quantitative sense with specific performance metrics against a predefined acceptance threshold.

Instead, the document is a 510(k) summary for a modified medical device (Intra.Ox™ Handheld Tissue Oximeter) seeking to demonstrate substantial equivalence to a predicate device (the original Intra.Ox™ Handheld Tissue Oximeter, K133983).

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will extract what is available and indicate where information is missing.

Here's a summary based on the provided text, focusing on the available information regarding the device's performance and the supporting studies for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria with specific thresholds (e.g., "accuracy > X% with a Y% confidence interval") and then report the device's performance against these thresholds. Instead, the performance claims are made in the context of demonstrating substantial equivalence to a predicate device.

The closest to "performance" stated is for Tissue Oxygen Saturation (StO2) Measurement Range:

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Modified Intra.Ox)
Measurement Range: 1-99% StO2	Measurement Range: 1-99% StO2
Agreement with gold standard (Co-oximeter) for StO2	"Substantially equivalent to the predicate device in limits of agreement to the gold standard as well as 95% confidence intervals in slope and intercept."
Comparable dynamic range for StO2 between healthy and compromised tissue for the predicate device	"Similar ranges of StO2 values for both healthy and compromised tissue", "comparable dynamic range values"
Excellent agreement in shape of deoxygenation curve with predicate device during ischemic events	"Excellent agreement in shape of the deoxygenation curve observed during ischemic events between the Intra.Ox and predicate device for each analyzed subject."
Good agreement with physiological variances between measurement sites with predicate device	"Good agreement considering the physiological variances inherent between measurement sites."
Healthy tissue StO2 values comparable to literature	Healthy tissue: 65% (modified Intra.Ox)
Mean desaturation dynamic range comparable to literature	Mean desaturation dynamic range: 27 percentage points (both devices)

2. Sample size used for the test set and the data provenance

Heterogeneous Blood Phantom Study: The sample size is not explicitly stated, nor is the data provenance beyond "heterogeneous phantom prepared with swine whole blood."
Clinical Study:
- Sample Size: 19 data sets from 19 subjects.
- Data Provenance: Healthy human volunteers. The country of origin is not specified but it is likely prospective, as it describes a specific study.

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.

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

This information is not provided in the document.

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. The device is a tissue oximeter, not an AI-assisted diagnostic tool that human readers would interact with. The clinical study compares the modified device's performance to the predicate device's performance, and both are standalone measurement devices.

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

Yes, standalone performance data was collected in both the Heterogeneous Blood Phantom Study and the Clinical Study, as the device provides direct measurements. The purpose was to compare the modified device's standalone performance to the predicate device's standalone performance.

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

Heterogeneous Blood Phantom Study: A "gold standard" blood co-oximeter was used as the ground truth reference.
Clinical Study: The "ground truth" for the clinical study was the physiological state induced (transient ischemic events temporarily mimicking compromised tissue) and implied "true" StO2 values based on this physiological state and comparison to the predicate device and literature. There is no mention of an independent, higher-level ground truth such as pathology or expert consensus on the physiological state itself, beyond the direct measurement of StO2.

8. The sample size for the training set

This information is not applicable/not provided. The Intra.Ox™ Handheld Tissue Oximeter is a spectrophotometric device, not an AI/machine learning model that typically requires a distinct "training set" in the same way. Its internal algorithms are based on physics and calibration, not statistical learning from a large dataset.

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

This information is not applicable/not provided for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 16, 2017

ViOptix, Inc. % Valerie Defiesta-Ng Senior Director, Regulatory Affairs Experien Group, LLC 224 Airport Parkway Suite 250 San Jose, California 95110

Re: K163472

Trade/Device Name: Intra.Ox Handheld Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: September 20, 2017 Received: September 21, 2017

Dear Valerie Defiesta-Ng:

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. Iisting 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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.htm for 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 Industry and Consumer Education (DICE) 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,

M.A. Willemen

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

Enclosure

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Indications for Use

510(k) Number (if known) K163472

Device Name Intra.Ox™ Handheld Tissue Oximeter

Indications for Use (Describe)

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.

The Intra. Ox™ Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.

The Intra.Ox™ Handheld Tissue Oximeter should only be used on adult patients.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Notification K163472

GENERAL INFORMATION [807.92(A)(1)]

Applicant:

ViOptix, Inc. 39655 Eureka Drive Newark, CA 94560-4806 USA Phone: 510-226-5860 Fax: 510-226-5864

Contact Person:

Valerie Defiesta-Ng Senior Director, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: 408-400-0856 Fax: 408-400-0865 Email: valerie@experiengroup.com

Date Prepared: November 13, 2017

DEVICE INFORMATION [807.92(A)(2)]

Classification: 21 CFR§870.2700

Product Code: MUD

Trade Name: Intra.Ox™ Handheld Tissue Oximeter

Generic/Common Name: Oximeter, Tissue Saturation

PREDICATE DEVICE(S) [807.92(A)(3)] Intra.Ox™ Handheld Tissue Oximeter (K133983)

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DEVICE DESCRIPTION [807.92(A)(4)]

INDICATIONS FOR USE [807.92(A)(5)]

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.

The Intra.Ox" Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.

The Intra.Ox™ Handheld Tissue Oximeter should only be used on adult patients.

TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the modified Intra.Ox Handheld Tissue Oximeter are substantially equivalent to the predicate device, Intra.Ox Handheld Tissue Oximeter (K133983). Table 1 lists the technological characteristics of the modified and predicate devices and provides rationale to support a determination of substantial equivalence. Any differences between the devices do not raise any different issues of safety or efficacy.

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Feature	Predicate Intra.Ox Handheld Tissue Oximeter	Modified Intra.Ox Handheld Tissue Oximeter	Substantial Equivalence Rationale
510(k) Number	K133983	TBD	--
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.	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.The Intra.Ox™ Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.The Intra.Ox™ Handheld Tissue Oximeter should only be used on adult patients.	The Intended Use of the Device is identical to the predicate. The addition of user information and patient population provides clarity to the use of the device.
Measured Parameters	Tissue oxygen saturation (% StO2)	Tissue oxygen saturation (% StO2)	N/A (same)
Operating Principle	Spectrophotometric oximetry	Spectrophotometric oximetry	N/A (same)
Energy Delivered	Near-infrared lightSource: LED chipsWavelengths: 760 mm, 810 mm, 850 mm, and 900 mm	Near-infrared lightSource: LED chipsWavelengths: 730 nm, 760 mm, 810 mm, 845 mm, and 895 mm	The difference in wavelengths of the modified device does not raise any different issues of safety or efficacy.
Single Patient Use	Yes	Yes	N/A (same)
Power Source	Battery poweredBattery type: 4 Lithium AABattery voltage 6 V total	Battery poweredBattery type: 4 Lithium AABattery voltage 6 V total	N/A (same)
Measurement Range	1-99% StO2	1-99% StO2	N/A (same)
Physical Design	Ergonomic hand-held design for range of hand sizes, ambidextrous use	Ergonomic hand-held design for range of hand sizes, includes thumb rest, ambidextrous use	The difference in physical design does not raise any different issues of safety or efficacy.
Dimensions and Weight	3 in. x 7 in.Less than 1 lb.	3 in. x 7 in.Less than 1 lb.	N/A (same)
Housing Materials	Polycarbonate	Polycarbonate	N/A (same)
Aperture Plate Material	Delrin	Delrin/Polish	Both devices are biocompatible per ISO 10993-1

Table 1. Summary of Technological Characteristics

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SUBSTANTIAL EQUIVALENCE

The Intra.Ox Handheld Tissue Oximeter is substantially equivalent to the predicate device with regard to intended use, indications for use, principle of operation and fundamental scientific technology. Any differences in the technological characteristics between the devices do not raise any different issues of safety or efficacy. Thus, the modified Intra.Ox Handheld Tissue Oximeter is substantially equivalent to the predicate device.

PERFORMANCE DATA [807.92(B)]

All necessary performance testing was conducted on the modified Intra.Ox Handheld Tissue Oximeter to support a determination of substantial equivalence to the predicate device. The tests performed include:

· Biocompatibility
- o Cytotoxicity MEM Elution
- Guinea Pig Maximization Sensitization O
- o Intracutaneous Reactivity Irritation
Transportation Testing ●
Software Verification and Validation
Heterogeneous Blood Phantom Study (Summary or results provided) ●
Non-significant Risk Clinical Study (Summary of results provided)

The collective performance testing demonstrates that the Intra.Ox™ Handheld Tissue Oximeter does not raise any new question of safety or effectiveness when compared to the predicate device. The results of performance testing demonstrate that the Intra. Ox™ Handheld Tissue Oximeter performs as intended.

Heterogeneous Phantom Study - Non-clinical

In this study, measurements were made using the modified Intra. Ox Handheld Tissue Oximeter in a heterogeneous phantom prepared with swine whole blood using an Intralipid solution to mimic tissue scattering and compared to a "gold standard" blood co-oximeter. The results show that the modified Intra. Ox Handheld Tissue Oximeter is substantially equivalent to the predicate device in limits of agreement to the gold standard as well as 95% confidence intervals in slope and intercept. These data support the conclusion that the modified Intra.Ox device provides as good or better agreement to the gold standard over the clinically relevant range than the predicate Intra.Ox Handheld Tissue Oximeter.

Clinical Study

Performance was determined by measuring tissue oxygen saturation (StO2) with the modified Intra.Ox Handheld Tissue Oximeter and the predicate Intra.Ox Handheld Tissue Oximeter during transient ischemic events on healthy human volunteers that temporarily mimics compromised tissue. A total of 19 data sets from 19 subjects, who were near-evenly distributed over age, gender, and skin color as determined by the Fitzpatrick skin type, were analyzed.

There was excellent agreement in shape of the deoxygenation curve observed during ischemic events between the Intra.Ox and predicate device for each analyzed subject. A direct comparison

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with paired data showed good agreement considering the physiological variances inherent between measurement sites.

Reference Figure 1. The similarities in values for healthy tissue (65% [modified Intra.Ox] and 61% [predicate Intra.Ox]) and mean desaturation dynamic range of 27 percentage points (both devices) agrees well with literature-reported values of skin and muscle transient ischemia.

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

Image /page/7/Figure/5 description: The image is a boxplot comparing Intra.Ox and Predicate under healthy and compromised conditions. The y-axis represents StO2 percentage, ranging from 0 to 100. The plot shows the median, 25%-75% range, and 9%-91% range for each condition. The data suggests differences in StO2 levels between healthy and compromised states for both Intra.Ox and Predicate.

Figure 1. Boxplot demonstrating comparable dynamic range values for modified Intra.Ox and predicate devices between healthy and compromised tissues.

Performance Standards

Compliance to the following performance standards were followed to conduct the performance tests as listed above.

ASTM F2096:2011, Standard Test Method for Detecting Gross Leaks in Packaging by ● Internal Pressurization (Bubble Test)
ISO 10993-1:2009, Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process
ISO 10993-2:2006, Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro ● cytotoxicity
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-12:2012, Biological evaluation of medical devices Part 12: Sample ● preparation and reference materials
ISO 13485:2003, Medical devices Quality management systems Requirements for ● regulatory purposes

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. BSI BS EN ISO 14971:2012, Medical devices - Application of risk management to medical devices
ISTA 2A:2011, Partial Simulation Performance Tests ●

SUMMARY

The modified Intra.OxTM Handheld Tissue Oximeter and the predicate Intra.OxTM Handheld Tissue Oximeter have the same intended use and has similar technology that does not raise new types of questions of safety or effectiveness. The performance data show that the modified Intra. Ox 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).