The ViOptix ODISsey Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services.

The ODISsey Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

Device Description

The ODISsey Tissue Oximeter is an optically based device that noninvasively estimates the percent oxygen saturation (StO2) in a volume of tissue underneath the sensor.

The T.Ox™ Tissue Oximeter is a lightweight and portable, AC poweroperated, unit with a lithium-ion battery backup that non-invasively estimates the percent oxygen saturation (StO2%) in a volume of tissue underneath the sensor. The console has a color LCD display monitor, a standard one sampling channel (with a two-channel option), and up to two fiber optic sensors. It has adjustable audible and visual alarms for:

· StO2 low and high alarm limits

· Low battery

The T.Ox™ Tissue Oximeter has visual alarms.

The T.Ox™ Tissue Oximeter consists of three parts:

· Small computer console display module

· AC power cord

· Fiber optic sensor(s)

If the console is using two channels, both channels can be used at the same time. Each channel samples and displays data independently of the other channel. Each channel can accommodate one sensor.

AI/ML Overview

The provided text is a 510(k) summary for the ViOptix ODISsey Tissue Oximeter, specifically a special 510(k) submission for changes in patient contact materials and design. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance in estimating oxygen saturation (StO2).

The document states:
"After performing non-clinical performance studies, Biocompatibility to ISO 10993, Packaging Validation, Sterilization Validations and Aging Studies, the data shows that the ODISsey Tissue Oximeter is substantially equivalent to the predicate as an estimate the percent oxygen saturation (StO2) in a volume of tissue."

This indicates that the focus of this specific 510(k) was on demonstrating substantial equivalence for the changes made (sensor use, sterility, packaging, cable cover materials), rather than re-proving the core performance of oxygen saturation estimation. The original predicate device (K042657) would have had performance data for its StO2 estimation, but that information is not present in this document.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study demonstrating performance in estimating StO2 from the provided text.

Based on the provided document, the following information can be extracted, but it primarily relates to non-clinical performance studies for material and design changes, not clinical performance for StO2 estimation:

Acceptance Criteria and Device Performance Study (as described for the changes in this Special 510(k))

Since this is a Special 510(k) for changes in materials and design, the "acceptance criteria" and "device performance" discussed are related to the safety and functionality of these changes to maintain substantial equivalence, rather than a clinical performance study measuring StO2 accuracy.

The document states that "non-clinical performance studies" were conducted. The "reported device performance" in this context is the conclusion drawn from these studies: that the device remains substantially equivalent to its predicate for estimating StO2 despite the changes.

Acceptance Criteria Category (for changes)	Reported Device Performance (Conclusion)
Biocompatibility (to ISO 10993)	Data shows substantial equivalence. (Implies new materials meet biocompatibility standards)
Packaging Validation	Data shows substantial equivalence. (Implies new sterile packaging maintains sterility and integrity)
Sterilization Validations	Data shows substantial equivalence. (Implies new sterilization process for the entire sensor is effective)
Aging Studies	Data shows substantial equivalence. (Implies the device, with new materials/design, maintains performance over time as expected)
Overall Substantial Equivalence	The data shows that the ODISsey Tissue Oximeter is substantially equivalent to the predicate as an estimate of the percent oxygen saturation (StO2) in a volume of tissue.

Details of the Study (related to the changes in this Special 510(k))

Due to the nature of this submission being a Special 510(k) for material and design changes, the document does not contain most of the requested information pertaining to a clinical performance study for StO2 estimation. The information below reflects what can be inferred or directly stated about the studies conducted for the changes rather than a full clinical performance study for StO2 accuracy.

Sample size used for the test set and the data provenance: Not specified for the non-clinical studies mentioned. These are likely bench tests and material analyses. The origin (e.g., country of origin) is not mentioned. These studies would be retrospective in the sense that they are conducted on the new design before market release.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for the non-clinical biocompatibility, packaging, sterilization, and aging studies. These studies rely on standard protocols and laboratory analysis, not expert consensus on ground truth in a clinical sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the non-clinical studies mentioned.
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: Not applicable. This device is an oximeter, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "performance" being discussed for this 510(k) is related to material safety and manufacturing processes, not the standalone accuracy of the StO2 algorithm itself, which was established by the predicate device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical studies, "ground truth" would be established by validated test methods (e.g., chemical analysis for biocompatibility, sterility indicator results for sterilization validation, physical integrity tests for packaging). This is not expert consensus, pathology, or outcomes data in a clinical sense.
The sample size for the training set: Not applicable. This document does not describe the development or training of an algorithm for StO2 estimation. It concerns physical device changes.
How the ground truth for the training set was established: Not applicable.

Summary of why most fields are "Not Applicable" for this document:

This document is a Special 510(k) for demonstrating substantial equivalence after material and design changes to an already cleared device. It primarily focuses on non-clinical performance, such as biocompatibility, sterilization, and packaging validation. It does not present a clinical performance study or data related to the accuracy of the device's core function (StO2 estimation), as that performance was established for the predicate device (K042657). Therefore, questions related to clinical study design, expert ground truth, reader studies, and algorithm training/ground truth are not addressed in this specific submission.

Summary

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Attachment B

JUL 0 1 2014

5. 510(k) Summary or 510(k) Statement

510(k) SUMMARY

510(k) Owner

ViOptix Inc. 47224 Mission Falls Ct. Fremont, CA 94539 TEL: 510.226.5860 FAX: 510.226.5864

Contact person

Greg Holland Requlatory Consultant to ViOptix Inc. Requlatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 TEL: 949.262-0411 FAX: 949.552.2821 EMAIL: greg@regulatoryspecialists.com

Date summary was prepared

June 4, 2014

Common Name Trade Name Classification Name Regulation Class Panel Product Code Predicate

Oximeter ODISsey Tissue Oximeter Oximeter, Tissue Saturation 870.2700 11 Cardiovascular MUD K042657, ViOptix ODISsey Tissue Oximeter

Description

The ODISsey Tissue Oximeter is an optically based device that noninvasively estimates the percent oxygen saturation (StO2) in a volume of tissue underneath the sensor.

Intended Use

The ODISsey Tissue Oximeter is intended for use as an estimate of the percent oxygen saturation (StO2).

Indications for Use

The ViOptix ODISsey Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices. hospitals, ambulatory care and Emergency Medical Services.

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The ODISsey Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

Technological Characteristics

The technological characteristic of the ODISsey Tissue Oximeter remain unchanged from the predicate K042657. This Special 510(k) is being submitted for a change in patient contact materials and design.

· StO2 low and high alarm limits

· Low battery

The T.Ox™ Tissue Oximeter has visual alarms.

The T.Ox™ Tissue Oximeter consists of three parts:

· Small computer console display module

· AC power cord

· Fiber optic sensor(s)

If the console is using two channels, both channels can be used at the same time. Each channel samples and displays data independently of the other channel. Each channel can accommodate one sensor.

Changes in the ViOptix ODISsey Tissue Oximeter from K042657.

	Original K042657	New Design
Sensor Use	Reusable	Single Use Only
Sterility	Sensor non sterile	Entire Sensor issterilized
Packaging	Non Sterile package	Entire Sensor is insterile package
Cable Cover	PVC for sheath	MD-565 aThermoplasticElastomer for sheath
Sensor Design	Can be laid flat andoptionally taped inplace	No Change
Sensor Material	Metal/Epoxy	No Change
Console	Electrical and Lasercontrol system	No Change
Software	Control of ViOptixODISsey Tissue	No Change

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	Oximeter
Wavelengths	Laser Light	No Change
Laser Power	Amount of Laser power	No Change

Conclusions from non-clinical performance data

ﺍﻟﺮ

After performing non-clinical performance studies, Biocompatibility to ISO 10993, Packaging Validation, Sterilization Validations and Aging Sudies, the data shows that the ODISsey Tissue Oximeter is substantially equivalent to the predicate as an estimate the percent oxygen saturation (StO2) in a volume of tissue.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

July 1, 2014

Vioptix, Inc. Mark Lonsinger Greg Holland, Regulatory Specialists Inc. 3722 Ave. Sausalito Irvine, California 92606

K141234 Re:

Trade/Device Name: Odissey Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter, Tissue Saturation Regulatory Class: Class II Product Code: MUD Dated: May 23, 2014 Received: May 27, 2014

Dear 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 comply

)

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Page 2 - Greg Holland

with all the Act's requirements, including, but not limited to: registration and listing (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. 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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/8 description: The image is a black and white drawing with many lines. The lines are arranged in a way that creates a complex and abstract pattern. The drawing appears to be a close-up of a detailed design, possibly an architectural rendering or an artistic sketch. The overall impression is one of intricacy and complexity.

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

Enclosure

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K141234 p.1 of 1

Indications for Use Statement

Indications for Use

510(k) Number (if known):

Device Name: ODISsey Tissue Oximeter

Indications for Use:

The ODISsev Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

× Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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)

Date:
01.4.07.01
11.11.32 -04'00'

Page 1 of 1

13 of 42 | Regulatory Specialists, Inc.

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).