ODISSEY TISSUE OXIMETER

K141234 · Vioptix, Inc. · MUD · Jul 1, 2014 · Cardiovascular

Device Facts

• Record ID: K141234
• Device Name: ODISSEY TISSUE OXIMETER
• Applicant: Vioptix, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: Jul 1, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended 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. 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 Story

ODISsey Tissue Oximeter is a portable, AC/battery-powered device for non-invasive estimation of tissue oxygen saturation (StO2%). System comprises a console with color LCD, power cord, and fiber optic sensors. Device uses laser light to sample tissue volume underneath the sensor; each channel operates independently. Used in clinical settings (hospitals, physician offices, EMS) by healthcare providers to monitor perfusion in skeletal muscle. Visual and audible alarms alert users to StO2 limits and low battery. Output provides real-time oxygenation data to assist clinicians in assessing circulatory status and identifying compromised circulation, potentially facilitating timely clinical intervention.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance testing, including biocompatibility per ISO 10993, packaging validation, sterilization validation, and aging studies.

Technological Characteristics

Portable console with color LCD; fiber optic sensors; laser light source. Patient contact materials: MD-565 thermoplastic elastomer sheath. Single-use sterile sensors. AC power with lithium-ion battery backup. Software controls laser and data processing. Connectivity: standalone unit with 1-2 sampling channels.

Indications for Use

Indicated for monitoring patients of any age/gender undergoing circulatory or perfusion examinations of skeletal muscle or where compromised circulation is suspected. Used in physician offices, hospitals, ambulatory care, and EMS.

Regulatory Classification

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.

Predicate Devices

• ViOptix ODISsey Tissue Oximeter (K042657)

Submission Summary (Full Text)

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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: [phone] FAX: [phone]

Contact person

Greg Holland Requlatory Consultant to ViOptix Inc. Requlatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 TEL: [phone] FAX: [phone] EMAIL: [e-mail]

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.

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.

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 is<br>sterilized |
| Packaging | Non Sterile package | Entire Sensor is in<br>sterile package |
| Cable Cover | PVC for sheath | MD-565 a<br>Thermoplastic<br>Elastomer for sheath |
| Sensor Design | Can be laid flat and<br>optionally taped in<br>place | No Change |
| Sensor Material | Metal/Epoxy | No Change |
| Console | Electrical and Laser<br>control system | No Change |
| Software | Control of ViOptix<br>ODISsey 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,

1

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 [phone] or [phone] 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 [phone] or [phone] 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

4. Indications for Use Statement

Indications for Use

510(k) Number (if known):

Device Name: ODISsey Tissue Oximeter

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.

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'

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