Intra.Ox Handheld Tissue Oximeter

K163472 · Vioptix, Inc. · MUD · Nov 16, 2017 · Cardiovascular

Device Facts

• Record ID: K163472
• Device Name: Intra.Ox Handheld Tissue Oximeter
• Applicant: Vioptix, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: Nov 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended 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 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.

Device Story

Handheld, battery-powered, sterile, single-use tissue oximeter; estimates percent oxygen saturation (StO2) in tissue volume. Operates via spectrophotometric oximetry using five near-infrared LED wavelengths (730, 760, 810, 845, 895 nm). Device makes direct physical contact with patient tissue; displays StO2 estimate on built-in screen. Used by physicians, surgeons, or nurses in medical environments. Provides real-time StO2 data to assist clinicians in assessing tissue perfusion and circulatory status; aids in monitoring compromised tissue. Ergonomic design includes thumb rest for ambidextrous use.

Clinical Evidence

Clinical study conducted on 19 healthy human volunteers. Subjects underwent transient ischemic events to mimic compromised tissue. Compared modified Intra.Ox to predicate device. Results showed excellent agreement in deoxygenation curve shapes and similar StO2 ranges for healthy and compromised tissue. Mean desaturation dynamic range was 27 percentage points for both devices. Bench testing included heterogeneous blood phantom study, confirming limits of agreement and 95% confidence intervals comparable to gold standard co-oximeter.

Technological Characteristics

Sterile, single-use, battery-powered (4 Lithium AA, 6V). Housing: Polycarbonate; Aperture plate: Delrin/Polish. Sensing: Spectrophotometric oximetry using 5 NIR LEDs (730, 760, 810, 845, 895 nm). Dimensions: 3 in. x 7 in.; Weight: <1 lb. Biocompatibility per ISO 10993-1. Quality management per ISO 13485:2003. Risk management per ISO 14971:2012.

Indications for Use

Indicated for adult patients undergoing circulatory or perfusion examinations to monitor tissue oxygen saturation (StO2).

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

• Intra.Ox™ Handheld Tissue Oximeter (K133983)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:14px;"> <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size:14px;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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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: [phone] Fax: [phone]

### Contact Person:

Valerie Defiesta-Ng Senior Director, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: [phone] Fax: [phone] Email: [e-mail]

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)]

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.

### 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.<br><br>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.<br><br>The Intra.Ox™ Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.<br><br>The Intra.Ox™ Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.<br><br>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 light<br>Source: LED chips<br>Wavelengths: 760 mm, 810 mm, 850 mm, and 900 mm | Near-infrared light<br>Source: LED chips<br>Wavelengths: 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 powered<br>Battery type: 4 Lithium AA<br>Battery voltage 6 V total | Battery powered<br>Battery type: 4 Lithium AA<br>Battery 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.<br>Less than 1 lb. | 3 in. x 7 in.<br>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.