(28 days)
Not Found
No
The summary describes a device that uses optical measurements and processing electronics to estimate tissue oxygen saturation. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The comparison to a predicate device with similar technological characteristics further suggests the absence of AI/ML.
No
Explanation: The device is an oximeter, which is used for non-invasively estimating oxygen saturation. This is a diagnostic function to monitor a patient's condition, not to treat or cure a disease or condition.
Yes
The device "non-invasively estimate[s] the percent oxygen saturation (StO2) in a volume of tissue" and is "indicated for use in monitoring patients during circulatory or perfusion examinations." This clearly points to its use in assessing a patient's medical condition.
No
The device description explicitly states it is a "sterile, cordless, battery-powered device" with physical components like a "Main Unit" (containing light sources, detectors, and processing electronics), a "Sheath," and a "Battery Pack." It also mentions direct physical contact with the patient's tissue. This clearly indicates a hardware component is integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Intra. Ox™ 2.0 Handheld Tissue Oximeter is described as a device that "non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue." It performs measurements by "direct physical contact to the patient's tissue."
- Lack of Sample Analysis: The device does not analyze a sample taken from the body. It directly measures a physiological parameter within the body's tissue.
Therefore, because it performs a non-invasive measurement directly on the patient's tissue rather than analyzing a sample taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue.
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.
The Intra. Ox™ 2.0 Handheld Tissue Oximeter should only be used on adult patients.
Product codes
MUD
Device Description
The ViOptix Intra.Ox 2.0 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 includes three components and an accessory:
- Main Unit: a re-usable module consists of light sources, detectors, and processing ● electronics to convert measurements of reflected light into an estimate of StO>:
- Sheath: a single-use, sterile Sheath placed around the Main Unit during device use . (provide in the Disposable Kit); and
- Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the . Main Unit to provide power.
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 2.0 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients.
Intended User / Care Setting
physicians, surgeons, nurses, or other skilled users in a medical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing:
- Mechanical Testing
- Sterility Testing
- Latch Testing
- Shelf-Life and Transport Testing
- Software Verification and Validation
- Heterogeneous Blood Phantom Study
Non-clinical Testing Summary: In a heterogenous phantom study, measurements were made using the Intra.Ox 2.0 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 cooximeter. The results show that the Intra.Ox 2.0 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 Intra.Ox 2.0 Handheld Tissue Oximeter provides as good or better agreement to the gold standard over the clinically relevant range than the predicate Intra.Ox Handheld Tissue Oximeter.
Clinical Testing Summary: Clinical testing was not required to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 3, 2022
ViOptix, Inc. % Valerie Defiesta-Ng Vice president, Reuglatory Affairs Veranex, Inc. (formerly Experien Group, LLC) 224 Airport Parkway, Suite 250 San Jose, California 95110
Re: K221010
Trade/Device Name: Intra.Ox 2.0 Handheld Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: April 4, 2022 Received: April 5, 2022
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya, D.Eng. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221010
Device Name Intra.Ox™ 2.0 Handheld Tissue Oximeter
Indications for Use (Describe)
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue.
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.
The Intra. Ox™ 2.0 Handheld Tissue Oximeter should only be used on adult patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Notification K221010
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 Vice President, Regulatory Affairs, Veranex, Inc. 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: 408-400-0856 Fax: 408-400-0865 Email: Valerie.Defiesta-Ng@veranexsolutions.com
Date Prepared: April 22, 2022
DEVICE INFORMATION [807.92(A)(2)]
Classification: 21 CFR§870.2700
Product Code: MUD
Trade Name: Intra.Ox™ 2.0 Handheld Tissue Oximeter
Generic/Common Name: Oximeter, Tissue Saturation
PREDICATE DEVICE(S) [807.92(A)(3)] Intra.Ox™ 2.0 Handheld Tissue Oximeter (K191676)
4
DEVICE DESCRIPTION [807,92(A)(4)]
The ViOptix Intra.Ox 2.0 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 includes three components and an accessory:
- Main Unit: a re-usable module consists of light sources, detectors, and processing ● electronics to convert measurements of reflected light into an estimate of StO>:
- Sheath: a single-use, sterile Sheath placed around the Main Unit during device use . (provide in the Disposable Kit); and
- Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the . Main Unit to provide power.
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 2.0 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.
The device shares the same indication for use and the same technological characteristics as the predicate device (K191676), 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™ 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue.
The Intra.Ox" 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.
The Intra.Ox"" 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.
The Intra.Ox™ 2.0 Handheld Tissue Oximeter should only be used on adult patients."
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a) (6)]
The technological characteristics of the modified Intra.Ox 2.0 Handheld Tissue Oximeter are substantially equivalent to the predicate device, Intra.Ox 2.0 Handheld Tissue Oximeter (K191676). Table 1 lists the technological characteristics of the predicate and modified devices and provides rationale to support a determination of substantial equivalence. Any differences between the devices do not raise any different questions of safety or efficacy.
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| Table 1: Summary of Technological Characteristics | |||
|---|---|---|---|
| Feature | Predicate Intra.Ox 2.0 | ||
| Handheld Tissue Oximeter | Modified Intra.Ox 2.0 | ||
| Handheld Tissue Oximeter | Substantial | ||
| Equivalence | |||
| Rationale | |||
| 510(k) Number | K191676 | TBD | -- |
| Indications for | |||
| Use | The Intra.OxTM 2.0 Handheld | ||
| Tissue Oximeter is intended to | |||
| non-invasively estimate the | |||
| percent oxygen saturation (StO2) | |||
| in a volume of tissue. |
The Intra.OxTM 2.0 Handheld
Tissue Oximeter is indicated for
use in monitoring patients during
circulatory or perfusion
examinations.
The Intra.OxTM 2.0 Handheld
Tissue Oximeter is intended to be
used by physicians, surgeons,
nurses, or other skilled users in a
medical environment.
The Intra.OxTM 2.0 Handheld
Tissue Oximeter should only be
used on adult patients. | The Intra.OxTM 2.0 Handheld
Tissue Oximeter is intended to
non-invasively estimate the
percent oxygen saturation (StO2)
in a volume of tissue.
The Intra.OxTM 2.0 Handheld
Tissue Oximeter is indicated for
use in monitoring patients during
circulatory or perfusion
examinations.
The Intra.OxTM 2.0 Handheld
Tissue Oximeter is intended to be
used by physicians, surgeons,
nurses, or other skilled users in a
medical environment.
The Intra.OxTM 2.0 Handheld
Tissue Oximeter should only be
used on adult patients. | N/A (same) |
| Measured
Parameters | Tissue oxygen saturation
(% StO2) | Tissue oxygen saturation
(% StO2) | N/A (same) |
| Principle of
Operation | Spectrophotometric oximetry | Spectrophotometric oximetry | N/A (same) |
| Energy
Delivered | Near-infrared light
Source: LED chips
Wavelengths: 730, 760, 810, 845,
and 895 nm | Near-infrared light
Source: LED chips
Wavelengths: 730, 760, 810, 845,
and 895 nm | N/A (same) |
| Single Patient
Use? | Yes, the Sheath is single patient
use.
The Main Unit is re-usable after
proper cleaning. | Yes, the Sheath is single patient
use.
The Main Unit is re-usable after
proper cleaning. | N/A (same) |
| Power Source | Battery Powered
Battery Type: 4 Lithium AA
Battery Voltage: 6 V total | Battery Powered
Battery Type: 4 Lithium AA
Battery Voltage: 6 V total | N/A (same) |
| StO2
Measurement
Range | StO2 displayed range shall be an
integer between 1 to 99%. | StO2 displayed range shall be an
integer between 1 to 99%. | N/A (same) |
| Physical Design | Ergonomic hand-held design for
range of hand sizes, includes
thumb rest, ambidextrous use.
Device contains a disposable kit
that contains a single-use battery
pack and sterile single-use
disposable sheath. | Ergonomic hand-held design for
range of hand sizes, includes
thumb rest, ambidextrous use.
Device contains a disposable kit
that contains a single-use battery
pack and sterile single-use
disposable sheath. | N/A (same) |
| Feature | Predicate Intra.Ox 2.0
Handheld Tissue Oximeter | Modified Intra.Ox 2.0
Handheld Tissue Oximeter | Substantial
Equivalence
Rationale |
| Dimensions and
Weight | 7.3" x 2.7" x 3.1"
L x W x H
Less than 1 lb | 7.3" x 2.7" x 3.1"
L x W x H
Less than 1 lb | N/A (same) |
| Components | Main Unit, Sheath,
Battery Pack and Quality Control
Target | Main Unit, Sheath, and
Battery Pack | Similar components.
The principle of
operation remains the
same for both devices.
The removal of the
Quality Control Target
does not raise different
questions of safety and
effectiveness as
demonstrated by
performance testing. |
Table 1: Summary of Technological Characteristics
6
SUBSTANTIAL EQUIVALENCE
The Intra.Ox 2.0 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 questions of safety or effectiveness. Thus, the modified Intra.Ox 2.0 Handheld Tissue Oximeter is substantially equivalent to the predicate device.
SUMMARY OF DESIGN MODIFICATION
The following design modifications have been implemented and do not affect the intended use, the Indications for Use, or alter the fundamental scientific technology of the device. ViOptix is proposing modifications to the cleared Intra. Ox 2.0 Handheld Tissue Oximeter (K191676) to optimize the design and improve manufacturability.
- The robustness of the latch-detection functions for sheath closure was improved. ●
- Adhesive was removed from the inside of the sheath window, a sterile pressure-relief vent was added to the lid, and the optical target was removed for the kit.
- An averaging functionality was added with screen modification to display both "live" and ● "average" readings.
- The removal of two non-functional components from a device Printed Circuit Board . Assembly (PCBA).
PERFORMANCE DATA [807.92(B)]
All necessary bench testing was conducted on the modified Intra.Ox 2.0 Handheld Tissue Oximeter to support a determination of substantial equivalence to the predicate device. Tests performed included:
- Mechanical Testing ●
- Sterility Testing ●
- Latch Testing ●
- Shelf-Life and Transport Testing ●
- Software Verification and Validation ●
7
- Heterogeneous Blood Phantom Study
The collective performance testing demonstrates that the Intra.Ox 2.0 Handheld Tissue Oximeter does not raise any different questions of safety or effectiveness when compared to the predicate device. The results of performance testing demonstrate that the Intra.Ox 2.0 Handheld Tissue Oximeter performs as intended.
[807.92(b)(1)]Non-clinical Testing Summary
In a heterogenous phantom study, measurements were made using the Intra.Ox 2.0 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 cooximeter. The results show that the Intra.Ox 2.0 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 Intra.Ox 2.0 Handheld Tissue Oximeter provides as good or better agreement to the gold standard over the clinically relevant range than the predicate Intra.Ox Handheld Tissue Oximeter.
[807.92(b)(2)]Clinical Testing Summary
Clinical testing was not required to demonstrate substantial equivalence.
CONCLUSION [807.92 (b) (3)]
Nonclinical performance testing has been performed on the Intra.Ox 2.0 Handheld Tissue Oximeter to evaluate the overall performance of the device. The results confirm that the Intra. Ox 2.0 Handheld Tissue Oximeter meets its specifications and meets requirements for its intended use. The Intra.Ox 2.0 Handheld Tissue Oximeter is substantially equivalent to the predicate device.