(28 days)
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.
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.
The provided text describes a 510(k) premarket notification for the ViOptix Intra.Ox 2.0 Handheld Tissue Oximeter. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K191676). Consequently, the "acceptance criteria" and "device performance" are framed in terms of equivalence to the predicate device and meeting specifications, rather than absolute performance metrics against a fixed clinical threshold.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list distinct "acceptance criteria" for the modified device in terms of specific performance thresholds for StO2 accuracy, beyond stating it should perform "as intended" and be "substantially equivalent" to the predicate. The performance data primarily focuses on demonstrating that the modifications did not negatively impact the device's performance compared to the predicate and a "gold standard."
| Acceptance Criteria (Implied from Substantial Equivalence and Performance Testing) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence to Predicate Device: Maintain the same intended use, indications for use, principle of operation, measured parameters, energy delivered, power source, StO2 measurement range, and physical design as the predicate. | All technological characteristics, including intended use, indications, principle of operation, measured parameters, energy delivered, power source, StO2 range, and physical design, are the same as the predicate device (K191676). The only component difference (removal of Quality Control Target) does not raise different questions of safety and effectiveness as demonstrated by performance testing. |
| Safety and Effectiveness Equivalence to Predicate Device: Modifications do not raise new questions of safety or effectiveness. | Performance testing (mechanical, sterility, latch, shelf-life, transport, software V&V, heterogeneous blood phantom study) demonstrates that the modified device performs as intended and does not raise different questions of safety or effectiveness compared to the predicate. |
| Agreement with "Gold Standard" (Heterogeneous Blood Phantom Study): Demonstrate agreement with a "gold standard" blood co-oximeter similar to or better than the predicate device. | The Intra.Ox 2.0 Handheld Tissue Oximeter showed substantial equivalence to the predicate device in limits of agreement to the gold standard, as well as 95% confidence intervals in slope and intercept. This supports that it provides "as good or better agreement" to the gold standard over the clinically relevant range. |
| Met specifications and requirements for intended use. | The collective performance testing demonstrates that the Intra.Ox 2.0 Handheld Tissue Oximeter performs as intended and meets its specifications and requirements for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The only specific performance study mentioned with a "test set" is the Heterogeneous Blood Phantom Study. The sample size for this study is not explicitly stated in the provided document. The data provenance is also not explicitly stated, however, it is a non-clinical phantom study rather than a human clinical study, using swine whole blood and an Intralipid solution. This implies an in-vitro or bench-top study, not tied to a specific country of origin in the way clinical data would be. It is a prospective study in the sense that the measurements were actively made for this evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
For the Heterogeneous Blood Phantom Study, the "ground truth" was established by a "gold standard" blood co-oximeter. This implies a technical or laboratory instrument, not human experts. Therefore, no human experts were used to establish ground truth for this particular test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since the ground truth was established by a "gold standard" instrument, there was no adjudication method involving human reviewers for the test set.
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
No MRMC comparative effectiveness study was done. The device itself is an oximeter, not an AI diagnostic tool requiring human interpretation or assistance augmentation. Clinical testing was explicitly stated as "not required."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the Heterogeneous Blood Phantom Study is a form of standalone performance study. The device, the Intra.Ox 2.0 Handheld Tissue Oximeter, was tested independently, and its measurements were compared to a "gold standard" blood co-oximeter. This test evaluated the algorithm's performance (how it estimates StO2 from optical measurements) in a controlled phantom environment without human intervention in the measurement process itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the Heterogeneous Blood Phantom Study, the ground truth was based on a "gold standard" blood co-oximeter.
8. The sample size for the training set
The document does not provide information on a training set sample size. The submission is for a modification to an already cleared device, and the focus is on demonstrating substantial equivalence through non-clinical performance testing. It is likely that the underlying algorithm was trained during the development of the original predicate device (K191676), but no details are given here for either device.
9. How the ground truth for the training set was established
As no information is provided on a training set in this document, there is no information on how its ground truth was established.
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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.
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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
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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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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)
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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 2.0Handheld Tissue Oximeter | Modified Intra.Ox 2.0Handheld Tissue Oximeter | SubstantialEquivalenceRationale |
| 510(k) Number | K191676 | TBD | -- |
| Indications forUse | The Intra.OxTM 2.0 HandheldTissue Oximeter is intended tonon-invasively estimate thepercent oxygen saturation (StO2)in a volume of tissue.The Intra.OxTM 2.0 HandheldTissue Oximeter is indicated foruse in monitoring patients duringcirculatory or perfusionexaminations.The Intra.OxTM 2.0 HandheldTissue Oximeter is intended to beused by physicians, surgeons,nurses, or other skilled users in amedical environment.The Intra.OxTM 2.0 HandheldTissue Oximeter should only beused on adult patients. | The Intra.OxTM 2.0 HandheldTissue Oximeter is intended tonon-invasively estimate thepercent oxygen saturation (StO2)in a volume of tissue.The Intra.OxTM 2.0 HandheldTissue Oximeter is indicated foruse in monitoring patients duringcirculatory or perfusionexaminations.The Intra.OxTM 2.0 HandheldTissue Oximeter is intended to beused by physicians, surgeons,nurses, or other skilled users in amedical environment.The Intra.OxTM 2.0 HandheldTissue Oximeter should only beused on adult patients. | N/A (same) |
| MeasuredParameters | Tissue oxygen saturation(% StO2) | Tissue oxygen saturation(% StO2) | N/A (same) |
| Principle ofOperation | Spectrophotometric oximetry | Spectrophotometric oximetry | N/A (same) |
| EnergyDelivered | Near-infrared lightSource: LED chipsWavelengths: 730, 760, 810, 845,and 895 nm | Near-infrared lightSource: LED chipsWavelengths: 730, 760, 810, 845,and 895 nm | N/A (same) |
| Single PatientUse? | Yes, the Sheath is single patientuse.The Main Unit is re-usable afterproper cleaning. | Yes, the Sheath is single patientuse.The Main Unit is re-usable afterproper cleaning. | 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) |
| StO2MeasurementRange | StO2 displayed range shall be aninteger between 1 to 99%. | StO2 displayed range shall be aninteger between 1 to 99%. | N/A (same) |
| Physical Design | Ergonomic hand-held design forrange of hand sizes, includesthumb rest, ambidextrous use.Device contains a disposable kitthat contains a single-use batterypack and sterile single-usedisposable sheath. | Ergonomic hand-held design forrange of hand sizes, includesthumb rest, ambidextrous use.Device contains a disposable kitthat contains a single-use batterypack and sterile single-usedisposable sheath. | N/A (same) |
| Feature | Predicate Intra.Ox 2.0Handheld Tissue Oximeter | Modified Intra.Ox 2.0Handheld Tissue Oximeter | SubstantialEquivalenceRationale |
| Dimensions andWeight | 7.3" x 2.7" x 3.1"L x W x HLess than 1 lb | 7.3" x 2.7" x 3.1"L x W x HLess than 1 lb | N/A (same) |
| Components | Main Unit, Sheath,Battery Pack and Quality ControlTarget | Main Unit, Sheath, andBattery Pack | Similar components.The principle ofoperation remains thesame for both devices.The removal of theQuality Control Targetdoes not raise differentquestions of safety andeffectiveness asdemonstrated byperformance testing. |
Table 1: Summary of Technological Characteristics
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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 ●
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- 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.
§ 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).