(84 days)
The Intra. Oxim 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (SKO2) 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. Oxim 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 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 StO2;
- . Sheath: a single-use, sterile Sheath placed around the Main Unit during device use (provided in the Disposable Kit);
- Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the . Main Unit to provide power; and
- . Quality Control (QC) Target: a single-use accessory (provided in the Disposable Kit) that provides an optical check once the Sheath is placed around the Main Unit.
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 provided text describes the 510(k) premarket notification for the Intra.Ox 2.0 Handheld Tissue Oximeter, asserting its substantial equivalence to a predicate device (Intra.Ox Handheld Tissue Oximeter, K163472). The document details performance data from a heterogeneous blood phantom study and a non-significant risk clinical study to support this claim.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of predetermined acceptance criteria with numerical targets for accuracy or other performance metrics. Instead, it relies on demonstrating "substantial equivalence" to the predicate device through agreement in measurement and physiological response.
The performance is reported in terms of agreement with a "gold standard" (blood cooximeter for the phantom study) and agreement with the predicate device (for the clinical study).
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Heterogeneous Blood Phantom Study | ||
| Agreement with Gold Standard | "Substantially equivalent to the predicate device in limits of agreement to the gold standard, as well as 95% confidence intervals in slope and intercept." (Implies that the device's agreement with the gold standard should be comparable to or better than the predicate.) | "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." "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 (StO2 measurement during transient ischemia) | ||
| Agreement in Deoxygenation Curve Shape | Not explicitly stated as a numerical criterion, but the implicit criterion is that the Intra.Ox 2.0 should show similar physiological responses during ischemic events as the predicate device. | "Excellent agreement in shape of the deoxygenation curve observed during ischemic events between the Intra.Ox 2.0 Handheld Tissue Oximeter and the predicate device for each analyzed subject." |
| Agreement in StO2 Values | Not explicitly stated as a numerical criterion, but the implicit criterion is that the Intra.Ox 2.0 should measure similar ranges of StO2 for both healthy and compromised tissue compared to the predicate device, demonstrating substantial equivalence. Also, agreement with literature-reported values. | "Direct comparison with paired data showed good agreement considering the physiological variances inherent between measurement sites." "Similar ranges of StO2 values for both healthy and compromised tissue." "Similarities in values for healthy tissue (65% [Intra.Ox 2.0] and 61% [predicate]) and mean desaturation dynamic range of 27 percentage points (both devices) agrees well with literature-reported values." |
2. Sample Size Used for the Test Set and Data Provenance
- Heterogeneous Blood Phantom Study (Test set): The sample size is not explicitly stated. The study involved measurements in a "heterogeneous phantom prepared with swine whole blood."
- Clinical Study (Test set):
- Sample Size: "A total of 18 data sets from 18 subjects."
- Data Provenance: Prospective, healthy human volunteers. The document does not specify the country of origin of the data, but it was an "IRB-approved study."
- The subjects were "near-evenly distributed over age, gender, and skin color as determined by the Fitzpatrick skin type."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish a ground truth for either the phantom study or the clinical study in the traditional sense of medical image interpretation.
- Heterogeneous Blood Phantom Study: The "gold standard" for this study was a "blood cooximeter." This suggests a reference instrument rather than expert opinion. The qualifications of a cooximeter operator would typically involve laboratory proficiency but are not specified here.
- Clinical Study: The "ground truth" for the clinical study was the measurement from the predicate device and the physiological response during induced ischemia. This is a comparative study against an existing cleared device, rather than against an expert-determined ground truth.
4. Adjudication Method for the Test Set
No adjudication method is described for either the phantom study or the clinical study. The clinical study involved direct comparison of measurements between the new device and the predicate device, not a human consensus or adjudication process.
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. This device is a measurement instrument (oximeter), not an AI-powered diagnostic tool requiring human interpretation. Therefore, the concept of human readers improving with or without AI assistance does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance evaluations of the device itself.
- Heterogeneous Blood Phantom Study: Evaluated the Intra.Ox 2.0 Handheld Tissue Oximeter's measurements against a blood cooximeter using a phantom.
- Clinical Study: Evaluated the Intra.Ox 2.0 Handheld Tissue Oximeter's measurements against the predicate Intra.Ox Handheld Tissue Oximeter in healthy human volunteers.
These studies assess the device's ability to measure StO2 and respond to physiological changes directly, without human interpretation as part of the primary measurement.
7. The Type of Ground Truth Used
- Heterogeneous Blood Phantom Study: The ground truth was established by a "blood cooximeter." This is a reference instrument.
- Clinical Study: The ground truth for comparative purposes was the predicate Intra.Ox Handheld Tissue Oximeter and the physiological changes induced by transient ischemia (i.e., the expected deoxygenation curve and StO2 values observed during healthy and compromised tissue states), benchmarked against "literature-reported values." This is a form of comparative ground truth against an established device and physiological understanding.
8. The Sample Size for the Training Set
No training set is mentioned or applicable in the context of this device. The Intra.Ox 2.0 Handheld Tissue Oximeter is a spectrophotometric oximeter that uses fixed algorithms based on physical principles, not a machine learning or AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ViOptix, Inc. % Valerie Defiesta-Ng Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, California 95110
September 16, 2019
Re: K191676
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: June 21, 2019 Received: June 24, 2019
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.
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
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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.
Neil R.P. Ogden, MS Assistant Director, THT4A4 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)
Device Name Intra.OxTM 2.0 Handheld Tissue Oximeter
Indications for Use (Describe)
The Intra. Oxim 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (SKO2) 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. Oxim 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.
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 K_191676
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 Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA, 95110 USA
Date Prepared: June 21, 2019
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
Intra.Ox™ 2.0 Handheld Tissue Oximeter
Generic/Common Name:
Oximeter, Tissue Saturation
Classification:
21 CFR§870.2700
Product Code:
MUD
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PREDICATE DEVICE(S) [807.92(a)(3)]
Intra.Ox™ Handheld Tissue Oximeter (K163472)
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 StO2;
- . Sheath: a single-use, sterile Sheath placed around the Main Unit during device use (provided in the Disposable Kit);
- Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the . Main Unit to provide power; and
- . Quality Control (QC) Target: a single-use accessory (provided in the Disposable Kit) that provides an optical check once the Sheath is placed around the Main Unit.
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 device shares the same Indications for Use and the same technological characteristics as the predicate 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™ 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 Intra.Ox 2.0 Handheld Tissue Oximeter are substantially equivalent to the predicate device, the Intra.Ox Handheld Tissue Oximeter (K163472). The table below lists the technological characteristics of the proposed device and predicate device 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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510(k) SUMMARY
| Intra.Ox Handheld TissueOximeter | Intra.Ox 2.0 Handheld issueOximeter | SubstantialEquivalence Rationale | |
|---|---|---|---|
| Feature | Primary Predicate Device | Subject Device | |
| 510(k) Number | K163472 | K191676 | -- |
| Indications for Use | The Intra.Ox Handheld TissueOximeter is intended tonon-invasively estimate the percentoxygen saturation (StO2) in avolume of tissue.The Intra.Ox Handheld TissueOximeter is indicated for use inmonitoring patients duringcirculatory or perfusionexaminations.The Intra.Ox Handheld TissueOximeter is intended to be used byphysicians, surgeons, nurses, orother skilled users in a medicalenvironment.The Intra.Ox Handheld TissueOximeter should only be used onadult patients. | The Intra.OxTM 2.0 Handheld TissueOximeter is intended tonon-invasively estimate the percentoxygen saturation (StO2) in avolume of tissue.The Intra.OxTM 2.0 Handheld TissueOximeter is indicated for use inmonitoring patients duringcirculatory or perfusionexaminations.The Intra.OxTM 2.0 Handheld TissueOximeter is intended to be used byphysicians, surgeons, nurses, orother skilled users in a medicalenvironment.The Intra.OxTM 2.0 Handheld TissueOximeter should only be used onadult patients. | Same |
| MeasuredParameters | Tissue oxygen saturation(% StO2) | Tissue oxygen saturation(% StO2) | Same |
| Operating Principle | Spectrophotometric oximetry | Spectrophotometric oximetry | Same |
| Energy Delivered | Near-infrared lightSource: LED chipsWavelengths: 730nm, 760mm,810mm, 845mm, and 895mm | Near-infrared lightSource: LED chipsWavelengths: 730nm, 760mm,810mm, 845mm, and 895mm | Same |
| Single Patient Useor Reusable | Main Unit - Single Patient Use | Main Unit - ReusableSheath - Single Patient UseBattery Pack - Single Patient UseQuality Control Target – SinglePatient Use | SimilarThe difference in use ofthe Main Unit of theSubject Device does notraise different questionsrelated to safety andeffectiveness, asdemonstrated byverification andvalidation testing. |
| Power Source | Battery poweredBattery type: 4 Lithium AABattery voltage 6V total | Battery poweredBattery type: 4 Lithium AABattery voltage 6V total | Same |
| Measurement Range | 1-99% StO2 | 1-99% StO2 | Same |
| Feature | Intra.Ox Handheld TissueOximeter | Intra.Ox 2.0 Handheld issueOximeter | SubstantialEquivalence Rationale |
| Physical Design | Ergonomic hand-held design forrange of hand sizes, includes thumbrest, ambidextrous use | Ergonomic hand-held design forrange of hand sizes, includes thumbrest, ambidextrous useDevice contains a disposable kit thatcontains a single-use Battery Packand sterile single-use disposablesheath. | Not the same.The difference inphysical design doesnot raise differentquestions related tosafety andeffectiveness, asdemonstrated byverification andvalidation testing. |
| Dimensions andWeight | 7in. x 2.9in x 3in.L x W x H | 7.3" x 2.7" x 3.1"L x W x H | Not the sameThe differences inphysical dimensions donot raise differentquestions related tosafety andeffectiveness, asdemonstrated byverification andvalidation testing. |
| Housing Materials | Polycarbonate | Polycarbonate | Same |
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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 Intra.Ox 2.0 Handheld Tissue Oximeter is substantially equivalent to the predicate device.
PERFORMANCE DATA [807.92(b)]
All necessary bench and clinical testing was conducted on the Intra.Ox 2.0 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
- Intracutaneous Reactivity Irritation O
- System Toxicity O
- Material Mediated Pyrogenicity o
- Mechanical Testing ●
- Sterilization Validation
- Packaging, Shelf-Life and Transportation Testing
- Software Verification and Validation ●
- Heterogeneous Blood Phantom Study ●
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- Human Factors Usability Study ●
- Non-Significant Risk Clinical 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 performance was determined by measuring tissue oxygen saturation (StO2) with the Intra.Ox 2.0 Handheld Tissue Oximeter and the predicate Intra.Ox Handheld Tissue Oximeter during transient ischemic events on healthy human volunteers, which temporarily mimics compromised tissue via a non-significant risk (NSR) IRB-approved study. A total of 18 data sets from 18 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 2.0 Handheld Tissue Oximeter and the predicate device for each analyzed subject. A direct comparison with paired data showed good agreement considering the physiological variances inherent between measurement sites.
Figure 1 shows the similarities in values for healthy tissue (65% [Intra.Ox 2.0 Handheld Tissue Oximeter] 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 Intra.Ox 2.0 Handheld Tissue Oximeter and predicate Intra.Ox devices measure similar ranges of StO2 values for both healthy and compromised tissue, thus demonstrating substantial equivalence.
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Image /page/8/Figure/1 description: This image is a boxplot comparing Intra.Ox 2.0 and Predicate. The y-axis is labeled "StO2%" and ranges from 0 to 100. The x-axis shows two groups, "Healthy" and "Compromised", for each of the two methods, Intra.Ox 2.0 and Predicate. The boxplot shows the distribution of StO2 values for each group and method, with the median, quartiles, and outliers displayed.
Predicate Device for Healthy and Compromised Tissue.
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
- BSI BS EN ISO 14971:2012, Medical devices - Application of risk management to medical devices
- ISTA 2A:2011, Partial Simulation Performance Tests
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CONCLUSIONS [807.92(b)(3)]
The Intra.Ox 2.0 Handheld Tissue Oximeter and the predicate Intra.Ox Handheld Tissue Oximeter have the same Indications for Use and utilize the same technological characteristics which do not raise different questions of safety or effectiveness. The performance data show that the Intra.Ox 2.0 Handheld Tissue Oximeter is safe and performs as intended and as such demonstrates substantial equivalence compared 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).