(228 days)
The HyperView™ Hyperspectral Tissue Oxygenation Measurement System is intended for use by physicians/healthcare professionals as a noninvasive tissue oxygenation measurement system that reports an approximate value of.
- · oxygen saturation (O2Sat),
- · oxyhemoglobin level (Oxy), and
- deoxyhemoglobin (Deoxy) level
in superficial tissue. The HyperView™M system displays two-dimensional, color-coded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.
The HyperView™ system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
HyperMed Imaging Inc.'s HyperView handheld hyperspectral imaging system consists of the HyperView Camera and the HyperView Accessories Kit that includes a Docking Station, Calibration Verification System, Power Cord and USB Cable Set.
The HyperView system provides noninvasive measurement of approximate tissue oxygenation, sensitive to local, regional, and systemic low/no-flow ischemia. HyperView uses multi-wavelength imaging technology to analyze the signature of light as it is absorbed by the patient's tissue. The HyperView system analyzes these light absorption signatures to measure oxyhemoglobin and deoxyhemoglobin levels in the tissue, and creates a color-coded image that illustrates relative concentrations of oxygenated hemoglobin and deoxygenated hemoglobin.
Quantitative data is provided for oxyhemoglobin and deoxyhemoglobin levels as well as oxygen saturation. The technology is suitable for surface assessment, as the visible spectrum light used penetrates no more than a few millimeters deep.
The HyperView is a handheld product consisting of several subassemblies including precision optical components, electro-optics, imaging sensor, a thermal sensor, flash illumination, flex circuits, printed circuit boards, a battery, plastics as well as image processing and graphics user interface software. Users will interact with the device using a built-in, resistive, touchscreen display and an image capture button similar to a digital camera. The product does not come in contact with the patient and no injectable contrast is required. The camera uses visible light to momentarily illuminate the patient's skin for photographic imaging. Such information is useful in determining viability of vascular delivery in the superficial skin and correspondingly, such information can assist the physician in determining the ability of the patient's vascular system to support normal tissue health and wound healing.
Here's an analysis of the acceptance criteria and study as described in the provided document:
Acceptance Criteria and Device Performance
The core of the acceptance criteria for the HyperView™ Hyperspectral Tissue Oxygenation Measurement System is its substantial equivalence to the predicate device, the OxyVu™-1. The study primarily evaluated the difference in measurements between the HyperView and the predicate device, aiming to show that these differences were within acceptable limits.
Table of Acceptance Criteria and Reported Device Performance
| Metric / Endpoint | Acceptance Criteria (Implicit) | Reported Device Performance (Mean Differences ± Standard Deviation or CIs) |
|---|---|---|
| Primary Efficacy Endpoint | ||
| O2Sat Measurement Difference | Not greater than 7% nor less than -7% between mean O2Sat values | 3.22% ± 3.38% (Lower CI: 2.58%, Upper CI: 3.87%) Image sequence analysis: 3.17%, 3.0%, 3.5% |
| Secondary Efficacy Endpoints | (Demonstrate similar performance to predicate within reasonable clinical limits) | |
| O2Sat by Skin Tone (Light) | Similar to predicate | 2.42% (mean difference) |
| O2Sat by Skin Tone (Medium) | Similar to predicate | 4.64% (mean difference) |
| O2Sat by Skin Tone (Dark - Forearm) | Similar to predicate | ≤ 4% (mean difference) |
| O2Sat in Ulcerated vs. Non-Ulcerated | Similar to predicate | Ulcer present: 1.91% (Lower CI: 0.55%, Upper CI: 3.26%) No ulcer: 3.8% |
| O2Sat with Peripheral Artery Disease | Similar to predicate | 2.6% (Lower CI: 1.14%, Upper CI: 4.06%) |
| Oxy (Oxyhemoglobin) Mean Difference | Similar to predicate (values on 0-255 scale) | 14.07 (5.5%) |
| Oxy by Skin Tone (Light, Plantar Foot) | Similar to predicate | 11.94 (4.7%) |
| Oxy by Skin Tone (Medium, Plantar Foot) | Similar to predicate | 17.85 (7.0%) |
| Oxy by Skin Tone (Forearm) | Similar to predicate | Light: 12.62 (4.9%) Medium: 13.64 (5.3%) Dark: 17.5 (6.8%) |
| Oxy with Ulcer Present | Similar to predicate | 11.3 (4.4%) |
| Oxy with Peripheral Artery Disease | Similar to predicate | 12.27 (4.8%) |
| Deoxy (Deoxyhemoglobin) Mean Difference | Similar to predicate (values on 0-255 scale) | 1.95 (0.8%) |
| Deoxy by Skin Tone (Light, Plantar Foot) | Similar to predicate | 2.9 (1.1%) |
| Deoxy by Skin Tone (Medium, Plantar Foot) | Similar to predicate | 0.28 (0.1%) |
| Deoxy by Skin Tone (Forearm) | Similar to predicate | Light: 2.47 (1.0%) Medium: 1.1 (0.4%) Dark: 2.38 (0.9%) |
| Deoxy with Ulcerated Tissue | Similar to predicate | 3.09 (1.2%) |
| Deoxy with Peripheral Artery Disease | Similar to predicate | 3.27 (1.3%) |
| Software Verification & Validation | Conformance per FDA Guidance and IEC 62304 | PASS |
| Electrical Safety (ANSI/AAMI ES60601-1) | Compliance with standard | PASS |
| EMC/EMI (IEC 60601-1-2) | Compliance with standard | PASS |
| Laser Safety (IEC 60825-1) | Compliance with standard | PASS |
| Photobiological Safety (IEC 62471) | Compliance with standard | PASS |
| Battery Safety (IEC 62133) | Compliance with standard | PASS |
| Transportation Safety (UN 38.3) | Compliance with standard | PASS |
| Transit Testing (ASTM D4169) | Compliance with standard | PASS |
Study Details
The provided document describes a clinical validation study to demonstrate that the HyperView system is substantially equivalent to its predicate device, the OxyVu™-1.
-
Sample size used for the test set and the data provenance:
- Sample Size: A minimum of 20 subjects was planned and met.
- Data Provenance: The study was conducted with subjects enrolled in an IRB approved study. This indicates a prospective collection of data for the purpose of the study. The country of origin of the data is not explicitly stated but implies a US-based study due to FDA submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This study does not use an expert-established ground truth in the typical sense of a diagnostic interpretation study. Instead, the "ground truth" for comparison is the measurement obtained from the predicate device, OxyVu™-1. The study's objective was to compare the investigational device (HyperView) to the legally marketed predicate.
- Therefore, no specific number or qualifications of experts for establishing ground truth are mentioned as the primary comparison is device-to-device.
-
Adjudication method for the test set:
- Not applicable. As described above, the study compared measurements from the new device directly against measurements from the predicate device. There was no explicit adjudication of findings by human readers or panels in this comparison in the manner of diagnostic performance studies.
-
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, an MRMC comparative effectiveness study was not done. This study focuses on the technical performance equivalence of the new device (HyperView) to a predicate device (OxyVu™-1) in measuring tissue oxygenation, oxyhemoglobin, and deoxyhemoglobin levels. It is not an AI-assisted diagnostic device where human reader performance improvement would be evaluated. Human readers (physicians/healthcare professionals) use the device, but their improvement with "AI" assistance is not the subject of this study.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance evaluation was implicitly done in the sense that the HyperView device's measurements (O2Sat, Oxy, Deoxy) were compared directly to the predicate device's measurements. The "algorithm only" performance is represented by the output of the HyperView system itself, which is then compared to the predicate's output. While a physician uses the device, the study quantifies the difference in the device's reported values, not how a physician's diagnostic accuracy changes using the device.
-
The type of ground truth used:
- The "ground truth" (or reference standard) used for comparison was the measurements obtained from the legally marketed predicate device, OxyVu™-1. The study design aimed to show that the HyperView system provided clinically comparable measurements to the established predicate.
-
The sample size for the training set:
- The document does not specify a separate training set sample size. The described clinical validation study is a test set for regulatory submission. The device likely underwent internal development and algorithm training, but details regarding a specific training dataset for the algorithm are not provided in this regulatory summary.
-
How the ground truth for the training set was established:
- As no specific training set or its ground truth establishment is detailed in this document, this information is not available from the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2016
Hypermed Imaging, Inc. % Julie Powell Vice President, Quality Assurance Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, Texas 78701
Re: K161237
Trade/Device Name: Hyperspectral Tissue Oxygenation Measurement System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: November 11, 2016 Received: November 14, 2016
Dear Julie Powell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark Jellison
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) K161237
Device Name
HyperView™ Hyperspectral Tissue Oxygenation Measurement System
Indications for Use (Describe)
The HyperView™ Hyperspectral Tissue Oxygenation Measurement System is intended for use by physicians/healthcare professionals as a noninvasive tissue oxygenation measurement system that reports an approximate value of.
- · oxygen saturation (O2Sat),
- · oxyhemoglobin level (Oxy), and
- deoxyhemoglobin (Deoxy) level
in superficial tissue. The HyperView™M system displays two-dimensional, color-coded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.
The HyperView™ system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
| 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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Section 5 – 510(k) Summary
Hyperview Hyperspectral Tissue Oxygenation Measurement System
K161237
1. Submission Sponsor
HyperMed Imaging, Inc.
8700 Trail Lake Drive West, Suite 200
Memphis, TN 38125
USA
Office number: (901) 453-3154
Contact: Carlyn Reynolds
Title: Vice President Regulatory Compliance & Quality Assurance
2. Submission Correspondent
Emergo Global Consulting, LLC
816 Congress Avenue, Suite 1400
Austin, TX 78701
Cell Phone: (269) 720-1329
Office Phone: (512) 327-9997
Contact: Julie Powell, Vice President, QA/RA
Email: project.management@emergogroup.com
3. Date Prepared
April 29, 2016
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4. Device Identification
| Trade/Proprietary Name: | HyperView™ Hyperspectral Tissue Oxygenation Measurement System |
|---|---|
| Common/Usual Name: | Tissue Saturation Oximeter |
| Classification Name: | Oximeter |
| Regulation Number: | 21 CFR 870.2700 |
| Product Code: | MUD, Oximeter |
| Device Class: | Class II |
| Classification Panel: | Cardiovascular |
5. Legally Marketed Predicate Device(s)
OxyVu™-1, 510(k) K073656, HyperMed, Inc.
6. Device Description
HyperMed Imaging Inc.'s HyperView handheld hyperspectral imaging system consists of the HyperView Camera and the HyperView Accessories Kit that includes a Docking Station, Calibration Verification System, Power Cord and USB Cable Set.
The HyperView system provides noninvasive measurement of approximate tissue oxygenation, sensitive to local, regional, and systemic low/no-flow ischemia. HyperView uses multi-wavelength imaging technology to analyze the signature of light as it is absorbed by the patient's tissue. The HyperView system analyzes these light absorption signatures to measure oxyhemoglobin and deoxyhemoglobin levels in the tissue, and creates a color-coded image that illustrates relative concentrations of oxygenated hemoglobin and deoxygenated hemoglobin.
Quantitative data is provided for oxyhemoglobin and deoxyhemoglobin levels as well as oxygen saturation. The technology is suitable for surface assessment, as the visible spectrum light used penetrates no more than a few millimeters deep.
The HyperView is a handheld product consisting of several subassemblies including precision optical components, electro-optics, imaging sensor, a thermal sensor, flash illumination, flex circuits, printed circuit boards, a battery, plastics as well as image processing and graphics user interface software. Users will interact with the device using a built-in, resistive, touchscreen display and an image capture button similar to a digital camera. The product does not come in contact with the patient and no injectable contrast is required. The camera uses visible light to momentarily illuminate the patient's skin for photographic imaging. Such information is useful in determining viability of vascular delivery in the superficial skin and correspondingly, such information can assist the physician in determining the ability of the patient's vascular system to support normal tissue health and wound healing.
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7. Indication for Use Statement
The HyperView™ Hyperspectral Tissue Oxygenation Measurement System is intended for use by physicians/healthcare professionals as a noninvasive tissue oxygenation measurement system that reports an approximate value of:
- oxygen saturation (O2Sat),
- oxyhemoglobin level (Oxy), and
- deoxyhemoglobin (Deoxy) level
in superficial tissue. The HyperView™ system displays two-dimensional, color-coded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.
The HyperView™ system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.
8. Substantial Equivalence Discussion
The following table compares the HyperView system to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| SUBJECT DEVICE | PREDICATE | SignificantDifferences | |
|---|---|---|---|
| Manufacturer | HyperMed Imaging, Inc. | HyperMed, Inc. | |
| Trade Name | HyperView™ System | OxyVu™-1 | |
| Product Code | MUD | MUD | Same |
| Regulation Number | 21 CFR 870.2700 | 21 CFR 870.2700 | Same |
| Regulation Name | Tissue Saturation Oximeter | Tissue Saturation Oximeter | Same |
| Indications for Use | The HyperView™Hyperspectral TissueOxygenationMeasurement System isintended for use byphysicians/healthcareprofessionals as anoninvasive tissueoxygenation measurementsystem that reports anapproximate value of:• oxygen saturation(O2Sat), • oxyhemoglobinlevel (Oxy), and | The OxyVu™-1Hyperspectral TissueOxygenation (HTO)Measurement Systemis intended for use byhealthcare professionals asa noninvasive tissueoxygenation measurementsystem that reports anapproximate value of:• oxygen saturation (HT-Sat),• oxyhemoglobin level (HT -Oxy), and | Same |
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| SUBJECT DEVICE | PREDICATE | Significant | |
|---|---|---|---|
| Manufacturer | HyperMed Imaging, Inc. | HyperMed, Inc. | Differences |
| Trade Name | HyperViewTM System | OxyVuTM-1 | |
| • deoxyhemoglobin(Deoxy) levelin superficial tissue. TheHyperViewTM systemdisplays two-dimensional,color-coded images oftissue oxygenation of thescanned surface andreports hyperspectraltissue oxygenationmeasurements forselected tissue regions.The HyperViewTM system isindicated for use todetermine oxygenationlevels in superficial tissuesfor patients with potentialcirculatory compromise. | • deoxyhemoglobin (HT-Deoxy) levelin superficial tissue. TheOxyVuTM-1 system displaystwo-dimensional colorcodedimages of tissueoxygenation of the scannedsurface and reportshyperspectral tissueoxygenation measurementsfor selected tissue regions.The OxyVuTM-1 system isindicated for use todetermine oxygenationlevels in superficial tissuesfor patients with potentialcirculatory compromise. | ||
| System Components | • Hand-held, batteryoperated deviceincluding built inresistive touchscreencontrol and userinterface software• PC software applicationfor reports• Desktop docking stationto provide batterycharging and USB tocomputer data interface• USB computer interface• Optionally tripodmountable• Calibration verificationcards are only requiredto be used by user forperiodic verification ofcalibration• Laser verification cardsare used for periodicverification of laseralignment | • System Console: Cart,System Electronics, CPU,Monitor, Keyboard,Pointing Device andPrinter (AC powered)• Hyperspectral imaginginstrument head withsupport arm: broadbandilluminator, camera andspectral filter forcollecting hyperspectralimaging cube• Single use OxyVuTM CheckPads for calibration | Different; the update ofthe system from thecart-based unit to ahand-held deviceinvolved changes to theproduct dimensions,user interface, powersource, and packaging.The change from cart-based unit to hand-heldunit had no effect onperformance. Therewere no additionalsafety or effectivenessconcerns as thehyperspectraltechnology used is thesame. |
| Calibration | Unit is factory calibrated | Calibration is required | Similar; both require |
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| SUBJECT DEVICE | PREDICATE | Significant | |
|---|---|---|---|
| Manufacturer | HyperMed Imaging, Inc. | HyperMed, Inc. | Differences |
| Trade Name | HyperView™ System | OxyVu™ -1 | |
| and does not requirecalibration before eachuse. | before each use | calibration.The change incalibration frequencyhad no effect onperformance. Thechange in calibrationfrequency does notpresent any additionalsafety or effectivenessconcerns. | |
| Time per patient image | < 1 second capture time5 — 10 minutes use | 3 minute capture time10 to 15 minutes use | Similar method tocapture images.Multiple images arecaptured simultaneouslyto reduce imaging time.The change in imagetime had no effect onperformance. Thepatient image timechange does not presentany additional safety oreffectiveness concerns. |
| Spectrum of Light Used | Visible Spectrum Light(400nm to 700nm) | Visible Spectrum Light(400nm to 700nm) | Same |
| Wavelengths of LightUsed for Data Analysisand Imaging | 8 Wavelengths | 15 Wavelengths | Similar; subject deviceuses a subset of 8 of the15 wavelengths used bythe predicate.The change in number ofwavelengths had noeffect on performance.The change in number ofwavelengths does notpresent any additionalsafety or effectivenessconcerns. |
| LEDs | CREE LEDs (filtered) | CREE LEDs (3.0 mW/cm²) | Similar; both use LEDs. |
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| SUBJECT DEVICE | PREDICATE | SignificantDifferences | |
|---|---|---|---|
| Manufacturer | HyperMed Imaging, Inc. | HyperMed, Inc. | |
| Trade Name | HyperViewTM System | OxyVuTM-1 | |
| Illuminator 1: 11.0mW/cm2Illuminator 2: 6.1 mW/cm2 | (unfiltered) | The change in LEDs andthe filtering of theiroutput had no effect onperformance. The LEDchange does not presentany additional safety oreffectiveness concerns. | |
| LED/LaserClassification | Class II Laser | Class I LED | Different; LED/Laserclassification changedfrom Class I to Class II.The classificationdifference had no effecton performance anddoes not present anyadditional safety oreffectiveness concerns. |
| Software | C, C++, Java and .net (for PCapplication) | Matlab and Java | Similar as both usesoftware.The change inprogramming languageshad no effect onperformance. Thischange does not presentany additional safety oreffectiveness concerns. |
| Region of Interest(ROI) Area | Support for freehanddrawing ROI selection(mm2) | Support for freehanddrawing ROI selection(mm2) | Same |
| Image Type | Diagnostic | Diagnostic | Same |
| Measures | Oxygen saturationOxyhemoglobin levelDeoxyhemoglobin level | Oxygen saturationOxyhemoglobin levelDeoxyhemoglobin level | Same |
| Method ofMeasurement | Spectral analysis at specificwavelengths of lightreturned from target (8wavelengths, which are a | Spectral analysis at specificwavelengths of lightreturned from target (15wavelengths) | Similar; as both usewavelengths of light formeasurement.The wavelengths for the |
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| SUBJECT DEVICE | PREDICATE | SignificantDifferences | |
|---|---|---|---|
| Manufacturer | HyperMed Imaging, Inc. | HyperMed, Inc. | |
| Trade Name | HyperViewTM Systemwavelengths) | OxyVuTM-1 | |
| hand-held subject deviceare a subset of thewavelengths used in thepredicate device and thechange from 15 to 8wavelengths had noeffect on performance.This change does notpresent any additionalsafety or effectivenessconcerns. | |||
| Output Display | NumericTwo-dimensional colormap of approximate tissueoxygenation | NumericTwo-dimensional color mapof approximate tissueoxygenation | Same |
| Graphical Images | • VIS - Visible• Sat – Saturation Map(new map based uponthe oxygen saturationlevel)• Oxy - Tissueoxygenation map• Deoxy - Tissuedeoxyhemoglobin map• Note: The HSI mapreplaced with SaturationMap. | • VIS - Visible• HSI - Tissue oxygenationmap of oxyhemoglobinand deoxyhemoglobin• Oxy - Tissue oxygenationmap• Deoxy - Tissuedeoxyhemoglobin mapNote: The OxygenSaturation value displayedwithout a map. | Similar; both use samegraphical images for VIS,Oxy, Deoxy. The HSImap was replaced withthe Saturation Map.The change from an HSIto an oxygen saturationmap had no effect onperformance. Thischange does not presentany additional safety oreffectiveness concerns. |
| Selection Tools | CircleRegionPerimeter with optionalsecond region | CircleRegionPerimeter | Similar; both devices usethe same SelectionTools, with addedfeature for thePerimeter Tool.The additional feature inthe Perimeter SelectionTool had no effect onhow the deviceperformed. This changedoes not present anyadditional safety or |
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K161237 p.8/12
| SUBJECT DEVICE | PREDICATE | SignificantDifferences | |
|---|---|---|---|
| Manufacturer | HyperMed Imaging, Inc. | HyperMed, Inc. | |
| Trade Name | HyperViewTM System | OxyVuTM-1 | effectiveness concerns. |
| Data Storage | DICOM images stored on device | Images stored in Matlab files | Similar; as both have data storage capabilities.The change in data storage type (to an industry standard format) had no effect on performance of the device. This change does not present any additional safety or effectiveness concerns. |
| Operating Distancefrom Patient | Approximately 15" | Approximately 17" | Similar; both products have approximately the same working distance from the patient.The change in operating distance from the patient had no effect on device performance. This change does not present any additional safety or effectiveness concerns. |
| Imaged Area | 100 mm x 100 mm | 80 mm x 80 mm | Similar; imaged area is increased with hand-held subject device.The increase in image area had no effect on performance. This change does not present any additional safety or effectiveness concerns. |
| Electrical SafetyTesting Passed | YesANSI/AAMI ES60601-1:2005/(R)2012IEC 60601-1-2:2007 | YesIEC 60601-1IEC 60601-1-2 | Same |
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K161237 p.9/12
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of the HyperView system, and in showing substantial equivalence to the predicate device of this 510(k) submission, HyperMed a number of tests. The HyperView system meets all requirements for design characteristics, non-clinical performance testing, EMC/EMI testing, electrical safety, laser safety and battery safety testing to confirm that the output meets the design inputs and specifications for the device.
The HyperView system passed all testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Software verification and validation testing per FDA Guidance and IEC 62304: conformance of software development life cycle for the HyperView System and compliance to the requirements of the FDA guidance document for software contained in a medical device.
- Electrical safety testing per ANSI/AAMI ES60601-1: PASS
- . Electromagnetic compatibility testing per IEC 60601-1-2: PASS
- Laser safety testing per IEC 60825-1:2007: PASS
- . Photobiological safety of lamps and lamp systems per IEC 62471:2006: PASS
- . Secondary cells and batteries safety testing per IEC 62133:2012 : PASS
- . Transportation safety testing of Lithium Batteries per UN 38.3:2009: PASS
- Transit testing per ASTM D4169:2014: PASS
The HyperView passed all the testing in accordance with internal requirements, national standards, and international standards shown above to support substantial equivalence of the subject device.
10. Clinical Performance Data
A validation study was performed with the HyperView system for assessing the hyperspectral imaging in persons with vascular disease and / or diabetes mellitus and potentially compromised tissue oxygenation. The study was conducted to evaluate the HyperView handheld system with the predicate OxyVu™-1 console system device. The study was performed in compliance with Good Clinical Practices (GCP) with subjects enrolled in an IRB approved study that were consented for participation according to the intended use of the device, defined inclusion criteria, and defined exclusion criteria; with the purpose of meeting the study objectives.
The study objectives were defined as the following:
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p.10/12
- Comparison of hyperspectral imaging tissue oxygenation as the difference in the mean tissue . oxygen saturation (O2Sat) measurements of the OxyVu™-1 compared to the HyperView handheld system.
- . Secondary endpoints for this study include testing of mean oxyhemoglobin (Oxy) and deoxyhemoglobin (Deoxy) levels with stratification by the following:
- Skin pigmentation and melanin concentration levels O
- Non-ulcerated and ulcerated areas O
- Degree of peripheral artery disease in the study limb o
The clinical study was planned for a minimum of 20 (twenty) subjects to be enrolled, which was met. The subjects had images taken of target areas with both the HyperView handheld system and the predicate device, during a single session. No follow up visits were required.
The outcomes measurements for the clinical study are summarized as follows:
Primary Efficacy Endpoint Results
The pre-specified primary efficacy endpoint for the validation study was to compare the O2Sat measurement difference between the investigational HyperView and predicate OxyVu™-1 device ((HyperView O2Sat minus OxyVuTM-1 O2Sat).
A Student's t-tests was performed using SAS version 9.4 (SAS Institute Inc., Cary, NC) to compare the mean differences with non-adjusted results. A difference that is not greater than 7% nor less than -7% between the mean O2Sat values for each device was deemed substantially equivalent.
A mean O2Sat difference of 3.22 +/- 3.38% was demonstrated between the HyperView and the OxyVu™-1 devices in this study. Lower confidence intervals and upper confidence intervals were 2.58% and 3.87% respectively.
A second analysis was performed comparing the study limbs by image sequence. The conclusions remained the same. The mean differences in O2Sat between the devices were 3.17%, 3.0% and 3.5% respectively.
Secondary Efficacy Endpoint Results
Secondary objectives entailed assessing O2Sat, Oxy, and Deoxy differences stratified by skin tone, presence of ulcers, and an ABI indicative of peripheral artery disease.
Stratification by Skin Tone:
The mean difference was 2.42% for the light skin tone and 4.64% for medium skin tone. While the means of these two groups were statistically different (P>.0002), the mean values and confidence intervals were all within a 5% difference between the two cameras.
An analysis on the index forearm region was also performed, as all three skin tone groups were represented for this location (light, medium, and dark). In this location, there were no
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statistically significant differences noted between the skin tone groups (P>0.1968). The mean differences were 4% or less for all three groups.
Stratification by Non-ulcerated and Ulcerate Study Limbs
Eleven study limbs (31%) had a foot ulcer present. Each study limb had 3 sets of paired images for a total of 33 paired data sets. The mean difference in O2Sat between the devices was 1.91% with lower and upper confidence intervals of 0.55% and 3.26% in study limbs with a foot ulcer and 3.8% when ulcers were not present. The mean O2Sat difference was significantly smaller between the devices when ulcers were present on the foot (P>0.0068).
Stratification by Peripheral Artery Disease (PAD) of the Study Limb
There were 15 study limbs that met this definition. The mean difference in O2Sat for this group was 2.6% with lower and upper confidence intervals of 1.14% and 4.06% respectively.
There were no statistically significant differences noted between the device measurements of O2Sat between study limbs with PAD compared to study limbs without PAD (P>0.4449).
Oxy Differences
An assessment was made of the difference in Oxy for paired images. Oxy values are on a numeric scale of 0 to 255. A mean Oxy difference of 14.07 (5.5%) was observed between the two devices.
Oxy differences by skin tone on the plantar surface of the foot demonstrated mean difference of 11.94 (4.7%) in light skin toned feet and 17.85 (7.0%) in medium skin toned feet.
Oxy differences by skin tone on the forearm demonstrated a mean difference of 12.62 (4.9%) in light toned skin, 13.64 (5.3%) in medium toned skin, and 17.5 (6.8%) in dark toned skin.
Differences in Oxy between the two devices with an ulcer present was 11.3 (4.4%).
Difference in Oxy between for subjects with peripheral artery disease was 12.27 (4.8%).
Deoxy Differences
An assessment was made of the difference in Deoxy for paired images. Deoxy values are on a numeric scale of 0 to 255. A mean difference of 1.95 (0.8%) was observed.
Deoxy differences by skin tone on the plantar surface of the foot demonstrated mean difference of 2.9 (1.1%) in light skin toned feet and 0.28 (0.1%) in medium skin toned feet.
Deoxy differences by skin tone of the forearm demonstrated a mean difference of 2.47 (1.0%) in light toned skin, 1.1 (0.4%) in medium toned skin, and 2.38 (0.9%) in dark toned skin.
Deoxy values between the two devices for study limbs with ulcerated tissue (challenged tissue) demonstrated a mean difference of 3.09 (1.2%).
The difference in Deoxy between the two devices in study limbs with PAD was 3.27 (1.3%).
The validation study concluded that the HyperView system is safe and effective for its intended use and the outcomes of the study met the stated objectives. The validation study supports the indication for use as a noninvasive tissue oxygenation measurement system that reports approximate values of
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oxygen saturation (O2Sat), oxyhemoglobin level (Oxy), and deoxyhemoglobin (Deoxy) level in superficial tissue.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device or the device has the same intended use and different technological characteristics provided it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device.
The HyperView™ Hyperspectral Tissue Oxygenation Measurement System, as designed and manufactured, is determined to be substantially equivalent to the referenced 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).