(228 days)
Not Found
No
The description focuses on multi-wavelength imaging and analyzing light absorption signatures, which are traditional signal processing techniques, not explicitly AI/ML. There is no mention of AI, ML, or related terms like deep learning or neural networks.
No
The device is a diagnostic tool that measures tissue oxygenation levels. It does not provide any form of treatment or therapy.
Yes
The device is intended for use by physicians/healthcare professionals to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise, which is a diagnostic purpose.
No
The device description explicitly states that the HyperView system consists of a camera and an accessories kit including a docking station, calibration verification system, power cord, and USB cable set. It also details hardware components within the camera such as optical components, imaging sensor, thermal sensor, flash illumination, circuits, boards, and a battery.
Based on the provided information, the HyperView™ Hyperspectral Tissue Oxygenation Measurement System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- HyperView's Function: The HyperView system is a noninvasive device that uses light to measure tissue oxygenation directly on the patient's skin. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's a "noninvasive tissue oxygenation measurement system" for use on "superficial tissue."
- Device Description: The description emphasizes that the device "does not come in contact with the patient" and uses "visible light to momentarily illuminate the patient's skin."
Therefore, the HyperView system falls under the category of a non-invasive diagnostic imaging or measurement device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
MUD
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Hyperspectral Imaging
Anatomical Site
Superficial tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians/healthcare professionals
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
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Validation study comparing HyperView handheld system to predicate OxyVu™-1 console system device.
Sample Size: A minimum of 20 subjects.
Key Results:
Primary Efficacy Endpoint Results:
- Mean O2Sat difference of 3.22 +/- 3.38% between HyperView and OxyVu™-1.
- Lower confidence interval: 2.58%, Upper confidence interval: 3.87%.
- Mean O2Sat differences remained similar (3.17%, 3.0%, 3.5%) when comparing study limbs by image sequence.
Secondary Efficacy Endpoint Results:
- Stratification by Skin Tone:
- Mean O2Sat difference: 2.42% for light skin tone, 4.64% for medium skin tone.
- Mean differences and confidence intervals for these two groups were within 5%.
- No statistically significant differences (P>0.1968) in O2Sat were noted between skin tone groups (light, medium, dark) for the index forearm region, with mean differences of 4% or less.
- Stratification by Non-ulcerated and Ulcerated Study Limbs:
- For study limbs with a foot ulcer (11 limbs, 33 paired data sets), mean O2Sat difference was 1.91% (confidence intervals: 0.55%, 3.26%).
- For non-ulcerated limbs, mean O2Sat difference was 3.8%.
- Mean O2Sat difference was significantly smaller (P>0.0068) when ulcers were present.
- Stratification by Peripheral Artery Disease (PAD) of the Study Limb:
- For 15 study limbs meeting PAD definition, mean O2Sat difference was 2.6% (confidence intervals: 1.14%, 4.06%).
- No statistically significant differences (P>0.4449) in O2Sat measurements between devices were noted for study limbs with PAD compared to those without.
- Oxy Differences (numeric scale 0 to 255):
- Mean Oxy difference: 14.07 (5.5%).
- By skin tone on plantar surface of foot: 11.94 (4.7%) for light, 17.85 (7.0%) for medium.
- By skin tone on forearm: 12.62 (4.9%) for light, 13.64 (5.3%) for medium, 17.5 (6.8%) for dark.
- With ulcer present: 11.3 (4.4%).
- With PAD: 12.27 (4.8%).
- Deoxy Differences (numeric scale 0 to 255):
- Mean Deoxy difference: 1.95 (0.8%).
- By skin tone on plantar surface of foot: 2.9 (1.1%) for light, 0.28 (0.1%) for medium.
- By skin tone on forearm: 2.47 (1.0%) for light, 1.1 (0.4%) for medium, 2.38 (0.9%) for dark.
- With ulcerated tissue: 3.09 (1.2%).
- With PAD: 3.27 (1.3%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/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
2
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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3
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
4
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.
5
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 | Significant
Differences |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 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 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 | The OxyVu™-1
Hyperspectral Tissue
Oxygenation (HTO)
Measurement System
is intended for use by
healthcare professionals as
a noninvasive tissue
oxygenation measurement
system that reports an
approximate value of:
• oxygen saturation (HT-
Sat),
• oxyhemoglobin level (HT -
Oxy), and | Same |
6
| SUBJECT DEVICE | PREDICATE | Significant | |
|---|---|---|---|
| Manufacturer | HyperMed Imaging, Inc. | HyperMed, Inc. | Differences |
| Trade Name | HyperViewTM System | OxyVuTM-1 | |
| • deoxyhemoglobin | |||
| (Deoxy) level | |||
| in superficial tissue. The | |||
| HyperViewTM 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 HyperViewTM system is | |||
| indicated for use to | |||
| determine oxygenation | |||
| levels in superficial tissues | |||
| for patients with potential | |||
| circulatory compromise. | • deoxyhemoglobin (HT- | ||
| Deoxy) level | |||
| in superficial tissue. The | |||
| OxyVuTM-1 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 OxyVuTM-1 system is | |||
| indicated for use to | |||
| determine oxygenation | |||
| levels in superficial tissues | |||
| for patients with potential | |||
| circulatory compromise. | |||
| System Components | • Hand-held, battery | ||
| operated device | |||
| including built in | |||
| resistive touchscreen | |||
| control and user | |||
| interface software | |||
| • PC software application | |||
| for reports | |||
| • Desktop docking station | |||
| to provide battery | |||
| charging and USB to | |||
| computer data interface | |||
| • USB computer interface | |||
| • Optionally tripod | |||
| mountable | |||
| • Calibration verification | |||
| cards are only required | |||
| to be used by user for | |||
| periodic verification of | |||
| calibration | |||
| • Laser verification cards | |||
| are used for periodic | |||
| verification of laser | |||
| alignment | • System Console: Cart, | ||
| System Electronics, CPU, | |||
| Monitor, Keyboard, | |||
| Pointing Device and | |||
| Printer (AC powered) | |||
| • Hyperspectral imaging | |||
| instrument head with | |||
| support arm: broadband | |||
| illuminator, camera and | |||
| spectral filter for | |||
| collecting hyperspectral | |||
| imaging cube | |||
| • Single use OxyVuTM Check | |||
| Pads for calibration | Different; the update of | ||
| the system from the | |||
| cart-based unit to a | |||
| hand-held device | |||
| involved changes to the | |||
| product dimensions, | |||
| user interface, power | |||
| source, and packaging. | |||
| The change from cart- | |||
| based unit to hand-held | |||
| unit had no effect on | |||
| performance. There | |||
| were no additional | |||
| safety or effectiveness | |||
| concerns as the | |||
| hyperspectral | |||
| technology used is the | |||
| same. | |||
| Calibration | Unit is factory calibrated | Calibration is required | Similar; both require |
7
| SUBJECT DEVICE | PREDICATE | Significant | |
|---|---|---|---|
| Manufacturer | HyperMed Imaging, Inc. | HyperMed, Inc. | Differences |
| Trade Name | HyperView™ System | OxyVu™ -1 | |
| and does not require | |||
| calibration before each | |||
| use. | before each use | calibration. | |
| The change in | |||
| calibration frequency | |||
| had no effect on | |||
| performance. The | |||
| change in calibration | |||
| frequency does not | |||
| present any additional | |||
| safety or effectiveness | |||
| concerns. | |||
| Time per patient image | .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
13
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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K161237
p.12/12
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.