(262 days)
Not Found
No
The summary describes "real-time digital analysis" and "optical properties of tissues and blood," but there is no mention of AI, ML, deep learning, or any related terms. The performance studies focus on equivalence to a predicate device based on detecting pulsatile flow, not on learning from data or making predictions based on complex patterns.
No.
The device is an optical imaging system intended for studying blood flow and producing images to depict blood perfusion. It is not described as providing treatment or therapy.
Yes
The device is an "optical imaging device intended for studies of blood flow in the microcirculation" and helps with "measuring perfusion of healthy and injured skin." While it doesn't offer a final diagnosis, it provides critical information (blood flow and perfusion data) that aids healthcare professionals in diagnosing and monitoring various conditions, such as burn wounds, diabetic ulcers, and other conditions related to microcirculation. This function of providing data to inform clinical decision-making aligns with the definition of a diagnostic device.
No
The device description explicitly states that the DeepView System 2.0 consists of hardware components including a Camera Head with LED optics, an Articulating Arm, a Touch-Screen Display, and a Mobile Cart, in addition to the software.
Based on the provided information, the SpectralMD™ DeepView™ Wound Imaging System 2.0 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- DeepView System Function: The DeepView System 2.0 is an optical imaging device that uses non-contact photoplethysmography (PPG) to measure blood flow in the microcirculation in vivo (within the living body). It does not analyze specimens taken from the body.
- Intended Use: The intended use describes the device as being used for studies of blood flow in the microcirculation and for measuring perfusion of healthy and injured skin. This is a direct measurement on the patient, not an analysis of a sample.
Therefore, the DeepView System 2.0 falls under the category of a medical device used for in vivo imaging and measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SpectralMD™ DeepView™ Wound Imaging System 2.0 is an optical imaging device intended for studies of blood flow in the microcirculation. The DeepView system is suitable for a wide variety of clinical applications including plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, physiology, neurosurgery and anesthetics. In particular, it can be used for measuring perfusion of healthy and injured skin including burn wounds, skin flaps (plastic and reconstructive surgery), chronic wounds, decubitus ulcers, and diabetic ulcers.
Product codes
DPT
Device Description
The DeepView System 2.0 is a prescription device that utilizes the principles of non-contact photoplethysmography (PPG) to capture images of tissue blood perfusion. This is accomplished by measuring the optical properties of tissues and blood as they vary in response to changing hemodynamic conditions. The device's software combines real-time digital analysis based on the interaction of light with vascular tissues below the skin's surface to produce 2-D color images on a touch-screen display depicting relative blood perfusion. The DeepView System consists of a Camera Head with LED optics, an Articulating Arm for Camera Head positioning, a Touch-Screen Display for image viewing, and for accessing and interacting with the Graphical User Interface (GUI). All components are integrated on a Mobile Cart that houses the hardware/software, uninterruptable power supply (UPS), and allows for transport between use environments. The DeepView System 2.0 is AC powered with a backup UPS, and is for use in healthcare/hospital facilities.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photoplethysmography (PPG)
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare/hospital facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The DeepView System 2.0 has been subjected to comparative testing against the original DeepView system (primary predicate) in order to demonstrate that DeepView 2.0 is capable of detecting the pulsatile component of fluid flow in an equivalent manner to that of the primary predicate. In this testing, the device's ability to detect pulsatile fluid flow, frequency detection, and capability to detect pulsatile flow under conditions simulating physiological properties of blood flow in human tissues was evaluated. The results demonstrated the ability of the DeepView 2.0 to identify the 2% alternating change (AC) modulation that is consistent with the tissue-volume change in human tissue resulting from blood flow; to identify the AC modulations at various frequencies within the frequencies of the human heart rate: and to detect fluid flow beneath the surface of an optically dense medium. These results demonstrate that the DeepView System 2.0 performs in an equivalent manner to the original DeepView System (primary predicate).
The DeepView System 2.0 was also been evaluated for electrical safety and electromagnetic compatibility and was found to meet AAMI/ANSI ES60601-1:2005/(R) 2012 & A1:2012; IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 and IEC 60601-1-2 (2007)/(R) 2012. The DeepView 2.0 has been designed in accordance with FDA guidance on human factors and usability engineering and subjected to usability testing validation. No clinical performance data were needed to support substantial equivalence. The results of the testing performed demonstrate the DeepView Wound Imaging System 2.0 to be substantially equivalent to the predicate and does not introduce any new issues of safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem consisting of three stylized human profiles facing to the right, with a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2017
SpectralMD. Inc. J. Michael DiMaio, MD CEO 2515 McKinney Avenue Dallas, TX 75201
Re: K163339
Trade Device Name:SpectralMD DeepView Wound Imaging System 2.0 Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular blood flow probe Regulatory Class: Class II Product Code: DPT Dated: July 20, 2017 Received: July 24, 2017
Dear Dr. DiMaio:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K163339
Device Name
Spectral MD Deep ViewTM Wound Imaging System 2.0
Indications for Use (Describe)
The SpectralMD™ DeepView™ Wound Imaging System 2.0 is an optical imaging device intended for studies of blood flow in the microcirculation. The DeepView system is suitable for a wide variety of clinical applications including plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, neurosurgery and anesthetics. In particular, it can be used for measuring perfusion of healthy and injured skin including burn wounds, skin flaps (plastic and reconstructive surgery), chronic wounds, decubitus ulcers and diabetic ulcers.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image is a logo for Spectral MD. The logo consists of a series of downward-pointing arrows in blue, green, and red, followed by the text "SpectralMD" in a simple, sans-serif font. Below the text, in a smaller font, is the tagline "Seeing the Unknown."
510(k) Summary
Submitted by:
SpectralMD, Inc. 2515 McKinney Ave., Suite 1000 Dallas, Texas 75201 855-436-2278
| Date Prepared: | August 11,, 2017 |
|---|---|
| Contact Person: | J. Michael DiMaio, M.D. / CEO |
| 855-436-2278 | |
| Trade Name: | SpectralMD™ DeepView™ Wound Imaging System 2.0 |
| Common Name: | Extravascular Blood Flow Probe |
| Classification | |
| Name: | Extravascular Blood Flow Probe |
| Reference: | 21 CFR §870.2120– Class II |
| Product Code: | DPT |
Predicate Devices:
K124049: DeepView Digital Video Physiological Portable Imaging System (Primary) K123216: EasyLDI Microcirculation Camera (Additional Predicate)
Device Description:
The DeepView System 2.0 is a prescription device that utilizes the principles of non-contact photoplethysmography (PPG) to capture images of tissue blood perfusion. This is accomplished by measuring the optical properties of tissues and blood as they vary in response to changing hemodynamic conditions. The device's software combines real-time digital analysis based on the interaction of light with vascular tissues below the skin's surface to produce 2-D color images on a touch-screen display depicting relative blood perfusion. The DeepView System consists of a Camera Head with LED optics, an Articulating Arm for Camera Head positioning, a Touch-Screen Display for image viewing, and for accessing and interacting with the Graphical User Interface (GUI). All components are integrated on a Mobile Cart that houses the hardware/software, uninterruptable power supply (UPS), and allows for transport between use environments. The DeepView System 2.0 is AC powered with a backup UPS, and is for use in healthcare/hospital facilities.
Indications for Use:
The SpectralMD™ DeepView™M Wound Imaging System 2.0 is an optical imaging device intended for studies of blood flow in the microcirculation. The DeepView System is suitable for a wide variety of clinical applications including plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, physiology, neurosurgery and anesthetics. In particular, it can be used for measuring perfusion of healthy and injured skin including burn wounds, skin flaps (plastic and reconstructive surgery), chronic wounds, decubitus ulcers, and diabetic ulcers.
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Image /page/4/Picture/0 description: The image shows the logo for Spectral MD. The logo consists of a stack of three downward-pointing arrows in blue, green, and red, followed by the text "SpectralMD" in a modern, sans-serif font. Below the text, in a smaller font, is the tagline "Seeing the Unknown."
Technological Comparison:
The DeepView System 2.0 utilizes the same photoplethysmography (PPG) technology as the original DeepView device (primary predicate) in which PPG technology utilizes light to detect pulsatile blood flow in patients and then provides 2D color images of relative perfusion. The devices are software controlled, consist of the same system components, and achieve the output in the same manner. Differences between the devices include an updated indication for use, software upgrades, broadband illumination, hardware and ergonomic improvements. The table below presents a comparison of key technological characteristics:
| TECHNOLOGICAL COMPARISON | |||
|---|---|---|---|
| Feature | Subject device | Primary Predicate | Additional Predicate |
| DeepView System 2.0 | DeepView Digital Video Physiological Portable Imaging System | Aimago EasyLDI and EasyLDI Studio | |
| 510(k) # | K163339 | K124049 | K123216 |
| Common Name | Extravascular Blood Flow Probe | Extravascular Blood Flow Probe | Laser Doppler Imager Viewing Software for desktop computer (Accessory) |
| Regulation | 21 CFR Part 870.2120 | 21 CFR Part 870. 2120 | 21 CFR Part 870.2120 |
| Prod. Code | DPT | DPT | DPT LXN |
| Submission & Class | 510(k) Class II | 510(k) Class II | 510(k) Unclassified |
| Technology | PPG | PPG | Laser Doppler /2-D Image |
| Illumination | LED | LED | Class 2M Laser |
| Wavelength | 400-900nm | 870 nm | 808 nm |
| -PPG | 850 nm | $870 nm \atop Optical intensity \ 1.73 mW/cm^2$ | NA |
| -PPG | $Optical intensity \ 0.98 mW/cm^2$ | ||
| -Color Ref. Image | 400-900 nm | NA - Black & White | 532-635 nm |
| -Color Ref. Image | $3.71 mW/cm^2 \ 0.16 mW/cm^2$ | ||
| -Guiding Beams | 524 nm | NA | Green focus lasers: 532 nm Red line lasers: 635 nm |
| Control Mech. | Software | Software | Software |
| Data Analysis | Proprietary Software Algorithm | Proprietary Software Algorithm | Proprietary Software Algorithm |
| Size | 28.5 x 40 x 67" | 24 x 24x 61" | unknown |
| Weight | 292 lbs | 150 lbs | unknown |
| Acquisition Modes | Relative Perfusion in Microcirculation via PPG imaging | Relative Perfusion in Microcirculation via PPG imaging | Relative Perfusion in Microcirculation via laser Doppler flux |
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Image /page/5/Picture/0 description: The image shows the logo for Spectral MD. The logo consists of a stack of three downward-pointing arrows in blue, green, and red, followed by the text "SpectralMD" in a clean, sans-serif font. Below the text, in a smaller font, is the tagline "Seeing the Unknown."
| Indications for
Use | The SpectralMD™ DeepView™
Wound Imaging System 2.0 is an
optical imaging device intended for
studies of blood flow in the
microcirculation. The DeepView
system is suitable for a wide variety
of clinical applications including
plastic surgery, diabetes,
dermatology, vascular surgery,
wound healing, neurology,
physiology, neurosurgery and
anesthetics. In particular, it can be
used for measuring perfusion of
healthy and injured skin including
burn wounds, skin flaps (plastic and
reconstructive surgery), chronic
wounds, decubitus ulcers, and
diabetic ulcers | The SpectralMD DeepView
System is intended for
studies of blood flow in the
microcirculation. The
DeepView System is
suitable for a wide variety of
clinical applications including
plastic surgery, diabetes,
dermatology, vascular
surgery, wound healing,
neurology, physiology,
neurosurgery and
anesthetics. | The Aimago EasyLDI
Microcirculation Camera is
intended for blood flow
measurements in the
microcirculation. In
particular, it can be used for
measuring perfusion of
healthy and injured skin
including burn wounds, skin
flaps (plastic and
reconstructive surgery) and
hand surgery. EasyLDI
Studio is intended as offline
viewer applications for
snapshots, videos, and
references recorded with the
Aimago EasyLDI
Microcirculation Camera. |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software
Modules | Blood Flow Study, Burn Wounds,
Diabetic/Ischemic Wounds, Decubitus
Wounds, Chronic Wounds | None | Burn Wounds, Skin Flaps
(plastic and reconstructive
surgery and hand surgery. |
| User Interface | Graphical Touch Screen User
Interface with keyboard and mouse
input, mechanical buttons | User Interface with keyboard
and mouse input,
mechanical buttons | Graphical Touch Screen
User Interface with keyboard
and mouse input,
mechanical buttons |
| Image Speed for
Full Scan | 27 sec | 30 sec | Unknown |
| Image Speed for
Processing | 30 sec | 30 sec | Unknown |
| Pulse Rate
Detection | 60-180 bpm | 60-200 bpm | Yes; unknown rate detection |
| Camera
Resolution | 1280 x 1024 | 1024 x 512 | 480 x 480 pixels |
The updated indications for use of the DeepView 2.0 include a listing of wound types commonly presenting within the cleared clinical applications of the original DeepView device (primary predicate) and do not indicate a new intended use or new target population. Software updates improve processing efficiency and an improved user interface that includes specific wound modules for facilitating patient/wound documentation (similar to the additional predicate cited). The DeepView 2.0 uses broadband illumination between 400-900 nm versus a single wavelength for the primary predicate. This broadband illumination is included so that in addition to PPG measurements (850 nm), the device will display a color reference image (400-900 nm), rather than a black and white reference image produced by the primary predicate. Further, the broadband range permits the addition of green guiding beams to facilitate camera placement above the imaging site. Note: the wavelengths used to capture PPG images are similar between the DeepView System 2.0 (850 nm) and the original DeepView device (870 nm). This minor difference in wavelength is inconsequential in obtaining PPG images, and remains within the non-
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Image /page/6/Picture/0 description: The image shows the logo for Spectral MD. The logo consists of three downward-pointing arrows in blue, green, and red, followed by the text "SpectralMD" in a simple, sans-serif font. Below the text, in a smaller, italicized font, is the tagline "Seeing the Unknown."
harmful range. Additional differences between the DeepView 2.0 and the primary predicate also include a high-resolution camera, a larger, HD touch-screen monitor, and ergonomic improvements to the Mobile Cart. These differences are not considered to raise new issues of safety and effectiveness.
Summary of Testing
The DeepView System 2.0 has been subjected to comparative testing against the original DeepView system (primary predicate) in order to demonstrate that DeepView 2.0 is capable of detecting the pulsatile component of fluid flow in an equivalent manner to that of the primary predicate. In this testing, the device's ability to detect pulsatile fluid flow, frequency detection, and capability to detect pulsatile flow under conditions simulating physiological properties of blood flow in human tissues was evaluated. The results demonstrated the ability of the DeepView 2.0 to identify the 2% alternating change (AC) modulation that is consistent with the tissue-volume change in human tissue resulting from blood flow; to identify the AC modulations at various frequencies within the frequencies of the human heart rate: and to detect fluid flow beneath the surface of an optically dense medium. These results demonstrate that the DeepView System 2.0 performs in an equivalent manner to the original DeepView System (primary predicate).
The DeepView System 2.0 was also been evaluated for electrical safety and electromagnetic compatibility and was found to meet AAMI/ANSI ES60601-1:2005/(R) 2012 & A1:2012; IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 and IEC 60601-1-2 (2007)/(R) 2012. The DeepView 2.0 has been designed in accordance with FDA guidance on human factors and usability engineering and subjected to usability testing validation. No clinical performance data were needed to support substantial equivalence. The results of the testing performed demonstrate the DeepView Wound Imaging System 2.0 to be substantially equivalent to the predicate and does not introduce any new issues of safety and effectiveness.
Conclusion
The SpectralMD DeepView Wound Imaging System 2.0 is substantially equivalent to the predicate devices based upon the indication for use, technological characteristics, and the data submitted.