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.

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.

AI/ML Overview

The provided text describes the SpectralMD DeepView Wound Imaging System 2.0 and its 510(k) submission for substantial equivalence to predicates.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

Crucially, the document states: "No clinical performance data were needed to support substantial equivalence." This means that the device's acceptance was not based on human reader studies, AI assistance, or the analysis of detailed clinical performance metrics like sensitivity, specificity, or AUC for diagnostic purposes. Instead, the focus was on demonstrating technological equivalence and safety.

Therefore, many of the typical criteria for evaluating AI/ML-based medical devices (especially those involving diagnostic performance improvement or standalone AI performance) are not applicable in this context, as the device is an imaging system measuring blood flow, not a diagnostic AI.

However, I can extract information related to the device's functional performance acceptance criteria and the engineering studies performed.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are framed around demonstrating equivalence to the predicate device in terms of fundamental functional performance related to blood flow detection and safety.

Acceptance Criterion (Implicit/Explicit)	Reported Device Performance (as stated in Summary of Testing)
Equivalent Detection of Pulsatile Fluid Flow	The DeepView 2.0 is "capable of detecting the pulsatile component of fluid flow in an equivalent manner to that of the primary predicate." Specific results: - Ability to identify the 2% alternating change (AC) modulation consistent with tissue-volume change from blood flow. - Ability to identify AC modulations at various frequencies within human heart rate frequencies. - Capability 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)."
Equivalent Frequency Detection of Pulsatile Flow	(See above) Demonstrated ability to identify AC modulations at various frequencies within human heart rate range.
Equivalent Capability under Simulated Physiological Conditions	(See above) Demonstrated ability to detect fluid flow beneath the surface of an optically dense medium.
Electrical Safety	Met AAMI/ANSI ES60601-1:2005/(R) 2012 & A1:2012; IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007.
Electromagnetic Compatibility (EMC)	Met IEC 60601-1-2 (2007)/(R) 2012.
Human Factors and Usability Engineering Compliance & Validation	Designed "in accordance with FDA guidance on human factors and usability engineering" and "subjected to usability testing validation."

Study Details (Based on the provided text)

Given the stated "No clinical performance data were needed," the "study" is primarily a series of engineering and bench testing studies to demonstrate functional and safety equivalence, not a traditional clinical trial.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of number of "cases" or "patients" as this was not a clinical performance study. The tests likely involved physical phantoms or controlled bench setups to simulate blood flow conditions.
- Data Provenance: Not applicable in the sense of patient data from specific countries. This was likely laboratory/bench testing.
- Retrospective/Prospective: Not applicable in a clinical sense. These were controlled engineering experiments.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for these engineering tests would be derived from the controlled experimental setup (e.g., known fluid flow rates, known material properties of optically dense media, precise electrical and EMC standards). No human "experts" establishing "ground truth" in terms of clinical interpretation were needed for these specific tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication is for clinical ground truth establishment, which was not performed here. The "adjudication" would be based on instrument readings and engineering standards.
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 study was done. The document explicitly states: "No clinical performance data were needed to support substantial equivalence." The device is an imaging system, and its software provides "specific wound modules for facilitating patient/wound documentation," but it's not described as having an AI component that assists human interpretation for a diagnostic outcome that would be subject to an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone AI performance study was done in the diagnostic sense. The "algorithm" here processes light interaction with tissue to produce 2D perfusion images. The performance assessed was its ability to detect pulsatile flow equivalently to the predicate device, not its ability to make a diagnostic determination on its own.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the functional tests was engineered and controlled experimental conditions (e.g., known AC modulation percentages, known frequency inputs, known optical properties of test media). For safety tests, it was adherence to recognized international electrical safety and EMC standards.
The sample size for the training set:
- Not applicable. The document describes a traditional medical device submission based on predicate equivalence, not an AI/ML device that requires a separate training set for algorithm development. While there's a "Proprietary Software Algorithm" for data analysis, there's no mention of a machine learning training phase or associated dataset.
How the ground truth for the training set was established:
- Not applicable. As no training set was described for an AI/ML model, no ground truth establishment for such a set is relevant here.

In summary, the DeepView System 2.0's acceptance was based on demonstrating technical and functional equivalence to its predicate device through bench and engineering testing, alongside adherence to safety and usability standards. It was not cleared as an AI-enabled diagnostic device requiring clinical performance studies with human readers or standalone AI performance metrics.

Summary

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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

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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

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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)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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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. / CEO855-436-2278
Trade Name:	SpectralMD™ DeepView™ Wound Imaging System 2.0
Common Name:	Extravascular Blood Flow Probe
ClassificationName:	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:

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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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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Indications forUse	The SpectralMD™ DeepView™Wound Imaging System 2.0 is anoptical imaging device intended forstudies of blood flow in themicrocirculation. The DeepViewsystem is suitable for a wide varietyof clinical applications includingplastic surgery, diabetes,dermatology, vascular surgery,wound healing, neurology,physiology, neurosurgery andanesthetics. In particular, it can beused for measuring perfusion ofhealthy and injured skin includingburn wounds, skin flaps (plastic andreconstructive surgery), chronicwounds, decubitus ulcers, anddiabetic ulcers	The SpectralMD DeepViewSystem is intended forstudies of blood flow in themicrocirculation. TheDeepView System issuitable for a wide variety ofclinical applications includingplastic surgery, diabetes,dermatology, vascularsurgery, wound healing,neurology, physiology,neurosurgery andanesthetics.	The Aimago EasyLDIMicrocirculation Camera isintended for blood flowmeasurements in themicrocirculation. Inparticular, it can be used formeasuring perfusion ofhealthy and injured skinincluding burn wounds, skinflaps (plastic andreconstructive surgery) andhand surgery. EasyLDIStudio is intended as offlineviewer applications forsnapshots, videos, andreferences recorded with theAimago EasyLDIMicrocirculation Camera.
SoftwareModules	Blood Flow Study, Burn Wounds,Diabetic/Ischemic Wounds, DecubitusWounds, Chronic Wounds	None	Burn Wounds, Skin Flaps(plastic and reconstructivesurgery and hand surgery.
User Interface	Graphical Touch Screen UserInterface with keyboard and mouseinput, mechanical buttons	User Interface with keyboardand mouse input,mechanical buttons	Graphical Touch ScreenUser Interface with keyboardand mouse input,mechanical buttons
Image Speed forFull Scan	27 sec	30 sec	Unknown
Image Speed forProcessing	30 sec	30 sec	Unknown
Pulse RateDetection	60-180 bpm	60-200 bpm	Yes; unknown rate detection
CameraResolution	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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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.

Regulation Number and Section

§ 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).