The Scout is a combination digital camera and long-wave infrared camera. The digital camera is indicated for the use of capturing visual images to measure the diameter, surface area, and perimeter of a part of the body or two body surfaces. The long-wave infrared camera is indicated for the use of capturing thermal images to measure the thermal intensity data of a part of the body or two body surfaces. Both components of the Scout are non-contact with respect to the patient and provide an adjunctive tool to help a trained and qualified health care professional measure and record external wound and body surface data.

Intended for qualified healthcare professionals who are trained in its use, the Scout is a non-invasive and non-radiating device.

The Scout is to be used on a patient population that includes non-pregnant female or male patients 18 years of age or older. The Scout is intended to be used in hospital, acute and sub-acute care settings, long term care, surgery, health care practitioner facilities, outpatient, home healthcare, or in any environment where health care is provided by a qualified health care professional.

The Scout does not provide a diagnosis or therapy.

Device Description

The Scout is a combination digital camera and long-wave infrared camera. The clinician simultaneously captures a visual and infrared image that can be uploaded and stored with a patient's electronic medical record. Body surface size and thermal intensity data can be measured and recorded.

The digital camera captures the visible light wavelengths from the electromagnetic spectrum that is visible to the human eye. The infrared camera captures the infrared radiation emitted by the human body from the electromagnetic spectrum that is not visible to the human eye.

Both cameras are housed in a plastic casing which transmits captured data to a PC.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies conducted for the WoundVision Scout device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for the WoundVision Scout primarily revolve around the accuracy and precision (reliability and repeatability) of its measurement functions for both visual and thermal imaging.

Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Implicit from Study Outcomes if not explicitly stated as "passing")	Reported Device Performance (from WV13CL-0004 & WV13CL-00061)
Visual Measurement Accuracy (Area)	Scout LxW equivalent to clinical reference standard ruler LxW method (Psi_R =.77, 95% CI (0.53, 1.02)).	Scout LxW: Psi_R =.77, 95% CI (0.53, 1.02) (Equivalent to ruler LxW). Overestimates true area by ~37-40%.
	Scout Trace desired to be closer to true area than LxW methods.	Scout Trace: Approximately 4% different from the true area.
Visual Measurement Accuracy (Perimeter)	Scout Trace desired to be closer to true perimeter.	Scout Trace: Approximately 2% different from the true perimeter.
Within-Operator Precision (Simulated Wounds)	Median %CV < 5 for all measurements.	Scout Perimeter: 1.94 %CV < 5%
		Scout Trace Area: 2.54 %CV < 5%
		Scout LxW Area: 3.87 %CV < 5%
Between-Operator Precision (Simulated Wounds)	Median %CV < 5 for all measurements.	Scout Perimeter: 1.97 %CV < 5%
		Scout Trace Area: 2.80 %CV < 5%
		Scout LxW Area: 4.20 %CV < 5%
Within-Operator Precision (Actual Wounds)	Median %CV < 10 for all measurements.	Scout Perimeter: 2.35 %CV < 10%
		Scout Trace Area: 3.72 %CV < 10%
		Scout LxW Area: 6.26 %CV < 10%
Between-Operator Precision (Actual Wounds)	Median %CV < 10 for all measurements.	Scout Perimeter: 3.71 %CV < 10%
		Scout Trace Area: 9.29 %CV < 10%
		Scout LxW Area: 9.82 %CV < 10%
Thermal Image Data Consistency (Varied Camera Angles)	Variation under +/- 6 pixels of the target temperature.	Hypothesized confirmed: Variation under +/- 6 pixels of the target temperature.
Thermal Image Data Consistency (Over Time)	Variation pattern similar amongst all imagers/target temperatures.	Hypothesized confirmed: Variation pattern similar amongst all imagers/target temperatures.
Thermal Intensity Scale Accuracy	Difference in pixel value between each degree C is 12.7 (+/- 2 pixels) throughout the temperature range.	Hypothesized confirmed: Difference was 12.7 (+/- 2 pixels) throughout the temperature range.
Thermal Intensity Distance Impact	Variation no greater than +/- 6 mean pixel value per 6" of distance change.	Hypothesized confirmed: Variation not greater than +/- 6 mode pixel value per 6" of distance change (largest recorded +3 pixels).
Thermal Intensity Environmental Temperature Impact	Environmental temperature affects thermal intensity pixel value when image captured.	Hypothesized confirmed: Environmental temperature affects thermal pixel value. Need for relative pixel value confirmed.
Thermal Image FOV Correction Impact	Thermal intensity not affected by applied FOV correction.	Hypothesized confirmed: Only two out of 30 data points showed slight mode difference of 1 pixel value.
Thermal Image Size Correction Accuracy	Low average % change between Visual Image and Thermal Image after scale correction.	Average % change after correction: -3.29% (vs. 15.58% without correction).

Study Details for WoundVision Scout

The information provided describes several clinical and bench testing studies that prove the device meets the acceptance criteria.

1. Clinical Study I: Accuracy and Reproducibility of the Scout [WV13CL-0004] (Simulated Wounds)

Sample Size: 19 metal shapes with known areas, imaged in 3 pre-defined head directions to simulate 57 different wounds.
Data Provenance: Not explicitly stated, but implies a controlled laboratory setting (simulated wounds). Retrospective or prospective is not specified, but the nature of controlling "pre-defined head directions" suggests a prospective, controlled study design.
Number of Experts & Qualifications: 3 clinicians. Qualifications not specified beyond "clinicians."
Adjudication Method: Not applicable as the ground truth was known areas of metal objects.
MRMC Comparative Effectiveness Study: No. This study assessed the device's accuracy against a known truth and compared its methods against a traditional ruler method.
Standalone Performance: Yes, this study assessed the algorithmic performance of the Scout's LxW and Trace methods in determining area and perimeter.
Type of Ground Truth: Known area of metal objects produced by a calibrated CNC Mill (Haas Model VF3) with Mastercam X6 machining software.
Training Set Sample Size: Not applicable/provided for this test set, as the device's performance was being evaluated. This study assessed the output of the device after its development.
Training Set Ground Truth: Not applicable/provided.

2. Clinical Study II: Comparison of Standardized Clinical Evaluation of Wounds Using Ruler Length by Width and Scout Length by Width Measure and Scout Perimeter Trace [WV13CL-00061] (Actual Wounds)

Sample Size: 40 wound images.
Data Provenance: Captured in clinical outpatient and inpatient settings. Retrospective or prospective is not specified, but the nature of using already "captured" images suggests a retrospective analysis of collected data.
Number of Experts & Qualifications: 5 independent operators. Qualifications not specified beyond "operators," although the discussion mentions "clinical experts and non-clinicians."
Adjudication Method: Not applicable for establishing ground truth, as the study focused on within- and between-operator variability of the Scout's measurements on these wound images. The previous study established the accuracy of the methods against a known ground truth.
MRMC Comparative Effectiveness Study: No, this focused on inter- and intra-reader variability of the device's measurements.
Standalone Performance: Yes, the study evaluated the precision of the Scout's algorithms (LxW Area, Trace Area, Perimeter) when used by different operators.
Type of Ground Truth: No direct "ground truth" for area/perimeter measurement was established for these 40 actual wounds within this study. Instead, the study assessed the precision (repeatability and reproducibility) of the device's measurements in a clinical setting when measuring real wounds. The performance metrics were coefficient of variation (CV%).
Training Set Sample Size: Not applicable/provided.
Training Set Ground Truth: Not applicable/provided.

3. Bench Testing Studies (WV13REP-0005, WV13REP-0006, WV13REP-0007, WV13REP-0008, WV13REP-0009, WV13REP-0010, WV13REP-0011)

These studies focused on the performance characteristics of the thermal imaging component of the Scout.

Sample Size: Not explicitly detailed in terms of number of images or targets for each study, but implied to be sufficient for bench testing.
Data Provenance: Controlled laboratory bench testing environment.
Number of Experts & Qualifications: Not applicable as these are bench tests of the device's hardware/software performance under controlled conditions.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: No.
Standalone Performance: Yes, these studies assess the standalone performance of the thermal imaging system under various controlled parameters (angles, distance, environment, FOV correction, size correction).
Type of Ground Truth: Calibrated targets (e.g., target temperature, known pixel values, or comparisons to unaltered visual images).
Training Set Sample Size: Not applicable/provided.
Training Set Ground Truth: Not applicable/provided.

Overall Conclusion from the Summary:

The studies collectively support the substantial equivalence of the Scout's visual camera and measurements to its predicate, demonstrating repeatability and reliability. They also validate the accuracy and performance of the adjunctive long-wave infrared camera. The device's measurement precision (within and between operators) falls within acceptable limits (typically <5% for simulated wounds, <10% for actual wounds) for all measured parameters, with the Scout Trace Perimeter consistently being the most precise. While LxW methods tended to overestimate true area, the Scout Trace method provided a much more accurate estimate.

Summary

{0}------------------------------------------------

WoundVision 510(k) SUMMARY

1. Submitted by:	WoundVision LLC5410 Emerson Way, Suite 1Indianapolis, IN 46226
Contact Person:	Mitch RoobChief Executive OfficerPhone: (888) 851-0098
Date of SummaryPreparation:	December 6th, 2013
2. Names:	Proprietary Name:WoundVision ScoutCommon Name:ScoutDevice Classification:21 CFR 878.4160Regulation Name: Surgical camera and accessories.Regulatory Class: Class IProduct Code: FXN
3. Marketed Device(s) toWhich Equivalencyis Claimed:	Aranz Medical, Silhouette, K070426
4. Device Description:	The Scout is a combination digital camera and long-wave infrared camera.The clinician simultaneously captures a visual and infrared image that canbe uploaded and stored with a patient's electronic medical record. Bodysurface size and thermal intensity data can be measured and recorded.The digital camera captures the visible light wavelengths from theelectromagnetic spectrum that is visible to the human eye. The infraredcamera captures the infrared radiation emitted by the human body fromthe electromagnetic spectrum that is not visible to the human eye.Both cameras are housed in a plastic casing which transmits captured datato a PC.
5. Intended Use:	The Scout is a combination digital camera and long-wave infrared camera. The digital camera is indicated for the use of capturing visual images to measure the diameter, surface area, and perimeter of a part of the body or two body surfaces. The long-wave infrared camera is indicated for the use of capturing thermal images to measure the thermal intensity data of a part of the body or two body surfaces. Both components of the Scout are non-contact with respect to the patient and provide an adjunctive tool to help a trained and qualified health care professional measure and record external wound and body surface data. Intended for qualified healthcare professionals who are trained in its use, the Scout is a non-invasive and non-radiating device. The Scout is to be used on a patient population that includes non-pregnant female or male patients 18 years of age or older. The Scout is intended to be used in hospital, acute and sub-acute care settings, long term care, surgery, health care practitioner facilities, outpatient, home healthcare, or in any environment where health care is provided by a qualified health care professional. The Scout does not provide a diagnosis or therapy.
	Discussion of Intended Use Differences:Although the intended use of WoundVision Scout differs from that of the predicate, none of the differences are critical to the use of the device nor do they affect the safety and effectiveness of the device. The Scout is able to use a visual image to obtain standard wound measurements similar to the predicate.
	By using a technology that combines a substantially equivalent method for measuring visual images with a method for measuring thermal images, the Scout also allows for a physiological measurement of thermal intensity data of a part of the body or two body surfaces adjunctive to the visual camera. The Scout's long-wave infrared camera and features serve as an auxiliary component and secondary measure (adjunct) to the Scout's substantially equivalent visual camera. Bench testing and clinical usability testing indicates that the method for obtaining relative thermal intensity data of the anatomical measurement site is reliable and repeatable.
6. Predicate DeviceTechnology ComparisonChart:	Scout	Silhouette
Similarities
Measurement	Measure the diameter, surfacearea, and perimeter of a part of thebody or the distance between twobody surfaces.	Wound measurement anddocumentation on all external woundtypes.
Life Supporting/Sustaining	Non-life supporting/sustaining	Non-life supporting/sustaining
Implant	Not an implant	Not an implant
Category	Pre-market Notification 510(k)	Exempt
- - - - - - - - - - -Differences_	1 : " : " :
Technology	Electronically records & storessource data (images &measurements).	Electronically records & stores sourcedata (images & measurements).
Method	Non-patient contactingPowered	Non-patient contactingPowered
Material	Molded plastic	Molded plastic
Measurement	Measures the diameter, perimeterand surface area of a part of thebody or two body surfaces using avisual image & measures thethermal intensity variation data ofa part of the body or two bodysurfaces using a thermal image.	Wound measurement anddocumentation on all external woundtypes.
The two main differences between the Scout and its predicate device isthat the Scout combines measurement of size with the measurement ofthermal intensity.The differences in technology of the Scout and its predicate do not affect
	safety and effectiveness.
Clinical Testing:	I. Accuracy and Reproducibility of the Scout [WV13CL-0004]with 3 pre-defined head directions to simulate 57 different wounds. The area of eachobject was calculated in cm2 utilizing three different methodologies:PUSH Tool v 3.0 ("Ruler LxW Area")the Scout LxW ("Scout LxW Area")the Scout Trace ("Scout Trace Area" and "Scout Perimeter")Each shape was measured by three clinicians twice, using each of the threemeasurement methodologies (six measurements for each shape's predefined headdirection). The Coefficient of Individual Agreement (CIA) methodology was utilized tocompare the clinical reference standard ruler LxW area, the Scout LxW area, and theScout Trace methodology. The accuracy of the area calculated by each of the threemethods (ruler LxW, Scout LxW, and the Scout Trace) was determined by comparingresults to the known area of metal objects produced by a calibrated CNC Mill (Haasof each measurement were assessed.	Objectives and Purpose: Nineteen metal shapes with known areas were imaged, eachthe reference standard LxW (diameter) ruler method as recommended in the NPUAPModel VF3) with Mastercam X6 machining software. Both inter- and intra-rater reliability

{1}------------------------------------------------

{2}------------------------------------------------

{3}------------------------------------------------

Results:• The determination of area utilizing the Scout LxW function was equivalent with theclinical reference standard ruler LxW (Psi_R =.77, 95% CI (0.53, 1.02).• Both the ruler LxW and the Scout LxW measurements overestimate the true area byapproximately 37-40%.• The Scout Trace was the most accurate measure and resulted in area approximately4% different than the true area and 2% different than the true perimeter.• While the within-operator precision is better, the within and between operatorprecision is acceptable for all measurements (median %CV < 5) with the ScoutPerimeter being the least variable.
The within operator precision:• Scout Perimeter 1.94 CV%• Scout Trace Area 2.54 CV%• Scout LxW Area 3.87 CV%
The between operator precision:• Scout Perimeter 1.97 CV%• Scout Trace Area 2.80 CV%• Scout LxW Area 4.20 CV%
In conclusion, the Scout LxW method is equivalent to the current clinical reference standardruler LxW for calculating area. The Scout Trace method results in an area much closer to thetrue area than either the ruler LxW or the Scout LxW method. The within and betweenoperator precision median %CV is less than 5 for all measurements.
II. Comparison of Standardized Clinical Evaluation of Wounds Using Ruler Length byWidth and Scout Length by Width Measure and Scout Perimeter Trace [WV13CL-00061]Objectives and Purpose: Performance of the Scout device and data was evaluated for40 wound images that were captured in clinical outpatient and inpatient settings. Eachof the 40 wound images were measured 3 times by 5 independent operators using theScout. Analyses were completed to demonstrate the coefficient of variation for withinand between operator for Scout LxW Area and Trace Area and Perimeter measurements.The results of this study demonstrate:
• The within operator precision is acceptable (median CV% <10) for all threemeasurements.• Scout Perimeter 2.35 CV%• Scout Trace Area 3.72 CV%• Scout LxW Area 6.26 CV%

{4}------------------------------------------------

The between operator variability is larger than the within but is still <10% for all . measurements (median %CV). The larger variability between readers suggests the differences in subjective perception of qualitative wound characteristics (wound edge) may influence wound assessment agreement and thus is to be expected. Scout Perimeter 3.71 CV% o Scout Trace Area 9.29 CV% O Scout LxW Area 9.82 CV% o The within operator results with actual wounds, median CV% 2.35-6.26, are similar to . those on simulated wounds of known size, median CV% 1.94-3.87 (WV13CL-0004) demonstrating that the device gives reliable results when used in the clinical setting for repeat measurements by the same operator. The between operator results with actual wounds median CV% 3.71-9.82, are . greater than those on simulated wounds of known size, median CV% 1.97-4.20. The determination of the shape or wound edge is cleaner with metal objects than with an actual wound image. These results are in alignment with findings reported in the literature that show the between operator differences exist not because of the measurement technique but instead due to the judgment of the operator performing the measurement. However, the between operator median %CV is less than 10 for all methodologies. ● Scout can be used by operators with varied backgrounds and provides similar results when clinical experts and non-clinicians utilize the device. Scout has been shown to provide reliable wound measurements on patient wounds . captured in a clinical setting. Scout provides accurate and reliable measurements of wound size, with the Scout . Perimeter being the least variable. Summary: The data from this study suggests that a single operator can measure the same . wound multiple times similarly. And as expected, multiple operators do not measure the same wound as well as a single operator. The variation that exists between readers in wound measurement is not necessarily due to the measurement technique but instead the judgment of the operator in determining the wound edges performing the measurement. . The within and between operator precision is acceptable for all measures but is similar for the Scout Trace Area (median %CV within- 3.72 and between 9.29) and the Scout LxW (median %CV within 6.26 and between 9.82). Perimeter measurement is more precise than both Traced Area and Scout LxW (median %CV within 2.35 and between 3.71). For all measurements, the within operator precision is better than the between operator.

•

{5}------------------------------------------------

			The results in the table below are similar to those observed in the study usingsimulated wounds of known size demonstrating that the Scout device providedacceptable results when utilized on patient wounds.
	MeasurementTéchnique	Within ShapeMedian CV%:	Within Wound'Median CV%	BetweenMedian CV.%;	Between.Wound,Median CV%.
	Scout LxW	3.87	6.26	4.20	9.82
	Scout Trace Area	2.54	3.72	2.80	ਕੇ 29
	Scout TracePerimeter	1.94	2.35	1.97	3.71
Bench Testing:
	I. Accuracy of Thermal Image Data at Varied Camera Angles [WV13REP-0005]
	II. Trend of Thermal Image Data Utilizing Scout [WV13REP-0006]		Objectives and Purpose: To show that the thermal image data (thermal pixelvalues) acquired is consistent when the angle of the imager to a calibrated targetchanges. The target captured in each image using the Scout and ImageCapturewill be analyzed using Scout ImageReview to measure outcome of the endpoints.It is expected that there may be some variation in the thermal pixel valuesmeasured but that when there are variances, it will be a simple shift of themeasured endpoints with a variance under +/- 6 pixels of the target temperature.Results: The hypothesis was confirmed with this test. There was some variation inthe thermal pixel values measured but the variance was a small shift of themeasured endpoints with a variance under +/- 6 pixels of the target temperature.Objectives and Purpose: The target captured in each image using Scout will beanalyzed using Scout ImageReview software to measure the outcome of the
			endpoints over time. It is expected that there may be some variation in the
			thermal pixel values measured of the target but that the variation pattern shouldbe similar amongst all imagers tested regardless of target temperature.
			Results: Variation in the thermal pixel values measured on the target werediscovered. The variation pattern was similar amongst all imagers testedregardless of target temperature. All three imager's at all three temperaturestrended downward in thermal pixel value for the first 15-20 minutes after imagerpower on and then thermal pixel value started to trend upward.
	III. Validation of the Thermal Intensity Scale Using a Scout Imager [WV13REP-0007]		Objectives and Purpose: To determine the accuracy of the scale of approximately12.7 pixels per 1°C. 12.7 pixels is determined from a 20°C range across a 254pixel value range (254/20 = 12.7 pixels per 1C). The L3 thermal camera core

{6}------------------------------------------------

	contains 254 unique pixel values evenly distributed across approximately 20°Cand it expected that the difference in pixel value between each degree C will be12.7 (+/- 2 pixels) throughout the temperature range.
	Results: The hypothesis was confirmed with this test. The difference in pixel valuebetween each degree C was 12.7 (+/- 2 pixels) throughout the temperaturerange.
	IV. Determining Distance Impact on Thermal Intensity Utilizing Scout Imager
	[WV13REP-0008]
	Objectives and Purpose: To determine how distance affects the thermal intensityof a calibrated, unchanging target. It is expected that thermal intensity will varybased on the distance of image capture. The variation will be no greater than a+/- 6 mean pixel value per 6" of distance change.
	Results: The hypothesis was confirmed with this test. The thermal variation wasnot greater than a +/- 6 mode pixel value per 6" of distance change. Further, thelargest variation recorded during the test was +3 pixel values.
	V. Determining Environment Temperature Impact on Thermal Intensity Utilizing aScout Imager [WV13REP-0009]
	Objectives and Purpose: To determine how environmental temperature affects
	the thermal intensity of a calibrated, unchanging target. Thermal intensity pixelvalue is affected by environmental temperature when the image was captured.
	Results: The hypothesis was confirmed that environmental temperature does
	affect the thermal pixel value displayed by the thermal imager. The amount of
	the effect could not be conclusively confirmed from the data collected. Theoutcome of this test confirms need for the use of relative pixel value.
	VI. Determining FOV Correction Impact on Thermal Intensity [WV13REP-0010]Objectives and Purpose: To determine how the applied thermal image field ofview (FOV) correction affects thermal intensity.
	Results: Thermal intensity pixel value is not affected by the applied FOVcorrection to the thermal image. Across 30 data comparison points, only twodisplayed a slight mode difference of 1 pixel value.
	VII. Determining the Size Correction Accuracy Applied to the Thermal Image[WV13REP-0011]
	Objectives and Purpose: To determine how equivalent the thermal image is to
	the unaltered visual image after a scale correction is applied to the thermal.
	Results: The average % change between the Visual Image and Thermal Image
	after correction was -3.29%. The average % change between the Visual Image andthe Thermal Image without correction was 15.58%.
Conclusions:
	In conclusion, clinical and non-clinical data supports the substantial equivalence ofthe Scout visual camera and measurements to its predicate and proves thosemeasurements to be repeatable and reliable. The tests also support the validationand accuracy of the adjunctive long-wave infrared camera.

{7}------------------------------------------------

{8}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of an eagle or other bird-like figure, with three curved lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 11, 2013

WoundVision, LLC c/o Pearl Pathways Gretchen Miller Bowker 29 East McCarty Street, Suite 100 Indianapolis, Indiana 46225

Re: K131596

Trade/Device Name: Wound Vision Scout Regulation Number: 21 CFR 878.4160 Regulation Name: Surgical camera and accessories Regulatory Class: Class I Product Code: FXN Dated: October 30, 2013 Received: October 31, 2013

Dear Ms. Bowker:

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

{9}------------------------------------------------

Page 2 - Gretchen Miller Bowker

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Joshua C. Nipper -S

Binita Ashar, MD, MBA, FACS Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image contains the word "WOUNDVISION" in bold, sans-serif font. To the right of the word is a circular graphic made up of many small dots. The dots are arranged in a grid-like pattern, creating a textured effect within the circle. The overall impression is of a logo or brand name accompanied by a visual element.

INDICATIONS FOR USE

510(k) Number (if known): K131596 Device Name: Scout

Intended for qualified healthcare professionals who are trained in its use, the Scout is a non-invasive and non-radiating device.

The Scout does not provide a diagnosis or therapy.

Page 1 of 1

Prescription Use	X
(Per 21 CFR 801 Subpart D)
AND/OR Over-the-Counter Use
(21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R-Ogden -S
2013.12.11 12:09:23
-05'00'

(Division Sign-Off) for BSA

Division of Surgical Devices

510(k) Number_K131596

Regulation Number and Section

§ 878.4160 Surgical camera and accessories.

(a)
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.