(191 days)
Not Found
No
The summary describes a device that captures and measures image data but does not mention any AI or ML algorithms being used for analysis, interpretation, or decision-making. The performance studies focus on measurement accuracy and reproducibility, not on the performance of an AI/ML model.
No
The "Intended Use / Indications for Use" section explicitly states, "The Scout does not provide a diagnosis or therapy."
No
The "Intended Use / Indications for Use" section explicitly states, "The Scout does not provide a diagnosis or therapy." The device functions as an adjunctive tool to help measure and record external wound and body surface data, rather than diagnose a condition.
No
The device description explicitly states that the Scout is a combination digital camera and long-wave infrared camera housed in a plastic casing, indicating it includes hardware components beyond just software.
Based on the provided information, the Scout device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the living body.
- Scout's Function: The Scout device is a combination digital and infrared camera that captures images of the external body surface. It measures physical characteristics (size, area, perimeter) and thermal intensity data directly from the patient's body.
- Non-Contact and Non-Invasive: The description explicitly states that the Scout is "non-contact with respect to the patient" and "non-invasive." This is in direct contrast to the nature of IVD tests which require obtaining and analyzing samples from within the body.
- Intended Use: The intended use is to "measure and record external wound and body surface data" as an "adjunctive tool" for healthcare professionals. This involves direct interaction with the patient's external body, not the analysis of samples.
Therefore, the Scout device falls under the category of a medical device used for external measurement and imaging, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
FXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital camera (visual images), Long-wave infrared camera (thermal images)
Anatomical Site
A part of the body or two body surfaces, external wound and body surface data.
Indicated Patient Age Range
18 years of age or older.
Intended User / Care Setting
Intended for qualified healthcare professionals who are trained in its use.
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.
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
I. Accuracy and Reproducibility of the Scout [WV13CL-0004]:
Nineteen metal shapes with known areas were imaged, each with 3 pre-defined head directions to simulate 57 different wounds. Three clinicians measured each shape twice, using three measurement methodologies: PUSH Tool v 3.0 ("Ruler LxW Area"), the Scout LxW ("Scout LxW Area"), and the Scout Trace ("Scout Trace Area" and "Scout Perimeter"). The accuracy of the area calculated by each of the three methods was determined by comparing results to the known area of metal objects produced by a calibrated CNC Mill (Haas Model VF3) with Mastercam X6 machining software.
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]:
Performance of the Scout device and data was evaluated for 40 wound images that were captured in clinical outpatient and inpatient settings. Each of the 40 wound images were measured 3 times by 5 independent operators using the Scout. Analyses were completed to demonstrate the coefficient of variation for within and between operator for Scout LxW Area and Trace Area and Perimeter measurements.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
I. Accuracy and Reproducibility of the Scout [WV13CL-0004]
- Study type: Accuracy and Reproducibility study using simulated wounds.
- Sample size: 19 metal shapes, each with 3 pre-defined head directions (57 simulated wounds). Measured by 3 clinicians, twice, using 3 methodologies.
- Key results:
- The determination of area utilizing the Scout LxW function was equivalent with the clinical 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 by approximately 37-40%.
- The Scout Trace was the most accurate measure and resulted in area approximately 4% different than the true area and 2% different than the true perimeter.
- 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%.
- The within and between operator precision median %CV is less than 5 for all measurements.
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]
- Study type: Clinical evaluation of wounds.
- Sample size: 40 wound images from clinical outpatient and inpatient settings. Measured 3 times by 5 independent operators.
- Key results:
- The within operator precision is acceptable (median CV%
§ 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.
0
WoundVision 510(k) SUMMARY
| 1. Submitted by: | WoundVision LLC
5410 Emerson Way, Suite 1
Indianapolis, IN 46226 | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Mitch Roob
Chief Executive Officer
Phone: (888) 851-0098 | | |
| Date of Summary
Preparation: | December 6th, 2013 | | |
| 2. Names: | Proprietary Name:
WoundVision Scout
Common Name:
Scout
Device Classification:
21 CFR 878.4160
Regulation Name: Surgical camera and accessories.
Regulatory Class: Class I
Product Code: FXN | | |
| 3. Marketed Device(s) to
Which Equivalency
is 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 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. | | |
| 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 Device
Technology Comparison
Chart: | Scout | Silhouette | |
| Similarities | | | |
| Measurement | Measure the diameter, surface
area, and perimeter of a part of the
body or the distance between two
body surfaces. | Wound measurement and
documentation on all external wound
types. | |
| 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 & stores
source data (images &
measurements). | Electronically records & stores source
data (images & measurements). | |
| Method | Non-patient contacting
Powered | Non-patient contacting
Powered | |
| Material | Molded plastic | Molded plastic | |
| Measurement | Measures the diameter, perimeter
and surface area of a part of the
body or two body surfaces using a
visual image & measures the
thermal intensity variation data of
a part of the body or two body
surfaces using a thermal image. | Wound measurement and
documentation on all external wound
types. | |
| The two main differences between the Scout and its predicate device is
that the Scout combines measurement of size with the measurement of
thermal 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 each
object 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 three
measurement methodologies (six measurements for each shape's predefined head
direction). The Coefficient of Individual Agreement (CIA) methodology was utilized to
compare the clinical reference standard ruler LxW area, the Scout LxW area, and the
Scout Trace methodology. The accuracy of the area calculated by each of the three
methods (ruler LxW, Scout LxW, and the Scout Trace) was determined by comparing
results to the known area of metal objects produced by a calibrated CNC Mill (Haas
of each measurement were assessed. | Objectives and Purpose: Nineteen metal shapes with known areas were imaged, each
the reference standard LxW (diameter) ruler method as recommended in the NPUAP
Model 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 the
clinical 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 by
approximately 37-40%.
• The Scout Trace was the most accurate measure and resulted in area approximately
4% different than the true area and 2% different than the true perimeter.
• While the within-operator precision is better, the within and between operator
precision is acceptable for all measurements (median %CV IV. Determining Distance Impact on Thermal Intensity Utilizing Scout Imager |
| | [WV13REP-0008] |
| | Objectives and Purpose: To determine how distance affects the thermal intensity
of a calibrated, unchanging target. It is expected that thermal intensity will vary
based 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 was
not greater than a +/- 6 mode pixel value per 6" of distance change. Further, the
largest variation recorded during the test was +3 pixel values. |
| | V. Determining Environment Temperature Impact on Thermal Intensity Utilizing a
Scout Imager [WV13REP-0009] |
| | Objectives and Purpose: To determine how environmental temperature affects |
| | the thermal intensity of a calibrated, unchanging target. Thermal intensity pixel
value 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. The
outcome 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 of
view (FOV) correction affects thermal intensity. |
| | Results: Thermal intensity pixel value is not affected by the applied FOV
correction to the thermal image. Across 30 data comparison points, only two
displayed 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 and
the Thermal Image without correction was 15.58%. |
| Conclusions: | |
| | In conclusion, clinical and non-clinical data supports the substantial equivalence of
the Scout visual camera and measurements to its predicate and proves those
measurements to be repeatable and reliable. The tests also support the validation
and 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
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.
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