(191 days)
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.
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.
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 |
§ 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.