Attachment A - Salient Characteristics.docx

Brand Name or Equal Worksheet (“Salient Characteristics”) Brand Name Item: Smith & Nephew Lens 4K Endo Video System

1) Essential/significant physical, functional, or performance characteristics.

a) Requirements - The unit must be specifically designed as a minimally invasive hip arthroscopy system. The unit must be capable of identifying and treating hip issues (labial/labrum tears, synovitis, dysplasia, etc.). The unit must include a light source, scopes, software, monitor, camera, stand and integrated insufflator and CO2 functionalities. The camera control unit must include an integrated light source. The light source must be LED. Camera head must operate for a minimum of 2 hours at ambient temperatures and must not exceed 99°. Camera head must be C-mounted with 4K capabilities using dedicated light channel sensors. The camera system must be cardiac floating (CF) rated (IEC 60601-1 classification). *Referring to the part of the medical device which comes into physical contact with the patient in order for the device to carry out its intended function. Camera system must be capable of real-time remote control of arthroscopic device settings.

b) Compatibility – Yes; the supplies must be interchangeable with existing S&N arthroscopy equipment.

c) Dimensions/Weight – (Not Specified)

d) Industry Standard – For healthcare facilities providing hip orthopedic operative surgery, it is the standard of care to have a hip endo video system.

e) Purpose – A minimally invasive hip arthroscopy system is used for a surgical procedure that allows doctors to view the hip joint without making a large incision (cut) through the skin and other soft tissues. The purpose of a hip arthroscopy is to diagnose and treat hip issues. *During hip arthroscopy, a surgeon inserts a small camera, called an arthroscope, into the hip joint. The surgeon uses these images to guide miniature surgical instruments to treat hip issues. Because it’s minimally invasive surgery (small cut) using miniature instruments, infection risks and the hospital length of stay are significantly reduced while greatly increasing the recovery time.

f) Governing Body or Organization – N/A Complete generic identification – The purpose of this unit is to diagnose and treat hip issues using a minimally invasive technique.

2) Applicable model/make/catalog number –, Smith & Nephew Lens 4K System.

3) Manufacturer name – Smith & Nephew