· How does the AccuCirc compare with other circumcision devices?
· When is use of the AccuCirc indicated/contraindicated?
· What is in the AccuCirc kit?
· Is the AccuCirc reusable or disposable?
· How much does the AccuCirc cost?
· What training and educational resources are available for the AccuCirc?
The AccuCirc is a revolutionary circumcision device that helps physicians provide precise, consistent and reliable circumcision outcomes. Specifically designed to protect infants from injury, it consists of two innovative components: the Foreskin Probe/Shielding Ring and the Single-Action Clamp.
These two components work together to deliver the delicate hemostatic crush and precision cut of the foreskin in a single actuation, improving the safety, consistency and convenience of the circumcision procedure. The Foreskin Probe/Shielding Ring ensures that the glans is protected and the foreskin is properly aligned, while the Single-Action Clamp ensures adequate hemostatis and the precise delivery of the protected, circular blade.
The AccuCirc comes in a single, self-contained kit and is completely disposable.
The AccuCirc uses the Foreskin Probe/Shielding Ring and the Single-Action Clamp to complete the circumcision procedure. No dorsal slit, freehand scalpels, scissors, reusable clamps or safety pins are required.
After a pen mark is made on the foreskin along the coronal margin, the probe is used to remove adhesions between the foreskin and the glans. The shielding ring is then inserted and placed on top of the glans without the need for a dorsal slit. The foreskin is then secured in place, and the pen mark is aligned along the top of the shielding ring.
The clamp is then placed over the probe until an audible click is heard, ensuring that only the properly-matched components are being used. The clamp’s lever arm is then activated downward against the clamp housing and locked in place, activating the crushing action and delivering the protected, circular blade to the top of the ring. The lever arm is then released from the locking clip and lifted up, so that both the clamp and the probe/ring can be removed and discarded with the foreskin.
Click here to view a demonstration of the AccuCirc or visit the Home Page to see an animation of how it works.
How does the AccuCirc compare with other circumcision devices?
The AccuCirc provides an adequate hemostatic crush, a precise incision and consistent outcomes. The following unique features minimize the risk of injury and help to improve outcomes:
- Making a pen mark along the coronal margin and aligning that mark on the top of the Shielding Ring ensures that your incision will be right on the pen mark.
- The foreskin holder, not a safety pin, allows for accurate positioning of the foreskin tissue prior to activation of the clamp ensuring predictable, reliable outcomes.
- No dorsal slit is required to insert the Shielding Ring. This minimizes the risk of injury, shortens the procedure time, and simplifies the procedure.
- The Shielding Ring protects the glans, ensuring the self-contained, circular blade will never come in contact with the glans.
- Only correctly-matched and correctly-sized components can be used or the device cannot be activated. For example, a 1.3 cm clamp could never be activated using a 1.1 cm shielding ring. When the correctly-sized shielding ring and clamp are locked into place, an audible click is heard and only then can the device be activated.
- No scissors, scalpels or reusable clamps are ever used with the AccuCirc.
- The AccuCirc comes with everything needed for the procedure in a single, self-contained kit and is completely disposable.
The AccuCirc was specifically designed to minimize the risk of injury and provide consistent, reliable circumcision outcomes. It has safety features, such as the foreskin probe, shielding ring, and protected circular blade, built directly into the device, so that it cannot be misused nor have its components mismatched like other available devices.
- First, the shielding ring, after being inserted into the foreskin and placed on top of the glans, serves as a protection or buffer from the blade.
- Second, the shaft of the shielding ring acts as a key that enables, or “turns on” the clamp only if the shielding ring and clamp sizes match.
- Third, the blade, which is smaller in diameter than the shielding ring, can never get past the shielding ring to reach the glans. The internal, protected blade (not a freehand scalpel) can only cut along the top of the shielding ring.
After a thorough evaluation of the device, the FDA cleared the AccuCirc for unrestricted use in the United States. Click here to download a PDF version of the AccuCirc 510(k).
The AccuCirc comes in two sizes: 1.1 cm and 1.3 cm. The 1.3 cm device is completely white in color, while the 1.1 cm device comes with green clamping arms and a green Foreskin Probe/Shielding Ring to distinguish it from the 1.3 cm device. As an added safety measure, a 1.1 cm probe can never be used with a 1.3 cm clamp and vice versa. The device itself will prevent the use of incorrectly-sized parts.
· When is use of the AccuCirc indicated/contraindicated?
The AccuCirc is indicated for circumcisions of the penile foreskin on full-term, newborn (up to 10 days) male infants.
The AccuCirc is contraindicated in cases of malformed or ambiguous genitalia, family history of bleeding problems, the child has not had at least one void since birth, or the ring of the probe cannot be easily inserted and/or the foreskin appropriately aligned on the top of the ring.
Click here to see the complete AccuCirc label.
Each AccuCirc comes with a complete, self-contained kit, which consists of the foreskin probe/shielding ring, single-action clamp and blade, fenestrated drape with adhesive backing, surgical marking pen, two curved hemostats, sanitizing wipe, 3 iodine swab sticks, lubricating jelly, Xerofoam petrolatum dressing, and gauze.
· Is the AccuCirc reusable or disposable?
The AccuCirc is completely disposable. After use, close the lever arm and deposit the combined clamp and probe into a sharps container, and the other kit items as per hospital protocol.
· How much does the AccuCirc cost?
Please contact your local sales representatives for price quotations. The disposable AccuCirc kit contains everything needed to complete a circumcision procedure and is often less expensive than the resterilization of reusable circumcision trays.
· What training and educational resources are available for the AccuCirc?
Clinical Innovations is committed to education and training on the proper use of the AccuCirc, especially as it is the only significant innovation to circumcision devices and procedures in nearly 50 years. We recognize that proficiency with a new procedure comes with hands-on practice and familiarity.
Consequently, we have developed a training model that enables physicians to practice and become familiar with the device. (Click here to see the model used in the AccuCirc demonstration video).
Please contact your local sales representatives to arrange an opportunity to utilize the AccuCirc model for hands-on application and training.