(26 days)
The sterile, disposable cable or tube holder is intended to limit the amount of excess cable or tubing that extends into the surgical field. The holders are offered in 1/2" and 3/4" sizes to allow for a variety of diameters. Pressure sensitive adhesive is attached to the back of both sizes to allow for easy attachment to a clean, dry surface.
The cable or suction tube holder is a sturdy nylon construction available in 1/2" or 3/4" diameter. Pressure sensitive adhesive backing allows for the holders to be positioned on a clean, dry surface. Flexible lock and release loops allow the cable or tube to be retained and held in place.
The provided text is a 510(k) summary for a "Cable Holder / Suction Tube Holder." It describes the device, its intended use, and identifies a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information. The 510(k) summary provided pertains to a simple medical device (a cable/suction tube holder) and not a diagnostic or AI-powered device that would typically undergo the kind of performance evaluation described in your request. Such detailed performance studies are usually associated with devices that generate, process, or interpret data, or make diagnostic recommendations.
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510(K) SUMMARY (as required by 807.92(c))
Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters. The sequence starts with the letter 'K', followed by the number '9', then '7', '1', '0', '4', and ends with '0'. The characters are written in a simple, slightly irregular style.
. . .
篇
| Submitter of 510(k): | Contour Fabricators, Inc.4100 East Baldwin Rd.Grand Blanc, MI 48439 |
|---|---|
| APR 16 1997 | |
| Phone: | (810)695-2910 |
| Fax: | (810)695-5336 |
| Contact Person: | Michael W. Czop |
| Date of Summary: | March 19, 1997 |
| Trade Name: | Cable HolderSuction Tube Holder |
| Classification Name: | n/a |
| Predicate Device: | Tecnadyne Scientific Incorporated,"Technadyne Endoscopic Instrument Holder"K940891 |
| Device Description: | The cable or suction tube holder is a sturdy nylon constructionavailable in 1/2" or 3/4" diameter. Pressure sensitive adhesivebacking allows for the holders to be positioned on a clean, drysurface. Flexible lock and release loops allow the cable or tube tobe retained and held in place. |
| Intended Use: | The sterile, disposable cable or tube holder is intended to limit theamount of excess cable or tubing that extends into the surgicalfield. The holders are offered in 1/2" and 3/4" sizes to allow for avariety of diameters. Pressure sensitive adhesive is attached to theback of both sizes to allow for easy attachment to a clean, dry |
surface.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.