(26 days)
Not Found
No
The 510(k) summary describes a simple mechanical device for holding cables or tubes and makes no mention of AI, ML, or any related computational technologies.
No
The device is described as a cable or tube holder intended to manage excess cables/tubing in the surgical field, rather than treating or diagnosing a medical condition.
No
Explanation: The device is described as a cable or tube holder designed to manage excess cables/tubing in the surgical field. Its function is to hold things in place, not to diagnose any condition or disease.
No
The device description clearly indicates a physical, disposable cable or tube holder made of nylon with adhesive backing, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to physically manage cables and tubing during surgery to keep the surgical field clear. This is a mechanical function, not a diagnostic one.
- Device Description: The description focuses on the physical construction and how it holds cables/tubing. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a surgical accessory designed for organizational purposes in the operating room.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Holder
Suction 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 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. |
| Intended Use: | 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.