(78 days)
Not Found
Not Found
No
The device description focuses on a physical cover for catheters and feeding tubes, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as a cover to eliminate the need for tape for dressings on catheters and to cover and secure PEG tubes, which are supportive functions and not directly therapeutic.
No
Explanation: The device, Cath Caddie, is described as a cover to secure catheters or tubes (like Hickman Catheters or PEG tubes) and eliminate the need for tape, addressing skin irritation. Its function is descriptive and protective, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly describes a physical product ("covers," "prototypes") designed to secure medical tubes, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Cath Caddie is described as a cover and securement device for catheters (Hickman Catheters and PEG tubes) placed in the body. It is a physical device used externally or on the skin to manage medical tubes.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes. Its function is purely mechanical – to cover and secure medical tubes.
Therefore, the Cath Caddie falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
K 961884
AUG - 1 1996
510(k) Summary - Cath Caddie, submitted by Mark-Clark, a division of M-C Industries, Inc.
The Cath Caddie was developed by the grandmother of a pediatric cancer patient who received chemotherapy via a Hickman Catheter Constant removal of taped dressings placed in his chest. resulted in skin irritations to the youth.
The inventor created the Cath Caddie for her grandchild to eliminate the need for tape. Subsequently, she provided Cath Caddies for several additional patients of Dr. David Rosen. She estimates that Dr.Rosen has issued as many as 1,500 of the covers through his practice and through the Children's Miracle Network. (See attached photo-copy of letter from Dr. David Rosen.)
Additional prototypes of the Cath Caddie were provided to Dr. Jerry H. Feagan who in turn passed them on to the Endoscopy and Surgery Center of Topeka. This practice utilized the Cath Caddie to cover and secure PEG tubes of enteral feeding tubes in the abdomens of some of their patients. Elizabeth Thomas, administrator of the center found the Cath Caddie to be superior and much more convenient than the use of taped dressings for this purpose.
This product - both in theory and in actual practice - appears to provide an actual benefit to patient and doctor alike. The elimination of tape prevents typical skin irritation caused by adhesives. Obviously, this provides improved patient comfort while also avoiding the risk of infection possible with skin This helps to avoid additional healthcare costs sores. associated with treating secondary problems (skin sores) and eliminates ongoing expense of tape and gauze dressings to the physician's practice.