(77 days)
Not Found
No
The summary describes a kit of components for catheter insertion and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is a tray that provides components to aid in catheteter insertion, not the therapeutic catheter itself.
No
The device is described as a "Catheter Insertion Tray" that provides components to aid in the administration of percutaneous catheterization. Its purpose is to facilitate the insertion of catheters, not to diagnose a condition.
No
The device description clearly states it is a "disposable device" and provides "components" which are physical items used in a medical procedure, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the administration of percutaneous catheterization." This is a procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device provides components for inserting catheters into the body. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting diseases, conditions, or states of health through in vitro examination.
The device is a kit containing instruments and supplies for a medical procedure performed directly on a patient. This falls under the category of medical devices used for treatment or diagnosis in vivo, not in vitro.
N/A
Intended Use / Indications for Use
The Catheter Insertion Trav is a single patient, single use, disposable device which is intended to conveniently provide components to aid in the administration of percutaneous catheterization.
Product codes
Not Found
Device Description
The Catheter Insertion Tray is intended to conveniently provide the components used to aid the insertion of percutaneous catheters such as: TPN/CVP catheters, PICC Line catheters, and Long Line catheters. The Catheter Insertion Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.
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
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
OCT - 7 1996 K962849
(D) 510(k) Summary:
This summary is submitted in conformance with the format described in the 21 CFR Part 807.92 interim rule dated April 28, 1992.
- (1) Submitted By:
MedCare Medical Group, Inc. 234 Old Homestead Highway E. Swanzey, NH 03446
Contact Person:
Craig J. Bell Director of Research and Development (603)352-3230
- (2) Name of Device:
Catheter Insertion Tray
Classification Name:
Unknown
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- (3) Identification of Predicate Devices:
(510(k) No. K936261) Catheter Insertion Tray Prep Tray - PICC Insertion Cat No. DP2-2150
MedCare Medical Group, Inc. E. Swanzey, NH 03446
1
(4) Description of Device Subject to Premarket Notification:
The Catheter Insertion Tray is intended to conveniently provide the components used to aid the insertion of percutaneous catheters such as: TPN/CVP catheters, PICC Line catheters, and Long Line catheters. The Catheter Insertion Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.
Intended Use of the Device: (ર)
The Catheter Insertion Trav is a single patient, single use, disposable device which is intended to conveniently provide components to aid in the administration of percutaneous catheterization.
(6) Technological Characteristics
The MedCare Catheter Insertion Tray is similar to the predicate device in that both of the device provide a variety of auxiliary components for the convenient administration of percutaneous catheterization. Both devices provide flexibility in componentry selection for kit customization , which provides the maximum convenience for the customer. The proposed Catheter Insertion Tray will provide additional convenience by offering the inclusion of a vessel dilator and guide wire to the tray.