(88 days)
K932211,K83145
Not Found
No
The summary describes a standard medical device kit for inserting a peripheral intravenous catheter and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No
The device is described as an insertion kit for a peripheral intravenous catheter, which is used for placement of the catheter, not for therapy itself.
No
The device is described as an "Intravenous Catheter Insertion Kit" used for the "placement of a peripheral catheter." Its function is to facilitate the insertion of a catheter, not to diagnose a medical condition.
No
The device description explicitly states it includes physical components like a catheter, introducer, and accessories, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the placement of a peripheral catheter." This is a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device components (catheter, introducer, accessories) are all used for the physical insertion of a catheter into a vein. They are not used to analyze biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting diseases, conditions, or measuring substances in a sample.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a medical device used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The SoloPak Peripheral Intravenous Catheter Insertion Kits are intended to be used for the placement of a peripheral catheter.
Product codes
Not Found
Device Description
The SoloPak Peripheral Intravenous Catheter Insertion Kits include a single lumen catheter, introducer, and the necessary accessories to perform the placement.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Clinicathrw Procedural Tray (K932211), Per-Q-Cath Tray (K83145)
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
Image /page/0/Picture/1 description: The image shows the logo for Douglas Medical Products, which includes a geometric shape to the left of the company name. Below the company name, it says "A SoloPak Company". The date "JUN 18 1996" is printed in the upper right corner of the image.
March 19, 1996
To Whom it may concern:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act and CFR 807.92:
Trade Name - SoloPak Peripheral Intravenous Catheter Insertion Tray Common Name - PICC Placement Tray, PICC Procedural Tray Classification Name - Percutaneous Intravascular Catheter Accessory
The SoloPak Peripheral Intravenous Catheter Insertion Kits are intended to be used for the placement of a peripheral catheter. The SoloPak Peripheral Intravenous Catheter Insertion Kits include a single lumen catheter, introducer, and the necessary accessories to perform the placement.
The components, processes and materials used to manufacture the SoloPak Peripheral Intravenous Catheter Insertion Kits are the same or the equivalent of the predicate devices named in this submission. The named predicate devices in this submission were the Clinicathrw Procedural Tray (K932211) marketed by SIMS Deltec, Inc. and the Per-Q-Cath Tray (K83145) marketed by Gesco Intl. . Inc. The SoloPak Peripheral Intravenous Catheter Insertion Kits are sterlized per AAMI guidelines to a 10 - sterility assurance level.
Based on the fact that the SoloPak Peripheral Intravenous Catheter Insertion Kits utilize similar and equivalent designs, materials, and components as currently legally marketed products, these products are safe and effective when used as intended.
Sincerely.
Roy Weathers
Ron Haselhors Director of RAIQA Douglas Medical Products