(88 days)
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.
This document, K961155, is a 510(k) premarket notification for the SoloPak Peripheral Intravenous Catheter Insertion Tray. It does not contain any information regarding acceptance criteria, device performance studies, or AI/algorithm-based assessments.
The document is a submission stating that the SoloPak Peripheral Intravenous Catheter Insertion Kits are substantially equivalent to predicate devices (Clinicathr Procedural Tray and Per-Q-Cath Tray). The safety and effectiveness are based on the kits utilizing similar and equivalent designs, materials, and components as legally marketed products, and sterilization according to AAMI guidelines.
Therefore, I cannot provide the requested information. The document does not describe:
- Acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods for a test set.
- MRMC comparative effectiveness studies or human reader improvement data.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
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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
§ 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.”