K Number
K954428
Device Name
SOLOPICC 24 (60CM) 20GA CATHETER
Date Cleared
1996-03-28

(188 days)

Product Code
Regulation Number
880.5200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SoloPICC and SoloMidline Peripheral Intravenous catheters are intended to be used for the administration of medications, fluids and nutritional therapy of thirty days or less duration.
Device Description
The SoloPICC and SoloMidline catheters are sterile, non-pvrogenic, single lumen radiopaque catheters with a PVC female Luer lock adapter. A stiffening stylet is inserted into the female adapter and runs the length of the catheter. The catheter is shrouded in a polyethylene protector and packaged in a printed tyvek\mylar peel pouch. A TFX T-Peelтм peelable introducer catheter is included in the tyvek\mylar package for catheter insertion purposes.
More Information

Not Found

No
The summary describes a standard intravenous catheter and its components, with no mention of AI or ML technology.

No.
The device is a catheter for administering medications and fluids, not for treating a disease or condition itself.

No

Explanation: The device description states its purpose is for "administration of medications, fluids and nutritional therapy," which are therapeutic functions, not diagnostic ones. There is no mention of the device being used to detect, identify, or monitor a medical condition.

No

The device description clearly outlines physical components such as catheters, stylets, adapters, and packaging, indicating it is a hardware 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 for the administration of medications, fluids, and nutritional therapy directly into the bloodstream. This is a therapeutic and delivery function, not a diagnostic one.
  • Device Description: The description details a catheter designed for insertion into a vein. This is a medical device used for direct patient care, not for testing samples outside the body.
  • Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, etc.) to diagnose a condition, monitor a disease, or screen for health issues.

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's purpose is to deliver substances into the body.

N/A

Intended Use / Indications for Use

The SoloPICC and SoloMidline Peripheral Intravenous catheters are intended to be used for the administration of medications, fluids and nutritional therapy of thirty days or less duration.

Product codes (comma separated list FDA assigned to the subject device)

Not Found

Device Description

The SoloPICC and SoloMidline catheters are sterile, non-pvrogenic, single lumen radiopaque catheters with a PVC female Luer lock adapter. A stiffening stylet is inserted into the female adapter and runs the length of the catheter. The catheter is shrouded in a polyethylene protector and packaged in a printed tyvek\mylar peel pouch. A TFX T-Peel™ peelable introducer catheter is included in the tyvek\mylar package for catheter insertion purposes.

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.

K801575, K914378

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

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).

0

K 954428

Image /page/0/Picture/1 description: The image shows the logo for Douglas Medical Products. The logo consists of a geometric shape on the left, followed by the word "Douglas" in a stylized font. Below "Douglas" is the text "A SoloPak Company". To the right of "Douglas" is the text "Medical Products".

September 16, 1995

MAR 2 8 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 - SoloPICC and SoloMidline Peripheral Intravenous Catheter Common Name - PICC, Peripherally Inserted Central Catheter, Flexible Intravenous Catheter Classification Name - Percutaneous Intravascular Catheter

The SoloPICC and SoloMidline Peripheral Intravenous catheters are intended to be used for the administration of medications, fluids and nutritional therapy of thirty days or less duration.

The SoloPICC and SoloMidline catheters are sterile, non-pvrogenic, single lumen radiopaque catheters with a PVC female Luer lock adapter. A stiffening stylet is inserted into the female adapter and runs the length of the catheter. The catheter is shrouded in a polyethylene protector and packaged in a printed tyvek\mylar peel pouch. A TFX T-Peelтм peelable introducer catheter is included in the tyvek\mylar package for catheter insertion purposes.

The processes and materials used to manufacture the SoloPICC and SoloMidline catheters are the same or the equivalent of the predicate devices named in this submission. The named predicate devices in this submission were the Luther Medical Products, Inc. L-Cath® Intravenous Placement Unit (K801575) and the Medical Profiles, Inc. Peripheral Intravenous Catheter (K914378). The SoloPICC and SoloMidline catheters are sterilized per AAMI guidelines to a 10 € sterlify assurance level. Each production lot is LAL tested per USP guidelines.

Based on the fact that the SoloPICC and SoloMidline catheters utilize similar and equivalent designs, materials, and components as currently legally marketed products, these products are safe and effective when used as intended.

Sincerely,

Ron Howard

Ron Haselhorst Director of RAIQA Douglas Medical Products