(206 days)
No
The description focuses on mechanical features for needle safety and does not mention any AI/ML components or functions.
No.
The device's function is for the injection or withdrawal of fluids and to prevent accidental needle sticks; it does not directly treat or diagnose a disease or condition.
No
The device is described as a safety needle for injecting or withdrawing fluids, with a feature to prevent needle sticks. Its function is to facilitate medical procedures, not to diagnose conditions.
No
The device description clearly outlines physical components like a cannula, hub, and safety shield, indicating it is a hardware device with a safety feature, not a software-only device.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "injection of fluids into or withdrawal of fluids from parts of the body below the surface of the skin." This describes a device used for direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo, not for testing samples in vitro.
- Device Description: The description details a needle with a safety shield designed for injection and withdrawal of fluids from the body. This aligns with a medical device used for patient care, not for laboratory testing of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The function is purely mechanical for fluid transfer and safety.
Therefore, the NOVAguard™ Safety Needle is a medical device used for injections and fluid withdrawal, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The primary function of the NOVAguard™ Safety Needle is for the injection of fluids into or withdrawal of fluids from parts of the body below the surface of the skin. The needle stick prevention feature helps prevent accidental needle sticks by shielding the needle after use.
Product codes
FMI
Device Description
NOV Aguard™ is a sharps injury protection device with a passively activated safety shield. The NOV Aguard™ product has a female luer connector, compatible with a luer-lock syringe, on one side and a stainless steel cannula on the other. A shield is mounted around the cannula. This product is packaged in a rigid container sealed by a Tyvek lid to facilitate sterilization. The product is removed from the package and connected to a luer-lock syringe simultaneously; this is accomplished when attaching the syringe, turning it in a clockwise direction. During this process, the shield is automatically moved to a position where the cannula tip is exposed so that the user can easily see it. An injection is given using the standard common technique. Inserting the cannula into the patient displaces the shield causing the shield legs to move apart and act like a spring. Upon removal, the spring force of the shield legs forces the shield over the tip of the cannula into a locked position.
The NOV Aguard™ Safety Needle is an assembly of three components. A cannula, a hub and a safety shield.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface of the skin.
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)
Finished products are tested and must meet all required release specifications prior to distribution. The array of testing required for release include but are not limited to; Physical testing and visual examination (in-process and finished product).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043397, K951254, K012736, K040531
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
APR 2 4 2009
Image /page/0/Picture/2 description: The image shows the logo for West, a company that delivers innovative solutions. The word "West" is written in a bold, sans-serif font, with the "t" extending into a diamond shape filled with horizontal lines. Below the word "West" is the tagline "Delivering Innovative Solutions" in a smaller, sans-serif font.
101 Gordon Drive · Lionville, PA 19341 TEL 610-594-2900 • FAX 610-594-3000 westpharma com
510(k) summary for the NOVAGUARD™ SAFETY NEEDLE (as required by section 807.92)
510(k) Notification submitted by:
Contact person:
Date Summary Prepared
Trade Name:
Classification name:
Common device name:
Predicate devices:
Manufacturer:
West Pharmaceutical Services Inc. 101 Gordon Drive Lionville, PA 19341 USA Phone: (610) 594-2900 Fax: (610) 594-3016
Mr. Ari Y. Sobel Director, Regulatory Affairs
September 30, 2008
NOVAguard™ Safety Needle
General Hospital Class II, 80FMI Per 21 CFR 880.5570 Hypodermic Single Lumen Needle (with Antistick Feature)
Hypodermic needle with safety sheath or needle with needle protection device
BD Eclipse™ Hypodermic Needle 510(k) No. K043397 Becton, Dickinson & Company
SATETYGLIDE™ NEEDLE 510(k) No. K951254 Becton, Dickinson Vacutainer Systems Preanalytical Solutions
MONOJECTTM SAFETY NEEDLE 510(k) No. K012736 Tyco Healthcare (Covidien)
TERUMO SURGUARD2TM SAFETY NEEDLE 510(k) No. K040531 Terumo Medical Corp
West Pharmaceutical Services Inc. 101 Gordon Drive Lionville, PA 19341 USA
1
Image /page/1/Picture/1 description: The image shows the logo for "West Delivering Innovative Solutions". The word "West" is in large, bold, black letters, with the tagline "Delivering Innovative Solutions" underneath in a smaller font. To the right of the word "West" is a diamond shape made up of horizontal lines, with a trademark symbol in the upper right corner.
101 Gordon Drive · Lionville, PA 19341 TEL 610-594-2900 · FAX 610-594-3000 westpharma.com
Material:
The NOV Aguard™ Safety Needle is classified as Externally Communicating Device, Blood Path Indirect, Limited Duration of Contact (