(110 days)
Not Found
No
The device description and performance studies focus on mechanical function and safety features, with no mention of AI or ML.
No
The device is described as an accessory for pre-filled syringes, designed to protect users from accidental needlesticks by covering the needle after injection. Its purpose is safety and protection, not to treat or diagnose a disease or condition directly.
No.
The device is an accessory for pre-filled syringes designed to prevent accidental needlesticks and does not gather information for diagnostic purposes.
No
The device description explicitly states it is composed of physical components (guard, body, spring, and plunger) and is an accessory for physical syringes, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an accessory for pre-filled syringes to prevent needlestick injuries during medication administration. This is a physical safety function related to drug delivery, not a diagnostic test performed on samples from the body.
- Device Description: The description focuses on the mechanical components (guard, body, spring, plunger) and how it covers the needle after injection. This aligns with a physical safety device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a medical device, specifically a safety accessory for drug delivery, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use remains the same. It is a safety mechanism to reduce occurrence of accidental needle sticks when using ISO standard glass prefilled syringes.
The indications for use remain the same with additional claims. The UltraSafe Passive Needle Guard is indicated for use as single use devices that are indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration. Additionally, the PLUS device is designed with a larger viewing window indicated where pharma company offering is a low fill volume and instructions request visualization. The PLUS device is designed with a robust plunger and built in extended finger flanges indicated where pharma customer offering is viscous.
Product codes (comma separated list FDA assigned to the subject device)
MEG
Device Description
The modification to the predicate device is the addition of the X100L PLUS device to the UltraSafe Passive Needle Guard X-Series family. The SSI UltraSafe PLUS Passive Needle Guard is an antineedlestick accessory for pre-filled ISO standard glass syringes. The device is composed of a guard, body, spring and plunger, is non-sterile and single use. The activation of the UltraSafe PLUS Passive Needle Guard device remains the same. Upon completion of the guard will slide forward, cover and lock over the needle of the syringe. It is a visual and/or audible recognition that the device safety feature has activated. The SSI devices are categorized as skin contact with a duration of category A- limited (
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
UltraSafe Passive PLUS Needle Guard
MAR 2 6 2013
| Company: | Safety Syringes, Inc.
2875 Loker Avenue East
Carlsbad, CA 92010 USA |
|-------------------------------------------|--------------------------------------------------------------------------------|
| Ph: | (760) 918-9908 |
| Fax: | (760) 918-0565 |
| Contact Person: | Suzanne Richardson
Vice President, Quality Assurance and Regulatory Affairs |
| | Mary Stanners, RAC
Senior Regulatory Specialist |
| Date Prepared: | December 5, 2012 |
| Trade/Proprietary Name: | UltraSafe PLUS Passive Needle Guard |
| Common Name: | Anti Stick Syringe |
| Classification Name: | Piston Syringe |
| Classification Number(s)/Product Code(s): | 21 CFR 880.5860 (MEG) |
Legally Marketed Predicate Device: UltraSafe Passive Needle Guard (510(k) K011369, K060743, K122558)
Device Description:
The modification to the predicate device is the addition of the X100L PLUS device to the UltraSafe Passive Needle Guard X-Series family. The SSI UltraSafe PLUS Passive Needle Guard is an antineedlestick accessory for pre-filled ISO standard glass syringes. The device is composed of a guard, body, spring and plunger, is non-sterile and single use. The activation of the UltraSafe PLUS Passive Needle Guard device remains the same. Upon completion of the guard will slide forward, cover and lock over the needle of the syringe. It is a visual and/or audible recognition that the device safety feature has activated. The SSI devices are categorized as skin contact with a duration of category A- limited (