(29 days)
Not Found
No
The device description and performance studies focus on mechanical function and material changes, with no mention of AI/ML technologies.
No.
The device is described as an "anti-needlestick accessory" that "aids in the protection of healthcare professionals, patients... and individuals that assist... from accidental needlesticks." Its function is safety-related by covering a needle, not to treat or diagnose a medical condition.
No
Explanation: The device is described as an "anti-needlestick accessory for pre-filled ISO standard glass syringes" that "aid[s] in the protection of healthcare professionals, patients...and individuals that assist self-injecting patients, from accidental needlesticks." Its function is to cover and lock over the needle after injection to prevent sharps injury. This is a safety accessory for drug delivery, not a device used to diagnose a medical condition.
No
The device description explicitly states it is composed of physical components (guard, body, spring, plunger) and is an accessory for physical syringes, indicating it is a hardware device.
Based on the provided information, 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 protect against accidental needlesticks during injection. This is a physical safety function related to drug delivery, not a diagnostic test performed on biological samples.
- Device Description: The description details the physical components and mechanism of the device, which is designed to cover a needle after injection. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device's function is purely mechanical and related to the safe administration of medication, not the diagnosis of a condition.
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. 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.
Product codes
MEG
Device Description
The SSI UltraSafe Passive Needle Guard (X-Series) is an anti-needlestick accessory for pre-filled ISO standard glass syringes. The device is composed of a guard, body, spring and plunger, is nonsterile and single use. The activation of the SSI UltraSafe Passive Needle Guard device remains the same. Upon completion of the injection, the guard will slide forward, cover and lock over the needle of the syringe. It is a tactile and visual recognition that the device safety feature has activated. The modifications to the predicate device include additional plungers manufactured from Purell PolyOne X50109 polypropylene homopolymer, Ineos H20Z-00 polypropylene homopolymer or medical grade Delrin SC690 NC010. 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
K122SS8
SEP 2 0 2012
510(k) SUMMARY
UltraSafe Passive Needle Guard
Company:
Safety Syringes, Inc. 2875 Loker Avenue East Carlsbad, CA 92010 USA (760) 918-9908 Ph: (760) 918-0565 Fax:
Contact Person:
Suzanne Richardson Vice President, Quality Assurance and Regulatory Affairs
Mary Stanners, RAC Senior Regulatory Specialist
Date Prepared:
August 17, 2012
Trade/Proprietary Name: UltraSafe 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 Delivery System (510(k) K011369, K060743)
Device Description:
The SSI UltraSafe Passive Needle Guard (X-Series) is an anti-needlestick accessory for pre-filled ISO standard glass syringes. The device is composed of a guard, body, spring and plunger, is nonsterile and single use. The activation of the SSI UltraSafe Passive Needle Guard device remains the same. Upon completion of the injection, the guard will slide forward, cover and lock over the needle of the syringe. It is a tactile and visual recognition that the device safety feature has activated. The modifications to the predicate device include additional plungers manufactured from Purell PolyOne X50109 polypropylene homopolymer, Ineos H20Z-00 polypropylene homopolymer or medical grade Delrin SC690 NC010. The SSI devices are categorized as skin contact with a duration of category A- limited (