Search Results

The VaporShield™ is a sterile, single-use, closed system transfer device (CSTD), incorporating a preassembled Drug Vial holder (DVH) and Syringe (1mL, 22GA). The preassembled device is intended for medication draw from a drug vial only. After medication draw, the DVH is removed from the syringe, and the syringe is used for direct injection of hazardous and non-hazardous medication via subcutaneous or intramuscular administration. The syringe incorporates a safety mechanism which automatically retracts the needle inside the device for drug containment, and prevention of accidental needlesticks and device reuse. The VaporShield mechanically prevents drug transfer external to the device to minimize individual and environmental drug exposure. The VaporShield is intended for use by medical professionals who prepare/administer injection(s) to adults and adolescents in healthcare facilities. The device is not intended for neonates (<28 days old), infants (< 2 yrs old), or children (> 2 yrs. old – 12 yrs. old). The VaporShield Device is not intended for Compounding, Reconstitution, Phlebotomy, Intravenous injection, Intraperitoneal injection, or Intrathecal injection.

The VaporShield closed system transfer device (CSTD) is sterile, for single use, and is intended for direct injection of hazardous or nonhazardous drugs. A single configuration includes a 1 mL syringe, 22G cannula, and is pre-assembled with a Drug Vial Holder (DVH). Preassembly of the syringe and drug vial holder components are interlocked via a flex tab snap-fit connection. During drug draw, the DVH ensures a stable connection between the drug vial and syringe. The VaporShield has three (3) settings, two for needle length, and one (1) for safety. The DVH can be removed from the syringe when the syringe is placed in locked setting.

The VaporShield includes a safety mechanism that is manually activated by full plunger depression. When activated, the safety mechanism retracts the needle inside the plunger rod for containment, preventing accidental needlestick, and disallowing device reuse.

Syringe is intended for parenteral injection (subcutaneous / intramuscular).

N/A

Ask a specific question about this device

The PowerPAK™ Syringe is indicated for general medical use in healthcare facilities by medical professionals for pediatric and adult population patients for aspiration of fluids. Phlebotomy is not an intended use of this device.

The PowerPAK™ Syringe is a 3mL syringe with a permanently attached needle system. Routes of Administration include subcutaneous, intradermal and intramuscular. Intraperitoneal are not intended uses of this device.

The needle system contains an internal mechanism that retracts the syringe after activation. Upon retraction, the needle is fully contained inside the syringe preventing reuse of the needle and accidenticks during normal handling and disposal.

The PowerPAK™ syringe is single-use, non-reusable, sterile safety syringe containing a 22GA needle with a usable needle length of 1.80 inches and a syringe capacity of 3mL. The PowerPAK™ Syringe is indicated for general medical use by healthcare providers in the aspiration and injection of fluids via subcutaneous, intradermal, and intramuscular routes of administration. Phlebotomy and intravenous use are not an intended use of this device.

The PowerPAK™ syringe is a 3mL safety syringe with a permanently attached needle system containing an internal mechanism that retracts the needle inside the plunger rod of the syringe to prevent reuse of the syringe and accidental needle sticks during normal handling and disposal. Activation of the syringe occurs when the forward plunger movement punctures the propellant gas cell inside the needle assembly and initiates needle retraction. Propellant is the same medical grade propellant currently used in legally marketed dose inhalers.

The subject device is a single use, non-reusable, sterile safety syringe comprised of three main components including a Plunger, Syringe body, and Needle System.

I am sorry, but the provided text describes an FDA 510(k) clearance letter for a medical device called the "PowerPAK Syringe." This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing against various ISO standards and FDA guidance documents.

The document does not contain information about:

1. Acceptance criteria and reported device performance in a table format for qualitative measures. The listed tests are primarily pass/fail against standards for physical properties, materials, and sterilization, not typical subjective performance metrics (like accuracy, precision, sensitivity, specificity, or image quality) that would require an acceptance criteria table.
2. Sample size used for a "test set" in the context of an AI/ML study. The tests mentioned are for device performance, biocompatibility, and sterilization, where sample sizes are typically specified by the relevant ISO standards.
3. Data provenance (country of origin, retrospective/prospective) related to AI/ML model training or testing.
4. Number of experts used or their qualifications for establishing ground truth.
5. Adjudication method for a test set.
6. Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human-in-the-loop performance improvement.
7. Standalone (algorithm-only) performance.
8. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
9. Sample size for a training set (AI/ML).
10. How ground truth for a training set was established (AI/ML).

The document primarily focuses on the device's physical and functional characteristics, safety features (needle retraction), biocompatibility, and sterilization, and its comparison to a similar predicate device. It confirms that the device meets existing performance standards for syringes and sharps injury prevention.

Therefore, I cannot provide the requested information as it is not present in the given text.

Ask a specific question about this device