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The IntegriTech Safety Injection System is a plated brass syringe with a threaded male on the end of the syringe barrel to which the metal or plastic hub of the injection needle is threaded. The barrel accommodates a 1.8 cc anesthetic carpule. The syringe has a plunger with a harpoon on one end which engages the rubber piston of the anesthetic carpule to allow aspiration of fluid during the injection to determine if the needle has entered a blood vessel. These characteristics are the same for the "Astra" syringe (K85-1903) to which we are claiming equivalence. In addition, the Safety Injection System includes a polycarbonate protective cover which in the extended position locks and completely covers the uncapped needle. This allows the syringe to be set aside during the procedure with the contaminated needle covered thereby protecting the operator, auxiliary and patient from a needlestick injury. The protective cover in the extended locked position also allows for the safe placement of the needle cap into the end of the cover which can then be retracted. This action simultaneously recaps the needle thus preventing a needlestick injury during the recapping process. The protective cover is equivalent to the polycarbonate cover on the disposable UltraSafe Aspirating Syringe by Safety Syringes, Inc. (510K #K944425, January 26, 1995). The difference is that the protective cover on the Safety Injection System (IntegriTech) is a solid autoclavable polycarbonate tube attached to an autoclavable chrome plated brass syringe barrel. This cover can be replaced as needed.
The provided text describes a medical device, the IntegriTech Safety Injection System, and claims its equivalence to existing predicate devices. However, the document does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics.
Therefore, I cannot populate the requested table or answer most of the questions. The document focuses on device description, predicate device claims, and safety features related to needlestick injury prevention, but not on performance criteria or study results in the context of diagnostic or treatment efficacy.
Based on the provided text, the following aspects are relevant:
Device Name: IntegriTech Safety Injection System
Device Type: Dental Aspirating Antistick Syringe / Cartridge Syringe
Equivalence Claimed to:
- Astra Aspirating Syringe (510K Number - K85-1903)
- UltraSafe Aspirating Syringe by Safety Syringes, Inc. (510K #K944425)
The document primarily focuses on establishing substantial equivalence to existing devices, particularly regarding:
- Basic syringe function: plunger, harpoon for aspiration, accommodation of 1.8 cc anesthetic carpule, threaded male end for needle attachment (similar to Astra syringe).
- Safety features: polycarbonate protective cover that covers the uncapped needle and facilitates recapping (similar to UltraSafe Aspirating Syringe).
Missing Information:
The provided text does not include any of the following information which would be necessary to answer the prompt thoroughly:
- A table of acceptance criteria and reported device performance.
- Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Ground truth type, training set size, or how ground truth for a training set was established.
Without a study describing performance metrics and their evaluation against pre-defined criteria, none of the detailed questions can be answered.
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.