(94 days)
The Safety-Needle is a single lumen needle for blood collection via venipuncture in conjunction with the S-Monovette® system. The Safety-Needle needle protector, when activated after removal of the needle from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries.
The Safety-Needle is individually packaged, sterile, single-use and non-pyrogenic.
The Safety-Needle is intended to be used in all hospitals and/or practices where S-Monovettes are used.
The Safety-Needle is a single lumen needle for blood collection via venipuncture in conjunction with the S-Monovette® system. The Safety-Needle needle protector, when activated after removal of the needle from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries.
The Safety-Needle is individually packaged, sterile, single-use and non-pyrogenic.
I am sorry, but the provided text is a 510(k) summary for a medical device (Safety Needle) and does not contain information about acceptance criteria, study details, or performance data. The document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It confirms marketing authorization but does not include any studies or data proving the device meets specific acceptance criteria in the way you've described.
Therefore, I cannot fulfill your request for the table of acceptance criteria and study data based on the provided text.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.