(144 days)
The Blood Collection Needle (with/without Needle Holder) is intended to be used with a vacuum blood collection tube for the collection of venous blood.
The subject devices are blood collection devices used in routine venipuncture procedures, which form a channel between the patient's vein and the evacuated blood collection tube intended to collect blood.
The Blood Collection Needle (with/without Needle Holder) is intended for single use only and consists of a bottom sheath or needle holder, needle tube, rubber cap, upper sheath, and hub. They are available in different configurations.
The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.
It is manufactured from tubular stainless steel sharpened at both ends and is attached to the hub:
- -The subject devices are available with a pre-attached needle holder or without a needle holder; the hub is threaded on one side to connect with the needle holder, which is used to guide the needle into an evacuated blood collection tube. This needle's end is shorter and fitted with a protective rubber cap and a needle holder.
- The opposite end of the needle is longer for withdrawing blood and is fitted with a needle sheath.
The subject devices are available in different specifications of needle gauge (25G-18G) and length (3/4"-1 1/2").
The proposed devices are only packaged as sterile, disposable, and single-patient use.
The devices are packaged for sterile, single-use, and single-patient use only.
There is no information in the provided text about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a blood collection needle, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and supporting studies in the way you've described.
Specifically, the document states:
- "To establish substantial equivalence to the identified predicate devices, we performed the tests noted below on the subject devices. The testing results proved that the device complies with the applicable standards requirement and is substantially equivalent to the predicate devices." (Page 8)
- "No clinical data was submitted in this submission." (Page 10)
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as this information is not present in the provided text for this specific device. The document primarily references compliance with various ISO and ASTM standards for performance, biocompatibility, sterilization, and packaging, rather than a specific study with defined acceptance criteria and detailed results.
§ 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.