Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen

• K Number: K213146
• Device Name: Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen
• Manufacturer: Jiangsu Rongye Technology Co., Ltd.
• Date Cleared: 2023-10-27 ( 760 days)
• Product Code: JKA , FMI
• Regulation Number: 862.1675
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Safety pen type blood Collection needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Safety butterfly type blood Collection needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The pen type blood Collection needle is intended to be used with vacuum blood collection of venous blood.

The butterfly type blood Collection needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen type blood collection needle" does not contain information about the acceptance criteria and the study that proves the device meets those criteria, nor does it detail any AI/algorithm specific performance metrics.

The document is a standard FDA clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device. It outlines regulatory requirements, general controls, and provides contact information for the FDA.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study (AI vs. without AI)
6. Standalone algorithm performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This type of detailed study information is typically found in the 510(k) submission itself, which is a much larger document than the summary clearance letter provided.

Regulation Number and Section

§ 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.