(46 days)
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No
The device description and performance studies focus on the mechanical and functional aspects of a blood collection set, with no mention of AI or ML.
No
The device is described as being for "venipuncture and the collection of blood specimens," which is a diagnostic or collection purpose, not a therapeutic one.
No
This device is for collecting blood specimens, which is a step in the diagnostic process, but it does not perform the diagnosis itself. Its function is primarily specimen collection and safety.
No
The device description explicitly states it is a needle and attached tubing, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "A needle and attached tubing for venipuncture and the collection of blood specimens from patients." This describes a device used to collect a biological sample from a patient.
- IVD Definition: In vitro diagnostics are devices intended for use in the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. They are used on the collected sample, not for the collection itself.
- Lack of Diagnostic Function: The description focuses on the collection process and safety features (safety shield). There is no mention of analyzing the collected blood or providing any diagnostic information based on the blood itself.
This device is a blood collection device, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
A needle and attached tubing for venipuncture and the collection of blood specimens from patients. Includes a safety shield to minimize the possibility of needlesticks.
Product codes
75JKA
Device Description
A needle and attached tubing for venipuncture and the collection of blood specimens from patients. Includes a safety shield to minimize the possibility of needlesticks.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Equivalent functional performance is demonstrated between the current Safety-Lok™ Blood Collection Set and the modified Safety-Lok™ Blood Collection Set in a study comparing flow rates; shield activation force; shield sustaining force; shield override force; heat stake break force; pressure testing; I.V. penetration and drag forces. The studies identified some differences; however these differences will not affect the overall performance of the modified product.
A simulated use study was conducted to evaluate the ease of package opening, ease of safety shield activation, ease of disposal and successful activation of the safety shield of the modified Safety-Lok™ Blood Collection Set manufactured by BDVS in comparison to the current Safety-Lok™ Blood Collection Set manufactured by Nissho. The principal device manufactured by the BDVS demonstrated equivalent or improved ease of package opening/product accessibility, shield activation and disposal. The Simulated Use and Actual Use studies for successful safety shield activation exhibited successful activation for both the prinicipal and predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Becton Dickinson VACUTAINER Systems 1 Becton Drive Franklin Lakes, New Jersey 07417-1885 (201) 847-4500
Image /page/0/Picture/1 description: The image contains a series of characters that appear to be handwritten. The characters include 'K', '6', '5', '2', and '2'. These characters are written in a dark ink and are connected by a horizontal line at the bottom.
BECTON
DICKINSON
FEB 1 0 1997
返
SUMMARY OF SAFETY AND EFFECTIVENESS G.
- G.1. Summary
| Submitter: | Eileen Schweighardt
Becton Dickinson VACUTAINER Systems
1 Becton Drive
Franklin Lakes, NJ 07417-1885
(201) 847-4570 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 19, 1996 |
| Device: | VACUTAINER® Brand Safety-Lok™ Blood Collection Set |
| Classification: | Accessory To: Tubes, Vials, Systems, Serum Separators, Blood
Collection (75JKA) |
| Predicate Device: | VACUTAINER® Brand Safety-Lok™ Blood Collection Set |
| Intended Use and
Product
Description: | A needle and attached tubing for venipuncture and the
collection of blood specimens from patients. Includes a safety
shield to minimize the possibility of needlesticks. |
| Proposed
Modification: | Alternate manufacturing site and alternate material suppliers. |
Becton Dickinson VACUTAINER Systems has determined that the establishment of an additional manufacturing site and alternate material suppliers does not affect the safety or effectiveness of the product for its intended use. Testing has shown that functional performance of the product is equivalent to the current product.
There are no new product claims associated with this 510(k).
1
Synopsis of Test Methods and Results
Equivalent functional performance is demonstrated between the current Safety-Lok™ Blood Collection Set and the modified Safety-Lok™ Blood Collection Set in a study comparing flow rates; shield activation force; shield sustaining force; shield override force; heat stake break force; pressure testing; I.V. penetration and drag forces. The studies identified some differences; however these differences will not affect the overall performance of the modified product.
A simulated use study was conducted to evaluate the ease of package opening, ease of safety shield activation, ease of disposal and successful activation of the safety shield of the modified Safety-Lok™ Blood Collection Set manufactured by BDVS in comparison to the current Safety-Lok™ Blood Collection Set manufactured by Nissho. The principal device manufactured by the BDVS demonstrated equivalent or improved ease of package opening/product accessibility, shield activation and disposal. The Simulated Use and Actual Use studies for successful safety shield activation exhibited successful activation for both the prinicipal and predicate devices.
Eileen Schuyhousen
Eileen Schweighardt Manager, Regulatory Affairs
12/23/96
Date