(50 days)
None
No
The device description and performance studies focus on the physical characteristics and performance of a hypodermic needle, with no mention of AI or ML.
No
The device is described as a needle intended to inject or withdraw fluids, which are diagnostic or procedural functions, not therapeutic.
No
The device is a hypodermic needle used for injecting or withdrawing fluids, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly states it is a physical needle made of stainless steel and polypropylene, intended for injecting or withdrawing fluids. It undergoes physical verification and validation tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "inject[ing] fluids into, or withdraw[ing] fluids from, parts of the body below the surface of the skin." This describes a direct interaction with the human body for therapeutic or diagnostic purposes in vivo (within the living organism).
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. They are used in vitro (outside the living organism).
- Device Description: The description of a hypodermic needle aligns with a device used for in vivo procedures, not for analyzing samples in vitro.
The information provided consistently points to a device used for direct interaction with the body, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The 27G x 3/" Thin Wall K-Pack II Needles being Hypodermic Single Lumen Needles are sterile medical devices for single use, intended to inject fluids into, or withdraw fluids from. parts of the body below the surface of the skin.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The 27G x ¾" Thin Wall K-Pack II Needles are sterile hypodermic single lumen needles, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface of the skin.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary verification and validation tests have been performed by testing the 27G x ½" Thin Wall K-Pack II Needles in accordance with EN ISO 7864 (1995). Summary of the verification activities including acceptance criteria is given in the table below:
- Cleanliness: Inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 lx to 700 lx, the surface of the hypodermic needle tube shall appear free from particles and extraneous matter. When examined under x2.5 magnification, the hub socket shall appear free from particles and extraneous matter.
- Limits for acidity or alkalinity: Δ pH for K-Pack Needles extract solution is within 1 unit of the control fluid.
- Limits for extractable metals: The extract solution of the 27G Thin Wall K-Pack II Needles has a content of extractable metals which is, when corrected for the metal content of the control fluid: Σ Pb, Sn, Zn, Fe ≤ 5 mg/l; Cd
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY as required by 807.92 Summary of Safety & Effectiveness Information
Submitter information
| Prepared for: | TERUMO EUROPE N.V.
Interleuvenlaan 40,
3001 Leuven,
BELGIUM |
|-----------------------------|-------------------------------------------------------------------------------------------------|
| Prepared by/Contact person: | Mrs. M.J. Aerts – Manager Regulatory Affairs
Tel. (+32) 16 38 13 53
Fax (+32) 16 40 02 49 |
| Date prepared: | July 2013 |
II.I. Device Name
Proprietary Name
. K-Pack II Needle - 27G x ¾¨ Thin Wall
Classification Name
Hypodermic Single Lumen Needle
21CFR, Section 880.5570
Classification: Class II
11.2. Reason for Submission
This 510k is being submitted to extend the cleared K-Pack II Needle (K984576) product line with the K-Pack II Needle - 27G x 34" Thin Wall.
The 27 Gauge needle size was added to 510k K984576 through internal documentation as specified under 510(k) Memorandum #K97-1 . "Deciding When to Submit a 510(k) for a Change to an Existing Device". It was concluded that the addition of the 27 Gauge size did not significantly affect the safety or effectiveness of the device and therefore no 510(k) was submitted.
The cannula wall of this 27G x ¾" needle is thinner than what is currently cleared for the 27 Gauge needle under the 510k K984576 and 510k K001572. The thinner needle is cleared for the 27G x 1/2" needle under the 510k K 110850.
The % " needle length was cleared for the 27 Gauge needle under the 510k K001572.
This Special 510k is being submitted due to potential issues of safety and effectiveness specific for the longer length of the 27 Gauge thin wall needle.
This 510k will provide supporting information that the 27G x ¾' Thin Wall K-Pack II Needles are safe and effective and an acceptable extension of the current K-Pack II Needle product line.
1
11.3. Intended Use
The 27G x 3/" Thin Wall K-Pack 11 Needles being Hypodermic Single Lumen Needles are sterile medical devices for single use, intended to inject fluids into, or withdraw fluids from. parts of the body below the surface of the skin.
Note: This is the same intended use as the predicate devices, K-Pack II Needle - K984576, 1 Neolus Needle - K001572 and 27G x ½" & 30G x ½" K-Pack II Needle Thin Wall -KI10850.
11.4. Description
The 27G x 4" Thin Wall K-Pack II Needles are sterile hypodermic single lumen needles, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.
11.5. Substantial Eguivalence
The 27G x 3/7 Thin Wall K-Pack II Needles are substantially cquivalent in intended use, design, technology/principal of operation. materials, and performance to the following cleared devices:
- K-Pack II Needles (K984576) 1.
- Neolus Needles (K001572) 2.
- 27G x ½¨ & 30G x ½¨ K-Pack II Needles Thin Wall (K 110850) 3.
Differences between the devices do not raise any significant issues of safety and effectiveness.
11.6. Summary of Verification Activities
All necessary verification and validation tests have been performed by testing the 27G x ½" Thin Wall K-Pack II Needles in accordance with EN ISO 7864 (1995). Summary of the verification activities including acceptance criteria is given in the table below:
2
| TEST | ACCEPTANCE CRITERIA |
|---|---|
| 1. Cleanliness | Inspected by normal or corrected-to-normal vision without magnification under an |
| illuminance of 300 lx to 700 lx, the surface of the hypodermic needle tube shall appear | |
| free from particles and extraneous matter. | |
| When examined under x2.5 magnification, the hub socket shall appear free from | |
| particles and extraneous matter. | |
| 2. Limits for acidity or alkalinity | Δ pH for K-Pack Needles extract solution is within 1 unit of the control fluid. |
| 3. Limits for extractable metals | The extract solution of the 27G Thin Wall K-Pack II Needles has a content of |
| extractable metals which is, when corrected for the metal content of the control fluid: | |
| $Σ$ Pb, Sn, Zn, Fe ≤ 5 mg/l | |
| Cd |