(73 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functionality of a hypodermic needle, with no mention of AI or ML.
No.
The device is a hypodermic needle intended for injecting or withdrawing fluids, which are procedures, but the needle itself does not directly treat or prevent a disease or condition; it is a tool for administering treatment rather than a therapeutic device in itself.
No
This device is a hypodermic needle intended for injecting or withdrawing fluids, not for diagnosing a condition.
No
The device description and performance studies clearly indicate a physical hypodermic needle, which is a hardware component. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin." This describes a device used for direct interaction with the body for therapeutic or diagnostic purposes in vivo (within a living organism).
- Device Description: The description details a hypodermic needle designed for connecting to a syringe, which is consistent with the intended use of injecting or withdrawing fluids from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside of a living organism) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, the 27G & 30G Thin Wall K-Pack II Needle is a general-purpose hypodermic needle, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 27G & 30G Thin Wall K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device 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 & 30G 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 ioined 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 & 30G 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, 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 & 30G 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
110850
JUN - 9 2011
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: | March 2011 |
II.1. Device Name
Proprietary Name K-Pack II Needle - 27G & 30G Thin Wall Classification Name Hypodermic Single Lumen Needle 21CFR, Section 880.5570 Classification: Class II
II.2. Reason for Submission
This 510k is being submitted to extend the cleared K-Pack II Needle (K984576) product line.
The cannula wall of these 27G & 30G needles is thinner than what is currently cleared under the 510k K984576 and 510k K001572 for the 27 Gauge needle and under the 510k K062608 for the 30 Gauge needle.
Please note that 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 30G Thin Wall K-Pack II Needle can also be packaged in a short case instead of a long one as cleared under 510k K062608.
The thinner needle and the shorter case were cleared for a 29 Gauge needle under the 510k K082820 and the shorter case was cleared for the 27 Gauge needle under the 510k K984576 (internal documentation).
This Special 510k is therefore being submitted due to potential issues of safety and effectiveness specific for a thinner wall needle for the 27 and 30 Gauge needle.
1
This 510k will provide supporting information that the 27G & 30G Thin Wall K-Pack II Needles are safe and effective and an acceptable extension of the current K-Pack II Needle product line.
II.3. Intended Use
The 27G & 30G 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.
Note: This is the same intended use as the predicate devices, K-Pack II Needle - K984576, Neolus Needle - K001572, 29G & 30G K-Pack II Needle - K062608 and 29G K-Pack II Needle Thin Wall - K082820.
II.4. Description
The 27G & 30G 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 ioined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.
II.5. Substantial Equivalence
The 27G & 30G Thin Wall K-Pack II Needles are substantially equivalent 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)
- 29 Gauge & 30 Gauge K- Pack II Needles (K062608) 3.
- 29 Gauge K-Pack II Needle Thin Wall (K082820) 4.
Differences between the devices do not raise any significant issues of safety and effectiveness.
II.6. Summary of Verification Activities
All necessary verification and validation tests have been performed by testing the 27G & 30G 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, 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 & 30G 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 |