(90 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a hypodermic needle with a passive safety feature. There is no mention of AI or ML in the intended use, device description, or performance testing.
No
This device is a hypodermic needle intended for use in combination with hypodermic syringes for subcutaneous and intramuscular injection, and also features a sharps protection mechanism. It facilitates the delivery of therapeutic substances, but is not a therapeutic device itself.
No
The device is a hypodermic needle intended for use in combination with hypodermic syringes for subcutaneous and intramuscular injection. Its function is to deliver substances, not to diagnose conditions.
No
The device description clearly outlines physical components like a stainless steel tube, polypropylene hub, and a passive sharps protection feature, indicating it is a hardware device. The performance studies also focus on physical characteristics and mechanical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "subcutaneous and intramuscular injection" in combination with hypodermic syringes. This describes a device used for administering substances into the body, not for examining specimens taken from the body to provide information about a physiological state, health, or disease.
- Device Description: The description details a hypodermic needle with a safety feature. This aligns with a device used for injection, not for in vitro diagnostic testing.
- Performance Studies: The performance studies focus on the physical characteristics and safety features of the needle (cleanliness, acidity/alkalinity, extractable metals, size, bonding strength, flow rate, safety feature activation, etc.). These are relevant to a device used for injection, not for the analytical performance of an IVD.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue outside of the body to diagnose or monitor medical conditions. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for Use
The K-Pack Surshield™ Needle is a sterile hypodermic needle for single use with a passive sharps protection feature that covers the cannula immediately and permanently after use; and is intended for use in combination with hypodermic syringes for subcutaneous and intramuscular injection.
Product codes
FMI
Device Description
The 27G K-Pack Surshield™ Needle is a hypodermic single lumen needle, 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. Furthermore the needle has a passive sharps protection feature that covers the cannula immediately and permanently after use. The K-Pack Surshield™ Needle is packed in a hard pack (cap - case) which is sealed with a perforated self-adhesive paper label.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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)
All necessary verification and validation tests have been performed by testing the K-Pack Surhiela™ Needle 27G x 1/2" - 0.4 x 12 mm in accordance with EN ISO 7864 (1995) and ISO 23908 (2011).
Key results summarized in a table of tests and acceptance criteria including:
- Cleanliness
- Limits for acidity or alkalinity
- Limits for extractable metals
- Size designation
- Colour coding
- Conical fitting
- Effective needle length
- Lubricant
- Needle point
- Bonding strength between hub and cannula
- Patency of lumen
- Flow rate
- Visual marking indicating status of safety feature
- Forces for activating the sharps injury protection feature
- Forces for challenging the safety feature
- Challenging the safety feature once in safe mode
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K 111794
SEP 2 2 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: | June 2011 |
II.1. Device Name
Proprietary Name
27G x ½" K-Pack Surshield™ Needle
Classification Name
Hypodermic Single Lumen Needle 21CFR, Section 880.5570 Classification: Class II
11.2. Reason for Submission
This premarket notification [510(k)] is being submitted for the 27G x 1/2' K-Pack Surshield '10 Needle which is an addition to the existing K-Pack Surshield™ Needle manufactured by Terumo Europe N.V. The size of the 27G x 1/2" needle is smaller than what is currently cleared under the 25 G x 5/8" K-Pack Surshield™ Needle (K 110527). The proposed 27G x ½³ K-Pack Surshield™ Needle has a regular wall and the cleared predicated device 25 G x 5/8" K-Pack Surshield 100 Needle has a thin wall. This Special 510k is being submitted because of potential issues of safety and effectiveness specific for a smaller needle with a regular wall. This 510k will provide supporting information that the 27G x 1/2" K-Pack Surshield" Needle is safe and effective and an acceptable addition to the existing K-Pack SurshieldTM Needle.
II.3. Intended Use
A single use injection needle with an integrated passive sharps protection feature designed to reduce needle stick injury and to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection.
11.4. Description
The 27G K-Pack Surshield™ Needle is a hypodermic single lumen needle, 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. Furthermore the needle has a passive sharps protection feature that covers the
1
a piston syringe. Furthermore the needle has a passive sharps protection feature that covers the cannula immediately and permanently after use. The K-Pack Surshield™ Needle is packed in a hard pack (cap - case) which is sealed with a perforated self-adhesive paper label.
II.5. Substantial Equivalence
The "27 G x 1/2" K-Pack Surshield Needle", manufactured by Terumo Europe N.V., submitted in this 510(k) file is substantially equivalent in intended use, description/specifications, technology/principles of operation, materials and performance to the following cleared devices: - 25G x 5/8" K-Pack Surshield™ Needle (K110527)
Any 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 K-Pack Surhiela™ Needle 27G x 1/2" - 0.4 x 12 mm in accordance with EN ISO 7864 (1995) and ISO 23908 (2011). Summary of the verification activities including acceptance criteria is given in the table below:
| 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 | A 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 K-Pack Surshield 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 |