(102 days)
Not Found
No
The description details a mechanical hypodermic needle with a passive safety feature and performance studies focus on physical characteristics and safety mechanism testing, with no mention of AI or ML.
No.
A therapeutic device is one that treats or prevents a disease. This device is a hypodermic needle for injection, which is a delivery mechanism for therapeutic agents, but is not therapeutic in itself.
No.
The device is a hypodermic needle intended for administering injections, not for diagnosing 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.
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 "subcutaneous and intramuscular injection as well as for injection in infusion lines." This describes a device used for administering substances into the body, which is a clinical procedure, not an in vitro diagnostic test.
- Device Description: The description details a hypodermic needle with a safety feature. This aligns with a device used for injections, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, whereas this device is used to introduce 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 as well as for injection in infusion lines.
Product codes
FMI
Device Description
The 25G 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
Not Found
Anatomical Site
Not Found
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
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Summary of Performance Studies
All necessary verification and validation tests have been performed by testing the K-Pack Surhield™ Needle 25G x 5/8" - 0.5 x 16 mm in accordance with EN ISO 7864 (1995) and ISO/FDIS 23908 (2010).
Key Metrics
- 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: A pH for K-Pack Needles extract solution is within 1 unit of the control fluid.
- 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: Sum Pb, Sn, Zn, Fe = 22N.
- Patency of lumen: A stylet with a diameter of 0.23 mm is passing through the needle.
- Flow rate: The flow rate for this needle is 3.0 ml/min.
- Visual marking indicating status of safety feature: Visual indication : Light blue = Ready for use; No colour = Shield already locked.
- Forces for activating the sharps injury protection feature: The force to activate the safety feature of the device is maximum 2.16 N. The force during use of the device is maximum 3.20 N.
- Forces for challenging the safety feature: Once in the safe mode, the safety feature shall withstand 10 cycles of a minimum overriding force of 80 N.
- Challenging the safety feature once in safe mode: Once in safe mode, the cannula tip cannot be accessed when the device is stressed during a 10 cycle procedure of minimum 80 N compressive load.
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
JUN - 6 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: | February 2011 |
II.1. Device Name
Proprietary Name
K-Pack Surshield™ Needle
Classification Name Hypodermic Single Lumen Needle 21CFR, Section 880.5570 Classification: Class II
II.2. Reason for Submission
New Device
II.3. Intended 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 as well as for injection in infusion lines.
II.4. Description
The 25G 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.
1
· II.5. Substantial Equivalence
The "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:
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- NovoFine® Autocover® 30G x 8 mm (K050106) manufactured by Novo Nordisk inc., used as predicate for the sharps protection feature.
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- Terumo Surguard®2 Safety Needle (K051865) manufactured by Terumo Philippines Corporation, used as predicate for the functionality of the needle. The difference between this predicate and the proposed device is that the proposed device contains a passive sharps protection feature while the predicate contains an active sharps protection feature.
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 Surhield™ Needle 25G x 5/8" - 0.5 x 16 mm in accordance with EN ISO 7864 (1995) and ISO/FDIS 23908 (2010). 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: | |
| $\u03a3$ Pb, Sn, Zn, Fe ≤ 5 mg/l | |
| Cd |