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510(k) Data Aggregation
(71 days)
K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack
The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall 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.
The subject K-Pack II Needles are hypodermic single lumen needles, for single use consisting of stainless steel 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 hypodermic syringe. The needle is packed in a hard pack (cap-case) made of polypropylene. The K-Pack II Needles - 27G x 1/2" Extra Thin Wall, 27G x 1/2" Ultra Thin Wall, 30G x 1/2" Extra Thin Wall and 30G x 1/2" Ultra Thin Wall will be an extension of the existing K-Pack II Needles product family.
The K-Pack II Needles are subject to a Special 510(k) submission due to the introduction of new product codes with increased cannula's inner diameter, resulting in different cannula wall types (ultra and extra thin wall versus thin wall). The device's performance was evaluated against several recognized consensus standards for hypodermic needles.
Here is a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is reported as meeting the acceptance criteria outlined by the specified standards.
| Requirement | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1. Cleanliness | Visual inspection: free from particles and extraneous matter (normal/corrected-to-normal vision, 300-700 lx); 2.5x magnification: hub socket free from particles and extraneous matter. | Meets criteria (implied by safety and effectiveness claim) |
| 2. Limits for acidity or alkalinity | △ pH for extract solution within 1 unit of control fluid (EN ISO 7864). | Meets criteria (implied by safety and effectiveness claim) |
| 3. Limits for extractable metals | Extract solution content (corrected for control fluid) of Σ Pb, Sn, Zn, Fe ≤ 5 mg/l and Cd |
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(50 days)
K-PACK II NEEDLE - 27G X 3/4 THIN WALL
The 27G x 3/4" 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.
The 27G x 3/4" 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.
Here's a breakdown of the acceptance criteria and the study information for the K-Pack II Needle - 27G x ¾" Thin Wall, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The device passed all validation activities as indicated by the submission of the 510(k), which implies that the reported device performance met the specified acceptance criteria. The summary states: "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)."
| TEST | ACCEPTANCE CRITERIA | Reported Device Performance (Implied) |
|---|---|---|
| 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. | Met Criteria |
| 2. Limits for acidity or alkalinity | Δ pH for K-Pack Needles extract solution is within 1 unit of the control fluid. | Met Criteria |
| 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 |
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(73 days)
K-PACK II NEEDLE- 27G & 30G THIN WALL
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.
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.
The provided text describes the 510(k) submission for the K-Pack II Needle - 27G & 30G Thin Wall. This is a medical device for injecting or withdrawing fluids, and the submission aims to demonstrate its substantial equivalence to existing devices. The key information is outlined below:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a table of acceptance criteria for various tests conducted according to EN ISO 7864 (1995). The "acceptance criteria" column lists the required standards, and the implication is that the reported device performance met these criteria, as the submission aims to prove safety and effectiveness. However, the document does not explicitly present the quantitative "reported device performance" results against each criterion. It only states that "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)." Therefore, the table below reflects the acceptance criteria as described.
| TEST | ACCEPTANCE CRITERIA | Reported Device Performance (Implied) |
|---|---|---|
| 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. | Met criterion (implied by submission for clearance). |
| 2. Limits for acidity or alkalinity | Δ pH for K-Pack Needles extract solution is within 1 unit of the control fluid. | Met criterion (implied by submission for clearance). |
| 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 |
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