(169 days)
The CT Injectable Safety Huber Needle is a device used to administer fluids from a container to a patient's vascular system through an implanted port. The CT Injectable Safety Huber Needle incorporates an active safety feature that aids in the prevention of accidental needle sticks.
The CT Injectable Safety Huber Needle is a safety needle designed with an anti-coring needle tip configuration. The primary use for Huber Needles is to deliver solutions to implanted ports. The safety feature is designed to protect the practitioner from accidental needle sticks.
The CT Injectable Safety Huber Needle is compatible with power injection procedures up to 300 psi.
The CT Injectable Safety Huber Needle is composed of a sharpened anticoring Huber style needle for port septum access having a safety feature which is manually operated and will prevent accidental needle sticks when advanced which is connected to a conventional style extension set for attachment to standard IV/Drug infusion line sets.
The proximal end of the needle cannula is adhesively sealed to the molded housing which contains a glue well and fluid thru hole. The fluid thru hole leads to the distal end of the extension line set that is also adhesively bonded in the molded housing. The distal end of the extension tubing contains a female luer connector with removable dust cap on the proximal end creating a fluid path from the needle tip thru the female luer. The infusion set is also offered in a configuration where the extension tubing contains a Y-Site connector with removable dust cap placed midway between the needle and the female luer connector. The extension tubing contains purple pigment to indicate its use for high pressure. The Y portion of the connector is a molded female luer that is sealed with a removable dust cap. A non-removable pinch clamp is located between the female luer and needle cannula. On line sets with a Y-Site connector, two pinch clamps are present located between the female luer and the Y-Site and the Y-Site and the needle cannula. The pinch clamps are designed that when engaged, fluid flow is restricted thru the extension tubing.
The needle cannula is constructed with a Huber style anti-coring needle tip. The cannula is stainless steel and is shielded by a removable star needle quard of plastic construction.
The molded wing housing is of plastic construction and contains rigid protruding wings. The under side of the wings contain a foam comfort pad. The comfort pad is constructed with an adhesive backing which is secured to the wing housing.
The molded wing housing is snap fitted into the molded housing via a securement post. The wing housing is of plastic construction with a protruding wing designed flush with the under surface of the housing. The wing housing contains a thru hole that easily slides over the needle cannula. The wing housing contains a torsion spring that is positioned on a post and is orientated in a positioning channel. The torsion spring is in a compressed state until the molded housing is removed from the winq housing at which time the torsion spring is automatically activated. The winq housing consists of a base to which the securement bag is adhesively bonded.
The molded housing is connected to the wing housing via the securement bag. The securement bag (a polyester film lamination) is adhesively bonded to the molded housing and the wing housing. The securement bag is compressed (accordion style) between the molded housing and wing housing and is of length sufficient to activate the torsion spring and to prevent the needle tip from entering the securement bag area.
In normal operation, the molded housing is activated during removal of the needle from the patient. The wing housing is held firmly in place while the molded housing is disengaged. The molded housing is disengaged from the wing housing by grasping the elevated portion of the molded housing and sliding the molded housing in an upward direction. The molded housing will disengage from the wing housing and will advance until the torsion spring is past the needle tip at which time the torsion spring will snap over the needle access hole. Upon spring activation, there will be an audible click sound as the spring snaps against the wing housing. The securement bag prevents the molded housing from advancing off the needle cannula and the torsion spring prevents the needle from advancing out of the housing.
Prior to use, the exposed portion of the needle cannula, including the sharpened needle tip area, is coated with a silicone fluid to render the needle lubricious and to reduce the insertion (penetration) and drag force to industry acceptable values.
Each needle size has I.D. Rings located within the pinch clamp to identify the appropriate infusion rate for the noted needle gauge size. Components will be assembled by the manufacturer into standard configurations with or without the "Y-Site" and packaged.
The provided text describes a 510(k) premarket notification for a medical device called the "CT Injectable Safety Huber Needle." This application primarily relies on substantial equivalence to a predicate device rather than extensive new studies proving acceptance criteria for the new device itself.
Here's a breakdown of the requested information based on the provided text, heavily noting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Feature (Aids in prevention of accidental needle sticks) | The device incorporates an active safety feature that aids in the prevention of accidental needle sticks. (Design description states: "manually operated and will prevent accidental needle sticks when advanced"). The device is "identical in design, safety aspects... as the predicate PFM Medical, EZ Huber Safety Infusion Set." |
| Anti-coring needle tip configuration | The needle cannula is constructed with a Huber style anti-coring needle tip. The device is "identical in design... as the predicate PFM Medical, EZ Huber Safety Infusion Set." |
| Compatibility with power injection procedures (up to 300 psi) | Pressure testing has been performed on each needle gauge size to determine pressure ratings. (Specific numerical results are not provided beyond "up to 300 psi"). The device is "identical in ... design... as the predicate PFM Medical, EZ Huber Safety Infusion Set." |
| Material Safety | All materials have been used in previous cleared submissions. |
| Sterilization | Standard sterilization procedures (not detailed, but implied by comparison to predicate). "Identical in ... sterilization... as the predicate PFM Medical, EZ Huber Safety Infusion Set." |
| Packaging | Standard packaging (not detailed, but implied by comparison to predicate). "Identical in ... packaging... as the predicate PFM Medical, EZ Huber Safety Infusion Set." |
2. Sample size used for the test set and the data provenance
- The document states: "Clinical studies were not deemed necessary since no changes have been made to the design, packaging, sterilization or indications for use that would have any effect on the safety and effectiveness of the device when compared to the legally marketed predicate device."
- This indicates that no formal test set (in the context of clinical studies) was used for proving acceptance criteria for this specific device as directly presented in the submission. The acceptance is based on substantial equivalence to the predicate device.
- Data Provenance: Not applicable for new clinical data on this specific device. The reliance is on existing data and regulatory clearances of the predicate device and the materials used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set data was generated for the new device.
4. Adjudication method for the test set
- Not applicable. No clinical test set data was generated for the new device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a manual medical instrument (Huber needle), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual medical instrument.
7. The type of ground truth used
- The "ground truth" for this submission is substantial equivalence to the predicate device (PFM Medical, EZ Huber Safety Infusion Set, K071846) as demonstrated through design, materials, and intended use comparison.
- For the pressure testing, the ground truth would be established by physical measurements against a specified pressure value (e.g., 300 psi), but the detailed results of this testing, including methodology and specific values, are not provided in this summary.
8. The sample size for the training set
- Not applicable as this is not an AI/algorithm-based device and no new clinical studies were performed. The "training set" for the predicate device's clearance would have been its own testing and clinical data, which is referenced indirectly through the substantial equivalence claim.
9. How the ground truth for the training set was established
- Not applicable for a training set for this specific device. For the predicate device, its ground truth would have been established through its own regulatory clearance process, likely involving engineering bench testing, material biocompatibility, and potentially clinical studies or historical device performance data.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.