Search Results

The ISP Safety Huber Needle Infusion Set is a safety IV administration set with a non-coring, ninety degree, right angled Huber needle, used to access a patient's surgically implanted vascular port. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or to withdraw blood through the implanted vascular port. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needle within the wing to help prevent needlestick injuries when using the device for vascular port access.

The Infusion Safety Products, Inc. ISP Safety Huber Needle Infusion Set is a non-coring safety IV administration set used to access a patient's surgically implanted vascular port. The Safety Huber Needle Infusion Set is constructed with a 90°, non-coring Huber needle that is available in 19ga, 20ga and 22ga and in ½", ¾", 1″ and 1½" lengths. It is offered in various model numbers. The device is lipid resistant and contains non-latex containing products. The PVC Tubing is non-DEHP, with a flow rate of approximately 5cc per sec. max / CT rated to 300 psi. The Safety Huber Needle Infusion Set is packaged in a semi-rigid form fill and seal package with a 1059B Tyvek® lid. The sets are sterilized using a validated ethylene oxide method. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or withdraw blood through the implanted vascular port (not included with the ISP Safety Huber Needle Infusion Set device is offered in the following configurations, each with various needle gauges and needle lengths: 1. Huber needle in a needle holder in a safety wing, a 7.50" length of PVC Tubing, ratchet clamp, female luer lock and vented-protector cap. Approximate Priming Volume: 0.25cc. 2. Huber needle in a needle holder in a safety wing, a 4.12″ length of PVC tubing with a ratchet clamp attached to a Y port with a non-vented cap, a second 4.12″ length of PVC off the Y port with a ratchet clamp, a female luer lock and non-vented protector cap. Approximate Priming Volume: 0.35cc. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needles by encapsulating the needle within the wing to help prevent needle stick injuries when using the device for vascular port access. The safety mechanism is engaged when the needle is removed from the access port. As the set is removed from the patient, the wing encapsulates the needle, making an audible click when secure, to prevent needle sticks to the clinician.

The provided text describes the non-clinical performance data for the ISP Safety Huber Needle Infusion Set, which is a medical device. This information is typically found in a 510(k) premarket notification to the FDA to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text, structured according to your request:

Acceptance Criteria and Reported Device Performance

The device's performance is compared against internal requirements, national standards, international standards, and the predicate device (Millennium Huber Plus Safety Infusion Set, K993848).

Additional Information on the Study:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • The document describes non-clinical performance data which are laboratory or bench tests. It doesn't specify a "test set" in the context of patient data. For the comparison tests like Needle Insertion/Removal Force, Occlusion, Leak, Bonding, Flow Rate, and Puncture Resistance, the sample sizes are not explicitly stated (e.g., "All devices tested withstood 10 lbs. of force" or "Neither the subject nor the predicate device showed occlusions").
  • For the simulated clinical study and sharps injury protection testing (ISO 23908), the sample size is also not explicitly detailed beyond "subject device" and "all devices".
  • Data provenance (country of origin, retrospective/prospective) is not applicable or provided given these are benchtop engineering/safety tests, not clinical studies with patient data.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

  • This question is not applicable to the non-clinical performance and engineering tests described in the document. Ground truth in this context would be defined by the technical specifications and standards (e.g., ISO, ASTM, AAMI) against which the device performance is measured, rather than expert interpretation of a diagnostic outcome.

• Adjudication method (e.g. 2+1, 3+1, none) for the test set

  • Not applicable. This is not a study involving human interpretation or clinical adjudication.

• 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

  • No. This is a medical device for infusing fluids/withdrawing blood and preventing needlestick injuries, not an AI-assisted diagnostic device. Therefore, an MRMC study or AI-related effectiveness is not relevant.

• If a standalone (i.e. algorithm only without human-in-the loop performance) was done

  • No. This device is a physical medical device, not an algorithm or software. The performance tests evaluate the physical properties and safety features of the device itself.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc)

  • The "ground truth" for the non-clinical performance data is defined by the established technical standards and specifications (e.g., ISO 23908 for sharps injury protection, ISO 10993 for biocompatibility, specific PSI limits for leak/occlusion, force measurements for insertion/removal). The device is shown to meet these objective, measurable criteria. For comparisons to the predicate, the predicate's known performance serves as a benchmark.

• The sample size for the training set

  • Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set".

• How the ground truth for the training set was established

  • Not applicable, as there is no training set for this device.

Ask a specific question about this device