Search Results

The NIPRO BioHole Needle with CAPICK Scab Remover is intended for use as a blood access device for dialysis procedures using a constant-site cannulation technique of needle insertion with an established, mature constant-site also known as a buttonhole access site.

The NIPRO BioHole Needle with CAPICK Scab Remover is a sterile, single-use device that consists of a hollow, winged needle, a flexible tube, mini clamp, locking connector and scab remover. This device is provided in four design types: fixed wing type A and B, and rotating wing type A and B. Needles are available in two lengths, 1″ and 1½″, as well as four gauges (14-17), with and without back eye. The flexible tubing comes in lengths of 150mm and 300mm. The NIPRO BioHole Needle with CAPICK Scab Remover is packaged individually in a plastic pouch with paper backing, which contains labeling that adequately defines indications for use and warnings. Each BioHole Needle is provided with a sterile CAPICK scab remover attached to the cap of the needle. The CAPICK is intended to aid the clinician in the removal of the scab on the constant-site tunnel tract prior to cannulation with BioHole Needle.

These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

The provided text describes a 510(k) summary for the NIPRO BioHole Needle with CAPICK Scab Remover. It outlines the device's purpose and compares it to predicate devices. However, the document does not contain the detailed information requested regarding specific acceptance criteria, study data, sample sizes (for test or training sets), expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The document states:

• "Performance testing was conducted to verify that the device is safe and effective for its intended use. Those reports along with associated data are included in this submission."
• "The results of the performance testing and the comparison of technological characteristics demonstrate that the NIPRO BioHole Needle with CAPICK performs equivalent to the predicate device and is safe and effective when used as intended."

This indicates that internal performance tests were conducted and submitted to the FDA, but the details of these tests are not provided in this summary. The FDA's letter (Page 2-3) confirms substantial equivalence based on the provided information, but again, does not detail the specific study results.

Therefore, I cannot fulfill your request for the specific table and study details as that information is not present in the provided text.

Ask a specific question about this device

The NIPRO BioHole™ Needle is intended for use as a blood access device for dialysis procedures using a constant-site cannulation technique of needle insertion with an established, mature constant-site also known as a buttonhole access site.

The NIPRO BioHole™ Needle is a sterile, single-use device that consists of a hollow, winged needle, a flexible tube, mini clamp and locking connector. This device is provided in four design types: fixed wing type A, turnable wing type A, fixed wing type B, turnable wing type B. Needles are available in two lengths, 1" and 1¼", as well as four gauges (14-17), with and without back eye. The flexible tubing comes in lengths of 150mm and 300mm. The NIPRO BioHole™ Needle is packaged individually in a plastic pouch with paper backing, which contains labeling that adequately defines indications for use and warnings. These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

The provided text is a 510(k) Summary for the NIPRO BioHole™ Needle. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and standalone effectiveness results for the new device against a specified ground truth.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria in the context of diagnostic or screening performance.

However, based on the non-clinical tests section, we can infer the general acceptance criteria and the nature of the "study":

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document mentions "Performance testing was conducted" (Page 1, 807.92(b)(1)), but does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective). This likely refers to engineering and biocompatibility tests rather than a clinical efficacy study with a "test set" in the sense of a machine learning model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable/not provided. The "ground truth" for this type of device submission would be compliance with engineering standards, biocompatibility requirements, and material specifications, verified through laboratory testing. There isn't a "test set" requiring expert labeling as would be the case for an AI/ML diagnostic device.

4. Adjudication method for the test set:

• Not applicable/not provided.

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:

• No, an MRMC comparative effectiveness study was not done, as this is not an AI/ML diagnostic device.

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

• No, this is not an algorithm, but a physical medical device.

7. The type of ground truth used:

• For the non-clinical tests mentioned, the "ground truth" would be established through objective measurements and adherence to recognized standards (e.g., sterilization validation, material strength tests, biocompatibility testing, fluid flow characteristics). These are typically physical or chemical properties, not expert consensus on an image or clinical outcome for a "test set."

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable.

In summary: The NIPRO BioHole™ Needle submission is a conventional 510(k) for a physical medical device. It demonstrates substantial equivalence through a comparison of technological characteristics with predicate devices and non-clinical performance testing (likely engineering, material, and biocompatibility tests). It does not involve AI/ML, clinical efficacy studies with ground truth derived from expert consensus, or multi-reader studies as would be seen for diagnostic software.

Ask a specific question about this device