(90 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device is safe. | "The results of the performance testing and the comparison of technological characteristics demonstrate that the NIPRO BioHole™ Needle ... is safe and effective when used as intended." (Page 1, 807.92(b)(3)) |
| Device is effective for its intended use. | "The results of the performance testing and the comparison of technological characteristics demonstrate that the NIPRO BioHole™ Needle performs equivalent to the predicate devices and is safe and effective when used as intended." (Page 1, 807.92(b)(3)) |
| Performs equivalent to predicate devices. | "The NIPRO BioHole™ Needle performs equivalent to the predicate devices..." (Page 1, 807.92(b)(3)) |
| Substantially equivalent to predicates (Medisystems Buttonhole Needle Set (K990803) and NIPRO AVF Needle (K955182)). | "The NIPRO BioHole™ Needle is substantially equivalent to the Medisystems Buttonhole Needle Set (K990803) in terms of indications for use, labeling, and overall performance characteristics. It is identical to the NIPRO AVF Needle in terms of materials of construction." (Page 1, 807.92(a)(6)) |
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.
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.