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510(k) Data Aggregation
(511 days)
NISSHO CORP.
The blood tubing sets are used to transport blood or fluids to a patient's vascular access device from a hemodialyzer. The reverse is also true in that the tubing set is used as to transport blood or fluids from a patient's vascular access device to a hemodialyzer.
The tubing sets that we intend to market include arterial and venous dialysis blood tubing (nonimplanted blood access device) as described in 21 CFR 876.5540. Various models of blood tubing sets are being manufactured for application with different dialysis machines. Twenty-seven arterial line models (A001 - A021, A026, A029-A032, and A035) and 14 venous line models are described (V600 -V607, V609 - V613, and V616). All components of blood tubing, including drip chambers, infusion tubing, monitor lines, ports and segments which are used to pump blood, retain and capture air and blood debris, infuse medications or fluids, sample blood, monitor pressure, and make connections to other devices are included. The materials used for the components include polyethylene (PE), polyvinylchloride (PVC), acrylonitrate butadiene styrene (ABS), polyoxymethylene (POM), polypropylene (PP), polycarbonate (PC) and polyethylene high density (PEHD).
This document describes the safety and effectiveness of the Nipro branded disposable blood tubing set for hemodialysis, asserting its substantial equivalence to legally marketed predicate devices. The information provided heavily focuses on performance and biocompatibility testing comparing the Nipro device to existing products (Kawasumi and gambro® blood tubing sets).
Here's an analysis of the provided information concerning acceptance criteria and supporting studies, organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Tests | ||
| Priming Volume Test | Within acceptable range (compared to predicate devices) | Observations found to be within acceptable range and test results were similar to values obtained for Kawasumi and gambro® blood tubing sets. |
| Pull Force at Connecting Joints | Specification not explicitly defined beyond "after disengagement of the test tubing..." | The subject and the legally marketed devices conformed to "the specification," but the numerical value of that specification isn't explicitly stated here, only that the disengagement result is recorded. It implies similarity to predicate devices. |
| Torque Force | Not explicitly defined | No explicit performance data given, only that it was measured. Implies similarity to predicate devices. |
| Endurance Test of the Pump Segment | ±10% variance from nominal values mean of outer diameter of the pump segment | The subject and the legally marketed devices conformed to this specification. |
| Air Leakage above Atmospheric Pressure | Leaks should occur at pressures > 2.0 kgf/cm² G | Results were similar to those obtained with legally marketed devices. Leaks occurred at pressures more than 2.0 kgf/cm² G. No clogging was noted. |
| Air Leakage below Atmospheric Pressure | No air bubbles in the pathway | No air bubbles occurred in samples tested and results were similar in legally marketed devices for comparison. |
| Biocompatibility Tests | ||
| Pyrogenicity | Nonpyrogenic | Results indicate that the blood tubing sets conform to the specifications set forth. Predicate devices for comparison show similar results when tested using these methods. |
| Cytotoxicity (Elution Test) | No biological reactivity | Results indication conformity and similarity to predicate devices. |
| Acute Toxicity (systemic injection) | No biological reactivity/death | Results indication conformity and similarity to predicate devices. |
| Intracutaneous reactivity | No erythema, edema, or necrosis | Results indication conformity and similarity to predicate devices. |
| Sensitization | Not a sensitizer | Results indication conformity and similarity to predicate devices. |
| Hemolysis | Not to exceed 10% | Results indication conformity and similarity to predicate devices. |
| Ames Mutagenicity | Not mutagenic | Results indication conformity and similarity to predicate devices. |
| Implantation | No hemorrhage, film, or encapsulation | Results indication conformity and similarity to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test set or the provenance of the data (e.g., country of origin, retrospective/prospective). It only mentions "samples tested" and "subject device" implying that a certain number of the Nipro blood tubing sets were tested alongside the predicate devices. The study appears to be a benchtop (in-vitro) and laboratory animal study for performance and biocompatibility, respectively, rather than a clinical trial with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not a study assessing an AI device where "ground truth" would be established by human experts in a clinical context. The "ground truth" for these tests are objective measurements and established biological assays with pre-defined specifications.
4. Adjudication Method for the Test Set
Not applicable. As this is not a study involving human interpretation of data for "ground truth," no adjudication method is relevant. The tests performed are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. This document describes the testing of a physical medical device (blood tubing set), not an AI algorithm for diagnostic or prognostic purposes. Therefore, an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This document is not about an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests are objective measurements (e.g., volume, force, diameter, pressure, presence/absence of bubbles) and established biological assay results (e.g., pyrogenicity, cytotoxicity, hemolysis) against pre-defined specifications or in comparison to legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, this question is not relevant.
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(204 days)
NISSHO CORP.
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(84 days)
NISSHO CORP.
The Nipro Safelet Cath is intended to be inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.
The devices that we intend to market are intravascular catheters as described in 21 CFR 880.5200. These devices are identical to those already marketed by Exel International, Inc. under K895768. Two types of catheters will be available: the container case types L (long) and S (short). Type L catheters have needles 11/2 to 21/2 inches long and Type S have needles 3/4 to 11/4 inches long. Six gauges of catheters are described here (14, 16, 18, 20, 22, and 24 gauge). The tip of the cannula is beveled. The proximal end of the catheter has a filter cap.
This document is a 510(k) summary for a medical device called "Nipro Safelet Cath," an intravascular catheter. It explicitly states that the device is identical to a previously marketed and cleared device, the "Exel Safelet Catheter" (K895768).
Therefore, the acceptance criteria and study data provided here are not for the Nipro Safelet Cath itself, but rather rely on the substantial equivalence to the predicate device. In such cases, no new performance studies are typically required for the new device if it is identical.
Given this, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone studies) specifically for the Nipro Safelet Cath from this document because it defers to the predicate device for all technical characteristics and equivalence.
The relevant section states:
"The Nissho and Exel devices are exactly the same devices, therefore, all technical characteristics are identical."
This means that the "study that proves the device meets the acceptance criteria" refers to the prior clearance of the Exel Safelet Catheter (K895768), and no new, independent study for the Nipro Safelet Cath is presented in this summary.
Therefore, I cannot populate the requested table and details based on the provided text, as this summary explicitly states the device is identical to a predicate and does not present new study data.
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(59 days)
NISSHO CORP.
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