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.

Device Description

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).

AI/ML Overview

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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for NISSHO CORPORATION. The logo consists of the word "Nipro" inside of an oval shape on the left, and the words "NISSHO CORPORATION" in bold font on the right. The text is all in black.

<954676
Page 1 of 5

MAR -

7205 Corporate Center Drive
Suite 305
Miami, Florida 33126
Tel: (305) 599-7174
Fax: (305) 599-8454

SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO BRANDED DISPOSABLE BLOOD TUBING SET FOR HEMODIALYSIS

$807.92 (a)(1)

Submitter:

Nissho Corporation

Contact Person:

Louis Candelario General Manager

September 16, 1996

Date of Summary Preparation:

$807.92 (a)(2)

Trade Name:

Nipro Arterial and Venous Blood Tubing Set for Hemodialysis

Common Name:

Classification Name:

Blood tubing set

Blood access device and accessories (21 CFR 876.5540)

8807.92 (a)(3)

Legally Marketed Substantially Equivalent Devices:

Kawasumi Blood Tubing Line gambro® Blood line set for hemodialysis

$807.92 (a)(4)

Description of Device:

Image /page/0/Picture/24 description: The image shows a collection of dark, blurry shapes and lines, with the numbers 1, 4, and 6 visible on the right side. The shapes and lines on the left side of the image are difficult to discern due to their poor quality. The numbers 1, 4, and 6 are written in a handwritten style. The image appears to be a scan or photograph of a document with some illegible text and numbers.

{1}------------------------------------------------

page 2 - SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO BRANDED DISPOSABLE BLOOD TUBING SET FOR HEMODIALYSIS

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).

8807.92 (a)(5)

Intended Use:

$807.92 (a)(6)

Comparison of Technical Characteristics:

The configuration of the subject device is similar to legally marketed devices from Kawasumi and gambro . Colored parts (red - arterial and blue- venous) as well as tubing colors are similar. Accessory lines are designed similarly also. Caps are placed at both ends of the blood circuit to maintain sterility.

Labeling for the competitor's devices is similar to the subject device. According to the device names on the labeling, the intended use for the competitors' products is similar to that of the subject device. They are arterial and venous blood tubing sets for hemodialysis. All of the devices are labeled as sterile and for single use only. The devices are restricted to sale by or on the order of a physician

The materials used to fabricate the tubing sets are similar as well. IR spectra of component materials of the predicate devices were used to identify them as similar to those of the subject device. The conclusion is that the materials of which the subject device is composed are substantially equivalent to those of the legally marketed predicate devices. Results from chemical and biological

{2}------------------------------------------------

page 3 - SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO BRANDED DISPOSABLE BLOOD TUBING SET FOR HEMODIALYSIS

tests demonstrate that Nissho's blood tubing sets are similar to those of gambro® and Kawasumi.

The following performance and biocompatibility tests were §807.92 (b)(1) performed on the subject device as well as the legally marketed devices for comparison.

1. Priming Volume Test

Auxiliary tubing is closed with clamp connectors and pathways are filled with distilled water. The tubing set is weighed and then the water is drained. Empty tubing sets are weighed again. Volume is expressed in milliliters (ml).

Observations found to be within acceptable range and tests results were similar to values obtained for Kawasumi and gambro® blood tubing sets.

Pull Force at Connecting Joints (A tensile strength tester is used.)

a. Between the main tubing (or saline line) and connected parts or other tubing.

b. Between heparin lines and connected parts.

A 50 mm sample of tubing with the connected part or other tubing is cut and set on the apparatus. After disengagement of the test tubing from the part or other tubing, the result is recorded from the printer.

The specification is defined as ±10% variance from nominal values mean of outer diameter of the pump segment. The subject and the legally marketed devices conformed to this specification.

Torque Force

The torque gauge is connected to the tubing which is connected with a female luer lock. The male luer lock cap is turned by hand and torque force read and recorded from dial gauge.

Endurance Test of the Pump Segment

The diameter of the rolling tube is measured before and after pumping at 200 ml/min for 4 hours at 37 C. The percentage of diameter increase is calculated and recorded.

The specification is defined as ±10% variance from nominal values mean of outer diameter of the pump segment. The subject and the legally marketed devices conformed to this specification.

1 4 8

{3}------------------------------------------------

page 4 - SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO BRANDED DISPOSABLE BLOOD TUBING SET FOR HEMODIALYSIS

5. Air Leakage above Atmospheric Pressure

Air compressor is set at 2.5 kgf/cm2 G and connections of tubing attached appropriately. Sample is then immersed into the water bath and pressure applied at 0.1kgf/cm² G within seconds. If there is no leakage at the connection, then pressure is gradually increased at 0.1 kgf/cm2 G intervals. The pressure at which leakage occurs is recorded.

Results were similar to those obtained with legally marketed devices . Leaks occurred at pressures more than 2.0 kgf/cm^2G. No clogging was noted.

6. Air Leakage below Atmospheric Pressure

The access port is punched 6 times in the same location using an 18G needle. The blood line is then attached to the appropriate fitting and the pathway filled with distilled water. The pressure is set 200 mmHg below atmospheric pressure at sea level. The presence or absence of air bubbles in the pathway is noted.

No air bubbles occurred in samples tested and results were similar in legally marketed devices for comparison.

The following tests were conducted on the finished sterilized device: pyrogenicity, cytotoxicity, acute toxicity (systemic injection) test, intracutaneous reactivity (skin reaction), sensitization, hemolysis, mutagenicity, and implantation. Specifications for these tests are outlined below.

Biocompatibility Test Specifications

Test	Specification
Pyrogenicity	Nonpyrogenic
Cytotoxicity (Elution Test)	No biological reactivity
Acute Toxicity (systemicinjection)	No biologicalreactivity/death
Intracutaneous reactivity	No erythema, edema, ornecrosis
Sensitization	Not a sensitizer
Hemolysis	Not to exceed 10%
Ames Mutagenicity	Not mutagenic
Implantation	No hemorrhage, film orencapsulation

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.

Image /page/3/Figure/12 description: The image shows a blurry picture of the number 149. The numbers are written in a simple, handwritten style. The image quality is poor, making it difficult to discern the details of the numbers.

{4}------------------------------------------------

page 5 - SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO BRANDED DISPOSABLE BLOOD TUBING SET FOR HEMODIALYSIS

Results from nonclinical tests performed on both the subject and legally 8807.92 (b)(3) marketed devices demonstrate that Nipro Disposable Blood Tubing Set for Hemodialysis is substantially equivalent. Similar results were obtained from tests on subject and predicate devices.
15U

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.