Who can help prepare an FDA 510(k) submission like NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P

Q: Who is the manufacturer of NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P?

NIKKISO CO., LTD. filed the 510(k) submission for NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P (K082719).

Q: What is the FDA product code for NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P?

KOC. It is classified under 21 CFR 876.5820 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P?

510(k) clearance (submission type: Traditional).

K082719 · NIKKISO CO., LTD. · KOC · Mar 30, 2009 · Gastroenterology, Urology

Device Facts

Record ID	K082719
Device Name	NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P
Applicant	NIKKISO CO., LTD.
Product Code	KOC · Gastroenterology, Urology
Decision Date	Mar 30, 2009
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5820
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician or other licensed practitioner.

Device Story

Disposable extracorporeal blood tubing set; connects patient vascular access to hemodialyzer. Components include pump tubing, air trap chambers, transducer filters, pressure monitoring lines, infusion lines, and clamps. Used during hemodialysis procedures with Nikkiso DBB-05 Hemodialysis Delivery System. Operates by facilitating blood flow, debris capture, medication/fluid infusion, blood sampling, and pressure monitoring. Used in clinical settings by healthcare professionals. Provides physical conduit for blood circuit; enables pressure monitoring via integral transducer protectors. Benefits patient by maintaining sterile, functional extracorporeal circuit for dialysis treatment.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, hemocompatibility, genotoxicity per ISO10993), sterility, pyrogenicity, and mechanical performance (blood pathway volume, flow dynamics, pump segment performance, occlusive clamping) per ANSI/AAMI RD17: 2007.

Technological Characteristics

Materials: PVC, PC, PP, Silicone, PBT, PTFE. Components: pump tubing, air trap chambers, transducer filters, pressure lines. Connectivity: physical connection to hemodialysis delivery system. Sterilization: Steam. Standards: ANSI/AAMI RD17: 2007, ISO10993, ISO11134, EN554. Single-use, non-pyrogenic.

Indications for Use

Indicated for patients requiring hemodialysis to provide extracorporeal blood access. No specific age or gender restrictions stated. Contraindications not explicitly listed.

Regulatory Classification

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.

Predicate Devices

Nipro® Blood Tubing Set with Transducer Protectors and Priming Set (K010264)

Reference Devices

Nikkiso DBB-05 Hemodialysis Delivery System (K061519)
Borla's transducer protector (K000702)

Related Devices

K230514 — Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series · NIKKISO CO., LTD. · Jun 16, 2023
K954676 — NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS · Nissho Corp. · Mar 4, 1997
K072024 — NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 · Nipro Medical Corp. · Oct 4, 2007
K032975 — JMS BLOOD TUBING SETS · Jms North America Corp. · Aug 16, 2004
K231589 — Blood Tubing Lines for Hemodialysis AV06C-E · NIKKISO CO., LTD. · Jul 28, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ K082719 NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS PREMARKET NOTIFICATION 510(k) # Section 6- 510(k) Summary MAR 3 0 2009 - a. Company name, address NIKKISO CO., LTD. 43-2, Ebisu 3-Chome, Shibuya-ku Tokyo, 150-8677, Japan - b. Contact Masashi Yoshida Manager Regulatory Affairs - c. Date prepared August 18, 2008 ### d. Name of device | Trade Name: | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS | |----------------------|--------------------------------------------------------| | Common Name: | Hemodialysis system and accessories | | Classification Name: | Hemodialysis system and accessories | # e. Predicate devices The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS is substantially equivalent to: | 510(k): | K010264 | |---------------|--------------------------------------------------------| | Trade name: | Nipro® Blood Tubing Set with Transducer Protectors and | | | Priming Set | | Product code: | FIB, FJK | ### f. Description of the device The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS includes arterial and venous dialysis blood tubing (non-implanted blood access device) as described in 21 CFR 876.5820. The devices are packaged together for convenient use during for hemodialysis procedures. Three models of the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS (AV06A-P, AV06B-P, AV06C-P) are being manufactured for use with the Nikkiso DBB-05 Hemodialysis Delivery System (K061519). The components of the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS include pump tubing, air trap chambers, transducer filters, pressure monitoring lines, NIKKISO CO., LTD. {1}------------------------------------------------ K082719 NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS PREMARKET NOTIFICATION 510(k) infusion lines for saline, access ports and tubing clamps which are all used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood, monitor pressure, and make connections to other devices. Major materials used for the various components are Polyvinyl chloride (PVC), polycarbonate (PC), polypropylene (PP). Materials in direct contact with blood are Polycarbonate (PC), Polyvinyl chloride (PVC), Silicone, Polypropylene (PP) and Polytetrafluoroethylene (PTFE). The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are restricted for sale by or on the orders of a physician. The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are packaged sterile and labeled for single use only and non-pyrogenic. Sterility and non-pyrogenicity were confirmed by sterilization validation and pyrogenicity testing. Biocompatibility tests were performed in compliance with ISO10993 requirements and include acute toxicity, intracutaneous reactivity, hemolysis testing, and implantation testing. The results of biocompatibility testing did not raise any question regarding biocompatibility, and support the equivalence to the predicate device. The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are designed for use with the Nikkiso DBB-05 Hemodialysis Delivery System (K061519). Image /page/1/Figure/8 description: The image shows a diagram of an arterial and venous circuit. The arterial circuit includes an access port, shunt connector (red), air trap chamber, pump segment, and transducer protector line for pressure monitor. The venous circuit includes a shunt connector (blue), air trap chamber, access port, and transducer protector line for pressure monitor. The diagram also shows the connection to the hemodializer (red and blue). Figure 1. NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS (AV06A-P) NIKKISO CO., LTD. {2}------------------------------------------------ K082719 NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS PREMARKET NOTIFICATION 510(k) # g. Indications for Use #### Indication for Use The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician or other licensed practitioner. # h. Statement of substantial equivalence The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS is substantially equivalent to the Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set (K010264) (Hereinafter "the Nipro tubing set"). Table 1 compares NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS to the Nipro tubing set. Both tubing lines have the same intended use, same configurations and same major materials. Both of the tubing lines are sterile and labeled as single use only and non-pyrogenic. Tests results from biocompatibility tests for the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS in compliance to ANSI/AAMI RD17: 2007 "Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofitters" (Hereinafter "RD17") and ISO10993 did not raise any concerns regarding biocompatibility. Nikkiso performed all tests required in RD17 for both NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS and the Nipro tubing set. As shown in Table 1, both tubing lines met the requirements in RD17 including sterility, pyrogenicity and mechanical characteristic tests. Based on the above considerations, Nikkiso concludes that the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS is substantially equivalent to the Nipro tubing set. {3}------------------------------------------------ K082719 # nikkline blood tubing lines with transducer protectors PREMARKET NOTIFICATION 510(k) # Table 1. Comparison table . ・ | No. | Item | Proposed Device | Predicate Device | |-----|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Indication for use | The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician or other licensed practitioner. | The Nipro Blood Tubing Set with Transducer Protector and Priming Sets are disposable blood tubing lines intended to provide extracorporeal access to the patient's blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge | | 2 | Configuration | The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are composed of various components such as tubing, luer locks, connectors, tubing clamps and air trap chambers that are configured for connecting a patient's vascular access system to a dialyzer. The tubing lines components are pre-configured and packaged as an arterial line, a venous line, an infusion lines, a saline line and pressure monitoring lines for use with the Nikkiso DBB-05 Hemodialysis Delivery System (K061519). | The Nipro blood tubing lines are composed of various components such as tubing, luer locks, connectors, clamps and drip chambers that are configured for connecting a patient's vascular access system to a dialyzer. The tubing lines components are pre-configured and packaged as an arterial line, a venous line, an infusion line, a saline line and pressure monitoring lines for use with various dialysis systems such as Fresenius, Baxter, Cobe, Althin, etc. | | 3 | Biological Safety | Meets ANSI/AAMI RD17: 2007 and ISO10993. Tests results from biocompatibility tests for The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS did not raise any concerns regarding biocompatibility including: • Cytotoxicity • Sensitization • Irritation or intracutaneous reactivity • Acute Systemic toxicity • Hemocompatibility • Genotoxicity | Meets ANSI/AAMI RD17 and ISO10993. | | 4 | Sterility -method | Steam sterilization | Ethylene Oxide sterilization | | | -SAL 10 $^{-6}$ | Assured SAL 10 $^{-6}$ by validation met ISO11134 and EN554. | Assured SAL 10 $^{-6}$ by validation met ISO11135-1 | | 5 | Pyrogenicity | Non- pyrogenic | Non-pyrogenic | | 6 | Single use or reuse | Single use only. | Single use only. | | 7 | Structural integrity | Meets 4.4.1 Structural integrity AAMI RD17: 2007. | Meets 4.4.1 Structural integrity AAMI RD17: 2007. | | 8 | Connection to hemodialyzer, hemodiafilter or hemofilter | Meets 4.4.2 Connection to hemodialyzer, hemodiafilter or hemofilter AAMI RD17: 2007. | Meets 4.4.2 Connection to hemodialyzer, hemodiafilter or hemofilter AAMI RD17: 2007. | | No. | Item | Proposed Device | Predicate Device | | 9 | Connection to vascular access device | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS Meets 4.4.3 Connection to vascular access device AAMI RD17: 2007. | The Nipro Tubing Set (K010264) Meets 4.4.3 Connection to vascular access device AAMI RD17: 2007. | | 10 | Connection to ancillary components | Meets 4.4.4 Connection to ancillary components AAMI RD17: 2007. | Meets 4.4.4 Connection to ancillary components AAMI RD17: 2007. | | 11 | Color coding | Meets 4.4.5 Color coding AAMI RD17: 2007. The arterial patient-connection is red, the venous patient-connection is blue. | Meets 4.4.5 Color coding AAMI RD17: 2007. The arterial patient-connection is red, the venous patient-connection is blue. | | 12 | Needle access ports | Meets 4.4.6.1 Needle access ports AMMI RD17: 2007. | Meets 4.4.6.1 Needle access ports AAMI RD17: 2007. | | 16 | Transducer protector | Meets 4.4.9.1 Integral transducer protectors AAMI RD17: 2007. | Using Borla's transducer protector (K000702). | | 20 | Raw materials | PVC, PC, PP, Silicone are used for the components in the product. PBT and PTFE are used specifically for the transducer protectors. | PVC, PE, PC, PP, POM are used for the components in the product. PBT and PTFE are used specifically for Borla's transducer protectors. | NIKKISO CO., LTD. ・ {4}------------------------------------------------ K082719 #### NIKKLINE BLOOD TUBING LINES WITH TRANSIDUCER PROTECTORS PREMARKET NOTIFICATION 510(k) #### Table 1. Comparison table (continued) PB.I. : Polybutylene terephthalate : Polycarbonate PC : Polyethylene PE - POM : Polyoxymethylene PP : Polypropylene : Polytetrafluoroethylene PTFE : Polyvinyl chloride PVC Silicone : Silicone Rubber ### Note: Tests including blood pathway volume, blood pathway flow dynamics, pump segment performance and occlusive clamping of tubing for the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS were performed successfully in accordance with AAMI RD17: 2007. Since the Nipro Tubing Set (K010264) was cleared by FDA and subjected to the same tests by Nipro, Nikkiso concludes that the test results for the Nipro Tubing Set and the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are substantially equivalent. {5}------------------------------------------------ K082719 NIKKIJINE BLQQID TUBING LINES WITH TRANSDUCER PROTECTORS PREMARKET NOTIFICATION 510(k) #### i. Conclusion Based on the above discussion and enclosed sections regarding substantial equivalence to predicate devices, NIKKISO CO., LTD. concludes that the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS is substantially equivalent to the Nipro® Blood Tubing Set with Transducer Protectors and Priming Set (K010264) and does not raise any new questions regarding safety or effectiveness. {6}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body. The logo is black and white. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # MAR 3 0 2009 Nikkiso Co. Ltd. c/o Dr. Fumiaki Kanai MIC International 4-1-17 Hongo Bunkyo-ku, Tokyo 113-0035 JAPAN Re: K082719 Trade/Device Name: NIKKLINE Blood Tubing Lines with Transducer Protectors Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KOC Dated: March 11, 2009 Received: March 17, 2009 Dear Dr. Kanai: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {7}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter. | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 | |----------------|----------------------------------|----------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 | | 21 CFR 892.xxx | (Radiology) | (240) 276-0120 | | Other | | (240) 276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html. Sincerely yours, Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): K082719 Device Name: NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS #### Indication for Use The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are disposable bloodlines intended to provide extracorporcal access to a patient's blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician or other licensed practitioner. Image /page/8/Picture/5 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CFR 801 Subpart D)" in a smaller font. There is a large "X" mark above a horizontal line, which is to the right of the words "Prescription Use". The text indicates that the product is intended for prescription use and is subject to the regulations outlined in 21 CFR 801 Subpart D. AND/OR Over-the Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |----------------------------------------------------------------|---------| | (Division Sign-Off) | | | Division of Reproductive, Abdominal, and Radiological Devices, | | | 510(k) Number | K082719 |