NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

K112628 · Nipro Medical Corporation · FJK · Sep 28, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K112628
• Device Name: NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
• Applicant: Nipro Medical Corporation
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Sep 28, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NIPRO Set - SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis.

Device Story

Disposable blood tubing set for hemodialysis; provides extracorporeal blood access. Includes arterial line, venous line, removable priming set, and pre-attached transducer protectors. Used in clinical settings by healthcare professionals during dialysis procedures. Connects patient to dialysis machine; arterial line attaches to bottom of dialyzer, venous to top. Shorter tubing design minimizes priming volume and bio-hazardous waste; allows increased blood processing efficiency during treatment. Device is single-use, sterile, and prescription-only.

Clinical Evidence

No clinical testing performed. Substantial equivalence supported by bench testing, including package integrity, pressure leak, pump segment endurance, injection port durability, priming volume assessment, tensile testing, transducer protector strikethrough testing, clamp performance, and hemocompatibility.

Technological Characteristics

Disposable bloodline set; components include drip chambers, clamps, transducer protectors, luer locks, injection ports, and tubing (main, heparin, saline, pump segment). Materials are color-coded. Designed for compatibility with Fresenius 2008H, 2008K/K2, and 2008T machines. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring hemodialysis to provide extracorporeal blood access. Compatible with Fresenius 2008H, 2008K/K2, and 2008T dialysis machines.

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 Set - Blood Tubing Set with Transducer Protector and Priming Set (K072024)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Nipro Medical Corporation. The logo consists of a stylized, abstract symbol on the left, resembling an infinity symbol or a stylized double helix. To the right of the symbol is the company name, "NIPRO," in bold, sans-serif font, with "MEDICAL CORPORATION" printed in a smaller font size below it.

3150 NW 107th Avenue Miami FL 33172 Tel: [phone] Fax: [phone]

### 510(k) Summary:

Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protectors and Priming Set

### 807.92(a)(1)

Applicant: Establishment Reg.:

Contact Person:

Nipro Medical Corporation 1056186

SEP 28 2012

Jessica Oswald Regulatory Affairs Specialist

Date of summary preparation: February 22, 2012

### 807.92(a)(2)

Trade Name: Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protectors and Priming Set Common Name: Blood tubing line

Classification Name: set, tubing, blood, with and without anti-regurgitation valve Regulation Number: 21 CFR 876.5820

Panel: 78

Product Code: FJK

### 807.92(a)(3)

Legally marketed substantial equivalent device: K072024 - NIPRO Set - Blood Tubing Set with Transducer Protector and Priming Set.

### 807.92(a)(4)

Description of device:

The SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. One device package includes 1 arterial line (A226Y), 1 venous line (V813), 1 attached but removable priming set and two pre-attached Transducer Protectors.

The SLIMLINE is packaged sterile and labeled for single use only. There is no ability to clean and reuse this device. It is restricted for sale by or on the order of a physician.

### 807.92(a)(5)

Indications for Use:

The NIPRO Set - SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis.

### 807.92(a)(6)

Comparison of technological characteristics:

The SLIMLINE is substantially equivalent to the predicate device in the following technological characteristics -

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# K112628 20f3 page

| Item of<br>Comparison | | | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SLIMLINE<br>Model # A226YV813 | Predicate<br>Model # A209YV803 | SE determination |
| Physical<br>characteristics: | Color-coded Components: drip<br>chambers, clamps, transducer<br>protectors, luer locks, luer lock<br>caps, injection ports and dialyzer<br>connections. | Same | |
| | Tubing: main tubing, heparin<br>line, saline pigtail and blood<br>pump segment | SE | Main tubing has been<br>shortened on the<br>SLIMLINE to minimize<br>priming volume and<br>bio-hazardous waste |
| Intended Use: | The NIPRO Set - SLIMLINE is a<br>disposable bloodline intended to<br>provide extracorporeal access to<br>the patient's blood during<br>Hemodialysis. It is compatible<br>with the Fresenius 2008H,<br>2008K/K2 and 2008T dialysis<br>machines. | The Nipro Set -<br>SLIMLINE is a<br>disposable bloodline<br>intended to provide<br>extracorporeal<br>access to the<br>patient's blood<br>during Hemodialysis.<br>The compatibility of<br>available<br>configurations is the<br>responsibility of the<br>physician in charge. | Machine models added<br>to the SLIMLINE<br>indications for use.<br>Removal of sentence<br>"The compatibility of<br>available configurations<br>is the responsibility of<br>the physician in charge" |
| | SLIMLINE will attach the arterial<br>line to the bottom of the dialyzer<br>and the venous to the top, with<br>the dialysate running cross-<br>current. | Arterial line attached<br>to the top, venous to<br>the bottom.<br>Dialysate is cross<br>current. | Blood and dialysate<br>filtering through the<br>dialyzer in opposite<br>directions |
| Operational<br>technique: | Priming set is provided pre-<br>attached and needs to be<br>removed and reattached before<br>recirculation | Priming set provided<br>in package but not<br>pre-attached. | Priming set provided<br>with arterial and<br>venous lines |
| | Dialyzer needs to be parallel to<br>machine module in order to<br>prevent kinking of bloodlines | Tubing length<br>sufficient to prevent<br>kinking | Kinking risks mitigated |
| Performance | (testing detailed below<br>807.92.b.1) | SE | Shorter tubing length of<br>SLIMLINE allows more<br>blood to be processed<br>during the same<br>treatment time. |

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### 807.92(b)(1)

Non-clinical tests submitted:

Bench testing was conducted to verify that the device is safe and effective for its intended use. Those tests include: Package integrity, Pressure leak (positive and negative), Endurance test of pump segment at Maximum flow rate and pressures of the dialysis machine, Pump segment performance, Endurance testing of any injection port after penetrated by 18G hypodermic needle, Priming volume assessment, Tensile testing of joints and materials of all tubing segment, ability of Transducer protector to withstand leakage when subjected to pressures up to 2 times the maximum labeled pressure (Strikethrough test), Performance test of the device's clamps, Hemocompatability test, Performance testing of tubing to resist kinking after repeated

clamping, particularly in the post pump tubing segment; these tests along with their associated results and conclusions are included in this submission.

### 807.92(b)(2)

Substantial equivalence was proven through bench testing. No clinical testing was required or performed in support of this 510k submission.

### 807.92(b)(3)

Conclusions drawn from non-clinical and clinical tests:

The results of the bench testing and the comparison of technological characteristics with the predicate device demonstrate that the SLIMLINE performs equivalent to the predicate device and is safe and effective when used as intended.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 that resembles an eagle or bird-like figure with stylized wings and tail feathers.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Jessica Oswald Regulatory Affairs Specialist Nipro Medical Corporation 3150 NW 107th Ave. MIAMI FL 33172

SEP 2 8 2012

Re: K112628

Trade/Device Name: Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set

Regulation Number: 21 CFR& 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II . Product Code: FJK Dated: August 28, 2012 Received: August 29, 2012

Dear Ms. Oswald:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have rovious your becared or 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 conimeres prior to May 20, 1977, ar eccordance with the provisions of the Federal Food, Drug, de noos that have boon rocaders of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dioroloro, maines of the Act include requirements for annual registration, listing of gences, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device to 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Trase oc advised that I Dr F unstallion that your device complies with other requirements of the Act that I DA has made a actorminations administered by other Federal agencies. You must Of any I cueral sundes that vegaranents, including, but not limited to: registration and listing Comply with an the Att 1 roques one and 1); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice-related advorse evone) (21 CFR Part 820); and if applicable, the electronic forth in are quarty by sions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific advice to: your avviro soffices/CDRH/CDRHOffices/ucm115809.htm for go to mip.nam.ida.gov/rtoout Drives. Health's (CDRH's) Office of Compliance. Also, please the Concertion be noos and reading by reference to premarket notification" (21CFR Part note the regulation entitled, "insoranants of receiverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may obtain other general mormances on J and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Ticho

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number:_K112628

Device Name: Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set

Indications for Use:

The Nipro Set - SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis.

Prescription Use _ > (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Hoover

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number. K112628

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SLIMLINE