NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693

K072024 · Nipro Medical Corp. · FJK · Oct 4, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K072024
• Device Name: NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693
• Applicant: Nipro Medical Corp.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Oct 4, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines 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.

Device Story

Disposable blood tubing set for hemodialysis; includes arterial and venous lines, transducer protectors, and priming sets. Components include tubing, drip chambers, infusion lines, pressure monitoring ports, clamps, and filters. Used in clinical settings by healthcare professionals to facilitate extracorporeal blood circulation, medication/fluid infusion, blood sampling, and pressure monitoring. Packaged sterile for single use; non-implanted. Physician determines configuration compatibility with specific dialysis machines. Benefits include safe extracorporeal access and debris capture during dialysis procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed, including pyrogenicity, acute toxicity, intracutaneous reactivity, hemolysis, implantation, and bacterial endotoxin testing. No clinical data presented.

Technological Characteristics

Disposable blood tubing set; components include PVC/plastic tubing, drip chambers, filters, and clamps. Sterile, single-use. No electronic or software components. Biocompatibility verified per standard testing protocols.

Indications for Use

Indicated for patients requiring hemodialysis; provides extracorporeal blood access via disposable bloodlines. Intended for prescription use only.

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 (K010264)

Submission Summary (Full Text)

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K072024
PAGE 1 OF 2

Image /page/0/Picture/1 description: The image shows the logo for Nipro. The logo consists of a stylized, intertwined symbol resembling two overlapping letter "N" shapes, followed by the word "NIPRO" in bold, sans-serif font. The logo is black and white.

3150 N.W. 107 Avenue Miami, Florida 33172 Tel .: [phone] Fax: [phone]

2007

## 510(k) Summary of Safety and Effectiveness for Nipro® Set

Blood Tubing Set with Transducer Protector and Priming Set

807.92(a)(1)

Applicant: Establishment Reg.: Nipro Medical Corporation 1056186

Contact Person: Jessica Oswald Regulatory Affairs Specialist

July 19, 2007 Date of summary preparation:

#### 807.92(a)(2)

Trade Name: Nipro@ Set - Blood Tubing Set with Transducer Protector and Priming Set

Common Name: Blood tubing set

Classification Name: set, tubing, blood, with and without anti-regurgitation valve

Requlation Number: 21 CFR 876.5820 Panel: 78 Product Code: FJK

Product Code: FIB

#### 807.92(a)(3)

Legally marketed substantial equivalent device: K010264 - NIPRO Set Blood Tubing Set with transducer protector and priming set.

#### 807.92(a)(4)

Description of device:

The Nipro® Blood Tubing Set with Transducer Protector and Priming Set includes arterial and venous dialysis blood tubing with transducer protectors and priming set (non-implanted blood access device) as described in 21 CFR 876.5820.

The devices are packaged together for convenient use during hemodialysis procedures. There are 13 different configurations of the arterial line and 6 different configurations of the venous line. The various blood set models are being manufactured for application with various models of dialysis machines. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump

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K072024
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Image /page/1/Picture/1 description: The image shows the logo for Nipro. The logo consists of a stylized, abstract symbol to the left of the word "NIPRO" in bold, sans-serif font. The symbol appears to be two overlapping shapes, creating an infinity-like or double helix design.

3150 N.W. 107 Avenue Miami, Florida 33172 Tel.: [phone] Fax: [phone]

> blood, retain and capture blood debris, infuse medications or fluids, sample blood and monitor pressure.

The devices are packaged sterile and labeled for single use only. There is no ability to clean and reuse these devices. They are restricted for sale by or on the order of a physician.

#### 807.92(a)(5)

Indications for Use:

The Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines 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.

#### 807.92(a)(6)

Comparison of technological characteristics:

The Nipro® Blood Tubing Set with Transducer Protector and Priming Set is substantially equivalent to the predicate device in the following technological characteristics -

- Design .
- Physical characteristics .
- . Basic Scientific Technology
- Intended Use .

#### 807.92(b)(1)

Non-clinical tests submitted :

Performance testing was conducted to verify that the device is safe and effective for its intended use. Those tests along with their associated results and conclusions are included in this submission. Biocompatibility testing was also conducted. Those tests include pyrogenicity, acute toxicity. intracutaneous reactivity, hemolysis testing, implantation testing and bacterial endotoxin testing.

#### 807.92(b)(3)

Conclusions drawn from non-clinical and clinical tests:

The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the Nipro® Blood Tubing Set with Transducer Protector and Priming Set performs equivalent to the predicate device and is safe and effective when used as intended.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border 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.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 4, 2007

Ms. Jessica Oswald Regulatory Affairs Specialist NIPRO® Medical Corporation 3150 NW 107th Avenue MIAMI FL 33172

Re: K072024

Trade/Device Name: NIPRO® Blood Tubing Set with Transducer Protector and Priming Set; Models A201-A219, V801-V806, 5M9634 and -93 Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: August 28, 2007 Received: September 4, 2007

Dear Ms. Oswald:

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, 1796, 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.

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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 of 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely vours.

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

### 510(k) Number:

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

#### Indications for Use:

The Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D)

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

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Reproductive, Abdominal and | |
| Radiological Devices | K072024 |
| 510(k) Number | |