NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1

K072988 · Nipro Medical Corporation · FIB · Feb 21, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K072988
• Device Name: NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
• Applicant: Nipro Medical Corporation
• Product Code: FIB · Gastroenterology, Urology
• Decision Date: Feb 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Indications for Use

The Nipro Transducer Protector TP-SURE is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.

Device Story

Nipro Transducer Protector TP-SURE is a single-use, disposable, sterile device used in hemodialysis delivery systems. It consists of a plastic housing containing a 0.1 µm hydrophobic filter. The device is installed between the blood tubing set and the hemodialysis machine's pressure monitor using male and female luer lock connectors. The hydrophobic filter acts as a barrier to prevent fluid flow into the pressure monitor while blocking viruses, bacteria, and particulate matter from contaminating the fluid pathway. It is operated by clinical staff in a dialysis setting. By preventing cross-contamination and protecting sensitive monitoring equipment, the device ensures the integrity of the hemodialysis circuit and patient safety during treatment.

Clinical Evidence

No clinical data. Bench testing only. Performance testing verified device safety and effectiveness, including biocompatibility testing (cytotoxicity, pyrogenicity, acute toxicity, intracutaneous reactivity, hemolysis, implantation, and bacterial endotoxin testing).

Technological Characteristics

Plastic housing with 0.1 µm hydrophobic filter; male and female luer lock connectors; single-use; sterile; non-electronic; mechanical barrier.

Indications for Use

Indicated for patients undergoing hemodialysis requiring pressure monitoring; device protects monitors and maintains sterility of fluid pathways in hemodialysis delivery systems.

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

• Medisystems Transducer Protectors (K983076)
• NIPRO Set - Blood Tubing Set with transducer protectors and priming set (K072024)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Nipro. The logo consists of a stylized, intertwined ribbon-like symbol on the left, followed by the word "NIPRO" in bold, sans-serif font. The logo is black and white.

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

2012 1

### 510(k) Summary NIPRO Transducer Protector TP-SURE

807.92(a) (1) Applicant: Establishment Reg.:

Nipro Medical Corporation 1056186

Contact Person:

Jessica Oswald Requlatory Affairs Specialist

February 21, 2008

Date of summary preparation:

807.92(a) (2)

Trade Name: NIPRO Transducer Protector TP-SURE Common Name: Transducer Protector Classification Name: protector, transducer, dialysis Requlation Number: 21 CFR 876.5820 Panel: 78 Product Code: FIB

807.92(a) (3)

Legally marketed substantial equivalent device:

K983076 - Medisystems Transducer Protectors

K072024 - NIPRO Set - Blood Tubing Set with transducer protectors and priming set.

#### 807.92(a) (4)

Description of device:

The Nipro Transducer Protector TP-SURE consists of a plastic housing that contains a hydrophobic filter with a reference pore size of 0.1 um. The housing has male and female luer lock connectors that allow its attachment between a blood tubing set and the pressure monitor on a hemodialysis machine.

The TP-SURE is to be used as protective device for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.1 µm hydrophobic filter helps prevent cross-contamination by viruses, bacterial and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor.

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.

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

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

#### 807.92(a) (5)

Indications for Use:

The Nipro Transducer Protector TP-SURE is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.

#### 807.92(a) (6)

Comparison of technological characteristics:

The NIPRO Transducer Protector TP-SURE 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 cytotoxicity, 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 Transducer Protector TP-SURE 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure.

FEB 21 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jessica Oswald Regulatory Affairs Specialist NIPRO Medical Corporation 3150 N.W. 107 Avenue MIAMIFL 33172

Re: K072988

Trade/Device Name: NIPRO Transducer Protector TP-SURE Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FIB Dated: February 14, 2008 Received: February 15, 2008

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, 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.

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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 (QS) 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C 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: K072988

Device Name: NIPRO Transducer Protector TP-SURE

Indications for Use:

The Nipro Transducer Protector TP-SURE is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓ AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K072988 |

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