MEDISYSTEMS TRANSDUCER PROTECTOR

K983076 · Medisystems Corp. · FIB · Nov 25, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K983076
• Device Name: MEDISYSTEMS TRANSDUCER PROTECTOR
• Applicant: Medisystems Corp.
• Product Code: FIB · Gastroenterology, Urology
• Decision Date: Nov 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Indications for Use

Medisystems Transducer Protectors are single use, disposable prescription devices intended for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathwav.

Device Story

Medisystems Transducer Protectors are single-use, disposable devices used in hemodialysis settings. The device consists of a filter housing containing a 0.2 um hydrophobic filter. It is placed in the blood tubing fluid pathway to protect pressure monitors. The hydrophobic filter acts as a barrier, preventing the passage of fluids, viruses, bacteria, and particulate matter into the pressure transducer while allowing air pressure transmission. This protects the hemodialysis machine's pressure monitoring system from contamination and fluid ingress, maintaining the sterility of the fluid pathway. The device is operated by clinical staff during hemodialysis procedures.

Clinical Evidence

Bench testing only. Testing included sterility, pyrogenicity, physical testing, and visual examination of in-process and finished products to ensure compliance with design specifications.

Technological Characteristics

Filter housing containing a 0.2 um hydrophobic filter. The device is a single-use, disposable component designed for hemodialysis pressure monitoring lines. It functions by utilizing the pore size and hydrophobic properties of the filter to block fluids, viruses, bacteria, and particulates at pressures below the device's rated limit.

Indications for Use

Indicated for use as protective devices for pressure monitors on hemodialysis machines and to maintain sterility of the blood tubing fluid pathway by preventing cross-contamination from viruses, bacteria, and particulate matter, and preventing fluid flow to the pressure transducer.

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 (K895856)
• Trimed Transducer Protectors (K820459B)

Submission Summary (Full Text)

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K983076
Page 1 of 2

部: 201

## Section I

## 510(k) Summary Required by 21 CFR §807.92

I. Submitter:

McKenna & Cuneo, L.L.P. A. Name:

B. Address: 1900 K Street, NW Washington, DC 20006

C. Phone and Fax Numbers: Phone: [phone] Fax [phone]

D. Contact Person: Mr. Larry Pilot

II. Date of preparation of this Summary: August 13, 1998

III. Trade Name: Medisystems Transducer Protectors

IV. Common Name: Transducer Protectors

V. Classification Name: Hemodialysis System and Accessories

VI. The Marketed Device(s) to which Equivalence is Claimed: The Transducer Protectors that are the subject of this submission are substantially equivalent to those described in Medisystems 510(k) number K895856 for the design and construction of the device and to those described in the Trimed 510(k) number K820459B for the claim of viral retention.

VII. Product Description: Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 um hydrophobic filter helps prevent cross-contamination by viruses, bacteria and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor.

VIII. Statement of Intended Use Compared to Predicate Device: Medisystems Transducer Protectors are single use, disposable prescription devices intended for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathwav. This is identical to the intended use of the legally marketed predicate device.

IX. Discussion of Technological Characteristics: The technical characteristics of the device consist of a filter housing that contains a 0.2 um hydrophobic filter. The combination of the pore

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size and hydrophobic nature of the filter also prevents the flow of fluids, viruses, bacteria, and particulate matter into the pressure monitor at pressures lower than the rated pressure of the device.

X. Safety and Effectiveness: To assure that the device is safe and effective, all finished products are tested and must meet all required release specifications before distribution. The testing required for release includes, but is not limited to; sterility, pyrogenicity, physical testing, and visual examination of both in-process and finished product.

The required testing is defined by written and approved procedures that conform to the product design specifications. This testing for the Medisystems Transducer Protectors is defined in detail in the "Device Master Records."

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Image /page/2/Picture/2 description: The image shows a circular logo for the Department of Health & Human Services. The logo features a stylized representation of three human figures connected at the shoulders, forming a triangular shape. The figures are silhouetted in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 25 1998

Medisystems Corp. c/o Mr. Larry R. Pilot McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006-1108 Re: K983076

Medisystem's In Line Transducer Protector Dated: September 2, 1998 Received: September 2, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 FIB

Dear Mr. Pilot:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrl/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section A

510(k) Number (if known): __

Device Name: Transducer Protectors

Indications For Use:

Medisystems Transducer Protectors are indicated for use as protective devices for pressure monitors on hemodialysis machines as well as to help protect the sterility of the blood tubing fluid pathway. The filter helps prevent cross-contamination by viruses, bacteria, and other particulate matter while preventing the flow of fluids to the hemodialysis machine's pressure transducer.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vimil A. Seryman
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological De

Prescription Use レ 510(k) Number Over-The-Counter Use

(Optional Format 1-2-96)