MEDISYSTEMS TRANDUCER PROTECTOR

K970536 · Medisystems Corp. · FIB · May 12, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970536
• Device Name: MEDISYSTEMS TRANDUCER PROTECTOR
• Applicant: Medisystems Corp.
• Product Code: FIB · Gastroenterology, Urology
• Decision Date: May 12, 1997
• 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 pathway.

Device Story

Single-use, disposable device; contains 0.2 µm hydrophobic filter within housing. Placed in hemodialysis fluid pathway; acts as barrier between blood tubing and machine pressure monitor. Filter prevents passage of bacteria/particulates; hydrophobic nature blocks fluid flow to monitor at pressures < 600 mmHg. Used in clinical hemodialysis settings; operated by trained dialysis staff. Protects equipment from fluid ingress; maintains sterility of blood circuit; prevents cross-contamination. Benefits patient by ensuring sterile fluid pathway and accurate pressure monitoring.

Clinical Evidence

Bench testing only. Device release relies on sterility, pyrogenicity, physical testing, and visual examination per established design specifications.

Technological Characteristics

Single-use, disposable filter housing containing 0.2 µm hydrophobic filter. Functions as a mechanical barrier to bacteria, particulates, and fluids. Rated for pressure protection up to 600 mmHg.

Indications for Use

Indicated for use in hemodialysis systems as a protective barrier for pressure monitors to maintain sterility of the blood tubing fluid pathway and prevent cross-contamination by bacteria and particulate matter.

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)

Submission Summary (Full Text)

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K970536

# Section I

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

MAY 12 1997

I. Submitter:

A. Name: Medisystems Corporation
B. Address: 1201 Third Avenue, Suite 3900
Seattle WA 98101-3016
C. Phone and Fax Numbers: Phone: [phone]
Fax [phone]
D. Contact Person: Mr. Fredric G. Swindler

II. Date of preparation of this Summary: February 10, 1997
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 which are the subject of this submission are substantially equivalent to those described in Medisystems’ 510(k) number K895856.

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 µm hydrophobic filter helps prevent cross-contamination by bacteria and particulate matter while preventing the flow of fluids to the machine pressure monitor at pressures less than 600 mmHg.

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 pathway. 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 µm hydrophobic filter. Due to the pore size of the

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K970536

filter, bacteria and particulate contamination are prevented from passing from the machine pressure monitor to the blood tubing set. The combination of the pore size and hydrophobic nature of the filter also prevents the flow of fluids, bacteria, and particulate matter into the pressure monitor at pressure 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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