HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME

K971687 · National Medical Care, Inc. · FJK · Jul 29, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971687
• Device Name: HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME
• Applicant: National Medical Care, Inc.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Jul 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hemodialysis Venous Blood Tubing Set is intended for use as the extracorporeal blood circuit during hemodialysis. It is intended for single use only. The Hemodialysis Venous Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

Device Story

Hemodialysis venous blood tubing set functions as extracorporeal blood circuit during hemodialysis. Device connects patient to hemodialyzer equipment; facilitates blood flow during treatment. Used in clinical settings by healthcare professionals. Single-use disposable component. Output is the physical transport of blood within the circuit. Benefits patient by enabling safe extracorporeal blood circulation during dialysis therapy.

Clinical Evidence

Bench testing only. Data provided for functional performance, biocompatibility of blood-contacting materials, and integrity of bonded connections.

Technological Characteristics

Extracorporeal blood tubing set. Materials tested for biocompatibility. Bonded connections tested for integrity. Sterilization method and packaging consistent with predicate devices. No electronic, software, or algorithmic components.

Indications for Use

Indicated for use as an extracorporeal blood circuit during hemodialysis in patients requiring conventional or high flux negative pressure hemodialysis treatment. For single 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.

Submission Summary (Full Text)

{0}------------------------------------------------

## SUMMARY OF SAFETY AND EFFECTIVENESS

The proposed hemodialysis venous blood tubing sets raise no new issues of safety or effectiveness. No new claims or indications are made.

The venous bloodlines are substantially equivalent to legally marketed bloodlines. These bloodlines have been functionally tested and data provided. The blood contact materials of the venous bloodlines have been tested for biocompatibility and data provided.

The integrity of the bonded connections of the bloodlines have been tested and data provided. Sterilization method and packaging are the same as the predicate devices.

JUL 2 9 1997

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol resembling an eagle or bird in flight. The symbol is composed of three curved lines that converge and then separate, creating a sense of movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## Jul 2 9 1997

Art Eilinsfeld Manager, Regulatory Affairs Fresenius Medical Care Two Ledgemont Center 95 Hayden Avenue Lexington, Massachusetts 02173 Re: K971687

Hemodialysis Venous Blood Tubing Set Dated: April 30 ... 1997 ....... ... ... ... ...... Received: May 2, 1997 Regulatory Class: II 21 CFR 876.5820/Procode: 78 FJK

Dear Mr. Eilinsfeld:

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 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 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 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 requirement, as set forth in the Quality System Regulation (QS) 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 vou might have under sections 531 through 542 of the Act for devices under 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 vitry 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/odrh/dsmamain html".

Sincerely yours.

W.Lilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

Page_1 of 1___________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Hemodialysis Venous Blood Tubing Set

Indications For Use:

The Hemodialysis Venous Blood Tubing Set is intended for use as the extracorporeal blood circuit during hemodialysis. It is intended for single use only. The Hemodialysis Venous Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

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

Concurrence of CDR., Office of Device Evaluation (ODE) Rober R. Jalling (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_199716 & OR Over - The Counter Use _ _ Prescription Use _ V (Per 21 CFR 801.109)

(Optional Format 1-2-96)

0070