COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET

K970253 · Gambro Healthcare · KDI · Sep 26, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970253
• Device Name: COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET
• Applicant: Gambro Healthcare
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Sep 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Centrysystem® 3 +plus™ Dialysis Control Unit is indicated for patients in acute or chronic renal failure and when hemodialysis is prescribed by the physician. Both high flux and low flux dialyzers may be used with the Centrysystem® 3 +plus™. The modifications to the Centrysystem® 3 do not significantly affect the intended uses previously claimed for this device. This device is a totally self-contained machine that provides the necessary control functions for hemodialysis therapy, including: - automatically primes the extracorporeal blood circuit (dialyzer and blood tubing set); - prepares dialysate; - monitors machine subsystems for proper performance and unsafe conditions; - pumps blood, dialysate and anticoagulant at predetermined rates; - controls fluid removal from the patient; and - automatically cleans, disinfects and rinses dialysate flow path. The Centrysystem Cartridge Blood Tubing Set is intended to be used and an extracorporeal circuit accessory to the Centrysystem® 3 +plus™ Dialysis Control Unit described above.

Device Story

Self-contained hemodialysis control unit; manages extracorporeal blood circuit priming, dialysate preparation, and anticoagulant delivery. Operates via automated control of blood and dialysate pumps; monitors system performance and safety conditions; manages fluid removal (ultrafiltration). Performs automated cleaning, disinfection, and rinsing of dialysate flow path. Used in clinical settings by trained healthcare professionals. Provides real-time monitoring and control of therapy parameters; enables precise fluid management and treatment delivery for renal failure patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and performance specifications.

Technological Characteristics

Self-contained hemodialysis control unit; includes blood, dialysate, and anticoagulant pumps; automated fluid removal control; automated disinfection/cleaning system. Compatible with Centrysystem Cartridge Blood Tubing Set.

Indications for Use

Indicated for patients with acute or chronic renal failure requiring hemodialysis as prescribed by a physician. Compatible with high and low flux dialyzers.

Regulatory Classification

Identification

A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).

Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ” (2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,” (3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,” (4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and (5) “Guidance for Hemodialyzer Reuse Labeling.”

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

# SEP 26 1997

Ms. Benita Bourque, RAC
Director of Regulatory Affairs
GAMBRO Healthcare
1185 Oak Street
Lakewood, Colorado 80215

Re: K970253
Centrysystem® 3 plus™ Dialysis Control Unit
Dated: June 27, 1997
Received: June 30, 1997
Regulatory class: III
21 CFR §876.5860/Product code: 78 KDI

Dear Ms. Bourque:

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 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 you might have under sections 531 through 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/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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510(k)Number: K970253

Device Name: Centrysystem® 3 +plus™ Dialysis Control Unit

Indications For Use:

The Centrysystem® 3 +plus™ Dialysis Control Unit is indicated for patients in acute or chronic renal failure and when hemodialysis is prescribed by the physician. Both high flux and low flux dialyzers may be used with the Centrysystem® 3 +plus™. The modifications to the Centrysystem® 3 do not significantly affect the intended uses previously claimed for this device. This device is a totally self-contained machine that provides the necessary control functions for hemodialysis therapy, including:

- automatically primes the extracorporeal blood circuit (dialyzer and blood tubing set);
- prepares dialysate;
- monitors machine subsystems for proper performance and unsafe conditions;
- pumps blood, dialysate and anticoagulant at predetermined rates;
- controls fluid removal from the patient; and
- automatically cleans, disinfects and rinses dialysate flow path.

The Centrysystem Cartridge Blood Tubing Set is intended to be used and an extracorporeal circuit accessory to the Centrysystem® 3 +plus™ Dialysis Control Unit described above.

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970253

Prescription Use ☑
(Per 21 CFR 801.109)

Over-the-Counter Use

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