Who is the manufacturer of PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)?

Renal Systems, Inc. filed the 510(k) submission for PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) (K970648).

What is the FDA product code for PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)?

MSF. It is classified under 21 CFR 876.5860 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)

K970648 · Renal Systems, Inc. · MSF · Jan 5, 1998 · Gastroenterology, Urology

Device Facts

Record ID	K970648
Device Name	PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
Applicant	Renal Systems, Inc.
Product Code	MSF · Gastroenterology, Urology
Decision Date	Jan 5, 1998
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5860
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Primus® Hollow Fiber Dialyzer is indicated for hemodialysis of patients with acute or chronic renal insufficiency. The Primus Dialyzer is intended for reuse.

Device Story

Primus Hollow Fiber Dialyzer facilitates hemodialysis for patients with acute or chronic renal insufficiency. Device designed for multiple-use (reuse) applications. Operates as extracorporeal blood purification component; removes waste products and excess fluid from patient blood via semi-permeable hollow fiber membranes. Used in clinical hemodialysis settings by trained healthcare professionals. Output is purified blood returned to patient circulation. Benefit includes management of renal failure symptoms and fluid balance.

Clinical Evidence

No clinical data provided; 510(k) clearance based on substantial equivalence to existing hemodialyzer technology.

Technological Characteristics

Hollow fiber membrane hemodialyzer. Designed for multiple-use (reuse) cycles. Class III device under 21 CFR 876.5860. No specific materials or software algorithms described.

Indications for Use

Indicated for hemodialysis in patients with acute or chronic renal insufficiency. Intended for reuse.

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.”

Related Devices

K034064 — FRESENIUS ULTRAFLO HPX HEMODIALYZER · Fresenius Medical Care North America · Jan 30, 2004
K131050 — NXSTAGE 1.6M2 DIALYZER · Nxstage Medical, Inc. · Dec 27, 2013
K982337 — CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER · Haidylena Medical Egypt · Dec 29, 1998
K955592 — COBE CENTRYSYSTEM 14 PES HEMODIALYZERS · Cobe Renal Care, Inc. · Apr 30, 1997
K031378 — FRESENIUS ULTRAFLUX HEMODIALYZER · Fresenius Medical Care North America · May 30, 2003

Submission Summary (Full Text)

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN - 5 1998 Ms. Lynn M. Lueders Director, Regulatory Affairs Renal Systems Division of Minntech Corporation 14605 28th Avenue North Minneapolis, Minnesota 55447 Re: K970648 Multiple Use Labeling for Primus® 1000, 1350 and 2000 Hollow Fiber Hemodialyzers Dated: October 17, 1997 Received: October 21, 1997 Regulatory Class: III 21 CFR §876.5860/Product Code: 78 MSF Dear Ms. Lueders: 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, 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 Enclosure {1} # Indications for Use 510(k) Number (if known): _________________________ Device Name: **Primus® Hollow Fiber Dialyzer** Indications for Use: _________________________ The Primus® Hollow Fiber Dialyzer is indicated for hemodialysis of patients with acute or chronic renal insufficiency. The Primus Dialyzer is intended for reuse. ![img-0.jpeg](img-0.jpeg) (PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ☑ (Per 21 CFR 801.109) OR Over-the-counter-use ☐ (Optional Format 1-2-96) Robert R. Nattling (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number **K970648**