HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L

K994198 · Toray Industries (America), Inc. · KDI · Aug 25, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K994198
• Device Name: HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
• Applicant: Toray Industries (America), Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Aug 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Hemofeel™-CH hemofilter is indicated for use in the prevention or treatment of fluid overload, electrolyte and acid/base imbalances in cases of acute renal failure or toxemia with oliguria or anuria. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.

Device Story

Hemofeel™-CH Hemofilter is a single-use extracorporeal device for continuous hemofiltration. Blood enters through an arterial port, flows through polymethylmethacrylate (PMMA) hollow fibers, and exits through a venous port. The device filters blood to remove toxins and excess fluid. It is used in clinical settings for critically ill patients; operated by healthcare professionals. Physician selects filter size based on patient weight and condition. The device assists in managing fluid and electrolyte balance, providing therapeutic benefit for renal failure and refractory heart failure patients.

Clinical Evidence

Clinical evaluation conducted in eight anuric, critically ill patients. Continuous hemofiltration demonstrated utility in managing fluid and electrolyte balance in acute renal failure. No complications related to device use were reported. Supporting bench testing included ultrafiltration coefficient, water permeability, pressure drop, hemolysis, and shelf-life stability testing, all meeting acceptance criteria.

Technological Characteristics

Polymethylmethacrylate (PMMA) hollow fiber membrane; polystyrene casing and headers. Gamma-ray sterilized. Single-use. Dimensions and surface area vary by model size. No electronic components or software.

Indications for Use

Indicated for patients with acute renal failure, toxemia, oliguria, or anuria requiring management of fluid overload, electrolyte, or acid/base imbalances. Also indicated for fluid removal in patients with pulmonary edema or congestive heart failure refractory to diuretic therapy.

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.”

Predicate Devices

• Renal Systems, Inc. Renaflo Hemofilter (K854011)
• Toray Industries Filtryzer™ Model BK-U (K935471)

Submission Summary (Full Text)

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# AUG 2 5 2000

## 510(k) SUMMARY K994198

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

#### Submitter's Name: Toray Industries (America), Inc.

600 Third Avenue, 5th floor New York, NY 10016-1921 Telephone: [phone]

Contact person: Mr. Hidehiko Okubo, Director, Medical and Pharmaceutical

Date of Summary: May 31, 2000

Device Name: Hemofeel™-CH Hemofilter

Device Classification Name: High permeability hemodialysis system (78 KDI); 21 CFR, Part 876.5860

Legally Marketed Devices to which Equivalence is Claimed: The legally marketed predicate devices are the Renal Systems. Inc. Renaflo Hemofiter (K854011), determined to be substantially equivalent to a legally marketed (preAmendment) device on December 5, 1985; and the Toray Industries Filtryzer™ Model BK-U (K935471), determined to be substantially equivalent to a legally marketed (preAmendment) device on May 19, 1995.

Device Description: The Hemofeel-CH Hemofilter consists of highly permeable polymethylmethacrylate (PMMA) hollow fibers housed in a polystyrene casing and secured at each end with polystyrene headers. Blood enters the device through the arterial inlet port, passes through the hollow fibers and exits at the opposite end through the venous outlet port. The Hemofeel-CH hemofilter is provided in a range of sizes based on the surface area of the hollow fiber membrane. Hemofilter size should be selected by the physician according to the patient's body weight and medical condition. The device is gamma-ray sterilized and intended for single use only.

Intended Use: The Hemofeel™-CH hemofilter is indicated for use in the prevention or treatment of fluid overload, electrolyte and acid/base imbalances in cases of acute renal failure or toxemia with oliguria or anuria. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.

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99499

Descriptive Summary of Technological Characteristics and Those of Predicate Devices: The features and capabilities of the Hemofeel are identical to those of the Renaflo Hemofilter. The two devices are similar in dimensions. For example, the two devices have essentially identical inner diameter, casing length, fiber length, membrane surface area, and blood volume. These similarities will logically result in substantially equivalent performance characteristics. Both the Hemofeel and the Filtryzer employ a PMMA membrane to filter the blood and remove toxins.

## Performance Data:

In Vitro Testing: Ultrafiltration coefficient testing, water permeability and pressure drop testing were conducted on the Hemofeel-CH hemofilter. All samples met the acceptance criteria. Hemolysis testing was also carried out on the device, with no hemolysis seen. These test results establish that the Hemofeel-CH hemofilter possesses performance characteristics that make it acceptable for its intended use.

Shelf life testing was conducted to establish the validity of the labeled three-year shelf life of the device. The results of the testing establish that biological, sterility, leak and water permeability characteristics are maintained at the end of the labeled shelf life.

Clinical: The Hemofeel-CH hemofitter was evaluated in the clinical setting in eight anuric critically ill patients. Continuous hemofiltration was found to be useful for the management of fluid and electrolyte balance in acute renal failure. There were no complications related to the use of the Hemofeel hemofilter. The data and information from the clinical study indicate that the Hemofeel is safe and effective for use in continuous hemofiltration.

Conclusion: The information and data provided in this 510(k) Notification establish that the Hemofeel-CH hemofilter is substantially equivalent to the legally marketed predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is in black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2000

Toray Industries (America), Inc. c/o Ms. Lisa S. Jones, R.A.C. Devices for the Future 540 College Street Bellaire, TX 77401-5010

Re: K994198 Hemofeel™ - CH Hemofilter Dated: May 31, 2000 Received: June 1, 2000 Regulatory Class: II 21 CFR §876.5860/Procode: 78 KDI

#### Dear Ms. Jones:

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 incluse for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror 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, Inerefore, market the device, subject to the general controls provisions of the Act. The general contrôls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against mistranding 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 requirements, as set forth in the Quality System Requlation (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 notfication submission does not affect any obligation you micht 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 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" (21CFR 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/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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May 31, 2000

Page 1 of 1

## 510(k) Number: K994198

Device Name: Hemofeel™-CH Hemofilter

Indications for Use: The Hemofeel™-CH hemofilter is indicated for use in the prevention or treatment of fluid overload, electrolyte and acid/base imbalances in cases of acute renal failure or toxemia with oliguria or anuria. It may also be used when removal of excess fluid is indicated, such as patients in pulmonary edema or congestive heart failure refractory to diuretic therapy.

(Concurrence of CDRH, Office of Device Evaluation (ODE)

Yhind A. Sypm

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(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 9941 510(k) Number .

Prescription Use
(Per 21 CFR 801.109) \$\underline{\hspace{1cm}} \checkmark\$

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Over-the-Counter Use