HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)

K980386 · Gambro Healthcare · KDI · Feb 24, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K980386
• Device Name: HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)
• Applicant: Gambro Healthcare
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Feb 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Hospal Multiflow 100 and Multiflow 100 Kits A0 (A0/B A0 and A0/0 ) and Multiflow 100 Kits B22 (B22, B22B, & B22/0) can be used whenever continuous arterio-venous or veno-venous hemofiltration, ultrafiltration or hemodialysis is indicated. This can be used for acute hemodialysis, hemofiltration or continuous ultrafiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration, and clotting times should be performed under the direction of a physician

Device Story

Extracorporeal hemofilter kit for continuous veno-venous/arterio-venous hemodialysis, hemofiltration, or ultrafiltration; utilizes AN69 (acrylonitrile and sodium methallyl sulfonate copolymer) hollow fiber membrane; blood flows through fibers while dialysate/filtrate flows counter-currently; removes uremic toxins and waste via diffusion and convection; operated by clinicians in clinical settings; includes blood lines, ultrafiltrate lines, and collection containers; provides therapy for acute renal failure; output is filtered blood returned to patient; performance monitored via vital signs and clotting times.

Clinical Evidence

No clinical data. Bench testing only: in vitro evaluation of blood/dialysate priming volumes, flow resistance, ultrafiltration coefficient, and sieving coefficients for urea, creatinine, phosphate, vitamin B12, inulin, myoglobin, and albumin.

Technological Characteristics

Hemofilter with 0.90 m2 surface area; 6,000 AN69 hollow fibers (240 micron ID, 50 micron wall thickness); polycarbonate housing/end caps; silicone O-rings; polyurethane potting; operates via hydrostatic/transmembrane pressure; non-software device.

Indications for Use

Indicated for patients requiring acute hemodialysis, hemofiltration, or continuous ultrafiltration via continuous arterio-venous or veno-venous access. Requires physician-directed monitoring of vital signs, therapy delivery, heparin administration, and clotting times.

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

• Hospal Kit Multiflow 60P (K924437)

Submission Summary (Full Text)

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2/24/99

510K Notification Hospal Multiflow 100, Multiflow 100 Kit A0, Multiflow 100 Kit B22 January 27th, , 1998

#### 510K(k) SUMMARY

SUBMITTER:

Gambro Healthcare Formerly: Cobe Renal Care, Inc. 1185 Oak Street Lakewood, CO 80215 [phone]

| DATE PREPARED: | October 15th, 1997 |
|-----------------------|---------------------------------------------------------------------|
| DEVICE NAME: | Hospal Multiflow 100, Multiflow 100 Kits A0, Multiflow 100 Kits B22 |
| CLASSIFICATION NAMES: | High Permeability Hemodialyzer |
| PREDICATE DEVICE: | Hospal Kit Multiflow 60P |

#### Device Description:

The Hospal Multiflow 100, Multiflow 100 Kit A0, Multiflow 100 Kit B22 are identical in construction in function to other hemofilters currently marketed in the United States. These devices are intended for use in continuous pump assisted veno-venous The membrane used in this device is Acrylonitrile and sodium hemofiltration and. methallyl sulfonate copolymer (AN69) which is identical to the membrane utilized in the Kit Multiflow 60P which have been previously approved for marketing in the United States under a 510K Notification (K884365).

Blood enters a blood inlet port where it is distributed to Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) hollow fibers. Each hollow fiber has an inner diameter of approximately 240 microns (wet hollow fiber internal diameter) and a wall thickness of 50 microns. There are 6,000 Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) hollow fibers having an effective length of 27 cm. The effective membrane surface area of the Multiflow 100 hemofilter is 0.90 m2. At either end of the device the hollow fibers are potted in polyurethane to isolate the blood compartment from the filtrate compartment. Each end of the hemofilter is sealed using a silicone O-ring and polycarbonate end cap. The housing of this hemofilter is also made of polycarbonate. The fibers used in this device are identical in design and materials to the previously approved Hospal Kit Multiflow 60P. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.

By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the Acrylonitrile and sodium methallyl sulfonate copolymer (AN69) membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate or filtrate compartment of the device. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the Acrylonitrile and sodium methallyl sulfonate copolymer

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(AN69) membrane and into the counter current flowing dialysis solution during CVVHD. During CVVH, no dialysis solution is perfused through the filtrate compartment in which case removal of plasma water and uremic toxins is accomplished by means of convection alone. The dialysate exits the devices via a dialysate outlet port. Schematic drawings of the Hospal Multiflow 100, Multiflow 100 Kit A0, and Multiflow 100 Kit B22 are included in this Section.

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# MULTIFLOW 100 KIT A0, MULTIFLOW 100 KIT B22

- The Multiflow 100 Kit A0 (A0, A0/B and A0/0) and Multiflow 100 Kit B22 (B22, ● B22/B, & B22/0) are an extracorporeal blood circuit with the Multiflow 100 , Hemofilter and are intended to be used with a variety of equipment for pump assisted The Multiflow 100 Kit B22 consists of the Multiflow 100 CVVH, and CVVHD. Hemofilter pre-attached to blood tubing. The Multiflow 100 Kits A0 (A0, A0/B and A0/0) and Multiflow 100 Kits B22 (B22/B22/B/B22/0) can be used for continuous veno-venous hemodialysis (CVVHD), continuous veno-venous hemofiltration (CVVH). These kits are designed to operate with pump-assisted blood circulation. An ultrafiltrate / dialysate collection and measurement set is also included with these kits.
- The component parts of the Multiflow Kits 100 B22/B22/0 are: .
- A Multiflow 100 Hemofilter 1.
- A arterial blood line 2.
- 3. A venous blood line
- 4. An ultrafiltrate line
- 5. A ultrafiltrate/dialysate measuring container (not in the B22/0 Kit)
- A 5 liter ultrafiltrate/dialysate collection container (included in only the B22Kit) 6.
- 7. A priming adaptor
- A reinfusion line 8.
- The component parts of the Multiflow Kits 100 A0. A0/B and A0/0 are:
- A Multiflow 100 Hemofilter 1.
- 2. An ultrafiltrate line
- A ultrafiltrate/dialysate measuring container (included in only the A0 Kit) 3.
- A 5 liter ultrafiltrate/dialysate collection container (included in only the A0/B Kit) ব:
- 5. A priming adaptor

# Predicate Devices:

The Hospal Multiflow 100 and Multiflow 100 Kits A0 and Multiflow 100 Kits B22 are substantially equivalent in construction, design, intended use, function and materials to other hemofilter kits currently marketed in the United States. The Hospal Multiflow 100 and Multiflow 100 Kits A0 and Multiflow 100 Kits B22 are substantially equivalent in function, design, composition, materials, and operation, to the Hospal Kit Multiflow 60P Kit (K924437) which is currently in commercial distribution in the United States.

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# Intended Use:

The Hospal Multiflow 100 and Multiflow 100 Kits A0 and Multiflow 100 Kits B22 can be used whenever continuous veno-venous hemofiltration or hemodialysis is indicated. This can be used for acute hemodialysis, hemofiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration, and clotting times should be performed under the direction of a physician.

This indication statement is essentially the same as the indication statement for the predicate device.

# Technological Characteristics:

Comparing the proposed device to the predicate device, some similarities and differences are noted in the design employed to accomplish the same intended use. Both the proposed and predicate devices utilize the same AN69, hollow fiber membrane manufactured by Hospal Industrie. Both the proposed and predicate devices utilize polycarbonate for the housing and header material and polyurethane for the membrane potting material. The predicate device is different from the proposed device in that it utilizes a larger membrane surface area and has a slightly larger blood side priming volume.

#### Summary of Non-Clinical Tests:

In vitro testing was performed on the Multiflow 100 to determine the following: blood side priming volume, dialysate side priming volume, dialysate and blood flow resistance, ultrafiltration coefficient, urea, creatinine, phosphate and vitamin B12, inulin, myoglobin, and albumin sieving coefficients. The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters.

# Clinical Test Results:

Clinical testing was not performed

# Conclusions:

Testing performed on the Multiflow 100 and Multiflow 100 A0 and Multiflow 100 B22 Kits indicates that they are safe, effective, and perform as well as the predicate device, when used in accordance with the instructions for use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K980386 Hospal Multiflow 100, Multiflow 100 Kits A0. and Multiflow 100 Kits B22 Dated: June 8, 1998 Received: June 9, 1998 Regulatory Class: III 21 CFR 876.5860/Procode: 78 KDI

Dear Dr. Shideman:

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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fective in the clarions, 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 Regulation (OS) 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 i submission does not affect any obligation you might have under sections 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 vitto 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/cdr/dsmadsmam.html".

Sincerely your

Lillian Yin, Ph.D.

Director. Division of Reproducti Abdominal. Far. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/4/Picture/13 description: The image shows a partial view of a logo, specifically the emblem of the U.S. Department of Health and Human Services (HHS). The emblem features a stylized depiction of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The word "DEPARTMENT" is partially visible along the left edge of the image, indicating the organizational affiliation of the logo.

FEB 2 4 1999

Jeffrey R. Shideman, Ph.D. GAMBRO Healthcare 1185 Oak Street Lakewood, CO 80215

Re: K98
II

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1.980386 510(k) Number (if known): ________________

Device Name: H _ Hospal Multiflow 100 and Multiflow 100 Kits A0 and B22 ﺩ ﺩ Indications For Use:

The Hospal Multiflow 100 and Multiflow 100 Kits A0 (A0/B A0 and A0/0 ) and Multiflow 100 Kits B22 (B22, B22B, & B22/0) can be used whenever continuous arterio-venous or veno-venous hemofiltration, ultrafiltration or hemodialysis is indicated. This can be used for acute hemodialysis, hemofiltration or continuous ultrafiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration, and clotting times should be performed under the direction of a physician

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Nathing/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 11980386 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)