ULTRACON ULTRAFILTRATOR

K971710 · Quantic Biomedical, Inc. · FJI · Feb 27, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K971710
• Device Name: ULTRACON ULTRAFILTRATOR
• Applicant: Quantic Biomedical, Inc.
• Product Code: FJI · Gastroenterology, Urology
• Decision Date: Feb 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UltraCon™ Ultrafiltrator is indicated for use as an ultrafiltrator for the selective removal of undesireable plasma water and small dissolved solutes from blood plasma proteins and formed cellular elements, as may be present in cases of acute hemodilution such as following cardiopulmonary bypass.

Device Story

UltraCon™ Ultrafiltrator is a sterile, single-use device for hemoconcentration. Input: diluted blood perfusate. Operation: blood flows through semipermeable cellulose diacetate hollow fibers; water and small solutes pass through membrane walls into a vented annular compartment for waste disposal; formed elements and proteins are concentrated. Used in clinical settings by physicians or qualified personnel. Output: concentrated blood components returned to patient circuit. Benefits: manages acute hemodilution by removing excess plasma water. Device is passive; requires no external monitor or controller. Flow rates and transmembrane pressures must be manually monitored and controlled by the operator.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and functional characteristics compared to predicate devices.

Technological Characteristics

Constructed of semipermeable cellulose diacetate hollow fiber membranes. Nominal membrane area 0.11 M²; molecular weight cutoff < 65,000 Daltons. Sterile, non-pyrogenic, gamma-irradiated. Passive filtration mechanism; no energy source, monitor, or controller required. Dimensions: 15 cm length, 1.8 cm diameter. Priming volume 5 ml.

Indications for Use

Indicated for patients experiencing acute hemodilution, such as following cardiopulmonary bypass, requiring selective removal of plasma water and small dissolved solutes from blood. Contraindicated for direct patient connection and for use as a dialyzer or for any dialysis procedure.

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.

Predicate Devices

• Altra FLUX™ 140 Hemodialyzer (K945620/A)
• Minifilter™ Hemofilter (Reference number unknown)
• Hemocor HPHTM 400 Hemoconcentrator (Reference number unknown)

Submission Summary (Full Text)

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# 1971710

## FEB < 7 1998

### 510(k) SUMMARY

#### SUBMITTED BY:

Andrew G. Hood President Quantic Biomedical, Inc. 810 "E" Street San Rafael, CA 94901-2819 USA

| Primary Phone: | 415-365-0995 |
|------------------|--------------|
| Primary Fax: | 415-365-0522 |
| Alternate Phone: | 415-453-1008 |
| Alternate Fax: | 415-457-0278 |

February 24, 1998 Date Submitted:

#### CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name: Conventional Hemodialyzer, under 21 CFR 876.5820

| Common or Usual Name: | Ultrafiltrator |
|-----------------------|--------------------------|
| Proprietary Name: | UltraCon™ Ultrafiltrator |

#### PREDICATE DEVICES

| Predicate Device 1; | Altra FLUX™ 140 Hemodialyzer,<br>Althin Medical, Inc.<br>Reference Number K945620/A. |
|---------------------|------------------------------------------------------------------------------------------|
| Predicate Device 2; | Minifilter™ Hemofilter,<br>Amicon Division, WR Grace & Co.<br>Reference Number unknown. |
| Predicate Device 3; | Hemocor HPHTM 400 Hemoconcentrator<br>Minntech Corporation.<br>Reference Number unknown. |

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#### INDICATIONS

The UltraCon™ Ultrafiltrator is indicated for use as an ultrafiltrator for the selective removal The Onacon - Ontaintation is mail dissolved solutes from blood plasma proteins and formed cellular elements, as may be present in cases of acute hemocillution such as following cardiopulmonary bypass.

#### DEVICE DESCRIPTION

The Ultracon™ Ultrafiltrator is constructed of semipermeable hollow fibers, which divide the device into two compartments. An inner pathway for diluted blood perfusate is defined by the inlet and outlet connectors and flow dispersion headers, which are connected through the inner lumen of semipermeable hollow fiber membranes. Surrounding the hollow fibers is an enclosed, vented compartment for the collection of ultrafiltrate waste water.

When dilute blood or a blood component is allowed to pass through the perfusate pathway, the device acts as an ultrafilter, removing a percentage of the plasma water and small solutes from the perfusate. When perfusate fluid passes through the inner diameter of the hollow fibers, water and small dissolved solutes can pass through the semipermeable membrane walls into the annular ultrafiltrate compartment, to then be discarded. This results in the concentration of formed elements and proteins as they pass along the perfusate pathway.

The UltraCon™ Ultrafiltrator is built with dry cellulose diacetate membranes, a unique material which has been shown to have a high level of biocompatibility. The absence of any bore fluid provides the convenience of using the device without the need for rinsing. Each device is supplied in a sealed plastic and foil package, to maintain a sterile, non-pyrogenic perfusate pathway.

Although constructed of highly permeable membrane material, the low total membrane surface area of the UltraCon™ Ultrafiltrator inherently limits the maximum rate of water removal. Neither an ultrafiltration rate monitor nor a controller is necessary. Average ultrafiltration rate will vary directly according to perfusate flow rate, transmembrane pressure, or temperature, and inversely according to its protein concentration and hematocrit.

### UltraCon™ Ultrafiltrator Specifications

| Overall unit length, cm | 15 |
|-------------------------------------------------------|----------|
| Effective fiber length, cm | 11 |
| Unit diameter, cm | 1.8 |
| Membrane area, nominal M² | 0.11 |
| Perfusate flow resistance, nominal, mm Hg/ml/min | 0.15 |
| Maximum allowable transmembrane pressure (TMP), mm Hg | 500 |
| Priming volume, ml | 5 |
| Residual volume, ml | 1 |
| Hemo-concentration (kUF) typical rate, ml/hr/mm Hg | 1 |
| Molecular weight nominal cutoff, Daltons | < 65,000 |

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## CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND COMPLICATIONS

While there are no known absolute contraindications to ultrafiltration therapy, maintenance of blood outside the body requires administration of anticoagulants and other medications to the patient or the collected blood. All drugs and medications should be closely monitored by the orescribing physician to detect any alteration in their effective concentration due to the ultrafiltration process. Because the clearance of some drugs may be variable, the directions and contraindications for use must be in keeping with the patient's medical history and status.

The UltraCon™ Ultrafiltrator is contraindicated for use with direct patient connection. Use as a dialyzer, or for any dialysis procedure, is also contraindicated.

The UltraCon™ Ultrafiltrator is intended for use solely by a physician, or under the direction of a physician by qualified personnel who understand its operation, and by prescription only. It is intended for single patient, single procedure use only, and should not be resterilized or reused.

The UltraCon™ Ultrafiltrator is sterilized by gamma irradiation. The blood pathway is sterile and nonpyrogenic in an unopened, undamaged package. The product should not be used if the protective package is damaged or if the perfusate port caps are missing. Aseptic technique is required to avoid contamination of the perfusate pathway when making connections.

During set up and priming, a leak test should be conducted to detect perfusate pathway leaks. During use, the filtrate should be carefully monitored for the appearance of blood, indicating a leak within the device. If red cells appear in the filtrate during use, a fiber rupture has occurred and the leaking device should be replaced with a new device. Perfusate flow rates should not exceed 60 ml/min and transmembrane pressures must not exceed 500 mm Hg. A vacuum regulator should be used if vacuum suction is desired for increased fluid removal rates. Rapid alterations of flow or transmembrane pressure may cause leakage. Perfusate flow and filtrate vacuum settings should be increased or decreased gradually.

The UltraCon™ Ultrafiltrator is made with a highly permeable membrane. Ultrafiltration will occur if the filtrate line is unclamped, even without applied vacuum. If no ultrafiltration is required, the filtrate line should be clamped. The high permeability of this ultrafilter allows high concentration levels to be achieved. Perfusate concentration to a hematocrit greater than 50% should be avoided. A minimum perfusate flow rate of 15 ml/min through the ultrafiltrator should be maintained at all times to prevent plugging of membrane channels or clotting. During use, the filtrate collection chamber must be positioned below the ultrafiltrator to prevent back filtration.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Product design, materials of construction, and function as an ultrafiltrator are substantially equivalent to FDA cleared predicate devices.

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Image /page/3/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN" around the left side of the circle. The right side of the circle is blank. Inside the circle is a symbol that looks like a stylized human figure.

FEB 2 7 1998

Quantic Biomedical, Inc. c/o Glenn N. Byrd. MBA Associate Director of Regulatory Affairs Advanced Bioresearch Associates 1700 Rockville Pike, Suite 450 Rockville, MD 20852

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K971710 UltraCon™ Ultrafiltrator Dated: February 24, 1998 Received: February 25, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 FJI

Dear Mr. Byrd:

We have reviewed vour Section 5100) 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 Feleral Food, Drug, and Councile 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 Feleval Regulations, Title 21. Parts 800 to 895. A substantially equivalience compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Rogulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (S 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 542 of the Act for derices 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 predication 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 intro 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/dsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

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

Enclosure

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Reference 510(k) K971710, Supplement page 4, 9/11/97

INDICATIONS FOR USE 3)

510(k) Number: K971710

UltraCon™ Ultrafiltrator Device Name:

Indications for Use:

: 1

The UltraCon™ Ultrafiltrator is indicated for use as an ultrafiltrator for the selective removal of undesireable plasma water and small dissolved solutes from blood plasma proteins and formed cellular elements, as may be present in cases of acute hemodilution such as following cardiopulmonary bypass.

y bypass.

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

Concurrance of CDRH, Office of Device Evaluation (ODE)

| | Daber D alling / |
|----------------------|--------------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| Prescription Use | 510(k) Number K971710 |
| (Per 21 CFR 801.109) | |

Over-the-Counter Use_

Prescription Use, by or on the order of a physician (PER 21 CFR 801.109)

(Optional Format 1-2-96)