ULTRACON ULTRAFILTRATOR

K981253 · Interpore Intl. · FJI · Dec 11, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981253
• Device Name: ULTRACON ULTRAFILTRATOR
• Applicant: Interpore Intl.
• Product Code: FJI · Gastroenterology, Urology
• Decision Date: Dec 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The UltraConcentrator™ Permeability Hemodialyzer is indicated for use as an ultrafiltrator for the selective removal of undesirable 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

Device functions as an ultrafiltrator to concentrate blood plasma proteins and cellular elements by removing plasma water and small solutes. Input: diluted blood perfusate. Mechanism: semi-permeable hollow fiber membranes; perfusate flows through inner lumen; water/solutes pass through membrane into vented outer compartment for disposal. Output: concentrated blood product. Used in clinical settings by qualified personnel; manual operation or via pneumatically driven UltraConcentrator Processor. Device is not for direct patient connection. Healthcare providers monitor hemoconcentration levels to ensure hematocrit does not exceed 50%. Benefits include restoration of plasma protein/cellular element concentration following hemodilution.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed of semi-permeable hollow fiber membranes. Nominal membrane area: 0.11 m². Molecular weight cutoff: <65,000 Daltons. Max transmembrane pressure: 500 mmHg. Sterilized by gamma irradiation. Single-use. Dimensions: 15 cm length, 1.8 cm diameter. Operates via manual injection or pneumatic processor.

Indications for Use

Indicated for use as an ultrafiltrator to remove plasma water and small solutes from blood plasma proteins and cellular elements in patients experiencing acute hemodilution, such as post-cardiopulmonary bypass. Contraindicated for use as a dialyzer, for dialysis with dialysate, or for direct connection to a patient's vascular system.

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

• Quantic Biomedical, Inc. UltraCon™ Ultrafiltrator (K971710)

Submission Summary (Full Text)

{0}------------------------------------------------

K981253

DEC | 1 1998

# 510(k) SUMMARY

# SUBMITTED BY

Lynn Rodarti Manager, Regulatory Affairs INTERPORE Cross International 181 Technology Drive Irvine, California 92618 [phone]

Date Submitted: April 3, 1998

# CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

| Classification Name: | Conventional Hemodialyzer |
|-------------------------|----------------------------------------------|
| Common/Usual Name: | Ultraconcentrator |
| Product Classification: | Class II |
| Proprietary Name: | UltraConcentrator™ Permeability Hemodialyzer |

### PREDICATE DEVICE

Quantic Biomedical, Inc. UltraCon™ Ultrafiltrator freference 510(k) K971710]

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

# INDICATIONS FOR USE

The UltraConcentrator™ Permeability Hemodialyzer is indicated for use as an ultrafiltrator for the selective removal of undesirable 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 DESCRIPTION

The UltraConcentrator Permeability Hemodialyzer is a device that is used to remove plasma water from dilute blood plamsa proteins, increasing the concentration of plasma proteins and formed cellular elements. The UltraConcentrator is constructed of semi-permeable 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

{1}------------------------------------------------

ge 2 of 4

headers which are connected through the inner lumen of semi-permeable, hollow fiber membranes. Surrounding the hollow fibers is an enclosed, vented compartment for the collection of ultrafiltrate waste water.

When perfusate fluid passes through the inner diameter of the hollow fibers, water and small dissolved solutes can pass through the semi-permeable membrane walls into the annular ultrafiltrate compartment to then be discarded.

The UltraConcentrator may be used manually or it may be used with the UltraConcentrator Processor, a pneumatically driven device that provides automatic processing of the UltraConcentrator.

The UltraConcentrator Permeability Hemodialyzer is not intended for use with direct patient connection, nor is it intended for use as a dialyzer. Although constructed of highly permeable membrane material, the low total membrane surface area of the UltraConcentrator inherently limits the maximum rate of water removal. Neither an ultrafiltration rate monitor nor a controller is necessary.+

#### ULTRACONCENTRATOR 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 (mm Hg): | 500 |
| Priming volume (mL): | 5 |
| Residual volume (mL): | 1 |
| Hemoconcentration (kUF) typical rate (mL/hr/mm Hg): | 1 |
| Molecular weight nominal cutoff (Daltons): | <65,000 |

{2}------------------------------------------------

# CONTRAINDICATIONS, WARNINGS, PRECAUTIONS

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 to the collected blood. All drugs and medications should be closely monitored by the prescribing 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.

- Contraindications 1.
The UltraConcentrator is contraindicated for use as a dialyzer or for dialysis with a dialysate. It is also contraindicated for any direct connection to a patient's vascular system or circulating blood volume.

- 2. Warnings and Precautions
- The UltraConcentrator Permeability Hemodialyzer is a device which a. should only be used by qualified personnel who understand its operation.
- This device is intended for single use only. Do not resterilize. b.
- This device was sterilized by gamma irradiation. C. The blood pathway is sterile and non-pyrogenic in an unopened, undamaged package. Do not use this device if the package is damaged or if perfusate port caps are missing or loose in the package.
- d. Do not exceed a vacuum of 20 inHg (50 cmHg).
- Perfusate concentrate to a hematocrit greater than 50% should be e. avoided.
- f. A minimum perfusate flow rate of 15 ml/min through the UltraConcentrator should be maintained at all times to prevent plugging of membrane channels or clotting.
- Blood flow should not exceed 60 ml/min. రు
- h. The transmembrane pressure must not exceed 500 mmHg. For manual operation, inject the perfusate through the UltraConcentrator over a span of at least 15 seconds.
- l. When used with the Processor, care should be exercised to avoid hematocrit level greater achieving a 50% than ın the hemoconcentrate.
- ) . Patient blood should at all times be drawn, handled and returned according to applicable established institutional guidelines.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

{3}------------------------------------------------

K98 22.

Page 4 of 4

# COMPARISON TO THE PREDICATE DEVICE

The UltraConcentrator is technologically substantially equivalent to the predicate in every respect.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DFC 1 1 1998

Ms. Lynn Rodarti Manager, Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618-2402 Re: K981253/S2 UltraConcentrator Permeability Hemodialyzer

Dated: September 22, 1998 Received: September 23, 1998 Regulatory Class: II CFR 876.5820/Procode: 78 FJI

Dear Ms. Rodarti:

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 (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 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 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 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/dsmadsmamain.html".

Sincerely your

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

{5}------------------------------------------------

Page 1 of 1

510(k) Number (if known): K981253

UltraConcentrator™ Permeability Hemodialyzer Device Name:

#### Indications for Use:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

UltraConcentrator™ Permeability Hemodialyzer is indicated for use The as an ultrafiltrator for the selective removal of undesirable 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(PER 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

*Williamfm*
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

| 510(k) Number | K981253/5 ⁰⁰² |
|---------------|--------------------------|
|---------------|--------------------------|