HEMOCOR HPH MINI HEMOCONCENTRATOR

K980859 · Minntech Corp. · KDI · May 12, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980859
• Device Name: HEMOCOR HPH MINI HEMOCONCENTRATOR
• Applicant: Minntech Corp.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: May 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hemocor HPH Mini Hemoconcentrator is intended for the relief or mitigation of overhydration, reduction of lower molecular weight constituents and to increase formed cellular elements and protein levels in the blood of patients during and/or after cardiopulmonary procedures.

Device Story

Hemoconcentrator for extracorporeal circuits; utilizes glycerin-free polysulphone membrane to remove excess fluid and low molecular weight constituents from blood during/after cardiopulmonary bypass. Device integrated into circuit via 3/16" and 1/4" barbed luer adaptors. Operates via ultrafiltration; blood flows through fiber bundle; fluid/solutes pass through membrane. Used in clinical settings by perfusionists/clinicians. Benefits include mitigation of overhydration and concentration of blood components. No software or electronic components.

Clinical Evidence

Bench testing only. Performance metrics evaluated include Ultrafiltration Rate vs. Transmembrane Pressure, Pressure Drop vs. Blood Flow Rate, Protein Rejection, Minimum Blood Flow Rate, and Blood Path Integrity.

Technological Characteristics

Materials: Polycarbonate housing, polyurethane potting, polysulphone membrane. Surface area: 0.07 m². Fiber length: 9.4 cm. Max transmembrane pressure: 500 mmHg. Blood flow range: 50-500 ml/min. Priming volume: 14 ml. Molecular weight cut-off: 65,000 daltons. Mechanical ultrafiltration device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients undergoing or recovering from cardiopulmonary procedures requiring relief of overhydration, reduction of low molecular weight constituents, or concentration of blood cellular elements and proteins.

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

• Hemocor HPH® 400 Hemoconcentrator

Submission Summary (Full Text)

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K980859
Page 1 of 2

MAY 1 2 1998

# 510(k) SUMMARY

# Submitter Information: 1.

| Name: | Minntech Corporation |
|-----------------|-------------------------------------------------------|
| Address: | 14605 28th Avenue North, Minneapolis, Minnesota 55447 |
| Contact Person: | Mark Murphy |
| Date Prepared: | March 3, 1998 |

#### Device Name: 2.

| Proprietary name: | Minntech Hemocor HPH® Mini Hemoconcentrator |
|----------------------|-----------------------------------------------|
| Common name: | Hemoconcentrator |
| Classification name: | Autotransfusion Apparatus per 21 CFR 868.5830 |

## Predicate Device: 3.

Hemocor HPH® 400 Hemoconcentrator

### Device Description: 4.

The Minntech Hemocor HPH® Mini Hemoconcentrator is made of glycerin-free polysulphone membrane. Barbed luer adaptors of 3/16" and 1/4" for blood path connection and a no-rinse feature provide versatility for insertion of the device into the extracorporeal circuit.

#### ર. Indications for Use:

| Device | Indications |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Minntech HPH Mini<br>Hemoconcentrator | The Hemocor HPH® Mini Hemoconcentrator is intended<br>for the relief or mitigation of overhydration and reduction<br>of lower molecular weight constituents during and/or<br>following cardiopulmonary procedures. |
| Minntech HPH 400<br>Hemoconcentrator | The Hemocor HPH® Hemoconcentrator is intended for<br>use as an ultrafiltration system to remove excess fluid<br>during and/or following cardiopulmonary bypass<br>procedures where acute hemodilution has been employed. |

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K 980859
Page 2 of 2

### Technological Characteristics: 6.

| Characteristic | Hemocor HPH Mini<br>Hemoconcentrator | Hemocor HPH 400<br>Hemoconcentrator |
|--------------------------------------------|--------------------------------------|-------------------------------------|
| Housing | Polycarbonate | Polycarbonate |
| Potting Material | Polyurethane | Polyurethane |
| Membrane | Polysulphone | Polysulphone |
| Membrane Surface Area | 0.07 m² | 0.3 m² |
| Effective Fiber Length (cm) | 9.4 | 9.4 |
| Maximumum Transmembrane<br>Pressure (mmHg) | 500 | 500 |
| Max. Blood Flow rate (ml/min) | 500 | 500 |
| Min. Blood Flow rate (ml/min) | 50 | 100 |
| Priming volume (ml) | 14 | 27 |
| Molecular weight cut-off<br>(daltons) | 65000 | 65000 |

tive summary of the Hemocor HPH® Mini and predicate device is as follows:

#### 7. Performance Testing:

The following performance testing was conducted to determine device effectiveness as a hemoconcentrator: Ultrafiltration Rate vs. Transmembrane Pressure, Pressure Drop vs. Blood Flow Rate, Protein Rejection, Minimum Blood Flow Rate & Blood Path Integrity.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mark Murphy Regulatory Affairs Associate MINNTECH® Corporation 14605 28th Avenue North Minneapolis, MN 55447

Dear Mr. Murphy:

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.

Re: K980859

Hemocor HPH Mini Hemoconcentrator

21 CFR 876.5860/Procode: 78 KDI

Dated: March 3, 1998

Regulatory Class: III

Received: March 5, 1998

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 equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, 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 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 S10(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/cdrb/dsmaldsmamain.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

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# Indications for Use

510(k) Number (if known):

Device Name:

Hemocor HPH Mini Hemoconcentrator

Indications for Use:

The Hemocor HPH Mini Hemoconcentrator is intended for the relief or mitigation of overhydration, reduction of lower molecular weight constituents and to increase formed cellular elements and protein levels in the blood of patients during and/or after cardiopulmonary procedures.

(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 D. Rathung
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K980859