FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS

K992275 · Fresenius USA, Inc. · KDI · Aug 4, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992275
• Device Name: FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
• Applicant: Fresenius USA, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Aug 4, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

Device Story

Fresenius F Series Low Volume Hemoconcentrator; hollow fiber-type filter; used during cardiopulmonary procedures to remove excess fluid and concentrate blood components. Device inputs: patient blood via extracorporeal circuit. Principle of operation: ultrafiltration across semi-permeable polysulfone membrane; driven by transmembrane pressure. Output: concentrated blood returned to patient; ultrafiltrate removed. Operated by clinical staff in surgical/clinical settings. Benefits: mitigation of overhydration; increased hematocrit/protein concentration. Design modification from predicate F400 includes reduced membrane surface area (0.35m² vs 0.7m²) and lower priming volume (27ml vs 42ml) to accommodate lower volume requirements.

Clinical Evidence

Bench testing only. Comparison of performance specifications including pressure drop and ultrafiltration rates at varying blood flow rates (100-300 ml/min) and transmembrane pressures. Non-pyrogenic status verified via LAL assay.

Technological Characteristics

Hollow fiber filter; Fresenius Polysulfone membrane; Polycarbonate housing; Polyurethane potting; Silicone O-ring; Luer blood connectors. Dimensions: 33cm length, 2.8cm diameter. 2530 fibers, 200µm lumen diameter, 40µm wall thickness. Sterilization: EtO. Molecular weight cutoff: ~65,000 Daltons. Max transmembrane pressure: 600 mmHg. Max blood flow: 300 ml/min.

Indications for Use

Indicated for patients undergoing cardiopulmonary procedures experiencing overhydration or requiring increased concentration of blood cells 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

• Fresenius F Series F400 Hemoconcentrator (K974584)

Submission Summary (Full Text)

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K99 2275 p.1/2

#### SPECIAL 510(k): DEVICE MODIFICATION FRESENIUS F SERIES HEMOCONCENTRATOR

# 510(k) Summary for the Fresenius Modified F400 and F400TS (Low Volume) Hemoconcentrators

| Submitter's Name and Address: | Fresenius Hemotechnology Inc.<br>110 Mason Circle Suite A<br>Concord, CA 94520 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone Number: | [phone] |
| Telefax Number: | [phone] |
| Contact Person: | Virginia Singer, Manager Regulatory Affairs and<br>Quality Assurance |
| Date Summary Prepared: | June 21, 1999 |
| Device Trade Name: | Fresenius F Series Low Volume Hemoconcentrator |
| Common name: | Hemoconcentrator |
| Classification Name: | High Permeability Hemodialysis System (21 CFR<br>876.5860) |
| Substantial Equivalence: | The proposed device is substantially equivalent to<br>the Fresenius F Series F400 Hemoconcentrator |
| Device Description: | The Low Volume Hemoconcentrator is similar to the<br>F Series F400 Hemoconcentrator. Both<br>hemoconcentrators are hollow fiber-type filters and<br>will be provided with and without a tubing set. The<br>Low Volume Hemoconcentrator has an active<br>membrane surface area of 0.35M2 and a priming<br>volume of 27 ml. |
| Intended Use: | Intended to relieve or mitigate overhydration in<br>patients undergoing cardiopulmonary procedures<br>and to increase the concentration of cells and<br>proteins in the blood. |
| Technological Characteristics: | The proposed device has the same technological<br>characteristics and is similar in design and<br>configurations compared with the predicate device<br>(See table on next page). |

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K992275 p 2/2

| Product Specifications | Low Volume<br>Hemoconcentrator<br>(This submission) | F400 Hemoconcentrator<br>(K974584) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Intended to relieve or mitigate<br>overhydration in patients<br>undergoing cardiopulmonary<br>procedures and to increase<br>the concentration of cells and<br>proteins in the blood. | Intended to relieve or<br>mitigate overhydration in<br>patients undergoing<br>cardiopulmonary procedures<br>and to increase the<br>concentration of cells and<br>proteins in the blood. |
| Active Membrane Surface (M²) | 0.35 | 0.7 |
| Priming Volume (ml) | 27 | 42 |
| Unit Length (with endcaps) (cm) | 33 | 33 |
| Unit Inner Diameter (cm) | 2.8 | 2.8 |
| Number of Fibers | 2530 | 4,600 |
| Fiber Lumen Diameter (µm) | 200 | 200 |
| Fiber Wall Diameter (µm) | 40 | 40 |
| Fiber Length (cm) | 22.5 | 22.5 |
| Fiber Membrane Material | Fresenius Polysulfone | Fresenius Polysulfone |
| Housing Material | Polycarbonate | Polycarbonate |
| Potting (resin) Material | Polyurethane | Polyurethane |
| End Cap | Screw-type, silicone O-ring | Screw-type, silicone O-ring |
| Blood Connector | Luer connector | Luer connector |
| Ultrafiltrate Connector (cm, inch) | 6.35, ¼ | 6.35, ¼ |
| Sterilization | EtO | EtO |
| Pyrogenicity | Non-pyrogenic (LAL assay) | Non-pyrogenic (LAL assay) |
| Glycerol rinse required | No | No |
| Molecular Weight Cutoff (daltons) | Approx. 65,000 | Approx. 65,000 |
| Max. Transmembrane Pressure (mmHg) | 600 | 600 |
| Max. Blood Flow (ml/min) | 300 | 500 |
| Pressure Drop (mmHg)* | | |
| Nominal, QB = 100 ml/min | 80.00 | 32.50 |
| Nominal, QB = 200 ml/min | 172.50 | 85.00 |
| Nominal, QB = 300 ml/min | 270.00 | 116.25 |
| Ultrafiltration Rate (ml/min) | | |
| Nominal, TMP=525, QB = 100 ml/min | 46.0 | 54.0 |
| Nominal, TMP=525, QB = 200 ml/min | 68.0 | 84.0 |
| Nominal, TMP=525, QB = 300 ml/min | 84.7 | 106.5** |

## Substantial Equivalence Comparison Chart Low Volume Hemoconcentrator vs. Predicate F400 Hemoconcentrator

*Pressure Drop and Ultrafiltration Rate will vary according to blood flow rate, transmembrane pressure, temperature, hematocrit and protein concentration.

** Data not previously reported in K974584

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 1999

Ms. Virginia Singer Manager, Regulatory Affairs and Quality Assurance Fresenius Hemotechnology Inc. 110 Mason Circle, Suite A Concord, CA 94520-1238

Re: K992275 Fresenius F Series Low Volume Hemoconcentrator Dated: June 30, 1999 Received: July 7, 1999 Regulatory Class: III 21 CFR §876.5860/Procode: 78 KDI

Dear Ms. Singer:

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 legally marketed predicate 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 (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 equivalent determination 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 531 through 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), piease 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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 Statement

Page 1 of 1

510(k) Number ( if known):

Fresenius F Series Modified F400 and F400TS (Low Volume) Hemoconcentrators Device Name:

The Fresenius F Series Hemoconcentrators are indicated to relieve or mitigate Indications for Use: overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

## (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)

Ewind le. Segman
OR

Over-The-Counter Use_

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