Optiflux dialyzer

K152367 · Fresenius Medical Care North America · KDI · Oct 29, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K152367
• Device Name: Optiflux dialyzer
• Applicant: Fresenius Medical Care North America
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Oct 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Optiflux dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

Device Story

Optiflux dialyzers are single-use devices for acute and chronic hemodialysis; they facilitate transfer of water and solutes between blood and dialysate via a semi-permeable membrane. The device utilizes counter-current flow, where dialysate flows opposite to blood in the extracorporeal circuit to maintain concentration gradients for waste removal (diffusion) and fluid removal (ultrafiltration). Used in clinical hemodialysis environments; operated by trained healthcare professionals. The device provides mechanical filtration; it does not involve software or automated analysis. Benefits include effective waste and fluid removal for patients with renal failure.

Clinical Evidence

No clinical studies were performed. Evidence consists of bench testing conducted in accordance with ISO 8637:2010, including clearance testing, sieving coefficient, ultrafiltration performance, membrane performance, structural integrity (pressure decay), biocompatibility (extractables/leachables, cytotoxicity, sensitization, irritation, systemic/chronic toxicity, genotoxicity, hemocompatibility), and sterility/pyrogenicity testing.

Technological Characteristics

Materials: Advanced Fresenius Polysulfone, polycarbonate, polyurethane, silicone. Principle: Counter-current hemodialysis via semi-permeable membrane. Form factor: Four sizes differentiated by membrane surface area. Sterilization: E-beam. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients with acute or chronic renal failure when conservative therapy is inadequate.

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

• Optiflux Ultra dialyzers (K123262)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 29, 2015

Fresenius Medical Care North America Denise Oppermann Senior Director Regulatory Affairs, Devices 920 Winter Street Waltham, MA 02451-1457

Re: K152367

Trade/Device Name: Optiflux Dialyzers F160NR, F180NR, F200NR and F250NR Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: August 20, 2015 Received: August 21, 2015

Dear Denise Oppermann,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K152367

Device Name

Optiflux Dialyzers F160NR, F180NR, F200NR, and F250NR

Indications for Use (Describe)

Optiflux Dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

#### 510(K) SUMMARY 5.

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.

#### 5.1. Submitter's Information

| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|-------------------|-------------------------------------------------------------------|
| Address: | 920 Winter Street<br>Waltham, MA<br>02451-1457 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Denise Oppermann, Senior Director<br>Regulatory Affairs – Devices |
| Preparation Date: | 20 August 2015 |

#### 5.2. Device Name

| Trade Name: | Optiflux® Series of Dialyzers F160NR,<br>F180NR, F200NR, F250NR |
|----------------------------------------|------------------------------------------------------------------------|
| Common Name: | Dialyzer, High Permeability with or<br>without Sealed Dialysate System |
| Classification Name : | High permeability hemodialysis system |
| Regulatory Class: | Class II per 21 CFR §876.5860 |
| Product Code/<br>Classification Panel: | KDI<br>Gastroenterology / Urology |

#### 5.3. Legally Marketed Predicate Device

The predicate devices are the FMCRTG, LLC Optiflux Ultra dialyzers, model numbers F160, F180, F190, F210 and F230. The Optiflux Ultra dialyzers were cleared in K123262 (06 January 2014). The Optiflux Ultra dialyzers have not been the subject of a design-related recall.

#### Device Description 5.4.

The Optiflux dialyzers are part of the FMCRTG family of single use dialyzers, which allow for the transfer of water and solutes between blood and the dialysate through a semi-

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Image /page/4/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left, resembling three stacked chevrons pointing downwards. To the right of the shape are the words "FRESENIUS" and "MEDICAL CARE" stacked on top of each other in a bold, blue sans-serif font. The overall design is clean and corporate, conveying a sense of stability and professionalism.

permeable membrane. They Optiflux dialyzers are available in four (4) sizes. The sizes are differentiated by membrane surface area.

#### 5.4.1. Device Identification

The proposed Optiflux series of dialyzers includes the following size dialyzers:

| Optiflux® F160NR Dialyzer |
|---------------------------|
| Optiflux® F180NR Dialyzer |
| Optiflux® F200NR Dialyzer |
| Optiflux® F250NR Dialyzer |

#### 5.4.2. Device Characteristics

The proposed Optiflux dialyzers are single use dialyzers manufactured from Advanced Fresenius Polysulfone, polycarbonate, silicone and Polyurethane. The dialyzers are provided with the blood pathway sterile and sterilized using e-beam sterilization.

#### 5.4.3. Environment of Use

The Optiflux dialyzers are used in environments where acute and chronic hemodialysis is performed.

#### 5.4.4. Brief Written Description of the Devices

The principle of hemodialysis involves the diffusion of solutes across a semi-permeable membrane. Dialyzers use a counter-current flow, where the dialysate is flowing in the opposite direction to blood flow in the extracorporeal circuit. Counter-current flow maintains the concentration gradient across the membrane for waste removal (diffusion) and fluid removal (ultrafiltration).

#### 5.4.5. Materials of Use

The Optiflux dialyzers are manufactured from Advanced Fresenius Polysulfone, polycarbonate, polyurethane and silicone. The Optiflux dialyzer are classified as an external communicating device with prolonged exposure (>24 hrs to ≤30 days) to circulating blood.

#### Key Performance Specifications/Characteristics 5.4.6.

Urea clearance is a key performance specification of the Optiflux dialyzers. FMCRTG uses sodium clearance as a marker for urea clearance as they exhibit similar movement across a membrane. Table 1 provides typical sodium clearance data for the Optiflux series of dialyzers.

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Image /page/5/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

#### In vitro Urea Clearance Typical for the Optiflux Dialyzer Models (Ob= Table 1: 300mL/min, Od= 500mL/min, UFR=0mL/min)

| Trade Name | Typical Urea Clearance<br>(Sodium Used as Marker) |
|--------------------------|---------------------------------------------------|
| Optiflux F160NR Dialyzer | 271 |
| Optiflux F180NR Dialyzer | 277 |
| Optiflux F200NR Dialyzer | 280 |
| Optiflux F250NR Dialyzer | 287 |

#### 5.5. Intended Use

Optiflux dialyzers are designed for single use acute and chronic hemodialysis.

#### 5.6. Indications for Use

Optiflux dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

### 5.7. Comparison of Technological Characteristics with the Predicate Device

The proposed Optiflux dialyzers and the predicate Optiflux Ultra dialyzers (K123262) have the following equivalent technological characteristics:

- The same intended use including the same indications
- Similar design and configuration ●
- Same basic scientific technology and principles of operation
- Same sterilization method, packaging and sterility label claims ●
- o Same materials - Advanced Fresenius Polysulfone (PS), polycarbonate (PC), polyurethane (PU) and silicone (SI).

#### 5.8. Performance Data

Performance testing was conducted in accordance with ISO 8637:2010. Results of the testing listed below support the determination of substantial equivalence.

- Performance testing - clearance testing, sieving coefficient, ultrafiltration performance and membrane performance
- Structural integrity testing positive and negative pressure decay testing and o blood compartment integrity
- o Biological safety testing (biocompatibility)
- Sterility and pyrogenicity testing. ●

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Image /page/6/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

#### 5.8.1. Biocompatibility Testing

The following testing was performed to support the biocompatibility of the dialyzers:

- Chemical analysis extractables and leachables ●
- Cytotoxicity
- Sensitization ●
- Irritation
- Systemic Toxicity ●
- Chronic Toxicity
- Genotoxicity ●
- Hemocompatibility
- Risk assessment of potential toxicity

#### 5.8.2. Animal Studies

No animal studies were performed in support of the Optiflux dialyzers.

#### 5.8.3. Clinical Studies

No clinical studies were performed in support of the Optiflux dialyzers.

#### Conclusions 5.9.

Based on the information and data provided in this Traditional 510(k), the Optiflux dialyzers are substantially equivalent in intended use, indications for use, design, principle of operation, technology, materials and performance to the predicate Optiflux Ultra dialyzers (K123262) and are safe and effective for their intended use.