CAREline Airless Hemodialysis Blood Tubing Sets

K172238 · Fresenius Medical Care Renal Therapies Group, LLC · KOC · Dec 14, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K172238
• Device Name: CAREline Airless Hemodialysis Blood Tubing Sets
• Applicant: Fresenius Medical Care Renal Therapies Group, LLC
• Product Code: KOC · Gastroenterology, Urology
• Decision Date: Dec 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CAREline Twister: The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the responsibility of the physician. • The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. • The Fresenius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement. The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure. • Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K2 and T Hemodialysis Machines. CAREline Standard: The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the resonsiblity of the physician. • The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. • Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K.2 and T Hemodialysis Machines.

Device Story

Extracorporeal blood tubing set for hemodialysis; transports arterial blood from patient access through hemodialyzer and back to venous access. Includes Pressure Output Device (POD) for pressure transmission to machine transducers; needleless access ports for medication/sampling; and optional Access Flow Reversing Connector (AFRC) for flow measurement without disconnecting lines. Used in clinical hemodialysis settings by trained personnel. Device facilitates therapy delivery and monitoring; AFRC simplifies access flow testing. Single-use, ethylene oxide sterilized.

Clinical Evidence

No clinical studies were performed. Substantial equivalence supported by bench testing, including structural integrity (pressure/pull testing), connector performance, clamp testing, biocompatibility (ISO 10993-1), and usability evaluation.

Technological Characteristics

Single-use extracorporeal blood tubing set. Materials: PVC, PC, PP, PE, MABS, TPE, acrylic-based polymer, polyisoprene, siloxanes, silicones. Features POD for pressure monitoring and needleless access ports. Sterilized via ethylene oxide. Complies with ISO 8638:2010. No electrical or software components.

Indications for Use

Indicated for patients requiring acute or chronic hemodialysis therapy. Used with prescribed hemodialyzer and Fresenius Medical Care 2008 Series K, K2, and T machines.

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

• CombiSet Blood Tubing with Access Flow Reversing Connector (Twister) (K022536)
• Streamline Airless System Set with Locksite Needleless Access Site (K080807)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 14, 2017

Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451

Re: K172238

Trade/Device Name: CAREline Airless Hemodialysis Blood Tubing Sets Regulation Number: 21 CFR& 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: KOC, FJK Dated: November 10. 2017 Received: November 13, 2017

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 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Charles Viviano -S

Benjamin R. Fisher, Ph.D. For 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) K172238

### Device Name

CAREline Airless Hemodialysis Blood Tubing Sets

Indications for Use (Describe)

CAREline Twister:

The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the responsibility of the physician.

· The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.

• The Fresenius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement. The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure.

· Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K2 and T Hemodialysis Machines.

CAREline Standard:

The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the resonsiblity of the physician.

• The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.

· Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K.2 and T Hemodialysis Machines.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top and "MEDICAL CARE" on the bottom.

K172238 Page 1 of 6

#### 5. 510(K) SUMMARY

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: | 24 July 2017 |

#### 5.2. Device Name

| Trade Name: | CAREline Airless Hemodialysis Blood Tubing Set |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Common Name: | KOC – Accessories, Blood Circuit,<br>Hemodialysis<br>FJK - Set, Tubing, Blood, With and Without<br>Anti-regurgitation Valve |
| Classification Name : | Hemodialysis system and accessories |
| Regulatory Class: | Class II per 21 CFR 876.5820 |
| Product Code: | KOC / FJK |
| Classification Panel: | Gastroenterology-Urology |

#### 5.3. Legally Marketed Predicate Device

### Primary Predicate - CombiSet® Blood Tubing with Access Flow 5.3.1. Reversing Connector (Twister®)

CombiSet Blood Tubing with Access Flow Reversing Connector (Twister), K022536, is the primary predicate for the CAREline Airless Hemodialysis Blood Tubing Sets (hereafter referred to as "CAREline bloodlines").

### Secondary Predicate - Streamline Airless System Set with Locksite® 5.3.2. Needleless Access Site

Streamline Airless System Set with Locksite Needleless Access Site, K080807, is the secondary predicate for the CAREline bloodlines.

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K172238 Page 2 of 6

#### 5.4. Device Description

The CAREline bloodlines are intended for use in acute and chronic hemodialysis therapy. The bloodline is part of the hemodialysis extracorporeal circuit, which transports arterial blood from the patient's arterial access (e.g., fistula or catheter) through a hemodialyzer and back to the patient's venous access.

#### 5.4.1. Device Identification

The proposed CAREline bloodlines include the following devices (Table 1):

#### Table 1: Proposed CAREline Bloodlines

| Product | Alternate name |
|------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| CAREline Airless Hemodialysis Blood Tubing Set with<br>Attached Priming Set | CAREline Standard bloodline |
| CAREline Airless Hemodialysis Blood Tubing Set with<br>Access Flow Reversing Connector (Twister) and Attached<br>Priming Set | CAREline Twister® bloodline |

#### 5.4.2. Environment of Use

The CAREline bloodlines are used in environments where acute and chronic hemodialysis are performed.

#### 5.4.3. Brief Written Description of the Device

The CAREline bloodlines are intended for use in acute and chronic hemodialysis therapy. The bloodline is part of the hemodialysis extracorporeal circuit, which transports arterial blood from the patient's arterial access (e.g., fistula or catheter) through a hemodialyzer and back to the patient's venous access.

#### 5.4.4. Materials of Use

The CAREline bloodlines are classified as an external communicating medical device with prolonged exposure (>24 hours < 30 days) to circulating blood in accordance with ISO 10993- 1:2009, FDA G95-1, and FDA Guidance on Hemodialysis blood tubing sets (2008).

Materials used in the manufacture of the CAREline bloodlines include:

- Tubing and Components:
- -Polyvinylchloride (PVC)
- -Polycarbonate (PC)
- Polypropylene (PP) -
- -Polyethylene (PE)
- Methyl Isobutyl Ketone (TetraMEK) -

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- । Cyclohexanone
- Pressure Output Device (POD): ●
- -Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS)
- Thermoplastic Elastomer (TPE) made of Medalist® MD |
- Twister (Twister model only): ●
- Acrylic-based polymer (Cryo XT) —
- Polyisoprene Rubber -
- -Siloxanes
- Silicones -
- Dimethyl alcohol -
- Isopropyl alcohol |

#### Key Performance Specifications/Characteristic 5.4.5.

The CAREline bloodlines are single-use devices sterilized by ethylene oxide (EO).

The CAREline bloodlines have the following performance characteristics:

- Transmission of arterial and venous pressures to the hemodialysis (HD) machine's pressure transducer via a Pressure Output Device (POD)
- . Collection of blood samples and administration of prescribed medications via a needleless access port (T-port)
- Prevention of stretched or kinked tubing via a dialyzer holder lock sleeve (a ● class I exempt accessory)
- Measurement of a patient's access flow via the Twister component, which is used to reverse blood flow to and from the arterial and venous vascular access sites.

### 5.5. Intended Use

The CAREline Airless Hemodialysis Blood Tubing Sets are indicated for use in acute and chronic hemodialysis therapy.

#### Indications for Use 5.6.

# CAREline Twister

The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician.

- The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. ●
- The Fresenius Access Flow Reversing Connector (AFRC) is for use during

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Image /page/6/Picture/1 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, also in blue. The symbol is made up of three downward-pointing chevrons stacked on top of each other.

hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement. The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure.

- Blood Tubing Set is intended to be used with Fresenius Medical Care ● 2008® Series K, K2 and T Hemodialysis Machines.
# CAREline Standard

The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician.

- The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. .
- Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T Hemodialysis Machines.

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

The CAREline bloodlines and the predicate devices share the following characteristics:

- Similar intended use including similar indications for use
- Similar design and configuration .
- . Same scientific technology and principles of operation
- . Same sterilization method, packaging, and sterility label claims
- Same materials - Polyvinylchloride (PVC), Polypropylene (PP), Polyethylene (PE)

### 5.8. Performance Data

Performance testing was conducted in accordance with ISO 8638:2010. Results of the testing listed below support the determination of substantial equivalence.

- Performance testing of connectors (hemodialyzer, vascular access device, and ancillary components)
- . Structural integrity testing
- Biological safety testing (biocompatibility) .
- . Sterility and pyrogenicity testing
- . Structural integrity - Pressure and pull testing
- Pressure testing Access ports and pressure output devices (PODs) ●

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Image /page/7/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.

K172238

- Endurance testing Conducted with Fresenius Medical Care 2008® Series K, K2, . and T Hemodialysis Machines
- Clamp testing Ability to occlude and effects of repeated use .
- . Usability evaluation

#### 5.8.1. Biocompatibility Testing

The following testing was performed to support the biological safety of the CAREline bloodlines:

- Chemical analysis Extractables and leachables ●
- Cytotoxicity
- Sensitization ●
- Irritation ●
- Systemic Toxicity ●
- Material Mediated Pyrogenicity
- Genotoxicity
- Hemocompatibility .

A toxicological risk assessment was also performed.

#### 5.8.2. Electrical Safety and Electromagnetic Compatibility (EMC)

No electrical safety and electromagnetic compatibility (EMC) tests were performed.

#### 5.8.3. Software Verification and Validation Testing

No software verification and validation tests were performed.

#### 5.8.4. Mechanical and Acoustic Testing

No mechanical or acoustic tests were performed.

#### 5.8.5. Animal Studies

No animal studies were performed.

#### 5.8.6. Clinical Studies

No clinical studies were performed.

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Image /page/8/Picture/1 description: The image shows 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 and is also blue.

#### 5.9. Conclusions

Based on the information and data provided in this Traditional 510(k) submission, the CAREline bloodlines are substantially equivalent in intended use, indications for use, design, principle of operation, technology, materials, and performance to the predicate devices (K022536, CombiSet Blood Tubing with Access Flow Reversing connector (Twister) and K080807, Streamline Airless System Set with Locksite Needleless Access Site). The devices are safe and effective for their intended use.