CRIT-LINE CLIP (CLIC) BLOOD CHAMBER

K141281 · Fresenius Medical Care Renal Therapies Group, LLC · KOC · Aug 14, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K141281
• Device Name: CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
• Applicant: Fresenius Medical Care Renal Therapies Group, LLC
• Product Code: KOC · Gastroenterology, Urology
• Decision Date: Aug 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

The CRIT-LINE Clip (CLiC) Blood Chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC Monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatment.

Device Story

The CLiC Blood Chamber is a sterile, single-use, disposable optical cuvette integrated into the extracorporeal circuit of a hemodialysis system. It connects between the arterial bloodline and the dialyzer. The device features polycarbonate viewing lenses that interface with the CLiC Monitor's sensor clip. The monitor uses light absorption principles to measure hematocrit, oxygen saturation, and blood volume changes. The chamber ensures uniform blood passage for optical sensing. It is used in clinical settings during hemodialysis; operated by healthcare professionals. The output is displayed on the CLiC Monitor, allowing clinicians to monitor patient status in real-time and adjust treatment parameters as necessary, potentially improving patient outcomes during dialysis.

Clinical Evidence

Bench testing only. Testing included structural integrity, ISO 594-2 connector performance, endurance testing at various flow rates, bond strength, mechanical hemolysis, and functional repeatability. Packaging, sterilization, and biocompatibility were validated. Human factors/usability testing confirmed the device can be safely and effectively connected to the extracorporeal circuit by the intended user population.

Technological Characteristics

Materials: Polycarbonate (clear and blue) and PVC. Sensing principle: Optical light absorption via CLiC Monitor. Form factor: Disposable cuvette with male Luer-lock and female DIN connectors. Connectivity: Passive interface with external monitor. Sterilization: Gamma radiation. Meets ISO 594-2 for connectors.

Indications for Use

Indicated for patients undergoing acute or chronic hemodialysis therapy requiring non-invasive monitoring of hematocrit, blood volume change, and oxygen saturation.

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

• CRIT-LINE Blood Chamber (K935958)

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

August 14, 2014

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

Re: K141281 Trade/Device Name: CRIT-LINE Clip (CLiC) Blood Chamber Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KOC Dated: May 15, 2014 Received: May 16, 2014

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Herbert P. Lerner -S

for

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)

N/A K141281

Device Name CRIT-LINE Clip (CLiC) Blood Chamber

### Indications for Use (Describe)

The CRIT-LINE Clip (CLiC) Blood Chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC Monitor's sensor clip during acute and chronic herapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatment.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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#### 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: | 5/15/2014 |

#### 5.2. Device Name

| Trade Name: | CRIT-LINE Clip (CLiC) Blood Chamber |
|-----------------------|------------------------------------------|
| Common Name: | CLiC Blood Chamber |
| Product Code: | KOC |
| Classification Panel: | Gastroenterology-Urology |
| Classification Name: | Accessories, Blood Circuit, Hemodialysis |
| Regulation: | 21 CFR 876.5820 |

#### 5.3. Legally Marketed Predicate Device

CRIT-LINE Blood Chamber (K935958)

#### Device Description 5.4.

The CRIT LINE™ Clip (CLiC) Blood Chamber is a non-invasive, disposable, transparent optical cuvette designed as a connection between the arterial bloodline and the hemodialyzer in the extracorporeal circuit during hemodialysis treatment. The chamber's two (2) polycarbonate viewing lenses serve to secure the CLiC Monitor's sensor clip and provide a uniform cross section, allowing a clear blood passage for the CLiC Monitor to transmit light through the blood. The CLiC Monitor uses the principle of light absorption to measure oxygen saturation (O2 SAT) and hematocrit (HCT) levels in the blood.

#### ર્ડ.
જિંત જિલ્લાના ગુજરાત રાજ્યના દિવસાય ખેતી ખેતી કરવામાં આવેલું એક ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેતી, ખેતમજૂરી તેમ જ પશ Comparison to Predicate

Table 1 contains a full description of the intended use and technological characteristics of the subject CLiC Blood Chamber as well as a comparison to the predicate CRIT-LINE Blood Chamber in each of these areas.

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| | Predicate Device | Proposed Device | |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Feature | CRIT-LINE Blood Chamber<br>(K935958) | CLiC Blood Chamber | Comment |
| Classification<br>Product Code /<br>Regulation | KOC/876.5820 | KOC/876.5820 | Substantially<br>Equivalent |
| Indications for<br>use | No Indications for Use statement<br>was provided in K935958. | The CRIT-LINE Clip (CLiC)<br>Blood Chamber is a sterile, single<br>use, disposable, optical cuvette<br>designed for use with the CLiC<br>Monitor's sensor clip during acute<br>and chronic hemodialysis therapy<br>to non-invasively measure<br>hematocrit, percent change in blood<br>volume, and oxygen saturation. The<br>blood chamber is connected<br>between the arterial bloodline and<br>the dialyzer within the<br>extracorporeal circuit during<br>hemodialysis treatment. | Substantially<br>Equivalent |
| Configuration | A clear polycarbonate lens is<br>sonically welded to a clear<br>polycarbonate body. A secure<br>connection with the arterial<br>bloodline is made by a male Luer-<br>lock connector. Connection to the<br>hemodialyzer is made by a female<br>conical fitting with external threads<br>(DIN connector) which is part of the<br>chamber body mold. Each<br>connection is capped; caps are<br>removed prior to treatment. | Two clear polycarbonate lenses are<br>sonically welded to a translucent,<br>blue polycarbonate body. A secure<br>connection with the arterial<br>bloodline is made by a male Luer-<br>lock connector. Connection to the<br>hemodialyzer is made by a<br>polyvinylchloride (PVC), female<br>conical fitting with external threads<br>(DIN connector). Each connection<br>is capped; caps are removed prior<br>to treatment. | Substantially<br>Equivalent |
| Blood Pathway | The blood pathway created by the<br>CRIT-LINE Blood Chamber<br>exposes the blood to only<br>polycarbonate. | The blood pathway created by the<br>CLiC chamber exposes the blood to<br>three different materials; PVC (DIN<br>connector), clear polycarbonate<br>(lenses), and blue polycarbonate<br>(chamber body). | Substantially<br>Equivalent |
| Connection to<br>Dialyzer | Female conical fitting with external<br>threads.<br>Part of the chamber body mold. | Female conical fitting with external<br>threads.<br>PVC component bonded to the<br>chamber body mold with a bonding<br>solution.<br>Meets ISO 594-2 performance<br>requirements. | Substantially<br>Equivalent |

# Table 1: Device Description and Comparison to the Predicate

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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, also in blue.

| Feature | Predicate Device | Proposed Device | Comment |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | CRIT-LINE Blood Chamber<br>(K935958) | CLiC Blood Chamber | |
| Connection to<br>Arterial<br>Bloodline | Male Luer-lock conical fitting with<br>internal threads.<br><br>Part of the chamber body<br>polycarbonate mold. | Male Luer-lock conical fitting with<br>internal threads.<br><br>Part of the chamber body<br>polycarbonate mold.<br><br>Meets ISO 594-2 performance<br>requirements. | Substantially<br>Equivalent |
| Connection<br>Caps | Caps do not come into contact with<br>the blood path and are discarded<br>prior to treatment. | Caps do not come into contact with<br>the blood path and are discarded<br>prior to treatment. | Substantially<br>Equivalent |
| Sensor Clip to<br>Lens Interface | The predicate blood chamber<br>includes a "Double D" pattern<br>molded into one side of the blood<br>chamber. This shape matches the<br>CRIT-LINE Monitor's sensor clip.<br>The chamber guides the optical<br>parts in the clip to the proper<br>positioning relative to the viewing<br>area and keeps the clip from<br>rotating on the chamber. | Each lens employs a uniform<br>annular ring to interface with the<br>complementary shroud design of<br>the CLiC Monitor's sensor clip.<br>The shroud fills the area between<br>the annular ring on the chamber and<br>the outside edge of the lens. Each<br>lens features an anti-rotation detent<br>which interlocks with<br>complementary tabs on both sides<br>of the CLiC Monitor's clip. This<br>prevents the rotation of the clip. | Substantially<br>Equivalent |
| Sterilization<br>Method | Gamma Radiation | Gamma Radiation | Substantially<br>Equivalent |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Substantially<br>Equivalent |
| Sterile Barrier | Unit Packaging | Unit Packaging | Substantially<br>Equivalent |
| Single use or<br>reuse | Single use only | Single use only | Substantially<br>Equivalent |
| Packaging | Medical grade peel pouch with label<br>information printed on the paper<br>portion. | Blister pack made from medical<br>paper with heat seal coating and a<br>high performance nylon-based<br>forming film pouch. Label<br>information is printed on medical<br>paper portion. | Substantially<br>Equivalent |
| Biological<br>Safety | Biologically Safe | Biologically Safe | Substantially<br>Equivalent |

# Table 1: Device Description and Comparison to the Predicate

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Image /page/6/Picture/0 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three 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 of "MEDICAL CARE".

#### 5.6. Performance Data

The following tables outline testing performed on the CLiC Blood Chamber to support the determination of substantial equivalence to the predicate device.

| Test Method | Test<br>Objective | Result |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Mechanical<br>Characteristics /<br>Structural Integrity | Ensure the blood chamber is capable of withstanding<br>extreme positive and negative pressure conditions. | Pass - Results within<br>acceptance criteria. |
| Dialyzer Connectors<br>(Female Din connector) | Ensure the connectors meet the performance requirements<br>of ISO 594-2. | Pass - Results within<br>acceptance criteria. |
| Connector to Vascular<br>Access Device (Male<br>Luer Connector) | Ensure the connectors meet the performance requirements<br>of ISO 594-2 | Pass – Results within<br>acceptance criteria. |
| Endurance Performance<br>Test:<br>Extracorporeal Circuit<br>Evaluation | Demonstrate the product performs at various flow rates<br>and bloodline-dialyzer combinations without resulting in<br>any tubing failure (i.e. loosening of connections). | Pass - Results within<br>acceptance criteria. |
| Endurance Performance<br>Test:<br>Effects of Flow Rates<br>on the CLiC Monitor<br>Evaluation | Demonstrate varying flow rates do not affect the CLiC<br>Blood Chamber 's ability to allow the CLiC Monitor to<br>record accurate and consistent measurements of<br>Hematocrit (HCT) and Percent Oxygen Saturation (O2<br>Sat). | Pass - Results within<br>acceptance criteria. |
| Endurance Performance<br>Test:<br>Extracorporeal Circuit<br>Evaluation of<br>Maximum Flow Rate | Demonstrate the product performs at maximum flow rates<br>without resulting in any tubing failure (i.e. loosening of<br>connections). | Pass - Results within<br>acceptance criteria. |
| Bond Strength Testing | Confirm the solvent bonding between the CLiC Blood<br>Chamber blue polycarbonate body and the clear PVC DIN<br>Connector. | Pass - Results within<br>acceptance criteria. |
| Torque Test | Test the material properties after Gamma sterilization. | Pass - Results within<br>acceptance criteria. |
| Blood Pathway Volume<br>(Priming Volume) | Establish the blood pathway volume of the blood chamber<br>for the information for use (IFU). | Pass - Results within<br>acceptance criteria. |
| Functional CLiC<br>Chamber Test | Evaluate the repeatability of the CLiC Blood Chamber by<br>examining differences in hematocrit and oxygen<br>saturation readings between individual chambers and<br>multiple blood chamber lots. | Pass - Results within<br>acceptance criteria. |
| Mechanical Hemolysis<br>Test | Evaluate the hemolytic properties of the CLiC Blood<br>Chamber when exposed to circulating blood flow. | Pass - Results within<br>acceptance criteria. |

## Table 2: Performance and Functional Testing

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Image /page/7/Picture/0 description: The image shows the Fresenius Medical Care logo. On the left is a blue symbol that looks like three chevrons stacked on top of each other. To the right of the symbol is the company name, "FRESENIUS MEDICAL CARE", in blue block letters.

| Test Method | Test Objective | Results |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Ship Testing (ISTA<br>1A) | Ensure the package design is robust and prevents product damage. | Pass - Results within<br>acceptance criteria. |
| Bubble emission test | Ensure packaging does not yield any gross leaks. | Pass - Results within<br>acceptance criteria. |
| Dye Penetration test | Ensure the porous medical packaging does not yield seal leaks. | Pass - Results within<br>acceptance criteria. |
| Peel Test | Determine that the packaging meets the specification for the force<br>required to separate the label portion of the packaging from film at the<br>separator tab. | Pass - Results within<br>acceptance criteria. |
| Film Tensile Strength | Determine that the film used on the packaging meets specification. | Pass - Results within<br>acceptance criteria. |
| Microbial Barrier<br>Aerosol Spore<br>Challenge | Determine the passage of airborne bacteria through CLiC Blood Chamber<br>packaging occurs at an acceptable level. | Pass - Results within<br>acceptance criteria. |

### Table 3: Packaging Qualification and Ship Testing

### Table 4: Sterilization Validation Testing

| Test Method | Test Objective | Results |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Sterilization Validation | Validate the gamma radiation sterilization process of the CLiC Blood<br>Chamber by achieving a required sterility assurance level. | Pass – Results within<br>acceptance criteria. |
| Bioburden Validation | Demonstrate the established sterilization dose maintains acceptable<br>levels of bioburden. | Pass – Results within<br>acceptance criteria. |
| Bacterial Endotoxins<br>Test (Nonpyrogenicity) | Validate the claim of “non-pyrogenic” on the device label. | Pass – Results within<br>acceptance criteria. |

## Table 5: Additional Performance Testing

| Test Method | Test Objective | Results |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biological Safety | Demonstrate the biological safety of the CLiC Blood Chamber. | Pass - Results support the<br>conclusion that the CLiC<br>Blood Chamber is biologically<br>safe. |
| Human Factors<br>(Usability Testing) | Evaluate the use of the CLiC Blood Chamber in an environment<br>representative of its intended use.<br>Determine if the instructions for use (IFU) allowed the intended<br>user population to connect the CLiC Blood Chamber to the<br>extracorporeal circuit correctly, safely, and effectively for its<br>intended use. | Pass - Results support a<br>conclusion that the CLiC<br>Blood Chamber has no<br>unacceptable residual risk and<br>is safe and effective for use by<br>the intended user population. |
| CLiC Blood Chamber<br>Storage Temperature<br>Test | Validate the storage temperature requirement on the device label. | Pass - Results within<br>acceptance criteria. |

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Image /page/8/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three downward-pointing chevrons stacked on top of each other.

#### 5.7. Conclusion

Based on a cumulative review of the verification and validation testing, the function of the CLiC Blood Chamber is substantially equivalent to the predicate CRIT-LINE Blood Chamber (K935958) and is safe and effective for its intended use.