CRIT-LINE CLIP (CLIC) BLOOD CHAMBER

K152953 · Fresenius Medical Care North America · KOC · Nov 5, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K152953
• Device Name: CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
• Applicant: Fresenius Medical Care North America
• Product Code: KOC · Gastroenterology, Urology
• Decision Date: Nov 5, 2015
• Decision: SESE
• Submission Type: Special
• 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. The CLiC system non-invasively measures hematocrit and oxygen saturation. The percentage change in blood volume is calculated from the real time hematocrit. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatments.

Device Story

The CRIT-LINE Clip (CLiC) Blood Chamber is a sterile, single-use, disposable optical cuvette; it functions as a component of the extracorporeal circuit in hemodialysis. The device is installed between the arterial bloodline and the dialyzer. It features clear polycarbonate lenses that provide a viewing window for the CLiC Monitor's sensor clip. The monitor transmits light through the blood within the chamber; it uses light absorption and scattering principles to measure hematocrit and oxygen saturation. Percent change in blood volume is calculated from real-time hematocrit data. The device is used in clinical settings by healthcare providers to monitor patient blood parameters during dialysis, aiding in clinical decision-making regarding fluid management and treatment adjustments. The current modification involves a change to the internal geometry (taper) of the dialyzer connector.

Clinical Evidence

Bench testing only. No clinical data was required or provided. Verification testing included structural integrity, liquid/air leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding, stress cracking, endurance performance, bond strength, and priming volume tests, all of which passed.

Technological Characteristics

Materials: clear polycarbonate (lenses), blue polycarbonate (body), PVC (DIN connector). Sensing principle: optical light absorption/scattering via CLiC Monitor. Form factor: disposable cuvette with male Luer-lock and female conical DIN connector. Connectivity: interfaces with CLiC Monitor sensor clip. Sterilization: Gamma radiation. Standards: ISO 594-2, ISO 8638:2010.

Indications for Use

Indicated for use during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation in patients undergoing hemodialysis treatment.

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 Clip (CLiC) Blood Chamber (K141281)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three figures representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

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

November 5, 2015

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

Re: K152953

> 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: October 6, 2015 Received: October 7, 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.

{1}------------------------------------------------

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K152953

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 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Fresenius Medical Care logo. On the left side of the logo, there is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the words "FRESENIUS MEDICAL CARE" are written in blue, 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: | 10/06/2015 |

#### 5.2. Device Name

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

#### 5.3. Legally Marketed Predicate Device

The predicate device is FMC-RTG's CRIT-LINE Clip (CLiC) Blood Chamber originally cleared under K141281 (14 August 2014).

#### Device Description 5.4.

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

The proposed device is the same as the predicate. CRIT LINE Clip (CLiC) Blood Chamber (K141281) with a change only to the internal geometry (taper) of the dialyzer connector (also referred to as the 'female DIN connector').

{4}------------------------------------------------

Image /page/4/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 and "MEDICAL CARE" on the bottom.

#### 5.5. 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. The CLiC system non-invasively measures hematocrit and oxygen saturation. The percentage change in blood volume is calculated from the real time hematocrit. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatments.

#### 5.6. Indications for 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.

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

The proposed device has the same technological characteristics as the predicate, CRIT-LINE Clip (CLiC) Blood Chamber (K141281) as detailed in Table 1.

| Feature | Predicate Device<br>(P/N CL10041021) | Proposed Device<br>(P/N CL10041021) | Comment |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | CLiC Blood Chamber<br>(K141281) | CLiC Blood Chamber | |
| Classification<br>Product Code<br>/ Regulation | KOC/876.5820 | KOC/876.5820 | Same |
| Feature | Predicate Device<br>(P/N CL10041021) | Proposed Device<br>(P/N CL10041021) | Comment |
| | CLiC Blood Chamber<br>(K141281) | CLiC Blood Chamber | |
| Indications for<br>use | 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<br>acute and chronic hemodialysis<br>therapy to non-invasively<br>measure hematocrit, percent<br>change in blood volume, and<br>oxygen saturation. The blood<br>chamber is connected between<br>the arterial bloodline and the<br>dialyzer within the extracorporeal<br>circuit during hemodialysis<br>treatment. | The CRIT-LINE Clip (CLiC)<br>Blood Chamber is a sterile,<br>single use, disposable, optical<br>cuvette designed for use with the<br>CLiC Monitor's sensor clip<br>during acute and chronic<br>hemodialysis therapy to non-<br>invasively measure hematocrit,<br>percent change in blood volume,<br>and oxygen saturation. The blood<br>chamber is connected between<br>the arterial bloodline and the<br>dialyzer within the<br>extracorporeal circuit during<br>hemodialysis treatment. | Same |
| Principle of<br>Operation | Disposable cuvette secured to the<br>extracorporeal circuit prior to<br>hemodialysis treatment to provide<br>a clear viewing surface for the<br>CLiC Monitor to transmit light<br>through the blood. | Disposable cuvette secured to the<br>extracorporeal circuit prior to<br>hemodialysis treatment to<br>provide a clear viewing surface<br>for the CLiC Monitor to transmit<br>light through the blood. | Same |
| Configuration | Two, clear polycarbonate lenses<br>are sonically welded to a<br>translucent, blue polycarbonate<br>body. A secure connection with<br>the arterial bloodline is made<br>with an integrally molded male<br>Luer-lock connector in the body.<br>Connection to the hemodialyzer<br>is made with a polyvinylchloride<br>(PVC), female conical fitting<br>with external threads (DIN<br>connector*) that is solvent<br>bonded to the chamber body.<br>Each connection is capped: caps<br>are removed prior to treatment to<br>cover the internal blood area and<br>threads. | Two, clear polycarbonate lenses<br>are sonically welded to a<br>translucent, blue polycarbonate<br>body. A secure connection with<br>the arterial bloodline is made<br>with an integrally molded male<br>Luer-lock connector in the body.<br>Connection to the hemodialyzer<br>is made with a polyvinylchloride<br>(PVC), female conical fitting<br>with external threads (DIN<br>connector*) that is solvent<br>bonded to the chamber body.<br>Each connection is capped: caps<br>are removed prior to treatment to<br>cover the internal blood area and<br>threads. | Same |
| Feature | Predicate Device<br>(P/N CL10041021)<br>CLiC Blood Chamber<br>(K141281) | Proposed Device<br>(P/N CL10041021)<br>CLiC Blood Chamber | Comment |
| Blood<br>Pathway | The blood pathway created by the<br>CLiC chamber exposes the blood<br>to three different materials; PVC<br>(DIN connector), clear<br>polycarbonate (lenses), and blue<br>polycarbonate (chamber body).<br>The inside of each polycarbonate<br>lens is molded with two mixing<br>posts that align when the lenses<br>are welded to the blue<br>polycarbonate body. These<br>mixing posts are positioned<br>directly below the male access<br>port. | The blood pathway created by<br>the CLiC chamber exposes the<br>blood to three different materials;<br>PVC (DIN connector), clear<br>polycarbonate (lenses), and blue<br>polycarbonate (chamber body).<br>The inside of each polycarbonate<br>lens is molded with two mixing<br>posts that align when the lenses<br>are welded to the blue<br>polycarbonate body. These<br>mixing posts are positioned<br>directly below the male access<br>port. | Same |
| Dialyzer<br>Connection<br>(DIN<br>Connector*) | Female conical fitting with<br>external threads, meeting ISO<br>8638 and 594-2 performance<br>requirements. | Female conical fitting with<br>external threads, meeting ISO<br>8638 and 594-2 performance<br>requirements. | Substantially<br>Equivalent |
| Arterial<br>Bloodline<br>Connection | Male Luer-lock conical fitting<br>with internal threads, meeting<br>ISO 8638 and 594-2 performance<br>requirements. | Male Luer-lock conical fitting<br>with internal threads, meeting<br>ISO 8638 and 594-2 performance<br>requirements. | Same |
| Connection<br>Caps | Caps do not come into contact<br>with the blood path and are<br>discarded prior to treatment.<br>Provided to cover the blood path<br>access and protect the threads. | Caps do not come into contact<br>with the blood path and are<br>discarded prior to treatment.<br>Provided to cover the blood path<br>access and protect the threads. | Same |
| Sensor Clip<br>to Lens<br>Interface | Each lens employs an exterior<br>uniform annular ring to interface<br>with the complementary shroud<br>design of the CLiC Monitor's<br>sensor clip. The shroud fills the<br>area between the annular ring on<br>the chamber and the outside edge<br>of the lens. Each lens features an<br>anti-rotation detent which<br>interlocks with complementary<br>tabs on both sides of the clip to<br>prevent rotation of the clip. | Each lens employs an exterior<br>uniform annular ring to interface<br>with the complementary shroud<br>design of the CLiC Monitor's<br>sensor clip. The shroud fills the<br>area between the annular ring on<br>the chamber and the outside edge<br>of the lens. Each lens features an<br>anti-rotation detent which<br>interlocks with complementary<br>tabs on both sides of the clip to<br>prevent rotation of the clip. | Same |
| Feature | Predicate Device<br>(P/N CL10041021) | Proposed Device<br>(P/N CL10041021) | Comment |
| | CLiC Blood Chamber<br>(K141281) | CLiC Blood Chamber | |
| Sterilization<br>Method | Gamma Radiation | Gamma Radiation | Same |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Same |
| Sterile<br>Barrier | Unit Packaging | Unit Packaging | Same |
| Single use or<br>reuse | Single use only | Single use only | Same |
| Biological<br>Safety | Biologically Safe | Biologically Safe | Same |

Device Description and Comparison to the Predicate Table 1:

{5}------------------------------------------------

Image /page/5/Picture/0 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, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

#### Table 1: Device Description and Comparison to the Predicate

{6}------------------------------------------------

Image /page/6/Picture/0 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, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

#### Table 1: Device Description and Comparison to the Predicate

{7}------------------------------------------------

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, also in blue. The symbol is made up of three downward-pointing chevrons, stacked on top of each other.

#### Table 1: Device Description and Comparison to the Predicate

*note: The term 'DIN Connector' is a legacy term used internally by FMC-RTG to describe the dialyzer connector and does not imply conformance to the German national standards Deutsches Institut für Normung (DIN) for locking connections.

#### Summary of Verification and/or Validation Data 5.8.

The application of Risk Management techniques was used to identify the appropriate verification and/or validation activities to support the proposed change. Based on the results of the testing, outlined in Table 2, FMC-RTG concludes that the modified connector does not introduce any new questions of safety and effectiveness to the finished device.

| Verification Test | Test Method Description | Pass / Fail |
|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-------------|
| Performance Test: Mechanical<br>Characteristic / Structural Integrity<br>per ANSI/AAMI/ISO 8638:2010 | Confirm the bonding between the chamber<br>and the DIN Connector P/N 55-4299 | PASS |
| Dialyzer Connector (Female DIN<br>Connector): Liquid Leakage Test<br>per ISO 594-2 | Ensure the connectors meet the<br>performance requirements of ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN<br>Connector): Air Leakage Test per<br>ISO 594-2 | Assure leakage resistance to satisfy the<br>requirements of ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN<br>Connector): Separation Force Test<br>per ISO 594-2 | Assure the separation force of the conical<br>fitting meets the ISO 594-2 requirements | PASS |

Table 2: Performance and Functional Testing

{8}------------------------------------------------

Image /page/8/Picture/0 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, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

| Verification Test | Test Method Description | Pass / Fail |
|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Dialyzer Connector (Female DIN<br>Connector): Unscrewing Torque<br>Test per ISO 594-2 | Assure an adequate unscrewing force to<br>satisfy the requirements of ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN<br>Connector): Ease of Assembly Test<br>per ISO 594-2 | Assure ease of assembly fit will satisfy the<br>requirements of ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN<br>Connector): Resistance to<br>Overriding Test per ISO 594-2 | Assure the reference fitting resists<br>overriding the test fitting to satisfy the<br>requirements of ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN<br>Connector): Stress Cracking Test<br>per ISO 594-2 | Assure the female fitting will resist stress<br>cracking to satisfy the requirements of ISO<br>594-2 | PASS |
| Endurance Performance Test per<br>ISO 8368:2010 | Demonstrate the product performs at<br>maximum labeled pressures without<br>resulting in loose connection or leaks | PASS |
| Bond Strength Test per ISO<br>8368:2010 | Confirm solvent bonding between the CLiC<br>blood chamber's blue polycarbonate body<br>and clear PVC DIN Connector meet<br>specification | PASS |
| Blood Pathway Volume (Priming<br>Volume) Test per ISO 8368:2010 | Verify the established the blood pathway<br>volume of the blood chamber meets<br>specification. | PASS |

#### 5.9. Conclusions

The only proposed change to the CLiC Blood Chamber relates to the internal geometry (taper) of the dialyzer connector. This change has no impact on the Intended Use, Indications for Use or the Technological Characteristic of the finished device.

Results of verification and/or validation testing demonstrate that the modified device meets the performance requirements of ISO 594-2. The safety and efficacy of the device for its intended use remain unchanged.