(90 days)
Not Found
No
The description focuses on the physical components and the principle of light absorption for measurement, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is a disposable optical cuvette designed to measure levels in the blood during hemodialysis, not to provide therapy itself. It facilitates monitoring, which aids in therapy but is not a therapeutic intervention.
Yes
The device is designed to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation, which are all diagnostic indicators.
No
The device description clearly states it is a "sterile, single use, disposable, optical cuvette" and a "non-invasive, disposable, transparent optical cuvette," which are physical hardware components. The performance studies also include testing for mechanical characteristics, structural integrity, and other physical properties of the chamber.
Based on the provided information, the CRIT-LINE Clip (CLiC) Blood Chamber is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes.
- CLiC Blood Chamber Function: The CLiC Blood Chamber is a component of an extracorporeal circuit used during hemodialysis. It is designed to allow a monitor to measure properties of the blood as it flows through the circuit, which is still considered part of the patient's circulation, albeit outside the body. The measurements (hematocrit, blood volume change, oxygen saturation) are taken in situ within the circuit, not on a separate specimen.
- Intended Use: The intended use is for "acute and chronic therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation" during hemodialysis treatment. This is a monitoring function during a therapeutic procedure, not a diagnostic test performed on a specimen.
While the device interacts with blood and provides measurements, the context of its use within the extracorporeal circuit during hemodialysis and the nature of the measurements being taken in situ distinguish it from a typical IVD device that analyzes a collected specimen.
N/A
Intended Use / 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 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.
Product codes
KOC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical cuvette
Anatomical Site
extracorporeal circuit during hemodialysis treatment.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tables outline testing performed on the CLiC Blood Chamber to support the determination of substantial equivalence to the predicate device.
Table 2: Performance and Functional Testing
- Mechanical Characteristics / Structural Integrity: Ensure the blood chamber is capable of withstanding extreme positive and negative pressure conditions. Result: Pass - Results within acceptance criteria.
- Dialyzer Connectors (Female Din connector): Ensure the connectors meet the performance requirements of ISO 594-2. Result: Pass - Results within acceptance criteria.
- Connector to Vascular Access Device (Male Luer Connector): Ensure the connectors meet the performance requirements of ISO 594-2. Result: Pass – Results within acceptance criteria.
- Endurance Performance Test: Extracorporeal Circuit Evaluation: Demonstrate the product performs at various flow rates and bloodline-dialyzer combinations without resulting in any tubing failure (i.e. loosening of connections). Result: Pass - Results within acceptance criteria.
- Endurance Performance Test: Effects of Flow Rates on the CLiC Monitor Evaluation: Demonstrate varying flow rates do not affect the CLiC Blood Chamber 's ability to allow the CLiC Monitor to record accurate and consistent measurements of Hematocrit (HCT) and Percent Oxygen Saturation (O2 Sat). Result: Pass - Results within acceptance criteria.
- Endurance Performance Test: Extracorporeal Circuit Evaluation of Maximum Flow Rate: Demonstrate the product performs at maximum flow rates without resulting in any tubing failure (i.e. loosening of connections). Result: Pass - Results within acceptance criteria.
- Bond Strength Testing: Confirm the solvent bonding between the CLiC Blood Chamber blue polycarbonate body and the clear PVC DIN Connector. Result: Pass - Results within acceptance criteria.
- Torque Test: Test the material properties after Gamma sterilization. Result: Pass - Results within acceptance criteria.
- Blood Pathway Volume (Priming Volume): Establish the blood pathway volume of the blood chamber for the information for use (IFU). Result: Pass - Results within acceptance criteria.
- Functional CLiC Chamber Test: Evaluate the repeatability of the CLiC Blood Chamber by examining differences in hematocrit and oxgen saturation readings between individual chambers and multiple blood chamber lots. Result: Pass - Results within acceptance criteria.
- Mechanical Hemolysis Test: Evaluate the hemolytic properties of the CLiC Blood Chamber when exposed to circulating blood flow. Result: Pass - Results within acceptance criteria.
Table 3: Packaging Qualification and Ship Testing
- Ship Testing (ISTA 1A): Ensure the package design is robust and prevents product damage. Result: Pass - Results within acceptance criteria.
- Bubble emission test: Ensure packaging does not yield any gross leaks. Result: Pass - Results within acceptance criteria.
- Dye Penetration test: Ensure the porous medical packaging does not yield seal leaks. Result: Pass - Results within acceptance criteria.
- Peel Test: Determine that the packaging meets the specification for the force required to separate the label portion of the packaging from film at the separator tab. Result: Pass - Results within acceptance criteria.
- Film Tensile Strength: Determine that the film used on the packaging meets specification. Result: Pass - Results within acceptance criteria.
- Microbial Barrier Aerosol Spore Challenge: Determine the passage of airborne bacteria through CLiC Blood Chamber packaging occurs at an acceptable level. Result: Pass - Results within acceptance criteria.
Table 4: Sterilization Validation Testing
- Sterilization Validation: Validate the gamma radiation sterilization process of the CLiC Blood Chamber by achieving a required sterility assurance level. Result: Pass – Results within acceptance criteria.
- Bioburden Validation: Demonstrate the established sterilization dose maintains acceptable levels of bioburden. Result: Pass – Results within acceptance criteria.
- Bacterial Endotoxins Test (Nonpyrogenicity): Validate the claim of “non-pyrogenic” on the device label. Result: Pass – Results within acceptance criteria.
Table 5: Additional Performance Testing
- Biological Safety: Demonstrate the biological safety of the CLiC Blood Chamber. Result: Pass - Results support the conclusion that the CLiC Blood Chamber is biologically safe.
- Human Factors (Usability Testing): Evaluate the use of the CLiC Blood Chamber in an environment representative of its intended use. Determine if the instructions for use (IFU) allowed the intended user population to connect the CLiC Blood Chamber to the extracorporeal circuit correctly, safely, and effectively for its intended use. Result: Pass - Results support a conclusion that the CLiC Blood Chamber has no unacceptable residual risk and is safe and effective for use by the intended user population.
- CLiC Blood Chamber Storage Temperature Test: Validate the storage temperature requirement on the device label. Result: Pass - Results within acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CRIT-LINE Blood Chamber (K935958)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
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.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.
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.
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 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 (800) 638-2041 or (301) 796-7100 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
2
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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3
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 |
| Waltham, MA | |
| 02451-1457 | |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| 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.
4
| Predicate Device | Proposed Device | ||
|---|---|---|---|
| Feature | CRIT-LINE Blood Chamber | ||
| (K935958) | CLiC Blood Chamber | Comment | |
| Classification | |||
| Product Code / | |||
| Regulation | KOC/876.5820 | KOC/876.5820 | Substantially |
| Equivalent | |||
| Indications for | |||
| use | No Indications for Use statement | ||
| was provided in K935958. | 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. | Substantially | ||
| Equivalent | |||
| Configuration | A clear polycarbonate lens is | ||
| sonically welded to a clear | |||
| polycarbonate body. A secure | |||
| connection with the arterial | |||
| bloodline is made by a male Luer- | |||
| lock connector. Connection to the | |||
| hemodialyzer is made by a female | |||
| conical fitting with external threads | |||
| (DIN connector) which is part of the | |||
| chamber body mold. Each | |||
| connection is capped; caps are | |||
| removed prior to treatment. | Two clear polycarbonate lenses are | ||
| sonically welded to a translucent, | |||
| blue polycarbonate body. A secure | |||
| connection with the arterial | |||
| bloodline is made by a male Luer- | |||
| lock connector. Connection to the | |||
| hemodialyzer is made by a | |||
| polyvinylchloride (PVC), female | |||
| conical fitting with external threads | |||
| (DIN connector). Each connection | |||
| is capped; caps are removed prior | |||
| to treatment. | Substantially | ||
| Equivalent | |||
| Blood Pathway | The blood pathway created by the | ||
| CRIT-LINE Blood Chamber | |||
| exposes the blood to only | |||
| polycarbonate. | The blood pathway created by the | ||
| CLiC chamber exposes the blood to | |||
| three different materials; PVC (DIN | |||
| connector), clear polycarbonate | |||
| (lenses), and blue polycarbonate | |||
| (chamber body). | Substantially | ||
| Equivalent | |||
| Connection to | |||
| Dialyzer | Female conical fitting with external | ||
| threads. | |||
| Part of the chamber body mold. | Female conical fitting with external | ||
| threads. | |||
| PVC component bonded to the | |||
| chamber body mold with a bonding | |||
| solution. | |||
| Meets ISO 594-2 performance | |||
| requirements. | Substantially | ||
| Equivalent |
Table 1: Device Description and Comparison to the Predicate
5
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 | |||
| (K935958) | CLiC Blood Chamber | ||
| Connection to | |||
| Arterial | |||
| Bloodline | Male Luer-lock conical fitting with | ||
| internal threads. |
Part of the chamber body
polycarbonate mold. | Male Luer-lock conical fitting with
internal threads.
Part of the chamber body
polycarbonate mold.
Meets ISO 594-2 performance
requirements. | Substantially
Equivalent |
| Connection
Caps | Caps do not come into contact with
the blood path and are discarded
prior to treatment. | Caps do not come into contact with
the blood path and are discarded
prior to treatment. | Substantially
Equivalent |
| Sensor Clip to
Lens Interface | The predicate blood chamber
includes a "Double D" pattern
molded into one side of the blood
chamber. This shape matches the
CRIT-LINE Monitor's sensor clip.
The chamber guides the optical
parts in the clip to the proper
positioning relative to the viewing
area and keeps the clip from
rotating on the chamber. | Each lens employs a uniform
annular ring to interface with the
complementary shroud design of
the CLiC Monitor's sensor clip.
The shroud fills the area between
the annular ring on the chamber and
the outside edge of the lens. Each
lens features an anti-rotation detent
which interlocks with
complementary tabs on both sides
of the CLiC Monitor's clip. This
prevents the rotation of the clip. | Substantially
Equivalent |
| Sterilization
Method | Gamma Radiation | Gamma Radiation | Substantially
Equivalent |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Substantially
Equivalent |
| Sterile Barrier | Unit Packaging | Unit Packaging | Substantially
Equivalent |
| Single use or
reuse | Single use only | Single use only | Substantially
Equivalent |
| Packaging | Medical grade peel pouch with label
information printed on the paper
portion. | Blister pack made from medical
paper with heat seal coating and a
high performance nylon-based
forming film pouch. Label
information is printed on medical
paper portion. | Substantially
Equivalent |
| Biological
Safety | Biologically Safe | Biologically Safe | Substantially
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
Objective | Result |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Mechanical
Characteristics /
Structural Integrity | Ensure the blood chamber is capable of withstanding
extreme positive and negative pressure conditions. | Pass - Results within
acceptance criteria. |
| Dialyzer Connectors
(Female Din connector) | Ensure the connectors meet the performance requirements
of ISO 594-2. | Pass - Results within
acceptance criteria. |
| Connector to Vascular
Access Device (Male
Luer Connector) | Ensure the connectors meet the performance requirements
of ISO 594-2 | Pass – Results within
acceptance criteria. |
| Endurance Performance
Test:
Extracorporeal Circuit
Evaluation | Demonstrate the product performs at various flow rates
and bloodline-dialyzer combinations without resulting in
any tubing failure (i.e. loosening of connections). | Pass - Results within
acceptance criteria. |
| Endurance Performance
Test:
Effects of Flow Rates
on the CLiC Monitor
Evaluation | Demonstrate varying flow rates do not affect the CLiC
Blood Chamber 's ability to allow the CLiC Monitor to
record accurate and consistent measurements of
Hematocrit (HCT) and Percent Oxygen Saturation (O2
Sat). | Pass - Results within
acceptance criteria. |
| Endurance Performance
Test:
Extracorporeal Circuit
Evaluation of
Maximum Flow Rate | Demonstrate the product performs at maximum flow rates
without resulting in any tubing failure (i.e. loosening of
connections). | Pass - Results within
acceptance criteria. |
| Bond Strength Testing | Confirm the solvent bonding between the CLiC Blood
Chamber blue polycarbonate body and the clear PVC DIN
Connector. | Pass - Results within
acceptance criteria. |
| Torque Test | Test the material properties after Gamma sterilization. | Pass - Results within
acceptance criteria. |
| Blood Pathway Volume
(Priming Volume) | Establish the blood pathway volume of the blood chamber
for the information for use (IFU). | Pass - Results within
acceptance criteria. |
| Functional CLiC
Chamber Test | Evaluate the repeatability of the CLiC Blood Chamber by
examining differences in hematocrit and oxygen
saturation readings between individual chambers and
multiple blood chamber lots. | Pass - Results within
acceptance criteria. |
| Mechanical Hemolysis
Test | Evaluate the hemolytic properties of the CLiC Blood
Chamber when exposed to circulating blood flow. | Pass - Results within
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 | ||
| 1A) | Ensure the package design is robust and prevents product damage. | Pass - Results within |
| acceptance criteria. | ||
| Bubble emission test | Ensure packaging does not yield any gross leaks. | Pass - Results within |
| acceptance criteria. | ||
| Dye Penetration test | Ensure the porous medical packaging does not yield seal leaks. | Pass - Results within |
| acceptance criteria. | ||
| Peel Test | Determine that the packaging meets the specification for the force | |
| required to separate the label portion of the packaging from film at the | ||
| separator tab. | Pass - Results within | |
| acceptance criteria. | ||
| Film Tensile Strength | Determine that the film used on the packaging meets specification. | Pass - Results within |
| acceptance criteria. | ||
| Microbial Barrier | ||
| Aerosol Spore | ||
| Challenge | Determine the passage of airborne bacteria through CLiC Blood Chamber | |
| packaging occurs at an acceptable level. | Pass - Results within | |
| 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 | |
| Chamber by achieving a required sterility assurance level. | Pass – Results within | |
| acceptance criteria. | ||
| Bioburden Validation | Demonstrate the established sterilization dose maintains acceptable | |
| levels of bioburden. | Pass – Results within | |
| acceptance criteria. | ||
| Bacterial Endotoxins | ||
| Test (Nonpyrogenicity) | Validate the claim of “non-pyrogenic” on the device label. | Pass – Results within |
| 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 |
| conclusion that the CLiC | ||
| Blood Chamber is biologically | ||
| safe. | ||
| Human Factors | ||
| (Usability Testing) | Evaluate the use of the CLiC Blood Chamber in an environment | |
| representative of its intended use. | ||
| Determine if the instructions for use (IFU) allowed the intended | ||
| user population to connect the CLiC Blood Chamber to the | ||
| extracorporeal circuit correctly, safely, and effectively for its | ||
| intended use. | Pass - Results support a | |
| conclusion that the CLiC | ||
| Blood Chamber has no | ||
| unacceptable residual risk and | ||
| is safe and effective for use by | ||
| the intended user population. | ||
| CLiC Blood Chamber | ||
| Storage Temperature | ||
| Test | Validate the storage temperature requirement on the device label. | Pass - Results within |
| acceptance criteria. |
8
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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.