(29 days)
Not Found
No
The summary describes a disposable optical cuvette that works with a monitor using light absorption and scattering principles. There is no mention of AI or ML in the device description, intended use, or performance studies. The changes described are purely mechanical.
No.
The device is a non-invasive optical cuvette used to measure hematocrit, change in blood volume, and oxygen saturation during hemodialysis; it does not directly provide therapy.
Yes
Explanation: The device is described as an "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 ability to measure these physiological parameters indicates its use for diagnostic purposes.
No
The device is a physical, disposable optical cuvette designed to be used with a monitor's sensor clip. The performance studies listed are for mechanical and structural integrity, indicating a hardware component.
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: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The CRIT-LINE Clip (CLiC) Blood Chamber is a component of an extracorporeal circuit used during hemodialysis. It allows a monitor to measure properties of the blood as it flows through the circuit, not on a collected specimen.
- Measurement Method: The device uses optical methods to measure hematocrit, blood volume changes, and oxygen saturation in the flowing blood. This is a real-time measurement within the circuit, not a laboratory test on a sample.
While the device interacts with blood and provides information about blood characteristics, its function is to facilitate real-time monitoring within a therapeutic circuit, not to perform a diagnostic test on a collected sample.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
KOC
Device Description
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').
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 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 and/or Validation Testing:
- Performance Test: Mechanical Characteristic / Structural Integrity per ANSI/AAMI/ISO 8638:2010 to confirm the bonding between the chamber and the DIN Connector P/N 55-4299 (PASS)
- Dialyzer Connector (Female DIN Connector): Liquid Leakage Test per ISO 594-2 to ensure the connectors meet the performance requirements of ISO 594-2 (PASS)
- Dialyzer Connector (Female DIN Connector): Air Leakage Test per ISO 594-2 to assure leakage resistance to satisfy the requirements of ISO 594-2 (PASS)
- Dialyzer Connector (Female DIN Connector): Separation Force Test per ISO 594-2 to assure the separation force of the conical fitting meets the ISO 594-2 requirements (PASS)
- Dialyzer Connector (Female DIN Connector): Unscrewing Torque Test per ISO 594-2 to assure an adequate unscrewing force to satisfy the requirements of ISO 594-2 (PASS)
- Dialyzer Connector (Female DIN Connector): Ease of Assembly Test per ISO 594-2 to assure ease of assembly fit will satisfy the requirements of ISO 594-2 (PASS)
- Dialyzer Connector (Female DIN Connector): Resistance to Overriding Test per ISO 594-2 to assure the reference fitting resists overriding the test fitting to satisfy the requirements of ISO 594-2 (PASS)
- Dialyzer Connector (Female DIN Connector): Stress Cracking Test per ISO 594-2 to assure the female fitting will resist stress cracking to satisfy the requirements of ISO 594-2 (PASS)
- Endurance Performance Test per ISO 8368:2010 to demonstrate the product performs at maximum labeled pressures without resulting in loose connection or leaks (PASS)
- Bond Strength Test per ISO 8368:2010 to confirm solvent bonding between the CLiC blood chamber's blue polycarbonate body and clear PVC DIN Connector meet specification (PASS)
- Blood Pathway Volume (Priming Volume) Test per ISO 8368:2010 to verify the established the blood pathway volume of the blood chamber meets specification (PASS)
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.
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 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the Fresenius Medical Care logo. 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 |
| Waltham, MA | |
| 02451-1457 | |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| 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').
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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
(P/N CL10041021) | Proposed Device
(P/N CL10041021) | Comment |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | CLiC Blood Chamber
(K141281) | CLiC Blood Chamber | |
| Classification
Product Code
/ Regulation | KOC/876.5820 | KOC/876.5820 | Same |
| Feature | Predicate Device
(P/N CL10041021) | Proposed Device
(P/N CL10041021) | Comment |
| | CLiC Blood Chamber
(K141281) | CLiC Blood Chamber | |
| 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. | 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. | Same |
| Principle of
Operation | Disposable cuvette secured to the
extracorporeal circuit prior to
hemodialysis treatment to provide
a clear viewing surface for the
CLiC Monitor to transmit light
through the blood. | Disposable cuvette secured to the
extracorporeal circuit prior to
hemodialysis treatment to
provide a clear viewing surface
for the CLiC Monitor to transmit
light through the blood. | Same |
| Configuration | Two, clear polycarbonate lenses
are sonically welded to a
translucent, blue polycarbonate
body. A secure connection with
the arterial bloodline is made
with an integrally molded male
Luer-lock connector in the body.
Connection to the hemodialyzer
is made with a polyvinylchloride
(PVC), female conical fitting
with external threads (DIN
connector*) that is solvent
bonded to the chamber body.
Each connection is capped: caps
are removed prior to treatment to
cover the internal blood area and
threads. | Two, clear polycarbonate lenses
are sonically welded to a
translucent, blue polycarbonate
body. A secure connection with
the arterial bloodline is made
with an integrally molded male
Luer-lock connector in the body.
Connection to the hemodialyzer
is made with a polyvinylchloride
(PVC), female conical fitting
with external threads (DIN
connector*) that is solvent
bonded to the chamber body.
Each connection is capped: caps
are removed prior to treatment to
cover the internal blood area and
threads. | Same |
| Feature | Predicate Device
(P/N CL10041021)
CLiC Blood Chamber
(K141281) | Proposed Device
(P/N CL10041021)
CLiC Blood Chamber | Comment |
| Blood
Pathway | 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).
The inside of each polycarbonate
lens is molded with two mixing
posts that align when the lenses
are welded to the blue
polycarbonate body. These
mixing posts are positioned
directly below the male access
port. | 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).
The inside of each polycarbonate
lens is molded with two mixing
posts that align when the lenses
are welded to the blue
polycarbonate body. These
mixing posts are positioned
directly below the male access
port. | Same |
| Dialyzer
Connection
(DIN
Connector*) | Female conical fitting with
external threads, meeting ISO
8638 and 594-2 performance
requirements. | Female conical fitting with
external threads, meeting ISO
8638 and 594-2 performance
requirements. | Substantially
Equivalent |
| Arterial
Bloodline
Connection | Male Luer-lock conical fitting
with internal threads, meeting
ISO 8638 and 594-2 performance
requirements. | Male Luer-lock conical fitting
with internal threads, meeting
ISO 8638 and 594-2 performance
requirements. | Same |
| Connection
Caps | Caps do not come into contact
with the blood path and are
discarded prior to treatment.
Provided to cover the blood path
access and protect the threads. | Caps do not come into contact
with the blood path and are
discarded prior to treatment.
Provided to cover the blood path
access and protect the threads. | Same |
| Sensor Clip
to Lens
Interface | Each lens employs an exterior
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 clip to
prevent rotation of the clip. | Each lens employs an exterior
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 clip to
prevent rotation of the clip. | Same |
| Feature | Predicate Device
(P/N CL10041021) | Proposed Device
(P/N CL10041021) | Comment |
| | CLiC Blood Chamber
(K141281) | CLiC Blood Chamber | |
| Sterilization
Method | Gamma Radiation | Gamma Radiation | Same |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Same |
| Sterile
Barrier | Unit Packaging | Unit Packaging | Same |
| Single use or
reuse | Single use only | Single use only | Same |
| Biological
Safety | Biologically Safe | Biologically Safe | Same |
Device Description and Comparison to the Predicate Table 1:
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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
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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
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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, 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 | ||
| Characteristic / Structural Integrity | ||
| per ANSI/AAMI/ISO 8638:2010 | Confirm the bonding between the chamber | |
| and the DIN Connector P/N 55-4299 | PASS | |
| Dialyzer Connector (Female DIN | ||
| Connector): Liquid Leakage Test | ||
| per ISO 594-2 | Ensure the connectors meet the | |
| performance requirements of ISO 594-2 | PASS | |
| Dialyzer Connector (Female DIN | ||
| Connector): Air Leakage Test per | ||
| ISO 594-2 | Assure leakage resistance to satisfy the | |
| requirements of ISO 594-2 | PASS | |
| Dialyzer Connector (Female DIN | ||
| Connector): Separation Force Test | ||
| per ISO 594-2 | Assure the separation force of the conical | |
| fitting meets the ISO 594-2 requirements | PASS |
Table 2: Performance and Functional Testing
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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 | ||
| Connector): Unscrewing Torque | ||
| Test per ISO 594-2 | Assure an adequate unscrewing force to | |
| satisfy the requirements of ISO 594-2 | PASS | |
| Dialyzer Connector (Female DIN | ||
| Connector): Ease of Assembly Test | ||
| per ISO 594-2 | Assure ease of assembly fit will satisfy the | |
| requirements of ISO 594-2 | PASS | |
| Dialyzer Connector (Female DIN | ||
| Connector): Resistance to | ||
| Overriding Test per ISO 594-2 | Assure the reference fitting resists | |
| overriding the test fitting to satisfy the | ||
| requirements of ISO 594-2 | PASS | |
| Dialyzer Connector (Female DIN | ||
| Connector): Stress Cracking Test | ||
| per ISO 594-2 | Assure the female fitting will resist stress | |
| cracking to satisfy the requirements of ISO | ||
| 594-2 | PASS | |
| Endurance Performance Test per | ||
| ISO 8368:2010 | Demonstrate the product performs at | |
| maximum labeled pressures without | ||
| resulting in loose connection or leaks | PASS | |
| Bond Strength Test per ISO | ||
| 8368:2010 | Confirm solvent bonding between the CLiC | |
| blood chamber's blue polycarbonate body | ||
| and clear PVC DIN Connector meet | ||
| specification | PASS | |
| Blood Pathway Volume (Priming | ||
| Volume) Test per ISO 8368:2010 | Verify the established the blood pathway | |
| volume of the blood chamber meets | ||
| 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.