(136 days)
No
The summary describes a blood tubing set and an optical cuvette for use with a separate monitor. The performance testing focuses on the physical and functional characteristics of the tubing set and the optical chamber's ability to allow light transmission for measurement by the Crit-Line monitor. There is no mention of AI or ML in the device description, intended use, or performance studies. The measurements (hematocrit, oxygen saturation) are described as functional tests of the optical chamber, not as outputs of an AI/ML algorithm.
Yes
The device is described as "intended for acute and chronic hemodialysis therapy," which is a therapeutic process for patients with kidney failure.
Yes
The input explicitly states that "The Crit-Line Blood Chamber is an optical cuvette designed for use with the Crit-Line monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation." Measuring these physiological parameters indicates a diagnostic function.
No
The device is a blood tubing set, which is a physical component of an extracorporeal hemodialysis circuit. It is described as a single-use, disposable, sterile device made of tubing and includes an integrated Crit-Line Technology component (an optical cuvette). While it interacts with software (the Crit-Line monitor), the device itself is a hardware component.
Based on the provided information, the device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The primary intended use is for transporting blood during hemodialysis therapy. While it facilitates the measurement of hematocrit, blood volume change, and oxygen saturation, these measurements are performed in the extracorporeal circuit using an optical method, not on a sample of blood in vitro (outside the body).
- Device Description: The device is described as a blood tubing set, part of the extracorporeal hemodialysis circuit. Its function is to transport blood and provide a viewing surface for the Crit-Line Sensor Clip.
- Crit-Line Blood Chamber: The Crit-Line Blood Chamber, which is integrated into the blood tubing set, is described as an optical cuvette for use with a sensor clip to non-invasively measure parameters. This further reinforces that the measurements are happening within the blood flow in the tubing, not on a separate blood sample.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or procedures typically associated with in vitro diagnostic testing of blood samples.
While the device facilitates measurements of blood parameters, the mechanism and context of these measurements (within the extracorporeal circuit during hemodialysis) classify it as a medical device used in conjunction with an IVD (the Crit-Line monitor and sensor clip, which perform the actual analysis), rather than an IVD itself.
N/A
Intended Use / Indications for Use
The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician.
The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
The Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T Hemodialysis Machines equipped with Crit-Line hardware.
The Crit-Line Blood Chamber is an optical cuvette designed for use with the Crit-Line monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation.
Product codes (comma separated list FDA assigned to the subject device)
KOC, FJK
Device Description
The CombiSet SMARTECH Hemodialysis Blood Tubing Sets (hereinafter referred to as "CombiSet SMARTECH Bloodlines") are the subject of this 510(k) and are available in two (2) configurations:
- CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and ● Integrated Crit-Line Technology (hereinafter referred to as the "Standard bloodline")
- . CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, no Heparin Line (hereinafter referred to as the "No heparin line")
The CombiSet SMARTECH Bloodlines are single-use, ethylene oxide (EO) sterilized blood tubing sets.
The CombiSet SMARTECH Bloodlines are part of the extracorporeal hemodialysis circuit. During hemodialysis, the extracorporeal circuit transports arterial blood from the patient's arterial access (e.g., fistula or catheter), through a hemodialyzer, and back to the patient's venous access. When the CombiSet SMARTECH Bloodlines are used with the Crit-Line Sensing System (which includes the Crit-Line Sensor Clip), the proposed devices will provide a clear viewing surface for the Crit-Line Sensor Clip to transmit light through the blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
The CombiSet SMARTECH Bloodlines are used in environments where acute and chronic hemodialysis are performed.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted in accordance with ISO 8638:2010 and Guidance for Industry and FDA Staff, Hemodialysis Blood Tubing Sets – Premarket Notification [510(k)] Submissions (23 April 2008). Testing conducted to support the determination of substantial equivalence is summarized in Table 3.
Table 3: Performance Testing Summary
- Structural Integrity: Demonstrate that the bloodlines can withstand 1.5X the labeled maximum positive and negative pressures.
- Pump Segment Performance: Evaluate performance characteristics of the bloodlines over the range of the inlet pressures (normally 0 mmHg to -250 mmHg). Flow rate settings will cover up to 600 mL/min.
- Visual Inspection for Endurance and Simulated Use Tests:
- Endurance: Demonstrate that bloodlines perform with no tubing failures (kinking, collapsing, or disconnection) at the maximum labeled flow rate and pressures for not less than 18 hr.
- Simulated Use: Demonstrate that bloodlines perform with no tubing failures (kinking, collapsing, or disconnection) under simulated use conditions for not less than 4 hr.
- Needle Access Port Test: Demonstrate that the needle access ports can withstand 1.5X the labeled pressures after being punctured with the largest gauge needle recommended in the labeling (21 gauge) – 6X for maximum positive pressure, 11X for maximum negative pressure per ISO 8638:2010.
- DIN Connectors: Demonstrate that the DIN connectors do not leak when subjected to fluid pressure of 300-330 kPa.
- Male and Female Luer Connectors Tests: Demonstrate that the applicable components of the bloodlines meet the dimensional and performance requirements of ISO 80369-7:2016 (Sections 5 and 6).
- Visual Inspection for Packaging (Shipping study): Demonstrate that shipping case, packaging configuration, and palletization pattern maintain the product's structural integrity during manual handling and motorized freight.
- Tensile Testing: Demonstrate that all bonded engagements in the bloodlines between components, and between components and tubing can withstand a tensile force of 15 lbf.
- Spike Flow Rate: Demonstrate that the spike, a component of the bloodlines, can deliver not less than 1000 mL of a sodium chloride solution in 10 min under a static head of 1 m.
- Spike Insertion Force: Demonstrate that the spike, a component of the bloodlines, is capable of piercing and penetrating the closure of an infusion device without coring and with force not exceeding 200 N, when inserted at a rate of 500 mm/min.
- Spike Leak Test: Demonstrate that the spike, a component of the bloodlines, will not leak after piercing an infusion device, remaining pierced for 5 hr, and then having an applied internal pressure of 20 kPa for 15 sec.
- Spike Disconnection Force: Demonstrate that the spike, a component of the bloodlines, is capable of being removed from the insertion point when a removal force is applied at a rate of 100 mm/min. Establish the removal force value.
- Labeling Content per FDA Guidance (Blood Tubing Set) and ISO 8638: Verify the Instructions for Use, color coded components, unit labels, shipping carton graphics, and case labels for the bloodlines meet the requirements of ISO 8638:2010 and Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Test – Premarket Notification [510(k)] Submissions (April 2008).
- Readability of Barcode with Human Readable Identification Codes: Demonstrate that the barcode information on the outer container labels and unit labels for the bloodlines is capable of being scanned.
- Level Detector Test: Demonstrate that the venous chamber of the bloodline interfaces correctly with the hemodialysis machine (2008 series) such that the venous clamp will activate (close) when the fluid level inside the venous chamber falls below the sensor heads.
- Air-Capture Chamber Fill Level: Demonstrate that the recommended fill level of the air-capture chambers is marked.
- Blood Filter Retention Test: Demonstrate that the blood filter of the bloodlines remains in the assembly position after tests at 1.5X the maximum recommended positive pressure, with a flow rate of 600 mL/min for not less than 18 hr.
- Transparency of Transducer Protectors: Demonstrate that the machine side of the transducer protectors (TPs) is clear to allow for visual inspection of blood contamination during use.
- Transducer Protector Leak Test: Demonstrate that the TP is capable of maintaining a secure and leak-free connection to the hemodialysis machine.
- Viral Retentiveness Test for Transducer Protectors: Demonstrate that the membrane inside the transducer protector prevents can prevent the passage of bacteriophage (Φ Χ174) from the patient side to the machine side up to a pressure of 600 mmHg for 1 hr.
- Torque Test (Connection of Blood Chamber to Dialyzer Connector): Demonstrate that the bond connection between the Arterial DIN connector and the CLiC Blood Chamber can withstand an applied torque of not less than 14.8 in-lbs without creating a leak at 15 psi for 10 min.
- Measure Gap between Lenses: Demonstrate that the distance between the lenses from the CLIC Blood Chamber is 0.078 ± 0.005 in.
- Functional CLIC Chamber Test (Hematocrit): Demonstrate that the measurement of HCT of the integrated CLIC Blood Chamber has a standard deviation X2 of ≤ 3%, and an average bias of ≤ 1%, when compared to the HCT measurements made using a production blood chamber (CL10041021) as control.
- Functional CLIC Chamber Test (O2 Sat): Demonstrate that the measurement of O2 Sat using the IBC blood chamber will have a standard deviation X2 of ≤ 3%, and an average bias of ≤ 2%, when compared to the O2 Sat measurements made using a production blood chamber (CL10041021) as control.
- Tubing Compliance Test: Demonstrate that tubing is capable of being occlusively clamped by the venous line clamp of the dialysis machine.
- Clamp Occlusion Test: Demonstrate that tubing is capable of being occlusively clamped by the bloodline clamps.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Functional CLiC Chamber Test - Hematocrit (HCT): The measured HCT using the CombiSet SMARTECH Bloodline has a standard deviation X2 of ≤ 3%, and an average bias of ≤ 1% (of the average HCT) as measured on control blood chambers.
- Functional CLiC Chamber Test - Oxygen Saturation (O2 Sat): The measured O2 Sat using the CombiSet SMARTECH Bloodline has a standard deviation X2 of ≤ 3%, and an average bias of ≤ 2% (of the average O2 Sat) as measured on control blood chambers.
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 18, 2020
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K201207
Trade/Device Name: CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, no Heparin Line Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KOC, FJK Dated: August 18, 2020 Received: August 19, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal. Gastrointestinal. Obesity and Transplant Devices OHT3: Office of GastroRenal. ObGyn. General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K201207
Device Name
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology and CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
Indications for Use (Describe)
The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician.
The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
The Blood Tubing Set is intended to be used with Fresenus Medical Care 2008® Series K, K2 and T Hemodialysis Machines equipped with Crit-Line hardware.
The Crit-Line Blood Chamber is an optical cuvette designed for use with the Crit-Line monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 logo for Fresenius Medical Care. On the left is a blue symbol that looks like three downward pointing arrows 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. 510(K) SUMMARY
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.
5.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA | |
| 02451-1457 | |
| Phone: | (781) 996-9103 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Regulatory Affairs – Devices | |
| Preparation Date: | 28 January 2020 |
5.2. Device Name
| Trade Name: | CombiSet SMARTECH Hemodialysis Blood Tubing Sets |
|---|---|
| Common Name: | Blood Tubing Set |
| Regulation Name: | Hemodialysis system and accessories |
| Regulatory Class: | Class II per 21 CFR § 876.5820 |
| Product Code: | KOC/FJK |
| Product Code Name: | KOC – Accessories, Blood Circuit, Hemodialysis |
| FJK - Set, Tubing, Blood, With and Without Anti-regurgitation | |
| Valve | |
| FDA Review Panel: | Gastroenterology/Urology |
5.3. Legally Marketed Predicate Device
The legally marketed primary predicate device is the CAREline Hemodialysis Blood Tubing Sets cleared under K172238. The legally marketed secondary predicate device is the Crit-Line Clip (CLiC) Blood Chamber cleared under K152953. These devices have not been subject to a designrelated recall.
The Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors (K120823) is being used as a reference device.
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Image /page/4/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three downward-pointing chevrons, stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
Device Description 5.4.
5.4.1. Device Identification:
The CombiSet SMARTECH Hemodialysis Blood Tubing Sets (hereinafter referred to as "CombiSet SMARTECH Bloodlines") are the subject of this 510(k) and are available in two (2) configurations:
- CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and ● Integrated Crit-Line Technology (hereinafter referred to as the "Standard bloodline")
- . CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, no Heparin Line (hereinafter referred to as the "No heparin line")
5.4.2. Device Characteristics
The CombiSet SMARTECH Bloodlines are single-use, ethylene oxide (EO) sterilized blood tubing sets.
5.4.3. Environment of Use
The CombiSet SMARTECH Bloodlines are used in environments where acute and chronic hemodialysis are performed.
5.4.4. Brief Written Description of the Device
The CombiSet SMARTECH Bloodlines are part of the extracorporeal hemodialysis circuit. During hemodialysis, the extracorporeal circuit transports arterial blood from the patient's arterial access (e.g., fistula or catheter), through a hemodialyzer, and back to the patient's venous access. When the CombiSet SMARTECH Bloodlines are used with the Crit-Line Sensing System (which includes the Crit-Line Sensor Clip), the proposed devices will provide a clear viewing surface for the Crit-Line Sensor Clip to transmit light through the blood.
5.4.5. Materials of Use
The CombiSet SMARTECH Bloodlines are classified as externally communicating, circulating blood, prolonged contact (> 24 hours to 30 days) duration, Class II (Category B) devices in accordance with FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (16 June 2016).
The materials used for each component of the CombiSet SMARTECH Bloodlines are listed in Table 1.
| Component | Material |
|---|---|
| Tubing and Components | Polyvinylchloride (PVC) |
| Polycarbonate (PC) |
Table 1: Materials of Composition
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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 stylized "F" on the left and the text "FRESENIUS MEDICAL CARE" on the right. The text is also in blue, and the two words are stacked on top of each other.
| Component | Material |
|---|---|
| Polypropylene (PP) | |
| Polyethylene (PE) | |
| Acrylonitrile Butadiene Styrene (ABS) | |
| Polyisoprene | |
| Transducer Protector | Polyester Polybutylene Terephthalate (PBT) |
| Polytetrafluoroethylene (PFTE) | |
| PC | |
| Integrated Crit-Line Blood | |
| Chamber | PVC |
| PE | |
| PC | |
| Bonding Solvents | Cyclohexanone |
| 50% Methyl Ethyl Ketone (MEK)/50% Cyclohexanone | |
| TetraMEK (95% Tetrahydrofuran/5% MEK) |
Table 1: Materials of Composition
5.4.6. Key Performance Specifications/Characteristics
The key performance specifications of the CombiSet SMARTECH Bloodlines are outlined in Table 2.
Table 2: Key Performance Specifications
| Feature | Specification |
|---|---|
| Maximum Blood Flow Rate | 600 mL/min |
| Maximum Arterial Pressure | -300 mmHg |
| Maximum Venous Pressure | +500 mmHg |
| Pump Segment [Inner/Outer Diameter (ID/OD)] | 8.0 mm/12.0 mm |
| Functional CLiC Chamber Test - Hematocrit | |
| (HCT) | The measured HCT using the CombiSet |
| SMARTECH Bloodline has a standard | |
| deviation X2 of ≤ 3%, and an average bias of | |
| ≤ 1% (of the average HCT) as measured on | |
| control blood chambers | |
| Functional CLiC Chamber Test - Oxygen | |
| Saturation (O2 Sat) | The measured O2 Sat using the CombiSet |
| SMARTECH Bloodline has a standard | |
| deviation X2 of ≤ 3%, and an average bias of | |
| ≤ 2% (of the average O2 Sat) as measured on | |
| control blood chambers |
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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, also in blue. The symbol is made up of three downward-pointing chevrons stacked on top of each other.
5.5. Intended Use
The CombiSet SMARTECH Bloodlines are intended for use in acute and chronic hemodialysis therapy.
5.6. Indications for Use
The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician.
The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.
The Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K. K-and T Hemodialysis Machines equipped with Crit-Line hardware.
The Crit-Line Blood Chamber is an optical cuvette designed for use with the Crit-Line monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation.
5.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the CombiSet SMARTECH Bloodlines are substantially equivalent to those of the primary predicate CAREline Bloodlines (K172237) and secondary predicate CLiC Blood Chamber (K152953):
- Indications for Use
- Technological Characteristics
- . Design
- Performance Requirements
5.8. Sterilization Testing
The CombiSet SMARTECH Bloodlines are sterilized by exposure to 100% ethylene oxide (EO). The sterility assurance level (SAL) is 106. Sterility and non-pyrogenicity are claimed for the fluid pathway of the bloodline.
5.8.1. EO Residual Testing
Residual testing for EO and ethylene chlorohydrin (ECh) was performed in accordance with AAMI/ANSI/ISO 10993-7:2008/(R)2012 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals. Acceptable results (i.e.,