(526 days)
The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling.
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.
The CombiSet Bloodline is a single-use, ethylene oxide (EO) sterilized blood tubing set. The CombiSet Bloodline is 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.
This document describes the premarket notification (510(k)) for the CombiSet Hemodialysis Blood Tubing Set. It does NOT describe a study involving an AI device or algorithm. Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, or comparative effectiveness with AI.
The document focuses on the substantial equivalence of the CombiSet Hemodialysis Blood Tubing Set to a predicate device (CombiSet SMARTECH Hemodialysis Blood Tubing Sets, K201207) through various performance, sterilization, and biocompatibility tests.
Here's the relevant information about the non-AI device's performance testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Conducted | Test Objective (Acceptance Criteria Implicit) | Reported Device Performance |
|---|---|---|
| Structural Integrity | Demonstrate that the bloodline can withstand 1.5X the labeled maximum positive and negative pressures | Met criteria |
| Pump Segment Performance | Evaluate performance characteristics of the bloodline over the range of the inlet pressures (normally 0 mmHg to -250 mmHg). Flow rate settings will cover up to 600 mL/min. | Met criteria |
| 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. | Met criteria |
| 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. | Met criteria |
| DIN Connectors | Demonstrate that the DIN connectors do not leak when subjected to fluid pressure of 300-330 kPa. | Met criteria |
| Male and Female Luer Connectors Tests | Demonstrate that the applicable components of the bloodline meet the dimensional and performance requirements of ISO 80369-7 2016 (Sections 5 and 6). | Met criteria |
| Visual Inspection for Packaging (Shipping study) | Demonstrate that the shipping case, packaging configuration, and palletization pattern maintain the product's structural integrity during manual handling and motorized freight. | Met criteria |
| Tensile Testing | Demonstrate that all bonded engagements in the bloodline between components, and between components and tubing can withstand a tensile force of 15 lbf. | Met criteria |
| Spike Flow Rate | Demonstrate that the spike, a component of the bloodline, can deliver not less than 1000 mL of a sodium chloride solution in 10 min under a static head of 1 m. | Met criteria |
| Spike Insertion Force | Demonstrate that the spike, a component of the bloodline, 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. | Met criteria |
| Spike Leak Test | Demonstrate that the spike, a component of the bloodline, 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. | Met criteria |
| Spike Disconnection Force | Demonstrate that the spike, a component of the bloodline, 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. | Met criteria |
| 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 bloodline meet the requirements of ISO 8638:2010 and FDA Guidance. | Met criteria |
| 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. | Met criteria |
| 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. | Met criteria |
| Air-Capture Chamber Fill Level | Demonstrate that the recommended fill level of the air-capture chambers is marked. | Met criteria |
| Blood Filter Retention Test | Demonstrate that the blood filter of the bloodline 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. | Met criteria |
| Transparency of Transducer Protectors | Demonstrate that the machine side of the TPs is clear to allow for visual inspection of blood contamination during use. | Met criteria |
| Transducer Protector Leak Test | Demonstrate that the TP is capable of maintaining a secure and leak-free connection to the hemodialysis machine. | Met criteria |
| Structural Integrity (Vented Caps) | Demonstrate that the vented caps can withstand 1.5X the labeled maximum positive and negative pressures. | Met criteria |
| Viral Retentiveness Test for Transducer Protectors | Demonstrate that the membrane inside the transducer protector prevents the passage of bacteriophage (Φ X174) from the patient side to the machine side up to a pressure of 750 mmHg for 1 hr. | Met criteria |
| Tubing Compliance Test | Demonstrate that tubing is capable of being occlusively clamped by the venous line clamp of the dialysis machine. | Met criteria |
| Clamp Occlusion Test | Demonstrate that tubing is capable of being occlusively clamped by the bloodline clamps. | Met criteria |
Note: The document explicitly states: "All testing met predetermined acceptance criteria."
2. Sample size used for the test set and the data provenance:
The document does not provide specific sample sizes (e.g., number of units tested) for each performance or biocompatibility test. It mentions that "samples" were tested.
- Data Provenance: The studies were conducted by Fresenius Medical Care Renal Therapies Group, LLC, likely internally or through contracted labs, as part of their 510(k) submission to the FDA. The country of origin for the data is not specified beyond being part of a US FDA submission. It is implicitly prospective testing of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes performance testing of a physical medical device (blood tubing set), not an AI device requiring expert ground truth for classification or diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the document describes performance testing of a physical medical device. The results of the physical tests (e.g., pressure resistance, leak tests) are objective measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This document is for a physical medical device (blood tubing set), not an AI device. No human reader studies or AI assistance were involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document is for a physical medical device, not an AI device or algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance is based on established engineering standards and regulatory requirements (e.g., ISO 8638:2010, ISO 80369-7:2016, AAMI/ANSI/ISO 10993-7:2008, ANSI/AAMI/ST72:2019, ISO 10993-1:2018, ASTM F1671-13). The device's ability to resist pressure, prevent leaks, sustain flow rates, and demonstrate biocompatibility according to these standards serves as the ground truth.
8. The sample size for the training set:
Not applicable. This document describes the testing of a physical medical device, not an AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 31, 2023
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K213992
Trade/Device Name: CombiSet Hemodialysis Blood Tubing Set Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: April 28, 2023 Received: May 1, 2023
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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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,
Gema Gonzalez -S
Gema Gonzalez, MS Acting 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
Enclosure
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Indications for Use
510(k) Number (if known)
K213992
Device Name CombiSet Hemodialysis Blood Tubing Set
Indications for Use (Describe)
The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling.
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.
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 contains the logo for Fresenius Medical Care. On the left side of the logo 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" and "MEDICAL CARE" are written in blue, with "FRESENIUS" on top and "MEDICAL CARE" on the bottom.
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 StreetWaltham, MA02451-1457 |
| Phone: | (781) 996-9103 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Preparation Date: | 20 December 2021 |
5.2. Device Name
| Trade Name: | CombiSet Hemodialysis Blood Tubing Set |
|---|---|
| Common Name: | Blood Tubing Set |
| Regulation Name: | Hemodialysis system and accessories |
| Regulatory Class: | Class II per 21 CFR § 876.5820 |
| Product Code: | FJK |
| Product Code Name: | Set, Tubing, Blood, With and Without Anti-regurgitation Valve |
| FDA Review Panel: | Gastroenterology/Urology |
5.3. Legally Marketed Predicate Device
The legally marketed predicate device is the CombiSet SMARTECH Hemodialysis Blood Tubing Sets (hereinafter referred to as "CombiSet SMARTECH") cleared under K201207. The predicate device has not been subject to a design-related recall.
Device Description 5.4.
5.4.1. Device Identification
The CombiSet Hemodialysis Blood Tubing Set (hereinafter referred to as "CombiSet Bloodline") is the subject of this 510(k).
5.4.2. Device Characteristics
The CombiSet Bloodline is a single-use, ethylene oxide (EO) sterilized blood tubing set.
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Image /page/4/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. The symbol is made up of three downward-pointing chevrons. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.4.3. Environment of Use
The CombiSet Bloodline is used in environments where acute and chronic hemodialysis are performed.
5.4.4. Brief Written Description of the Device
The CombiSet Bloodline is 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.
Materials of Use 5.4.5.
The CombiSet Bloodline is classified as externally communicating, circulating blood, prolonged contact (> 24 hours to 30 days) duration. Class II (Category B) device 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" (4 September 2020).
The materials used for each component of the CombiSet Bloodline are listed in Table 1.
| Component | Material |
|---|---|
| Tubing and Components | Polyvinylchloride (PVC)Polypropylene (PP)Polyethylene (PE)Methylmethacrylate acrylonitrile butadiene styrene (MABS)Polyisoprene |
| Transducer Protector | Polypropylene (PP)Polytetrafluoroethylene (PFTE) on Polyester |
| Bonding Solvents | CyclohexanoneTetraMEK (95% Tetrahydrofuran/5% MEK) |
Table 1: Materials of Composition
5.4.6. Key Performance Specifications/Characteristic
The key performance specifications of the CombiSet Bloodline are outlined in Table 2.
Table 2: Key Performance Specifications/Characteristics
| 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 |
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Image /page/5/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left, which is made up 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.
5.5. Intended Use
The CombiSet Bloodline is intended for use in acute and chronic hemodialysis therapy.
Indications for Use 5.6.
The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling.
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.
5.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the CombiSet Bloodline are equivalent to those of the predicate CombiSet SMARTECH (K201207):
- Indications for Use
- Principle of Operation
- Technological Characteristics
- Design
- Performance Requirements
5.8. Sterilization Testing
The CombiSet Bloodline is sterilized by exposure to 100% ethylene oxide (EO). The sterility assurance level (SAL) is 10-6. Sterility and non-pyrogenicity are claimed for the fluid pathway of the bloodline.
EO Residual Testing 5.8.1.
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., < 4.6 mg/device for EO and ECh) were obtained for the subject bloodline.
Bacterial Endotoxin (Pyrogenicity) Testing 5.8.2.
The CombiSet Bloodline was tested for bacterial endotoxin (pyrogenicity) with Limulus Amebocyte Lysate (LAL) and was determined to be non-pyrogenic (< 20 EU/device) in accordance with ANSI/AAMI/ST72:2019 Bacterial Endotoxins - Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.
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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 abstract symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line. The logo is simple and modern, and the blue color gives it a sense of professionalism and trustworthiness.
5.8.3. Sterile Barrier Testing
Sterility of the blood pathway is maintained by the sterile fluid path of the device itself which includes the following components:
- Vented Caps
- Transducer Protectors (TPs) ●
- Tubing and all other components that make up the structural integrity of the bloodline's fluid path
The vented caps were qualified as part of the sterile barrier by microbial challenge tests in accordance with ANSI/AAMI/ISO 11607-1.
The TPs were qualified as part of the sterile barrier by a viral penetration test adapted from ASTM F1671-13.
The tubing and other components were qualified as part of the sterile barrier through the structural integrity test adapted from ISO 8638 and ASTM F2096-11. Testing was performed on samples after aging and distribution simulation.
5.9. Performance Data
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.
| Test Conducted | Test Objective |
|---|---|
| Structural Integrity | Demonstrate that the bloodline can withstand 1.5X the labeled maximumpositive and negative pressures |
| Pump SegmentPerformance | Evaluate performance characteristics of the bloodline over the range of the inletpressures (normally 0 mmHg to -250 mmHg). Flow rate settings will cover upto 600 mL/min. |
| Visual Inspectionfor Endurance andSimulated Use Tests | EnduranceDemonstrate that bloodlines perform with no tubing failures (kinking,collapsing, or disconnection) at the maximum labeled flow rate and pressuresfor not less than 18 hrSimulated UseDemonstrate that bloodlines perform with no tubing failures (kinking,collapsing, or disconnection) under simulated use conditions for not less than4 hr |
| Table 3: | Performance Testing Summary |
|---|---|
| Test Conducted | Test Objective |
| Needle Access PortTest | Demonstrate that the needle access ports can withstand 1.5X the labeledpressures after being punctured with the largest gauge needle recommended inthe labeling (21 gauge) - 6X for maximum positive pressure, 11X for maximumnegative pressure per ISO 8638:2010 |
| DIN Connectors | Demonstrate that the DIN connectors do not leak when subjected to fluidpressure of 300-330 kPa.ISO 80369-7:2016 specifies the test method, but it does not specifyrequirements for hemodialyzer blood compartment port connectors. However,the liquid leakage test from this standard has been adopted using the referenceconnector from ISO 8638 to test the DIN connectors for this device. |
| Male and FemaleLuer ConnectorsTests | Demonstrate that the applicable components of the bloodline meet thedimensional and performance requirements of ISO 80369-7 2016 (Sections 5and 6) |
| Visual Inspectionfor Packaging(Shipping study) | Demonstrate that the shipping case, packaging configuration, and palletizationpattern maintain the product's structural integrity during manual handling andmotorized freight |
| Tensile Testing | Demonstrate that all bonded engagements in the bloodline 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 bloodline, can deliver not lessthan 1000 mL of a sodium chloride solution in 10 min under a static head of1 m |
| Spike InsertionForce | Demonstrate that the spike, a component of the bloodline, is capable of piercingand penetrating the closure of an infusion device without coring and with forcenot exceeding 200 N, when inserted at a rate of 500 mm/min |
| Spike Leak Test | Demonstrate that the spike, a component of the bloodline, will not leak afterpiercing an infusion device, remaining pierced for 5 hr, and then having anapplied internal pressure of 20 kPa for 15 sec |
| Spike DisconnectionForce | Demonstrate that the spike, a component of the bloodline, is capable of beingremoved from the insertion point when a removal force is applied at a rate of100 mm/min. Establish the removal force value. |
| Labeling Contentper FDA Guidance(Blood Tubing Set)and ISO 8638 | Verify the Instructions for Use, color coded components, unit labels, shippingcarton graphics, and case labels for the bloodline meet the requirements of ISO8638:2010 and Guidance for Industry and FDA Staff: Hemodialysis BloodTubing Test - Premarket Notification [510(k)] Submissions (April 2008) |
| Readability ofBarcode withHuman ReadableIdentification Codes | Demonstrate that the barcode information on the outer container labels and unitlabels for the bloodlines is capable of being scanned |
| Test Conducted | Test Objective |
| Level Detector Test | Demonstrate that the venous chamber of the bloodline interfaces correctly withthe hemodialysis machine (2008 series) such that the venous clamp will activate(close) when the fluid level inside the venous chamber falls below the sensorheads |
| Air-CaptureChamber Fill Level | Demonstrate that the recommended fill level of the air-capture chambers ismarked |
| Blood FilterRetention Test | Demonstrate that the blood filter of the bloodline remains in the assemblyposition after tests at 1.5X the maximum recommended positive pressure, with aflow rate of 600 mL/min for not less than 18 hr |
| Transparency ofTransducerProtectors | Demonstrate that the machine side of the TPs is clear to allow for visualinspection of blood contamination during use |
| TransducerProtector Leak Test | Demonstrate that the TP is capable of maintaining a secure and leak-freeconnection to the hemodialysis machine |
| Structural Integrity(Vented Caps) | Demonstrate that the vented caps can withstand 1.5X the labeled maximumpositive and negative pressures |
| Viral RetentivenessTest for TransducerProtectors | Demonstrate that the membrane inside the transducer protector prevents canprevent the passage of bacteriophage (Φ X174) from the patient side to themachine side up to a pressure of 750 mmHg for 1 hr |
| Tubing ComplianceTest | Demonstrate that tubing is capable of being occlusively clamped by the venousline clamp of the dialysis machine |
| Clamp OcclusionTest | Demonstrate that tubing is capable of being occlusively clamped by thebloodline clamps |
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Image /page/7/Picture/0 description: The image contains 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".
Table 3: Performance Testing Summary
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Image /page/8/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
Table 3: Performance Testing Summary
All testing met predetermined acceptance criteria. Results of the proposed device's design verification tests met the requirements and demonstrated that, like the predicate device, the CombiSet Bloodline is safe and effective for its intended use.
5.9.1. Biocompatibility Testing
Biocompatibility testing was conducted in accordance with ISO 10993-1:2018 and 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" (4 September 2020). The following tests were conducted to support the biological safety of the CombiSet Bloodline:
- Cytotoxicity, Neutral Red Uptake ●
- Sensitization, Guinea Pig Maximization
- Intracutaneous Irritation ●
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Image /page/9/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. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
- Material-Mediated Pyrogenicity
- Hemocompatibility, ASTM Hemolysis (Direct and Indirect) .
- Hemocompatibility, Dynamic (Mechanical) Hemolysis ●
- Hemocompatibility, Complement Activation, SC5b-9 ●
- Hemocompatibility, Partial Thromboplastin Time (PTT)
- Hemocompatibility, Platelet and Leukocyte Count ●
- Systemic Toxicity
- Genotoxicity, Ames Assay ●
- Genotoxicity, in vitro Mouse Lymphoma
- Semi-quantitative Leachable Chemical Evaluation, 20% Ethanol (Volatiles, Semi-● Volatiles, Non-Volatiles, Metals)
- Semi-quantitative Extractable Chemical Evaluation, Water, Isooctane, 100% Ethanol ● (Volatiles, Semi-Volatiles, Non-Volatiles, Metals)
A Toxicological Risk Assessment was also performed.
5.9.2. Human Factors Validation Testing
A Human Factors assessment was conducted for the CombiSet Bloodline to demonstrate its safe and effective use in accordance with FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
Electrical Safety and Electromagnetic Compatibility (EMC) 5.9.3.
Not applicable. The CombiSet Bloodline is not an electrical mechanical device.
5.9.4. Software Verification and Validation Testing
Not applicable. The CombiSet Bloodline does not contain software.
5.9.5. Animal Studies
No animal studies were performed.
5.9.6. Clinical Studies
No clinical studies were performed.
5.10. Conclusion
The information provided in this submission demonstrates that the CombiSet Bloodline functions as intended and the differences between the proposed and the predicate devices do not raise any new concerns with regard to safety or effectiveness.
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Image /page/10/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left, which is made up of three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the words "FRESENIUS" and "MEDICAL CARE" are written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
The intended use, indications for Use, principle of operation, design characteristics, sterilization method and materials of the CombiSet Bloodline are substantially equivalent to that of the predicate device. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the CombiSet Bloodline is safe and effective for its intended use.
§ 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.