(178 days)
No
The document describes a physical medical device (dialyzer) and its performance characteristics, with no mention of AI or ML technology in its operation or analysis.
Yes
The device is used for hemodialysis in patients with renal failure, which is a medical treatment to remove waste products from the blood, serving a therapeutic purpose.
No
The device description indicates that the Hemoflow F3 and F4 dialyzers are used for hemodialysis by transporting toxins and excess fluid from the blood. This is a treatment function, not a diagnostic one.
No
The device description clearly states that the Hemoflow F3 and F4 dialyzers are physical, single-use hemodialyzers with specific membrane surface areas and are configured to connect to bloodline sets and hemodialysis machines. This indicates a hardware medical device, not a software-only one.
Based on the provided text, the Hemoflow F3 and F4 dialyzers are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "hemodialysis of patients... with acute or chronic renal failure." This describes a therapeutic treatment performed directly on the patient's blood outside the body, not a test performed on a sample of blood or other bodily fluid to diagnose or monitor a condition.
- Device Description: The description details a device that filters blood using a semi-permeable membrane to remove toxins and excess fluid. This is a physical process, not a chemical or biological test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information about a patient's condition
- Using reagents or calibrators
The device is a therapeutic medical device used in the process of hemodialysis.
N/A
Intended Use / Indications for Use
The Hemoflow F3 and F4 dialyzers are intended for hemodialysis of patients, including pediatric patients, with acute or chronic renal failure when conservative therapy is judged to be inadequate. Consider body and dialyzer surface area, blood flow, body weight, and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
FJI
Device Description
The Hemoflow F3 and F4 dialyzers are low-flux, single-use, ethylene oxide (EO) sterilized hemodialyzers. The dialyzers are provided blood pathway sterile and non-pyrogenic. The membrane surface areas of the F3 and the F4 dialyzers are 0.3 m2 and 0.7 m2, respectively.
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
patients, including pediatric patients
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)
Performance testing was conducted in accordance with ISO 8637:2010 and Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998. Testing conducted to support the determination of substantial equivalence is summarized in Table 2: Test Conducted - Blood Compartment Volume, Clearance – Sodium (marker for urea), Creatinine, Phosphate, and Vitamin B12, Ultrafiltration, Pressure Drop, Structural Integrity, Blood Compartment Integrity, Simulated Shipping and Distribution. All testing met predetermined acceptance criteria. Results of the proposed devices' design verification tests met the requirements and demonstrated that, like the predicate device, the Hemoflow F3 and F4 dialyzers are safe and effective for their intended use.
Biocompatibility Testing: Testing was performed to support the biological safety of the Hemoflow F3 and F4 dialyzers, including Chemical analysis extractables and leachables, Cytotoxicity, ISO Elution Method with MEM, Sensitization, Guinea Pig Maximization, Intracutaneous Irritation, Acute Systemic Toxicity, Systemic Toxicity, Short-Term Repeated Exposure, Material-Mediated Pyrogenicity, Genotoxicity (Bacterial Reverse Mutation Assay, in vitro Mouse Lymphoma Gene Mutation Assay, Mouse Micronucleus in vivo Assay), Hemocompatibility (ASTM Hemolysis (Direct and Indirect Extract), Complement Activation - SC5b-9 fragment, ASTM Partial Thromboplastin Time, Mechanical Hemolysis, in vitro Thrombogenicity Assay), and PVP Testing. A toxicological risk assessment was also performed.
Human Factors Validation Testing: The Hemoflow F3 and F4 dialyzers were validated for safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
Clinical Studies: A retrospective data analysis performed on the Hemoflow F3 and F4 dialyzers included 10 pediatric ESRD patients on HD treated for 12 consecutive weeks. Hemoflow F3 and F4 dialyzers provided adequate clearance with a mean spKt/V of 1.78 and 2.18, respectively, and were well tolerated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Typical Urea Clearance (Sodium Used as Marker): Hemoflow F3 Dialyzer - 117, Hemoflow F4 Dialyzer - 155.
Mean spKt/V from clinical studies: Hemoflow F3 - 1.78, Hemoflow F4 - 2.18.
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.
August 23, 2019
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K190459
Trade/Device Name: Hemoflow™ F3 and F4 Dialyzers Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: Class II Product Code: FJI Dated: July 25, 2019 Received: July 26, 2019
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. You must comply with all the Act's
1
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 (OS) 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,
Carolyn Y. Neuland, Ph.D. Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastro-Renal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K190459
Device Name Hemoflow™ F3 and F4 Dialyzers
Indications for Use (Describe)
The Hemoflow F3 and F4 dialyzers are intended for hemodialysis of patients, including pediatric patients, with acute or chronic renal failure when conservative therapy is judged to be inadequate. Consider body and dialyzer surface area, blood flow, body weight, and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.
| 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/1 description: The image shows the Fresenius Medical Care logo. On the left side of the logo, there are three blue downward-pointing arrows stacked on top of each other. To the right of the arrows, the words "FRESENIUS MEDICAL CARE" are written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
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) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Regulatory Affairs – Devices | |
| Preparation Date: | 22 February 2019 |
5.2. Device Name
| Trade Name: | Hemoflow F3 and F4 Dialyzers |
|---|---|
| Common Name: | Dialyzer |
| Regulation Name: | Hemodialysis system and accessories |
| Regulatory Class: | Class II per 21 CFR § 876.5820 |
| Product Code: | FJI |
| Product Code Name: | Dialyzer, Capillary, Hollow Fiber |
| Classification Panel: | Gastroenterology/Urology |
5.3. Legally Marketed Predicate Device
The legally marketed predicate devices are the Fresenius Hemoflow F3, F4 dialyzers cleared under K874872. These devices have not been subject to a design-related recall.
The Gambro Polyflux 6H Hemodialyzer (K051520) and Fresenius Optiflux Dialyzers (K152367 and K162488) are used as reference devices.
5.4. Device Description
Device Identification 5.4.1.
The Hemoflow F3 and F4 dialyzers are the subject of this 510(k).
5.4.2. Device Characteristics
The Hemoflow F3 and F4 dialyzers are low-flux, single-use, ethylene oxide (EO) sterilized hemodialyzers. The dialyzers are provided blood pathway sterile and non-pyrogenic. The membrane surface areas of the F3 and the F4 dialyzers are 0.3 m2 and 0.7 m2, respectively.
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Image /page/4/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.
5.4.2.1. Environment of Use
The Hemoflow F3 and F4 dialyzers are used in environments where acute and chronic hemodialysis are performed.
5.4.2.2. Brief Written Description of the Device
The Hemoflow F3 and F4 dialyzers are low-flux, sterile devices designed for single-use acute and chronic hemodialysis. The dialyzers are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzers contain a semi-permeable membrane that allows for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.
5.4.2.3. Materials of Use
The Hemoflow F3 and F4 dialyzers 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 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).
| Component | Material |
|---|---|
| Housing | Polycarbonate |
| Potting Resin | Polyurethane |
| Fiber Bundle | Polysulfone |
| Screw Flange | Polycarbonate |
| O-Ring | Silicone |
| Blood Port Cap(s) | High Density Polyethylene |
The Hemoflow F3 and F4 dialyzers' components are composed of the following materials:
Key Performance Characteristics 5.4.2.4.
Urea clearance is a key performance specification of the Hemoflow F3 and F4 dialyzers. FMCRTG uses sodium clearance as a marker for urea clearance because sodium and urea exhibit similar movement across a membrane. Sodium clearance data from the Instructions for Use (IFU) for the Hemflow F3 and F4 dialyzers are provided in Table 1.
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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 emblem on the left and the company name on the right. The emblem is made up of three downward-pointing chevron shapes stacked on top of each other. The text "FRESENIUS MEDICAL CARE" is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
In vitro Urea Clearance for the F3 and F4 Dialyzer Models* Table 1:
| Trade Name | Typical Urea Clearance
(Sodium Used as Marker) |
|----------------------|---------------------------------------------------|
| Hemoflow F3 Dialyzer | 117 |
| Hemoflow F4 Dialyzer | 155 |
*Qb = 200 mL/min, Qd = 500 mL/min, Quf = 0 mL/min
5.5. Intended Use
Hemoflow F3 and F4 dialyzers are designed for single use acute and chronic hemodialysis.
5.6. Indications for Use
The Hemoflow F3 and F4 dialyzers are intended for hemodialysis of patients, including pediatric patients, with acute or chronic renal failure when conservative therapy is judged to be inadequate. Consider body and dialyzer surface area, blood flow, body weight, and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.
5.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the Hemoflow F3 and F4 dialyzers are equivalent to those of the predicate Fresenius Hemoflow F3 and F4 dialyzers (K874872).
- Intended use ●
- Principle of operation
- Design characteristics ●
- Sterilization method
- o Patient fluid-contacting materials: polysulfone, polycarbonate, polyurethane, and silicone
5.8. Performance Data
Performance testing was conducted in accordance with ISO 8637:2010 and Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998. Testing conducted to support the determination of substantial equivalence is summarized in Table 2.
| Test Conducted | Test Method Description |
|---|---|
| Blood Compartment Volume | Calculated, considering the fiber inner diameter, fiber crimp, |
| the minimum and maximum blood volume, O-ring | |
| compression volume, dialyzer housing length, and | |
| polyurethane height. |
| Table 2: Performance Testing Summary | |
|---|---|
| -------------------------------------- | -- |
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Image /page/6/Picture/1 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.
| Test Conducted | Test Method Description |
|---|---|
| Clearance – Sodium (marker for | |
| urea), Creatinine, Phosphate, and | |
| Vitamin B12 | Calculated by analyzing the test samples over the specified |
| range of blood and dialysate flow rates. | |
| Ultrafiltration | Calculated as the slope from a plot of the measured |
| ultrafiltration rate UFR (over the applied transmembrane | |
| pressure (TMP) range) versus the applied TMP. | |
| Pressure Drop | The dialysate and blood compartments were filled with |
| dialysate and bovine blood, respectively. Inlet and outlet | |
| pressures of the blood and dialysate compartments were | |
| measured across the range of flow rates with the dialyzers in a | |
| horizontal configuration. | |
| Structural Integrity | The positive and negative pressure decay was measured by a |
| pressure monitor connected at one end of the dialyzer while | |
| applying 900 mmHg and -700 mmHg from opposite ends. | |
| Blood Compartment Integrity | Air and water were added to the top blood port and the |
| dialysate side, respectively. A pressure differential was | |
| applied across the dialyzer membrane. | |
| Simulated Shipping and | |
| Distribution | Testing was conducted per ASTM D4169-16. Performance |
| testing was conducted before and after simulated shipping to | |
| demonstrate that the product and package integrity and | |
| sterility are maintained throughout the intended product shelf | |
| life. |
Performance Testing Summary Table 2:
All testing met predetermined acceptance criteria. Results of the proposed devices' design verification tests met the requirements and demonstrated that, like the predicate device, the Hemoflow F3 and F4 dialyzers are safe and effective for their intended use.
5.8.1. Biocompatibility Testing
Testing was performed to support the biological safety of the Hemoflow F3 and F4 dialyzers.
- Chemical analysis extractables and leachables ●
- Cytotoxicity, ISO Elution Method with MEM
- Sensitization, Guinea Pig Maximization ●
- Intracutaneous Irritation ●
- Acute Systemic Toxicity ●
- Systemic Toxicity, Short-Term Repeated Exposure ●
- Material-Mediated Pyrogenicity ●
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Image /page/7/Picture/1 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.
- Genotoxicity, Bacterial Reverse Mutation Assay ●
- Genotoxicity, in vitro Mouse Lymphoma Gene Mutation Assay o
- Genotoxicity, Mouse Micronucleus in vivo Assay
- Hemocompatibility, ASTM Hemolysis (Direct and Indirect Extract) ●
- Hemocompatibility, Complement Activation - SC5b-9 fragment
- Hemocompatibility, ASTM Partial Thromboplastin Time ●
- Hemocompatibility, Mechanical Hemolysis
- Hemocompatibility, in vitro Thrombogenicity Assay ●
- 0 PVP Testing
A toxicological risk assessment was also performed.
Human Factors Validation Testing 5.8.2.
The Hemoflow F3 and F4 dialyzers were validated for safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
5.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)
Not applicable. The Hemoflow F3 and F4 dialyzers are not electrical mechanical devices.
Software Verification and Validation Testing 5.8.4.
Not applicable. The Hemoflow F3 and F4 dialyzers do not contain software.
5.8.5. Mechanical and Acoustic Testing
No mechanical or acoustic tests were performed.
5.8.6. Animal Studies
No animal studies were performed.
5.8.7. Clinical Studies
A retrospective data analysis performed on the Hemoflow F3 and F4 dialyzers included 10 pediatric ESRD patients on HD treated for 12 consecutive weeks. Hemoflow F3 and F4 dialyzers provided adequate clearance with a mean spKt/V of 1.78 and 2.18, respectively, and were well tolerated.
5.9. Conclusion
The intended use, principle of operation, design characteristics, sterilization method and patient fluidcontacting materials of the Hemoflow F3 and F4 dialyzers are substantially equivalent to that of the predicate devices. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the Hemoflow F3 and F4 devices are safe and effective for their intended use.