(148 days)
Not Found
No
The device description and performance studies focus on the chemical composition, physical properties, and biocompatibility of dialysis solutions, with no mention of AI or ML.
Yes
The intended use statement explicitly indicates that the device is used as a dialysate in Continuous Renal Replacement Therapy, which is a therapeutic intervention.
No
The device is a dialysate used in Continuous Renal Replacement Therapy, which is a treatment modality, not a diagnostic one. Its purpose is to perform dialysis, not to diagnose a condition.
No
The device description clearly states it is a solution consisting of chemical components, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a dialysate in Continuous Renal Replacement Therapy." This is a therapeutic treatment administered directly to a patient, not a test performed on a sample taken from a patient to diagnose or monitor a condition.
- Device Description: The description lists the chemical components of the solution, which are used for dialysis, not for analyzing a biological sample.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents for detecting analytes, sample preparation steps, or analytical methods.
- Performance Studies: The performance studies focus on the physical properties of the solution and packaging, biocompatibility, and human factors, which are relevant for a therapeutic device, not an IVD.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the safety and compatibility of any tissue or organ for transplantation. This device does not fit that definition.
N/A
Intended Use / Indications for Use
pureFLOW solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
Product codes (comma separated list FDA assigned to the subject device)
KPO
Device Description
The pureFLOW solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, sodium bicarbonate, and glucose. The pureFLOW dialysis are available in four (4) formulations which differ in potassium chloride concentration. The pureFLOW solutions are each provided in a 2-compartment bag. One compartment contains 4.75 L of a slightly alkaline bicarbonate solution and the other compartment contains 0.25 L of an acidic electrolyte, glucose solution. The 2 solutions are mixed before use by opening the peel seam between the compartments, yielding 5 L of a ready-to-use sterile solution. The dialysate bags are made of a gas barrier foil, a material manufactured without PVC, latex, or plasticizer. The pureFLOW 400 series solutions contain calcium are used for treatment modalities using heparin anticoagulation. Each bag is equipped with an HF-connector, a luer-lock connector, and an injection port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The pureFLOW solutions are used in acute care environments where CRRT is performed.
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 to evaluate the stability of the eyelets, integrity and robustness of the bag system packaging, integrity and penetration force of the septum and injection port, and the bag's performance regarding temperature, pressure, and gas barrier properties. Biocompatibility testing was performed in accordance with ISO 10993-1:2018 and FDA guidance, assessing chemical characterization, cytotoxicity, sensitization, irritation, material mediated pyrogenicity, hemocompatibility, and genotoxicity. A toxicological risk assessment was also conducted. Human factors validation testing found the solutions safe and effective. No electrical safety/EMC, software, animal, or clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it.
May 10, 2024
Fresenius Medical Care Renal Therapies Group, LLC Timothy Groves Regulatory Affairs - Senior Lead 920 Winter Street Waltham, MA 02451
Re: K233950
Trade/Device Name: pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: KPO Dated: April12, 2024 Received: April 12, 2024
Dear Timothy Groves:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Maura Rooney -S
Maura Rooney 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 Healthh
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
Indications for Use (Describe)
pureFLOW solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/4/Picture/0 description: The image contains 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".
510(K) SUMMARY 1.
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.
Submitter's Information 1.1.
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA | |
| 02451-1457 | |
| Phone: | (781) 460-1087 |
| Fax: | (781) 699-9635 |
| Contact Person: | Timothy Groves, Senior Lead |
| Preparation Date: | 15 December 2023 |
1.2. Device Name
| Trade Names: | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401
(F00012069); pureFLOW 400 (F00012070) |
|--------------------|-----------------------------------------------------------------------------------------------------------|
| Common Name: | Dialysis Solutions for Continuous Renal Replacement Therapy
(CRRT) |
| Regulation Name: | Hemodialysis System and Accessories |
| Regulatory Class: | Class II per 21 CFR § 876.5820 |
| Product Code: | KPO |
| Product Code Name: | Dialysate Concentrate for Hemodialysis (Liquid or Powder) |
| FDA Review Panel: | Gastroenterology/Urology |
1.3. Legally Marketed Predicate Device
The legally marketed predicate device for the proposed pureFLOW dialysis solutions manufactured in Guadalajara, Mexico is the pureFLOW dialysis solutions manufactured from St. Wendel, Germany (K233159). This device is not currently subject to a design-related recall.
Device Description 1.4.
1.4.1. Device Identification
1.4.1.1. pureFLOW Dialysis Solutions
The pureFLOW solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, sodium bicarbonate, and glucose. The pureFLOW dialysis are available in four (4) formulations which differ in potassium chloride concentration. A list of available calcium containing solutions is provided in Table 1.
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Image /page/5/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue abstract symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The text is in blue and is stacked in two lines.
| Part Number | Description |
|---|---|
| F00012067 | pureFLOW 402 (0 mEq/L K+) |
| F00012070 | pureFLOW 400 (2 mEq/L K+) |
| F00012068 | pureFLOW 406 (3 mEq/L K+) |
| F00012069 | pureFLOW 401 (4 mEq/L K+) |
pureFLOW 400 series Products Table 1:
1.4.2. Device Characteristics
pureFLOW solutions are single-use, steam sterilized dialysis solutions for use in Continuous Renal Replacement Therapy (CRRT).
1.4.3. Environment of Use
The pureFLOW solutions are used in acute care environments where CRRT is performed.
1.4.4. Brief Written Description of the Device
pureFLOW solutions are sterile dialysates for use in CRRT. The pureFLOW solutions are each provided in a 2-compartment bag. One compartment contains 4.75 L of a slightly alkaline bicarbonate solution and the other compartment contains 0.25 L of an acidic electrolyte, glucose solution. The 2 solutions are mixed before use by opening the peel seam between the compartments, yielding 5 L of a ready-to-use sterile solution. The dialysate bags are made of a gas barrier foil, a material manufactured without PVC, latex, or plasticizer. The pureFLOW 400 series solutions contain calcium are used for treatment modalities using heparin anticoagulation.
1.4.5. Materials of Use
The pureFLOW solutions are classified as externally communicating, blood path indirect, 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 (04 September 2020).
Each bag is equipped with an HF-connector, a luer-lock connector, and an injection port. The pureFLOW bags are composed of the materials listed in Table 2.
| Component | Material |
|---|---|
| Solution Bag | Multi-layer Gas Barrier Film |
| Connective Tubing | Polyolefin/Elastomer |
| Injection Port | Polypropylene |
| Luer -Lock Connector with Cap | Synthetic Rubber |
| Polycarbonate |
Table 2: pureFLOW Bag Materials
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Image /page/6/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo, there are three downward-pointing chevron shapes stacked on top of each other. To the right of the chevrons, the text "FRESENIUS" is on the top line and "MEDICAL CARE" is on the bottom line. The logo is blue and the background is white.
Table 2: pureFLOW Bag Materials
| Component | Material |
|---|---|
| Thermoplastic Elastomer | |
| HF Connector with Cap | Polycarbonate |
| Silicone | |
| Overwrap | Polyolefin/Elastomer |
1.4.6. Key Performance Specifications/Characteristics
The key performance specifications of pureFLOW solutions are outlined in Table 3.
| Table 3: | Key Performance Specifications |
|---|---|
| ---------- | -------------------------------- |
| Chemical Component | Ionic Contribution (mEq/L, mixed) |
|---|---|
| pureFLOW 400 series | |
| Sodium (Na+) | 140 |
| Potassium (K+) | 0, 2, 3, or 4 |
| Magnesium (Mg2+) | 1.0 |
| Calcium (Ca2+) | 3.0 |
| Chloride (Cl-) | 109, 111, 112, or 113 |
| Bicarbonate (HCO3-) | 35 |
| Glucose | 5.55 |
1.5. Intended Use
pureFLOW solutions are each intended to be used with commercially available CRRT systems as dialysate for the treatment of patients with acute renal failure.
1.6. Indications for Use
pureFLOW solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
1.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the pureFLOW solutions are substantially equivalent to those of the predicate pureFLOW solutions (K233159):
- Intended Use
- Design
- Principle of Operation .
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Image /page/7/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", with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line. The text is also in blue.
- Performance Specifications ●
1.8. Performance Data
The container closure system of the proposed pureFLOW solutions is identical to the predicate pureFLOW solutions manufactured in St. Wendel, Germany (K233159), with the exception of the bag film material (additional layer of PVOH), a new injection port (septum) material, and modified eyelet holes. Therefore, functional performance testing submitted in K233159 is being leveraged to support the proposed pureFLOW container closure system. Testing conducted to support the determination of substantial equivalence is summarized in Table 4.
| Test Conducted | Test Method Description |
|---|---|
| 5 L Bag Hanging | Evaluate the stability of the eyelets (all 3 or a single one) over a period |
| of 24 hrs when hanging on hooks | |
| Shipping and Distribution | Demonstrate the integrity and robustness of the bag system packaging |
| within the distribution environment | |
| Injection Port | Determine the integrity and penetration force of the septum and |
| injection port | |
| Temperature and Pressure | |
| Resistance | Demonstrate that the performance of the bag meets specification for |
| temperature and pressure resistance | |
| Gas Barrier | Evaluate the integrity of the bag as a CO2 barrier |
Table 4: Performance Testing Summary
Biocompatibility Testing 1.8.1.
Biocompatibility testing was conducted to evaluate the material changes 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" (08 September 2023). The following endpoints were assessed to support the biological safety of the pureFLOW solutions container closure system:
- Chemical Characterization
- Cytotoxicity
- Sensitization
- Irritation
- Material Mediated Pyrogenicity ●
- Hemocompatibility
- Genotoxicity
A toxicological risk assessment was also performed.
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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 chevron shapes stacked on top of each other, pointing downwards. 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.
1.8.2. Human Factors Validation Testing
The pureFLOW solutions were found to be safe and effective for their intended users, uses, and use environments.
1.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)
Not applicable. The pureFLOW solutions are not electrical mechanical devices.
Software Verification and Validation Testing 1.8.4.
Not applicable. The pureFLOW solutions do not contain software.
1.8.5. Animal Studies
No animal studies were performed.
Clinical Studies 1.8.6.
No clinical studies were performed.
1.9. Conclusion
The intended use, design, principle of operation, and performance specifications of the pureFLOW solutions are substantially equivalent to those of the predicate device. Differences between the pureFLOW solutions and the predicate do not raise new concerns with regard to safety or efficacy. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, pureFLOW solutions are safe and effective for their intended use.