The pureFLOW solutions are single-use, sterile, ready-to-use dialysis solutions consisting of sodium chloride, potassium chloride, magnesium chloride, calcium chloride (400 series only), sodium bicarbonate, and glucose. The pureFLOW dialysis solutions containing calcium are available in four (4) formulations which differ in potassium chloride concentration. The calcium-free pureFLOW dialysis solutions are available in two (2) formulations which differ in potassium chloride concentration. pureFLOW solutions are single-use, steam sterilized dialysis solutions for use in Continuous Renal Replacement Therapy (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 calcium-containing pureFLOW 400 series solutions are used for treatment modalities using heparin anticoagulation while the calcium-free pureFLOW 500 series solutions are used for treatment modalities using regional citrate anticoagulation.

AI/ML Overview

The provided document, K233159, is an FDA 510(k) summary for the pureFLOW dialysis solutions. This document primarily describes the device, its intended use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device. It does not contain information related to software-based AI/ML device performance or clinical studies using human readers.

Therefore, I cannot fulfill most of the requested points as the information is not present in the provided text. The document explicitly states:

5.8.4. Software Verification and Validation Testing: "Not applicable. The pureFLOW solutions do not contain software."
5.8.6. Clinical Studies: "No clinical studies were performed."

Given this, there is no information on:

Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Acceptance criteria for AI/ML performance.
Study design for AI/ML performance, including sample sizes, data provenance, expert qualifications, or adjudication methods for ground truth.
Effect size of human reader improvement with AI assistance.
Training set details for AI/ML models.

However, I can extract information regarding the general performance testing and the context of the device:

Device: pureFLOW dialysis solutions (pureFLOW 402, 400, 406, 401, 502, 504)
Intended Use: As a dialysate in Continuous Renal Replacement Therapy (CRRT).

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

Based on the provided document, the "performance" is demonstrated through various physical, chemical, and biological tests to ensure the product's quality, safety, and functionality as a sterile dialysis solution and its container system. The document lists "Key Performance Specifications/Characteristics" for the chemical components of the solutions. It also details the various "Performance Testing" conducted. While these are not acceptance criteria in the sense of AI/ML metrics (like sensitivity, specificity), they are the performance criteria for this physical device.

Test Conducted	Acceptance Criteria (Implied by "Demonstrate")	Reported Device Performance (Implied by Conclusion of SE)
Chemical Component (Ionic Contribution)	Expected ionic contributions for Sodium (Na+), Potassium (K+), Magnesium (Mg2+), Calcium (Ca2+), Chloride (Cl-), Bicarbonate (HCO3-), and Glucose. (Specific target ranges not provided in this summary, but presumed to meet specifications for safe and effective CRRT dialysate.)	pureFLOW 400 series: Na+ (140 mEq/L), K+ (0, 2, 3, or 4 mEq/L), Mg2+ (1.0 mEq/L), Ca2+ (3.0 mEq/L), Cl- (109, 111, 112, or 113 mEq/L), HCO3- (35 mEq/L), Glucose (5.55). pureFLOW 500 series: Na+ (133 mEq/L), K+ (2 or 4 mEq/L), Mg2+ (1.5 mEq/L), Ca2+ (0), Cl- (116.5 or 118.5 mEq/L), HCO3- (20 mEq/L), Glucose (5.55).
5 L Bag Hanging	Stability of eyelets (all 3 or single) over 24 hours when hanging on hooks.	Successful (implied by "Testing conducted to support the determination of substantial equivalence" and overall conclusion).
Shipping and Distribution	Integrity and robustness of the bag system packaging within the distribution environment.	Successful.
Primary Bag Welding	Pull tension of foils, fixed seams of primary packaging, peel-stitched primary packaging and secondary packaging.	Successful.
Tube Welding	Pull force of tube welding/seals.	Successful.
HF-Connector and Luer Connector	Torque for removing protective cap, torque of male/female connector, breaking strength of HF-connector cone, leakage and tightness of connectors, pull-out force of connectors and injection ports.	Successful.
Injection Port	Penetration force of the septum and injection port.	Successful.
Eyelet	Pull force strength of the bag eyelet.	Successful.
Gas Barrier Measurement	Integrity of the bag as a CO2 barrier.	Successful.
Sterility	Solution is sterile.	Successful.
Luer-Lock Connector	Tightness after stress crack resistance testing.	Successful.
Temperature and Pressure Resistance of Bag	Resistance of the bag towards temperature and pressure.	Successful.
Biocompatibility (Chemical Characterization, Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Hemocompatibility, Genotoxicity, Toxicological Risk Assessment)	In accordance with ISO 10993-1:2018 and FDA guidance (04 September 2020), endpoints assessed demonstrate biological safety of the container closure system. (Specific criteria for each test not detailed in summary).	Successful.
Human Factors Validation Testing	Device is safe and effective for its intended users, uses, and use environments.	Found to be safe and effective.

2. Sample sizes used for the test set and the data provenance:

The document does not specify exact sample sizes for each of the performance tests (e.g., how many bags were tested for hanging, welding, etc.).
Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as these are primarily laboratory/engineering tests on manufactured product, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This is not applicable as the device is not an AI/ML product for which expert-annotated ground truth is required. Performance is demonstrated through physical, chemical, and biological testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for the reasons stated above.

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:

No. The document explicitly states: "No clinical studies were performed." and "The pureFLOW solutions do not contain software." Therefore, no MRMC study was conducted, and this question is not relevant to the described device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. The device does not contain software or an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this type of medical device (physical product, dialysate solution), "ground truth" is established by adherence to predefined engineering specifications, chemical composition limits, sterility requirements, and biocompatibility standards, validated through laboratory testing, rather than clinical outcomes or expert consensus on diagnostic images.

8. The sample size for the training set:

Not applicable. The device does not involve a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized symbol. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name of the agency in blue text to the right and below.

June 28, 2024

Fresenius Medical Care Renal Therapies Group, LLC Timothy Groves RA Fellow - Regulatory Affairs North America 920 Winter Street Waltham. Massachusetts 02451

Re: K233159 Trade/Device Name: pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis System And Accessories Regulatory Class: Class II Product Code: KPO

Dear Timothy Groves:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on December 1, 2023. Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction. Please see the attached revised clearance letter.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Maura Rooney, OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, (781) 462-8128 or Maura.Rooney(@fda.hhs.gov.

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 Health

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Image /page/1/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 28, 2024

Fresenius Medical Care Renal Therapies Group, LLC Timothy Groves RA Fellow - Regulatory Affairs North America 920 Winter Street Waltham, Massachusetts 02451

Re: K233159

Trade/Device Name: pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis System and accessories Regulatory Class: II Product Code: KPO Dated: September 27, 2023 Received: September 27, 2023

Dear Timothy Groves:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on December 1, 2023.

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/cdrb/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.

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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.

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,

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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)

K233159

Device Name

pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/5/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".

K233159 Page 1 of 6

pureFLOW dialysis solutions Traditional 510(k)

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) 460-1087
Fax:	(781) 699-9635
Contact Person:	Timothy Groves, Senior Lead
Preparation Date:	27 September 2023

5.2. Device Name

Trade Names:	pureFLOW
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

5.3. Legally Marketed Predicate Device

The legally marketed predicate device for the proposed pureFLOW dialysis solutions is the PrismaSATE dialysate (K162887). This device is not currently subject to a design-related recall.

The B.Braun Modified Duosol Bicarbonate Dialysate (K052393), NxStage Pureflow-B Dialysis Solutions (K053286), and Haemopharm Biofluids S.R.L's HMB32 Dialysis Solution (K212052) are used as reference devices.

Device Description 5.4.

5.4.1. Device Identification

5.4.1.1. pureFLOW Dialysis Solutions

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Image /page/6/Picture/0 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three chevrons stacked on top of each other, pointing downwards. To the right of the symbol is the text "FRESENIUS MEDICAL CARE", with "FRESENIUS" on top of "MEDICAL CARE". The text is also in blue.

(4) formulations which differ in potassium chloride concentration. A list of available calcium containing solutions is provided in Table 1.

Part Number	Description
F00011288	pureFLOW 402 (0 mEq/L K+)
F00011367	pureFLOW 400 (2 mEq/L K+)
F00011291	pureFLOW 406 (3 mEq/L K+)
F00011292	pureFLOW 401 (4 mEq/L K+)

pureFLOW Products (400 series, calcium-containing) Table 1:

The calcium-free pureFLOW dialysis solutions are available in two (2) formulations which differ in potassium chloride concentration. A list of available calcium-free solutions is provided in Table 2.

Table 2:	pureFLOW Products (500 series, calcium-free)
Part Number	Description
F00010458	pureFLOW 502 (2 mEq/L K+)
F00010459	pureFLOW 504 (4 mEq/L K+)

5.4.2. Device Characteristics

pureFLOW solutions are single-use, steam sterilized dialysis solutions for use in Continuous Renal Replacement Therapy (CRRT).

5.4.3. Environment of Use

The pureFLOW solutions are used in acute care environments where CRRT is performed.

Brief Written Description of the Device 5.4.4.

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 calcium-containing pureFLOW 400 series solutions are used for treatment modalities using heparin anticoagulation while the calcium-free pureFLOW 500 series solutions are used for treatment modalities using regional citrate anticoagulation.

5.4.5. 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 (16 June 2016).

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Image /page/7/Picture/0 description: The image shows the Fresenius Medical Care logo. On the left side of the logo, there is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the words "FRESENIUS MEDICAL CARE" are written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

The pureFLOW 400 and 500 series solution container closure systems are constructed from identical materials, with the exception of colorants used in the HF-Connectors. Each bag is equipped with an HF-connector, a luer-lock connector, and an injection port. The HF-connectors of the pureFLOW 400 and 500 series container closure systems contain blue and yellow colorants, respectively. The pureFLOW bags are composed of the materials listed in Table 3.

Component	Material
Solution Bag	Multi-layer Gas Barrier Film
Connective Tubing	Polyolefin/Elastomer
Injection Port	Polypropylene
	Synthetic Rubber
Luer -Lock Connector with Cap	Polycarbonate
	Thermoplastic Elastomer
HF Connector with Cap	Polycarbonate
	Silicone
Overwrap	Polyolefin/Elastomer

Table 3: pureFLOW Bag Materials

5.4.6. Key Performance Specifications/Characteristics

The key performance specifications of pureFLOW solutions are outlined in Table 4.

Table 4:	Key Performance Specifications
----------	--------------------------------

Chemical Component	Ionic Contribution (mEq/L, mixed)
	pureFLOW 400 series	pureFLOW 500 series
Sodium (Na+)	140	133
Potassium (K+)	0, 2, 3, or 4	2 or 4
Magnesium (Mg2+)	1.0	1.5
Calcium (Ca2+)	3.0	0
Chloride (Cl-)	109, 111, 112, or 113	116.5 or 118.5
Bicarbonate (HCO3-)	35	20
Glucose	5.55	5.55

ર.ડ. 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.

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Image /page/8/Picture/0 description: The image shows the Fresenius Medical Care logo. 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.

5.6. Indications for Use

pureFLOW solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

Comparison of Technological Characteristics with the Predicate Device 5.7.

The following technological characteristics of the pureFLOW solutions are substantially equivalent to those of the predicate PrismaSATE dialysate (K162887):

Intended Use ●
Design ●
Principle of Operation ●
Performance Specifications o

5.8. Performance Data

Testing conducted to support the determination of substantial equivalence is summarized in Table 5.

Table 5: Performance Testing Summary

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K233159 Page 5 of 6

Image /page/9/Picture/1 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 MEDICAL CARE" is displayed in a bold, sans-serif font. The text and chevrons are all in the same shade of blue.

pureFLOW dialysis solutions Traditional 510(k)

Test Conducted	Test Method Description
5 L Bag Hanging	Evaluate the stability of the eyelets (all 3 or a single one) over a period of24 hrs when hanging on hooks
Shipping and Distribution	Demonstrate the integrity and robustness of the bag system packagingwithin the distribution environment
Primary Bag Welding	Evaluate the pull tension of foils, fixed seams of primary packaging, peel-stitched primary packaging, and peel-stitched secondary packaging
Tube Welding	Evaluate the pull force of tube welding/seals
HF-Connector and LuerConnector	Evaluate torque for removing the protective cap from the female connector and the torque of male and female connector Evaluate breaking strength of the cone of the HF-connector Evaluate the leakage and tightness of the connectors Evaluate the pull-out force of the connectors and injection ports
Injection Port	Determine the penetration force of the septum and injection port
Eyelet	Determine the pull force strength of the bag eyelet
Gas Barrier Measurement	Evaluate the integrity of the bag as a CO2 barrier
Sterility	Demonstrate that the solution is sterile
Luer-Lock Connector	Evaluate the tightness after stress crack resistance testing
Temperature and PressureResistance of Solution Bag	Determine the resistance of the bag towards temperature and pressure

Biocompatibility Testing 5.8.1.

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" (04 September 2020). 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/10/Picture/0 description: The image shows the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that looks like 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.

5.8.2. Human Factors Validation Testing

The pureFLOW solutions were found to be safe and effective for their intended users, uses, and use environments.

5.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)

Not applicable. The pureFLOW solutions are not electrical mechanical devices.

5.8.4. Software Verification and Validation Testing

Not applicable. The pureFLOW solutions do not contain software.

5.8.5. Animal Studies

No animal studies were performed.

5.8.6. Clinical Studies

No clinical studies were performed.

5.9. 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.

Regulation Number and Section

§ 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.