This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate on equivalent in a 36.83x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.

-or-

For DB-206; DB-207; DB-208:

This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 45x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.

-or-

For DB-209; DB-210; DB-211:

This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 35x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.

Device Description

The MedicaLyte® Bicarbonate Powder devices for bicarbonate dialysis are comprised of USP grade sodium bicarbonate for 35X (DB-209, DB-210 and DB-211) and 45X (DB-206, DB-207 and DB-208) proportioning dialysis machines and USP grade sodium bicarbonate and USP grade sodium chloride for 36.83X proportioning dialysis machines (DB-203, DB-204 and DB-These products may be used in conventional, commercially available hemodialysis 205). machines or monitors as one of the necessary components of three-component hemodialysis solution. The hemodialysis concentrate solutions presented in this 510(k) premarket notification are intended to be used in three-stream hemodialysis machines in which an acid concentrate is proportioned into one stream, a bicarbonate solution is prepared from the bicarbonate powder is proportioned into a second stream, and water is proportioned into the third stream of the hemodialysis machine proportioning system. These three streams are then mixed by the hemodialysis machine to prepare the final proportioned hemodialysis solution. The final hemodialysis solution is separated from the patient's blood by semi-permeable membranes which permit the passage of waste products and toxins contained in the patient's blood circulating through the hemodializer, and such waste products and toxins pass through the semi-permeable membranes into the hemodialysis solution and exit the hemodializer with the hemodialysis solution. By such treatment, waste products and toxins are removed from the patient's blood during acute and end-stage renal failure.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, MedicaLyte® Bicarbonate Powder. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the context of diagnostic performance.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for this specific product.

The acceptance criteria for a 510(k) submission like this are generally met by demonstrating that the new device has the same intended use and similar technological characteristics as legally marketed predicate devices, without raising new questions of safety or effectiveness.

Here's an analysis based on the provided document:

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

For a 510(k) submission based on substantial equivalence for a chemical concentrate, the "acceptance criteria" are typically defined by demonstrating that the new device's chemical composition and yield, when prepared according to label directions, are equivalent to those of established predicate devices. The "reported device performance" is the chemical output of the new device when prepared as directed.

Acceptance Criterion (Implicit)	Reported Device Performance (MedicaLyte® Bicarbonate Powder)
Similar Volume Yields (as predicate devices)	Matches predicate devices: 2.5 Gallons, 15 Gallons, 25 Gallons (for 36.83X & 35X); 2.1 Gallons, 15 Gallons, 25 Gallons (for 45X)
Similar Sodium Bicarbonate Yields (as predicate devices)	Matches predicate devices: 39 mEq/L (for 36.83X); 37 mEq/L (for 45X); 35 mEq/L (for 35X)
Similar Sodium Chloride Yields (as predicate devices - only applicable for 36.83X)	Matches predicate devices: 20 mEq/L (for 36.83X)
Same Chemical Composition	Comprised of USP grade sodium bicarbonate (for 35X and 45X) and USP grade sodium bicarbonate and USP grade sodium chloride (for 36.83X), same as predicates.
Same Intended Use	Used with specific proportioning dialysis machines for treating patients in need of hemodialysis, same as predicates.

Note: The tables in the original document (Table 1, 2, and 3) explicitly state that "The Volume, Component and Yield columns apply equally to the Device and Predicate Device." This is a direct statement of equivalence, which serves as the "acceptance criteria" being met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. For chemical concentrates, testing typically involves laboratory analysis of the chemical properties of the prepared solutions, not a "test set" of patient data or clinical images. The data provenance would likely be from the manufacturer's internal quality control and analytical chemistry labs, but these specifics are not stated.

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. "Ground truth" in the context of chemical composition is established through analytical chemistry methods and adherence to pharmacopeial standards (USP grade), not through expert consensus in the same way it would be for a diagnostic image.

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

This is not applicable for this type of device and submission. Adjudication methods are relevant for clinical assessments, especially in cases of subjective interpretation or when establishing a clinical diagnosis.

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

This is not applicable. MRMC studies and AI assistance are relevant for diagnostic devices that involve human interpretation of medical images or data. This device is a chemical concentrate.

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

This is not applicable. This device is a chemical concentrate, not an algorithm or an AI-based system.

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

The "ground truth" for this device is based on analytical chemistry verification against established specifications for pharmaceutical-grade ingredients (USP grade sodium bicarbonate and sodium chloride) and the expected mEq/L yield when reconstituted according to label directions. This is implicitly compared to the known specifications and performance of the predicate devices.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an AI/ML algorithm or a complex diagnostic device for this chemical concentrate.

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

This is not applicable for the same reasons as point 8.

Summary

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K131202 Page 1 of 6

APR 0 3 2014

Dialysis Medical Solutions, LLC

Dialysis Concentrate for Hemodialysis (Powder) "Traditional" 510(k) Premarket Notification

510(K) SUMMARY UNDER 21 CFR 807.92

This 510(k) summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content in this 510(k) summary has been provided in conformance with 21 CFR Part 807.92.

Submitter's Information A.

(1) Name:	McNees, Wallace & Nurick LLC
(2) Address:	21 East State St., Suite 1700, Columbus, OH 43215 USA
(3) Phone:	614-719-2858
(4) Fax:	614-469-4653
(5) Contact Person:	(Mr.) Courtney J. Miller, J.D., LL.M.
(6) Preparation Date:	April 18, 2013
(7) Revision Date:	September 24, 2013

On Behalf of Applicant Entity (owner of 510(k))

(1) Applicant Name:	Dialysis Medical Solutions, LLC
(2) Applicant Address:	509 Fishing Creek Rd., Lewisberry, PA 17339 USA
(3) Applicant Phone:	717-938-8391
(4) Applicant Fax:	717-938-3957
(5) Establishment Reg. No:	1528807

B. Device Name

(1) Trade Name:	MedicaLyte® Bicarbonate Powder
(2) Common Name:	Dialysis Concentrate for Hemodialysis (Powder) (Sodium Bicarbonate or Sodium Bicarbonate Chloride)
(3) Classification:	Class II, per 21 CFR 876.5820 (Dialysate Concentrate for Hemodialysis (liquid or powder))
(4) Product Code:	KPO: Gastroenterology/Urology

510(k) Premarket Notification for Dialysis Medical Solutions, LLC MedicaLyte" Bicarbonate Powder

Tab 5: Page 1

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Dialysis Medical Solutions, LLC Dialysis Concentrate for Hemodialysis (Powder) "Traditional" 510(k) Premarket Notification

510(K) SUMMARY UNDER 21 CFR 807.92

C. Legally Marketed Predicate Device

Rockwell Medical Supply RenalPure® Powder Bicarbonate for Hemodialysis (K954527)

Medivator Inc. Renasol® and Centrisol® Bicarbonate Concentrate Powder (K843963)

Di-Chem, Inc. Hemo-Lyte Dry Sodium Bicarbonate-Chloride Concentrate and Dry Sodium Bicarbonate Concentrate (K012328)

D. Device Description

The MedicaLyte® Bicarbonate Powder devices for bicarbonate dialysis are comprised of USP grade sodium bicarbonate for 35X (DB-209, DB-210 and DB-211) and 45X (DB-206, DB-207 and DB-208) proportioning dialysis machines and USP grade sodium bicarbonate and USP grade sodium chloride for 36.83X proportioning dialysis machines (DB-203, DB-204 and DB-These products may be used in conventional, commercially available hemodialysis 205). machines or monitors as one of the necessary components of three-component hemodialysis solution. The hemodialysis concentrate solutions presented in this 510(k) premarket notification are intended to be used in three-stream hemodialysis machines in which an acid concentrate is proportioned into one stream, a bicarbonate solution is prepared from the bicarbonate powder is proportioned into a second stream, and water is proportioned into the third stream of the hemodialysis machine proportioning system. These three streams are then mixed by the hemodialysis machine to prepare the final proportioned hemodialysis solution. The final hemodialysis solution is separated from the patient's blood by semi-permeable membranes which permit the passage of waste products and toxins contained in the patient's blood circulating through the hemodializer, and such waste products and toxins pass through the semipermeable membranes into the hemodialysis solution and exit the hemodializer with the hemodialysis solution. By such treatment, waste products and toxins are removed from the patient's blood during acute and end-stage renal failure.

510(k) Premarket Notification for Dialysis Medical Solutions, LLC MedicaLyte" Bicarbonate Powder

{2}------------------------------------------------

· Dialysis Medical Solutions, LLC Dialysis Concentrate for Hemodialysis (Powder) "Traditional" 510(k) Premarket Notification

510(K) SUMMARY UNDER 21 CFR 807.92

E. Intended Use

For DB-203; DB-204; DB-205;

This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 36.83x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.

-or-

For DB-206; DB-207; DB-208;

-or-

For DB-209; DB-210; DB-211:

These indication statements are essentially equivalent to the indication statement for the predicate devices.

Technological Characteristics: F.

Comparing the proposed MedicaLyte® Bicarbonate Powder devices to the RenalPure® Powder Bicarbonate predicate devices, the devices utilize the chemical compositions and produce the same bicarbonate solutions for hemodialysis (as described in Table 1). There are no significant differences, and therefore a finding of substantial equivalence is appropriate.

Tab 5: Page 3

510(k) Premarket Notification for Dialysis Medical Solutions, LLC MedicaLyte" Bicarbonate Powder

{3}------------------------------------------------

Dialysis Medical Solutions, LLC

Dialysis Concentrate for Hemodialysis (Powder) "Traditional" 510(k) Premarket Notification

510(K) SUMMARY UNDER 21 CFR 807.92

TABLE 1. Performance Comparison Table (Bicarbonate Stream Dialysate Generated from Concentrate According to Label Directions)*

Device	Volume	Component	Yield	Predicate Device
DB-203:MedicaLyte® BicarbonatePowder (36.83X)	2.5 Gallons	Sodium	59 mEq/L	RB Series RenalPure®Powder Bicarbonate2.5 Gallon Packet
		Bicarbonate	39 mEq/L
		Chloride	20 mEq/L
DB-204:MedicaLyte® BicarbonatePowder (36.83X)	15 Gallons	Sodium	59 mEq/L	RB Series RenalPure®Powder Bicarbonate15 Gallon Packet
		Bicarbonate	39 mEq/L
		Chloride	20 mEq/L
DB-205:MedicaLyte® BicarbonatePowder (36.83X)	25 Gallons	Sodium	59 mEq/L	RB Series RenalPure®Powder Bicarbonate25 Gallon Packet
		Bicarbonate	39 mEq/L
		Chloride	20 mEq/L
DB-206:MedicaLyte® BicarbonatePowder (45X)	2.1 Gallons	Sodium	37 mEq/L	CB Series RenalPure®Powder Bicarbonate2.1 Gallon Packet
		Bicarbonate	37 mEq/L
DB-207:MedicaLyte® BicarbonatePowder (45X)	15 Gallons	Sodium	37 mEq/L	CB Series RenalPure®Powder Bicarbonate15 Gallon Packet
		Bicarbonate	37 mEq/L
DB-208:MedicaLyte® BicarbonatePowder (45X)	25 Gallons	Sodium	37 mEq/L	CB Series RenalPure®Powder Bicarbonate25 Gallon Packet
		Bicarbonate	37 mEq/L
DB-209:MedicaLyte® BicarbonatePowder (35X)	2.5 Gallons	Sodium	35 mEq/L	FB Series RenalPure®Powder Bicarbonate2.5 Gallon Packet
		Bicarbonate	35 mEq/L
DB-210:MedicaLyte® BicarbonatePowder (35X)	15 Gallons	Sodium	35 mEq/L	FB Series RenalPure®Powder Bicarbonate15 Gallon Packet
		Bicarbonate	35 mEq/L
DB-211:MedicaLyte® BicarbonatePowder (35X)	25 Gallons	Sodium	35 mEq/L	FB Series RenalPure®Powder Bicarbonate25 Gallon Packet
		Bicarbonate	35 mEq/L

*The Volume, Component and Yield columns apply equally to the Device and Predicate Device.

Comparing the relevant proposed MedicaLyte® Bicarbonate Powder devices to the Renasol® and Centrisol® Bicarbonate Concentrate Powder predicate devices, the devices utilize the chemical compositions and produce the same bicarbonate solutions for hemodialysis (as described in Table 2). There are no significant differences, and therefore a finding of substantial equivalence is appropriate.

510(k) Premarket Notification for Dialysis Medical Solutions, LLC MedicaLyte" Bicarbonate Powder

{4}------------------------------------------------

Dialysis Medical Solutions, LLC

Dialysis Concentrate for Hemodialysis (Powder) "Traditional" 510(k) Premarket Notification

510(K) SUMMARY UNDER 21 CFR 807.92

TABLE 2. Performance Comparison Table (Bicarbonate Stream Dialysate Generated from Concentrate According to Label Directions)*

Device	Volume	Component	Yield	Predicate Device
DB-203:MedicaLyte® BicarbonatePowder (36.83X)	2.5 Gallons	Sodium	59 mEq/L	BC-1 Renasol®BicarbonateConcentrate Powder
		Bicarbonate	39 mEq/L
		Chloride	20 mEq/L
DB-204:MedicaLyte® BicarbonatePowder (36.83X)	15 Gallons	Sodium	59 mEq/L	BC-1-15 Renasol®BicarbonateConcentrate Powder
		Bicarbonate	39 mEq/L
		Chloride	20 mEq/L
DB-205:MedicaLyte® BicarbonatePowder (36.83X)	25 Gallons	Sodium	59 mEq/L	BC-1-25 Renasol®BicarbonateConcentrate Powder
		Bicarbonate	39 mEq/L
		Chloride	20 mEq/L
DB-206:MedicaLyte® BicarbonatePowder (45X)	2.1 Gallons	Sodium	37 mEq/L	MB-330 Centrisol®BicarbonateConcentrate Powder
		Bicarbonate	37 mEq/L
DB-207:MedicaLyte® BicarbonatePowder (45X)	15 Gallons	Sodium	37 mEq/L	MB-330-15 Centrisol®BicarbonateConcentrate Powder
		Bicarbonate	37 mEq/L
DB-208:MedicaLyte® BicarbonatePowder (45X)	25 Gallons	Sodium	37 mEq/L	MB-330-25 Centrisol®BicarbonateConcentrate Powder
		Bicarbonate	37 mEq/L

*The Volume, Component and Yield columns apply equally to the Device and Predicate Device, except that MB-330 lists a total volume of 2.11 Gallons rather than 2.1 Gallons due to listing an additional significant figure in the conversion from metric to English standard units.

Comparing the relevant proposed MedicaLyte® Bicarbonate Powder devices to the Hemo-Lyte Dry Sodium Bicarbonate-Chioride Concentrate and Dry Sodium Bicarbonate Concentrate predicate devices utilize the chemical compositions and produce the same bicarbonate solutions for hemodialysis (as described in Table 3). There are no significant differences, and therefore a finding of substantial equivalence is appropriate.

510(k) Premarket Notification for Dialysis Medical Solutions, LLC MedicaLyte" Bicarbonate Powder

{5}------------------------------------------------

Dialysis Medical Solutions, LLC

Dialysis Concentrate for Hemodialysis (Powder) "Traditional" 510(k) Premarket Notification

510(K) SUMMARY UNDER 21 CFR 807.92

TABLE 3. Performance Comparison Table (Bicarbonate Stream Dialysate Generated from Concentrate According to Label Directions)*

Device	Volume	Component	Yield	Predicate Device
DB-203:MedicaLyte® BicarbonatePowder (36.83X)	2.5 Gallons	Sodium	59 mEq/L	DB-1-2.5 Hemo-LyteDry SodiumBicarbonate-ChlorideConcentrate
		Bicarbonate	39 mEq/L
		Chloride	20 mEq/L
DB-204:MedicaLyte® BicarbonatePowder (36.83X)	15 Gallons	Sodium	59 mEq/L	DB-1-15 Hemo-LyteDry SodiumBicarbonate-ChlorideConcentrate
		Bicarbonate	39 mEq/L
		Chloride	20 mEq/L
DB-205:MedicaLyte® BicarbonatePowder (36.83X)	25 Gallons	Sodium	59 mEq/L	DB-1-25 Hemo-LyteDry SodiumBicarbonate-ChlorideConcentrate
		Bicarbonate	39 mEq/L
		Chloride	20 mEq/L
DB-206:MedicaLyte® BicarbonatePowder (45X)	2.1 Gallons	Sodium	37 mEq/L	DB-2-2.1 Hemo-LyteDry SodiumBicarbonateConcentrate
		Bicarbonate	37 mEq/L
DB-207:MedicaLyte® BicarbonatePowder (45X)	15 Gallons	Sodium	37 mEq/L	DB-2-15 Hemo-LyteDry SodiumBicarbonateConcentrate
		Bicarbonate	37 mEq/L
DB-208:MedicaLyte® BicarbonatePowder (45X)	25 Gallons	Sodium	37 mEq/L	DB-2-25 Hemo-LyteDry SodiumBicarbonateConcentrate
		Bicarbonate	37 mEq/L

*The Volume, Component and Yield columns apply equally to the Device and Predicate Device.

G. Conclusion

The MedicaLyte® Bicarbonate Powder devices are believed to be substantially equivalent in design, materials, and intended use to the commercially available Rockwell Medical Supply RenalPure® Powder Bicarbonate (K954527) predicate devices, the Medivator Inc. Renasol® and Centrisol® Bicarbonate Concentrate Powder (K843963) predicate devices, and the Di-Chem, Inc. Hemo-Lyte Dry Sodium Bicarbonate-Chloride Concentrate and Dry Sodium Bicarbonate Concentrate (K012328) predicate devices, and are therefore expected to be as safe, as effective, and perform as well as the predicate devices.

510(k) Premarket Notification for Dialysis Medical Solutions, LLC MedicaLyte" Bicarbonate Powder

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is aligned horizontally and is the main focus of the image. To the left of the text is a symbol that appears to be part of the department's logo.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 3, 2014

Dialysis Medical Solutions. LLC % David M. Marcus, J.D., Ph.D. Associate / Registered Patent Attorney McNees Wallace & Nurick LLC 21 East State Street, Suite 1700 Columbus, OH 43215

Re: K131202

Trade/Device Name: MedicaLyte® Bicarbonate Powder Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: February 24, 2014 Received: February 25, 2014

Dear David M. Marcus,

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. 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.

{7}------------------------------------------------

Page 2 - David M. Marcus, J.D., Ph.D.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/7/Picture/6 description: The image shows the text "Benjamin Fisher -S". The word "Benjamin" is on the left side of the image, followed by the letters "FDA" in a stylized font. The word "Fisher" is on the right side of the image, followed by the letter "S".

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Dialysis Medical Solutions, LLC Dialysis Concentrate for Hemodialysis (Powder) "Traditional" 510(k) Premarket Notification

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K131202

Device Name: MedicaLyte® Bicarbonate Powder

Indications for Use:

For DB-203; DB-204; DB-205;

-or-

For DB-206; DB-207; DB-208:

-or-

For DB-209; DB-210; DB-211:

AND/OR Over-The-Counter Use __ Prescription Use x (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Benjamin R. Fisherp Benjamin R. Fisher - 38 18.0000

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Premarket Notification for Dialysis Medical Solutions, LLC MedicaLyte® Bicarbonate Powder

Tab 4: Page 1

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.