The Dimesol Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician / clinician in charge.

Device Description

The Dimesol blood tubing sets for hemodialysis are single use arterial and venous blood line (tubing) sets for use with polyethersulfone hollow-fiber hemodialyzers or other dialyzers that are indicated for hemodialysis treatment of acute and chronic renal failure. These tubing sets are intended for use as the extracorporeal blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer. These tubing sets are intended for single use only. The major device components of these tubing sets are manufactured from medical-grade polyvinyl chloride (PVC), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), and fire-retardant polyethylene (PE).

AI/ML Overview

The document provided is a 510(k) summary for the Dimesol Tubing Sets for Hemodialysis. It establishes substantial equivalence to predicate devices rather than proving the device meets explicit acceptance criteria through a standalone study. Therefore, some information typically found in a study demonstrating such criteria (like sample sizes for test/training sets, expert qualifications, or adjudication methods) is not applicable or not provided in the context of this 510(k) submission.

Here is a summary based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of explicit quantitative acceptance criteria with reported numerical performance values in a distinct table, the document refers to compliance with established international standards for various performance characteristics and biocompatibility. The "acceptance criteria" are implied by adherence to these standards and by demonstrating equivalence to predicate devices.

Aspect	Acceptance Criteria (Implied by Standards & Predicate)	Reported Device Performance
Biocompatibility	Conforms to ISO 10993 Series (e.g., Cytotoxicity, Sensitization, Hemolysis)	"Compatible with ISO 10993 series standards"
		Biocompatible for listed tests (see TABLE 5)
Performance - General	Conforms to ISO 8638:2010 (General requirements for hemodialysis blood line systems)	"Conforms to ISO 8638: 2010"
Performance - Structural	Conforms to ISO 594-2:1998 (Luer conical fittings with 6% (Luer) taper for syringes, needles, and certain other medical equipment)	"Conforms to ISO 594-2: 1998"
Specific Performance Tests	(e.g., Structural Integrity, Connectors, Tubing Compliance, Priming Volume, Tensile Strength, Simulated Operation, Endurance Testing)	Tests performed, found to be "within the accepted test parameters" of ISO 8638 and ISO 594-2 (see TABLE 6)
Material Equivalence	Equivalent materials to predicate devices (PVC, PP, PC, ABS, PE)	Uses PVC, PP, PC, ABS, PE (see TABLE 3)
Sterilization Method	Electron beam (SAL 10-6)	Electron beam (SAL 10-6)
Non-pyrogenic	Non-pyrogenic	Non-pyrogenic

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the tests conducted to demonstrate compliance with ISO standards. It states that tests were performed but does not detail the number of units tested.

The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. The manufacturing entity is Bain Medical Equipment (Guangzhou) Co., Ltd. in Guangzhou, China. The testing was conducted to international standards (ISO), which are globally recognized.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to a 510(k) submission for a hemodialysis tubing set, as it is a medical device and not an AI/software device that typically requires expert consensus for ground truth establishment. The "ground truth" for demonstrating the safety and effectiveness of this device comes from compliance with recognized performance and biocompatibility standards.

4. Adjudication Method for the Test Set

Not applicable for this type of medical device submission. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment, often seen in diagnostic imaging or AI performance evaluations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Dimesol Tubing Sets for Hemodialysis are physical medical devices, not an AI or software product. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted or would be relevant for this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a physical medical device and not an algorithm or AI product.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established by compliance with recognized international standards (ISO 10993 for biocompatibility, ISO 8638 and ISO 594-2 for performance) and by demonstrating substantial equivalence to legally marketed predicate devices that have already met these standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this physical medical device.

Summary

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 30, 2018

Dimesol, Inc. % Courtney J. Miller Partner Frost Brown Todd LLC 10 West Broad Street, Suite 2300 Columbus. OH 43215

Re: K171952

Trade/Device Name: Dimesol Tubing Sets for Hemodialysis Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: FJK, FKB Dated: February 12, 2018 Received: February 13, 2018

Dear Courtney J. Miller:

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.

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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Benjamin R. Fisher -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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INDICATIONS FOR USE STATEMENT

510(k) Number: K171952

FORM: FDA 3881

Device Name: Dimesol Tubing Sets for Hemodialysis

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K171952-REVISED 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:	Frost Brown Todd LLC
(2) Address:	10 West Broad St., Suite 2300, Columbus, OH 43215 USA
(3) Phone:	614-559-7288
(4) Fax:	614-464-1737
(5) Contact Person:	(Mr.) Courtney J. Miller, J.D., LL.M.
(6) Preparation Date:	June 27, 2017

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

(1) Applicant Name:	DIMESOL, INC.
(2) Applicant Address:	509 Fishing Creek Rd., Lewisberry, PA 17339 USA
(3) Applicant Phone:	717-938-8391
(4) Applicant Fax:	717-938-3957

Manufactured for Dimesol, Inc. by:

(1) Manufacturer Name:	Bain Medical Equipment (Guangzhou) Co., Ltd.
(2) Manufacturer Address:	10 Juncheng Road, Eastern Area, Guangzhou Economic &Technological Development District, Guangzhou, China510760
(3) Manufacturer Phone:	0086-20-82265249
(4) Manufacturer Fax:	0086-20-32067500

B. Device Name

(1) Trade Name:	Dimesol Tubing Sets for Hemodialysis
	(2) Common Name: Blood Tubing (or Blood Line or Tubing) Sets for Hemodialysis
(3) Classification:	Class II, per 21 CFR 876.5820 (Hemodialysis system and
	accessories)
(4) Product Code:	FJK / FKB: Gastroenterology/Urology
(5) Standard(s):	MDD 93/42/EEC; ISO 8638; ISO9001; ISO13485

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K171952-REVISED 510(K) SUMMARY UNDER 21 CFR 807.92

C. Legally Marketed Predicate Device(s)

Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024) - JMS Blood Tubing Sets (K032975)

D. Device Description

[0001] The Dimesol blood tubing sets for hemodialysis are single use arterial and venous blood line (tubing) sets for use with polyethersulfone hollow-fiber hemodialyzers or other dialyzers that are indicated for hemodialysis treatment of acute and chronic renal failure. TABLE 1. below, provides the basic product codes used for the Dimesol (blood tubing sets for hemodialysis. There are five (5) basic product codes that represent the various configurations (i.e., models) in which the device may be manufactured. TABLE 1 also provides the dimensions (in millimeters) for the pump segment and further identifies the hemodialysis system with which the devices are compatible. TABLE 2, below, provides the basic device components and their respective functions for both the arterial and venous lines.

TABLE 1. Product Codes and Specifications

Product Code	Pump Seqment(IDxODxLength in mm)	System/DeviceCompatibilities
EDIM-BL-001E	8.00x12.00x350	Fresenius 2008K
EDIM-BL-002E	8.00x12.00x350	Fresenius 2008K
EDIM-BL-003E	8.00x12.00x350	Fresenius 2008K
EDIM-BL-004E	8.00x12.00x350	Fresenius 2008K
EDIM-BL-005E	8.00x12.00x350	Fresenius 2008K

TABLE 2. Basic Device Components and Functions (Dimesol: Arterial and Venous Lines)

	Component	Function
1	Vented DialyzerConnector Caps	Prevents contamination of blood path through Dialyzer Connector (Arterial/Venous Lines).
2	Dialyzer Connectors	Connects the arterial and venous lines to the appropriate dialyzer blood port (Blue for venous line and Red for arterial line).
3	Blood (Drip) Chamber(with or w/o filter)	Provides an air space for monitoring pressures and trapping air bubbles. Venous blood chamber includes conical mesh filter to block clots and to trap foam, or air bubbles before entering patient
4	Blood (Drip) Chamber Cover	Permits monitoring line and level adjustment line to be sited
5	Large On/Off Clamps	Typically located along the main blood lines for permitting occlusion of blood tubing set
6	Small On/Off Clamps	Typically located at all heparin lines, monitoring lines, and level

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K171952-REVISED 510(K) SUMMARY UNDER 21 CFR 807.92

7	Luer Lock Connectors	adjusting lines for occlusion, if necessary.
8	Vented Caps for Luer Lock Connectors	Female luer lock connectors provide a connection site based on an internationally recognized standard within the entire blood tubing set.
9	Recirculation Luer Lock Connectors	Vented caps cover the luer lock connectors to prevent contamination.
10	Transducer Protectors (TP)	Recirculation connectors allow the connection of hemodialysis blood tubing for recirculation within the extracorporeal blood circuit.
11	Blood Injection Ports	Prevent blood contamination risk at pressure monitoring line to dialysis machine through the hydrophobic membrane
12	Patient Connectors (Self-Injection)	Provide access sites for blood sampling and/or medications administration (Red and Blue).
13	Heparin Infusion Line	International connection to vascular access devices (e.g., AV Fistula needle set) in the extracorporeal blood circuit.
14	Pump Segment and T-Connectors	Provides adequate anticoagulant for blood before entering dialyzer via a syringe pump. Normally includes a female luer lock connector, a small clamp, and small diameter tubing.
15	Tubing Segments	Delivery of blood at pre-determined pump rate.
16	Drainage Bag	Transports blood and fluid during hemodialysis; available in various sizes and lengths.
17	Negative Pressure Pillow	Collects priming saline waste.
18	IV	Collapses when predetermined negative pressures are detected.
19	Suspended Spike (Cap)	Infusion
		Priming (plugged into saline bag)

Dimesol tubing sets for hemodialysis are intended for use as the extracorporeal [0002] blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer. These tubing sets are intended for single use only. The major device components of these tubing sets are manufactured from medical-grade polyvinyl chloride (PVC), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), and fire-retardant polyethylene (PE).

E. Indications for Use

[0003] The Dimesol Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician / clinician in charge.

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K171952-REVISED 510(K) SUMMARY UNDER 21 CFR 807.92

F. Substantial Equivalence

[0004] The Dimesol (DORA) blood tubing sets (or simply "tubing sets") for hemodialysis are considered by the Submitter to be substantially equivalent in construction, design, materials, performance, and intended use to the JMS Blood Tubing Sets (K032975) and/or the Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024). All of these tubing sets are intended for use as a portion of the extracorporeal blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer. The comparison to the JMS Blood Tubing Sets (K032975) is based primarily on structure, components, materials, and other features common to both the Dimesol blood tubing sets and JMS Blood Tubing Sets (K032975). However, the comparison to the Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024) is based on structure, components, and materials, as well as performance and biocompatibility.

[0005] As detailed in TABLE 3, below, the Dimesol (DORA) blood tubing sets for hemodialysis and the predicate JMS Blood Tubing Sets (K032975) and/or the Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024) have equivalent structural and materials characteristics. As detailed in TABLE 4, below, the Dimesol (DORA) blood tubing sets for hemodialysis and the predicate JMS Blood Tubing Sets (K032975) and/or the Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024) have equivalent general characteristics. As illustrated in TABLE 5, below, the Dimesol (DORA) blood tubing sets for hemodialysis were tested for various biocompatibility factors and found to be within the accepted test parameters of ISO 10993. The Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024) was also determined to meet the requirements of ISO 10993; thus, the two devices are substantially equivalent with regard to biocompatibility. As illustrated in TABLE 6, below, the Dimesol (DORA) blood tubing sets for hemodialysis were tested for various performance characteristics and found to be within the accepted test parameters of ISO 8638 and ISO 594-2. The Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024) was also determined to meet the requirements of ISO 8638 and ISO 594-2; thus, the two devices are substantially equivalent with regard to performance characteristics.

	Component	Material	BloodContacting	Supplier	JMSBlood Tubing Sets(K032975)	NiproBloodTubing Sets(K072024)
1	Vented DialyzerConnector Caps	PP	No	Bain Medical	component orequivalent present	component orequivalent present
2	DialyzerConnectors	PVC	Yes	Bain Medical	component orequivalent present	component orequivalent present

TABLE 3. Substantial Equivalence Comparison Table: Components and Materials (A/V)

510(k) Premarket Notification for Dimesol, Inc. Blood Tubing Sets for Hemodialysis

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K171952-REVISED 510(K) SUMMARY UNDER 21 CFR 807.92

3	Blood (Drip)Chamber(with or w/o filter)	PVC	Yes	Bain Medical	component or equivalent present	component or equivalent present
4	Blood (Drip) Chamber Cover	PVC	Yes	Bain Medical	component or equivalent present	component or equivalent present
5	Large On/Off Clamps	PP	No	Bain Medical	component or equivalent present	component or equivalent present
6	Small On/Off Clamps	PP	No	Bain Medical	component or equivalent present	component or equivalent present
7	Luer Lock Connectors	PC	Yes	Bain Medical	component or equivalent present	component or equivalent present
8	Vented Caps for Luer Lock Connectors	PE	No	Bain Medical	component or equivalent present	component or equivalent present
9	Recirculation Luer Lock Connectors	PP	Yes	Bain Medical	component or equivalent present	component or equivalent present
10	Transducer Protectors (TP)	SBC	Yes	Bain Medical	component or equivalent present	component or equivalent present
11	Blood Injection Ports	PVC	Yes	Bain Medical	component or equivalent present	component or equivalent present
12	Patient Connectors (Self-Injection)	PC	Yes	Bain Medical	component or equivalent present	component or equivalent present
13	Heparin Infusion Line	PP	No	Bain Medical	component or equivalent present	component or equivalent present
14	Pump Segment and T-Connectors	PVC	Yes	Bain Medical	component or equivalent present	component or equivalent present
15	Tubing Segments	PVC	Yes	Bain Medical	component or equivalent present	component or equivalent present

TABLE 4. Substantial Equivalence Comparison Table: General Factors (A/V)

	Factor	Dimesol (DORA) AVF Needle Set	JMS Blood Tubing Sets (K032975)	Nipro Blood Tubing Sets (K072024)
1	Device Class	II	SE	SE
2	Product Code	FJK	SE	SE
3	Regulation No.	21 CFR 876.5820	SE	SE
4	intended use	hemodialysis	SE	SE
5	indications for use	acute and chronicrenal failure	SE	SE
6	instructions for use	- remove cap- insert needle intopatient's vein- connect with bloodtubing set	SE	SE
7	configuration of device	See Device Description	SE	SE
8	implantable device	non-implantable	SE	SE

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K171952-REVISED 510(K) SUMMARY UNDER 21 CFR 807.92

9	target population	dialysis patients	SE	SE
10	anatomical sites	arterial / venous access	SE	SE
11	location of use	hospital use	SE	SE
12	energy used and/or	electric peristalticblood pump	SE	SE
13	human factors	used by medicalprofessionals	SE	SE
14	design factors	hemodialysis circuitarterial and venous lines	SE	SE
15	performance	single use	SE	SE
16	materials	PVC, PP, PC, ABS, PE	PVC, PE, PP, ABS,PC	SE
17	biocompatibility	Compatible with ISO10993 series standards	Biocompatible10993 compatible	biocompatible
18	environmentalcompatibility	disposable	SE	SE
19	sterilization method	electron beam(SAL 10-6)	SE(SAL 10-6)	SE(SAL 10-6)
20	Non-pyrogenic	Non-pyrogenic	SE	SE

TABLE 5. Biocompatibility Comparison with K072024

Dimesol Blood Tubing Sets (K171952)	Predicate Device(K072024)
Cytoxicity	Biocompatible
Sensitization	Conforms to ISO10993-1
Intracutaneous Reactivation
Acute systemic Toxicity
Hemolysis
Partial Thromboplastin Time
Complement System
In vitro Chromosomal Aberration
Bacterial Reverse Mutation
Mouse Bone Marrow Micronucleus
Pyrogen
Mechanical Hemolysis

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K171952-REVISED 510(K) SUMMARY UNDER 21 CFR 807.92

TABLE 6. Performance Comparison with K072024

Dimesol Blood Tubing Sets (K171952)		Predicate Device(K072024)
Specific Tests Performed	Conforms to ISO8638: 2010	Conforms to ISO8638: 2010
Structural Integrity	Conforms to ISO594-2: 1998	Conforms to ISO594-2: 1998
Connectors to Hemodialyzer
Needle Access Ports
Transducer Protectors
Tubing Compliance
Priming Volume
Pump Segment Performance
Conical Fitting
Tensile Strength
Simulated Operation
Repeated Closing
Endurance Testing

G. Conclusion

[0006] The Dimesol blood tubing sets for hemodialysis are believed to be substantially equivalent in construction, design, materials, performance, and intended use to the JMS Blood Tubing Sets (K032975) and/or the Nipro Blood Tubing Set with Transducer Protector and Priming Set (K072024). All of these tubing sets are intended for use as a portion of the extracorporeal blood circuit during hemodialysis and to connect a dialysis patient to a hemodialyzer. In addition, testing of the Dimesol Blood Tubing Sets for Hemodialysis indicates that they are safe and effective for their intended use. The device labeling contains or includes a Package Insert, which includes indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the device. This information promotes safe and effective use of the blood tubing set. Dimesol, Inc. believes that the information provided in this submission clearly describes the Dimesol Blood Tubing Sets for Hemodialysis and demonstrates that they are believed to be substantially equivalent to the aforementioned predicate device(s).

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.