Dimesol Tubing Sets for Hemodialysis

K171952 · Dimesol, Inc. · FJK · Mar 30, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K171952
• Device Name: Dimesol Tubing Sets for Hemodialysis
• Applicant: Dimesol, Inc.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Mar 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Dimesol Tubing Sets are single-use extracorporeal blood circuits connecting patients to hemodialyzers and delivery systems. Components include arterial/venous lines, pump segments, drip chambers with filters, clamps, luer lock connectors, and injection ports. Operated by medical professionals in hospital settings; tubing interfaces with electric peristaltic blood pumps. Device facilitates blood transport, anticoagulant infusion, pressure monitoring, and air bubble trapping. Benefits include maintaining sterile extracorporeal circuit integrity during hemodialysis.

Clinical Evidence

Bench testing only. Device performance validated against ISO 8638 (hemodialysis equipment) and ISO 594-2 (conical fittings). Biocompatibility testing performed per ISO 10993 series, including cytotoxicity, sensitization, systemic toxicity, and hemolysis. No clinical data presented.

Technological Characteristics

Materials: PVC, PP, PC, ABS, PE. Components: arterial/venous lines, pump segments, drip chambers, clamps, luer locks. Sterilization: electron beam (SAL 10^-6). Standards: ISO 8638, ISO 594-2, ISO 10993, ISO 9001, ISO 13485. Non-implantable, single-use disposable.

Indications for Use

Indicated for patients with acute and chronic renal failure requiring hemodialysis treatment.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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:

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.

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 &<br>Technological Development District, Guangzhou, China<br>510760 |
| (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<br>(IDxODxLength in mm) | System/Device<br>Compatibilities |
|--------------|--------------------------------------|----------------------------------|
| 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 Dialyzer<br>Connector 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<br>(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 | Blood<br>Contacting | Supplier | JMS<br>Blood Tubing Sets<br>(K032975) | Nipro<br>BloodTubing Sets<br>(K072024) |
|---|-----------------------------------|----------|---------------------|--------------|---------------------------------------|----------------------------------------|
| 1 | Vented Dialyzer<br>Connector Caps | PP | No | Bain Medical | component or<br>equivalent present | component or<br>equivalent present |
| 2 | Dialyzer<br>Connectors | PVC | Yes | Bain Medical | component or<br>equivalent present | component or<br>equivalent 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)<br>Chamber<br>(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 chronic<br>renal failure | SE | SE |
| 6 | instructions for use | - remove cap<br>- insert needle into<br>patient's vein<br>- connect with blood<br>tubing 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 peristaltic<br>blood pump | SE | SE |
| 13 | human factors | used by medical<br>professionals | SE | SE |
| 14 | design factors | hemodialysis circuit<br>arterial and venous lines | SE | SE |
| 15 | performance | single use | SE | SE |
| 16 | materials | PVC, PP, PC, ABS, PE | PVC, PE, PP, ABS,<br>PC | SE |
| 17 | biocompatibility | Compatible with ISO<br>10993 series standards | Biocompatible<br>10993 compatible | biocompatible |
| 18 | environmental<br>compatibility | disposable | SE | SE |
| 19 | sterilization method | electron beam<br>(SAL 10-6) | SE<br>(SAL 10-6) | SE<br>(SAL 10-6) |
| 20 | Non-pyrogenic | Non-pyrogenic | SE | SE |

## TABLE 5. Biocompatibility Comparison with K072024

| Dimesol Blood Tubing Sets (K171952) | Predicate Device<br>(K072024) |
|-------------------------------------|-------------------------------|
| Cytoxicity | Biocompatible |
| Sensitization | Conforms to ISO<br>10993-1 |
| 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<br>(K072024) |
|-------------------------------------|--------------------------------|--------------------------------|
| Specific Tests Performed | Conforms to ISO<br>8638: 2010 | Conforms to ISO<br>8638: 2010 |
| Structural Integrity | Conforms to ISO<br>594-2: 1998 | Conforms to ISO<br>594-2: 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).