DORA Tubing Sets for Hemodialysis

K161582 · Bain Medical Equipment (Guangzhou) Co., Ltd. · FJK · Jun 16, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K161582
• Device Name: DORA Tubing Sets for Hemodialysis
• Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Jun 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DORA 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

DORA Tubing Sets for Hemodialysis are single-use, sterile, disposable bloodlines; consist of arterial (red) and venous (blue) lines, recirculate connector, and drainage bag. Used in clinical hemodialysis settings to establish extracorporeal blood circuit between patient and hemodialyzer/delivery system. Operated by clinicians/physicians. Device facilitates blood flow during dialysis treatment; ensures secure connection via luer locks and clamps. Benefits include maintaining sterile, controlled extracorporeal access for patient blood purification.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified with ISO 8638 (extracorporeal blood circuits), ISO 594-2 (luer fittings), and ISO 10993 series (biocompatibility, including cytotoxicity, sensitization, systemic toxicity, hemolysis, and mutagenicity). Seal strength verified per ASTM F88/F88M-09.

Technological Characteristics

Single-use sterile tubing set; arterial/venous lines with luer lock fittings (ISO 594-2). Materials evaluated for biocompatibility per ISO 10993. Sterilization via e-beam (SAL 10^-6). Conforms to ISO 8638 for extracorporeal circuits. Includes clamps, filters, drip chambers, drain bag, and recirculating connector.

Indications for Use

Indicated for patients requiring hemodialysis treatment to connect the patient to a hemodialyzer and hemodialysis delivery system.

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® Set - Blood Tubing Set with Transducer Protector and Priming Set (K072024)

Submission Summary (Full Text)

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

June 16, 2017

Bain Medical Equipment (Guangzhou) Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China

Re: K161582

Trade/Device Name: DORA Tubing Sets for Hemodialysis Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: FJK Dated: May 11, 2017 Received: May 19, 2017

Dear Diana Hong:

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 mav 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 (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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K161582

Device Name

DORA Tubing Sets for Hemodialysis

#### Indications for Use (Describe)

The DORA 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# Tab #5 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: _K161582

- 1. Date of Preparation: 03/14/2017
- 2. Sponsor Identification

## Bain Medical Equipment (Guangzhou) Co., Ltd

No.10 Juncheng Road, Eastern Zone of Guangzhou Economic & Technological Development District, 510760, Guangdong, P.R.China

Establishment Registration Number: Not yet registered or the Number

Contact Person: Mu Fangzhen Position: Management Representative Tel: [phone] ext.340 Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: DORA Tubing Sets for Hemodialysis Common Name: Blood tubing sets Model(s): BAIN-BL-001E, BAIN-BL-002E, BAIN-BL-003E, BAIN-BL-004E, BAIN-BL-005E

### Regulatory Information

Classification Name: Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Classification: 2 Product Code: FJK Regulation Number: 876.5820 Review Panel: Gastroenterology/Urology

#### Intended Use Statement:

The DORA 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 proposed devices, DORA Tubing Sets for Hemodialysis, mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as two accessories which are recirculate connector and drainage bag.

They are available in five (5) models, following very similar design principles, and has some differences in dimensions and configurations.

The proposed devices are provided in sterile condition, it is subject to e-beam sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.

- 5. Identification of Predicate Device(s)
#### K072024

Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set Nipro Medical Coporation

#### 6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 8638 Third Edition 2010-07-01. Cadiovascular Implants And Extracorporeal Blood > 2 / 4

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Circuit For Hemodialyzers, Hemodialfilters, And Hemofilters. 9-89

- > ISO 594-2 Second Edition 1998-09-01, Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 2: Lock Fittings. 6-129
- > ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity;
- ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic A toxicity;
- > ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
- > ISO 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood;
- > ASTM F 756-08, Standard practice for assessment of hemolytic properties of material;
- > ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

- Substantially Equivalent (SE) Comparison 8.

| Item | Proposed Device | Predicate Device, K072024 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | II | II |
| Product Code | FJK | FJK |
| Regulation Number | 21 CFR part 876.5820 | 21 CFR part 876.5820 |
| Intended Use | The DORA Tubing Sets for<br>Hemodialysis are single-use sterile<br>medical devices intended to connect<br>the patient to the hemodialyzer and<br>the hemodialysis delivery system in<br>hemodialysis treatment.<br>The compatibility of available<br>configurations is the responsibility<br>of the physician/clinician in charge. | Nipro® Set - Blood Tubing Set<br>with Transducer Protector and<br>Priming Set are disposable<br>bloodlines intended to provide<br>extracorporeal access to the patient's<br>blood during hemodialysis.<br>The compatibility of available<br>configuration is the responsibility of<br>the physician in charge. |
| Feature | Pre-Pump<br>Post-Pump<br>Color Coded component<br>Sterile<br>Non-pyrogenic<br>Single Use<br>Prescription Device | Pre-Pump<br>Post-Pump<br>Color Coded component<br>Sterile<br>Non-pyrogenic<br>Single Use<br>Prescription Device |
| Configuration | Arteria Line<br>Venous Line | Tubing |

Table 1 Comparison of Technology Characteristics

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| | Drip Chamber | Drip Chamber |
|------------------|---------------------------------|----------------------------|
| | Branch Lines | Infusion Tubing; |
| | | Pressure Monitoring Lines; |
| | Female Luer Lock | Ports |
| | Clamps | Clamps |
| | Filter | Filters |
| | Drain Bag | N.A. |
| | Recirculating Connector | |
| Performance | Conforms to | Conforms to |
| | ISO 8638:2010 | ISO 8638:2010 |
| | ISO 594-2: 1998 | ISO 594-2: 1998 |
| Materials | Various materials | Unknown |
| Biocompatibility | Cytotoxicity; | Conforms to ISO 10993-1 |
| | Sensitization | |
| | Intracutaneous reactivity; | |
| | Acute systemic toxicity; | |
| | Hemolysis | |
| | Partial Thromboplastin Time | |
| | Complement System | |
| | In vitro Chromosomal Aberration | |
| | Bacterial Reverse Mutation | |
| | Mouse Bone Marrow Micronucleus | |
| | Pyrogen | |
| Sterilization | SAL (10-6) | SAL (10-6) |

Discussion: The intended use of the proposed and predicate device is different in text. The proposed device has two (2) additional accessories which are drain bag and the recirculating. These two (2) accessories will not affect the actual hemodialysis; the materials of the propose device have been evaluated for their biocompatibility. Therefore, no difference will result in any safety and effectiveness issue.

### Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.