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.

AI/ML Overview

This document is a 510(k) premarket notification for DORA Tubing Sets for Hemodialysis. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, it does not contain the detailed information about acceptance criteria and study design for performance metrics that would typically be found in a clinical study report or a more comprehensive performance evaluation for an AI-powered medical device.

Based on the provided text, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria for performance metrics in a table format, nor does it provide quantitative performance data like sensitivity, specificity, or accuracy. Instead, it refers to conformity with established international standards for medical devices.

Acceptance Criteria (Standard Conformance)	Reported Device Performance
ISO 8638:2010 (Cadiovascular Implants And Extracorporeal Blood Circuit For Hemodialyzers, Hemodialfilters, And Hemofilters)	Conforms to ISO 8638:2010
ISO 594-2:1998 (Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 2: Lock Fittings)	Conforms to ISO 594-2:1998
ISO 10993-5:2009 (Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity)	Biocompatibility tests conducted (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Hemolysis, Partial Thromboplastin Time, Complement System, In vitro Chromosomal Aberration, Bacterial Reverse Mutation, Mouse Bone Marrow Micronucleus)
ISO 10993-11:2006 (Biological evaluation of medical devices -- Part 11: Tests for systemic A toxicity)	Biocompatibility tests conducted (see above)
ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)	Biocompatibility tests conducted (see above)
ISO 10993-4:2002 (Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood)	Biocompatibility tests conducted (see above)
ASTM F 756-08 (Standard practice for assessment of hemolytic properties of material)	Biocompatibility tests conducted (see above)
ASTM F88/F88M-09 (Standard Test Method for Seal Strength of Flexible Barrier Materials)	Non-clinical tests conducted to verify design specifications and substantial equivalence
Sterility Assurance Level (SAL) of 10-6	Achieved SAL of 10-6 through e-beam sterilization

2. Sample size used for the test set and the data provenance

This document describes non-clinical laboratory testing and does not involve patient data or a "test set" in the context of an AI/algorithm study. The testing was performed on the device itself. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document does not involve AI or an algorithm requiring ground truth established by experts.

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

This document does not involve AI or an algorithm requiring ground truth adjudication.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was conducted or is mentioned in this document. The device is a physical medical device (tubing sets), not an AI-powered diagnostic or assistive tool.

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

Not applicable. The device is not an algorithm.

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

Not applicable. This is a physical medical device. The "ground truth" for its performance is adherence to established engineering and biocompatibility standards.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning algorithm that requires a training set.

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

Not applicable. This device is not an AI/machine learning algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

Type of Use (Select one or both, as applicable)
	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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
1. 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: +86 20 8226 5249 ext.340 Fax: +86 20 3206 7500 Email: mufangzhen@baingz.com

1. 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: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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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:

Device Description

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.

1. 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
1. 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 forHemodialysis are single-use sterilemedical devices intended to connectthe patient to the hemodialyzer andthe hemodialysis delivery system inhemodialysis treatment.The compatibility of availableconfigurations is the responsibilityof the physician/clinician in charge.	Nipro® Set - Blood Tubing Setwith Transducer Protector andPriming Set are disposablebloodlines intended to provideextracorporeal access to the patient'sblood during hemodialysis.The compatibility of availableconfiguration is the responsibility ofthe physician in charge.
Feature	Pre-PumpPost-PumpColor Coded componentSterileNon-pyrogenicSingle UsePrescription Device	Pre-PumpPost-PumpColor Coded componentSterileNon-pyrogenicSingle UsePrescription Device
Configuration	Arteria LineVenous 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.

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.