Y-Connector hemostasis valve is intended to minimize blood loss during the introduction, withdrawal and use of devices that have an outer diameter of 8F catheter during diagnostic and interventional procedures.

The Insertion Tool facilitates introduction of a guidewire through the Y-Connector and into the guiding catheter.

The Torque Device attaches to guidewires and provides a handle to assist in manipulation of the guidewire.

Device Description

The Y-connector kit is single use disposable device. It including Y connector, Insertion tool and torque device. It is mainly use for PTCA or PTA procedures to create the entrance and minimize blood loss when intervention device are inserted into the human vascular system.

The Y connector with a rotating luer lock, a sidearm and a hemostasis valve that is designed to provide a port for interventional system. The seal of hemostasis valve can be opened by pushing the switch cap, and closed by releasing switch cap.

The insertion tool is used to facilitate placement of a guide wire tip through the Y connector.

The torque device is designed to hold the guide wire and provide a handle for manipulating, so the doctor can control the guide wire to the right position.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Y-connector Kit." This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical study proving novel performance criteria. Therefore, the information regarding acceptance criteria and a study proving device meeting those criteria will be based on the substantial equivalence claims and bench testing performed.

Here's an analysis of the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance data in a quantitative manner as one might find in a clinical trial. Instead, it describes compliance with design specifications and recognized standards. The "acceptance criteria" are implied by the standards and performance characteristics of the predicate device.

Implied Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (from standards/predicate)	Reported Device Performance	Remark (SE = Substantially Equivalent)
Intended Use	Minimize blood loss during introduction/withdrawal of 8F catheters in diagnostic/interventional procedures; facilitate guidewire introduction; manipulate guidewire.	Matches predicate's intended use with 8F catheter (predicate was 7F).	SE (with slight difference in catheter size)
Product Code	DTL, DQX	DTL, DQX	SE
Regulation Number	21 CFR 870.4290, 21 CFR 870.1330	21 CFR 870.4290, 21 CFR 870.1330	SE
Classification	Class II	Class II	SE
Principle of Operation	Manual operation	Manual operation	SE
Components	Y-connector, insertion tool, torque device	Y-connector, insertion tool, torque device	SE
Conical Fitting	Compliance with ISO 594-1:1986 and ISO 594-2:1998 (Luer taper standards)	Complies with ISO 594-1:1986 and ISO 594-2:1998	SE
Biocompatibility	General biocompatibility requirements for medical devices (no specific pass/fail values given, but compliance with ISO standards implied)	Passed: In Vitro Hemolytic Properties, In Vitro Cytotoxicity (ISO 10993-5), Skin Irritation (ISO 10993-10), Skin Sensitization (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Pyrogen (ISO 10993-11).	SE
Hemostasis Valve Design	Seal mechanism to open/close for device insertion and blood loss minimization. (Predicate: push distally to open, pull proximally to close)	Push switch cap to open, release to close.	Not directly SE, but functionally similar. Design analysis reported.
Where Used	Diagnostic and interventional procedures	Diagnostic and interventional procedures	SE

Study that Proves the Device Meets Acceptance Criteria:

The document describes "Bench tests were conducted to verify that the proposed device met all device specification as were substantially equivalent (SE) to the predicate device." It also mentions "Biocompatibility testing and reference standards."

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

The document does not specify the sample sizes for the bench tests. It only states that "Bench tests were conducted."

Sample size: Not specified.
Data provenance: The tests were conducted internally by Shanghai Kindly Medical Instruments Co., Ltd. (China). The data is presumably prospective (i.e., designed specifically for this submission).

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 type of information (experts, their qualifications, and ground truth establishment) is typically relevant for clinical studies, especially those involving subjective interpretation (e.g., imaging diagnosis). Since this submission primarily relies on bench testing and substantial equivalence, there is no mention of experts establishing a ground truth for a test set in the context of clinical performance. The "ground truth" for the bench tests would be the established engineering and biological standards.

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

Not applicable for a submission based on bench testing and substantial equivalence, which does not involve subjective human interpretation of clinical data requiring 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

Not applicable. This is a medical device submission for a physical y-connector kit, not an AI software/algorithm, and no MRMC study was performed or needed.

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

Not applicable. This is a medical device submission for a physical y-connector kit, not an algorithm.

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

For the bench tests, the "ground truth" would be the established scientific and engineering principles codified in the referenced ISO standards (ISO 594-1, ISO 594-2, ISO 10993 series) and the functional performance characteristics of the predicate device. For biocompatibility, the ground truth is defined by the acceptable levels of biological response as outlined in the ISO 10993 standards.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

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

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem depicting three stylized human profiles facing right, with flowing lines suggesting movement or connection. The logo is black and white.

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

October 3, 2017

Shanghai Kindly Medical Instruments Co.,ltd. Jeffery Hui Official Correspondent No. 925 Jinyuan Yi Rd Shanghai. 201803 CN

Re: K170024

Trade/Device Name: Y-connector Kit Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, Or Fitting Regulatory Class: Class II Product Code: DTL, DQX Dated: August 3, 2017 Received: September 7, 2017

Dear Jeffery Hui:

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. 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 devicerelated 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.

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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,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K170024

Device Name Y-Connector Kit

T-Connector Kit

Indications for Use (Describe)

The Insertion Tool facilitates introduction of a guidewire through the Y-Connector and into the guiding catheter.

The Torque Device attaches to guidewires and provides a handle to assist in manipulation of the guidewire.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Section III- 510(k) Summary

This 510(k) Summary of 510(k) is being submitted in accordance with the requirements of the guidance The 510(k) Program and 21 CFR 807.92.

510(k) Number: K170024

1. Date of Submission: Sep.15, 2017

2. Submitter

Shanghai Kindly Medical Instruments Co., Ltd. No. 925, Jinyuan yi Road, Shanghai, 201803, China Establishment Registration Number: 3009605245 Contact Person: Xu Jianhai Position: RA Supervisor Tel.:+086-021-59140056 Fax: +086-021-59140056 Email: xujianhai@kdlchina.net

3. Proposed Device

Proposed Device Name: Y-connector Kit Proposed Device Model: YCK113 Classification: Class II Product Code: DTL&DQX Regulation Number: 21 CFR 870.4290, 21 CFR 870.1330 Classification Name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass and catheter guide wire Review Panel: Cardiovascular

4. Predicate device

a. 510(k) Number: K042060

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Product Name: EasyPass™ US Y-connector Hemostatic Valve Manufacturer: Millimed A/S Product code: DTL&DQX Regulation Number: 21 CFR 870.4290, 21 CFR 870.1330

5. Device description

The insertion tool is used to facilitate placement of a guide wire tip through the Y connector.

The torque device is designed to hold the guide wire and provide a handle for manipulating, so the doctor can control the guide wire to the right position.

6. Intended Use Statement:

The Insertion Tool facilitates introduction of a guidewire through the Y-Connector and into the guiding catheter.

The Torque Device attaches to guidewires and provides a handle to assist in manipulation of the guidewire.

7. Non-clinical Test Conclusion

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Bench tests were conducted to verify that the proposed device met all device specification as were substantially equivalent (SE) to the predicate device. The test result demonstrates that the proposed devices comply with the following standards:

ISO 594-1:1986, Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 1: General Requirements.

ISO 594-2 1998, Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 2: Lock Fittings.

Biocompatibility testing and reference standards:

In Vitro Hemolytic Properties of Materials.
In Vitro Cytotoxicity -- ISO 10993-5:2009, Biocompatibility Evaluation of Medical Device - Part 5: Tests for In Vitro Cytotoxicity.

-- ISO 10993-10:2010, Biocompatibility Evaluation of Medical 3) Skin Irritation Device - Part 10: Tests for Irritation and Shin Sensitization.

-- ISO 10993-10:2010, Biocompatibility Evaluation of Medical 4) Skin Sensitization Device - Part 10: Tests for Irritation and Shin Sensitization.

Acute Systemic Toxicity -- ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - Part 11: Tests for systemic toxicity.
Pyrogen -- ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - Part 11: Tests for systemic toxicity.

8. Clinical Test

It is not applicable

9. Summary Comparing the Technological Characteristics

Comparisons of the proposed and predicate devices show that the technological characteristics are identical or substantially equivalent to the currently marked predicate devices.

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Item	Proposed Device	Predicate DeviceK042060	Remark
Product Code	DTL DQX	DTL DQX	SE
RegulationNo.	870.4290, 870.1330	870.4290, 870.1330	SE
Class	II	II	SE
Intended Use	Y-Connector hemostasis valve isintended to minimize blood lossduring the introduction, withdrawaland use of devices that have anouter diameter of 8F catheterduring diagnostic andinterventional procedures.The Insertion Tool facilitatesintroduction of a guidewirethrough the Y-Connector and intothe guiding catheter.The Torque Device attaches toguidewires and provides a handleto assist in manipulation of theguidewire.	The EasyPassTM US Y-connectorHemostatic Valve is intended tomaintain hemostasis during theintroduction, use and withdrawal ofdiagnostic and interventional devicesthat have an outer diameter of 7French or smaller.The guide wire insertion toolfacilitates introduction of the guidewire through the hemostasis valveand into the guiding catheter.The torque device, inserted over theproximal end of the guide wire,provided a handle for easiermanipulation of the guide wire.	SE
PrincipleofOperation	By manual operation	By manual operation	SE
Components	Y-connector, insertion tool torquedevice	Y-connector, insertion tool torquedevice	SE
Conical fitting	Comply with ISO 594-1:1986 ISO594-2:1998	Comply with ISO ISO 594-1:1986ISO 594-2:1998	SE
Design	The Y connector with a rotatingluer lock, a sidearm and ahemostasis valve with push-rotatemechanism. The seal of hemostasisvalve can be opened bypushing-rotating the switch cap,and closed by pulling-rotatingswitch cap.	To open the hemostasis valve, avalve opener cap with a centerpassage tube is pushed distally. Thehemostasis valve is closed bypulling the valve opener capproximally.	Analysis
Where used	Diagnostic and interventionalprocedures	Diagnostic and interventionalprocedures	SE

10.Conclusion

The proposed device, Y-connector kit, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols. The y-connector kit is substantially equivalent to the legally market predicate device.

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.