The High Pressure Tubing is a sterile, single use device which can withstand injection pressure to 1200psi. The High Pressure Tubing is composed of tubing with connector at each end. The connector is a female-male combination and rotating adapter. The High Pressure Tubing is supplied sterile by Ethylene Oxide and disposable device. The material of tube is PU with polvamides liner, and the appearance is braided.

AI/ML Overview

The provided document describes the 510(k) premarket notification for a medical device called "High Pressure Tubing." The submission argues for the substantial equivalence of the proposed device to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on 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" and "reported device performance" in the format typically associated with a clinical or analytical performance study of a diagnostic or AI device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing against established standards and a comparison of technological characteristics.

However, we can infer some criteria and reported performance from the "Non-clinical Test Conclusion" and the comparison table.

Acceptance Criteria (Inferred)	Reported Device Performance
Mechanical Integrity / Luer Compatibility: Conical fittings comply with ISO 594-1:1986 and ISO 594-2:1998	Proposed device complies with ISO 594-1:1986, ISO 594-2:1998
Pressure Withstand Capability: Withstand specified injection pressure	Proposed device "can withstand injection pressure to 1200psi"
Infusion Equipment Standards: Compliance with ISO 8536-4:2010	Proposed device complies with ISO 8536-4:2010
Sterility: Supplied sterile by Ethylene Oxide	Proposed device "is supplied sterile by Ethylene Oxide"
Single Use: Designed for single use	Proposed device "is a sterile, single use device"
Materials: Tubing material PU with polyamides liner for 1200psi	Tubing material is PU with polyamides liner for 1200psi

The document states: "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, ISO 594-2:1998, ISO 8536-4:2010."

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 provide details on the sample size used for the bench testing (e.g., number of tubing samples tested for pressure, luer compatibility, etc.). It only mentions that "Bench tests were conducted." The provenance of this test data (country of origin, retrospective/prospective) is also not specified beyond the fact that the manufacturer is "Shanghai Kindly Medical Instruments Co., Ltd."

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 information is not applicable and not provided. The device is a piece of medical tubing, not a diagnostic or AI device requiring expert interpretation for ground truth establishment. The "ground truth" for this device relates to its physical and functional specifications meeting industry standards, which is assessed through engineering and materials testing, not expert clinical review.

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

This information is not applicable and not provided. As explained above, the assessment is based on objective measurements against engineering standards, not subjective expert judgment 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

This information is not applicable and not provided. The device is medical tubing, not an AI or diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

This information is not applicable and not provided. The device is medical tubing, not an algorithm. Standalone algorithm performance studies are not relevant.

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

The "ground truth" for this device is based on established engineering and medical device standards (ISO standards) and the device's own predetermined specifications (e.g., withstand 1200psi). It's essentially "compliance with specified physical and performance characteristics."

8. The sample size for the training set

This information is not applicable and not provided. The device is medical tubing; there is no "training set" in the context of machine learning or AI that would be relevant here.

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

This information is not applicable and not provided. As there is no training set for this type of medical device, the establishment of ground truth for such a set is not relevant.

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 consists of a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The profiles are silhouetted in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

October 6, 2017

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

Re: K170014

Trade/Device Name: High Pressure Tubing Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT 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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Indications for Use

510(k) Number (if known) K170014

Device Name High Pressure Tubing

Indications for Use (Describe)

The High Pressure Tubing is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.

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.

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

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"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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510(k) Summary - K170014

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

510(k) Number: K170014

1. Date of Submission: Aug.03, 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: High Pressure Tubing Proposed Device Model: 30cm, 60cm, 90cm, 120cm, 150cm, Classification: Class II Product Code: DXT Classification Name: Angiography Injector and Syringes Regulation Number: 21 CFR 870.1650 Review Panel: Cardiovascular

4. Predicate device

510(k) Number: K140356 a.
Product Name: SunmedTM High Pressure Line

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Manufacturer: Sunny Medical Device (Shenzhen) Co., Ltd.

5. Device description

The High Pressure Tubing is a sterile, single use device which can withstand injection pressure to 1200psi.

The High Pressure Tubing is composed of tubing with connector at each end. The connector is a female-male combination and rotating adapter.

The High Pressure Tubing is supplied sterile by Ethylene Oxide and disposable device. The material of tube is PU with polvamides liner, and the appearance is braided.

6. Indications for Use Statement:

The High Pressure Tubing is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.

7. Non-clinical Test Conclusion

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.

ISO 8536-4:2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed.

8. Clinical Test

It is not applicable

9. Summary Comparing the Technological Characteristics

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The predicate device was compare in the following areas and found to have identical technological characteristic.

Item	Proposed Device	Predicate DeviceK140356	Remark
Class	II	II	Same
Intended Use	The High Pressure Tubing isindicated for use as a connectingline for injection of contrastmedia or saline during coronaryangiographic procedures.	The sunmedTM high pressure line is usedas a connecting line for injection of acontrast, saline or other diagnostic fluids(by connecting the female luer of highpressure with an angiography syringe andconnecting the male luer or rotating maleluer of high pressure with the catheter)during coronary angiography procedures.This product is composed of female luer,male luer (including rotating male luer),and tubing and with or without caps.	Same
Operatingprinciple	Manual connect the male luer orrotating male luer of highpressure with other catheterdevice.	Manual connect the male luer or rotatingmale luer of high pressure with othercatheter device.	Same
Pressure Rating	1200psi	500psi, 900psi, 1200psi	Similar
Conical fitting	Comply with ISO 594-1:1986,ISO 594-2:1998	Comply with ISO ISO 594-1:1986, ISO594-2:1998	Same
Components	Tubing, female/male luer,rotating adapter	Female luer, male luer (including rotatingluer), and tubing and with or without caps.	Same
Flexible	Yes	Yes	Same
Design	Designed to multiple length andconnector types. PU tubing withpolyamides liner for 1200psi	Designed to multiple length and connectortypes. PU tubing with Nylon liner for1200psi and PVC tubing for 500psi.	Similar
Size	30cm,60cm,90cm,120cm,150cm,	30cm,50cm,60cm,90cm,75cm,100cm,120cm,150cm,200cm	Same
Packagematerial	Dupont Tyvek Medicalpaper-plastic pouch.	Medical paper-plastic pouch, Tyvek plasticpouch	Same

10.Conclusion

The proposed device, Pressure high tubing, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols. The Pressure high tubing is substantially equivalent to the legally market predicate device.

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.