Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an US legally marketed angiographic injectors.

Device Description

The proposed devices include 2 models of plastic, disposable syringes and 5 connection tubes of different specifications. They are intended to be used with an U.S. legally marketed angiography injector, compatibilities are shown in Table 1. The connection tubes are used to connect the syringe and the catheter. The tubes are also available in three configurations, which are straight tube (used with single shot syringe), type Y and type T tube (used with dual shot syringe), they can withstand maximum pressure of 400 psi. The proposed devices are used with the J shape tube / spike cleared in K151960.

AI/ML Overview

The provided FDA 510(k) summary (K182289) describes the substantial equivalence of Sterile High-pressure Angiographic Syringes for Single-use to a predicate device, focusing on mechanical and material properties rather than AI/algorithm performance. Therefore, most of the requested information regarding AI acceptance criteria, study design (MRMC, standalone), ground truth establishment, and training/test set details for AI models is not applicable to this document.

The document primarily addresses the physical and functional characteristics of a medical device (syringes and connection tubes) and its compliance with relevant international standards.

However, based on the non-clinical tests described, we can infer a form of acceptance criteria and the "study" (non-clinical testing) that proves the device meets these criteria.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance (Non-AI Medical Device)

Acceptance Criteria (Inferred from Standards & Claims)	Reported Device Performance (Non-Clinical Test Conclusion)
Resistant Liquid Leak Pressure: Must withstand a certain pressure without leakage. (Implicitly, the proposed device seeks to demonstrate a higher resistance than the predicate)	Syringe: 400 psi (Tested)
Connection Tube: 400 psi (Tested)
Material & Design Compatibility: Conformance to specified luer taper standards for secure connections.	ISO 594-1:1986 (Conical fittings, Part 1: General requirements) - Complies
ISO 594-2:1998 (Conical fittings, Part 2: Lock fittings) - Complies
Syringe Functionality (Manual Use): Conformance to general requirements for single-use hypodermic syringes for manual use.	ISO 7886-1:2017 (Sterile hypodermic syringes for single use, Part 1: Syringes for manual use) - Complies
Syringe Functionality (Power-Driven Use): Conformance to requirements for single-use hypodermic syringes for use with power-driven pumps.	ISO 7886-2:1996 (Sterile hypodermic syringes for single use, Part 2: Syringes for use with power-driven syringe pumps) - Complies
Sterility: EO sterilized.	EO Sterilized
Single Use: Designed for single use.	Yes
Biocompatibility: Conformance to standards for biological evaluation of medical devices.	ISO 10993 series Standards - Conforms to requirements

Explanation of "Study" Proving Acceptance Criteria (Non-Clinical Testing):

The "study" here refers to non-clinical bench testing conducted to verify the device's technical specifications and compliance with relevant standards.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of units tested. The document mentions "The test samples of syringe 100104 and 100114 with accessories are tested for liquid leakage and flow characteristics." This implies a series of physical tests on multiple units of the specified models. Regulatory submissions for devices of this nature typically involve testing a statistically representative sample size, but the exact number isn't provided in this summary.
- Data Provenance: The tests were conducted internally by the manufacturer, Shenzhen Baoan Medical Supplies Co., Ltd. (China). The data is retrospective in the sense that it was collected as part of product development and validation prior to submission.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. For a medical device like a syringe, "ground truth" is established through engineering specifications, material science, and performance standards, not through expert consensus on medical images or diagnoses. The "truth" is whether the device meets the physical and functional requirements (e.g., does it leak at 400 psi? Does it conform to luer taper dimensions?). These are objective measurements not requiring expert clinical adjudication.
Adjudication Method for the Test Set:
- Not Applicable. As mentioned above, the tests are objective, measurable physical and mechanical tests. There is no subjective interpretation requiring adjudication by multiple readers or experts.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is a clinical study design typically used for diagnostic devices (like imaging AI) to assess the impact of a new technology on human reader performance. This document concerns a physical device (syringe), not a diagnostic tool or AI.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/algorithm. This question is irrelevant to the device described.
The Type of Ground Truth Used:
- Engineering Specifications and International Standards: The ground truth for this device's performance is defined by adherence to established international standards (ISO 594-1, ISO 594-2, ISO 7886-1, ISO 7886-2, ISO 10993 series) and the manufacturer's own design specifications (e.g., target resistant liquid leak pressure). This is a physical/mechanical "ground truth."
The Sample Size for the Training Set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing processes are based on engineering principles and established device standards, not trained data.
How the Ground Truth for the Training Set was Established:
- Not Applicable. Again, this is not an AI/machine learning device. "Ground truth" for manufacturing and design would be derived from engineering drawings, material specifications, and regulatory requirements rather than labeled training data.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 10, 2018

Shenzhen Baoan Medical Supplies Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN

Re: K182289

Trade/Device Name: Sterile High-pressure Angiographic Syringes for Single-use Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: August 3, 2018 Received: August 23, 2018

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lydia S. Glaw -S 2018.10.10 14:25:31 -04'00'

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)

K182289

Device Name

Sterile High-pressure Angiographic Syringes for Single-use

Indications for Use (Describe)

Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an US legally marketed angiographic injectors.

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)

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510(k) Summary

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

The assigned 510(k) Number: K182289

1. Date of Preparation: 9/28/2018
1. Sponsor Identification

Shenzhen Baoan Medical Supplies Co., Ltd

No. 6, Shenkeng Road, Shenkeng Industrial Zon Liuyue Community, Henggang, Longgang District, Shenzhen, 518173, China

Establishment Registration Number: 3012395857

Contact Person: Mingan Mu Position: Deputy General Manager Tel: +86-755-28638515 Fax: +86-755-28638033 Email: boon@szboon.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 001-3609253199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Sterile High-pressure Angiographic Syringes for Single-use; Common Name: Disposable angiographic syringe; Models: 100104 and 100114

Regulatory Information Classification Name: Angiographic injector and syringe Classification: II Product Code: DXT; Regulation Number: 21 CFR 870.1650; Review Panel: Cardiovascular;

Indications for Use:

Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an US legally marketed angiographic injectors.

Device Description:

Model(Syringe)	Volume(ml)	Type	Resistant LiquidLeak Pressure (psi)	Compatible Angiographic Injector

100114	200/200	Dual Shot	400	CT 9000 & CT9000 ADV, K912944

Table 1 Compatibility between Syringes and Injectors

The connection tubes are used to connect the syringe and the catheter. The tubes are also available in three configurations, which are straight tube (used with single shot syringe), type Y and type T tube (used with dual shot syringe), they can withstand maximum pressure of 400 psi.

The proposed devices are used with the J shape tube / spike cleared in K151960.

Identification of Predicate Device 5.

510k Number: K151960

Product Name: Sterile High-pressure Angiographic Syringes for Single-use; Manufacturer: Shenzhen Baoan Medical Supplies Co., Ltd

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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 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 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings

ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use;

ISO 7886-2:1996 Sterile hypodermic syringes for single use- Part 2: Syringes for use with power-driven syringe pumps.

The test samples of syringe 100104 and 100114 with accessories are tested for liquid leakage and flow characteristics. Actually, there is no design change between proposed device and predicate, the testing using 400 psi pressure is to demonstrate the increased resistant liquid leakage pressure statement. Therefore, other testing is not necessary for this submission.

1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Substantially Equivalent Comparison

ITEM	Proposed Device	Predicate Device, K151960
Product Code	DXT	DXT
Regulation No.	21 CFR 870.1650	21 CFR 870.1650
Class	II	II
Indications for Use	Sterile High-pressure AngiographicSyringes for Single-use are intended forthe injection of contrast media orsaline; they shall be used with an USlegally marketed angiographicinjectors.	Sterile High-pressure AngiographicSyringes for Single-use are intended forthe injection of contrast media orsaline; they shall be used with an USlegally marketed angiographicinjectors.
Mode of Operation	Power-driven operation, single use	Power-driven operation, single use

Table 2 Substantially Equivalent Comparison

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	Angiographic Syringe	Angiographic Syringe
Configuration	Connection Tube/	Connection TubeJ shape tube/Spike
Sterility	EO Sterilized	EO Sterilized
Single Use	Yes	Yes
Resistant LiquidLeak Pressure (psi)	Syringe: 400 psiConnection Tube: 400 psi	Syringe: 300 psiConnection Tube: 300 psi
Other Performance	Comply with ISO 7886-1, ISO 7886-2,ISO 594-1 and ISO 594-2	Comply with ISO 7886-1, ISO 7886-2,ISO 594-1 and ISO 594-2
Biocompatibility	Conforms to the requirements of ISO10993 series Standards	Conforms to the requirements of ISO10993 series Standards

The proposed devices are stated to have a higher resistant liquid leak pressure. For this modification, liquid leak testing has been conducted on the models in this submission and test results have demonstrated the resistant liquid leak pressure is 400 psi for syringes and connection tube. Therefore, this modification will not impact the safety and effectiveness of device. In addition, the modified devices only include angiographic syringe and connection tube and they should be used with the J shape tube/spike cleared in K151960.

Substantially Equivalent (SE) Conclusion 9.
Based on the comparison above, the proposed devices are determined to be Substantially Equivalent (SE) to the 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.