The Disposable High Pressure Syringe is intended for the injection of contrast media or saline. This syringe is for single use and it shall be used with US legally marketed angiographic injectors.

Device Description

The Disposable High Pressure Syringe is available in packs, which may include different configurations of syringes and accessories, the accessories include connector tube, Quick fill tube and Spike.

The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S. legally marketed angiography injector.

The connector tube is used to connect the syringe and the catheter. They are also available in three configurations, which are WLP Series tube with one syringe connector (used with single shot syringe), WLT Series tube and WLM Series tube with two syringe connectors (used with dual shot syringe). The three connector tubes can withstand maximum pressure of 350psi.

The Quick Fill Tube and the Spike is used to draw drug into the syringe.

The proposed devices are intended to be used with an U.S. legally marketed angiography injector; compatibilities are shown in Table 1.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called the "Disposable High Pressure Syringe" by Union Medical Shenzhen Co., Ltd. It details the device's indications for use, description, compatibility, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria for this device are largely based on compliance with a set of recognized international and national standards. The reported device performance is that it "complies" with these standards.

Acceptance Criteria (Standard Compliance)	Reported Device Performance
ISO 10993-7:2008 (Ethylene oxide sterilization residuals)	Complies
ASTM F 88/F88M-2015 (Seal strength)	Complies
ASTM F1140/F1140M-13 (Internal pressurization failure resistance)	Complies
USP37-NF32 <85> (Bacterial Endotoxins Limit)	Complies (implied by "complies with the following standards")
ISO 11737-2:2009 (Sterilization of medical devices - Microbiological methods)	Complies
ISO 7886-2:1996 (Sterile hypodermic syringes for single use with power-driven syringe pumps)	Complies
ISO 594-1:1986 (Conical fittings with 6% Luer taper - General Requirements)	Complies
ISO 594-2:1998 (Conical fittings with 6% Luer taper - Lock Fitting)	Complies
ISO 10993-4:2002 (Biological evaluation of medical devices - Interactions with blood)	Conforms to requirements of ISO 10993 series Standards
ISO 10993-5:2009 (Biological evaluation of medical devices - In Vitro cytotoxicity)	Conforms to requirements of ISO 10993 series Standards
ISO 10993-10:2010 (Biological evaluation of medical devices - Irritation and skin sensitization)	Conforms to requirements of ISO 10993 series Standards
ISO 10993-11:2006 (Biological evaluation of medical devices - Systemic toxicity)	Conforms to requirements of ISO 10993 series Standards
Intended Use	Meets the stated intended use: "The Disposable High Pressure Syringe is intended for the injection of contrast media or saline. This syringe is for single use and it shall be used with US legally marketed angiographic injectors."
Mode of Operation	Power-driven operation, single use
Sterility	EO Sterilized
Single Use	Yes

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 explicitly state the sample sizes used for the non-clinical tests. It only lists the standards to which the device complies. Therefore, details like the exact number of syringes tested for seal strength or biocompatibility are not provided.

The data provenance is also not explicitly stated. However, the sponsor is "Union Medical Shenzhen Co., Ltd." located in Shenzhen, China, and the designated submission correspondent is "Mid-Link Consulting Co., Ltd" in Shanghai, China. This suggests the testing and data generation likely occurred in China. The testing appears to be prospective, as it's part of a premarket submission to demonstrate compliance before market release.

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 to this submission. The device is a physical, disposable medical device (syringe), not an AI or diagnostic imaging device that requires human expert review to establish ground truth for a test set. The "ground truth" for this device is based on objective measurements and compliance with engineering and biological safety standards.

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

This information is not applicable. Adjudication methods are typically associated with subjective assessments or disagreements among experts in diagnostic or AI performance studies. For a physical device undergoing engineering and biological testing, the results are typically quantitative and objective, and do not involve "adjudication" in this sense.

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. An MRMC study is not relevant for a disposable syringe. This type of study investigates the performance of diagnostic devices or AI algorithms when used by multiple readers with multiple cases.

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

This information is not applicable. This refers to the performance of an AI algorithm operating independently, which is not relevant for a physical medical device like a syringe.

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

The "ground truth" for this device is established through:

International and national standards: These standards define acceptable physical properties (e.g., seal strength, Luer taper), chemical properties (e.g., EO residuals, bacterial endotoxins), and biological properties (e.g., biocompatibility).
Objective physical and chemical measurements: Laboratory tests measure parameters like pressure resistance, seal integrity, and residual chemicals.
Biological assays: Tests assess cytotoxicity, irritation, sensitization, and systemic toxicity.

8. The sample size for the training set:

This information is not applicable. The concept of a "training set" refers to data used to train machine learning models. This device is a physical product, not an AI model, and therefore does not have a training set.

9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 12, 2017

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

Re: K170279

Trade/Device Name: Disposable High Pressure Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: November 21, 2017 Received: November 24, 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 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 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);

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Page 2 - Diana Hong

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-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,

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)

K170279

Device Name Disposable High Pressure Syringe

Indications for Use (Describe)

The Disposable High Pressure Syringe is intended for the injection of contrast media or saline. This syringe is for single use and it shall be used with US legally marketed angiographic injectors.

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)

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

The assigned 510(k) Number: K170279

1. Date of Preparation: 11/14/2017
Sponsor Identification 2.

Union Medical Shenzhen Co., Ltd.

Room 603, Building 3, Fantasia MIC Plaza, Nanhai Avenue, Nanshan District, Shenzhen, 518062, China

Establishment Registration Number: Not yet registered

Contact Person: Mr. Wenguo Zhang Position: General Manager Tel: +86-755-88898501 Fax: +86-755-26818966 Email: wgzhang@126.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (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: Disposable High Pressure Syringe Common Name: Disposable angiographic syringe Models:

SMR101, SMR102, SMR103, SMR104, SMR201, SMR202, SMR204, SMR301, SMR302, SLF101, SLF102, SLF201, SLF202, SLF301, SNE102, SNE103, SNE104, SNE301 and SEZ101

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

Indications for Use:

The Disposable High Pressure Syringe is intended for the injection of contrast media or saline. This syringe is for single use and it shall be used with US legally marketed angiographic injectors.

Device Description

The Disposable High Pressure Syringe is available in packs, which may include different configurations of syringes and accessories, the accessories include connector tube, Quick fill tube and Spike.

The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S. legally marketed angiography injector.

The Quick Fill Tube and the Spike is used to draw drug into the syringe.

The proposed devices are intended to be used with an U.S. legally marketed angiography injector; compatibilities are shown in Table 1.

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No.	Models(P/N)	Volume(ml)	Type	Applicable Injection Systems/510(k) Number
1	SMR101	200ml	Single Shot	MEDRAD Visitron CT 610 (K991557), EnVision CT Injection System (K993782)
2	SMR102	200ml	Single Shot	MEDRAD CT Stellant Injection System(K023183)
3	SMR103	125ml	Single Shot	MEDRAD Visitron CT 610 (K991557), EnVision CT Injection System (K993782)
4	SMR104	200/200ml	Dual Shots	MEDRAD CT Stellant Injection System(K023183)
5	SMR201	150ml	Single Shot	MEDRAD Mark V Injection System (K822536)
6	SMR202	200ml	Single Shot	MEDRAD Mark V Injection System (K822536)
7	SMR203	60ml	Single Shot	MEDRAD Mark V Injection System (K822536)
8	SMR204	130ml	Single Shot	MEDRAD Mark IV Injection System (K903390)
9	SMR301	60/60ml	Dual Shots	MEDRAD Spectris MR Injection System(K935668)
10	SMR302	110/60ml	Dual Shots	MEDRAD Solaris MR Injection System(K033247)
11	SLF101	200ml	Single Shot	LF CT9000 Injection System (K912944)
12	SLF102	200/200ml	Dual Shots	LF OptiVantage Dual-Head Injection System(K042744)
13	SLF201	150ml	Single Shot	LF Angiomat 6000 Injection System (K944875)
14	SLF202	150ml	Single Shot	LF Angiomat Illumena Injection System(K963071)
15	SLF301	60/60ml	Dual Shots	LF MRI OPTISTAR Injection System (K984088)
16	SNE101	100ml	Single Shot	NEMOTO Dual Shot ALPHA7 Injection System(K133189)
17	SNE102	200ml	Single Shot	NEMOTO Dual Shot ALPHA7 Injection System(K133189)
18	SNE103	200/60ml	Dual Shots	Nemoto Dual Shot CT Injection System(K052633)
19	SNE104	200/100ml	Dual Shots	Nemoto Dual Shot CT Injection System(K052633)
20	SNE301	60/60ml	Dual Shots	NEMOTO MRI Injection System (K091734)
21	SEZ101	200ml	Single Shot	EZEM Empower CT Injection System(K063029)

Table 1 Compatibility between Syringes and Injectors

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న్. Identification of Predicate Device
510(k) Number: K151960

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

Non-Clinical Test Conclusion 6.
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 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
ASTM F 88/F88M-2015 Standard test method for seal strength of flexible barrier materials;
ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages;
USP37-NF32 <85> Bacterial Endotoxins Limit;
A ISO 11737-2:2009 Sterilization of medical devices- Microbiological methods- Part 2: Test of sterility performed in the definition, validation and maintenance of a sterilization process;
A ISO 7886-2:1996 Sterile hypodermic syringes for single use -- Part 2: Syringes for use with power-driven syringe pumps
A ISO594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General Requirements;
ISO594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fitting;
ISO 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood:
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity;
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
A ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
1. Clinical Test Conclusion

No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device
Product Code	DXT	K151960DXT
Regulation Number	CFR 870.1650	CFR 870.1650
Intended Use	The proposed device is intended for theinjection of contrast media or saline. Thissyringe is for single use with US legallymarketed angiographic injectors.	High-pressure AngiographicSyringes for Single-use are syringesfor the injection of contrast media orsaline. This syringe is for single usewith US legally marketed angiographicinjectors.
Mode of operation	Power-driven operation, single use	Power-driven operation, single use
Configuration	Angiographic SyringeConnector tubeQuick Fill Tube/Spike	Angiographic SyringeConnecting tubeJ shape tube/Spike
Sterility	EO Sterilized	EO Sterilized
Single Use	Yes	Yes
Performance	Comply with:ISO 7886-2ISO 594-1ISO 594-2	Comply with:ISO 7886-2ISO 594-1ISO 594-2
Biocompatibility	Conforms to the requirements of ISO10993 series Standards	Conforms to the requirements of ISO10993 series Standards

Table 1 Comparison of Technology Characteristics

Substantially Equivalent (SE) Conclusion 9.

Based on the comparison, the intended use, mode of operation, sterility of proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

In addition, the results of performance tests performed on the proposed device can also demonstrate the proposed device is complied with FDA recognized standards, which the predicate device was also complied with. The results of biocompatibility studies performed on the proposed device demonstrate that the patient materials used in proposed device are biocompatible.

Based on the comparison above, the proposed device, Disposable High Pressure Syringe, is 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.