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 are available in packs, which may include different configurations of syringes and accessories. 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, compatibilities are shown in Table 1.

AI/ML Overview

The provided document is a 510(k) summary for the Shenzhen Baoan Medical Supplies Co., Ltd. Sterile High-pressure Angiographic Syringes for Single-use. This type of submission is for medical devices, and the "acceptance criteria" and "device performance" primarily refer to compliance with recognized standards and biocompatibility, rather than clinical efficacy or diagnostic accuracy.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various international and national standards that the device complies with, which serve as the acceptance criteria for its non-clinical performance and safety. The reported device performance is that it "complies with" these standards.

Acceptance Criteria (Standards Complied With)	Reported Device Performance
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals	Complies
ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials	Complies
ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages	Complies
ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration	Complies
USP37-NF32 <85> Bacterial Endotoxins Limit	Complies
ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Test of sterility	Complies
ISO 7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use	Complies
ISO 7886-2:1996 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven Syringe Pumps	Complies
ISO594:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1	Complies
ISO594:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2	Complies
ISO 10993-4:2002 AMD 2006 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood	Complies
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity	Complies
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Complies
ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity	Complies
ASTM F 756-08, Standard practice for assessment of hemolytic properties of material	Complies
USP37-NF32 <151> Pyrogen test	Complies
Biocompatibility requirements of ISO 10993 series Standards	Conforms to the requirements (for both proposed and predicate devices)

2. Sample Size Used for the Test Set and Data Provenance:

The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications..." and lists various standards for these tests. However, it does not specify the sample sizes used for these non-clinical tests (e.g., number of syringes tested for seal strength or internal pressurization). The data provenance is generally from laboratory testing performed by the manufacturer to demonstrate compliance with the listed standards. No country of origin is explicitly stated for the testing itself, but the manufacturer is based in China. The data is prospective in the sense that the manufacturer conducted these tests to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This type of information is not applicable to this 510(k) submission. The document focuses on the engineering and material safety aspects of a medical device (angiographic syringes), not on diagnostic accuracy where expert ground truth would be established. The "ground truth" here is compliance with established engineering and biological safety standards, which are verified through objective testing methods rather than expert consensus on images or case outcomes.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Not applicable. Adjudication methods like "2+1" typically refer to the process of resolving discrepancies in expert interpretations (e.g., in reading medical images). Since no expert interpretations are involved in establishing the "ground truth" for these engineering and biological tests, no such adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This type of study is relevant for assessing the clinical utility or diagnostic effectiveness of devices, often involving human readers interpreting medical data. This syringe device is a non-active, sterile, single-use product, and its evaluation focuses on its physical and biological integrity, not its interaction with clinical interpretation.

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

Not applicable. This device is a physical medical product (angiographic syringe), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used:

The "ground truth" for this device's evaluation is primarily based on compliance with recognized national and international consensus standards for medical device physical performance, sterility, and biocompatibility. This involves objective measurements against predefined thresholds and specifications outlined in standards like ISO 7886, ISO 10993, ASTM F88, etc.

8. The Sample Size for the Training Set:

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device, not an AI/ML product. The manufacturer did not develop this device using machine learning.

9. How the Ground Truth for the Training Set was Established:

The concept of a training set and its ground truth is not applicable for this device submission.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three stylized human profiles facing to the right.

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

January 7, 2016

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

Re: K151960

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: November 26, 2015 Received: December 1, 2015

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

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) K151960

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)

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

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Exhibit #2 510(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: K151960

1. Date of Preparation: 11/26/2015
1. Sponsor Identification

Shenzhen BaoAn Medical Supplies Co., Ltd Industrial Zone, Shenkeng, Liuyue Community, Henggang Street, Longgang District, Shenzhen, Guangdong, 518173, China

Establishment Registration Number: Not yet registered

Contact Person: Mr. 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. 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: Sterile High-pressure Angiographic Syringes for Single-use Common Name: Disposable angiographic syringe Models: 100101, 100103, 100104, 100113, 100114, 100121, 100124, 200101, 200102, 200103, 200104, 300101, 300103 and 300105

Regulatory Information

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

Indication 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	Compatible Angiographic Injector
The Sterile High-pressure Angiographic Syringes for Single-use models listed below are
compatible with the following Medrad Injector models
100101	200ml	Single Shot	MCT & MCT plus CT, K924116Visitron CT, K991557En Vision CT, K993782
100103	200ml	Single Shot	Stellant CT, K023183
100113	200/200ml	Dual Shots	Stellant CT, K023183
200101	65/65ml	Dual Shots	Solaris, K033247
200102	65/115ml	Dual Shots	Solaris, K033247
300101	150ml	Single Shot	Mark V, K903390
300105	130ml	Single Shot	Mark III & Mark IV, K903390
The Sterile High-pressure Angiographic Syringes for Single-use models listed below are
compatible with the following LIEBEL – FLARSHEIM Injector models
100104	200ml	Single Shot	CT 9000 & CT9000 ADV, K912944
100114	200/200ml	Dual Shots	CT 9000 & CT9000 ADV, K912944

Table 1 Compatibility between Syringes and Injectors

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200103	60/60ml	Dual Shots	Optistar LE, Elite, K073592
300103	150ml	Single Shot	ILLUMENA, K963071
The Sterile High-pressure Angiographic Syringes for Single-use models listed below are
compatible with the following E-Z-EM Injector models
100111	200ml	Single Shot	Empower CT, K073178
100121	200/200ml	Dual Shots	Empower CT, K073178
The Sterile High-pressure Angiographic Syringes for Single-use models listed below are
compatible with the following Nemoto Injector models
100124	60/100ml	Dual Shots	CT, K052633
200104	60/60ml	Dual Shots	Sonic Shot, K091734

The connecting tubes, which is 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 or type T tube (used with dual shot syringe) and high pressure tube, used with syringes which can withstanding maximum pressure of 1200 psi.

J shape tube, which is used to draw contrast media/saline into the syringe barrel.

ડ. Identification of Predicate Device
510(k) Number: K072696 Product Name: ANT Angiographic Syringes Manufacturer: Shenzhen Ant Hi-Tech Industrial Co., Ltd.
1. 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:
A ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals:
ASTM F 88/F88M-09 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:
ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;
USP37-NF32 <85> Bacterial Endotoxins Limit;
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;
ISO 7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Svringes for manual use;

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ISO 7886-2:1996 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven Syringe Pumps;
ISO594:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General Requirements;
ISO594:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fitting;
ISO 10993-4:2002 AMD 2006 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;
ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
ASTM F 756-08, Standard practice for assessment of hemolytic properties of material
USP37-NF32 <151> Pyrogen test
1. Clinical Test Conclusion

No clinical study is included in this submission.

Substantially Equivalent (SE) Comparison 8.

Item	Proposed Device	Predicate Device
Product Code	DXT	DXT
Regulation Number	CFR 870.1650	CFR 870.1650
Intended Use	Sterile High-pressure AngiographicSyringes for Single-use are intended forthe injection of contrast media or saline;they shall be used with an US legallymarketed angiographic injectors.	ANT Angiographic Syringes aresyringes for the injection of contrastmedia or saline. This syringe is forsingle use with US legally marketedangiographic injectors.
Mode of operation	Power-driven operation, single use	Power-driven operation, single use
Configuration	Angiographic SyringeConnecting tubeJ shape tube/Spike	Angiographic SyringeConnecting tubeJ shape tube/Spike
Sterility	EO Sterilized	EO Sterilized
Single Use	Yes	Yes
Performance	Comply with:ISO 7886-1	Comply with:ISO 7886-1

Table 2 Comparison of Technology Characteristics

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	ISO 594-1	ISO 594-1
	ISO 594-2	ISO 594-2
Biocompatibility	Conforms to the requirements of ISO	Conforms to the requirements of ISO
	10993 series Standards	10993 series Standards

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Substantially Equivalent (SE) Conclusion 9.

Based on the comparison, the intended use, mode of operation, and 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 devices are 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 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.