Sterile High-pressure Angiographic Syringes for Single-use

• K Number: K151960
• Device Name: Sterile High-pressure Angiographic Syringes for Single-use
• Manufacturer: SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD
• Date Cleared: 2016-01-07 ( 175 days)
• Product Code: DXT
• Regulation Number: 870.1650

Intended 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

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.

Predicate Devices

K072696

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a disposable syringe and its intended use with an angiography injector. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies focus on material and mechanical properties, not algorithmic performance.

Therapeutic

No
The device is described as an angiographic syringe intended for the injection of contrast media or saline, which are diagnostic/imaging substances, not therapeutic agents. Its function is to facilitate the diagnostic process by assisting with imaging, not to treat a condition.

Diagnostic

No

Explanation: The device is intended for the injection of contrast media or saline, which are used in imaging. It does not perform any diagnostic function itself.

SaMD (Software as a Medical Device)

No

The device description clearly states the device is a plastic, disposable syringe, which is a physical hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the "injection of contrast media or saline." This is a direct intervention on the patient, not a test performed on a sample taken from the patient.
• Device Description: The device is described as "plastic, disposable syringes." Syringes are used for administering substances into the body, not for analyzing samples outside the body.
• Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for the delivery of substances into the body during an angiographic procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DXT

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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;
• 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 Pyrogen test

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072696

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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 [phone] or [phone] 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 [phone] or [phone] 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
• 2. 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: [phone] Fax: [phone] Email: [e-mail]

• 3. 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: [phone], Fax: [phone] Email: [e-mail]

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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

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.

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, K924116
Visitron CT, K991557
En 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.

• 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:

• 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 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 Pyrogen test

• 7. 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 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.	ANT Angiographic Syringes are
syringes for the injection of contrast
media or saline. This syringe is for
single use with US legally marketed
angiographic injectors.
Mode of operation	Power-driven operation, single use	Power-driven operation, single use
Configuration	Angiographic Syringe
Connecting tube
J shape tube/Spike	Angiographic Syringe
Connecting tube
J 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.