DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT

• K Number: K082439
• Device Name: DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT
• Manufacturer: SHANDONG WEIGAO MEDICAL POLYMER CO., LTD
• Date Cleared: 2009-03-23 ( 210 days)
• Product Code: DXT
• Regulation Number: 870.1650

Intended Use

Disposable Angiographic Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.

Device Description

The applicant device of Disposable Angiographic Syringe are plastic, single-use, disposable syringes to be offered in 50/50ml, 50/200ml, 60/60 mL, 60/100mL, 90ml,, 120 ml., 130 mL, 150 mL and 200mL sizes. The syringes will be offered made of PP and PETG both materials, of which, are available in current legally marketed products. All series follow same design principle, same material, and same intended use. The only differences are volume and the connection (nozzle) to different angiography injector from different manufacturer. The connection differs to fit with US legally Market Angiographic Injectors. The connector difference is only to fit the injector and does not affect the performance of the syringes.

Predicate Devices

K072696

Reference Devices

K072696

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are for a simple, disposable syringe for contrast injection, with no mention of any computational or analytical capabilities that would involve AI/ML.

Therapeutic

No
The device is described as a syringe for injecting contrast media or saline, which is a diagnostic or procedural aid, not a device intended for treating a disease or condition.

Diagnostic

No.
This device is a syringe for injecting contrast media or saline, which are used in diagnostic procedures, but the syringe itself is not performing a diagnostic function. It is a delivery device.

SaMD (Software as a Medical Device)

No

The device is a physical, disposable syringe made of plastic, intended for injecting contrast media or saline. It is a hardware device, not software.

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 medical intervention on a patient, not a test performed on a sample taken from the body to diagnose a condition.
• Device Description: The description details a syringe, a device used for delivering substances into the body.
• Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This syringe is used to administer substances into the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Disposable Angiographic Syringe is intended for the injection of contrast media or saline. This syringe is for single us with US legally marketed angiographic injectors.

Product codes

DXT

Device Description

The applicant device of Disposable Angiographic Syringe are plastic, single-use, disposable syringes to be offered in 50/50ml, 50/200ml, 60/60 mL, 60/100mL, 90ml,, 120 ml., 130 mL, 150 mL and 200mL sizes. The syringes will be offered made of PP and PETG both materials, of which, are available in current legally marketed products.

All series follow same design principle, same material, and same intended use. The only differences are volume and the connection (nozzle) to different angiography injector from different manufacturer. The connection differs to fit with US legally Market Angiographic Injectors. The connector difference is only to fit the injector and does not affect the performance of the syringes.

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

Laboratory testing was conducted to validate and verify that Disposable Angiographic Syringe met all design specifications and was substantially equivalent to the predicate device.

Key Metrics

Not Found

Predicate Device(s)

K072696

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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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510(k) Summary for K082439 Shandong Weigao Group Medical Polymer Co., Ltd Disposable Angiographic Syringe

Appendix III 510(k) Summary

As Required by CFR 807.92

The assigned 510(k) Number is: K082439

• l . Date Prepared: March 18, 2009;
• 2. Sponsor

ShanDong WeiGao Group Medical Polymer Co., Ltd No.312 Shichang Road, Weihai Shangdong, 264209, China Contact Person: Ms. Zhao Suxia Tel: [phone] Fax: [phone] E-Mail: [e-mail]

• 3. Submission Correspondent Ms. Diana Hong / Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongshan Zhongxin Mansion No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai. 200030. China
• 4. Device Name and Classification: Device Trade Name: Disposable Angiographic Syringe Models: CT-200-MA. CT-200A-MA. CT-200B-MA. CT-200+200-MA, CT-200-LF, CT-100-NE, CT-200-NE. MRI-60460-MA, MRI-60+110-MA Device Common Name: Angiographic injector and syringe Device Classification Name: Injector and syringe, angiographic Product Code: DXT Regulation Number: 870.1650 Device Class: 11
• 5. Predicate Device Identification: ANT Angiographic Syringes K-number: K072696
• 6. Intended Use:

Disposable Angiographic Syringe is intended for the injection of contrast media or saline. This syringe is for single us with US legally marketed angiographic injectors.

1

7. Device Description:

The applicant device of Disposable Angiographic Syringe are plastic, single-use, disposable syringes to be offered in 50/50ml, 50/200ml, 60/60 mL, 60/100mL, 90ml,, 120 ml., 130 mL, 150 mL and 200mL sizes. The syringes will be offered made of PP and PETG both materials, of which, are available in current legally marketed products.

All series follow same design principle, same material, and same intended use. The only differences are volume and the connection (nozzle) to different angiography injector from different manufacturer. The connection differs to fit with US legally Market Angiographic Injectors. The connector difference is only to fit the injector and does not affect the performance of the syringes.

Model (Syringe)	Volume (m1)	Model (Compatible Injectors)
		The Disposable Angiographic Syringe models listed below are compatible with the following
corresponding Medrad Injector models
CT-200-111	2(10	MCF & MCT Plus CT. Vistron CT. En Vision CT
C7-200A-AIA	200	Stellant CT
CT-200B-MA	200	Siellant C"T
CT-200 : 200-MA	2(1)	Stellant ("T
MICI-60 60-11A	(1/60)	Spectris
MRI-60-110-11A	(6(1) 1 (1)	Solaris
		The Disposable Angiographic Syringe model listed below is compatible with the following Libel
Flarsheim Injector models
('T-200-LF	200	CT9000, CT9000ADV
		The Disposable Anglographic Syringe models listed below are compatible with the following
corresponding Nemoto Kyorindo Injector models
CT-100-NE	100	Dual Shot C1
CT-200-NIS	200	Dual Shot CT

The differences of syringe volume and nozzle type are presented below:

8. Test Conclusion

Laboratory testing was conducted to validate and verify that Disposable Angiographic Syringe met all design specifications and was substantially equivalent to the predicate device.

ಳು.

ಪ Substantially Equivalent Conclusion:

The subject device, Disposable Angiographic Syringe, is substantially equivalent to the predicate device.

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Public Health Service

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2009

ShanDong WeiGao Group Medical Polymer Co., Ltd. c/o Ms. Diana Hong Suite 8D, No. 19, Lane 999, Zhongshan No. 2 Road(S) Shanghai, 200030, China

Re: K082439

Disposable Angiographic Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Injector and Syringe, Angiographic Regulatory Class: Class II Product Code: DXT Dated: February 26, 2009 Received: February 26, 2009

Dear Ms. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Diana Hong

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. Vutines

Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Submission - Chapter II Indication fur Use Form Report No.: A2008-003-035

Indication for Use

510(k) Number:

Device Name: Disposable Angiographic Syringe

Indications for Use:

Disposable Angiographic Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.

Prescription Use __ Y (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ _ of ﺴﺮ

umma R. Vaclines
(Division Sign. Or

(Division Sign-Off) Division of Cardiovascular Devicer

510(k) Number_Ko 82439