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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Disposable Angiographic Syringe (K082439) based on the provided text:

Important Note: The provided document is a 510(k) Summary and an FDA clearance letter. It typically does not contain detailed study protocols, raw data, or specific acceptance criteria with quantifiable metrics and reported performance values. The information provided will reflect what is typically found in such a summary, which is often high-level and attests to testing being completed successfully rather than providing a detailed report of the results.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific acceptance criteria values (e.g., "burst pressure > X psi") and corresponding reported performance metrics are not provided in this 510(k) summary. The summary states:

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

This indicates that internal design specifications served as the acceptance criteria, and the device's performance met these unstated specifications. For a detailed table, one would need to access the full testing report submitted to the FDA, which is not publicly available in this summary.

General Inference of Acceptance Criteria: Based on the device type (angiographic syringe), acceptance criteria would likely relate to:

Acceptance Criteria Category (Inferred)	Reported Device Performance (Inferred)
Material Biocompatibility	Meets biocompatibility standards.
Sterility	Meets sterility assurance levels.
Functional Performance (e.g., plunger force, leakage)	Operates as intended without issues.
Pressure Resistance/Burst Strength	Withstands intended operating pressures.
Compatibility with Injectors	Fits and functions with listed injectors.
Durability/Integrity	Maintains integrity during use.
Dimensional Accuracy	Meets specified dimensions.

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

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: The studies were laboratory tests conducted by the manufacturer, Shandong Weigao Group Medical Polymer Co., Ltd., which is located in China. The data would be prospective in nature, as it was generated specifically for the 510(k) submission.

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

This information is not applicable and not provided. For a medical device like an angiographic syringe, ground truth is typically established through:

Engineering specifications.
Material testing standards.
Performance test protocols.
Compliance with recognized standards (e.g., ISO, ASTM).

It does not involve expert consensus in the same way an AI diagnostic algorithm for medical imaging would. The "ground truth" for this device's performance is objective physical and chemical measurements against pre-defined engineering and safety standards.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, particularly in clinical studies involving interpretation (e.g., by radiologists). For laboratory testing of a device's physical properties, the results are typically quantitative measurements, not subject to expert adjudication of subjective interpretations.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to assess the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. It is not relevant for the clearance of a basic medical device like a disposable syringe, whose function is mechanical and material-based.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

No, a standalone study in the context of an "algorithm only" performance was not done. This device is a physical medical instrument, not an AI algorithm. The performance evaluation involved laboratory testing of the syringe itself, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation was based on engineering specifications, material science standards, and performance testing against predetermined criteria. These would cover aspects like:

Specified material properties (PP and PETG).
Dimensional tolerances.
Pressure resistance.
Seal integrity.
Biocompatibility (often tested against ISO 10993).
Sterility (e.g., SAL of 10^-6).
Leakage rates.
Functional compatibility with specified injectors.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning algorithms. This device is a physical product and does not involve a training set. The manufacturer's design and manufacturing processes are iteratively refined through quality control, but this isn't analogous to an ML training set.

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

This information is not applicable and not provided. As explained in point 8, there is no "training set" in the context of this device.

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;
1. Sponsor

ShanDong WeiGao Group Medical Polymer Co., Ltd No.312 Shichang Road, Weihai Shangdong, 264209, China Contact Person: Ms. Zhao Suxia Tel: +86-631-5621632 Fax: +86-631-5620555 E-Mail: Zsx9001@sina.com

1. 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
1. 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
1. Predicate Device Identification: ANT Angiographic Syringes K-number: K072696
1. 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.

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7. Device Description:

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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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

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.