(221 days)
Not Found
No
The device description and intended use clearly define the device as simple, single-use plastic syringes for injecting contrast media or saline, with no mention of any software, algorithms, or intelligent capabilities.
No.
The device is for the injection of contrast media or saline, which are diagnostic agents, not therapeutic agents.
No
This device is a syringe for injecting contrast media or saline, which are substances used to enhance images for diagnostic purposes. However, the syringe itself does not perform any diagnostic function; it is a delivery mechanism.
No
The device description clearly states the device is a physical, single-use, disposable syringe made of plastic, indicating it is a hardware medical device.
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" using angiographic injectors. This is a direct medical intervention on a patient, not a test performed on a sample taken from the body.
- Device Description: The device is a syringe designed for injecting substances into a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to diagnose or monitor medical conditions. This device is used to deliver substances directly into a patient's body during a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
DXT
Device Description
The applicant device of ANT Angiographic Syringes are plastic, single-use, disposable syringes to be offered in 10 mL, 12 mL, 20mL, 60mL, 60ml, 65ml, 100ml, 115 ml, 125 mL, 130ml, 140ml and 200mL sizes. The syringes will be offered made of polypropylene or PET- both materials, of which, are available in current legally marketed products.
Variants: All variants include 7 series as followings: Series 1: Model 100101, Model 100103, Model 100103, Model 100202, Model 100202, Model 100203, Model 100204, Model 100301, Model 100302, Series 2: Model 200101, Model 200201, Model 200202, Model 200203, Model 200301, Series 3: Model 300101, Model 300102, Model 300202, Model 300301, Model 300302, Series 4: Model 400101, Series 5: Model 500101, Model 500102, Series 6: Model TR0012, Series 7: Model CS0010, Model CS0020,
All 8 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 from company Medrad. 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
Effectiveness: All the variant models of the applicant device are evaluated regarding the performance.
Safety Considerations: With accordance with the Table 1 Initial Evaluation Tests for Consideration and Table 2 Supplementary Evaluation Tests for Consideration in ISO 10993-1:2003(E), Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, the necessary tests for Biocompatibility Testing includes: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Systemic Toxicity (Acute), Haemo-compatibility.
Per 21 CFR 73.3107, Carbazole violet (Pigment Violet 23) (CAS Reg. No. 6358-30-1, Color Index No. 51319) is exempt from the certification requirement of 721(c) of FD&C Act.
Conclusion: The all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of all the possible skin-contact component material in the finished product meets the requirement of Biocompatibility
The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Assigned 510(k) Number is:
1. Applicant Device Information
Trade/Proprietary Name: ANT Angiographic Syringes Common Name: Angiographic injector and syringe. Classification Name: Injector and syringe, angiographic Device Class: II Product Code: DXT Regulation Number: 870.1650 Intended Use: ANT Angiographic Syringes are syringes for the injection of contrast media or saline. This syringe is for single us with US legally marketed angiographic injectors.
2. Submitter Information
Manufacturer Name:
Shenzhen Ant Hi-Tech Industrial Co., Ltd. Building 11, Lishan Industrial Park, Xinghai Ave, Nanshan District, Shenzhen, China
Contact Person of the Submission:
Ms. Diana. Hong Mr. Eric. Chen Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, China 20030 Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809 Email: Diana.hong@mid-link.net Eric.chen@mid-link.net
3. Predicate Device
K051799
1
Trade/Proprietary Name: Disposable CT/MR Syringes for Nemoto Injectors Common/Usual Name: Syringes for CT and MR Injections Classification Name: Angiographic Injector & Syringe
Submitter Name: Coeur, Inc. Address: 704 Cadet Court Lebanon, TN 37087 Phone: (615) 574-7923 Contact: Debra F. Manning, VP, Q & RA
4. Device Description
The applicant device of ANT Angiographic Syringes are plastic, single-use, disposable syringes to be offered in 10 mL, 12 mL, 20mL, 60mL, 60ml, 65ml, 100ml, 115 ml, 125 mL, 130ml, 140ml and 200mL sizes. The syringes will be offered made of polypropylene or PET- both materials, of which, are available in current legally marketed products.
Variants: All variants include 7 series as followings: Series 1: Model 100101, Model 100103, Model 100103, Model 100202, Model 100202, Model 100203, Model 100204, Model 100301, Model 100302, Series 2: Model 200101, Model 200201, Model 200202, Model 200203, Model 200301, Series 3: Model 300101, Model 300102, Model 300202, Model 300301, Model 300302, Series 4: Model 400101, Series 5: Model 500101, Model 500102, Series 6: Model TR0012, Series 7: Model CS0010, Model CS0020,
All 8 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 from company Medrad. The connector difference is only to fit the injector and does not affect the performance of the syringes.
2
5. Substantially Equivalence Determination
Comparison Analysis:
The Applicant device has the same classification intended use, sterilizations, performance, biocompatibility, chemical specifications and similar physical and mechanications with the predicate device. The only difference between applicant device and predicate device is some physical specifications variant which is too slight to influence the effectiveness and safety.
Conclusion:
The applicant device is Substantially Equivalent (SE) to the predicate device in terms of Effectiveness and Safety.
3
6. Effectiveness and Safety Considerations
Effectiveness:
All the variant models of the applicant device are evaluated regarding the performance.
Safety Considerations:
With accordance with the Table 1 Initial Evaluation Tests for Consideration and Table 2 Supplementary Evaluation Tests for Consideration in ISO 10993-1:2003(E), Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, the necessary tests for Biocompatibility Testing includes: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Systemic Toxicity (Acute), Haemo-compatibility.
Per 21 CFR 73.3107, Carbazole violet (Pigment Violet 23) (CAS Reg. No. 6358-30-1, Color Index No. 51319) is exempt from the certification requirement of 721(c) of FD&C Act.
Conclusion: The all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of all the possible skin-contact component material in the finished product meets the requirement of Biocompatibility
The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. 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 with three human profiles incorporated into its design. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shenzhen Ant Hi-Tech Industrial Co., LTD c/o Ms. Diana Hong Suite 8D, No. 19, Lane 999 Zhongshan No.2 Road (S) Shanghai, 200030. China
Re: K072696
Ant Angiographic Syringes, Model 100101,102,103,100201 Regulation Number: 21 CFR 870.1650 Regulation Name: Injector and Syringe, Angiographic Regulatory Class: Class II (two) Product Code: DXT Dated: Undated Received: April 28, 2008
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.
MAY - 2 2008
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.
5
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 (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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Duina R. hichner
Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K072696
Device Name: ANT Angiographic Syringes
Indications for Use:
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.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dune D. Achter
(Division Sign-Off) Division or Cardiovascular Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number_K022696
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