(154 days)
Not Found
No
The description focuses on the mechanical components and performance of a syringe-like device for injecting and aspirating fluids. There is no mention of any computational or analytical capabilities that would suggest the use of AI/ML.
No.
This device is an angiography injector designed to administer or withdraw fluids, primarily contrast media, during interventional procedures, which is a diagnostic or procedural aid, not a device that itself treats a disease or condition.
No
Explanation: The device is an Angiography Injector, intended to aspirate and inject contrast media and other fluids. Its function is to deliver or withdraw substances, not to provide diagnostic information.
No
The device description clearly outlines physical components (Piston, Plunger cap, Push-button, Barrel, Plunger, Adapter) and mentions sterilization and packaging, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aspirate and inject contrast media in the interventional procedure" and "inject fluids into, or withdraw fluids from the body." This describes a device used directly on or in the patient for therapeutic or procedural purposes.
- Device Description: The description details a syringe-like device for handling fluids within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing. IVDs typically involve analyzing blood, urine, tissue, or other bodily fluids outside the body.
- Performance Studies: The performance studies focus on the physical and biological safety of the device itself (leakage, force, biocompatibility, sterilization, etc.), not on the accuracy or performance of a diagnostic test.
In summary, the Angiography Injector is a medical device used for administering or withdrawing substances from the body during a medical procedure, which falls under the category of a therapeutic or procedural device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Angiography Injector is intended to aspirate and inject contrast media in the interventional procedure. It can also be used to inject fluids into, or withdraw fluids from the body.
Product codes (comma separated list FDA assigned to the subject device)
DXT
Device Description
The Angiography Injector is intended to provide the function of aspirating and injecting contrast media in the interventional procedure. It can also be used to inject fluids into, or withdraw fluids from the body. The proposed device is intended for single use and is provided sterile using EO sterilization.
The Angiography Injector consists of six components: 1) Piston, 2) Plunger cap, 3) Push-button 4) Barrel, 5) Plunger and 6) Adapter (rotating or fixed). The proposed device is available in volume of 6mL, 8mL, 10mL and 12mL.
The primary package is blister package and plastic paper package. The blister package and plastic paper package all consist of PE film and Tyvek®2FS paper.
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
Surgical operating room
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)
Bench Performance Testing: The completion of the performance testing listed in the table below demonstrates that the proposed device meets the defined design specifications and is suitable for its intended use.
Test Items: Appearance, Lubricant, Graduated scale, Luer connector, Nozzle lumen, Force to operate the piston, Freedom from air and liquid leakage past plunger stopper, Tolerance on graduated capacity, Fit of plunger stopper/plunger in barrel, Dead space, Particulate Evaluation, Simulated use testing, Reducing (oxidizable) matter, Limits for extractable metals, Limits for acidity or alkalinity, Residue of evaporation, UV adsorption, EO residual.
Biocompatibility Testing: To demonstrate the biological safety of the body-contacting materials of the Angiography Injector, the following biocompatibility testing in accordance with "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff" were completed.
Test Items: In Vitro Cytotoxicity Test, In Vitro Hemolytic, Intracutaneous Reactivity, Skin Sensitization, Acute Systemic Toxicity, Pyrogen.
Sterilization: The Ethylene Oxide sterilization process is validated as per ISO 11135-1 Sterilization of health care products -Ethylene Oxide - Part 1 (Requirements for development, validation and routine control of a sterilization process for medical devices), Method C (Overkill Method: This method is based on demonstrating that the sterilization of a microbial challenge (biological indicator) exceeds the challenge posed by the bioburden of the product. Confirmatory EO residual testing was conducted on the subject device to confirm that the design differences did not impact residual EO levels of the device. The testing confirmed that EO residuals were within the limits specified in ISO 10993-7.
Packaging and Shelf Life: The proposed shelf life of subject device is 3 years. The shelf life study for Angiography Injector was planned as per ASTM 1980 recommended conditions. The study was conducted with elevated temperature conditions and with real time conditions. As per ASTM 1980 recommended accelerated aging conditions were used to establish the shelf life of the Angiography Injector. The real time shelf time study is still on going. The results of the accelerated aging study has not shown any significant changes in product characteristics.
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.
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
§ 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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 23, 2024
Shandong INT Medical Instruments Co., Ltd. Zhang Wei RA specialist No. 188. Fuzhou Road Rizhao. Shandong 276599 China
Re: K242143
Trade/Device Name: Angiography Injector Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: December 5, 2024 Received: December 6, 2024
Dear Zhang Wei:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Shruti N. Mistry -S
Shruti Mistry Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
K242143
Device Name
Angiography Injector
Indications for Use (Describe)
The Angiography Injector is intended to aspirate and inject contrast media in the interventional procedure. It can also be used to inject fluids into, or withdraw fluids from the body.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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K242143 - 510(K) summary
I. Submitter
| Submission Sponsor | Shandong INT Medical Instruments Co., Ltd.
No. 188, Fuzhou Road, Rizhao, Shandong 276599, China |
|---------------------------|----------------------------------------------------------------------------------------------------|
| Submission Correspondent: | Zhang Wei
RA specialist
Tel.: +8615601952252
E-mail: zhangwei@int-medical.com |
| Submission Date: | December 5, 2024 |
Proposed Device II.
| Trade or Proprietary Name: | Angiography Injector |
|---|---|
| Common or Usual Name: | Angiographic Injector And Syringe |
| Regulation Number: | 21 CFR 870.1650 |
| Product code: | DXT |
| Regulatory Class: | Class II |
| Review Panel: | Cardiovascular |
| Reason for Submission: | New device |
III. Predicate Devices
| Primary predicate device | |
|---|---|
| 510(k) Number: | K163084 |
| Trade name: | Merit Coronary Control Syringe |
| Classification: | Class II |
| Product Code: | DXT |
| Manufacturer: | Merit Medical Systems, Inc. |
IV. Indications for Use
The Angiography Injector is intended to aspirate and inject contrast media in the interventional procedure. It can also be used to inject fluids into, or withdraw fluids from the body.
V. Device Description
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The Angiography Injector is intended to provide the function of aspirating and injecting contrast media in the interventional procedure. It can also be used to inject fluids into, or withdraw fluids from the body. The proposed device is intended for single use and is provided sterile using EO sterilization.
The Angiography Injector consists of six components: 1) Piston, 2) Plunger cap, 3) Push-button 4) Barrel, 5) Plunger and 6) Adapter (rotating or fixed). The proposed device is available in volume of 6mL, 8mL, 10mL and 12mL.
The primary package is blister package and plastic paper package. The blister package and plastic paper package all consist of PE film and Tyvek®2FS paper.
VI. Comparison to the Predicate Device
The proposed Angiography Injector has the same indications for use, as well as similar materials, design and mode of action as the Merit Coronary Control Syringe predicate device.
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| Item | Proposed device | Predicate device
K163084 | Discussion |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Product name | Angiography Injector | Merit Coronary Control Syringe | |
| Product Code | DXT | DXT | Same |
| Regulation No. | 21 CFR 870.1650 | 21 CFR 870.1650 | Same |
| Class | Class II | Class II | Same |
| Indications for
Use | The Angiography Injector is intended to
aspirate and inject contrast media in the
interventional procedure. It can also be
used to inject fluids into, or withdraw
fluids from the body. | The Merit Coronary Control Syringe is
intended to be used for the intraarterial
or intravenous administration of
radiographic contrast media. The
syringe can also be used to inject fluids
into, or withdraw fluids from the body. | Same |
| Mode of Action | Intended for manual use | Intended for manual use | Same |
| Environment of
use | Surgical operating room | Surgical operating room | Same |
| Materials | Barrel - PC
Plunger - ABS
Piston - Polyisoprene rubber
Plunger Cap - HDPE
Push-button - ABS
Rotating adapter - PC + Silicone | Barrel - PC
Plunger - ABS
Seal - Silicone
Rotator O - Ring - Silicone | Similar1
(Discussion 1) |
| Design Standards | Luer Connector to ISO 80369-7
Injector to ISO 7886-1 | Luer Connector to ISO 80369-7
Injector to ISO 7886-1 | Same |
| Duration of Use | Less than 24h | Less than 24h | Same |
| Volume | 612mL | 620 mL | Similar2
(Discussion 2) |
| Graduation | Printed with accurate graduation lines | Printed with accurate graduation lines | Same |
| | that are compliant with ISO 7886-1. | that are compliant with ISO 7886-1. | |
| Sterile | Yes | Yes | Same |
| Single for Use | Yes | Yes | Same |
| Prescription
(Rx Only) | Yes | Yes | Same |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same |
| SAL | 10-6 | 10-6 | Same |
| Shelf life | 3 years | 3 years | Same |
| Barrel
Transparency | Clear | Clear | Same |
| Physical and
Mechanical | ISO 7886-1 | ISO 7886-1 | Same |
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8
Comparison Discussion
The following differences between the subject and predicate device do not raise new or different questions of safety and effectiveness.
Discussion 11 The difference in the materials does not raise additional questions for safety and effectiveness of the device when compared to the predicate device. The biocompatibility evaluation test of the subject devices have been performed on the final finished device which includes all materials of construction. The test results show that the acceptance criteria have been met.
Discussion 22 The volume of the proposed device is slightly different from the predicate device. This difference does not raise new or different questions of safety and effectiveness when compared to the predicate device. The performance tests have been carried out according to ISO 7886, and the test results show that the requirements of the standard have been met.
VII. Bench Performance Testing
The completion of the performance testing listed in the table below demonstrates that the proposed device meets the defined design specifications and is suitable for its intended use.
Test Items: Appearance Lubricant Graduated scale Luer connector Nozzle lumen Force to operate the piston Freedom from air and liquid leakage past plunger stopper Tolerance on graduated capacity Fit of plunger stopper/plunger in barrel Dead space Particulate Evaluation Simulated use testing 5 / 7 Reducing (oxidizable) matter
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Limits for extractable metals Limits for acidity or alkalinity Residue of evaporation UV adsorption EO residual Sterility Bacterial endotoxin
VIII. Biocompatibility Testing
To demonstrate the biological safety of the body-contacting materials of the Angiography Injector, the following biocompatibility testing in accordance with "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff" were completed.
Test Items:
In Vitro Cytotoxicity Test In Vitro Hemolytic Intracutaneous Reactivity Skin Sensitization Acute Systemic Toxicity Pyrogen
IX. Sterilization
The subject device is sterilized by traditional Ethylene Oxide sterilization methods. The Ethylene Oxide sterilization process is validated as per ISO 11135-1 Sterilization of health care products -Ethylene Oxide - Part 1 (Requirements for development, validation and routine control of a sterilization process for medical devices), Method C (Overkill Method: This method is based on demonstrating that the sterilization of a microbial challenge (biological indicator) exceeds the challenge posed by the bioburden of the product. Confirmatory EO residual testing was
10
conducted on the subject device to confirm that the design differences did not impact residual EO levels of the device. The testing confirmed that EO residuals were within the limits specified in ISO 10993-7.
X. Packaging and Shelf Life
The subject device is supplied sterile. The sterile barrier packaging is designed to maintain sterility until it open.
The proposed shelf life of subject device is 3 years. The shelf life study for Angiography Injector was planned as per ASTM 1980 recommended conditions. The study was conducted with elevated temperature conditions and with real time conditions. As per ASTM 1980 recommended accelerated aging conditions were used to establish the shelf life of the Angiography Injector. The real time shelf time study is still on going. The results of the accelerated aging study has not shown any significant changes in product characteristics.
XI. Clinical Testing
No clinical study is included in this submission.
XII. Conclusion
The proposed device has the same indications and has similar design features and technological characteristic as the predicate device. Non-clinical testing data demonstrates that the proposed device is substantially equivalent to the predicate device.