(48 days)
No
The summary describes a simple mechanical device (syringes and tubes) for injecting contrast media. There is no mention of AI, ML, image processing, or any computational analysis of data. The testing focuses on mechanical properties like leakage and flow characteristics.
No.
The device is intended for the injection of contrast media or saline, which is a diagnostic/delivery function, not a therapeutic one.
No
The device is a syringe and connection tubes used for the injection of contrast media or saline during angiographic procedures. It is a tool used in a medical procedure, not a device that provides diagnostic information itself.
No
The device description clearly outlines physical components (plastic, disposable syringes, connection tubes) and performance testing related to these physical components (liquid leakage, flow characteristics, pressure resistance). There is no mention of software as the primary or sole component.
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" during angiographic procedures. 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 and 5 connection tubes." These are instruments used for delivering substances into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The focus is on the delivery of substances for imaging purposes.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the delivery of substances during a medical procedure.
N/A
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
DXT
Device Description
The proposed devices include 2 models of plastic, disposable syringes and 5 connection tubes of different specifications. They are intended to be used with an U.S. legally marketed angiography injector, compatibilities are shown in Table 1. The connection tubes are 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 and type T tube (used with dual shot syringe), they can withstand maximum pressure of 400 psi. The proposed devices are used with the J shape tube / spike cleared in K151960.
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: ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment-Part 1: General requirements ISO 594-2: 1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use; ISO 7886-2:1996 Sterile hypodermic syringes for single use- Part 2: Syringes for use with power-driven syringe pumps. The test samples of syringe 100104 and 100114 with accessories are tested for liquid leakage and flow characteristics. Actually, there is no design change between proposed device and predicate, the testing using 400 psi pressure is to demonstrate the increased resistant liquid leakage pressure statement. Therefore, other testing is not necessary for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 10, 2018
Shenzhen Baoan Medical Supplies Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN
Re: K182289
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: August 3, 2018 Received: August 23, 2018
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lydia S. Glaw -S 2018.10.10 14:25:31 -04'00'
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K182289
-
- Date of Preparation: 9/28/2018
-
- Sponsor Identification
Shenzhen Baoan Medical Supplies Co., Ltd
No. 6, Shenkeng Road, Shenkeng Industrial Zon Liuyue Community, Henggang, Longgang District, Shenzhen, 518173, China
Establishment Registration Number: 3012395857
Contact Person: Mingan Mu Position: Deputy General Manager Tel: +86-755-28638515 Fax: +86-755-28638033 Email: boon@szboon.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 001-3609253199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Sterile High-pressure Angiographic Syringes for Single-use; Common Name: Disposable angiographic syringe; Models: 100104 and 100114
Regulatory Information Classification Name: Angiographic injector and syringe Classification: II Product Code: DXT; Regulation Number: 21 CFR 870.1650; Review Panel: Cardiovascular;
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.
Device Description:
The proposed devices include 2 models of plastic, disposable syringes and 5 connection tubes of different specifications. 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 | Resistant Liquid
Leak Pressure (psi) | Compatible Angiographic Injector |
|--------------------|----------------|-----------|-----------------------------------------|----------------------------------|
| | | | | |
| 100114 | 200/200 | Dual Shot | 400 | CT 9000 & CT9000 ADV, K912944 |
Table 1 Compatibility between Syringes and Injectors
The connection tubes are 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 and type T tube (used with dual shot syringe), they can withstand maximum pressure of 400 psi.
The proposed devices are used with the J shape tube / spike cleared in K151960.
Identification of Predicate Device 5.
510k Number: K151960
Product Name: Sterile High-pressure Angiographic Syringes for Single-use; Manufacturer: Shenzhen Baoan Medical Supplies Co., Ltd
5
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:
ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment-Part 1: General requirements
ISO 594-2: 1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use;
ISO 7886-2:1996 Sterile hypodermic syringes for single use- Part 2: Syringes for use with power-driven syringe pumps.
The test samples of syringe 100104 and 100114 with accessories are tested for liquid leakage and flow characteristics. Actually, there is no design change between proposed device and predicate, the testing using 400 psi pressure is to demonstrate the increased resistant liquid leakage pressure statement. Therefore, other testing is not necessary for this submission.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
-
- Substantially Equivalent Comparison
| ITEM | Proposed Device | Predicate Device, K151960 |
|---|---|---|
| Product Code | DXT | DXT |
| Regulation No. | 21 CFR 870.1650 | 21 CFR 870.1650 |
| Class | II | II |
| 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. | 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. | ||
| Mode of Operation | Power-driven operation, single use | Power-driven operation, single use |
Table 2 Substantially Equivalent Comparison
6
| Angiographic Syringe | Angiographic Syringe | |
|---|---|---|
| Configuration | Connection Tube | |
| / | Connection Tube | |
| J shape tube/Spike | ||
| Sterility | EO Sterilized | EO Sterilized |
| Single Use | Yes | Yes |
| Resistant Liquid | ||
| Leak Pressure (psi) | Syringe: 400 psi | |
| Connection Tube: 400 psi | Syringe: 300 psi | |
| Connection Tube: 300 psi | ||
| Other Performance | Comply with ISO 7886-1, ISO 7886-2, | |
| ISO 594-1 and ISO 594-2 | Comply with ISO 7886-1, ISO 7886-2, | |
| ISO 594-1 and ISO 594-2 | ||
| Biocompatibility | Conforms to the requirements of ISO | |
| 10993 series Standards | Conforms to the requirements of ISO | |
| 10993 series Standards |
The proposed devices are stated to have a higher resistant liquid leak pressure. For this modification, liquid leak testing has been conducted on the models in this submission and test results have demonstrated the resistant liquid leak pressure is 400 psi for syringes and connection tube. Therefore, this modification will not impact the safety and effectiveness of device. In addition, the modified devices only include angiographic syringe and connection tube and they should be used with the J shape tube/spike cleared in K151960.
- Substantially Equivalent (SE) Conclusion 9.
Based on the comparison above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.