(316 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and material properties of a disposable syringe and its accessories, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is for the injection of contrast media or saline, which are diagnostic agents, not therapeutic agents. The device itself does not provide therapy.
No
The device is a high-pressure syringe intended for the injection of contrast media or saline, which are substances used to enhance images for diagnostic purposes, but the syringe itself does not perform or interpret diagnostics. It is a delivery device, not a diagnostic one.
No
The device description clearly states it is a physical, disposable syringe made of plastic, along with accessories like tubes and spikes. It is intended for use with physical angiography injectors.
Based on the provided text, 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 describes a device used in vivo (within the body) for diagnostic imaging procedures, not a device used in vitro (outside the body) to examine specimens like blood or tissue.
- Device Description: The description focuses on the physical components (syringes, tubes, spike) and their function in delivering substances into the body via an angiography injector. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing information about a patient's health status based on in vitro testing.
Therefore, this device is an in vivo medical device used for administering substances during angiography, not an IVD.
N/A
Intended Use / Indications for Use
The Disposable High Pressure Syringe is intended for the injection of contrast media or saline. This syringe is for single use and it shall be used with US legally marketed angiographic injectors.
Product codes
DXT
Device Description
The Disposable High Pressure Syringe is available in packs, which may include different configurations of syringes and accessories, the accessories include connector tube, Quick fill tube and Spike.
The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S. legally marketed angiography injector.
The connector tube is used to connect the syringe and the catheter. They are also available in three configurations, which are WLP Series tube with one syringe connector (used with single shot syringe), WLT Series tube and WLM Series tube with two syringe connectors (used with dual shot syringe). The three connector tubes can withstand maximum pressure of 350psi.
The Quick Fill Tube and the Spike is used to draw drug into the syringe.
The proposed devices are intended to be used with an U.S. legally marketed angiography injector; compatibilities are shown in Table 1.
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 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
- ASTM F 88/F88M-2015 Standard test method for seal strength of flexible barrier materials;
- ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages;
- USP37-NF32 Bacterial Endotoxins Limit;
- ISO 11737-2:2009 Sterilization of medical devices- Microbiological methods- Part 2: Test of sterility performed in the definition, validation and maintenance of a sterilization process;
- ISO 7886-2:1996 Sterile hypodermic syringes for single use -- Part 2: Syringes for use with power-driven syringe pumps
- ISO594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General Requirements;
- ISO594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fitting;
- ISO 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood:
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity;
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
- ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
No clinical study is included in 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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 12, 2017
Union Medical Shenzhen Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN
Re: K170279
Trade/Device Name: Disposable High Pressure Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: November 21, 2017 Received: November 24, 2017
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Diana Hong
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-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,
Kenneth J. Cavanaugh -S
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 Disposable High Pressure Syringe
Indications for Use (Describe)
The Disposable High Pressure Syringe is intended for the injection of contrast media or saline. This syringe is for single use and it shall be used with US legally marketed angiographic injectors.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 807 Subpart C) |
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 of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K170279
-
- Date of Preparation: 11/14/2017
- Sponsor Identification 2.
Union Medical Shenzhen Co., Ltd.
Room 603, Building 3, Fantasia MIC Plaza, Nanhai Avenue, Nanshan District, Shenzhen, 518062, China
Establishment Registration Number: Not yet registered
Contact Person: Mr. Wenguo Zhang Position: General Manager Tel: +86-755-88898501 Fax: +86-755-26818966 Email: wgzhang@126.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Disposable High Pressure Syringe Common Name: Disposable angiographic syringe Models:
SMR101, SMR102, SMR103, SMR104, SMR201, SMR202, SMR204, SMR301, SMR302, SLF101, SLF102, SLF201, SLF202, SLF301, SNE102, SNE103, SNE104, SNE301 and SEZ101
Regulatory Information Classification Name: Angiographic injector and syringe Classification: II Product Code: DXT Regulation Number: CFR 870.1650 Review Panel: Cardiovascular
Indications for Use:
The Disposable High Pressure Syringe is intended for the injection of contrast media or saline. This syringe is for single use and it shall be used with US legally marketed angiographic injectors.
Device Description
The Disposable High Pressure Syringe is available in packs, which may include different configurations of syringes and accessories, the accessories include connector tube, Quick fill tube and Spike.
The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S. legally marketed angiography injector.
The connector tube is used to connect the syringe and the catheter. They are also available in three configurations, which are WLP Series tube with one syringe connector (used with single shot syringe), WLT Series tube and WLM Series tube with two syringe connectors (used with dual shot syringe). The three connector tubes can withstand maximum pressure of 350psi.
The Quick Fill Tube and the Spike is used to draw drug into the syringe.
The proposed devices are intended to be used with an U.S. legally marketed angiography injector; compatibilities are shown in Table 1.
5
| No. | Models
(P/N) | Volume(ml) | Type | Applicable Injection Systems/510(k) Number |
|-----|-----------------|------------|-------------|------------------------------------------------------------------------------|
| 1 | SMR101 | 200ml | Single Shot | MEDRAD Visitron CT 610 (K991557), En
Vision CT Injection System (K993782) |
| 2 | SMR102 | 200ml | Single Shot | MEDRAD CT Stellant Injection System
(K023183) |
| 3 | SMR103 | 125ml | Single Shot | MEDRAD Visitron CT 610 (K991557), En
Vision CT Injection System (K993782) |
| 4 | SMR104 | 200/200ml | Dual Shots | MEDRAD CT Stellant Injection System
(K023183) |
| 5 | SMR201 | 150ml | Single Shot | MEDRAD Mark V Injection System (K822536) |
| 6 | SMR202 | 200ml | Single Shot | MEDRAD Mark V Injection System (K822536) |
| 7 | SMR203 | 60ml | Single Shot | MEDRAD Mark V Injection System (K822536) |
| 8 | SMR204 | 130ml | Single Shot | MEDRAD Mark IV Injection System (K903390) |
| 9 | SMR301 | 60/60ml | Dual Shots | MEDRAD Spectris MR Injection System
(K935668) |
| 10 | SMR302 | 110/60ml | Dual Shots | MEDRAD Solaris MR Injection System
(K033247) |
| 11 | SLF101 | 200ml | Single Shot | LF CT9000 Injection System (K912944) |
| 12 | SLF102 | 200/200ml | Dual Shots | LF OptiVantage Dual-Head Injection System
(K042744) |
| 13 | SLF201 | 150ml | Single Shot | LF Angiomat 6000 Injection System (K944875) |
| 14 | SLF202 | 150ml | Single Shot | LF Angiomat Illumena Injection System
(K963071) |
| 15 | SLF301 | 60/60ml | Dual Shots | LF MRI OPTISTAR Injection System (K984088) |
| 16 | SNE101 | 100ml | Single Shot | NEMOTO Dual Shot ALPHA7 Injection System
(K133189) |
| 17 | SNE102 | 200ml | Single Shot | NEMOTO Dual Shot ALPHA7 Injection System
(K133189) |
| 18 | SNE103 | 200/60ml | Dual Shots | Nemoto Dual Shot CT Injection System
(K052633) |
| 19 | SNE104 | 200/100ml | Dual Shots | Nemoto Dual Shot CT Injection System
(K052633) |
| 20 | SNE301 | 60/60ml | Dual Shots | NEMOTO MRI Injection System (K091734) |
| 21 | SEZ101 | 200ml | Single Shot | EZEM Empower CT Injection System
(K063029) |
Table 1 Compatibility between Syringes and Injectors
6
- న్. Identification of Predicate Device
510(k) Number: K151960
Product Name: Sterile High-pressure Angiographic Syringes for Single-use Manufacturer: Shenzhen Baoan Medical Supplies Co., Ltd
-
Non-Clinical Test Conclusion 6.
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 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
-
ASTM F 88/F88M-2015 Standard test method for seal strength of flexible barrier materials;
-
ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages;
-
USP37-NF32 Bacterial Endotoxins Limit;
-
A ISO 11737-2:2009 Sterilization of medical devices- Microbiological methods- Part 2: Test of sterility performed in the definition, validation and maintenance of a sterilization process;
-
A ISO 7886-2:1996 Sterile hypodermic syringes for single use -- Part 2: Syringes for use with power-driven syringe pumps
-
A ISO594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General Requirements;
-
ISO594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fitting;
-
ISO 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood:
-
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity;
-
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
-
A ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
-
- Clinical Test Conclusion
No clinical study is included in this submission.
7
8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | DXT | K151960 |
| DXT | ||
| Regulation Number | CFR 870.1650 | CFR 870.1650 |
| Intended Use | The proposed device is intended for the | |
| injection of contrast media or saline. This | ||
| syringe is for single use with US legally | ||
| marketed angiographic injectors. | High-pressure Angiographic | |
| Syringes for Single-use are syringes | ||
| for the injection of contrast media or | ||
| saline. This syringe is for single use | ||
| with US legally marketed angiographic | ||
| injectors. | ||
| Mode of operation | Power-driven operation, single use | Power-driven operation, single use |
| Configuration | Angiographic Syringe | |
| Connector tube | ||
| Quick Fill Tube/Spike | Angiographic Syringe | |
| Connecting tube | ||
| J shape tube/Spike | ||
| Sterility | EO Sterilized | EO Sterilized |
| Single Use | Yes | Yes |
| Performance | Comply with: | |
| ISO 7886-2 | ||
| ISO 594-1 | ||
| ISO 594-2 | Comply with: | |
| ISO 7886-2 | ||
| ISO 594-1 | ||
| ISO 594-2 | ||
| Biocompatibility | Conforms to the requirements of ISO | |
| 10993 series Standards | Conforms to the requirements of ISO | |
| 10993 series Standards |
Table 1 Comparison of Technology Characteristics
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison, the intended use, mode of operation, sterility of proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
In addition, the results of performance tests performed on the proposed device can also demonstrate the proposed device is complied with FDA recognized standards, which the predicate device was also complied with. The results of biocompatibility studies performed on the proposed device demonstrate that the patient materials used in proposed device are biocompatible.
Based on the comparison above, the proposed device, Disposable High Pressure Syringe, is determined to be Substantially Equivalent (SE) to the predicate device.