(154 days)
No
The device description and performance studies focus on the physical characteristics and material properties of disposable syringes and accessories for contrast media injection, with no mention of AI or ML.
No
Explanation: The device is intended for the "injection of contrast media or saline," which is diagnostic, not therapeutic. It also references "US legally marketed angiographic injectors," implying a diagnostic imaging context.
No
This device is intended for the injection of contrast media or saline, which are used to enhance images during diagnostic procedures. The device itself is an angiographic syringe for injection, not a diagnostic device that interprets or generates diagnostic information.
No
The device description clearly outlines physical components such as plastic syringes, connection tubes, J shape tubes, and spikes, indicating it is a hardware device, not software-only.
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." This is a direct administration of substances into the body, not for testing samples taken from the body.
- Device Description: The device is a syringe and accessories used for injection. This aligns with a device used for administering substances, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies focus on physical and material properties of the syringe and its components (sterility, leak testing, biocompatibility, etc.), which are relevant to an injection device, not an IVD.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for Use
The proposed device is intended for the injection of contrast media or saline. This syringe use with US legally marketed angiographic injectors.
Product codes (comma separated list FDA assigned to the subject device)
DXT
Device Description
The proposed devices are available in packs, which may include different configurations of syringes and accessories. 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, compatibilities are shown in Table 1.
The connection tubes, which is used to connect the syringe and the catheter. The tubes are available in two configurations, which are Type Y and Type T tube. The different between these tubes is tube shape, which is available in Y shape for Y tube and T shape for T tube.
J shape tube, which is used to draw contrast media/ saline into the syringe barrel.
Spikes, which are used to draw contrast media/saline into the syringe barrel.
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
No clinical study is included in this submission.
Description of the test set, sample size, data source, and annotation protocol
No clinical study is included in this submission.
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 F88/F88M-15 Standard test method for seal strength of flexible barrier materials;
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;
- USP 41-NF36 2018 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;
- 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 a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fitting:
- ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- 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 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
- USP Particulate matters
- ASTM F 756-17, Standard practice for assessment of hemolytic properties of material
- USP 41-NF36:2018 Pyrogen Test (USP Rabbit Test)
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.
K091734, K890898, K984088, K033247, K132928, K023183, K052633, K903390, K031339, K935668
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.
0
Image /page/0/Picture/0 description: The image shows 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 28, 2020
Youwo (Guangzhou) Medical Device Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China
Re: K201395
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: September 24, 2020 Received: September 25, 2020
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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).
Sincerely,
For CAPT Alan Stevens 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
2
Indications for Use
510(k) Number (if known) K201395
Device Name
Sterile High-pressure Angiographic Syringes for Single-use
Indications for Use (Describe)
The proposed device is intended for the injection of contrast media or saline. This syringe use with 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
Tab 6 510(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: K201395
-
- Date of Preparation: 10/20/2020
-
- Sponsor Identification
Youwo (Guangzhou) Medical Device Co., Ltd.
First Floor and Fourth Floor, Building D, No.188 Kaiyuan Ave, Hi-tech Industrial Development Zone, 510530 Guangzhou, P.R. China
Establishment Registration Number: Not yet registered
Contact Person: Meijin Song Position: Quality Manager Tel: +86 20-81729108 Fax: +86 20-81242709 Email: dollars1008@163.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Huifan Wang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
P.O. Box 126-119, Shanghai, 200126, China
Tel: +86-21-22815850, Fax: +1-360-925-3199 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
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 Statement:
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.
Device Description
The proposed devices are available in packs, which may include different configurations of syringes and accessories. 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, compatibilities are shown in Table 1.
| No | Model | Single or Dual
Shots | Injector |
|----|-------------|-------------------------|----------|
| 1 | I-50ml -B | Single | K091734 |
| 2 | I-60ml -A | Single | K890898 |
| 3 | I-60ml -B | Single | K984088 |
| 4 | I-65ml -A | Single | K033247 |
| 5 | I-100ml -B | Single | K091734 |
| 6 | I-115ml -A | Single | K033247 |
| 7 | I-150ml -A | Single | K132928 |
| 8 | I-190ml -A | Single | K023183 |
| 9 | I-200ml -A | Single | K023183 |
| 10 | I-200ml -B | Single | K091734 |
| 11 | II-125ml -A | Single | K052633 |
| 12 | II-150ml -A | Single | K903390 |
| 13 | II-200ml -A | Single | K031339 |
Table 1 Compatibility between Syringes and Injectors
5
| 14 | I 200-200ml -A | Dual | K023183 |
|---|---|---|---|
| 15 | I 200-200ml -B | Dual | K091734 |
| 16 | I 115-115ml -A | Dual | K033247 |
| 17 | I 100-100ml -B | Dual | K091734 |
| 18 | I 100-200ml -B | Dual | K091734 |
| 19 | I 50-100ml -B | Dual | K091734 |
| 20 | I 50-200ml -B | Dual | K091734 |
| 21 | I 60-60ml -A | Dual | K890898 |
| 22 | I 60-60ml -B | Dual | K984088 |
| 23 | I 65-65ml -A | Dual | K935668 |
| 24 | I 65-115ml -A | Dual | K033247 |
| 25 | II 200-200ml -A | Dual | K031339 |
| 26 | I 190-190ml -A | Dual | K023183 |
| 27 | I 50-50ml -B | Dual | K091734 |
| 28 | II 100-100ml -B | Dual | K091734 |
| 29 | I 60-100ml -B | Dual | K052633 |
The connection tubes, which is used to connect the syringe and the catheter. The tubes are available in two configurations, which are Type Y and Type T tube. The different between these tubes is tube shape, which is available in Y shape for Y tube and T shape for T tube.
J shape tube, which is used to draw contrast media/ saline into the syringe barrel.
Spikes, which are used to draw contrast media/saline into the syringe barrel.
- ર : 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
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:
- Non-Clinical Test Conclusion
-
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
6
-
ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials;
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;
-
USP 41-NF36 2018 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;
-
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 a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fitting:
-
ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
-
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 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
-
USP Particulate matters
-
ASTM F 756-17, Standard practice for assessment of hemolytic properties of material
-
USP 41-NF36:2018 Pyrogen Test (USP Rabbit Test)
-
- Clinical Test Conclusion
No clinical study is included in this submission.
7
8. Substantially Equivalent (SE) Comparison
| | Proposed Device | Predicate Device
K151960 | Remark |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| ITEM | | | |
| Product Code | DXT | DXT | Same |
| Regulation No. | CFR 870.1650 | CFR 870.1650 | Same |
| Class | II | II | Same |
| 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. | 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. | Same |
| Mode of
Operation | Power-Driven | Power-Driven | Same |
| | Angiographic Syringe | Angiographic Syringe | Same |
| Configuration | Connection tube | Connection tube | Same |
| | J shape tube/ Spike | J shape tube/Spike | Same |
| Specification | | | |
| Syringe volume
(ml) | Single shot: 50, 60, 65, 100, 115,
150, 190, 200, 125
Dual shot: 200/200,
115/115,
100/100,
100/200,
50/100,
50/200, 60/60, 65/65, 65/115,
190/190, 50/50, 60/100 | Single shot: 200, 150, 130
Dual shot: 200/200, 65/65,
65/115, 60/60, 60/100 | |
| Connection tube
length (mm) | 300, 500, 600, 750, 900, 1000,
1200, 1500, 1800, 2000, 2500,
3200 | 1500, 1800, 500, 700, 1000,
1200 | Analysis 1 |
| Spike length
(mm) | 36, 39, 44, 49 | 58.85, 47.35 | |
| J shape tube
length (mm) | 250 | 240 | |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Performance | Comply with:
ISO 7886-1, ISO 594-1 and ISO
594-2 | Comply with:
ISO 7886-1, ISO 594-1 and ISO
594-2 | Same |
| Biocompatibility | | | |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Irritation | No Irritation | No Irritation | Same |
| Sensitization | No Sensitization | No Sensitization | |
| Acute Toxicity | No Acute Toxicity | No Acute Toxicity | |
| Hemolysis | No Hemolysis | No Hemolysis | |
| Pyrogen | No Pyrogen | No Pyrogen | |
| Particulate testing | Comply with USP 788 | Comply with USP 788 | Same |
| Sterilization | EO Sterilized | EO Sterilized | Same |
| Patient-contact material- Angiographic syringe | | | |
| Barrel | polypropylene (PP) or
Polyethylene terephthalate
(PET) | polypropylene (PP) or
Polyethylene terephthalate
(PET) | Same |
| Piston | Medical rubber | Polyisoprene rubber | Analysis 2 |
| Patient-contact material-Connection tube | | | |
| Tube | polyvinyl chloride (PVC) | polyvinyl chloride (PVC) | Same |
| Luer connectors | Polycarbonate (PC) | Polycarbonate (PC) | Same |
| Patient-contact material-Spike and J shape tube | | | |
| Closure-piercing device | acrylonitrile-butadiene-styrene
(ABS) | acrylonitrile-butadiene-styrene
(ABS) | Same |
| Filter membrane | Medical rubber | Polypropylene (PP) | Analysis 2 |
| J shape tube | Polyethylene (PE) | Polyethylene (PE) | Same |
Table 2 General Comparison
5 / 7
8
Analysis 1
Although the proposed device has more product specification than that of the predicate device, the performance test results of syringes meet the criteria of ISO 7886-1, ISO 594-1 and ISO 594-2. The performance test results of connection tube meet the criteria of ISO 594-1 and ISO 594-2. The performance test results of shape tube showed no leaks. Therefore the specification difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate device.
Analysis 2
The patient contact material of piston and filter membrane for the proposed device is different from predicate device. However, the contact classification for the proposed device is same as the predicate device, both of them belong to blood path and indirect limited contact. In addition, biocompatibility tests which include Cytotoxicity, Irritation, Sensitization, Acute Toxicity, Hemolysis and Pyrogen have been evaluated for the proposed device and the test result does not show any adverse effects. Therefore, this difference is not considered to affect substantially equivalence.
-
- Substantially Equivalent (SE) Conclusion
9
Based on the comparison above, the proposed device, Sterile High-pressure Angiographic Syringes for Single-use, is determined to be Substantially Equivalent (SE) to the predicate device.