(302 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and material properties of disposable syringes and accessories, with no mention of AI or ML.
No.
The device is described as a sterile disposable syringe intended for injecting contrast media or saline, which are diagnostic and imaging purposes, not therapeutic treatment of a disease.
No
The device is a syringe for injecting contrast media or saline, which are used in diagnostic procedures but the syringe itself does not perform a diagnostic function.
No
The device description clearly outlines physical components such as plastic syringes, connecting tubes, J shape tubes, and spikes, indicating it is a hardware medical device.
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" using an angiographic injector. This describes a device used in vivo (within the body) for imaging procedures, not for testing samples in vitro (outside the body).
- Device Description: The description details syringes, connecting tubes, and accessories used for delivering substances into the body. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing conditions based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver substances into the body for imaging, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The Sterile Disposable Syringes are intended for the injection of contrast media or saline, they shall be used with an U.S legally marketed angiographic injector.
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 configuration 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.
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:
Cleanliness - Clause 5 of ISO 7886-2:1996
Limits for acidity or alkalinity - Clause 6 of ISO 7886-2:1996
Limits for extractable metals - Clause 7 of ISO 7886-2:1996
Lubricant - Clause 8 of ISO 7886-2:1996
Tolerance on graduated capacity - Clause 9 of ISO 7886-2:1996
Graduated scale - Clause 10 of ISO 7886-2:1996
Barrel - Clause 11 of ISO 7886-2:1996
Piston/ plunger assembly - Clause 12 of ISO 7886-2:1996
Nozzle - Clause 13 of ISO 7886-2:1996
Performance - Clause 14 of ISO 7886-2:1996
Gauging - Clause 4.1 of ISO 594-1:1986
Liquid leakage - Clause 4.2 of ISO 594-1:1986
Air leakage - Clause 4.3 of ISO 594-1:1986
Separation force - Clause 4.4 of ISO 594-1:1986
Stress cracking - Clause 4.5 of ISO 594-1:1986
Gauging - Clause 4.1 of ISO 594-2:1998
Leakage - Clause 4.2 of ISO 594-2:1998
Separation force - Clause 4.3 of ISO 594-2:1998
Unscrewing torque - Clause 4.4 of ISO 594-2:1998
Ease of assembly - Clause 4.5 of ISO 594-2:1998
Resistance to overriding - Clause 4.6 of ISO 594-2:1998
Stress cracking - Clause 4.7 of ISO 594-2:1998
Sterile Barrier Packaging Testing performed on the proposed device:
Seal strength - ASTM F88/F88-09
Dye penetration - ASTM F1929-12
Sterilization and Shelf Life Testing performed on the proposed device:
EO residue - ISO 10993-7:2008
ECH residue - ISO 10993-7:2008
Bacteria Endotoxin Limit - USP 38-NF 33
Shelf Life Evaluation - Physical, Mechanical, Chemical, Package Test were performed on aging samples to verify the claimed shelf life of the device
Biocompatibility Testing:
The patient-contact materials of proposed devices are identified and the proposed devices were tested for Cytotoxicity (ISO 10993-5), Skin Sensitization (ISO 10993-10), Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Hemolytic Property (ASTM F756), Pyrogen (ISO 10993-11) and Complement Activity (ISO 10993-4).
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.
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.
July 6, 2018
Shenyang MasTech Medical Device Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai, 200120 CN
Re: K172694
Trade/Device Name: Sterile Disposable Syringes Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: May 31, 2018 Received: June 5, 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. 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
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 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.
Michael John -S 2018.07.06 11:58:42 -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 Disposable Syringes
Indications for Use (Describe)
The Sterile Disposable Syringes are intended for the injection of contrast media or saline, they shall be used with an U.S legally marketed angiographic injector.
| 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
Exhibit #10 510(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: K172694
-
- Date of Preparation: 05/29/2018
-
- Sponsor Identification
Shenyang MasTech Medical Device Co., Ltd. Zhaojia Village, Qianjin Street, Dadong District, Shenyang 110165, China
Establishment Registration Number: Not yet registered
Contact Person: Liu Han Position: General Manager Tel: +86-24-24331351 Fax: +86-24-24326101 Email: sy@mastech-medical.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (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: Sterile Disposable Syringes Common Name: Disposable angiographic syringe
Regulatory Information
Classification Name: Angiographic injector and syringe; Classification: II; Product Code: DXT Regulation Number: CFR 870.1650 Review Panel: Cardiovascular
Intended Use Statement:
The Sterile Disposable Syringes are intended for the injection of contrast media or saline, they shall be used with an US legally marketed angiographic injector.
Device Description
The proposed devices are available in packs, which may include different configuration 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.
| Model (Syringe) | Volume (ml) | Type | K Number of Compatible Angiographic Injector |
|---|---|---|---|
| DSA-150-MARK | 150ml | Single shot | K903390 |
| DSA-150-LF | 150ml | Single shot | K860204 |
| DSA-130-NE | 125ml | Single shot | K092896 |
| CT/DSA-150-LF | 150ml | Single shot | K963071, K873687 |
| CT-200-MARK | 200ml | Single shot | K993728, K991557, K982814, K934086, K924116, K913624 |
| CT-200-MARK-E | 200ml | Single shot | K071378, K063029, K011160 |
| CT-200/200-MARK-E | 200/200ml | Dual shoot | K071378, K063029, K031571 |
| CT-200-LF | 200ml | Single shot | K912944 |
| CT-100-NE | 100ml | Single shot | K133189, K071691, K062168, K052633 |
| CT-200-NE | 200ml | Single shot | K133189, K071691, K062168, |
Table 1 Compatibility between Syringes and Injectors
5
| K052633 | |||
|---|---|---|---|
| CT/MRI-60-NE | 50ml | Single shot | K133189, K091734 (MRI), |
| K071691, K062168, K052633 | |||
| MRI-60-LF | 60/60ml | Dual shoot | K073592, K984088 |
| MRI-60-MARK | 65/65ml | Dual shoot | K011991, K935668 |
| MRI-100-MARK | 65/115ml | Dual shoot | K042784, K033247, K012950 |
| MRI-100-EZEM | 100/100ml | Dual shoot | K020892 |
The connecting tubes, which is used to connect the syringe and the catheter. The tubes are available in three configurations, which are straight tube, Type T tube and spiral tube. The different between these tubes is tube shape, which is available in straight shape for straight tube, spiral shape for spiral tube and T shape for T tube. The Type T tube is available in a various specifications to connect different model of syringe.
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.
- న్. Identification of Predicate Device
510(k) Number: K072696 Product Name: ANT Angiographic Syringes Manufacturer: Shenzhen Ant Hi-Tech Industrial Co., Ltd.
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:
| Cleanliness | Clause 5 of ISO 7886-2:1996 |
|---|---|
| Limits for acidity or alkalinity | Clause 6 of ISO 7886-2:1996 |
| Limits for extractable metals | Clause 7 of ISO 7886-2:1996 |
| Lubricant | Clause 8 of ISO 7886-2:1996 |
| Tolerance on graduated capacity | Clause 9 of ISO 7886-2:1996 |
| Graduated scale | Clause 10 of ISO 7886-2:1996 |
| Barrel | Clause 11 of ISO 7886-2:1996 |
| Piston/ plunger assembly | Clause 12 of ISO 7886-2:1996 |
| Nozzle | Clause 13 of ISO 7886-2:1996 |
| Performance | Clause 14 of ISO 7886-2:1996 |
6
| Gauging | Clause 4.1 of ISO 594-1:1986 |
|---|---|
| Liquid leakage | Clause 4.2 of ISO 594-1:1986 |
| Air leakage | Clause 4.3 of ISO 594-1:1986 |
| Separation force | Clause 4.4 of ISO 594-1:1986 |
| Stress cracking | Clause 4.5 of ISO 594-1:1986 |
| Gauging | Clause 4.1 of ISO 594-2:1998 |
| Leakage | Clause 4.2 of ISO 594-2:1998 |
| Separation force | Clause 4.3 of ISO 594-2:1998 |
| Unscrewing torque | Clause 4.4 of ISO 594-2:1998 |
| Ease of assembly | Clause 4.5 of ISO 594-2:1998 |
| Resistance to overriding | Clause 4.6 of ISO 594-2:1998 |
| Stress cracking | Clause 4.7 of ISO 594-2:1998 |
Sterile Barrier Packaging Testing performed on the proposed device:
| Seal strength | ASTM F88/F88-09 |
|---|---|
| Dye penetration | ASTM F1929-12 |
Sterilization and Shelf Life Testing performed on the proposed device:
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP 38-NF 33 |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Test |
| were performed on aging samples to verify the | |
| claimed shelf life of the device |
Biocompatibility Testing:
The patient-contact materials of proposed devices are identified and the proposed devices were tested for Cytotoxicity (ISO 10993-5), Skin Sensitization (ISO 10993-10), Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Hemolytic Property (ASTM F756), Pyrogen (ISO 10993-11) and Complement Activity (ISO 10993-4).
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
7
Substantially Equivalent (SE) Comparison 8.
Table 1 Comparison of Technology Characteristics
| Item | Proposed Device | | | Predicate Device
K072696 | | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------------------------|
| Product Code | DXT | | | DXT | | |
| Regulation
Number | CFR 870.1650 | | | CFR 870.1650 | | |
| Intended Use | The Sterile Disposable Syringes are intended for the injection of contrast
media or saline, they shall be used with an U.S legally marketed
angiographic injector. | | | ANT Angiographic Syringes are syringes for the injection of contras
media or saline. This syringe is for single use with U.S leally marketec
angiographic injection. | | |
| Operation mode | Power-driven operation, single use | | | Power-driven operation, single use | | |
| Configuration
and Material | Angiographic
Syringe | Configuration | Material | Angiographic
Syringe | Configuration | Material |
| | | Barrel | Polycarbonate (PC) or
Polypropylene (PP) | | Barrel | Polypropylene (PP) or
Polyethylene terephthalate (PET) |
| | | Piston | Natural Rubber | | Piston | Unknown |
| | | Piston Seat | Polycarbonate (PC) or
Polypropylene (PP) | | Piston Seat | Unknown |
| | | Protective Cap | Polypropylene (PP) | | Protective Cap | Unknown |
| | | Connecting
tube | Tubing | | Polyvinyl Chloride (PVC) | Connecting
tube |
| | | | Check Valve | | Polycarbonate (PC) | |
| J shape tube | | Polyethylene (PE) | J shape tube | | Unknown | |
| Spike | | Acrylonitrile-butadiene-styrene (ABS) | Spike | | Unknown | |
| Sterility | EO Sterilized | | | EO Sterilized | | |
| Single Use | Yes | | | Yes | | |
S001
8
| Biocompatibility | Cytotoxicity | No cytotoxicity. | Cytotoxicity | No cytotoxicity. |
|---|---|---|---|---|
| Irritation | No intracutaneous reactivity. | Irritation | No intracutaneous reactivity. | |
| Sensitization | No skin sensitization | Sensitization | No skin sensitization | |
| Systemic Toxicity | No systemic toxicity | Systemic Toxicity | No systemic toxicity | |
| Hemolysis | No hemolysis | Hemolysis | No hemolysis | |
| Pyrogen | No pyrogen | Pyrogen | No pyrogen | |
| Complement Activation | No complement | Complement Activation | No complement | |
| Performance | Comply with ISO 7886-2, ISO594-1 and ISO 594-2 | Comply with ISO 7886-2, ISO594-1 and ISO 594-2 |
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.
S001