(302 days)
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.
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. 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.
This document is a 510(k) Summary for Sterile Disposable Syringes, which is a regulatory submission to the FDA. It details the device, its intended use, and non-clinical testing performed to establish substantial equivalence to a predicate device. It specifically states: "No clinical study is included in this submission."
Therefore, the following information about acceptance criteria and studies to meet them cannot be provided from the given text:
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A table of acceptance criteria and the reported device performance: While the document lists various non-clinical tests and standards (e.g., ISO 7886-2, ISO 594-1, ISO 594-2), it does not explicitly state numerical acceptance criteria for these tests or specific reported device performance results in a comparative table for a clinical study. It only states that the device "complies with the following standards" and that “non clinical tests were conducted to verify that the proposed device met all design specifications”. For biocompatibility, it states "No cytotoxicity," "No intracutaneous reactivity," etc., which can be considered performance relative to certain criteria.
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Sample sized used for the test set and the data provenance: No clinical test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no clinical test set/study.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there is no clinical test set/study.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (syringes) and not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device (syringes) and not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as there is no clinical test set/study. The ground truth for the non-clinical tests would be the established specifications and standards (e.g., ISO for sterility, gauging, leakage).
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The sample size for the training set: Not applicable as there is no clinical study or algorithm that requires a training set. The device is a physical product (syringes).
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How the ground truth for the training set was established: Not applicable as there is no clinical study or algorithm that requires a training set.
Summary of available information regarding non-clinical acceptance and performance:
The non-clinical tests performed on the proposed device (Sterile Disposable Syringes) were conducted to verify that it met all design specifications and was Substantially Equivalent (SE) to the predicate device (ANT Angiographic Syringes K072696).
The tests and their compliance statements are:
| Test/Characteristic | Standard/Description | Reported Device Performance/Compliance Statement |
|---|---|---|
| Cleanliness | Clause 5 of ISO 7886-2:1996 | Complies with standard |
| Limits for acidity/alkalinity | Clause 6 of ISO 7886-2:1996 | Complies with standard |
| Limits for extractable metals | Clause 7 of ISO 7886-2:1996 | Complies with standard |
| Lubricant | Clause 8 of ISO 7886-2:1996 | Complies with standard |
| Tolerance on graduated capacity | Clause 9 of ISO 7886-2:1996 | Complies with standard |
| Graduated scale | Clause 10 of ISO 7886-2:1996 | Complies with standard |
| Barrel | Clause 11 of ISO 7886-2:1996 | Complies with standard |
| Piston/plunger assembly | Clause 12 of ISO 7886-2:1996 | Complies with standard |
| Nozzle | Clause 13 of ISO 7886-2:1996 | Complies with standard |
| Performance | Clause 14 of ISO 7886-2:1996 | Complies with standard |
| Gauging | Clause 4.1 of ISO 594-1:1986 | Complies with standard |
| Liquid leakage | Clause 4.2 of ISO 594-1:1986 | Complies with standard |
| Air leakage | Clause 4.3 of ISO 594-1:1986 | Complies with standard |
| Separation force | Clause 4.4 of ISO 594-1:1986 | Complies with standard |
| Stress cracking | Clause 4.5 of ISO 594-1:1986 | Complies with standard |
| Gauging | Clause 4.1 of ISO 594-2:1998 | Complies with standard |
| Leakage | Clause 4.2 of ISO 594-2:1998 | Complies with standard |
| Separation force | Clause 4.3 of ISO 594-2:1998 | Complies with standard |
| Unscrewing torque | Clause 4.4 of ISO 594-2:1998 | Complies with standard |
| Ease of assembly | Clause 4.5 of ISO 594-2:1998 | Complies with standard |
| Resistance to overriding | Clause 4.6 of ISO 594-2:1998 | Complies with standard |
| Stress cracking | Clause 4.7 of ISO 594-2:1998 | Complies with standard |
| Seal strength (Packaging) | ASTM F88/F88-09 | Complies with standard |
| Dye penetration (Packaging) | ASTM F1929-12 | Complies with standard |
| EO residue | ISO 10993-7:2008 | Complies with standard |
| ECH residue | ISO 10993-7:2008 | Complies with standard |
| Bacteria Endotoxin Limit | USP 38-NF 33 <85> | Complies with standard |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Test | Performed on aging samples to verify the claimed shelf life of the device |
| Cytotoxicity | ISO 10993-5 | No cytotoxicity |
| Skin Sensitization | ISO 10993-10 | No skin sensitization |
| Intracutaneous Reactivity | ISO 10993-10 | No intracutaneous reactivity |
| Acute Systemic Toxicity | ISO 10993-11 | No systemic toxicity |
| Hemolytic Property | ASTM F756 | No hemolysis |
| Pyrogen | ISO 10993-11 | No pyrogen |
| Complement Activity | ISO 10993-4 | No complement |
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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);
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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
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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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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
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- Date of Preparation: 05/29/2018
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- 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
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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
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| 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 |
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| 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 <85> |
| 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
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Substantially Equivalent (SE) Comparison 8.
Table 1 Comparison of Technology Characteristics
| Item | Proposed Device | Predicate DeviceK072696 | ||||
|---|---|---|---|---|---|---|
| Product Code | DXT | DXT | ||||
| RegulationNumber | CFR 870.1650 | CFR 870.1650 | ||||
| Intended Use | The Sterile Disposable Syringes are intended for the injection of contrastmedia or saline, they shall be used with an U.S legally marketedangiographic injector. | ANT Angiographic Syringes are syringes for the injection of contrasmedia or saline. This syringe is for single use with U.S leally marketecangiographic injection. | ||||
| Operation mode | Power-driven operation, single use | Power-driven operation, single use | ||||
| Configurationand Material | AngiographicSyringe | Configuration | Material | AngiographicSyringe | Configuration | Material |
| Barrel | Polycarbonate (PC) orPolypropylene (PP) | Barrel | Polypropylene (PP) orPolyethylene terephthalate (PET) | |||
| Piston | Natural Rubber | Piston | Unknown | |||
| Piston Seat | Polycarbonate (PC) orPolypropylene (PP) | Piston Seat | Unknown | |||
| Protective Cap | Polypropylene (PP) | Protective Cap | Unknown | |||
| Connectingtube | Tubing | Polyvinyl Chloride (PVC) | Connectingtube | |||
| 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
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| 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
§ 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.