Sterile Disposable Syringes

K172694 · Shenyang Mastech Medical Device Co., Ltd. · DXT · Jul 6, 2018 · Cardiovascular

Device Facts

• Record ID: K172694
• Device Name: Sterile Disposable Syringes
• Applicant: Shenyang Mastech Medical Device Co., Ltd.
• Product Code: DXT · Cardiovascular
• Decision Date: Jul 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

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.

Device Story

Sterile disposable syringes designed for use with power-driven angiographic injectors to deliver contrast media or saline. Device components include syringe barrel, piston, piston seat, protective cap, connecting tubes (straight, spiral, or T-shape), J-shape tubes, and spikes. Used in clinical settings by healthcare professionals. Syringes are single-use, EO-sterilized, and available in various volumes (50ml to 200ml). Operation involves manual loading of contrast/saline via spike or J-tube, followed by power-driven injection via the angiographic injector. Output is the controlled delivery of fluid into the patient's vascular system. Benefits include reliable, sterile fluid delivery for diagnostic imaging procedures.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 7886-2 (cleanliness, acidity/alkalinity, extractable metals, lubricant, capacity, scale, barrel, plunger, nozzle, performance), ISO 594-1/2 (gauging, leakage, separation force, stress cracking, torque, assembly), ASTM F88/F1929 (packaging), and ISO 10993-7 (EO/ECH residue). Biocompatibility verified via cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, hemolysis, pyrogen, and complement activity testing.

Technological Characteristics

Materials: Polycarbonate (PC), Polypropylene (PP), Natural Rubber, Polyethylene (PE), Acrylonitrile-butadiene-styrene (ABS). Sensing/Actuation: Mechanical, power-driven by external angiographic injector. Dimensions: 50ml to 200ml volumes. Connectivity: None (mechanical interface). Sterilization: Ethylene Oxide (EO). Standards: ISO 7886-2, ISO 594-1, ISO 594-2, ISO 10993, ASTM F88, ASTM F1929, ASTM F756, USP <85>.

Indications for Use

Indicated for injection of contrast media or saline using a legally marketed angiographic injector.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• ANT Angiographic Syringes (K072696)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K172694

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) | |
|-------------------------------------------------|---------------------------------------|
| | <div> <input type="checkbox"/> </div> |
| | <div> <input type="checkbox"/> </div> |

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

- 1. Date of Preparation: 05/29/2018
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

#### Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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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),<br>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).

- 7. Clinical Test Conclusion
No clinical study is included in this submission.

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#### Substantially Equivalent (SE) Comparison 8.

Table 1 Comparison of Technology Characteristics

| Item | Proposed Device | | | Predicate Device<br>K072696 | | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------------------------|
| Product Code | DXT | | | DXT | | |
| Regulation<br>Number | CFR 870.1650 | | | CFR 870.1650 | | |
| Intended Use | The Sterile Disposable Syringes are intended for the injection of contrast<br>media or saline, they shall be used with an U.S legally marketed<br>angiographic injector. | | | ANT Angiographic Syringes are syringes for the injection of contras<br>media or saline. This syringe is for single use with U.S leally marketec<br>angiographic injection. | | |
| Operation mode | Power-driven operation, single use | | | Power-driven operation, single use | | |
| Configuration<br>and Material | Angiographic<br>Syringe | Configuration | Material | Angiographic<br>Syringe | Configuration | Material |
| | | Barrel | Polycarbonate (PC) or<br>Polypropylene (PP) | | Barrel | Polypropylene (PP) or<br>Polyethylene terephthalate (PET) |
| | | Piston | Natural Rubber | | Piston | Unknown |
| | | Piston Seat | Polycarbonate (PC) or<br>Polypropylene (PP) | | Piston Seat | Unknown |
| | | Protective Cap | Polypropylene (PP) | | Protective Cap | Unknown |
| | | Connecting<br>tube | Tubing | | Polyvinyl Chloride (PVC) | Connecting<br>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

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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