Disposable High Pressure Syringe

K170279 · Union Medical Shenzhen Co., Ltd. · DXT · Dec 12, 2017 · Cardiovascular

Device Facts

• Record ID: K170279
• Device Name: Disposable High Pressure Syringe
• Applicant: Union Medical Shenzhen Co., Ltd.
• Product Code: DXT · Cardiovascular
• Decision Date: Dec 12, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended 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 Story

Disposable plastic syringe system for delivery of contrast media or saline during angiographic procedures. Components include syringes, connector tubes, quick fill tubes, and spikes. Device operates by manual loading of contrast/saline into syringe, followed by attachment to a US-marketed power-driven angiographic injector. Injector provides the force for fluid delivery through the syringe and connector tube into the patient's catheter. Used in clinical settings by trained medical personnel. Output is the controlled delivery of contrast media or saline to facilitate diagnostic imaging. Benefits include reliable, sterile, single-use fluid delivery, reducing risk of cross-contamination and ensuring compatibility with existing clinical injection hardware.

Clinical Evidence

No clinical data included. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993 series), sterility (ISO 11737-2, ISO 10993-7), seal strength (ASTM F88/F88M), package integrity (ASTM F1140/F1140M), and mechanical performance (ISO 7886-2, ISO 594-1/2).

Technological Characteristics

Plastic disposable syringe system; EO sterilized. Includes connector tubes (max pressure 350psi), quick fill tubes, and spikes. Conforms to ISO 7886-2 (syringes for power-driven pumps), ISO 594-1/2 (Luer fittings), and ISO 10993 (biocompatibility).

Indications for Use

Indicated for the injection of contrast media or saline in patients requiring angiographic procedures using US legally marketed angiographic injectors. For single use only.

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

• Sterile High-pressure Angiographic Syringes for Single-use (K151960)

Reference Devices

• MEDRAD Visitron CT 610 (K991557)
• En Vision CT Injection System (K993782)
• MEDRAD CT Stellant Injection System (K023183)
• MEDRAD Mark V Injection System (K822536)
• MEDRAD Mark IV Injection System (K903390)
• MEDRAD Spectris MR Injection System (K935668)
• MEDRAD Solaris MR Injection System (K033247)
• LF CT9000 Injection System (K912944)
• LF OptiVantage Dual-Head Injection System (K042744)
• LF Angiomat 6000 Injection System (K944875)
• LF Angiomat Illumena Injection System (K963071)
• LF MRI OPTISTAR Injection System (K984088)
• NEMOTO Dual Shot ALPHA7 Injection System (K133189)
• Nemoto Dual Shot CT Injection System (K052633)
• NEMOTO MRI Injection System (K091734)
• EZEM Empower CT Injection System (K063029)

Submission Summary (Full Text)

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

K170279

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)

| <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|------------------------------------------------------------------------------------------------------|
| <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 807 Subpart C) </div> |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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

- 1. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

### Mid-Link Consulting Co., Ltd

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

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

{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<br>(P/N) | Volume(ml) | Type | Applicable Injection Systems/510(k) Number |
|-----|-----------------|------------|-------------|------------------------------------------------------------------------------|
| 1 | SMR101 | 200ml | Single Shot | MEDRAD Visitron CT 610 (K991557), En<br>Vision CT Injection System (K993782) |
| 2 | SMR102 | 200ml | Single Shot | MEDRAD CT Stellant Injection System<br>(K023183) |
| 3 | SMR103 | 125ml | Single Shot | MEDRAD Visitron CT 610 (K991557), En<br>Vision CT Injection System (K993782) |
| 4 | SMR104 | 200/200ml | Dual Shots | MEDRAD CT Stellant Injection System<br>(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<br>(K935668) |
| 10 | SMR302 | 110/60ml | Dual Shots | MEDRAD Solaris MR Injection System<br>(K033247) |
| 11 | SLF101 | 200ml | Single Shot | LF CT9000 Injection System (K912944) |
| 12 | SLF102 | 200/200ml | Dual Shots | LF OptiVantage Dual-Head Injection System<br>(K042744) |
| 13 | SLF201 | 150ml | Single Shot | LF Angiomat 6000 Injection System (K944875) |
| 14 | SLF202 | 150ml | Single Shot | LF Angiomat Illumena Injection System<br>(K963071) |
| 15 | SLF301 | 60/60ml | Dual Shots | LF MRI OPTISTAR Injection System (K984088) |
| 16 | SNE101 | 100ml | Single Shot | NEMOTO Dual Shot ALPHA7 Injection System<br>(K133189) |
| 17 | SNE102 | 200ml | Single Shot | NEMOTO Dual Shot ALPHA7 Injection System<br>(K133189) |
| 18 | SNE103 | 200/60ml | Dual Shots | Nemoto Dual Shot CT Injection System<br>(K052633) |
| 19 | SNE104 | 200/100ml | Dual Shots | Nemoto Dual Shot CT Injection System<br>(K052633) |
| 20 | SNE301 | 60/60ml | Dual Shots | NEMOTO MRI Injection System (K091734) |
| 21 | SEZ101 | 200ml | Single Shot | EZEM Empower CT Injection System<br>(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 <85> 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;
- 7. 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<br>DXT |
| Regulation Number | CFR 870.1650 | CFR 870.1650 |
| Intended Use | The proposed device is intended for the<br>injection of contrast media or saline. This<br>syringe is for single use with US legally<br>marketed angiographic injectors. | High-pressure Angiographic<br>Syringes for Single-use are syringes<br>for the injection of contrast media or<br>saline. This syringe is for single use<br>with US legally marketed angiographic<br>injectors. |
| Mode of operation | Power-driven operation, single use | Power-driven operation, single use |
| Configuration | Angiographic Syringe<br>Connector tube<br>Quick Fill Tube/Spike | Angiographic Syringe<br>Connecting tube<br>J shape tube/Spike |
| Sterility | EO Sterilized | EO Sterilized |
| Single Use | Yes | Yes |
| Performance | Comply with:<br>ISO 7886-2<br>ISO 594-1<br>ISO 594-2 | Comply with:<br>ISO 7886-2<br>ISO 594-1<br>ISO 594-2 |
| Biocompatibility | Conforms to the requirements of ISO<br>10993 series Standards | Conforms to the requirements of ISO<br>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.