Sterile High-pressure Angiographic Syringes for Single-use

K182289 · Shenzhen Baoan Medical Supplies Co., Ltd. · DXT · Oct 10, 2018 · Cardiovascular

Device Facts

• Record ID: K182289
• Device Name: Sterile High-pressure Angiographic Syringes for Single-use
• Applicant: Shenzhen Baoan Medical Supplies Co., Ltd.
• Product Code: DXT · Cardiovascular
• Decision Date: Oct 10, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an US legally marketed angiographic injectors.

Device Story

Disposable plastic syringes and connection tubes; used with power-driven angiographic injectors for contrast media or saline delivery. Syringes available in dual-shot configurations; connection tubes include straight, Y, and T types. Operates at pressures up to 400 psi. Used in clinical settings by healthcare professionals. Device connects to catheters via tubes to facilitate fluid injection during angiography procedures. Benefits include reliable high-pressure fluid delivery for diagnostic imaging.

Clinical Evidence

No clinical data. Bench testing only, including liquid leakage and flow characteristics, confirming compliance with ISO 594-1, ISO 594-2, ISO 7886-1, and ISO 7886-2 standards.

Technological Characteristics

Plastic disposable syringes and connection tubes; EO sterilized; single-use. Rated for 400 psi. Conforms to ISO 594-1, ISO 594-2, ISO 7886-1, ISO 7886-2, and ISO 10993 biocompatibility standards.

Indications for Use

Indicated for injection of contrast media or saline using US legally marketed angiographic injectors.

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

• CT 9000 & CT9000 ADV (K912944)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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 10, 2018

Shenzhen Baoan Medical Supplies Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN

Re: K182289

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: August 3, 2018 Received: August 23, 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. 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 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

# Lydia S. Glaw -S 2018.10.10 14:25:31 -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)

K182289

Device Name

Sterile High-pressure Angiographic Syringes for Single-use

Indications for Use (Describe)

Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an 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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# 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: K182289

- 1. Date of Preparation: 9/28/2018
- 2. Sponsor Identification

## Shenzhen Baoan Medical Supplies Co., Ltd

No. 6, Shenkeng Road, Shenkeng Industrial Zon Liuyue Community, Henggang, Longgang District, Shenzhen, 518173, China

Establishment Registration Number: 3012395857

Contact Person: Mingan Mu Position: Deputy General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (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 High-pressure Angiographic Syringes for Single-use; Common Name: Disposable angiographic syringe; Models: 100104 and 100114

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:

Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an US legally marketed angiographic injectors.

Device Description:

The proposed devices include 2 models of plastic, disposable syringes and 5 connection tubes of different specifications. They are intended to be used with an U.S. legally marketed angiography injector, compatibilities are shown in Table 1.

| Model<br>(Syringe) | Volume<br>(ml) | Type | Resistant Liquid<br>Leak Pressure (psi) | Compatible Angiographic Injector |
|--------------------|----------------|-----------|-----------------------------------------|----------------------------------|
| | | | | |
| 100114 | 200/200 | Dual Shot | 400 | CT 9000 & CT9000 ADV, K912944 |

Table 1 Compatibility between Syringes and Injectors

The connection tubes are used to connect the syringe and the catheter. The tubes are also available in three configurations, which are straight tube (used with single shot syringe), type Y and type T tube (used with dual shot syringe), they can withstand maximum pressure of 400 psi.

The proposed devices are used with the J shape tube / spike cleared in K151960.

#### Identification of Predicate Device 5.

510k Number: K151960

Product Name: Sterile High-pressure Angiographic Syringes for Single-use; Manufacturer: Shenzhen Baoan Medical Supplies Co., Ltd

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#### 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:

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 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings

ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use;

ISO 7886-2:1996 Sterile hypodermic syringes for single use- Part 2: Syringes for use with power-driven syringe pumps.

The test samples of syringe 100104 and 100114 with accessories are tested for liquid leakage and flow characteristics. Actually, there is no design change between proposed device and predicate, the testing using 400 psi pressure is to demonstrate the increased resistant liquid leakage pressure statement. Therefore, other testing is not necessary for this submission.

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

- 8. Substantially Equivalent Comparison

| ITEM | Proposed Device | Predicate Device, K151960 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DXT | DXT |
| Regulation No. | 21 CFR 870.1650 | 21 CFR 870.1650 |
| Class | II | II |
| Indications for Use | Sterile High-pressure Angiographic<br>Syringes for Single-use are intended for<br>the injection of contrast media or<br>saline; they shall be used with an US<br>legally marketed angiographic<br>injectors. | Sterile High-pressure Angiographic<br>Syringes for Single-use are intended for<br>the injection of contrast media or<br>saline; they shall be used with an US<br>legally marketed angiographic<br>injectors. |
| Mode of Operation | Power-driven operation, single use | Power-driven operation, single use |

### Table 2 Substantially Equivalent Comparison

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| | Angiographic Syringe | Angiographic Syringe |
|-----------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|
| Configuration | Connection Tube<br>/ | Connection Tube<br>J shape tube/Spike |
| Sterility | EO Sterilized | EO Sterilized |
| Single Use | Yes | Yes |
| Resistant Liquid<br>Leak Pressure (psi) | Syringe: 400 psi<br>Connection Tube: 400 psi | Syringe: 300 psi<br>Connection Tube: 300 psi |
| Other Performance | Comply with ISO 7886-1, ISO 7886-2,<br>ISO 594-1 and ISO 594-2 | Comply with ISO 7886-1, ISO 7886-2,<br>ISO 594-1 and ISO 594-2 |
| Biocompatibility | Conforms to the requirements of ISO<br>10993 series Standards | Conforms to the requirements of ISO<br>10993 series Standards |

The proposed devices are stated to have a higher resistant liquid leak pressure. For this modification, liquid leak testing has been conducted on the models in this submission and test results have demonstrated the resistant liquid leak pressure is 400 psi for syringes and connection tube. Therefore, this modification will not impact the safety and effectiveness of device. In addition, the modified devices only include angiographic syringe and connection tube and they should be used with the J shape tube/spike cleared in K151960.

- Substantially Equivalent (SE) Conclusion 9.
Based on the comparison above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.