Single-use Sterile High-pressure Angiographic Syringes and Accessories

K241109 · Shenzhen Boon Medical Supply Co., Ltd. · DXT · Aug 22, 2024 · Cardiovascular

Device Facts

• Record ID: K241109
• Device Name: Single-use Sterile High-pressure Angiographic Syringes and Accessories
• Applicant: Shenzhen Boon Medical Supply Co., Ltd.
• Product Code: DXT · Cardiovascular
• Decision Date: Aug 22, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

Single-use Sterile High-pressure Angiographic Syringe and Accessories are intended for the injection of contrast media or saline, they shall be used with U.S. legally marketed angiographic injectors.

Device Story

Single-use sterile high-pressure angiographic syringes and accessories (connection tubes, J-shape tubes, spikes) facilitate contrast media or saline delivery during angiographic procedures. Devices are intended for use with legally marketed power-driven angiographic injectors. Syringes are available in various volumes (e.g., 50ml to 200ml) and pressure ratings (300, 400, 1200 psi). Connection tubes link syringes to catheters; spikes and J-shape tubes assist in drawing fluids into the syringe barrel. Operation is performed by clinical staff in a hospital or clinical setting. The device ensures fluid delivery to the patient's vascular system during imaging, aiding in diagnostic or interventional procedures. Biocompatible materials are used for patient-contact components.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (cytotoxicity, irritation, sensitization, acute toxicity, hemolysis), sterility, and performance testing (leakage, flow characteristics, pressure ratings, and compatibility with various injectors).

Technological Characteristics

Materials: PP/PET (barrel), polyisoprene (piston), polydimethylsiloxane (lubricant), PVC/PU (tubing), PC (connectors), ABS (spike/cap). Energy: Power-driven via external injector. Connectivity: Mechanical luer connectors (ISO 80369-7). Sterilization: Ethylene Oxide (EO). Standards: ISO 7886-1/2, ISO 10993 series, ASTM F88/F1929/F756, USP <85>/<151>.

Indications for Use

Indicated for injection of contrast media or saline using U.S. legally marketed angiographic injectors. No specific patient population or contraindications defined.

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 (K211564)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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.

#### August 22, 2024

Shenzhen Boon Medical Supply Co., Ltd. Shengyu Fan International Regulation Commissioner No.18 Jirong Road, Shenkeng, Henggang Street Longgang District Shenzhen, Guangdong 518173, China

Re: K241109

Trade/Device Name: Single-use Sterile High-pressure Angiographic Syringes and Accessories Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: July 20, 2024 Received: July 22, 2024

Dear Shengyu Fan:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Shruti N. Mistry -S

> Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K241109

#### Device Name

Single-use Sterile High-pressure Angiographic Syringes and Accessories

Indications for Use (Describe)

Single-use Sterile High-pressure Angiographic Syringe and Accessories are intended for the injection of contrast media or saline, they shall be used with U.S. 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)

#### 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 is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

- 1. Date of Preparation: March 3, 2024
### 2. Applicant Identification: Shenzhen Boon Medical Supply Co., Ltd. No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District Shenzhen Guangdong, China 518173

Establishment Registration Number: 3012395857 Contract Person: Gui Wenjuan

Position: Management Representative Tel: [phone]

Fax: [phone] E-mail: [e-mail]

### Subject Device Information:

The assigned 510(k) Number: K241109 Trade Name: Single-use Sterile High-pressure Angiographic Syringes and Accessories Common Name: Disposable angiographic syringe Models

Regulatory Information:

Classification Name: Injector And Syringe, Angiographic Classification: II Product Code: DXT Regulation Number: 21 CFR 870.1650 Review Panel: General Hospital

### 3. Identification of Predicate Device

510(k) Number: K211564 Product Name: Sterile High-pressure Angiographic Syringes for Single-use Manufacturer: Shenzhen Boon Medical Supply Co., Ltd.

- 4. Designated Submission Correspondent Shengyu Fan (Primary Contact Person) E-mail:
# [e-mail]

DARCO International Co., Ltd. 510 Shotgun Rd. Suite 520, Sunrise, FI 33326

Tel: [phone]

Fax: [phone]

{4}------------------------------------------------

E-mail: [e-mail]

{5}------------------------------------------------

### 5. Description of Proposed Device

| Product Name | Models |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Syringe | 100101, 100103, 100113, 200101, 200102, 300101, 300105, 100104,<br>100114, 200103, 300103, 100111, 100121, 100123, 100124, 100125,<br>200104, 100108, 100118, 100129, 100130, 100109, 100119, 200107,<br>300102, 300108, 300110, 300111, 300112, 100110, 100120, 100112,<br>100122, 300107, 200105, 200113, 200110, 200111 |
| Connection Tube | 400101, 400102, 400103, 600101, 600102, 500105, 500106, 500107,<br>500108, 400201, 400202, 400203, 400204, 600201, 600202, 500101,<br>500102, 500103, 500104, 500201, 500202, 500203, 500204, 500205,<br>500206, 500207, 500208 |
| J Shape tube | 700103 |
| Spike | 700101, 700102, 700104-1, 700104-2,<br>700105-1, 700105-2, 700106, 700107-1, 700107-2,<br>700204-1, 700204-2,<br>700205-1, 700205-2, 700206, 700207-1, 700207-2 |

### Indications for Use:

Single-use Sterile High-pressure Angiographic Syringe and Accessories are intended for the injection of contrast media or saline, they shall be used with U.S. legally marketed angiographic injectors.

### Device Description:

The proposed device is intended for the injection of contrast media or saline. It includes disposable syringes, connection tube, J shape tube, and spike.

Syringe: The syringes are intended to be used with an U.S. legally marketed angiographic injector.

Compatibility is shown in the Table 1 Compatibility between Syringe and Injectors. (Note: the newly added and the difference between K211564 and the proposed device is highlighted in Red.)

{6}------------------------------------------------

# 510(K) Summary Table 1 Compatibility between Syringe and Injectors

| Model<br>(Syringe) | Volume (ml) | Type | Resistant<br>liquid leak<br>pressure (psi) | Injector |
|--------------------|-------------|-------------|--------------------------------------------|----------------------------------------------------------------------------------|
| 100101 | 200ml | Single shot | 400 | MCT&MCT Plus CT, K924116<br>Vistron CT, K991557<br>EnVision CT, K934086 |
| 100103 | 200ml | Single shot | 400 | Stellant-S, K182273 |
| 100113 | 200/200ml | Dual shots | 400 | Stellant-D, K182273 |
| 200101 | 65/65ml | Dual shots | 300 | Spectris, K935668 |
| 200102 | 65/115ml | Dual shots | 300 | Solaris MRI, K033247 |
| 300101 | 150ml | Single shot | 1200 | Mark V, K822536 |
| 300105 | 130ml | Single shot | 1200 | Mark III&Mark IV, K822536 |
| 100104 | 200ml | Single shot | 400 | CT 9000&CT9000 ADV, K912944<br>CT OptiVantage, K063503 |
| 100114 | 200/200ml | Dual shots | 400 | CT 9000&CT9000 ADV, K912944<br>CT OptiVantage, K063503 |
| 200103 | 60/60ml | Dual shots | 300 | Optistar LF, Elite, K073592 |
| 300103 | 150ml | Single shot | 1200 | ILLUMENA, K963071 |
| 100111 | 200ml | Single shot | 400 | Empower CT, K071378 |
| 100121 | 200/200ml | Dual shots | 400 | Empower CT, K071378 |
| 100123 | 100/200ml | Dual shots | 400 | Dual Shots, K052633<br>Dual shots Alpha, K062168 |
| 100124 | 60/100ml | Dual shots | 400 | Dual Shots, K052633<br>Dual shots Alpha, K062168 |
| 100125 | 60/200ml | Dual shots | 400 | Dual Shots, K052633<br>Dual shots Alpha, K062168 |
| 200104 | 60/60ml | Dual shots | 300 | Sonic Shot, K091743 |
| 100108 | 200ml | Single shot | 400 | Dual shots CT, K062168<br>Dual shots Alpha, K062168 |
| 100118 | 200/200ml | Dual shots | 400 | Dual shots CT, K133189<br>Dual shots Alpha, K062168 |
| 100129 | 125ml | Single shot | 400 | CT Optione, K152361 CT<br>OptiVantage, K063503 CT 9000&CT<br>9000ADV,<br>K912944 |
| 100130 | 125/125ml | Dual shots | 400 | CT Optione, K152361 CT<br>OptiVantage, K063503 CT 9000&CT<br>9000ADV,<br>K912944 |
| | | | | |
| 100109 | 100ml | Single shot | 400 | Dual Shots, K062168<br>Dual shots Alpha, K062168 |
| 100119 | 100/100ml | Dual shots | 400 | Dual Shots, K062168<br>Dual shots Alpha, K062168 |
| 200107 | 100/100ml | Dual shots | 300 | EZEM Empower MR, K062449 |
| 300102 | 125ml | Single shot | 1200 | 120S, K092896 |
| 300108 | 150ml | Single shot | 1200 | Mark VII, K122086 |
| 300110 | 150ml | Single shot | 1200 | Rempress, K092896 |
| 300111 | 150ml | Single shot | 1200 | Angiomat 6000, K944875 |
| 300112 | 200ml | Single shot | 1200 | Illumena, K963071 |
| 100110 | 200ml | Single shot | 400 | Medrad V Plus, K903390 |
| 100120 | 200/200ml | Dual shots | 400 | Medrad V Plus, K903390 |
| 100112 | 200ml | Single shot | 400 | Accutron CT& Accutron CT-D |
| 100122 | 200/200ml | Dual shots | 400 | Accutron CT-D |
| 300107 | 200ml | Single shot | 1200 | Accutron HP& Accutron HP-D |
| 200105 | 65/65ml | Dual shots | 300 | Accutron MR, |
| 200113 | 65/200ml | Dual shots | 300 | Accutron MR, |
| 200110 | 65/115ml | Dual shots | 300 | Medrad MRXperion,<br>K182276 |
| 200111 | 115ml | Single shot | 300 | Spectris&Solaris, K033247 |

{7}------------------------------------------------

Connection tube: it is used to connect the syringe and the catheter. The tubes (extension tube) are also available in various configurations, which are Type B (used with single shot syringe, highlighted in Red mark), renamed "Straight tube" to "Type B" and added a new model (400204) connecting tube in the Table. The product structure, manufacturing process, product materials have not changed. Type Y and type T tube are used with dual shots syringe. The pressure specification for connection tube is provided in Table 2 Pressure Specifications for Connection Tube. (Note: the newly added and the difference between K211564 and proposed device is highlighted in Red)

| Model | Maximum Withstanding Pressure<br>(psi) | Type |
|--------|----------------------------------------|--------|
| 400101 | 400 | Type B |
| 400102 | 400 | Type Y |
| 400103 | 400 | Type T |
| 600101 | 400 | Type T |
| 600102 | 400 | Type Y |
| 500105 | 1200 | Type B |

Table 2 Pressure Specifications for Connection Tube

{8}------------------------------------------------

| 510(K) Summary | | |
|----------------|------|--------|
| 500106 | 1200 | Type B |
| 500107 | 1200 | Type B |
| 500108 | 1200 | Type B |
| 400201 | 400 | Type B |
| 400202 | 400 | Type Y |
| 400203 | 400 | Type T |
| 400204 | 400 | Type B |
| 600201 | 400 | Type T |
| 600202 | 400 | Type Y |
| 500101 | 1200 | Type B |
| 500102 | 1200 | Type B |
| 500103 | 1200 | Type B |
| 500104 | 1200 | Type B |
| 500201 | 1200 | Type B |
| 500202 | 1200 | Type B |
| 500203 | 1200 | Type B |
| 500204 | 1200 | Type B |
| 500205 | 1200 | Type B |
| 500206 | 1200 | Type B |
| 500207 | 1200 | Type B |
| 500208 | 1200 | Type B |

J shape tube: it is used to draw contrast media/saline into the syringe barrel before installation.

Spike: it is used to draw contrast media/saline into the syringe barrel before the syringe installation. The pressure specification for the spike is provided in the following table as Table 3 Pressure Specifications for Spike (Note: this model is only used to distinguish whether it is made with or without DEHP). The product materials, manufacturing process and product structure have not changed. Spikes not made with DEHP are marked with Red. The new additions of spike models are: 700204- 1, 700204-2,700205-1, 700205-2, 700206, 700207-1, 700207-2)

| | Table 3 Pressure Specifications for Spike | |
|--|-------------------------------------------|--|
| | | |

| Model (contains<br>DEHP)<br>Original | Model (not<br>made with DEHP)<br>New<br>added | Maximum<br>Withstanding<br>Pressure (psi) | Type |
|--------------------------------------|-----------------------------------------------|-------------------------------------------|------------------------------------|
| 700101 | / | / | Long Spike |
| 700102 | / | / | Short Spike |
| 700104-1 | 700204-1 | 400 | Single Air<br>Chamber Transfer Set |

{9}------------------------------------------------

| 700104-2 | 700204-2 | 400 | Single Air Chamber<br>Transfer Set with<br>Extension<br>Tube |
|----------|----------|-----|--------------------------------------------------------------|
| 700105-1 | 700205-1 | 400 | Dual Air Chamber<br>Transfer Set |
| 700105-2 | 700205-2 | 400 | Dual Air Chamber<br>Transfer Set with<br>Extension Tube |
| 700106 | 700206 | / | Transfer Set with<br>C-Clamp |
| 700107-1 | 700207-1 | / | Transfer Set with<br>Clave Connector |
| 700107-2 | 700207-2 | / | Clave connector<br>ansfer set with Check<br>valve |

### 6. Non-Clinical Test Conclusion

Nonclinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-7:2008 Biological evaluation of Medical device- Part 7: Ethylene oxide sterilization residuals;

ASTM F88/F88M-23 Standard test method for seal strength of flexible barrier materials: ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;

USP-NF<85> Bacterial Endotoxin Limit;

ISO 7886-1: 2017 Sterile hypodemic syringes for Single-use-Part 1: Syringes for manual use; ISO 7886-2: 2020 Sterile hypodemic syringes for Single-use-Part 2: Syringes for use with power-driven syringe pumps;

- The test items include Lubricant weight, Graduated capacity tolerance, overall length of । scale, syringe dimension, nozzle lumen, dead space, liquid leakage, air leakage and flow characteristics;
ISO 80369-7: 2021 Small-bore connectors for liquids and gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: Tests for In Vitro Cytotoxicity;

ISO 10993-10:2021 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization;

ISO 10993-4: 2017 Biological Evaluation of Medical Device -Part 4: Selection of tests for interactions with blood:

ASTM F756: 2017, Standard Practice for Assessment of Hemolytic Properties of Materials USP-NF <151> Pyrogen Test

Compatibility Test Report includes information between injectors, syringe, connection tube and spike/J shape tube. The compatibility test demonstrated that each device meets performance

{10}------------------------------------------------

under maximum sustained pressure specifications.

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

{11}------------------------------------------------

# 8. Substantially Equivalent (SE) Comparison

# Table 4 Comparison of Technology Characteristics

| Item | Proposed Device K241109 | Predicate Device K211564 | Comments | |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------|
| Product Code | DXT | DXT | Same | |
| Regulation<br>Number | CFR 870.1650 | CFR 870.1650 | Same | |
| Indications for Use | The proposed device, Single-use<br>Sterile High-pressure Angiographic<br>Syringes and Accessories are<br>intended for the injection of contrast<br>media or saline, they shall be used<br>with U.S. legally marketed<br>angiographic injectors. | The predicate device, Sterile High-<br>pressure Angiographic Syringes<br>for Single-use are intended for the<br>injection of contrast media or saline;<br>they shall be used with an US legally<br>marketed angiographic injectors | Different 1 | |
| Prescription only<br>(Rx) | Prescription only (Rx) | Prescription only (Rx) | Same | |
| Mode of operation | Power-driven operation, single-use | Power-driven operation, single-use | Same | |
| Configuration | Angiographic Syringe | Angiographic Syringe | Same | |
| | Connection tube | Connection tube | Same | |
| | J shape tube/ Spike | J shape tube/ Spike | | |
| Sterility | EO Sterilized | EO Sterilized | Same | |
| Single Use | Yes | Yes | Same | |
| Syringe | 300psi, 400psi, 1200psi | 300psi, 400psi, 1200psi | Same | |
| Connection tube | 300psi, 400psi, 1200psi<br>New model added (400204). | 300psi, 400psi, 1200psi | Different 2 | |
| J shape tube | / | / | | |
| Spike | 400psi | 400psi | Same | |
| Syringe Specification<br>(Volume/ ml) | 200, 150, 125, 130, 100, 200/200,<br>60/100, 125/125, 100/100, 65/65, 65/<br>115, 60/60, 50/50, 100/200, 115,<br>65/200<br>11 new models added. | 200, 150, 125, 130, 100, 200/200, 60/100,<br>125/125,100/100,65/65,65/115,60/60,<br>50/50 | Different 3 | |
| Connection tube Specification<br>(overall length,mm) | 200~2500, 1500~2500, 1500, 1800,<br>2000, 2500, 500, 750, 1000, 1200 | 200~2500, 1500~2500, 1500, 1800, 2000,<br>2500, 500, 750, 1000, 1200 | Same | |
| J shape tube Specification<br>(overall length, mm) | 240 | 240 | Same | |
| | | | | |
| Spike Specification (overall<br>length,mm) | | 58.8,47.3, 1000,2800, 1200,2900,<br>180,260,340,420,500,450,550,600 | 58.8,47.3, 1000,2800, 1200,2900, 180,2<br>60,340,420,500,450,550,600 | Same |
| Performance | | | | |
| Syringe | | ISO 7886 | ISO 7886 | Same |
| Luer connector | | ISO 80369-7 | ISO 80369-7 | Same |
| Compatibility | | Pass | Pass | Same |
| Patient-Contact Material | | | | |
| Syringe | Barrel | PP (Polypropylene) or PET<br>(Polyethylene terephthalate) | PP (Polypropylene) or PET (Polyethylene<br>terephthalate) | Same |
| Syringe | Piston | Polyisoprene rubber | Polyisoprene rubber | Same |
| Syringe | Lubricant | Polydimethylsiloxane | Polydimethylsiloxane | Same |
| Connection tube | Tubing | PVC (Polyvinylchloride with DEHP)<br>or PVC<br>(Polyvinylchloride without DEHP)<br>or PU (Polyurethane) | PVC (Polyvinylchlori de with DEHP) or<br>PVC<br>(Polyvinylchloride without DEHP) or<br>PU (Polyurethane) | Same |
| Connection tube | Luer<br>connectors | PC (Polycarbonate) | PC (Polycarbonate) | Same |
| Connection tube | UV<br>adhesive | Ultraviolet adhesive | Ultraviolet adhesive | Same |
| Spike | Closure-<br>piercing<br>device | ABS (acrylonitrile-butadiene<br>-styrene) | ABS (acrylonitrile-butadiene<br>-styrene) | Same |
| Spike | Filter<br>membrane | PP<br>(polypropylene) | PP<br>(polypropylene) | Same |
| Spike | Tube | Polyvinyl chloride (PVC) | Polyvinyl chloride (PVC) | Same |
| Spike | Luer<br>connector | carbonate (PC) | carbonate (PC) | Same |
| Spike | Protective<br>cap | Acrylonitrile-butadiene<br>-styrene (ABS) | Acrylonitrile-butadiene<br>-styrene (ABS) | Same |
| J shape tube | PE (Polyethylene) | | PE (Polyethylene) | Same |
| | No Cytotoxicity | | No Cytotoxicity | Same |
| | No Irritation | | No Irritation | Same |
| Biocompatibility | No Sensitization | | No Sensitization | Same |
| | No Pyrogen | | No Pyrogen | Same |
| | No Acute Toxicity | | No Acute Toxicity | Same |
| | No Hemolysis | | No Hemolysis | Same |
| Endotoxin Limit | 20 EU per device | | 20 EU per device | Same |
| Shelf Life | 5-year | | 5-year | Same |

{12}------------------------------------------------

{13}------------------------------------------------

{14}------------------------------------------------

{15}------------------------------------------------

- 9. Equivalence Discussion:
Different #1: Compared to the predicate device, the proposed device changed the product name from Sterile High-pressure Angiographic Syringes for Single-use to: Single-use Sterile Highpressure Angiographic Syringes and Accessories. The indications for use of the product share the same contents.

Different #2: Compared to the predicate device, a new connection tube model 400204 is introduced to the proposed device. Model 400204 is almost identical to 400202, the only difference is that the former has one more check valve than the latter. And the materials, manufacturing process, pressure rating (up to 400 psi, see compatibility test report), wall thickness (0.70±0.05mm) and length (200mm - 2500 mm) of 400204 are the same with the existing models of 400201, 400202 and 400203. The results of performance tests completed on the proposed device demonstrate that the proposed devices comply with FDA recognized standards, which the predicate device also complied with. The results of biocompatibility studies performed on the proposed device demonstrate that the patient materials used in the proposed device are biocompatible

Different #3: Compared the predicated device, the specifications of syringes have added 115ml, 100/200ml and 65/200ml in the proposed device, and the compatibility table between the proposed device and predicate device are shown in Table 1. The difference and the newly added devices are marked in Red.

The results of performance tests completed on the proposed device demonstrate that the proposed devices comply with FDA recognized standards, which the predicate device also complied with. The results of biocompatibility studies performed on the proposed device demonstrate that the patient materials used in the proposed device are biocompatible.

- 10. Substantial Equivalence Conclusion:
Based on the comparison above, the differences between the subject and predicate devices do not raise any new or different questions of safety and effectiveness when compared to the predicate device. The proposed device, Single-use Sterile High Pressure Angiographic Syringes and Accessories is determined to be Substantially Equivalent (SE) to the predicate device.