Superpipe Angiographic Catheter

K193647 · Suzhou Hengrui Disheng Medical Co., Ltd. · DQO · Jul 29, 2020 · Cardiovascular

Device Facts

• Record ID: K193647
• Device Name: Superpipe Angiographic Catheter
• Applicant: Suzhou Hengrui Disheng Medical Co., Ltd.
• Product Code: DQO · Cardiovascular
• Decision Date: Jul 29, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The SUPERPIPE Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system.

Device Story

The SUPERPIPE Angiographic Catheter is a diagnostic intravascular catheter used in angiographic procedures. It consists of a hub, strain relief tubing, a braided shaft, and a soft tip. The device is manually operated by a clinician to navigate the vascular system and deliver radiopaque media, guide wires, or therapeutic agents to specific anatomical sites. The shaft features a stainless steel mesh braid sandwiched between polyamide elastomer layers, while the tip is a mixture of polyurethane and polyamide elastomers. The device is provided sterile and is intended for single use. By facilitating precise delivery of contrast agents and interventional tools, the catheter enables diagnostic imaging and therapeutic interventions, potentially improving clinical outcomes in vascular procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing performed in accordance with ISO 10555-1, including assessments for tensile force, burst pressure, torque strength, kink resistance, flow rate, and simulated use. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous, acute systemic toxicity, pyrogen, hemolysis, in-vivo thromboresistance, and complement activation assays.

Technological Characteristics

Diagnostic intravascular catheter; 4Fr, 5Fr, 6Fr sizes. Construction: stainless steel mesh braid, polyamide elastomers, polyurethane elastomer tip, LLDPE strain relief, polyethylene terephthalate hub. Manual operation. Sterilized via ethylene oxide. Complies with ISO 10555-1.

Indications for Use

Indicated for use in angiographic procedures to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Radifocus Optitorque Angiographic Catheter (K992051)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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.

July 29, 2020

Suzhou Hengrui Disheng Medical Co.,Ltd. Li Ling Regulatory Affairs Manager No. 11 Building, No.8 Jinfeng Road Suzhou, 215163 Cn

## Re: K193647

Trade/Device Name: Superpipe Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: June 15, 2020 Received: June 22, 2020

## Dear Li Ling:

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/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K193647

Device Name SUPERPIPE Angiographic Catheter

Indications for Use (Describe)

The SUPERPIPE Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system.

| 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

| Submitter: | Suzhou Hengrui Disheng Medical Co., Ltd<br>No. 11 Building<br>No. 8 Jinfeng Road<br>Suzhou, China<br>215163 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Li Ling<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | June 15, 2020 |
| Trade Name: | SUPERPIPE Angiographic Catheter |
| Common Name: | Diagnostic Intravascular Catheter |
| Classification: | Class II, 21 CFR Part 870.1200 |
| Product Code: | DQO |
| Predicate Device: | K992051 - Radifocus Optitorque Angiographic Catheter<br>(Terumo Medical Corp.)<br>This predicate device has not been subject to a design-related<br>recall. |
| Device Description: | Angiographic Catheter consists of a catheter hub, a strain relief<br>tubing, catheter shaft (including braided section and non-braided<br>section) and catheter tip. It is comprised of a two-layer<br>construction featuring stainless steel mesh sandwiched between<br>layers of polyamide elastomers of the catheter braided section.<br>The non-braided section is comprised of layers of polyamide<br>elastomers. And the soft catheter tip is comprised of the mixture<br>of polyurethane and polyamide elastomers. The device is offered<br>in lengths of 80cm, 100cm and 110cm. |
| Comparison with | The subject devices and predicate device have identical / similar |
| Predicate Device: | technological characteristics as shown in the following table. |

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Indications for Use: The SUPERPIPE Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system.

| Description | Subject Device: Angiographic<br>Catheter | Predicate Device :<br>Radifocus Optitorque |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | K193647 | K992051 |
| Manufacturer | Suzhou Hengrui Disheng Medical Co.,<br>Ltd | Terumo Medical Corp. |
| Classification | II | II |
| Product Code | DQO | DQO |
| Regulation | 21 CFR 870.1200 | 21 CFR 870.1200 |
| Indications<br>for Use | The SUPERPIPE Angiographic<br>Catheter is intended for use in<br>angiographic procedures. It delivers<br>radiopaque media, guide wires,<br>catheters, and therapeutic agents to | The Radifocus Optitorque is intended for<br>use in angiographic procedures. It<br>delivers radiopaque media and<br>therapeutic agents to selected sites in the<br>vascular system. |
| Operation<br>Principle | selected sites in the vascular system.<br>Manual | Manual |
| Catheter<br>Effective<br>Length | 80cm<br>100cm<br>110cm | 65-120 cm |
| Catheter<br>Outer<br>Diameter | 4Fr / 1.40mm<br>5Fr / 1.70mm<br>6Fr / 2.00mm | 4Fr / 1.40mm<br>5Fr / 1.70mm<br>6Fr / 2.00mm |
| Catheter<br>Inner<br>Diameter | 4Fr / 1.05mm<br>5Fr / 1.13mm, 1.20mm<br>6Fr / 1.20mm, 1.30mm | 4Fr / 1.05mm<br>5Fr / 1.22mm<br>6Fr / 1.32mm |
| Guide wire<br>Compatibility | 0.038"(0.97mm) | 0.038"(0.97mm) |
| Sterilization | Sterile / Ethylene oxide | Sterile / Ethylene oxide |
| Description | Subject Device: Angiographic<br>Catheter | Predicate Device :<br>Radifocus Optitorque |
| Usability | Single use | Single use |
| Catheter<br>Body | Shaft:<br>Inner Layer: Polyamide<br>elastomer<br>Braid: Stainless steel<br>Outer Layer: Polyamide<br>Elastomer | Shaft:<br>Inner Layer: Polyamide<br>elastomer, Polyurethane<br>elastomer<br>Braid: Stainless steel<br>Outer Layer: Polyamide<br>elastomer, Polyurethane<br>elastomer |
| | Tip:<br>Polyamide Elastomer, Polyurethane<br>elastomer | Tip: Polyurethane elastomer |
| | Strain relief tubing:<br>LLDPE | Strain relief: Polyurethane elastomer |
| | Catheter hub:<br>Polyethylene terephthalate -1, 4-<br>cyclohexanedimethanol ester | Hub: Polyamide |

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The SUPERPIPE Angiographic Catheter is substantially equivalent to the Radifocus Optitorque Angiographic Catheter in technology/principal of operation is similar in the material and design. The main differences between the Angiographic Catheter and the predicate device are the size and the material. These differences do not raise any significant issues of safety or effectiveness. Performance (bench) testing and biocompatibility testing were performed to demonstrate that the proposed device performs as intended and does not raise new questions of safety or efficacy compared to the predicate devices.

- The following performance data were provided in support of the Performance Data: substantial equivalence determination.
Non-Clinical Performance Testing

Performance testing was performed per ISO 10555-1. The test items, methods and method references of Superpipe Angiographic Catheter are as follows:

- o Catheter Sizes

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- . Catheter Surface
- Catheter Color o
- Side Holes 0
- Catheter Hub
- Distal Tip ●
- Distal Shape ●
- Freedom from Leakage
- . Peak Tensile Force of Catheter
- Burst Pressure under Static Conditions ●
- Radio-detectability ●
- Torsion Transmissibility o
- Torque strength ●
- Kink test ●
- Push and withdrawal Ability
- Simulated Use
- Flow rate ●
- . EO and ECH Residual
- Sterile
- Bacterial Endotoxin ●
- Visual Inspection test of the inner pouch
- Sealing-strength of the Inner Pouch ●
- Dye Leakage Test of the Inner Pouch ●

### Biocompatibility Testing

Biocompatibility evaluation for the Angiographic Catheter was conducted in accordance with current standards and the following tests were included:

- Cytotoxicity study o
- Sensitization study
- Intracutaneous study ●
- Acute systemic toxicity study ●
- Pyrogen study ●
- Hemolysis study
- In-vivo thromboresistance study ●
- Complement activation assay ●

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K193647 SUPERPIPE Angiographic Catheter 510(k) Summary

The Angiographic Catheter was found to be substantially equivalent in Conclusion: its design, intended use, technology, principal of operation, and performance to the predicate device. There are not significant differences between the Angiographic Catheter and the predicate device that raise new issues of safety and effectiveness.