(212 days)
No
The description focuses on the physical construction and intended use of a catheter, with no mention of AI or ML technologies.
No
The device is used to deliver therapeutic agents, but it is not a therapeutic device itself. Its primary function is for diagnostic angiographic procedures and delivery of other devices or media.
No
The device is an angiographic catheter used to deliver substances or other devices for procedures. While these procedures might be for diagnostic purposes, the catheter itself is a delivery tool, not a diagnostic device that directly provides diagnostic information by itself. Its intended use is described as "delivers radiopaque media, guide wires, catheters, and therapeutic agents," indicating an interventional or preparatory role rather than a diagnostic one.
No
The device description clearly outlines physical components like a catheter hub, shaft, and tip, made of materials like stainless steel mesh and polyamide elastomers. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use in "angiographic procedures" to "deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system." This describes a device used within the body for diagnostic imaging and therapeutic delivery, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details the physical components of a catheter designed for insertion into the vascular system. This aligns with the intended use and not with the typical components of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements associated with in vitro testing.
Therefore, the SUPERPIPE Angiographic Catheter is a medical device used for interventional procedures within the body, not an IVD.
N/A
Intended Use / 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.
Product codes
DQO
Device Description
Angiographic Catheter consists of a catheter hub, a strain relief tubing, catheter shaft (including braided section and non-braided section) and catheter tip. It is comprised of a two-layer construction featuring stainless steel mesh sandwiched between layers of polyamide elastomers of the catheter braided section. The non-braided section is comprised of layers of polyamide elastomers. And the soft catheter tip is comprised of the mixture of polyurethane and polyamide elastomers. The device is offered in lengths of 80cm, 100cm and 110cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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:
- Catheter Sizes
- Catheter Surface
- Catheter Color
- Side Holes
- Catheter Hub
- Distal Tip
- Distal Shape
- Freedom from Leakage
- Peak Tensile Force of Catheter
- Burst Pressure under Static Conditions
- Radio-detectability
- Torsion Transmissibility
- 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
- Sensitization study
- Intracutaneous study
- Acute systemic toxicity study
- Pyrogen study
- Hemolysis study
- In-vivo thromboresistance study
- Complement activation assay
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
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
| Submitter: | Suzhou Hengrui Disheng Medical Co., Ltd
No. 11 Building
No. 8 Jinfeng Road
Suzhou, China
215163 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Li Ling
Regulatory Affairs Manager
Phone: +86- 512-6805-0607
Fax: +86- 512-6680-6133
Email: liling02@hrmedical.com.cn |
| 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
(Terumo Medical Corp.)
This predicate device has not been subject to a design-related
recall. |
| Device Description: | Angiographic Catheter consists of a catheter hub, a strain relief
tubing, catheter shaft (including braided section and non-braided
section) and catheter tip. It is comprised of a two-layer
construction featuring stainless steel mesh sandwiched between
layers of polyamide elastomers of the catheter braided section.
The non-braided section is comprised of layers of polyamide
elastomers. And the soft catheter tip is comprised of the mixture
of polyurethane and polyamide elastomers. The device is offered
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. |
4
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
Catheter | Predicate Device :
Radifocus Optitorque |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K193647 | K992051 |
| Manufacturer | Suzhou Hengrui Disheng Medical Co.,
Ltd | Terumo Medical Corp. |
| Classification | II | II |
| Product Code | DQO | DQO |
| Regulation | 21 CFR 870.1200 | 21 CFR 870.1200 |
| 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 | The Radifocus Optitorque is intended for
use in angiographic procedures. It
delivers radiopaque media and
therapeutic agents to selected sites in the
vascular system. |
| Operation
Principle | selected sites in the vascular system.
Manual | Manual |
| Catheter
Effective
Length | 80cm
100cm
110cm | 65-120 cm |
| Catheter
Outer
Diameter | 4Fr / 1.40mm
5Fr / 1.70mm
6Fr / 2.00mm | 4Fr / 1.40mm
5Fr / 1.70mm
6Fr / 2.00mm |
| Catheter
Inner
Diameter | 4Fr / 1.05mm
5Fr / 1.13mm, 1.20mm
6Fr / 1.20mm, 1.30mm | 4Fr / 1.05mm
5Fr / 1.22mm
6Fr / 1.32mm |
| Guide wire
Compatibility | 0.038"(0.97mm) | 0.038"(0.97mm) |
| Sterilization | Sterile / Ethylene oxide | Sterile / Ethylene oxide |
| Description | Subject Device: Angiographic
Catheter | Predicate Device :
Radifocus Optitorque |
| Usability | Single use | Single use |
| Catheter
Body | Shaft:
Inner Layer: Polyamide
elastomer
Braid: Stainless steel
Outer Layer: Polyamide
Elastomer | Shaft:
Inner Layer: Polyamide
elastomer, Polyurethane
elastomer
Braid: Stainless steel
Outer Layer: Polyamide
elastomer, Polyurethane
elastomer |
| | Tip:
Polyamide Elastomer, Polyurethane
elastomer | Tip: Polyurethane elastomer |
| | Strain relief tubing:
LLDPE | Strain relief: Polyurethane elastomer |
| | Catheter hub:
Polyethylene terephthalate -1, 4-
cyclohexanedimethanol ester | Hub: Polyamide |
5
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
6
- . 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 ●
7
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.