(212 days)
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.
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.
This is a 510(k) summary for the SUPERPIPE Angiographic Catheter, which is a medical device for delivering radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria in a study involving AI or human readers for diagnostic tasks.
Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them, especially in the context of AI and human reader performance, is not available in this document. This document details the engineering and biocompatibility testing performed to demonstrate that the device is safe and effective for its intended use, mainly comparing it to a predicate device.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted, but it does not explicitly state specific quantitative acceptance criteria or the numerical results/performance metrics for each test. Instead, it states that "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 tests performed include:
-
Non-Clinical Performance Testing (per ISO 10555-1):
- 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:
- Cytotoxicity study
- Sensitization study
- Intracutaneous study
- Acute systemic toxicity study
- Pyrogen study
- Hemolysis study
- In-vivo thromboresistance study
- Complement activation assay
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is bench testing and biocompatibility testing, not clinical studies involving patient data or test sets in the context of AI performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The device is an angiographic catheter, and the evaluation is based on engineering and biocompatibility tests, not diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical imaging context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. This document does not describe an AI medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This document does not describe an AI medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. The "ground truth" for the performance tests would be the established engineering standards (e.g., ISO 10555-1) and biocompatibility test methods, not clinical outcomes or expert consensus.
8. The sample size for the training set
This information is not applicable and not provided. This document does not describe an AI medical device requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
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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 (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
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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., LtdNo. 11 BuildingNo. 8 Jinfeng RoadSuzhou, China215163 |
|---|---|
| Contact Person: | Li LingRegulatory Affairs ManagerPhone: +86- 512-6805-0607Fax: +86- 512-6680-6133Email: 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-relatedrecall. |
| Device Description: | Angiographic Catheter consists of a catheter hub, a strain relieftubing, catheter shaft (including braided section and non-braidedsection) and catheter tip. It is comprised of a two-layerconstruction featuring stainless steel mesh sandwiched betweenlayers of polyamide elastomers of the catheter braided section.The non-braided section is comprised of layers of polyamideelastomers. And the soft catheter tip is comprised of the mixtureof polyurethane and polyamide elastomers. The device is offeredin 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: AngiographicCatheter | 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 |
| Indicationsfor Use | The SUPERPIPE AngiographicCatheter is intended for use inangiographic procedures. It deliversradiopaque media, guide wires,catheters, and therapeutic agents to | The Radifocus Optitorque is intended foruse in angiographic procedures. Itdelivers radiopaque media andtherapeutic agents to selected sites in thevascular system. |
| OperationPrinciple | selected sites in the vascular system.Manual | Manual |
| CatheterEffectiveLength | 80cm100cm110cm | 65-120 cm |
| CatheterOuterDiameter | 4Fr / 1.40mm5Fr / 1.70mm6Fr / 2.00mm | 4Fr / 1.40mm5Fr / 1.70mm6Fr / 2.00mm |
| CatheterInnerDiameter | 4Fr / 1.05mm5Fr / 1.13mm, 1.20mm6Fr / 1.20mm, 1.30mm | 4Fr / 1.05mm5Fr / 1.22mm6Fr / 1.32mm |
| Guide wireCompatibility | 0.038"(0.97mm) | 0.038"(0.97mm) |
| Sterilization | Sterile / Ethylene oxide | Sterile / Ethylene oxide |
| Description | Subject Device: AngiographicCatheter | Predicate Device :Radifocus Optitorque |
| Usability | Single use | Single use |
| CatheterBody | Shaft:Inner Layer: PolyamideelastomerBraid: Stainless steelOuter Layer: PolyamideElastomer | Shaft:Inner Layer: Polyamideelastomer, PolyurethaneelastomerBraid: Stainless steelOuter Layer: Polyamideelastomer, Polyurethaneelastomer |
| Tip:Polyamide Elastomer, Polyurethaneelastomer | Tip: Polyurethane elastomer | |
| Strain relief tubing:LLDPE | Strain relief: Polyurethane elastomer | |
| Catheter hub:Polyethylene terephthalate -1, 4-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.
§ 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).