(308 days)
No
The device description and performance studies focus on the physical and functional characteristics of a traditional angiography catheter, with no mention of AI or ML capabilities.
No
The device is described as being for "delivery of radiopaque contrast media" and does not perform any therapeutic function.
Yes
The device is described as an "Angiography Catheter" intended for the "delivery of radiopaque contrast media to selected sites during the angiography procedure." Angiography is a diagnostic imaging technique used to visualize blood vessels. The device facilitates this diagnostic procedure by delivering the contrast agent necessary for the imaging. Furthermore, one of the reference devices is explicitly named "Alvision™ Interventional Cardiology Diagnostic Catheter" and "Alvicath™ Endovascular Diagnostic Catheter," further indicating the diagnostic nature of devices in this category.
No
The device description clearly outlines physical components like tubes, hubs, shafts, and tips, and the performance studies focus on physical and material properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of radiopaque contrast media during angiography procedures. This is a procedural device used in vivo (within the body) to facilitate imaging, not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The description details a catheter designed to be inserted into the vascular system. This is consistent with an interventional or diagnostic medical device used directly on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
Therefore, the KDL Angiography Catheter is a medical device used in a clinical setting for a diagnostic imaging procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
KDL Angiography Catheter are intended for delivery of radiopaque contrast media to selected sites during the angiography procedure of the peripheral and coronary vascular system.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The proposed device consists of tube hub, strain relief, catheter shaft with stainless steel braid layer, soft extension and distal tip. The catheter shaft is made of Pebax contain Barium Sulfate that is radiopaque and a middle stainless steel braid layer. Soft extension and distal tip is made of Pebax contain Barium Sulfate without stainless steel braid layer that could prevent vascular injury when pushed into the blood vessel.
The distal tip of the catheter is available in 32 kinds tip shape configurations. The outer diameter is available in 4F, 5F, 6F, 7F sizes and the length is available in 100cm except for Pig angiography catheter in length of 110cm. The side hole on distal tip is used to disperse the contrast media and balance pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary 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)
The following nonclinical bench testing was conducted on KDL angiography catheter to support to determine the performance proposed device is substantially equivalent to the predicate device.
-
- Appearance
-
- Length
-
- Out diameter
-
- Hub
-
- Side holes
-
- Corrosion resistance
-
- Liquid leakage
-
- Air leakage
-
- Burst pressure
-
- Dynamic flow rate and pressure
-
- Bond strength
-
- Tip pull test
-
- Kink and flexibility test
-
- Torque resistance
-
- Catheter insertion/retraction force
-
- Guidewire compatibility
-
- Particulate
-
- Radio-detectability
-
- EO residuals
-
- Sterility
-
- Bacterial endotoxin
Biocompatibility testing was conducted in compliance with ISO 10993-1, for externally communicating devices with limited exposure (
§ 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
May 14, 2021
Shanghai Kindly Medical Instruments Co., Ltd. Jeffery Hui Official Correspondent No. 925, Jinyuan yi Road Shanghai, Shanghai 201803 China
Re: K201929
Trade/Device Name: KDL Angiography Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: July 8, 2020 Received: July 10, 2020
Dear Jeffery Hui:
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Interventional 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) K201929
Device Name KDL Angiography Catheter
Indications for Use (Describe)
K.DL Angiography Catheter are intended for delivery of radiopaque contrast media to selected sites during the angiography procedure of the peripheral and coronary vascular system.
Type of Use (Select one or both, as applicable)
| Reproductive Use (Per 21 CFR 201.66) Subject to Disapproval |
|---|
| On-Site Compounding (21 CFR 201.66) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the 510(k) guidance and 21 CFR 807.92.
510(k) Number: K201929
- Date of Submission: May 13, 2021 1.
2. Applicant
Shanghai Kindly Medical Instruments Co., Ltd. Address: 925 Jinyuan Yi Road, Shanghai, China, 201803 Contact: Jianhai Xu, Regulatory Affairs Supervisor Tel.:+086-021-59140056 Fax: +086-021-59140056 Email: xujianhai(@kdlchina.com
Proposed Device 3.
Device Name: KDL Angiography Catheter Review Panel: Cardiovascular Regulation Number: 21 CFR 870.1200 Regulation name: Diagnostic intravascular catheter. Regulation Class: Class II Product Code: DQO
4. Predicate Device
| Device Name | 510(k) No. | Product Code | |
|---|---|---|---|
| Predicate Device | Radifocus® Optitorque™ | ||
| Angiographic Catheter | K150232 | DQO | |
| Reference Device | Alvision™ Interventional | ||
| Cardiology Diagnostic Catheter | |||
| Alvicath™ Endovascular | |||
| Diagnostic Catheter | K143604 | DQO |
ട. Device Description
The proposed device consists of tube hub, strain relief, catheter shaft with stainless steel braid layer, soft extension and distal tip. The catheter shaft is made of Pebax contain Barium Sulfate that is radiopaque and a middle stainless steel braid layer. Soft extension and distal tip is made
4
of Pebax contain Barium Sulfate without stainless steel braid layer that could prevent vascular injury when pushed into the blood vessel.
The distal tip of the catheter is available in 32 kinds tip shape configurations. The outer diameter is available in 4F, 5F, 6F, 7F sizes and the length is available in 100cm except for Pig angiography catheter in length of 110cm. The side hole on distal tip is used to disperse the contrast media and balance pressure.
6. Intended Use Statement
KDL Angiography Catheter are intended for delivery of radiopaque contrast media to selected sites during the angiography procedure of the peripheral and coronary vascular system.
7. Substantially Equivalent comparison
5
| Proposed Device | Predicate Device | Reference Device | Note | |
|---|---|---|---|---|
| Item | K201929 | K150232 | K143604 | |
| Product code | DQO | DQO | DQO | Same |
| Indication for use | KDL Angiography | |||
| Catheter are intended for | ||||
| delivery of radiopaque | ||||
| contrast media to selected | ||||
| sites in the angiography | ||||
| procedure of the peripheral | ||||
| and coronary vascular | ||||
| system. | The Radifocus Optitorque | |||
| Angiographic Catheter is indicated | ||||
| for use in cardiac and vascular | ||||
| procedures. It is designed to | ||||
| deliver radiopaque media, guide | ||||
| wires, catheters, and therapeutic | ||||
| agents to selected sites in the | ||||
| vascular system. The different | ||||
| shapes are designed to selectively | ||||
| engage arteries from access sites | ||||
| such as the femoral, radial, and | ||||
| brachial artery. | Alvision™ Interventional | |||
| Cardiology Diagnostic Catheters | ||||
| are intended for use in the delivery | ||||
| of radio-opaque media to selected | ||||
| sites in the coronary vascular | ||||
| system. | ||||
| Alvicath™ Endovascular | ||||
| Diagnostic Catheters are intended | ||||
| for use in the delivery of | ||||
| radio-opaque media to selected | ||||
| sites in the peripheral vascular | ||||
| system. | Same | |||
| Principle of | ||||
| Operation | The proposed device is | |||
| introduced into the blood | ||||
| vessel by the guide wire. | The predict device is introduced | |||
| into the blood vessel by the guide | ||||
| wire. | The predict device is introduced | |||
| into the blood vessel by the guide | ||||
| wire. | Same | |||
| Design | ||||
| Description | KDL Angiography | |||
| Catheter consist of tube | ||||
| hub, strain relief, catheter | ||||
| shaft with stainless steel | ||||
| braid layer, catheter soft | ||||
| extension. | The Radifocus Optitorque | |||
| Angiographic Catheter consist of | ||||
| catheter shaft, the soft tip, soft | ||||
| tube, tube hub and strain relief. | Alvision™ and Alvicath™ are | |||
| sterile, nonpyrogenic, single lumen | ||||
| catheters with a soft distal tip and a | ||||
| proximal strain relief and luer hub. | Same | |||
| Distal shape | 32 distal shape | |||
| configurations | A variety of distal shape | |||
| configurations | A variety of distal shape | |||
| configurations | Similar | |||
| Catheter size | 4F, 5F, 6F, 7F | 4F, 5F, 6F | 4F, 5F, 6F, 7F | Same as |
| K143604 | ||||
| Effective | ||||
| Length(cm) | 100 cm,110 cm. | 65cm, 80 cm, 90 cm, 100 cm, 110 | ||
| cm. | 45 cm, 60 cm, 65 cm, 80 cm,100 | |||
| cm,110 cm | Similar | |||
| Side holes | Yes | Yes | Yes | Same |
| Sterile package | Yes | Yes | Yes | Same |
| Guidewire | ||||
| compatibility | Accept a maximum | |||
| guidewire diameter of | ||||
| 0.038" | Accept a maximum guidewire | |||
| diameter of 0.038" | Accept a maximum guidewire | |||
| diameter of 0.038" | Same | |||
| Method of | ||||
| supply | Sterile and single use | Sterile and single use | Sterile and single use | Same |
| Material | Pebax, Barium Sulfate, | |||
| stainless steel, | ||||
| Thermoplastic | ||||
| polyurethane (TPU), | ||||
| Polycarbonate (PC). | Pebax, Barium Sulfate, 316 | |||
| stainless steel, Bismuth Oxide, | ||||
| Nylon, Barium Sulfate, | ||||
| Polyurethane elastomer, | ||||
| Polyamide elastomer, Polyamide, | ||||
| Polyethylene | Stainless steel wire, Nylon 12, | |||
| Barium Sulfate, Pebax. | Different | |||
| Maximum | ||||
| Pressure | 1200 psi | 4 Fr: 750 psi | ||
| 5 Fr and 6 Fr: 1000 psi | 1200 psi | Same as | ||
| K143604 | ||||
| Shelf life | Three years | Three years | Three years | Same |
| Sterilization | ||||
| Method | EO | EO | EO | Same |
| Sterility | ||||
| Assurance Level | 10-6 | 10-6 | 10-6 | Same |
6
7
8. The results of the comparison
The indication for use, design and materials were used to determine equivalent performance in KDL angiography catheter, Radifocus Optitorque Angiographic Catheter and Alvision™, Alvicath™ Diagnostic Catheters.
9. Performance data
The following nonclinical bench testing was conducted on KDL angiography catheter to support to determine the performance proposed device is substantially equivalent to the predicate device.
-
- Appearance
-
- Length
-
- Out diameter
-
- Hub
-
- Side holes
-
- Corrosion resistance
-
- Liquid leakage
-
- Air leakage
-
- Burst pressure
-
- Dynamic flow rate and pressure
-
- Bond strength
-
- Tip pull test
-
- Kink and flexibility test
-
- Torque resistance
-
- Catheter insertion/retraction force
-
- Guidewire compatibility
-
- Particulate
-
- Radio-detectability
-
- EO residuals
-
- Sterility
-
- Bacterial endotoxin
10. Biocompatibility Testing Summary
Biocompatibility testing was conducted in compliance with ISO 10993-1, for externally communicating devices with limited exposure (In Vitro hemolytic | ASTM F756-17 | The test result showed the test article had no influence on hemolytic properties |
| Acute System Toxicity | ISO 10993-5:2009 | Under the conditions of this study, there was no evidence of systemic toxicity from the extract, the test article extract met the requirements of this study. |
| In Vitro Cytotoxiciy | ISO 10993-10:2010 | Under the conditions of this study, the test article extract did not show potential toxicity to L-929 cells. |
| Skin Sensitization | ISO 10993-10:2010 | No evidence of causing skin sensitization |
| Intracutaneous
Reactivity | ISO 10993-11:2017 | The test results showed that the polar and non-polar test article extracts did not induce intracutaneous reactivity in rabbit under the test condition |
| Pyrogenicity | ISO 10993-11:2006 | No rabbit an individual rise in temperature of 0.5°C or more |
| In vivo
Thrombogenicity | ISO 10993-4:2017 | Met the requirement of in vivo thrombogenicity test |
| Complement Activation | ISO 10993-4:2017 | No influence on complement activity |
Biocompatibility tests results
In accordance with ISO 10993-1, the testing results demonstrated that KDL angiography catheter is biocompatible.
10. Conclusion
Based on the indication for use, technological characteristics and performance testing results, KDL angiography catheter is substantially equivalent to Radifocus Optitorque Angiographic Catheter and Alvision™, Alvicath™ Diagnostic Catheters.