(695 days)
No
The description focuses on the physical characteristics and electrical performance of a diagnostic catheter, with no mention of AI or ML capabilities.
No.
The device is used for "electrogram recording and cardiac stimulation during diagnostic electrophysiology studies," indicating a diagnostic rather than therapeutic purpose.
Yes
Explanation: The "Intended Use / Indications for Use" explicitly states that the device is a "Diagnostic Catheter" and is used for "electrogram recording and cardiac stimulation during diagnostic electrophysiology studies." The "Device Description" also refers to it as a "diagnostic catheter."
No
The device description clearly describes a physical catheter with electrodes and a cable, and the performance studies include mechanical, electrical, and sterilization testing, all indicative of a hardware medical device.
Based on the provided information, the EasyFinder™ Fixed Curve Diagnostic Catheter is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states it's for "electrogram recording and cardiac stimulation during diagnostic electrophysiology studies." This involves interacting directly with the patient's body to record electrical signals and stimulate the heart.
- Device Description: The description details a catheter designed to be inserted into the body to map cardiac structures.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body. IVDs are specifically designed for testing these types of samples.
The device is a diagnostic catheter used in vivo (within the living body) for electrophysiological studies.
N/A
Intended Use / Indications for Use
EasyFinder™ Fixed Curve Diagnostic Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.
Product codes
DRF
Device Description
The EasyFinder™ Fixed Curve Diagnostic Catheter is a sterile, single-use diagnostic catheter with multiple electrodes and a fixed distal curve. It has been designed to facilitate electrophysiological mapping of cardiac structures in 28 models and 6 kinds of curves.
The catheter has a high-torque shaft with a fixed curve section containing an array of platinum electrodes. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
The catheter is connected to separately cleared diagnostic electrophysiology equipment via an accessory, the FORLNK™ Cable for Mapping Catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional healthcare environment
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)
Non-clinical performance testing was completed for the EasyFinder™ Fixed Curve Diagnostic Catheter and accessory FORLNK™ Cable for Mapping Catheter to support their substantial equivalence to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- (1) Biocompatibility Verification: The biological safety of the catheter was verified as per the requirements of ISO 10993-1:2018 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process and FDA's modified ISO quidelines in accordance with the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
- (2) Mechanical Verification: Mechanical testing was performed to verify compliance of the catheter with ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements.
- (3) Electrical Verification: Electrical testing was performed to verify compliance of the catheter and accessory cable with applicable IEC 60601-1: 2005 Medical electrical equipment – Part1: General requirements for basic safety and essential performance, IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances – Requirements and tests and IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.
- (4) Bench Validation: Validation testing of the catheter was performed to validate the design of the device with regards to radiopacity. Validation testing of the accessory cable was performed to evaluate the design and function of the cable.
- (5) Cleaning and Sterilization Validation: Validation testing was performed to demonstrate that the catheter and accessory cable could be cleaned and sterilized in accordance with ISO 11135:2014 Sterilization of health care products-Ethylene Oxide: Requirements for development, validation and routine control of a sterilization process for medical device, AAMI TIR 28:2009 Product Adoption and Process Equivalency for Ethylene Oxide sterilization and the FDA guidance document.
- (6) Shelf Life Validation: Validation testing was performed to demonstrate the shelf life of the catheter and accessory cable are three years.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
December 30, 2022
Shanghai MicroPort EP MedTech Co., Ltd. Min Zhu RA Engineer Building 23&28, Lane 588, Tianxiong Rd. Shanghai, Shanghai 201318 People's Republic of China
Re: K210313
Trade/Device Name: EasyFinder™ Fixed Curve Diagnostic Catheter; FORLNK™ Cable for Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II Product Code: DRF Dated: January 25, 2021 Received: February 3, 2021
Dear Xia Tian:
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.
1
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 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.
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices 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) K210313
Device Name
EasyFinder™ Fixed Curve Diagnostic Catheter FORLNK™ Cable for Mapping Catheter
Indications for Use (Describe)
EasyFinder™ Fixed Curve Diagnostic Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.
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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Image /page/3/Picture/0 description: The image shows the EverPace logo. The logo consists of the letters 'e' and 'o' connected together, followed by the word 'EverPace' in blue. The 'e' is blue, and the 'o' is red. There is a trademark symbol in the upper right corner of the logo.
510(k) Summarv
Submitter Information
- Shanqhai MicroPort EP MedTech Co., Ltd. A. Company Name: B. Company Address: Building 23&28, Lane 588, Tianxiong Rd., 201318 Shanghai, PEOPLE'S REPUBLIC OF CHINA C. Company Phone: +86 21 38954600*53701 D. Company Facsimile: +86 21 20903925 E. Email: zhumin@everpace.com F. Contact Person: Zhu, Min December 30, 2022 G. Summary Prepared on:
Identification of Proposed Device
| A. Device Trade Name: | EasyFinder™ Fixed Curve Diagnostic Catheter
FORLNK™ Cable for Mapping Catheter |
|-------------------------|-----------------------------------------------------------------------------------|
| B. Device Common Name: | Electrode recording catheter |
| C. Classification Name: | Catheter, Electrode Recording, Or Probe,
Electrode Recording |
| D. Regulation Number | 21 CFR 870.1220 |
| E. Product Code: | DRF |
| F. Device Class: | Class II |
| G. Review Panel | Cardiovascular |
Device Description
The EasyFinder™ Fixed Curve Diagnostic Catheter is a sterile, single-use diagnostic catheter with multiple electrodes and a fixed distal curve. It has been designed to facilitate electrophysiological mapping of cardiac structures in 28 models and 6 kinds of curves.
The catheter has a high-torque shaft with a fixed curve section containing an array of platinum electrodes. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
The catheter is connected to separately cleared diagnostic electrophysiology equipment via an accessory, the FORLNK™ Cable for Mapping Catheter.
Indications for Use Statement
EasyFinder™ Fixed Curve Diagnostic Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.
Identification of Predicate Device
| A. Product Name: | IBI-1100(TM) ELECTROPHYSIOLOGY
CATHETER |
| ------------------ | -------------------------------------------- |
|---|
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Image /page/4/Picture/0 description: The image shows the EverPace logo. The logo consists of a stylized "E" and "O" in blue and red, respectively, followed by the word "EverPace" in blue. A small "TM" symbol is located to the upper right of the word "EverPace".
- B. Manufacturer: IRVINE BIOMEDICAL, INC.
- C. 510(k) Number: K946333
- 21 CFR 870.1220 D. Regulation Number
- E. Product Code: DRF
- F. Device Class: Class II
Identification of Reference Device
- A. Product Name: Cordis Webster Fixed Curve Catheter
- B. Manufacturer: Cordis Webster, Inc.
- K992965 C. 510(k) Number
- D. Requlation Number 21 CFR 870.1220
- E. Product Code: DRF
- F. Device Class: Class II
Non-Clinical Performance Testing
Non-clinical performance testing was completed for the EasyFinder™ Fixed Curve Diagnostic Catheter and accessory FORLNK™ Cable for Mapping Catheter to support their substantial equivalence to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- (1) Biocompatibility Verification: The biological safety of the catheter was verified as per the requirements of ISO 10993-1:2018 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process and FDA's modified ISO quidelines in accordance with the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
- (2) Mechanical Verification: Mechanical testing was performed to verify compliance of the catheter with ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements.
- (3) Electrical Verification: Electrical testing was performed to verify compliance of the catheter and accessory cable with applicable IEC 60601-1: 2005 Medical electrical equipment – Part1: General requirements for basic safety and essential performance, IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances – Requirements and tests and IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.
5
Image /page/5/Picture/0 description: The image shows the logo for EverPace. The logo consists of a stylized "E" and "O" connected together, with the "E" in blue and the "O" in red. To the right of the symbol is the word "EverPace" in blue font. A small trademark symbol is located in the upper right corner of the word "EverPace".
- (4) Bench Validation: Validation testing of the catheter was performed to validate the design of the device with regards to radiopacity. Validation testing of the accessory cable was performed to evaluate the design and function of the cable.
- (5) Cleaning and Sterilization Validation: Validation testing was performed to demonstrate that the catheter and accessory cable could be cleaned and sterilized in accordance with ISO 11135:2014 Sterilization of health care products-Ethylene Oxide: Requirements for development, validation and routine control of a sterilization process for medical device, AAMI TIR 28:2009 Product Adoption and Process Equivalency for Ethylene Oxide sterilization and the FDA guidance document.
- (6) Shelf Life Validation: Validation testing was performed to demonstrate the shelf life of the catheter and accessory cable are three years.
Clinical Tests Conclusion
No clinical study is included in this submission.
| Description | Proposed Device | Predicate Device
(K946333) | Remark |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product Code | DRF | DRF | SE |
| Regulation No. | 21 CFR 870.1220 | 21 CFR 870.1220 | SE |
| Class | Class II | Class II | SE |
| Indications for
Use | EasyFinder™ Fixed Curve
Diagnostic Catheter is used
for electrogram recording and
cardiac stimulation during
diagnostic electrophysiology
studies. | IBI-1100(TM)
ELECTROPHYSIOLOGY
CATHETER is used for
electrogram recording and
cardiac stimulation during
diagnostic electrophysiology
studies. | SE |
| Configuration | Cable connector | Cable connector | SE |
| | Tip electrode | Tip electrode | SE |
| | Ring electrode | Ring electrode | SE |
| | High-torque shaft | High-torque shaft | SE |
| Dimensional
Comparison | Catheter effective length | Catheter effective length | Similar |
| | Length of color code | Length of color code | SE |
| | Electrode length | Electrode length | Similar |
| | Electrode diameter | Electrode diameter | SE |
| | Electrode spacing | Electrode spacing | SE |
Comparison to Predicate Device
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Image /page/6/Picture/0 description: The image shows the logo for EverPace. The logo consists of a stylized "E" and "O" connected together, with the "E" in blue and the "O" in red. To the right of the symbol is the word "EverPace" in blue, with a trademark symbol in the upper right corner.
| Outside diameter of catheter shaft | Outside diameter of catheter shaft | SE | |
|---|---|---|---|
| Curve shape | Curve shape | Similar | |
| Functional | |||
| Performance | Comply with ISO 10555-1 | Comply with ISO 10555-1 | SE |
| Biological | |||
| Characteristics | Comply with ISO 10993-1 | Comply with ISO 10993-1 | Similar |
| Intended | |||
| Healthcare | |||
| Environment | Professional healthcare | ||
| environment | Professional healthcare | ||
| environment | SE | ||
| Sterilization | |||
| Method | EO sterilized | EO sterilized | SE |
| Single Use | Yes | Yes | SE |
| Shelf Life | 3 years | 3 years | SE |
Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
The proposed and predicate devices share the same indications for use and fundamental scientific technology, including principles of operation and mechanism of action. Design and technological differences between the proposed and predicate devices do not raise any new concerns of safety and effectiveness. The results of verification and validation testing demonstrate that the EasyFinder™ Fixed Curve Diagnostic Catheter and the accessory cable are as safe, as effective, and perform in a manner that is substantially equivalent to the predicate device.