(267 days)
Not Found
No
The device description focuses on mechanical components and manual steering. There is no mention of AI, ML, image processing, or data-driven decision making. The performance studies are standard bench and biocompatibility tests for a mechanical device.
No.
The device is an introducer sheath, which is a tool used to facilitate the placement of other cardiovascular catheters. It does not directly provide therapy.
No
The device description indicates that the PathBuilder™ Steerable Introducer is used to introduce other catheters into the heart. It facilitates access for procedures, but does not itself gather data for diagnostic purposes.
No
The device description clearly details physical components such as a steerable sheath, dilator, guidewire, handle, hemostasis valve, and sideport, indicating it is a hardware medical device.
Based on the provided information, the PathBuilder™ Steerable Introducer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to introduce cardiovascular catheters into the heart. This is a procedure performed within the body (in vivo) to facilitate other medical interventions.
- Device Description: The description details a physical device designed for insertion into blood vessels and the heart. It describes mechanical components like a sheath, dilator, guidewire, handle, and valves.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens outside the body (in vitro), such as blood, urine, or tissue samples, to provide information about a patient's health. The PathBuilder™ Steerable Introducer does not interact with or analyze biological specimens in this manner.
Therefore, the PathBuilder™ Steerable Introducer is a medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The PathBuilder Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
PathBuilder™ Steerable Introducer is composed of a steerable sheath, a dilator and a guidewire. It is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The steerable sheath is introduced into a body vessel, along with the dilator, over the guidewire, it is available in a variety of lengths, sizes and curve configurations; Dilator is assembled with the sheath and introduced into a body vessel over the guidewire. It is used to provide support to the sheath and ensure smooth advancement; the guidewire is percutaneously placed into the body vessel to function as a guide for the introduction into the chambers of the heart.
The distal end of steerable sheath is embedded with a marker band and vent holes. The steerable sheath is finished at the proximal end with a hemostasis valve and sideport with a three-way stopcock. By turning the rotating collar on handle, the steerable sheath can be bidirectionally bended to facilitate the steerable sheath to reach complex heart structures more conveniently. The distal end of dilator has a tip, while its proximal end is connected with luer fitting. The inner diameter of dilator distal end is smaller than the main body for the purpose of locking the position of a puncture needle. The distal end of dilator has a fixed curve to adapt to the heart structure.
The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise ≥180° and counter-clockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, interatrial septum
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 PathBuilder™ Steerable Introducer to support its substantial equivalence to the predicate device. The test results demonstrated that the proposed device complies with the following standards and guidance:
(1) Biocompatibility Verification: The biological safety of the introducer 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 guidelines in accordance with the FDA quidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
a) Cytocompatiblity
b) Sensitization
c) Irritation
d) Acute Systemic Toxicity
e) Hemocompatibility
f) Complement Activation
g) Thrombogenicity
(2) Bench Validation: Validation testing of the introducer was performed to validate the design of the device. This testing included visual inspection, dimensional verification, packaging testing (visual inspection, sealing strength, dye penetration), transit testing and mechanical failure/performance (Peak tensile force of joints, flexion testing and fracture testing of quidewire). Additionally, the compatibly of the of the introducer, guidewire and dilator was validated with compatibility, bending load, controlling curve force, insertion withdrawal force, pushing force, simulated use fatigue testing (put the device through repeated physiologically relevant turns and observed for damage), radio detectability, freedom from leakage, dilator hub and 3way stopcock Luer testing. All samples were sterilized and aged prior to testing. All tested samples passed bench testing.
(3) Cleaning and Sterilization Validation: Validation testing was performed to demonstrate that the introducer could be 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.
(4) Shelf Life Validation: Validation testing was performed to demonstrate the shelf life of the introducer is three years.
No clinical study was used to support this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
February 8, 2022
Shanghai MicroPort EP MedTech Co., Ltd. Tian Xia RA Engineer Building 23&28, Lane 588, Tianxiong Rd. Shanghai, Shanghai 201318 China
Re: K211530
Trade/Device Name: PathBuilder Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 29, 2021 Received: January 10, 2022
Dear Tian Xia:
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.
Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211530
Device Name PathBuilder Steerable Introducer
Indications for Use (Describe)
The PathBuilder Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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 logo for EverPace. The logo consists of a stylized "E" made up of a blue horizontal bar and a red circle. To the right of the "E" is the word "EverPace" in blue font. A small "TM" symbol is located in the upper right corner of the word "EverPace".
510(k) # K211530 510(k) Summary
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*3613
- D. Company Facsimile: +86 21 20903925
- E. Email: txia@everpace.com
- F. Contact Person: Xia, Tian
- G. Summary Prepared on: October 20, 2021
Identification of Proposed Device
- PathBuilder™ Steerable Introducer A. Trade Name:
- B. Common Name: Catheter Introducer
- Introducer, Catheter C. Classification Name:
- D. Regulation Number 21 CFR 870.1340
- E. Product Code: DYB
- F. Device Class: Class II
- G. Review Panel Cardiovascular
- H. 510(k) Number K211530
Device Description
PathBuilder™ Steerable Introducer is composed of a steerable sheath, a dilator and a guidewire. It is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The steerable sheath is introduced into a body vessel, along with the dilator, over the guidewire, it is available in a variety of lengths, sizes and curve configurations; Dilator is assembled with the sheath and introduced into a body vessel over the guidewire. It is used to provide support to the sheath and ensure smooth advancement; the guidewire is percutaneously placed into the body vessel to function as a guide for the introduction into the chambers of the heart.
The distal end of steerable sheath is embedded with a marker band and vent holes. The steerable sheath is finished at the proximal end with a hemostasis valve and sideport with a three-way stopcock. By turning the rotating collar on handle, the steerable sheath can be bidirectionally bended to facilitate the steerable sheath to reach complex heart structures more conveniently. The distal end of dilator has a tip, while its proximal end is connected with luer fitting. The inner diameter of dilator distal end is smaller than the main body for the purpose of locking the position of a puncture needle. The distal end of
4
dilator has a fixed curve to adapt to the heart structure.
The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise ≥180° and counter-clockwise ≥90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
Intended Use Statement
The PathBuilder™ Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Identification of Predicate Device
- Agilis™ NxT Steerable Introducer A. Product Name:
- B. Manufacturer: St. Jude Medical C. 510(k) Number: K081645 D. Regulation Number 21 CFR 870.1340 E. Product Code: DYB F. Device Class: Class II
Non-Clinical Performance Testing
Non-clinical performance testing was completed for the PathBuilder™ Steerable Introducer to support its substantial equivalence to the predicate device. The test results demonstrated that the proposed device complies with the following standards and guidance:
- (1) Biocompatibility Verification: The biological safety of the introducer 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 guidelines in accordance with the FDA quidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
- Cytocompatiblity a)
- Sensitization b)
- Irritation C)
- Acute Systemic Toxicity d)
- Hemocompatibility e)
5
- Complement Activation f)
- Thrombogenicity q)
- (2) Bench Validation: Validation testing of the introducer was performed to validate the design of the device . This testing included visual inspection, dimensional verification, packaging testing (visual inspection, sealing strength, dye penetration), transit testing and mechanical failure/performance (Peak tensile force of joints, flexion testing and fracture testing of quidewire). Additionally, the compatibly of the of the introducer, guidewire and dilator was validated with compatibility, bending load, controlling curve force, insertion withdrawal force, pushing force, simulated use fatigue testing (put the device through repeated physiologically relevant turns and observed for damage), radio detectability, freedom from leakage, dilator hub and 3way stopcock Luer testing. All samples were sterilized and aged prior to testing. All tested samples passed bench testing.
- (3) Cleaning and Sterilization Validation: Validation testing was performed to demonstrate that the introducer could be 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.
- (4) Shelf Life Validation: Validation testing was performed to demonstrate the shelf life of the introducer is three years.
Clinical Tests Conclusion
No clinical study was used to support this submission.
| Description | Proposed Device | Predicate Device
(K081645) | Remark | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------|
| Product Code | DYB | DYB | SE | |
| Regulation No. | 21 CFR 870.1340 | 21 CFR 870.1340 | SE | |
| Class | Class II | Class II | SE | |
| Intended Use | The PathBuilderTM
Steerable Introducer is
indicated for introducing
various cardiovascular
catheters into the heart,
including the left side of | The AgilisTM NxT
Steerable Introducer is
indicated for introducing
various cardiovascular
catheters into the heart,
including the left side of | SE | |
| | the heart through the | the heart through the | | |
| | interatrial septum. | interatrial septum. | | |
| | The PathBuilder™
Steerable Introducer is | The Agilis™ NxT
Steerable Introducer is | | |
| Indications for Use | indicated for introducing
various cardiovascular
catheters into the heart,
including the left side of
the heart through the
interatrial septum. | indicated for introducing
various cardiovascular
catheters into the heart,
including the left side of
the heart through the
interatrial septum. | SE | |
| | Configuration | Steerable sheath | Steerable sheath | SE |
| | | Dilator | Dilator | SE |
| | | Guidewire | Guidewire | SE |
| Functional
performance | Comply with ISO 11070:
2014 | Comply with ISO 11070:
2014 | SE | |
| Biological
characteristics | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SE | |
| | Total length of steerable
sheath | Total length of steerable
sheath | SE | |
| | Outer diameter of
steerable sheath | Outer diameter of
steerable sheath | SE | |
| | Inner diameter of
steerable sheath tip | Inner diameter of
steerable sheath tip | SE | |
| | Curve shape of steerable
sheath tip | Curve shape of steerable
sheath tip | SE | |
| Dimensional
Comparision | Effective length of dilator | Effective length of dilator | SE | |
| | Outer diameter of dilator | Outer diameter of dilator | SE | |
| | Inner diameter of dilator
tip | Inner diameter of dilator
tip | SE | |
| | Curve shape of dilator tip | Curve shape of dilator tip | SE | |
| | Effective length of
guidewire | Effective length of
guidewire | SE | |
| | Outer diameter of
guidewire | Outer diameter of
guidewire | SE | |
| | Inner diameter of J-curve
tip | Inner diameter of J-curve
tip | SE | |
| | Intended
healthcare
environment | Professional healthcare
environment | Professional healthcare
environment | SE |
| | | Sterilization
method | EO Sterilized | EO Sterilized |
| Single use | | Yes | Yes | SE |
| Shelf Life | 3 years | 3 years | SE | |
Comparison to Predicate Device
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Shanghai MicroPort EP MedTech Co., Ltd.
Building 23&28, Lane 588, Tianxiong Rd., 201318 Shanghai, PEOPLE'S REPUBLIC OF CHINA 4 / 5
7
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 intended 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 PathBuilder™ Steerable Introducer is substantially equivalent to the predicate device.