(217 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of a guiding introducer, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is an introducer for catheters, designed to facilitate access to the heart, not to directly treat a condition or provide therapy.
No
The device description indicates that the PathBuilder™ Transseptal Guiding Introducer is used for "introducing various cardiovascular catheters into the left side of the heart through the interatrial septum." This describes a procedural, interventional, or therapeutic function (facilitating access for other catheters), not a diagnostic function. While it mentions pressure monitoring and blood sampling as capabilities of the sideport, its primary stated purpose is for introducing catheters, making it an access device rather than a diagnostic one.
No
The device description explicitly details physical components (sheath, dilator, guidewire, marker band, vent holes, sideport, valve, hub, tip) and performance studies (biocompatibility, bench validation, cleaning/sterilization, shelf life) related to these hardware components. There is no mention of software as a component or function of the device.
Based on the provided information, the PathBuilder™ Transseptal Guiding Introducer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to introduce cardiovascular catheters into the left side of the heart through the interatrial septum. This is a procedure performed in vivo (within the living body) for diagnostic or therapeutic purposes related to the heart's structure and function.
- Device Description: The device components (sheath, dilator, guidewire) and their functions are all related to facilitating access and navigation within the cardiovascular system in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples taken from the body to provide diagnostic information. The PathBuilder™ Transseptal Guiding Introducer is a surgical/interventional tool used directly within the body.
N/A
Intended Use / Indications for Use
The PathBuilder™ Transseptal Guiding Introducer is introducing various cardiovascular catheters into 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™ Transseptal Guiding Introducer is comprised of a sheath, a dilator and a guidewire. At the distal end of the sheath, a marker band is embedded to mark the position of the sheath during the procedure. Near the marker band, there are three vent holes to reduce cavitation during aspiration and device withdrawal. At the proximal end of the sheath, a sideport with three-way stopcock is located for aspiration, fluid infusion, blood sampling and pressure monitoring. Sheath is fitted with a valve to provide hemostasis during catheter introduction and/or exchange over a guidewire. The dilator, which is mainly used to expand the opening during the inter-atrial septal puncture, is a straight tube with a specially curved portion. The distal end of the dilator is designed to a tip and there is a hub at the proximal end where the needle goes through. The internal lumen of dilator is tapered at the distal tip to fix the location of the needle. Both the sheath and dilator are with a specially curved portion to accommodate positioning against the atrial septum. When the dilator is inserted into the sheath, the sheath tip fit that of dilator well, which help the set to enter the sheath. Guidewire is a thin wire leading the introducer set to the desired position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left side of the heart through the 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 to support substantial equivalence.
Testing included:
(1) Biocompatibility Verification: The biological safety of the introducer was verified as per the requirements of ISO 10993-1:2018. Includes Cytocompatibility, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Complement Activation, and Thrombogenicity.
(2) Bench Validation: Validated the design of the device. This 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 guidewire). Additionally, the compatibility of the introducer, guidewire and dilator was validated with compatibility, bending load, 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 3-way 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 and AAMI TIR 28:2009.
(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
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March 23, 2022
Shanghai MicroPort EP MedTech Co., Ltd. Tian Xia RA Engineer Building 23&28, Lane 588, Tianxiong Rd. Shanghai China
Re: K212626
Trade/Device Name: PathBuilder™ Transseptal Guiding Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 15, 2022 Received: February 22, 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) K212626
Device Name
PathBuilder Transseptal Guiding Introducer
Indications for Use (Describe)
The PathBuilder Transseptal Guiding Introducer is introducing various cardiovascular catheters into 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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3
Image /page/3/Picture/0 description: The image shows the logo for EverPace. The logo consists of two interlocking shapes, one blue and one red, followed by the word "EverPace" in blue. The shapes are abstract and modern, and the word "EverPace" is written in a clean, sans-serif font. There is a trademark symbol to the right of the word "EverPace".
510(k) # K212626 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: February 15, 2022
Identification of Proposed Device
- PathBuilder™ Transseptal Guiding Introducer A. Trade Name: B. Common Name: Catheter Introducer C. Classification Name: Introducer, Catheter D. Regulation Number 21 CFR 870.1340 E. Product Code: DYB F. Device Class: Class II G. Review Panel Cardiovascular H. 510(k) Number K212626
Device Description
PathBuilder™ Transseptal Guiding Introducer is comprised of a sheath, a dilator and a guidewire. At the distal end of the sheath, a marker band is embedded to mark the position of the sheath during the procedure. Near the marker band, there are three vent holes to reduce cavitation during aspiration and device withdrawal. At the proximal end of the sheath, a sideport with three-way stopcock is located for aspiration, fluid infusion, blood sampling and pressure monitoring. Sheath is fitted with a valve to provide hemostasis during catheter introduction and/or exchange over a guidewire. The dilator, which is mainly used to expand the opening during the inter-atrial septal puncture, is a straight tube with a specially curved portion. The distal end of the dilator is designed to a tip and there is a hub at the proximal end where the needle goes through. The internal lumen of dilator is tapered at the distal tip to fix the location of the needle. Both the sheath and dilator are with a specially curved portion to accommodate positioning against the atrial septum. When the dilator is inserted into the sheath, the sheath tip fit that of dilator well, which help the set to enter the sheath. Guidewire is a thin wire leading the introducer set to the desired position.
4
Intended Use Statement
The PathBuilder™ Transseptal Guiding Introducer is indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
Identification of Predicate Device
- Fast-Cath™ Transseptal Catheter Introducer A. Product Name:
- B. Manufacturer: St. Jude Medical
- K964518
- 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™ Transseptal Guiding Introducer to support its substantial equivalence to the predicate device. The test results demonstrated that the proposed device complies with the following standards and quidance:
- (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 guidance 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 ರು)
- Hemocompatibility e)
- Complement Activation f)
- Thrombogenicity ರು)
- (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 guidewire). Additionally, the compatibly of the of the introducer, guidewire and dilator was validated with compatibility,
5
EverPace
bending load, 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 3-way 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
(K964518) | 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
Transseptal Guiding
Introducer is indicated
for introducing various
cardiovascular catheters
into the left side of the
heart through the
interatrial septum. | The Fast-CathTM
Transseptal Catheter
Introducer is indicated
for introducing various
cardiovascular catheters
into the left side of the
heart through the
interatrial septum. | SE |
| Indications for Use | The PathBuilderTM
Transseptal Guiding
Introducer is indicated
for introducing various
cardiovascular catheters
into the left side of the
heart through the
interatrial septum. | The Fast-CathTM
Transseptal Catheter
Introducer is indicated
for introducing various
cardiovascular catheters
into the left side of the
heart through the
interatrial septum. | SE |
Comparison to Predicate Device
6
Image /page/6/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. The letters are bold and sans-serif, and there is a trademark symbol in the upper right corner of the word "EverPace".
| Configuration | sheath | sheath | SE | |
|---|---|---|---|---|
| Dilator | Dilator | SE | ||
| Guidewire | Guidewire | SE | ||
| Dimensional | ||||
| Comparison | Sheath | Effective length | Effective length | SE |
| Diameter | Diameter | SE | ||
| Inner diameter of | ||||
| sheath tip | Inner diameter of | |||
| sheath tip | SE | |||
| Inner diameter of main | ||||
| body | Inner diameter of main | |||
| body | SE | |||
| The length of necking at | ||||
| sheath tip | The length of necking at | |||
| sheath tip | SE | |||
| Curve shape | Curve shape | SE | ||
| Dilator | Effective length | Effective length | SE | |
| Diameter | Diameter | SE | ||
| Inner diameter of | ||||
| dilator tip | Inner diameter of | |||
| dilator tip | SE | |||
| Inner diameter of main | ||||
| body | Inner diameter of main | |||
| body | SE | |||
| Guidewire | Curve shape | Curve shape | SE | |
| Guidewire | Effective length | Effective length | SE | |
| Diameter | Diameter | 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 | |||
| 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 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™ Transseptal Guiding Introducer is substantially equivalent to the predicate device.