(217 days)
Not Found
No
The 510(k) summary describes a purely mechanical device (a needle and stylet) and does not mention any software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical, biocompatibility, and sterilization aspects.
No.
A therapeutic device is one that treats a disease or condition. This device is used to puncture the interatrial septum to gain left heart access, which is an interventional step during a diagnostic or therapeutic procedure, but not a therapy itself.
No
The device is a needle used to puncture the interatrial septum to gain left heart access, which is a procedural/interventional function, not a diagnostic one.
No
The device description clearly outlines a physical needle with various components (thin section, curved section, main body, pointer flange, hub, stylet) and describes its mechanical function (puncturing the interatrial septum). The performance studies focus on biocompatibility, bench validation of physical properties, cleaning/sterilization, and shelf life, all related to a physical medical device. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access." This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical needle designed for puncturing tissue.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide diagnostic information. IVDs are used to perform tests on these types of samples.
Therefore, the PathBuilder™ Transseptal Needle is a surgical/interventional device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PathBuilder™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
Product codes
DRC
Device Description
PathBuilder™ Transseptal Needle is consisted of thin section, curved section, main body, pointer flange, hub and stylet. The distal end of PathBuilder™ Transseptal Needle is curved for easy positioning within the heart when used together with the catheter introducer. The outer diameter of needle stepped down within the curved section for better fitness to the dilator which fixes the maximum length of the needle into the dilator. The distal tip of the needle is beveled to facilitate the transseptal process. The proximal end of PathBuilder™ Transseptal Needle is with a pointer flange which indicates the curve orientation of the needle. And a hub is equipped for aspiration, fluid injection/infusion etc. The stylet is straight. The proximal end of the stylet is curved to lock on the hub when inserted into the needle lumen. The stylet is used to help insert the needle into the dilator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interatrial septum, left heart
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™ Transseptal Needle 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 transseptal needle 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".
(2) Bench Validation: Validation testing of the transseptal needle was performed to validate the design of the device. This testing included visual inspection, dimensional verification, packaging testing (visual inspection, sealing strength, dye penetration) and mechanical failure/performance (Joint forces between each parts). Additionally, the compatibly of the needle and dilator was validated with compatibility, puncture force, radio detectability, luer fitting. 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 transseptal needle 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 transseptal needle is three years.
No clinical study was used to support this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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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: K212625
Trade/Device Name: PathBuilder™ Transseptal Needle Regulation Number: 21 CFR 870.1390 Regulation Name: Trocar Regulatory Class: Class II Product Code: DRC 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.
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
1
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212625
Device Name PathBuilder Transseptal Needle
Indications for Use (Describe)
The PathBuilder Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
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 EverPace logo. 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, with a trademark symbol in the upper right corner.
510(k) # K212625 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
ldentification of Proposed Device
- PathBuilder™ Transseptal Needle A. Trade Name:
- B. Common Name: Transseptal Needle
- C. Classification Name: Trocar
- 21 CFR 870.1390 D. Regulation Number
- E. Product Code: DRC
- F. Device Class: Class II
- G. Review Panel Cardiovascular
- H. 510(k) Number K212625
Device Description
PathBuilder™ Transseptal Needle is consisted of thin section, curved section, main body, pointer flange, hub and stylet. The distal end of PathBuilder™ Transseptal Needle is curved for easy positioning within the heart when used together with the catheter introducer. The outer diameter of needle stepped down within the curved section for better fitness to the dilator which fixes the maximum length of the needle into the dilator. The distal tip of the needle is beveled to facilitate the transseptal process. The proximal end of PathBuilder™ Transseptal Needle is with a pointer flange which indicates the curve orientation of the needle. And a hub is equipped for aspiration, fluid injection/infusion etc. The stylet is straight. The proximal end of the stylet is curved to lock on the hub when inserted into the needle lumen. The stylet is used to help insert the needle into the dilator.
Intended Use Statement
The PathBuilder™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.
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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" 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 small "TM" symbol in the upper right corner.
ldentification of Predicate Device
- A. Product Name: BRK™ Transseptal Needle
- B. Manufacturer: St. Jude Medical
- C. 510(k) Number: K122587
- D. Regulation Number 21 CFR 870.1390
- E. Product Code: DRC
- F. Device Class: Class II
Non-Clinical Performance Testing
Non-clinical performance testing was completed for the PathBuilder™ Transseptal Needle 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 transseptal needle 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)
- b) Sensitization
- Irritation C)
- Acute Systemic Toxicity ರು)
- Hemocompatibility e)
- f) Complement Activation
- Thrombogenicity ರು)
- (2) Bench Validation: Validation testing of the transseptal needle was performed to validate the design of the device. This testing included visual inspection, dimensional verification, packaging testing (visual inspection, sealing strength, dye penetration) and mechanical failure/performance (Joint forces between each parts). Additionally, the compatibly of the needle and dilator was validated with compatibility, puncture force, radio detectability, luer fitting. 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 transseptal needle could be sterilized in accordance with ISO 11135:2014 Sterilization of health care products-
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Image /page/5/Picture/0 description: The image shows the EverPace logo. The logo consists of a stylized "E" and "O" connected together, followed by the word "EverPace" in a sans-serif font. The "E" and part of the "O" are in blue, while the rest of the "O" is in red. There is a trademark symbol next to the word EverPace.
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 transseptal needle is three years.
Clinical Tests Conclusion
No clinical study was used to support this submission.
| Description | Proposed Device | Predicate Device (K122587) | Remark |
|---|---|---|---|
| Product Code | DRC | DRC | SE |
| Regulation | |||
| No. | 21 CFR 870.1390 | 21 CFR 870.1390 | SE |
| Class | Class II | Class II | SE |
| Intended Use | The PathBuilderTM Transseptal | ||
| Needle is used to puncture the | |||
| interatrial septum during a | |||
| transseptal catheterization | |||
| procedure to gain left heart | |||
| access. | The BRKTM Transseptal Needle | ||
| is used to puncture the | |||
| interatrial septum during a | |||
| transseptal catheterization | |||
| procedure to gain left heart | |||
| access. | SE | ||
| Indications | |||
| for Use | The PathBuilderTM Transseptal | ||
| Needle is used to puncture the | |||
| interatrial septum during a | |||
| transseptal catheterization | |||
| procedure to gain left heart | |||
| access. | The BRKTM Transseptal Needle | ||
| is used to puncture the | |||
| interatrial septum during a | |||
| transseptal catheterization | |||
| procedure to gain left heart | |||
| access. | SE | ||
| Hub | Hub | SE | |
| Configuration | Pointer flange | Pointer flange | SE |
| Needle tip | Needle tip | SE | |
| Dimensional | |||
| Comparison | Effective length | Effective length | SE |
| Diameter | Diameter | SE | |
| Effective length of stylet | Effective length of stylet | SE | |
| Outer diameter of stylet | Outer diameter of stylet | SE | |
| Curve shape | Curve shape | 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 | Similar |
| Intended | Professional healthcare | Professional healthcare | SE |
Comparison to Predicate Device、
Shanghai MicroPort EP MedTech Co., Ltd.
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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" in blue and red, respectively, followed by the word "EverPace" in blue. The "TM" symbol is located to the right of the word "EverPace".
| healthcare
| environment | environment | ||
|---|---|---|---|
| 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 Needle is substantially equivalent to the predicate device.