(232 days)
The ExpanSure Transseptal Dilation System is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.
The ExpanSure Transseptal Dilation System represents a modification to the legally marketed TorFlex Transseptal Guiding Sheath (K102948). The subject device comprises a dilator (ExpanSure Dilator) and J-tip quidewire, which are single-use and supplied sterile to the user.
The ExpanSure Dilator consists of an inner and outer polyethylene layer containing radio-pacifier for visibility under fluoroscopy during procedures. The inner and outer shaft layers are separated by a braid material for torqueability. The outer surface of the dilator is coated with a silicone lubricant. The ExpanSure Dilator is compatible with .032″ and .035″ transseptal devices/quidewires and 12.5 Fr introducer sheaths. The J-tip quidewire supplied with the ExpanSure Dilator is .032".
This document describes the FDA's 510(k) clearance for the ExpanSure™ Transseptal Dilation System. The acceptance criteria and the study proving the device meets these criteria are primarily based on performance testing to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing efficacy with human data.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with quantitative acceptance criteria and reported numerical performance values for direct comparison. Instead, it states that "All test requirements were met as specified by applicable standards and the test protocols." The acceptance criteria are implicit in the standards and internal requirements listed.
| Acceptance Criteria (Implied by Standards/Tests) | Reported Device Performance |
|---|---|
| Mechanical Integrity: | |
| Air Leakage (ISO 11070:2014) | Met specifications |
| Liquid Leakage (ISO 11070:2014) | Met specifications |
| Torque Transmission + Strength of Union Torque (ISO 11070:2014, Baylis requirements) | Met specifications |
| Three Point Bend (Baylis requirements) | Met specifications |
| Strength of Union Tip Deflection (Baylis requirements) | Met specifications |
| Strength of Union Tip to Shaft (Baylis requirements) | Met specifications |
| Strength of Union Shaft to Hub (Baylis requirements) | Met specifications |
| Biocompatibility: | |
| Biocompatibility (ISO 10993-1:2009/Cor.1:2010, FDA guidance) | Met specifications |
| Sterilization: | |
| Sterility Assurance Level (SAL) of 10-6 (ISO 11135-1:2014) | Met specifications (achieved via Ethylene Oxide) |
| Residual Limits (ISO 10993-7:2008/Cor.1:2009) | Met specifications |
| Packaging Integrity: | |
| Seal Strength and Sterile Barrier Integrity (ANSI/AAMI/ISO 11607:2006 Parts 1 & 2) over proposed shelf life | Met specifications (demonstrated through ship testing) |
| General Physical Properties: | |
| Visual Analysis (ISO 11070:2014, Baylis requirements) | Met specifications |
| Dimensional Measurements (ISO 11070:2014, Baylis requirements) | Met specifications |
| Curve Retention (Baylis requirements) | Met specifications |
| Coating Integrity and Friction Testing (Baylis requirements) | Met specifications |
| Luer Testing (Baylis requirements) | Met specifications |
| Corrosion Resistance (Baylis requirements) | Met specifications |
| Pyrogenicity: | |
| Pyrogen Limit Specifications (FDA and USP) | Met specifications (LAL testing, Kinetic Chromogenic method) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document relates to pre-market regulatory clearance based on engineering and bench testing, not clinical data or a test set of patient cases. Therefore, concepts like "sample size for a test set," "country of origin of the data," or "retrospective/prospective" studies are not applicable in the context of this 510(k) submission. The "sample" would refer to the number of devices tested in each mechanical, biocompatibility, sterilization, and physical test. This information (specific lot numbers, number of units per test) is generally detailed in the actual test reports submitted to the FDA, but not summarized in this public 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a medical device 510(k) clearance based on substantial equivalence to a predicate device, demonstrated through engineering and bench testing, not an AI/imaging device requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" in the context of human interpretation or clinical cases.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. An MRMC study is not relevant for this type of device (vessel dilator). The clearance is based on demonstrating the device's physical and biological properties meet safety and performance standards equivalent to a legally marketed predicate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm. Performance tests evaluate the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by validated engineering and biological standards (e.g., ISO standards, Baylis self-enforced requirements, FDA guidance) that define acceptable performance parameters for vessel dilators. Compliance with these standards serves as the "ground truth" for demonstrating safety and performance.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model. There is no "training set" of data in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).