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K Number
K172950
Device Name
TSN Transseptal Needle
Manufacturer
Pressure Products Medical Device Manufacturing LLC
Date Cleared
2018-02-21

(148 days)

Product Code
DRC
Regulation Number
870.1390
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Needle is intended for single use only.

Device Description

The Transseptal Needle consists of a stainless-steel needle and stylet. The needle comes in three lengths equivalent to the lengths of a conventional Brockenbrough (BRK) needle (predicate) - 71cm, 89cm, and 98cm, and two curves, Curve0 and Curve1. The needle size is 18 gauge with an inner diameter of .033" at the proximal body and necks down to 21 gauge with an inner diameter of .018" at the distal end, terminating with an angled tip. The components of the Transseptal Needle include the Transseptal Needle and Stylet, and sterile packaging and labeling. There are six model numbers for the Transseptal Needle, TSN071, TSN089, TSN098, TSN171, TSN189, and TSN198. The Transseptal Needle is sterilized by 100% ethylene oxide cycle and is for single-use only. The Transseptal Needle is used in a healthcare facility/hospital.

The Transseptal needle is used in transseptal procedures to puncture the fossa ovalis and gain access to the left atrium through the right side of the heart. The device is used by inserting the device through a transseptal dilator and sheath assembly. The devices are inserted in the femoral vein. The Transseptal needle tip is able to perforate through the fossa ovalis, a thin wall between the right and left atrium. The needle's duration in the body is less than 24 hours.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the "TSN Transseptal Needle". The information provided pertains to the device itself and its equivalence to a predicate device, not to an AI/ML-based diagnostic or prognostic tool. Therefore, the questions regarding acceptance criteria, study details, expert involvement, MRMC studies, standalone performance, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable to this document.

The document discusses the substantial equivalence of the TSN Transseptal Needle to a legally marketed predicate device (St. Jude Medical, BRK Transseptal Needle, K122587). The focus is on the needle's design, materials, indications for use, and performance testing related to its physical and functional characteristics.

Here’s a breakdown of what is available and why the requested information is not applicable:

  • Device: TSN Transseptal Needle
  • Purpose: To puncture the interatrial septum during transseptal catheterization.
  • Regulatory Classification: Class II, Product Code DRC (Trocar, 21 CFR 870.1390).

Why the Requested Information is Not Applicable:

The provided text describes a mechanical medical device, not an AI/ML system. The concept of "acceptance criteria" in this context refers to engineering specifications and performance tests ensuring the device's physical integrity, functionality (e.g., puncture force, guidewire passage), and biocompatibility, rather than diagnostic accuracy or algorithmic performance.

Therefore, the following specific points from your request cannot be answered from the provided text:

  1. A table of acceptance criteria and the reported device performance (in the context of AI/ML): The document lists performance tests (e.g., visual/dimensional inspection, particulate testing, mating joint pull test, water/air leak testing, biocompatibility tests). These are mechanical and material performance criteria, not AI/ML model performance metrics like sensitivity, specificity, or AUC.
  2. Sample sizes used for the test set and the data provenance: Not applicable to a mechanical device. The "tests" here are physical experiments on samples of the device, not a test set of patient data for an algorithm.
  3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for a physical device is established through engineering specifications and industry standards.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is for evaluating human interpretation with and without AI assistance.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm.
  7. The type of ground truth used: For a mechanical device, ground truth relates to meeting design specifications and safety standards, established through physical testing and material science, not clinical outcomes for diagnostic accuracy.
  8. The sample size for the training set: Not applicable, as there is no AI/ML model to train.
  9. How the ground truth for the training set was established: Not applicable.

Information that is available regarding "performance testing" for this mechanical device:

  • Performance Testing Categories: Visual and dimensional inspection, Particulate testing (USP), Mating Joint Pull test, Guidewire Restriction Inspection, Strength of Union Cannula Hub and Cannula, Needle Point Inspection, Hub Female Luer Taper, Water Leak Testing, Air Leak Testing, Packaging Testing.
  • Biocompatibility Testing: Conducted per ISO 10993 (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemocompatibility). The device met the requirements.
  • Comparison to Predicate: The device was found substantially equivalent to the St. Jude Medical, BRK Transseptal Needle (K122587) in design, technological characteristics, materials, and performance testing. Key differences (reverse bevel, clear hub, stylet handle/diameter, non-skiving) are noted and presumably were addressed in the performance testing to demonstrate equivalence.

§ 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.