(94 days)
The Spectra Guidewire Introducer Needle is intended to be used by medical professionals as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.
The Spectra Guidewire Introducer Needle is indicated for percutaneous introduction and placement of guidewires in vascular procedures.
The Spectra Guidewire Introducer Needle consists of a stainless steel needle and a colored translucent standard female Luer lock hub locking connector for rapid (flashback) visualization. The Spectra Guidewire Introducer Needle is available in a single-wall style with or without a Seldinger shield. The stainless steel needles are available with and without an echogenic feature. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need.
Spectra Guidewire Introducer Needles will be marketed as sterile, non-pyrogenic, and single use devices. Additionally, the device will be marketed as a guidewire introducer needle for use as an accessory in procedure kits. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The Spectra Guidewwire Introducer Needle will be incorporated into the procedure kit, packaged and sterilized.
The provided text describes the submission of a 510(k) premarket notification for the Spectra Guidewire Introducer Needle, arguing its substantial equivalence to predicate devices rather than claiming novel effectiveness. Therefore, the document does not contain a study that proves the device meets specific performance acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, it focuses on demonstrating that the device is safe and effective for its intended use by meeting established standards and exhibiting similar technological characteristics to legally marketed predicate devices.
Here's a breakdown based on your request, highlighting what information is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The submission mentions that "The Spectra Guidewire Introducer Needle will meet all established acceptance criteria for performance testing" and that "Performance data gathered demonstrated that the Spectra Guidewire Introducer Needle is substantially equivalent to the noted predicate devices." However, the specific quantitative acceptance criteria (e.g., tensile strength, flow rates, sharp-ness specifications) and the precise reported performance values are not detailed in the provided text.
The acceptance criteria are generally framed around adherence to recognized standards for medical devices and comparison to predicate devices, rather than novel performance benchmarks.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterilization Requirements | Meets ISO 11135:2007 (Ethylene Oxide Sterilization). |
| Biocompatibility Requirements | Meets ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. (Implicitly, the device passed these tests and is considered biocompatible). |
| Technological Characteristics | Substantially equivalent design, materials, and method of use to predicate devices (Teleflex Medical Introducer Needle (K851140) and Cook Percutaneous Entry Needle (Pre-amendment device, Reference Medical Device Listing No. 187040)). This implies performance in aspects like needle stiffness, tip geometry, hub connection, flashback visualization, etc., are comparable to the predicates. |
| Safety and Effectiveness | Demonstrated safe and effective for its intended use, based on FDA's decision tree for substantial equivalence. This is a conclusion based on the combined assessment of materials, design, manufacturing, and comparison to predicates. |
| Intended Use & Indications | Shares the same intended use and indications for use as predicate devices: "intended to be used by medical professionals as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols." However, the sample size used for the test set (i.e., how many devices were tested for performance, how many units of materials, etc.) is not specified.
Regarding data provenance, the testing would have been conducted by Spectra Medical Devices, Inc. or contractors they employed, likely in the US (given the company's address in Wilmington, Massachusetts). The data is retrospective in the sense that it was generated for the purpose of this 510(k) submission, not from a prospective clinical trial on human subjects. The type of data is primarily in vitro and bench testing data to demonstrate compliance with standards and equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable in this context. The "ground truth" for a medical device like an introducer needle in a 510(k) submission is established by engineering specifications, material standards, and comparisons to legally marketed predicate devices, not by expert consensus on clinical findings. Performance is measured against physical and chemical parameters, not against interpretations of medical images or patient outcomes by experts.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human expert assessment of data (e.g., radiology reads). In the context of a 510(k) for an introducer needle, "adjudication" is not a standard part of the device's technical performance testing. Device performance is determined by meeting pre-defined physical and material specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data, often with AI assistance. The Spectra Guidewire Introducer Needle is a physical surgical instrument, not a diagnostic imaging device or an AI algorithm intended to assist human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not applicable. The Spectra Guidewire Introducer Needle is a physical medical device, not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used
For this device, the "ground truth" for performance assessment is primarily based on:
- Established engineering specifications and material standards: These define what constitutes acceptable strength, biocompatibility, sterility, dimensions, etc. (e.g., ISO 11135, ISO 10993).
- Performance characteristics of predicate devices: The "ground truth" for equivalency is that the new device performs similarly to legally marketed devices that have already been deemed safe and effective. This is assessed via various physical and chemical bench tests (e.g., material compatibility, physical dimensions, functional tests implicitly covered by "design, materials, and method of use").
There is no "pathology" or "outcomes data" ground truth in the context of this 510(k) submission to demonstrate substantial equivalence of a guidewire introducer needle. Clinical outcomes would typically be part of a PMA (Premarket Approval) submission for a novel, high-risk device.
8. The Sample Size for the Training Set
This is not applicable. A "training set" refers to data used to train an algorithm or AI model. As established, this device is a physical medical instrument, not a software or AI product.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
§ 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).