(86 days)
The Lev-OR™ Dilation Catheter OTW is used to access discrete regions of the peripheral vasculature. It may be used to facilitate the placement and exchange of guidewires and other interventional devices and may be used for the infusion or delivery of diagnostic and/or therapeutic agents.
The Lev-OR The Dilation Catheters OTW is a family of intravascular catheters each with a shaft designed for use in the peripheral vasculature. The lumen in the catheter permits the use of a guidewire to facilitate advancement of the catheter to and through the lession to be treated.
The different models of the Lev-OR™ Dilation Catheter OTW (herein referred to as "Catheter") have varying distal section stiffnesses. The model can be identified by the printed label on the device packaging.
The Catheter body low profile and gentle taper facilitate smooth advancement through target locations such as complex lesions. The distal 25cm of the catheter, treated with a lubricious hydrophilic coating, is activated when wet.
The Catheter has a radiopaque distal tip and can accommodate a range of 0.014" - 0.035" diameter guidwires depending on the model.
A standard female luer connector at the proximal end provides fluid injection capabilities.
Depending on the model, the Catheter is intended to be used in conjunction with 0.014" . 0.035" guidewires or Baylis Medical RF PowerWire™ during percutaneous transluminal angioplasty (PTA).
The Baylis Medical Company Inc. Lev-OR™ Dilation Catheter OTW (K101117) is a family of intravascular catheters designed for use in the peripheral vasculature. The device's substantial equivalence was determined through a series of performance tests, benchtop studies, and other general physical tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Safe for intended use (non-cytotoxic) | Materials demonstrated safety for intended use. |
| Sensitization | Safe for intended use (non-sensitizing) | Materials demonstrated safety for intended use. | |
| Irritation or Intracutaneous Reactivity | Safe for intended use (non-irritating) | Materials demonstrated safety for intended use. | |
| Systemic Toxicity (acute) | Safe for intended use (non-toxic) | Materials demonstrated safety for intended use. | |
| Hemocompatibility | Safe for intended use (hemocompatible) | Materials demonstrated safety for intended use. | |
| Sterilization | Sterilization Validation | Compliant with ANSI/AAMI/ISO 11135:2007 and FDA LAL Guideline | Conducted as per standards; Ethylene Oxide residue levels compliant with ISO 10993-7:2008. |
| Mechanical Testing | Flow Rate Measurement | Acceptable for intended use (sufficient flow) | Performed, results indicate acceptability for intended use. |
| Freedom from Liquid Leakage | No liquid leakage | Performed, results indicate acceptability for intended use. | |
| Burst Pressure | Withstands intended pressure | Performed, results indicate acceptability for intended use. | |
| Freedom from Air Leakage | No air leakage | Performed, results indicate acceptability for intended use. | |
| Force at Break / Distal Tip Integrity | Sufficient strength to prevent breakage | Performed, results indicate acceptability for intended use. | |
| Force at Break - Tensile Proximal Hub | Sufficient strength at the hub | Performed, results indicate acceptability for intended use. | |
| Torsion | Resists twisting/maintains integrity during use | Performed, results indicate acceptability for intended use. | |
| Other General Physical Tests | Corrosion Resistance | No signs of corrosion | Did not exhibit signs of corrosion. |
| Bench Top Study | Device Compatibility | Compatible with other interventional devices | Acceptable for intended use. |
| Smooth Tracking | Smooth advancement through target locations | Acceptable for intended use. | |
| Radiopacity | Visible under fluoroscopy | Acceptable for intended use. | |
| Overall Length | Correct and consistent length | Acceptable for intended use. | |
| Ease of Use | User-friendly | Acceptable for intended use. | |
| Dilation of Channel/Pushability | Effectively dilates and can be pushed through lesions | Acceptable for intended use. | |
| Fluid Delivery | Effective delivery of fluids | Acceptable for intended use. | |
| Intended Use | Performs as described in intended use | Acceptable for intended use. | |
| Reinsertion | Can be reinserted without compromising integrity | Acceptable for intended use. | |
| Coating Durability | Hydrophilic coating remains intact and functional | Acceptable for intended use. | |
| Packaging | Packaging Testing | Compliant with ANSI/AAMI/ISO 11607:2006 | Conducted as per standard. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The provided summary does not specify the exact sample sizes for each test in the test set. All testing appears to be prospective benchtop and laboratory testing, not human clinical data. The studies were conducted by Baylis Medical Company Inc., based in Mississauga, Ontario, Canada, implying the data provenance is likely Canada, though specific lab locations are not mentioned.
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):
This information is not provided in the 510(k) summary. The ground truth for the test set was established through standard engineering and laboratory testing protocols where specific physical or biological parameters define success or failure, rather than interpretation by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the tests performed are objective, quantitative or qualitative measurements based on established standards, not subjective assessments requiring expert adjudication.
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:
This is not applicable as the device is a physical catheter, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI improvement metrics are relevant or were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for all tests was based on established scientific and engineering standards, governmental regulations (e.g., FDA guidelines, ISO standards), and internal Baylis Medical Company Inc. specifications for device performance, material safety, and manufacturing quality. For example:
- Biocompatibility: Established toxicology and biocompatibility standards.
- Sterilization: ANSI/AAMI/ISO 11135:2007 and FDA LAL Guideline.
- Mechanical Testing: Defined physical limits for strength, leakage, pressure, etc.
- Bench Top Study: Functional performance assessed against design specifications and intended use.
- Packaging: ANSI/AAMI/ISO 11607:2006.
8. The sample size for the training set:
This is not applicable as this is a physical medical device, not a machine learning model. There is no concept of a "training set" in the context of the studies described.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).