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.

Device Description

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).

AI/ML Overview

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.

Summary

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K201117

Baylis Medical Company Inc.

510(k) Summary 6.0

6.1 Submitter Information

A. Company Name: Baylis Medical Company Inc.
B. Company Address: 2645 Matheson Blvd. E. Mississauga, Ontario Canada L4W 5S4
C. Company Phone: (905) 602-4875
D. Company Facsimile: (905) 602-5671
E. Contact Person: Meghal Khakhar
F. Summary Prepared on: July 14, 2010

6.2 Device Identification

A. Device Trade Name: Lev-ORTM Dilation Catheter OTW
B. Device Common Name: Lev-OR™ Dilation Catheter OTW
C. Classification Name: Percutaneous Catheter (21 CFR 870.1250)
D. Device Class: II
E. Device Code: DQY

6.3 Identification of Predicate Device

Predicate devices are:

Skyway Support Catheter (K060327) by Vascular Solutions, Inc. .
Gopher Support Catheter (K070372) by Vascular Solutions, Inc. .

101 1 2010

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6.4 Device Description

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).

6.5 Intended Use

6.6 Substantial Equivalence

This device is substantially equivalent to predicate devices with respect to fundamental scientific technology. This determination is based upon results from performance tests as listed below:

Biocompatibility:

1. Cytotoxicity
1. Sensitization
1. Irritation or Intracutaneous reactivity
1. Systemic toxicity (acute)

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1. Haemocompatibility
  The results of these tests demonstrate that the materials used to construct the Lev-OR Dilation Catheter OTW are safe for the intended use of the product.

Sterlization Validation was conducted as per ANSI/AAMI/ISO 11135:2007 and FDA Guideline on Validation of the Limulus Amebocyte Lysate (LAL) Test as an End-Product Endotoxin Test. Ethylene Oxide residue levels are in compliance with ISO 10993-7:2008.

Mechanical Testing:

0 Flow Rate Measurement
Freedom from Liquid Leakage o
Burst Pressure o
Freedom from Air Leakage o
0 Force at break / distal tip integrity
Force at break tensile proximal hub O
o Torsion

Other General Physical Tests:

Corrosion Resistance testing demonstrated that the Lev-OR Dilation Catheter OTW did not exhibit signs of corrosion.

Bench Top Study:

o Device Compatibility
Smooth Tracking o
O Radiopacity
Overall Length o
Ease of Use o
Dilation of channel/Pushability o
o Fluid delivery
o Intended Use
o Reinsertion
o Coating Durability

The results of the bench top study indicate that the above attributes of the Lev-OR Dilation Catheter OTW are acceptable for the intended use of the device.

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Packaging Testing was conducted as per ANSI/AAMI/ISO 11607:2006.

The results of these tests demonstrate that this device is safe and effective and performs as per the intended use.

The data and information presented in this application (including biocompatibility tests, sterilization validation, mechanical testing, bench top model testing, general physical testing, packaging testing, and device similarities) support a determination of substantial equivalence and, therefore, the market clearance of the Lev-OR Dilation Catheter OTW through this 510(k) Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three wavy lines that form a human profile.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

[JUL 1 6 2010

Baylis Medical Co., Inc. c/o Ms. Meghal Khakhar Manager, Regulatory and Scientific Affairs 2645 Matheson Blvd. E Mississauga, Ontario, Canada L4W 5S4

Re: K101117

Trade/Device Name: Lev-OR Dilation Catheter OTW Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: July 6, 2010 Received: July 8, 2010

Dear Ms. Khakhar

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. 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

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or any Federal 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm1for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

R. Vachner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K10 l l | 7

Device Name: Lev-OR™ Dilation Catheter OTW

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. L. L

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_KI 0 l l 7

Page 1 of 1

Regulation Number and Section

§ 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).