The SureFlex™ Steerable Guiding Sheath Kit is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

Device Description

The SureFlex™ Steerable Guiding Sheath Kit is a single-use device which is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The kit contains a steerable sheath, a dilator, and a guidewire. The steerable sheath is comprised of a stainless steel braided nylon tube with a soft, pebax distal tip. A platinum/iridium marker band is positioned near the distal tip to ensure precise tracking and placement of the sheath during procedures. The sheath is finished at the proximal end with a hemostasis valve and 2.distal side ports with a 3-way stopcock for the injection or aspiration of fluids. The steerable sheath comes in small, medium, and large curve options which can be deflected 90° counter-clockwise and 180° clockwise. The dilator is comprised of an HDPE tube with a tapered tip and has a male luer hub connector at the proximal end for connection to the sheath. The guidewire is stainless steel and coated with PTFE.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the SureFlex™ Steerable Guiding Sheath Kit, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes various tests performed to demonstrate the substantial equivalence of the SureFlex™ Steerable Guiding Sheath Kit to its predicate devices. The acceptance criteria are implied by the successful completion of these tests, indicating the device "meets the requirements" or "can withstand" certain stresses.

Acceptance Criteria Category	Specific Test/Requirement	Reported Device Performance
Biocompatibility	Cytotoxicity	Meets requirements
	Sensitization	Meets requirements
	Irritation or Intracutaneous Reactivity	Meets requirements
	Systemic Toxicity (Acute)	Meets requirements
	Hemocompatibility (including Hemolysis and Thrombosis)	Meets requirements
Mechanical Testing	Torque Transmission and Strength of Union Torque Test	Can withstand without failure
	Freedom from Liquid Leakage through Hemostasis Valves	Can withstand without failure
	Freedom from Air Leakage through Hemostasis Valve	Can withstand without failure
	Freedom from Liquid Leakage	Can withstand without failure
	Freedom from Air Leakage	Can withstand without failure
	Strength of Union Pull Test	Can withstand without failure
	Tip Transition	Can withstand without failure
	Snap Fit	Can withstand without failure
	Valve Insertion Force	Can withstand without failure
Physical Testing	Surface Defects	Passed
	Range of Motion + Geometry	Passed
	Curve Retention + Integrity Test	Passed
	Corrosion Resistance	Passed
	Friction Testing	Passed
	Handle Lubricity	Passed
	Tip Stiffness	Passed
Bench Testing	Compatibility for use with 8.5F devices in a clinical setting	Determined to be compatible
Radiopacity and Particulate Testing	Radiopacity	Performed (implies successful demonstration)
	Particulate	Performed (implies successful demonstration)

Study Details

Based on the provided K122926 document, the "study" described is a series of performance tests to demonstrate substantial equivalence, rather than a clinical trial or a specific comparative effectiveness study with human readers.

Here's a breakdown of the requested information based on the document:

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for any of the individual tests. The document mentions "The SureFlex™ Steerable Guiding Sheath Kit" passing various tests, implying that representative samples of the device were tested.
- Data Provenance: Not specified. These are laboratory/bench tests, not clinical data from specific countries. The testing was conducted by Baylis Medical Company Inc., which is based in Mississauga, Ontario, Canada.
- Retrospective or Prospective: Not applicable as these are laboratory performance tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for these performance tests is based on established engineering and biocompatibility standards and specifications, not expert consensus on medical images or patient outcomes.
Adjudication method for the test set:
- Not applicable. The results are based on objective measurements and compliance with predetermined specifications/standards for each test.
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 comparative effectiveness study was not done. This document describes the pre-market submission for a physical medical device (guiding sheath kit) and its mechanical, physical, and biocompatibility properties, not an AI-powered diagnostic device. Therefore, questions regarding "human readers" or "AI assistance" are not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for these performance tests is based on engineering specifications, industry standards, and regulatory requirements for medical devices (e.g., biocompatibility standards, mechanical strength requirements, fluid leakage limits).
The sample size for the training set:
- Not applicable. This is not a machine learning or AI-driven device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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K122926 page 1 of 3

SureFlex™ Steerable Guiding Sheath Kit

Baylis Medical Company Inc.

6. 510(k) Summary

Submitter Information

A. Company Name: Baylis Medical Company Inc.

B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario L4W 5S4 Canada

C. Company Phone: (905) 602-4875
D. Company Facsimile: (905) 602-5671

E. Contact Person: Meghal Khakhar

F. Summary Prepared on: September 18, 2012

Device Identification

A. Device Trade Name: SureFlex™ Steerable Guiding Sheath Kit

B. Device Common Name: Catheter Introducer

C. Classification Name: 21 CFR 870.1340

D. Product Code: DYB

E. Device Class: Class II

Identification of Predicate Devices

Predicate Device10 - 1 - 2 - 2 2 2 2 - 2 - 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -	ManufacturerCompany of the county of the county ofand the country of the first and the first of the first of the	1 510(k) No.
Agilis NxT Steerable Introducer	St. Jude Medical	K061363
		K081645

Indications for Use

The SureFlex™ Steerable Guiding Sheath Kit is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

JAN 2 4 2013

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122926 page 2 of 3

SureFlex™ Steerable Guiding Sheath Kit

Baylis Medical Company Inc.

Device Description

Substantial Equivalence

The SureFlex™ Steerable Guiding Sheath Kit is determined to be substantially equivalent to the predicate devices with respect to intended use, design, technological characteristics, and principles of operation. This determination is based on the results of performance tests as listed below:

i} Biocompatibility Testing
The SureFlex™ Steerable Guiding Sheath Kit meets the requirements of the following biocompatibility requirements:
Cytotoxicity .
Sensitization .
Irritation or Intracutaenous Reactivity ●
Systemic Toxcitiv (Acute) .
. Hemocompatibility (including Hemolysis and Thrombosis)

ii) Mechanical Testing

The SureFlex™ Steerable Guiding Sheath Kit can withstand the following mechanical stresses without failure:

Torque Transmission and Strength of Union Torque Test �
. Freedom from Liquid Leakage through Hemostasis Valves
Freedom from Air Leakage through Hemostasis Valve .
Freedom from Liquid Leakage .
Freedom from Air Leakage .
. Strength of Union Pull Test
Tip Transition .
Snap Fit .
Valve Insertion Force .

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iii) Physical Testing

The SureFlex™ Steerable Guiding Sheath Kit has passed the following physical tests:

Surface Defects .
. Range of Motion + Geometry
Curve Retention + Integrity Test .
Corrosion Resistance ●
Friction Testing .
Handle Lubricity .
� Tip Stiffness

Bench Testing v)

Bench testing was conducted to determine that the SureFlex™ Steerable Guiding Sheath Kit is compatible for use with 8.5F devices in a clinical setting.

Radiopacity and Particulate Testing vi)
The following validation tests were performed on the SureFlex™ Steerable Guiding Sheath Kit:
Radiopacity ●
Particulate .

The SureFlex™ Steerable Guiding Sheath Kit is determined to be substantially equivalent to the predicate devices based on the performance tests described above. The technological differences between the proposed and predicate devices do not raise any new concerns of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human form or a caduceus, with three curved lines representing the human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

JAN 2 4 2013

Baylis Medical Co., Inc Meghal Khakhar 2645 Matheson Blvd. E Mississauga, Ontario CA L4W 5S4

Re: K122926

Trade/Device Name: Sureflex Steerable Guiding Sheath Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: December 19, 2012 Received: December 21, 2012

Dear Meghal Khakhar:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused of ingd the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use Stated in the encrosure) to regary to togally with Medical Device Amendments, or to conmiered pror to May 2019 11:37 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costine Act (11ct) that the not request to the general controls provisions of the Act. The r ou may, merers, mains of the Act include requirements for annual registration, listing of general controls provisions of the recess labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Trease note: ODICP as 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 If your device is oldsbilled (boo as a ) Existing major regulations affecting your device can be may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in the over oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that I Driver that your device complies with other requirements of the Act that I DA has made a actorized is administered by other Federal agencies. You must or any I call the Act's requirements, including, but not limited to: registration and listing (21 Compy with an the Fee 8 required 801); medical device reporting (reporting of medical CI K Part 607); adomig (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 If you desire specific advice to: your ContersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mip.//www.lua.gov/rtbout.br/?count by CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of CCDRH (21 GFF) Dev mote the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation entitled, "Misoraname 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 Tou may ovann other general and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (000) 050 2011 01 (0) (2011 01 (2011) 05/10/2019 05/10/2019 01/11/2017 01/11

Sincerely yours,

Matthew G. Hillebrenner

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): 嵐 | 22926

Device Name: SureFlex™ Steerable Guiding Sheath Kit

Indications for Use:

The SureFlex™ Steerable Guiding Sheath Kit is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Hillben

ion Sign-Off) (Division Sign-Oh)
Division of Cardiovascular Devices

K122926 510(k) Number

Page 1 of 1

Regulation Number and Section

§ 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).