SUREFLEX STEERABLE GUIDING SHEATH KIT

K122926 · Baylis Medical Co., Inc. · DYB · Jan 24, 2013 · Cardiovascular

Device Facts

• Record ID: K122926
• Device Name: SUREFLEX STEERABLE GUIDING SHEATH KIT
• Applicant: Baylis Medical Co., Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jan 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended 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.

Device Story

SureFlex™ Steerable Guiding Sheath Kit is a single-use catheter introducer system designed for cardiovascular catheterization and angiography. The kit includes a steerable sheath, dilator, and guidewire. The sheath features a stainless steel braided nylon tube, a soft Pebax distal tip, and a platinum/iridium marker band for visualization. Proximal end includes a hemostasis valve and two side ports with a 3-way stopcock for fluid management. The sheath offers small, medium, and large curve options with 90° counter-clockwise and 180° clockwise deflection capabilities. The dilator is an HDPE tube with a tapered tip. The device is used by clinicians in a clinical setting to facilitate the placement of cardiovascular catheters. It provides a stable conduit for catheter access to heart chambers, aiding in precise tracking and placement during procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility), mechanical testing (torque, leak, pull, snap fit, valve insertion), and physical testing (surface defects, range of motion, curve retention, corrosion, friction, lubricity, tip stiffness). Radiopacity and particulate testing were also performed.

Technological Characteristics

Materials: stainless steel braided nylon tube, Pebax distal tip, platinum/iridium marker band, HDPE dilator, PTFE-coated stainless steel guidewire. Features: hemostasis valve, 3-way stopcock, steerable deflection (90° CCW/180° CW). Single-use. Mechanical sensing/actuation via manual handle manipulation.

Indications for Use

Indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Agilis NxT Steerable Introducer (K061363)
• Agilis NxT Steerable Introducer (K081645)

Submission Summary (Full Text)

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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: [phone]
D. Company Facsimile: [phone]

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 Device<br>10 - 1 - 2 - 2 2 2 2 - 2 - 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - | Manufacturer<br>Company of the county of the county of<br>and 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

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.

### 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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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 [phone] or [phone] or at its Internet address [phone] 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

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