ExpanSure Transseptal Dilation System

K182064 · Baylis Medical Company, Inc. · DRE · Mar 21, 2019 · Cardiovascular

Device Facts

• Record ID: K182064
• Device Name: ExpanSure Transseptal Dilation System
• Applicant: Baylis Medical Company, Inc.
• Product Code: DRE · Cardiovascular
• Decision Date: Mar 21, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ExpanSure Transseptal Dilation System is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

Device Story

ExpanSure Transseptal Dilation System facilitates access to left atrium during transseptal procedures. Device consists of a dilator and J-tip guidewire; supplied sterile for single use. Dilator features inner/outer polyethylene layers with radiopaque material for fluoroscopic visibility; braid material for torqueability; silicone lubricant coating. Compatible with .032" and .035" guidewires and 12.5 Fr introducer sheaths. Used by physicians in clinical settings. Device provides mechanical dilation to support catheter introduction. Benefits include reliable access to left heart chambers.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including mechanical verification (ISO 11070:2014), biocompatibility (ISO 10993-1), sterilization (ISO 11135-1), packaging integrity (ISO 11607), and pyrogen testing.

Technological Characteristics

Materials: Polyethylene, braid, silicone lubricant. Radiopaque for fluoroscopy. Dimensions: Compatible with .032"/.035" guidewires and 12.5 Fr sheaths. Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 11070:2014 (mechanical/physical), ISO 10993-1:2009 (biocompatibility), ISO 11135-1:2014 (sterilization), ISO 11607:2006 (packaging).

Indications for Use

Indicated for patients requiring access to the left atrium via transseptal technique.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

• TorFlex Transseptal Guiding Sheath (K102948)

Submission Summary (Full Text)

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March 21, 2019

Baylis Medical Company Inc. May Tsai Team Leader, Regulatory Affairs 2775 Matheson Blvd. East Mississauga, Ontario Canada L4W 5S4

Re: K182064

Trade/Device Name: ExpanSure™ Transseptal Dilation System Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: February 25, 2019 Received: February 26, 2019

Dear Ms. Tsai:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 or any Federal

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Rachel E. Neubrander -S

for 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) K182064

Device Name ExpanSure Transseptal Dilation System

#### Indications for Use (Describe)

The ExpanSure Transseptal Dilation System is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary

# Submitter Information

- A. Company Name: Baylis Medical Company Inc.
- B. Company Address: 2775 Matheson Blvd. East Mississauga, Ontario L4W 4P7 Canada
- C. Company Phone: [phone]
- D. Company Facsimile: [phone]
- E. Contact Person: May Tsai Manager, Regulatory Affairs
- F. Summary Prepared on: 18-Mar-2019

# Device Identification

- A. Device Trade Name: ExpanSure™ Transseptal Dilation System
- B. Device Common Name: Vessel Dilator For Percutaneous Catheterization
- C. Classification Name: CFR 870.1310 Vessel Dilator For Percutaneous Catheterization
- D. Product Code: DRE
- E. Device Class: Class II

#### Identification of Legally Marketed Device

| Table 8.1: Predicate Device | | | |
|----------------------------------------------|--------------------------------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate<br>Device | Manufacturer | 510(k) | Indications for Use |
| TorFlex™<br>Transseptal<br>Guiding<br>Sheath | Baylis Medical<br>Company Inc. | K102948 | The TorFlex Transseptal Guiding<br>Sheath is used for the percutaneous<br>introduction of various types of<br>cardiovascular catheters to all heart<br>chambers, including the left atrium<br>via transseptal perforation / puncture. |

# Table 8.1 : Predicate Device

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# Indications for Use

The ExpanSure Transseptal Dilation System is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

# Device Description

The ExpanSure Transseptal Dilation System represents a modification to the legally marketed TorFlex Transseptal Guiding Sheath (K102948). The subject device comprises a dilator (ExpanSure Dilator) and J-tip quidewire, which are single-use and supplied sterile to the user.

The ExpanSure Dilator consists of an inner and outer polyethylene layer containing radio-pacifier for visibility under fluoroscopy during procedures. The inner and outer shaft layers are separated by a braid material for torqueability. The outer surface of the dilator is coated with a silicone lubricant. The ExpanSure Dilator is compatible with .032″ and .035″ transseptal devices/quidewires and 12.5 Fr introducer sheaths. The J-tip quidewire supplied with the ExpanSure Dilator is .032".

# Comparison to Predicate Devices

The subject ExpanSure Transseptal Dilation System and predicate TorFlex Transseptal Guiding Sheath (K102948) have the same intended use.

The proposed and predicate devices share fundamental scientific technology, including principles of operation and mechanism of action (Table 8.2). Differences in design and technological characteristics between the proposed and predicate devices do not raise different questions of safety and effectiveness. The results of verification and validation testing provide reasonable assurance of substantial equivalence of the ExpanSure Transseptal Dilation System with the predicate device.

| Characteristic | Subject Device Compared to Predicate<br>TorFlex Transseptal Guiding Sheath<br>(K102948) |
|-----------------------------------|-----------------------------------------------------------------------------------------|
| Intended Use | Identical |
| Indications for Use | Similar |
| Fundamental scientific technology | Identical |
| Operating principles | Identical |
| Mechanism of action | Identical |
| Technological aspects | Similar |

Table 8.2: Comparison of Subject and Predicate Device

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# Performance Testing

Performance testing has been completed to demonstrate substantial equivalence of the subject and predicate devices. All test requirements were met as specified by applicable standards and the test protocols. The device was subjected to the following verification and validation activities:

# Mechanical Testing

Mechanical verification testing was conducted for the subject ExpanSure Dilator to ensure compliance with the requirements of ISO 11070:2014 and Baylis self-enforced requirements. The following tests were performed:

- 1. Air Leakage
- 2. Liguid Leakage
- 3. Torque Transmission + Strength of Union Torque
- 4. Three Point Bend
- 5. Strength of Union Tip Deflection
- 6. Strength of Union Tip to Shaft
- 7. Strength of Union Shaft to Hub

## Biocompatibility Verification

Biocompatibility testing was performed in accordance with current requirements of ISO 10993-1:2009/Cor.1:2010 and the FDA quidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16, 2016).

#### Sterilization Verification

Sterilization verification was completed for the subject device to current requirements of ISO 11135-1:2014. Sterilization is performed with Ethylene Oxide to a Sterility Assurance Level (SAL) of 10-6. Residual limits are in accordance with ISO 10993-7:2008/Cor.1:2009.

#### Packaging Verification

Ship testing was performed to ensure the integrity of the device packaging through the rigors of shipping and handling. The seal strength and sterile barrier integrity is validated per ANSI/AAMI/ISO 11607:2006 (Parts 1 and 2) over the proposed shelf life of the device.

#### General Physical Testing

General physical verification testing was conducted for the ExpanSure Dilator to ensure compliance with ISO 11070:2014 and Baylis selfenforced requirements. The following tests were performed:

- 1. Visual Analysis
- 2. Dimensional Measurements
- 3. Curve Retention

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- 4. Coating Integrity and Friction Testing
- 5. Luer Testing
- 6. Corrosion Resistance

#### Pyrogen Testing

The ExpanSure Transseptal Dilation System is supplied non-pyrogenic. LAL testing using the Kinetic Chromogenic method was conducted to ensure the device meets current FDA and USP pyrogen limit specifications.

#### Conclusions

The subject ExpanSure Transseptal Dilation System and predicate TorFlex Transseptal Guiding Sheath (K102948) have the same intended use. The subject and predicate devices also share the same fundamental scientific technology, including principles of operation and mechanism of action. Differences in design and technological characteristics do not raise any different questions of safety and effectiveness. The results of verification and validation activities support the substantial equivalence of the subject ExpanSure Transseptal Dilation System to the predicate device.