(232 days)
No
The device description focuses on mechanical components and materials, and there is no mention of AI, ML, or related concepts in the provided text.
No.
The device, the ExpanSure Transseptal Dilation System, is described as a system for accessing the left atrium via a transseptal technique and is a modification of a guiding sheath. Its function is to facilitate access and dilate, not to treat a disease or condition itself.
No
Explanation: The device is used to facilitate access to the left atrium through a transseptal technique, which is a procedural/surgical function rather than a diagnostic one. Its description focuses on its physical components and compatibility for procedural use (dilation and guiding), and there is no mention of it being used to detect, identify, or characterize a disease or condition.
No
The device description clearly outlines physical components (dilator, guidewire, sheath) made of materials like polyethylene and silicone, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure ("access to the left atrium via the transseptal technique"). IVDs are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a dilator and guidewire, which are instruments used directly within the body during a medical procedure.
- Anatomical Site: The device is used within the left atrium, an internal anatomical site.
- Input Imaging Modality: Fluoroscopy is an imaging technique used during a procedure on a patient, not for analyzing a specimen.
The device is clearly intended for use in vivo (within the body) during a medical procedure, which is the defining characteristic of a non-IVD medical device.
N/A
Intended Use / 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.
Product codes
DRE
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".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
left atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Air Leakage
- Liguid Leakage
- Torque Transmission + Strength of Union Torque
- Three Point Bend
- Strength of Union Tip Deflection
- Strength of Union Tip to Shaft
- Strength of Union Shaft to Hub
Biocompatibility Verification: Performed in accordance with ISO 10993-1:2009/Cor.1:2010 and FDA guidance.
Sterilization Verification: Performed in accordance with ISO 11135-1:2014, Ethylene Oxide to a SAL of 10-6. Residual limits per ISO 10993-7:2008/Cor.1:2009.
Packaging Verification: Ship testing performed to ensure integrity. Seal strength and sterile barrier integrity validated per ANSI/AAMI/ISO 11607:2006 (Parts 1 and 2).
General Physical Testing: - Visual Analysis
- Dimensional Measurements
- Curve Retention
- Coating Integrity and Friction Testing
- Luer Testing
- Corrosion Resistance
Pyrogen Testing: LAL testing using the Kinetic Chromogenic method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: (905) 602-4875
- D. Company Facsimile: (905) 602-5671
- 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 | |||
| Device | Manufacturer | 510(k) | Indications for Use |
| TorFlex™ | |||
| Transseptal | |||
| Guiding | |||
| Sheath | Baylis Medical | ||
| Company Inc. | K102948 | The TorFlex Transseptal Guiding | |
| Sheath is used for the percutaneous | |||
| introduction of various types of | |||
| cardiovascular catheters to all heart | |||
| chambers, including the left atrium | |||
| via transseptal perforation / puncture. |
Table 8.1 : Predicate Device
4
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
TorFlex Transseptal Guiding Sheath
(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
5
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:
-
- Air Leakage
-
- Liguid Leakage
-
- Torque Transmission + Strength of Union Torque
-
- Three Point Bend
-
- Strength of Union Tip Deflection
-
- Strength of Union Tip to Shaft
-
- 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:
-
- Visual Analysis
-
- Dimensional Measurements
-
- Curve Retention
6
-
- Coating Integrity and Friction Testing
-
- Luer Testing
-
- 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.