(178 days)
Not Found
No
The summary describes a mechanical device (sheath, dilator, guidewire) and its physical properties and performance testing, with no mention of AI or ML.
No
Explanation: This device is a guiding sheath designed to introduce other catheters and is not used to treat a disease or condition itself. It is an accessory device, not a therapeutic one.
No
Explanation: The device, a guiding sheath, is used for the introduction of catheters and for catheterization and angiography, which are procedures for intervention or visualization, not primary diagnosis.
No
The device description clearly outlines physical components (sheath, dilator, guidewire) and performance studies related to physical properties (mechanical testing, sterilization, packaging), indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "percutaneous introduction of various types of cardiovascular catheters to all heart chambers". This describes a procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a physical device (sheath, dilator, guidewire) used for guiding catheters within the body. This is consistent with a medical device used in a procedure, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool used in a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DYB; DQY; DRE
Device Description
The TorFlex™ Transseptal Guiding Sheath kit consists of three components: a sheath, a dilator, and a J-tipped guidewire. The TorFlex™ Transseptal Guiding Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The radiopaque tip maximizes visualization of the sheath during manipulation. The dilator provides support for the sheath and has a tapered tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all heart chambers, including the 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)
i) Biocompatibility Testing
Test information and results for the following biocompatibility tests demonstrate that the device is safe for its intended use:
. Cytotoxicity
. Sensitization
. Irritation or Intracutaneous Reactivity
Systemic Toxicity (Acute) ●
Hemocompatibility .
. Pyrogenecity
ii) Mechanical Testing
The following tests were performed and determined that the device is able to withstand the following physical stresses without failure:
. Torque transmission + Strength of union -Torque test
Flow rate measurement .
. Three point bend test
. Freedom from liquid leaking through hemostasis valves + valve integrity
Freedom from air leakage through hemostasis valves + valve integrity .
. Freedom from liquid leakage
. Freedom from air leakage
. Strength of union-Pull test
. Valve insertion force
. Tip transition
Snap fit .
iii) General Physical Testing
The following general physical characteristics of the device were evaluated:
Surface Defects
. Corrosion Resistance
iv) Bench Testing
Bench testing was performed to assess the compatibility of the sheath with 8F devices.
v) Sterlization Validation
Sterilization Validation for the TorFlex™ Transseptal Guiding Sheath was conducted as per ANSI/AAMI/ISO 11135-1 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.
vii) Packaging Validation
The packaging for the TorFlex™ Transseptal Guiding Sheath Kit has been validated in accordance with ANSI/AAMI/ISO 11607.
The test results demonstrate that the proposed device is safe and effective and performs as per the intended use. The proposed and 510(k)-cleared TorFlex™ Transseptal Guiding Sheath (K013919) are determined to be substantially equivalent with respect to fundamental scientific technology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
6. 510(k) Summary
APR - 1 2011
Submitter Information
لر
- 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; ext 252
- D. Company Facsimile: (905) 602-5671
- E. Contact Person: Meghal Khakhar
- F. Summary Prepared on: October 04, 2010
Device Identification
- A. Device Trade Name: TorFlex™ Transseptal Guiding Sheath
- B. Device Common Name: Dilator; Sheath; J-tipped Guidewire
- C. Classification Name: 1) Catheter introducer
- 2) Vessel dilator for percutaneous catheterization
-
- Percutaneous catheter
D. Device Class: Class II
- E. Device Code: 1) DYB 2) DRE
- 3) DQY
Identification of Predicate Device
The predicate device is the TorFlex™ Transseptal Guiding Sheath, which is cleared under 510(k) Premarket Notification Number K013919. Modifications to the current device include changes to the sheath design and materials, kit packaging, and device manufacturer and sterilizer. The indication for use, operation principle, and fundamental scientific technology of the original and proposed TorFlex™ Transseptal Guiding Sheath remains the same.
Device Description
The TorFlex™ Transseptal Guiding Sheath kit consists of three components: a sheath, a dilator, and a J-tipped guidewire.
1
The TorFlex™ Transseptal Guiding Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The radiopaque tip maximizes visualization of the sheath during manipulation. The dilator provides support for the sheath and has a tapered tip.
Intended Use
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.
Substantial Equivalence
The proposed and 510(k)-cleared TorFlex™ Transseptal Guiding Sheath (K013919) are determined to be substantially equivalent with respect to fundamental scientific technology.
This determination is based upon results from performance tests as listed below:
i) Biocompatibility Testing
Test information and results for the following biocompatibility tests demonstrate that the device is safe for its intended use:
- . Cytotoxicity
- . Sensitization
- . Irritation or Intracutaneous Reactivity
- Systemic Toxicity (Acute) ●
- Hemocompatibility .
- . Pyrogenecity
ii) Mechanical Testing
The following tests were performed and determined that the device is able to withstand the following physical stresses without failure:
- . Torque transmission + Strength of union -Torque test
- Flow rate measurement .
- . Three point bend test
- . Freedom from liquid leaking through hemostasis valves + valve integrity
- Freedom from air leakage through hemostasis valves + valve integrity .
- . Freedom from liquid leakage
- . Freedom from air leakage
- . Strength of union-Pull test
- . Valve insertion force
- . Tip transition
- Snap fit .
2
iii) General Physical Testing
The following general physical characteristics of the device were evaluated:
- Surface Defects
- . Corrosion Resistance
Bench Testing iv)
Bench testing was performed to assess the compatibility of the sheath with 8F devices.
v) Sterlization Validation
Sterilization Validation for the TorFlex™ Transseptal Guiding Sheath was conducted as per ANSI/AAMI/ISO 11135-1 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.
vii) Packaging Validation
The packaging for the TorFlex™ Transseptal Guiding Sheath Kit has been validated in accordance with ANSI/AAMI/ISO 11607.
The test results demonstrate that the proposed device is safe and effective and performs as per the intended use. The proposed and 510(k)-cleared TorFlex™ Transseptal Guiding Sheath (K013919) are determined to be substantially equivalent with respect to fundamental scientific technology.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Baylis Medical Co., Inc. c/o Mr. Meghal Khakhar Manager, Regulatory & Scientific Affairs 2645 Matheson Blvd. E. Mississauga, Ontario Canada L4W 5S4
APR - 1 2011
Re: K102948
Trade/Device Name: TorFlex™ Transseptal Guiding Sheath Regulatory Number: 21 CFR 870.1340 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DYB; DQY; DRE Dated: March 24, 2011 Received: March 25, 2011
Dear Mr. 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.
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.
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Page 2 – Mr. Meghal Khakhar
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 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.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
M. G. Hillemann
Gram 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): |