(163 days)
Not Found
No
The summary describes a physical catheter and cable for electrophysiology studies, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a "diagnostic" catheter used for the "evaluation of a variety of cardiac arrhythmias" and to "facilitate electrophysiology studies of the heart." Its purpose is to gather information about heart conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Diagnostic Fixed Electrophysiology Lumen Catheter and Diagnostic Electrophysiology Cable can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites." The term "evaluation" in a medical context, especially for arrhythmias, directly implies diagnosis. Furthermore, the device name itself includes "Diagnostic."
No
The device description explicitly details a physical catheter and cable, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description: The description clearly states that this device is a catheter intended to be placed in the heart percutaneously. This means it is used inside the body for direct physiological measurement.
- Intended Use: The intended use is for "evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites," which involves measuring electrical activity directly within the heart.
Therefore, based on the provided information, this device is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Diagnostic Fixed Electrophysiology Lumen Catheter and Diagnostic Electrophysiology Cable can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The Diagnostic Fixed Electrophysiology Lumen Catheter is a sterile, single-use 6F diagnostic catheter with multiple electrodes and a fixed distal curve. The catheter body is a continuous tube with a central lumen for fluid infusion through a last chance filter (LCF) female luer connector. The catheter is intended to be placed in the heart percutaneously to facilitate electrophysiology studies of the heart, such as the coronary sinus and atrioventricular annulus. The catheter is connected to separately cleared diagnostic electrophysiology equipment via an accessory, the Diagnostic Electrophysiology Cable. The cable is supplied sterile and is reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, coronary sinus and atrioventricular annulus
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)
Non-clinical performance testing was completed for the Diagnostic Fixed Electrophysiology Lumen Catheter and accessory cable to support their safety and effectiveness with regards to the intended use as well as substantial equivalence to the predicate device. The following verifications and validations were completed:
- Biocompatibility Verification: The biological safety of the catheter was verified as per the requirements of ISO 10993-1:2009/Cor.1:2010 and FDA's modified ISO guidelines in accordance with the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process".
- Mechanical Verification: Mechanical testing was performed to verify compliance of the catheter with ISO 10555-1:2013 and specified Baylis Medical requirements. The accessory cable was verified to meet applicable IEC 60601-1:2005+A1:2012 and specified Baylis Medical requirements
- Electrical Verification: Electrical testing was performed to verify compliance of the catheter and accessory cable with applicable IEC 60601-1:2005+A1:2012 and specified Baylis Medical requirements.
- Bench Validation: Validation testing of the catheter was performed to validate the design of the device with regards to insertability, radiopacity, compatibility with ancillary devices and torquability. Validation testing of the accessory cable was performed to evaluate the design and function of the cable.
- Cleaning and Re-Sterilization Validation: Validation testing was performed to demonstrate that the accessory cable could be cleaned and re-sterilized in accordance with the FDA guidance document Reprocessing Medical Devices in Health Care Settings: Validations Methods and Labeling.
- Reuse Verification: Testing was performed to verify compliance of the accessory cable with specified Baylis Medical requirements when reused as per the device labelling.
- Packaging Validation: Ship testing was performed to ensure the integrity of the device packaging through the rigors of shipping and handling. Stability testing was also completed to demonstrate the integrity of the primary packaging (i.e. sterile barrier) as per ANSI/AAMI/ISO 11607-1:2006 and ANSI/AAMI/ISO 11607-2:2006 over the proposed device shelf life of the catheter and accessory cable.
The Diagnostic Fixed Electrophysiology Lumen Catheter and accessory cable met all requirements as specified by the test protocols.
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
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
0
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June 7, 2019
Baylis Medical Company Inc. Meghal Khakhar Vice President, Regulatory & Scientific Affairs 2580 Matheson Blvd. East Mississauga, Ontario L4W 4J1 Canada
Re: K183632
Trade/Device Name: Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: April 17, 2019 Received: April 18, 2019
Dear Meghal 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. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183632
Device Name
Diagnostic Fixed Electrophysiology Lumen Catheter Diagnostic Electrophysiology Cable
Indications for Use (Describe)
The Diagnostic Fixed Electrophysiology Lumen Catheter and Diagnostic Electrophysiology Cable can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Type of Use (Select one or both, as applicable)
| ☒ Residential (Per 24 CFR 982.4) | ☐ Other: Supportive Housing (SH) |
|---|---|
| --------------------------------------------- | --------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Baylis Medical Company Inc.
7. 510(k) Summary
Submitter Information
| A. Company Name: | Baylis Medical Company Inc. |
|---|---|
| B. Company Address: | 2580 Matheson Blvd. East |
| Mississauga, Ontario L4W 4J1 | |
| Canada | |
| C. Company Phone: | (905)602-4875 |
| D. Company Facsimile: | (905)602-5671 |
| E. Contact Person: | Meghal Khakhar |
| F. Summary Prepared on: | 19-Dec-2018 |
Device Identification
| A. Device Trade Name: | Diagnostic Fixed Electrophysiology Lumen Catheter
Diagnostic Electrophysiology Cable |
|-------------------------|-----------------------------------------------------------------------------------------|
| B. Device Common Name: | Electrode recording catheter |
| C. Classification Name: | 21 CFR 870.1220 Catheter, Electrode Recording, Or
Probe, Electrode Recording |
| D. Product Code: | DRF |
| E. Device Class: | Class II |
Identification of Predicate Device
The predicate for the Diagnostic Fixed Electrophysiology Lumen Catheter is listed in Table 1.
Table 1: Predicate Device
| Predicate Device | Manufacturer | 510(k) | Product Code |
|---|---|---|---|
| Response Electrophysiology | |||
| Catheter with Lumen | St. Jude Medical | K120544 | DRF |
4
Indications for Use
The Diagnostic Fixed Electrophysiology Lumen Catheter and Diagnostic Electrophysiology Cable can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Device Description
The Diagnostic Fixed Electrophysiology Lumen Catheter is a sterile, single-use 6F diagnostic catheter with multiple electrodes and a fixed distal curve. The catheter body is a continuous tube with a central lumen for fluid infusion through a last chance filter (LCF) female luer connector. The catheter is intended to be placed in the heart percutaneously to facilitate electrophysiology studies of the heart, such as the coronary sinus and atrioventricular annulus. The catheter is connected to separately cleared diagnostic electrophysiology equipment via an accessory, the Diagnostic Electrophysiology Cable. The cable is supplied sterile and is reusable.
Comparison to Predicate Device
The characteristics of the proposed and predicate devices are compared in Table 2.
| Characteristic | Comment |
|---|---|
| Intended Use | Identical |
| Indications for Use | Identical |
| Fundamental scientific technology | Identical |
| Operating principles | Identical |
| Mechanism of action | Identical |
| Materials | Similar |
| Key technological characteristics (e.g. dimensions) | Similar |
| Accessory devices | Identical |
| Packaging configuration | Similar |
| Environment of use | Identical |
| Sterility and Reusability | Identical |
| Sterilization method | Identical |
Table 2: Comparison between Characteristics of Proposed and Predicate Devices
Performance Testing
Non-clinical performance testing was completed for the Diagnostic Fixed Electrophysiology Lumen Catheter and accessory cable to support their safety and
5
Baylis Medical Company Inc.
effectiveness with regards to the intended use as well as substantial equivalence to the predicate device. The following verifications and validations were completed:
-
- Biocompatibility Verification: The biological safety of the catheter was verified as per the requirements of ISO 10993-1:2009/Cor.1:2010 and FDA's modified ISO guidelines in accordance with the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process".
-
- Mechanical Verification: Mechanical testing was performed to verify compliance of the catheter with ISO 10555-1:2013 and specified Baylis Medical requirements. The accessory cable was verified to meet applicable IEC 60601-1:2005+A1:2012 and specified Baylis Medical requirements
-
- Electrical Verification: Electrical testing was performed to verify compliance of the catheter and accessory cable with applicable IEC 60601-1:2005+A1:2012 and specified Baylis Medical requirements.
- Bench Validation: Validation testing of the catheter was performed to validate 4. the design of the device with regards to insertability, radiopacity, compatibility with ancillary devices and torquability. Validation testing of the accessory cable was performed to evaluate the design and function of the cable.
-
- Cleaning and Re-Sterilization Validation: Validation testing was performed to demonstrate that the accessory cable could be cleaned and re-sterilized in accordance with the FDA guidance document Reprocessing Medical Devices in Health Care Settings: Validations Methods and Labeling.
- Reuse Verification: Testing was performed to verify compliance of the accessory 6. cable with specified Baylis Medical requirements when reused as per the device labelling.
-
- Packaging Validation: Ship testing was performed to ensure the integrity of the device packaging through the rigors of shipping and handling. Stability testing was also completed to demonstrate the integrity of the primary packaging (i.e. sterile barrier) as per ANSI/AAMI/ISO 11607-1:2006 and ANSI/AAMI/ISO 11607-2:2006 over the proposed device shelf life of the catheter and accessory cable.
The Diagnostic Fixed Electrophysiology Lumen Catheter and accessory cable met all requirements as specified by the test protocols.
6
Conclusions
The proposed and predicate devices share the same intended use and fundamental scientific technology, including principles of operation and mechanism of action. Design and technological differences between the proposed and predicate devices do not raise any new concerns of safety and effectiveness. The results of verification and validation testing demonstrate that the Diagnostic Fixed Electrophysiology Lumen Catheter and the accessory cable are as safe, as effective, and perform in a manner that is substantially equivalent to the predicate device.