(74 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML capabilities or data processing.
No
The device is described as a steerable sheath used for percutaneous catheter introduction into the heart, facilitating access for other procedures, rather than directly treating a disease or condition.
No
Explanation: The device is described as a steerable sheath for catheter introduction and access to heart chambers, which is an interventional or access tool, not a diagnostic one.
No
The device description clearly details a physical, steerable sheath with a handle, actuator knob, hemostasis valve, side flush line, and dilator. This is a hardware device, not software.
Based on the provided information, the FARADRIVE Sheath is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- FARADRIVE Sheath Function: The FARADRIVE Sheath is a medical device used to facilitate the physical introduction of catheters into the heart chambers. It is a tool for accessing anatomical locations within the body, not for analyzing biological samples.
- Intended Use: The intended use clearly states "for percutaneous catheter introduction into the chambers of the heart". This describes a procedural tool, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the physical components and mechanisms for steering and accessing the heart, not on any analytical or testing capabilities.
Therefore, the FARADRIVE Sheath is a procedural medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FARADRIVE Sheath is intended for percutaneous catheter introduction into the chambers of the heart, including the left side of the heart through the interatrial septum.
The FARADRIVE Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the interatrial septum.
Product codes
DRA
Device Description
The FARADRIVE Steerable Sheath is used to facilitate access to the vasculature and into the chambers of the heart. The handle is furnished with a rotating Actuator Knob that enables a single plane unidirectional deflection and has the ability to actively straighten the distal end of the FARADRIVE Steerable Sheath curve when rotated.
The FARADRIVE Steerable Sheath includes an integral hemostasis valve to minimize blood loss or air ingress during catheter and dilator manipulation and a side flush line with three-way stopcock for blood aspiration, fluid infusion, blood sampling and pressure monitoring. The sheath also includes distal vent holes to facilitate aspiration and minimize cavitation. The supplied dilator is shaped to assist in facilitating vascular or chamber access when fully inserted into the sheath. The proximal end of the dilator includes a feature that will lock to the sheath hub when fully inserted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chambers of the heart, vasculature, left side of the heart through the interatrial septum
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
The non-clinical performance testing included in this 510(k) application provides evidence that the FARADRIVE Steerable Sheath conforms to user needs and its intended use and is thus substantially equivalent to the predicate previously cleared under K223824. No new safety or effectiveness issues were raised during device performance testing. The following test data is provided in this 510(k) application:
- Sterilization validation, including EO Cycle Validation and Product Qualification, for the . sterile FARADRIVE Steerable Sheath
- Biocompatibility assessment and testing for the patient-contacting components of the ● FARADRIVE Steerable Sheath
- Design verification testing of the FARADRIVE Steerable Sheath and its packaging, ● demonstrating that the device and its packaging meets the design input requirements as per the product and packaging specifications
- Design verification testing at nominal (T=0) timepoint O
- Design verification testing at an accelerated aging timepoint for a labeled shelf life of O T=24 months
- Design validation testing summary for the FARAPULSE Pulsed Field Ablation System ● demonstrating that the system conforms to user needs and intended use
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(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.
December 11, 2023
Boston Scientific Corporation Nicholas Zurn Regulatory Affairs Specialist II 4100 Hamline Avenue North St. Paul, Minnesota 55112
Re: K233248
Trade/Device Name: FARADRIVE™ Steerable Sheath Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: September 28, 2023 Received: September 28, 2023
Dear Nicholas Zurn:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233248
Device Name FARADRIVE™ Steerable Sheath
Indications for Use (Describe)
The FARADRIVE Sheath is intended for percutaneous catheter introduction into the chambers of the heart, including the left side of the heart through the interatrial septum.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Image /page/4/Picture/0 description: The image shows the logo for Boston Scientific. The logo is in a dark blue color and features a serif font. The words "Boston Scientific" are stacked on top of each other.
510(k) Summary in Compliance with 21 CFR 807.92
Submitter Information:
Submitter Name: Boston Scientific Corporation
Submitter Address: 4100 Hamline Avenue North St. Paul. Minnesota 55112-5798 USA
Contact #1: Nicholas Zurn Regulatory Affairs Specialist II Phone: (651) 287 5061 Email: nicholas.zurn(@bsci.com
Contact #2: Richard Kimura Principal Regulatory Affairs Specialist Phone: (651) 582 4000 Email: richard.kimura@bsci.com
Date Prepared: 28-September-2023
Device Information:
Generic Name: Steerable Sheath
Trade Name: FARADRIVE™ Steerable Sheath
Product Code: DRA (Catheter, Steerable)
510(k) Number: K233248
Device Class: Class II
Review Panel: Cardiovascular (DRA)
5
Classification Regulations: 21 CFR 870.1280
Predicate Device Information:
POLARSHEATH™ Steerable Sheath 12F
Manufacturer: Boston Scientific Corporation 510(k) #: K223824 FDA Clearance Date: March 22nd, 2023 Product Code: DRA
Reference Device Information:
MitraClip G4 Steerable Guide Catheter
Manufacturer: Abbott Medical 510(k) #: K190167 FDA Clearance Date: May 29th, 2019 Product Code: DRA
Indications for Use:
The FARADRIVE Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the interatrial septum.
Device Description:
The FARADRIVE Steerable Sheath is used to facilitate access to the vasculature and into the chambers of the heart. The handle is furnished with a rotating Actuator Knob that enables a single plane unidirectional deflection and has the ability to actively straighten the distal end of the FARADRIVE Steerable Sheath curve when rotated.
The FARADRIVE Steerable Sheath includes an integral hemostasis valve to minimize blood loss or air ingress during catheter and dilator manipulation and a side flush line with three-way stopcock for blood aspiration, fluid infusion, blood sampling and pressure monitoring. The sheath also includes distal vent holes to facilitate aspiration and minimize cavitation. The supplied dilator is shaped to assist in facilitating vascular or chamber access when fully inserted into the sheath. The proximal end of the dilator includes a feature that will lock to the sheath hub when fully inserted.
6
Substantial Equivalence & Comparison of Technological Characteristics:
| Characteristic | Predicate Device (K223824)
POLARSHEATH™ Steerable Sheath
12F (Boston Scientific
Corporation) | Subject Device (K233248)
FARADRIVE Steerable Sheath
(Boston Scientific Corporation) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The POLARSHEATH™ steerable
sheath is indicated for percutaneous
catheter introduction into the
vasculature and into the chambers of
the heart. | The FARADRIVE Sheath is intended
for percutaneous catheter
introduction into the vasculature and
into the chambers of the heart,
including the left side of the heart
through the interatrial septum. |
| Single Use or Reusable | Single Use | Single Use |
| Shaft Design | Deflectable shaft with single lumen | Deflectable shaft with single lumen |
| Deflection | Unidirectional to 155° | Unidirectional to 180° with active
straightening back to 0° |
| Hemostasis Valve | Yes | Yes |
| Side Flush Port Tubing | Yes | Yes |
| Stopcock | No | Yes |
| Braided Shaft | Yes | Yes |
| Radiopaque Marker(s) | Yes | Yes |
| Guidewire Compatibility | 0.032 inches (0.81mm) and 0.035
inches (0.89mm) | 0.035 inches (0.89mm) |
| Sterilization | Provided sterile via Ethylene Oxide | Provided sterile via Ethylene Oxide |
| Packaging | Tyvek nylon/polyethylene pouch | Tyvek nylon/polyethylene pouch |
| Shelf Life | 12 months | 24 months |
| Sheath Dimensions | | |
| Overall Length | 82cm | 91cm |
| Usable Length | 68cm | 74cm |
| Sheath OD | 5.3mm (15.9Fr) | 5.8mm (17.4Fr) |
| Characteristic | Predicate Device (K223824)
POLARSHEATH Steerable Sheath
12F (Boston Scientific
Corporation) | Subject Device (K233248)
FARADRIVE Steerable Sheath
(Boston Scientific Corporation) |
| Sheath ID | 4.2mm (12.7Fr) | 4.3mm (13Fr) |
| Dilator Dimensions | | |
| Dilator Usable Length | 85cm | 94cm |
| OD | 0.159 inches | 0.163 inches |
| ID | 0.039 inches | 0.037 inches |
| Materials | | |
| | - Pebax with stainless steel braid and
PTFE liner
- Silicone Rubber
- Polycarbonate
- Polyethylene | - Pebax, Nylon 12, with stainless
steel braid and hydrophilic coated
Pebax liner - Silicone Rubber
- Polycarbonate
- Polyethylene |
Table 1 - COMPARISON OF THE SUBJECT FARADRIVE STEERABLE SHEATH VERSUS PREDICATE POLARSHEATH STEERABLE SHEATH 12F
7
Summary of Non-Clinical Performance Testing:
The non-clinical performance testing included in this 510(k) application provides evidence that the FARADRIVE Steerable Sheath conforms to user needs and its intended use and is thus substantially equivalent to the predicate previously cleared under K223824. No new safety or effectiveness issues were raised during device performance testing. The following test data is provided in this 510(k) application:
- Sterilization validation, including EO Cycle Validation and Product Qualification, for the . sterile FARADRIVE Steerable Sheath
- Biocompatibility assessment and testing for the patient-contacting components of the ● FARADRIVE Steerable Sheath
- Design verification testing of the FARADRIVE Steerable Sheath and its packaging, ● demonstrating that the device and its packaging meets the design input requirements as per the product and packaging specifications
- Design verification testing at nominal (T=0) timepoint O
- Design verification testing at an accelerated aging timepoint for a labeled shelf life of O T=24 months
- Design validation testing summary for the FARAPULSE Pulsed Field Ablation System ● demonstrating that the system conforms to user needs and intended use
8
Conclusion:
Based on the intended use, fundamental technological characteristics, and performance testing, the proposed FARADRIVE Steerable Sheath device has shown to be appropriate for its intended use and is substantially equivalent to the predicate device.