(31 days)
Not Found
No
The device description and performance studies focus solely on the mechanical function and material properties of the esophageal retractor, with no mention of AI or ML.
No
The device is described as a "sterile mechanical deviation device for esophageal protection during cardiac ablation procedures" and its purpose is to "deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury" rather than directly treating a medical condition or disease. It is a protective device used during a therapeutic procedure.
No
Explanation: The device is described as a "mechanical deviation device for esophageal protection" whose purpose is to "deviate the esophagus away from the ablation energy source." It is used to prevent injury during a procedure, not to diagnose a condition.
No
The device description clearly states it is a "sterile mechanical deviation device" with physical components (Outer Sheath and Mechanical Deflection Device) that are placed in the esophagus. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to mechanically deviate the esophagus during a cardiac ablation procedure to reduce the risk of injury. This is a therapeutic/interventional use, not a diagnostic one.
- Device Description: The device is described as a "sterile mechanical deviation device" that is "placed in the lumen of the esophagus." It uses "mechanical means to deviate the esophagus." This description aligns with a physical medical device used during a procedure, not a device used to perform tests on samples from the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
The device's function is to physically manipulate an anatomical structure during a medical procedure. This falls under the category of a surgical or interventional device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The esolution® Esophageal Retractor is indicated for use in patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury.
Product codes
QXU
Device Description
The esolution® Esophageal Retractor is a sterile mechanical deviation device for esophageal protection during cardiac ablation procedures. This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses mechanical means to deviate the esophagus away from the source of ablation energy. The esolution® Esophageal Retractor contains two main components: an Outer Sheath, which is placed in the esophagus prior to the initiation of the therapeutic ablation procedure and a Mechanical Deflection Device that is inserted into the Outer Sheath once the Outer Sheath has been positioned in the esophagus for the indicated atrial fibrillation ablation therapeutic care. The purpose of this 510(k) is to capture the modifications made to the esolution® Esophageal Retractor required for manufacturability including changes to materials and design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
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)
The modified esolution® Esophageal Retractor (Gen 2.1) has been evaluated through non-clinical performance testing. The esolution® (Gen 2.1) was tested for biocompatibility, tensile strength, deflection, and vacuum leak. The testing demonstrated that the esolution® (Gen 2.1) met performance requirements listed in the special controls and is substantially equivalent to the predicate device.
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
N/A
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 9, 2024
S4 Medical Corp. % Jennifer Daudelin Director, MedTech Regulatory Affairs ProPharma MedTech 1129 20th Street NW. Suite 600 Washington, District of Columbia 20036
Re: K243233
Trade/Device Name: esolution® Esophageal Retractor Regulation Number: 21 CFR 870.5710 Regulation Name: Mechanical Device For Esophageal Protection During Cardiac Ablation Procedures Regulatory Class: Class II Product Code: OXU Dated: October 9, 2024 Received: October 9, 2024
Dear Jennifer Daudelin:
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.
1
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" (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 (OS) 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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
assistance/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 Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243233
Device Name esolution® Esophageal Retractor
Indications for Use (Describe)
The esolution® Esophageal Retractor is indicated for use in patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Registration Use (Retail, STR, MMJ, Delivery, Place of Worship) | One-Time Consumption (STR, MMJ, Catering, Special Event) |
|---|---|
| --------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------- |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for the S4 Medical Corp. 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
| Sponsor: | S4 Medical Corp.
34 South Main St, Suite 200
Chagrin Falls, OH 44022 | | | | | | |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------|-------|--|--|--|
| Contact: | Jennifer A. Daudelin, M.S.J.
ProPharma MedTech
1129 20th Street NW, Suite 600
Washington DC 20036
Ph: 347-954-0395
Email: jennifer.daudelin@propharmagroup.com | | | | | | |
| Date Prepared: | October 7, 2024 | | | | | | |
| Proposed Class: | II | | | | | | |
| Proprietary Name: | esolution® Esophageal Retractor | | | | | | |
| Common Name:
Mechanical deviation device for esophageal protection during | | | | | | | |
| | cardiac ablation procedures | | | | | | |
| Classification Name: | Mechanical deviation device for esophageal protection during | | | | | | |
| | cardiac ablation procedures | | | | | | |
| Regulation Number: | 21 CFR 870.5710 | | | | | | |
| Product Codes: | QXU | | | | | | |
| Predicate Device: | | | | | | | |
| Manufacturer | Device Name | 510(k) Number | Procode | Class | | | |
| S4 Medical Corp. | esolution® Esophageal
Retractor | DEN230006 | QXU | II | | | |
5
Indications for Use
The esolution® Esophageal Retractor is indicated for use in patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury.
Device Description
The esolution® Esophageal Retractor is a sterile mechanical deviation device for esophageal protection during cardiac ablation procedures. This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses mechanical means to deviate the esophagus away from the source of ablation energy. The esolution® Esophageal Retractor contains two main components: an Outer Sheath, which is placed in the esophagus prior to the initiation of the therapeutic ablation procedure and a Mechanical Deflection Device that is inserted into the Outer Sheath once the Outer Sheath has been positioned in the esophagus for the indicated atrial fibrillation ablation therapeutic care. The purpose of this 510(k) is to capture the modifications made to the esolution® Esophageal Retractor required for manufacturability including changes to materials and design.
Performance Data – Non-Clinical
The modified esolution® Esophageal Retractor (Gen 2.1) has been evaluated through non-clinical performance testing. The esolution® (Gen 2.1) was tested for biocompatibility, tensile strength, deflection, and vacuum leak. The testing demonstrated that the esolution® (Gen 2.1) met performance requirements listed in the special controls and is substantially equivalent to the predicate device.
| Product
Characteristic | Subject Device
esolution (Gen 2.1) | Predicate Device
esolution | Comparison |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K243233 | DEN230006 | NA |
| Intended Use | The esolution® Esophageal
Retractor is indicated for use in
patients undergoing
percutaneous cardiac catheter
ablation of atrial fibrillation to
deviate the esophagus away | The esolution® Esophageal
Retractor is indicated for use in
patients undergoing
percutaneous cardiac catheter
ablation of atrial fibrillation to
deviate the esophagus away | Same – esolution Gen
2.1 has the same
indications for use and
intended use as the
predicate esolution. |
| Product
Characteristic | Subject Device
esolution (Gen 2.1) | Predicate Device
esolution | Comparison |
| | from the ablation energy source
and to reduce the risk of
ablation-related esophageal
injury. | from the ablation energy source
and to reduce the risk of
ablation-related esophageal
injury. | |
| Principle of
operation | Mechanical esophageal
retraction with suction | Mechanical esophageal
retraction with suction | Same - no change |
| Major Components | Outer sheath and mechanical
deflection device | Outer sheath and mechanical
deflection device | Same - no change |
| Materials | ABS | ABS | Similar - new |
| | Silicone | Silicone | materials do not raise
different questions of |
| | Stainless Steel 316 | Stainless Steel 316 | safety and
effectiveness |
| | Polyvinyl chloride (PVC) | Polyvinyl chloride (PVC) | |
| | Polypropylene | Polyurethane | Biocomp 10993-1 |
| | Nylon 12 | | repeated for Subject |
| | Polycarbonate | | Device |
| | Thermoplastic Elastomer | | |
| Single Use | Yes | Yes | Same |
| Sterilization
Method | Electron Beam Radiation | Electron Beam Radiation | Same |
| Sterilization
Assurance Level
(SAL) | 10-6 | 10-6 | Same |
| Biocompatibility | Meets requirements of ISO
10993-1 and "Use of
International Standard ISO
10993-1, Biological evaluation
of medical devices - Part 1:
Evaluation and testing within a
risk management process"
guidance document including:
• Cytotoxicity
• Irritation
• Sensitization | Meets requirements of ISO
10993-1 and "Use of
International Standard ISO
10993-1, Biological evaluation
of medical devices - Part 1:
Evaluation and testing within a
risk management process"
guidance document including:
• Cytotoxicity
• Irritation
• Sensitization | Same |
| Packaging | PETG Tray/Blister with a
sealed Tyvek lid. | PETG Tray/Blister in Single
Tyvek pouch | Similar — different
packaging
configuration does not |
| Product
Characteristic | Subject Device
esolution (Gen 2.1) | Predicate Device
esolution | Comparison |
| | | | questions of safety and
effectiveness |
| Device Insertion/
Withdrawal from
cannula | Successful insertion/
withdrawal from cannula | Successful insertion/ withdrawal
from cannula | Same |
| Tensile | Minimum strength of 15N | Minimum strength of 15N | Same |
| Deflection | Deflect and exert 0.7 lbf | Deflect and exert 0.7 lbf | Same |
| Vacuum Leak/
Decay Test | Maintain at least 200 mm Hg
Vacuum when 300mmHg is
applied | Maintain at least 200 mm Hg
Vacuum when 300mmHg is
applied | Same |
Technological Characteristics Comparison to Predicate Devices
6
7
Substantial Equivalence
The esolution® (Gen 2.1) has the same indications for use and similar design features as compared with the predicate device (DEN230006). The bench testing demonstrates that the performance characteristics of the esolution® (Gen 2.1) are equivalent to those of the legally marketed predicate device, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. Any differences between the subject and predicate devices would not render the device NSE or raise different questions of safety and effectiveness.