esolution® Esophageal Retractor

K243233 · S4 Medical Corp. · QXU · Nov 9, 2024 · Cardiovascular

Device Facts

• Record ID: K243233
• Device Name: esolution® Esophageal Retractor
• Applicant: S4 Medical Corp.
• Product Code: QXU · Cardiovascular
• Decision Date: Nov 9, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5710
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Sterile mechanical deviation device for esophageal protection during cardiac ablation. Consists of an outer sheath and a mechanical deflection device. Placed in the esophageal lumen to physically displace the esophagus away from the ablation energy source, reducing risk of injury. Used in clinical settings during atrial fibrillation ablation procedures. Operates via mechanical retraction assisted by suction. Healthcare providers insert the outer sheath into the esophagus, followed by the deflection device. Output is the physical displacement of the esophagus, which allows the physician to perform ablation with reduced risk of collateral thermal damage to the esophageal tissue.

Clinical Evidence

Bench testing only. Evaluated biocompatibility per ISO 10993-1 (cytotoxicity, irritation, sensitization), tensile strength (min 15N), deflection (0.7 lbf), and vacuum leak/decay (maintain >= 200 mmHg).

Technological Characteristics

Materials: ABS, Silicone, Stainless Steel 316, PVC, Polypropylene, Nylon 12, Polycarbonate, Thermoplastic Elastomer. Principle: Mechanical esophageal retraction with suction. Form factor: Outer sheath and mechanical deflection device. Sterilization: Electron Beam Radiation (SAL 10^-6). Single-use.

Indications for Use

Indicated for patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and reduce risk of ablation-related esophageal injury.

Regulatory Classification

Identification

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

Predicate Devices

• esolution® Esophageal Retractor (DEN230006)

Submission Summary (Full Text)

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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.

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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

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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### 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <label><input type="checkbox"/> Registration Use (Retail, STR, MMJ, Delivery, Place of Worship)</label> | <label><input type="checkbox"/> One-Time Consumption (STR, MMJ, Catering, Special Event)</label> |
|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|

|× | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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## 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.<br>34 South Main St, Suite 200<br>Chagrin Falls, OH 44022 | | | | | | |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------|-------|--|--|--|
| Contact: | Jennifer A. Daudelin, M.S.J.<br>ProPharma MedTech<br>1129 20th Street NW, Suite 600<br>Washington DC 20036<br>Ph: 347-954-0395<br>Email: [e-mail] | | | | | | |
| Date Prepared: | October 7, 2024 | | | | | | |
| Proposed Class: | II | | | | | | |
| Proprietary Name: | esolution® Esophageal Retractor | | | | | | |
| Common Name:<br>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<br>Retractor | DEN230006 | QXU | II | | | |

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## 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<br>Characteristic | Subject Device<br>esolution (Gen 2.1) | Predicate Device<br>esolution | Comparison |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K243233 | DEN230006 | NA |
| Intended Use | The esolution® Esophageal<br>Retractor is indicated for use in<br>patients undergoing<br>percutaneous cardiac catheter<br>ablation of atrial fibrillation to<br>deviate the esophagus away | The esolution® Esophageal<br>Retractor is indicated for use in<br>patients undergoing<br>percutaneous cardiac catheter<br>ablation of atrial fibrillation to<br>deviate the esophagus away | Same – esolution Gen<br>2.1 has the same<br>indications for use and<br>intended use as the<br>predicate esolution. |
| Product<br>Characteristic | Subject Device<br>esolution (Gen 2.1) | Predicate Device<br>esolution | Comparison |
| | from the ablation energy source<br>and to reduce the risk of<br>ablation-related esophageal<br>injury. | from the ablation energy source<br>and to reduce the risk of<br>ablation-related esophageal<br>injury. | |
| Principle of<br>operation | Mechanical esophageal<br>retraction with suction | Mechanical esophageal<br>retraction with suction | Same - no change |
| Major Components | Outer sheath and mechanical<br>deflection device | Outer sheath and mechanical<br>deflection device | Same - no change |
| Materials | ABS | ABS | Similar - new |
| | Silicone | Silicone | materials do not raise<br>different questions of |
| | Stainless Steel 316 | Stainless Steel 316 | safety and<br>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<br>Method | Electron Beam Radiation | Electron Beam Radiation | Same |
| Sterilization<br>Assurance Level<br>(SAL) | 10-6 | 10-6 | Same |
| Biocompatibility | Meets requirements of ISO<br>10993-1 and "Use of<br>International Standard ISO<br>10993-1, Biological evaluation<br>of medical devices - Part 1:<br>Evaluation and testing within a<br>risk management process"<br>guidance document including:<br>• Cytotoxicity<br>• Irritation<br>• Sensitization | Meets requirements of ISO<br>10993-1 and "Use of<br>International Standard ISO<br>10993-1, Biological evaluation<br>of medical devices - Part 1:<br>Evaluation and testing within a<br>risk management process"<br>guidance document including:<br>• Cytotoxicity<br>• Irritation<br>• Sensitization | Same |
| Packaging | PETG Tray/Blister with a<br>sealed Tyvek lid. | PETG Tray/Blister in Single<br>Tyvek pouch | Similar — different<br>packaging<br>configuration does not |
| Product<br>Characteristic | Subject Device<br>esolution (Gen 2.1) | Predicate Device<br>esolution | Comparison |
| | | | questions of safety and<br>effectiveness |
| Device Insertion/<br>Withdrawal from<br>cannula | Successful insertion/<br>withdrawal from cannula | Successful insertion/ withdrawal<br>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/<br>Decay Test | Maintain at least 200 mm Hg<br>Vacuum when 300mmHg is<br>applied | Maintain at least 200 mm Hg<br>Vacuum when 300mmHg is<br>applied | Same |

Technological Characteristics Comparison to Predicate Devices

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### 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.