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.

AI/ML Overview

This document is a 510(k) premarket notification summary for a medical device called the "esolution® Esophageal Retractor (Gen 2.1)". The purpose of the 510(k) submission is to demonstrate that the modified device (Gen 2.1) is substantially equivalent to a previously cleared predicate device (esolution®, DEN230006).

Acceptance Criteria and Device Performance for (esolution® Esophageal Retractor (Gen 2.1))

The document focuses on non-clinical performance data to establish substantial equivalence, primarily comparing the modified device to its predicate. The acceptance criteria are essentially the performance characteristics demonstrated by the predicate device and reproduced by the subject device.

Here's the breakdown of the acceptance criteria and reported device performance based on the provided text:

Acceptance Criteria (Performance Requirement)	Reported Device Performance (esolution® Gen 2.1)	Comparison to Predicate (esolution®)
Intended Use	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.	Same
Principle of Operation	Mechanical esophageal retraction with suction.	Same
Major Components	Outer sheath and mechanical deflection device.	Same
Materials	ABS, Silicone, Stainless Steel 316, Polyvinyl chloride (PVC), Polypropylene, Nylon 12, Polycarbonate, Thermoplastic Elastomer.	Similar - new materials do not raise different questions of safety and effectiveness.
Single Use	Yes	Same
Sterilization Method	Electron Beam Radiation	Same
Sterilization Assurance Level (SAL)	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.	Same
Packaging	PETG Tray/Blister with a sealed Tyvek lid.	Similar - different packaging configuration does not raise questions of safety and effectiveness.
Device Insertion/Withdrawal from Cannula	Successful insertion/withdrawal from cannula.	Same
Tensile Strength	Minimum strength of 15N.	Same
Deflection	Deflect and exert 0.7 lbf.	Same
Vacuum Leak/Decay Test	Maintain at least 200 mm Hg Vacuum when 300mmHg is applied.	Same

Analysis of the Study Proving Device Acceptance:

Based on the provided document, the study conducted to prove the device meets acceptance criteria is a non-clinical performance testing intended to demonstrate substantial equivalence to a predicate device.

Sample Size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size for each non-clinical test (e.g., number of units tested for tensile strength or deflection). It broadly states, "The esolution® (Gen 2.1) was tested for biocompatibility, tensile strength, deflection, and vacuum leak."
- Data Provenance: The data is generated from "non-clinical performance testing," which implies laboratory or bench testing. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the testing was either conducted in the U.S. or at a facility whose data is accepted by the FDA for U.S. market approval. It is inherently prospective for the Gen 2.1 device, as the testing was performed to support this specific regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of non-clinical testing (biocompatibility, mechanical performance) does not typically involve human experts in the way clinical studies for AI algorithms do for ground truth establishment. The "ground truth" here is objective physical measurements and adherence to established engineering and biocompatibility standards (e.g., ISO 10993-1, specified mechanical strengths). Therefore, there is no mention of experts establishing ground truth in the context of diagnostic performance.
Adjudication method for the test set:
- Not applicable as this is non-clinical mechanical and material testing, not a diagnostic or clinical study requiring adjudication of expert interpretations.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) might be assisted by AI. The esolution® Esophageal Retractor is a mechanical device, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical medical device, not a software algorithm. The "performance" here refers to its physical and material properties, not an algorithm's output.
The type of ground truth used:
- The "ground truth" for the non-clinical tests are engineering specifications, material science standards (e.g., ISO), and predefined performance thresholds (e.g., minimum tensile strength of 15N, deflection of 0.7 lbf). These are objective, measurable outcomes rather than expert consensus, pathology, or clinical outcomes data.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI. It is a manufactured mechanical device.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied for this type of device.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K243233

Device Name esolution® Esophageal Retractor

Indications for Use (Describe)

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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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 200Chagrin Falls, OH 44022
Contact:	Jennifer A. Daudelin, M.S.J.ProPharma MedTech1129 20th Street NW, Suite 600Washington DC 20036Ph: 347-954-0395Email: 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® EsophagealRetractor	DEN230006	QXU	II

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Indications for Use

Device Description

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.

ProductCharacteristic	Subject Deviceesolution (Gen 2.1)	Predicate Deviceesolution	Comparison
510(k) number	K243233	DEN230006	NA
Intended Use	The esolution® EsophagealRetractor is indicated for use inpatients undergoingpercutaneous cardiac catheterablation of atrial fibrillation todeviate the esophagus away	The esolution® EsophagealRetractor is indicated for use inpatients undergoingpercutaneous cardiac catheterablation of atrial fibrillation todeviate the esophagus away	Same – esolution Gen2.1 has the sameindications for use andintended use as thepredicate esolution.
ProductCharacteristic	Subject Deviceesolution (Gen 2.1)	Predicate Deviceesolution	Comparison
	from the ablation energy sourceand to reduce the risk ofablation-related esophagealinjury.	from the ablation energy sourceand to reduce the risk ofablation-related esophagealinjury.
Principle ofoperation	Mechanical esophagealretraction with suction	Mechanical esophagealretraction with suction	Same - no change
Major Components	Outer sheath and mechanicaldeflection device	Outer sheath and mechanicaldeflection device	Same - no change
Materials	ABS	ABS	Similar - new
	Silicone	Silicone	materials do not raisedifferent questions of
	Stainless Steel 316	Stainless Steel 316	safety andeffectiveness
	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
SterilizationMethod	Electron Beam Radiation	Electron Beam Radiation	Same
SterilizationAssurance Level(SAL)	10-6	10-6	Same
Biocompatibility	Meets requirements of ISO10993-1 and "Use ofInternational Standard ISO10993-1, Biological evaluationof medical devices - Part 1:Evaluation and testing within arisk management process"guidance document including:• Cytotoxicity• Irritation• Sensitization	Meets requirements of ISO10993-1 and "Use ofInternational Standard ISO10993-1, Biological evaluationof medical devices - Part 1:Evaluation and testing within arisk management process"guidance document including:• Cytotoxicity• Irritation• Sensitization	Same
Packaging	PETG Tray/Blister with asealed Tyvek lid.	PETG Tray/Blister in SingleTyvek pouch	Similar — differentpackagingconfiguration does not
ProductCharacteristic	Subject Deviceesolution (Gen 2.1)	Predicate Deviceesolution	Comparison
			questions of safety andeffectiveness
Device Insertion/Withdrawal fromcannula	Successful insertion/withdrawal from cannula	Successful insertion/ withdrawalfrom 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 HgVacuum when 300mmHg isapplied	Maintain at least 200 mm HgVacuum when 300mmHg isapplied	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.

Regulation Number and Section

N/A