The Chemo Mouthpiece is intended to be used to cool the oral mucosa to reduce the incidence and severity of chemotherapy induced oral mucositis in adult patients.

Device Description

The Chemo Mouthpiece is a device that reduces the temperature in the oral cavity to reduce the incidence and severity of oral mucositis (OM) associated with chemotherapy. The device is completely passive (e.g. there are no electrical components) and is designed to manually circulate saline solution and purified water inside a mouthpiece worn by the patient. The Chemo Mouthpiece (CMP) is designed with an inner chamber, an outer chamber, and breathing tubes. Prior to use the device is placed inside a standard freezer for a minimum of 6 hours, which freezes the water solid in the inner chamber, while the saline solution chamber in the outer chamber becomes cold but remains in liquid form. The device is then retrieved from the freezer and placed by the user in the oral cavity per the instructions for use. Cryotherapy is maintained continuously as the user squeezes the device to circulate the cold saline solution around the in the device. Breathing tubes that run throughout the length of the device facilitate breathing during device use.

AI/ML Overview

The Chemo Mouthpiece is intended to cool the oral mucosa to reduce the incidence and severity of chemotherapy-induced oral mucositis in adult patients. The 510(k) summary provides details of the non-clinical performance testing conducted to demonstrate that the device meets its performance specifications.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Implied / Stated)	Reported Device Performance	Conclusion
Device Cooling Test	Ability to characterize the cooling capacity and demonstrate surface temperatures cooler than the predicate device, meeting design specifications.	The results indicated that the Chemo Mouthpiece met its design specifications and demonstrated surface temperatures that were cooler than that of the predicate device.	Pass
Mechanical Integrity Testing	Demonstration of mechanical durability and meeting mechanical integrity requirements under simulated worst-case conditions.	The results indicated that the Chemo Mouthpiece device design met its mechanical integrity requirements when used under stimulated worst case conditions.	Pass
Shelf Life and Package Integrity Testing	Package seal integrity after accelerated aging (to support 24-month shelf-life) and continued thermal performance of aged samples.	Results indicated that following accelerated aging package seal met its design requirements and thermal testing on the aged samples indicated that the device continued to meet its design specifications in terms of its cooling capacity.	Pass
Biocompatibility	Patient-contacting components (silicone, PVC, and polypropylene) to be found biocompatible according to specific ISO and USP standards (Cytotoxicity, Sensitization, Irritation, Acute Systemic, Pyrogenicity).	Patient contacting component was found to be biocompatible.	Pass

2. Sample Size Used for the Test Set and Data Provenance:

The provided text only refers to non-clinical performance testing. It does not mention a "test set" in the context of clinical data, nor does it provide sample sizes for any of the non-clinical tests. Therefore, there is no information about data provenance (country of origin, retrospective/prospective) related to a test set of patient data. The tests are laboratory-based.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The reported studies are non-clinical performance tests (cooling capacity, mechanical integrity, shelf-life, biocompatibility) of the device itself, not studies evaluating diagnostic or therapeutic accuracy against a clinical ground truth.

4. Adjudication Method for the Test Set:

Not applicable. There is no clinical test set with associated ground truth requiring adjudication. The studies are technical performance evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document focuses on the technical performance of the device and its substantial equivalence to a predicate, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm only without Human-in-the-Loop Performance) Was Done:

Not applicable. The Chemo Mouthpiece is a passive medical device, not an algorithm or AI system. Its performance is evaluated directly through physical and chemical testing, not through algorithmic output.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by the technical specifications and standards against which the device's performance is measured.

Device Cooling Test: Ground truth is the defined temperature range or cooling capacity that the device is expected to achieve, and comparison to the predicate device's cooling.
Mechanical Integrity Testing: Ground truth is the defined mechanical durability and integrity requirements under simulated worst-case conditions.
Shelf Life and Package Integrity Testing: Ground truth includes the defined package seal integrity after accelerated aging and the thermal specifications for the aged device.
Biocompatibility: Ground truth is established by the specified ISO and USP standards (ISO 10993-5, ISO 10993-10, ISO 10993-11, USP<151>).

8. The Sample Size for the Training Set:

Not applicable. This is a passive medical device, not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set is relevant for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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.

January 23, 2024

Chemo Mouthpiece, LLC % Devjani Saha Director, Neurology Regulatory Affairs MCRA 803 7th Street, NW, 3rd Floor Washington, District of Columbia 20001

Re: K232917

Trade/Device Name: Chemo Mouthpiece Regulation Number: 21 CFR 872.5590 Regulation Name: Intraoral cooling device Regulatory Class: Class II Product Code: QUA Dated: December 14, 2023 Received: December 15, 2023

Dear Devjani Saha:

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 (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 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.

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).

{2}------------------------------------------------

Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K232917

Device Name Chemo Mouthpiece

Indications for Use (Describe)

The Chemo Mouthpiece is intended to be used to cool the oral mucosa to reduce the incidence and severity of chemotherapy induced oral mucositis in adult patients.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary

This 510(k) Summary is submitted in accordance with the requirement of 21 CFR 807.92.

510(k) Number:	K232917
Date Prepared:	December 14, 2023
Applicant:	Chemo Mouthpiece LLC10 Railroad AvenueCloster, NJ 07624David Yoskowitz, CEODYoskowitz@chemomouthpiece.com
Contact Person:	Devjani SahaDirector, Neurology Regulatory AffairsMCRA803 7th St, NW 3rd FloorWashington DC 20001

Device Classification

Trade/Device Name	Chemo Mouthpiece
Device Regulation Number:	21 CFR 872.5590
Device/Regulation Name:	Intraoral cooling device
Product Code:	QUA
Device Class/ RegulationClassification:	Class II

Device Description

Principles of Operation

The Chemo Mouthpiece device operates on the principle of conductive thermal heat exchange between the different layers of the device. The cold temperature of the device is maintained via conductive thermal exchange between the circulating saline solution in the outer chamber and the frozen water in the inner chamber. Placement of the device in the oral cavity initiates cryotherapy inducing temporary vasoconstriction reducing blood flow thereby decreasing the vascular delivery of chemotherapy agents to the oral mucosa hence preventing or reducing the incidence and severity of oral mucositis.

{5}------------------------------------------------

Indications for Use

Chemo Mouthpiece is an intraoral cryotherapy device. The Chemo Mouthpiece is intended to be used to cool the oral mucosa to reduce the incidence and severity of chemotherapy induced oral mucositis in adult patients.

Information	The CooralSystemDEN210027	ChemoMouthpieceK232917	ComparisonDiscussion
Regulation	21 CFR872.5590Intraoral coolingdevice	21 CFR 872.5590Intraoral coolingdevice	Same21 CFR 872.5590 describes an intraoralcooling device as "a prescription use devicethat is intended to cool the mouth forpatients to reduce the likelihood of oralmucositis. The device consists of aremovable mouthpiece that cools the oralmucosal surfaces".Similar to the proposed predicate, ChemoMouthpiece can be classified under thisregulation based on the following:It is a prescription use deviceIt is intended to cool the mouth ofpatients to reduce the likelihood oforal mucositis.The device consists of a removalmouthpiece that cools the oralmucosa surface.
Intended Use	Cool the oralmucosa toreduce thelikelihood oforal mucositis.	Cool the oralmucosa to reducethe likelihood oforal mucositis.	Same
Indications forUse (IFU)	The CooralSystem isintended to coolthe oral mucosaduringchemotherapytreatments toreduce thelikelihood andseverity ofchemotherapyinduced Oral	Chemo Mouthpieceis an intraoralcryotherapy device.The ChemoMouthpiece isintended to be usedtocool the oralmucosa to reducethe incidence andseverity ofchemotherapyinduced oral	Similar:The IFUs between the two devices areidentical except for the following:The Chemo Mouthpiece indicationsincludes the statement that it is anintraoral cryotherapy device. Thisstatement is in line with clinicalguidelines for oral mucositis (e.g.Multinational Association ofSupportive Cancer Care forManagement of Patients with OM
	Mucositis in adult patients.	mucositis in adult patients.	[MASCC]¹ and the NationalComprehensive Cancer Network[NCCN] Task Force²) whichcategorizes treatments used to coolthe oral mucosa duringchemotherapy delivery as "oralcryotherapy". This statement wasnot included in the predicate device,however it does not change theintended use (e.g. cooling of theoral mucosa for reducing thelikelihood of OM) and insteadfurther supports it.- Cooral system specifies that thedevice should be used duringchemotherapy treatments.However, the footprint of theChemo Mouthpiece device is muchsmaller and was designed to beportable and easy to use by patientsin their own homes. As such theChemo Mouthpiece is intended tobe used not only when patients arereceiving their chemotherapyregimens but also at homefollowing their infusion. Thisdifference in the indications for usedoes not change the intended use.- The proposed indications forChemo Mouthpiece replaces theterm likelihood (from the predicateindications) with the wordincidence. The term incidence andlikelihood are synonymous and themodification does not introduce anew intended use.
Principal of Operation	coolingtechnology thatallows for heattransfer betweenthe mouthpieceand the oralmucosa therebycooling the oralmucosa	cooling technologythat allows for heattransfer between themouthpiece and theoral mucosa therebycooling the oralmucosa	Same:Both devices use the same principal ofoperation based on heat transfer and localvasoconstriction thereby reducingstomatotoxic levels of chemotherapy in theoral mucosa.
			Different
Device Design	The CooralSystem is aclosed conduitsystem whichcontinuouslycirculates waterdelivered by athermostat unit.The water iscirculatedthrough aremovalmouthpiece thatis inserted intothe patient'smouth duringinfusion.	The ChemoMouthpiece is apassive device thathas no electricalcircuitry orsoftware/firmwarecomponents.Instead, patientssqueeze the outerchamber of thedevice to circulatecold saline solutionover a frozen innerchamber andthroughout themouthpiece that isplaced in patient'smouth.	The Cooral System includes electroniccircuitry and firmware. In contrast theChemo Mouthpiece is a completely passivedevice without any electrical orsoftware/firmware components. TheChemo Mouthpiece also has a smaller formfactor than the predicate device whichallows the device to be used at homefollowing infusion.These differences in device design do notraise new questions of safety andeffectiveness since both devices operateunder the same principle of operation. Theability of the Chemo Mouthpiece design toresult in sufficient cooling to reduce thelikelihood of oral mucositis is supported bythe results of performance testing.
NonclinicalPerformanceTesting	BiocompatibilityassessmentThermal testingto evaluatecoolingconsistency andperformance.Testing todemonstratematerialintegrity.Device designverification andvalidationtesting.Electromagneticcompatibilityand ElectricalSafety testingSoftwareverification andvalidation	BiocompatibilityassessmentThermal testing toevaluate coolingconsistency andperformance.Testing todemonstratematerial integrity.Device designverification andvalidation testing.	DifferentBoth devices underwent testing tocharacterize the cooling consistency,material integrity, and biocompatibilityrisks associated with the device. However,unlike the predicate device the ChemoMouthpiece does not include electricalcircuitry or software. As such, EMC,electrical safety, and software verificationand validation were not needed for theChemo Mouthpiece.
Non-Clinical Performance Tests
Test	Overview Summary	Results and Conclusions
Device Cooling Test	Thermal testing was performed tocharacterize the cooling capacity ofthe Chemo Mouthpiece.	Pass - The results indicated that the ChemoMouthpiece met its design specifications anddemonstrated surface temperatures that werecooler than that of the predicate device.
MechanicalIntegrity Testing	Mechanical integrity testing wasconducted to evaluate the mechanicaldurability of the device.	Pass – The results indicated that the ChemoMouthpiece device design met its mechanicalintegrity requirements when used understimulated worst case conditions.
Shelf Life and PackageIntegrity Testing	Shelf life and package integrity testingwere conducted following acceleratedaging to support a 24 month shelf-life.	Pass: Results indicated that followingaccelerated aging package seal met itsdesign requirements and thermal testingon the aged samples indicated that thedevice continued to meet its designspecifications in terms of its coolingcapacity.

Substantial Equivalence Summary

{6}------------------------------------------------

් Elad S, Cheng KKF, Lalla RV, et al; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28. Erratum in: Cancer. 2021 Oct 1;127(19):3700. PMID: 32786044; PMCID: PMC7540329

2 Bensinger et al. (2008); National Comprehensive Cancer Network (NCCN) Task Force Report: Prevention and Management of -Mucositis in Cancer Care. Journal of National Comprehensive Cancer Network . Vol 6. Supplement 1.

{7}------------------------------------------------

{8}------------------------------------------------

Summary of Performance Testing and Standards

The following performance data were provided in support of the substantial equivalence determination for the Chemo Mouthpiece device. Performance testing of the subject device was conducted to demonstrate that the device meets its performance specifications. Results of design verification and validation activities did not raise any new or different questions of safety or effectiveness. The risk management process was used throughout the non-clinical verification activities in accordance with ISO 14971. The following tests/analysis were conducted.

Biocompatibility
Biocompatibility Overview	Conclusions
Components tested: Chemo Mouthpiece base	Pass - Patient contacting component
Patient Contacting Material: Silicone, PVC, and polypropylene	was found to be biocompatible.
Tissue Contacting: Surface Device – Breached or Compromised Surfaces
Duration of Contact: Prolonged exposure
Biocompatibiltiy Assessments: Cytotoxicity per USI 10993-5, Annex 5;
Sensitization per ISO 10993-10, Irritation per ISO 10993-10 Annex B.3,
Acute Systemic per ISO 10993-11 and Pyrogenicity per USP<151>

{9}------------------------------------------------

Basis for Determination of Substantial Equivalence

The subject device and predicate devices have the same intended use, device regulation number/name/identification and product codes. The differences in the Indications for Use and technological characteristics between the subject device, Chemo Mouthpiece and the predicate the Cooral System do not raise new questions regarding safety and effectiveness.

Substantial Equivalence Conclusion

Conclusions drawn from the nonclinical testing demonstrate the device is as safe and effective as the predicate device. The subject and predicate devices have the same intended use. The Chemo Mouthpiece is substantially equivalent to the predicate device.

Regulation Number and Section

N/A