Chemo Mouthpiece

K232917 · Chemo Mouthpiece, LLC · QUA · Jan 23, 2024 · Dental

Device Facts

• Record ID: K232917
• Device Name: Chemo Mouthpiece
• Applicant: Chemo Mouthpiece, LLC
• Product Code: QUA · Dental
• Decision Date: Jan 23, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Intraoral cryotherapy device; reduces oral mucosa temperature to induce temporary vasoconstriction; decreases vascular delivery of chemotherapy agents to oral mucosa; prevents/reduces oral mucositis. Passive device; no electrical/software components. User freezes device in standard freezer (min 6 hours); inner chamber contains frozen water; outer chamber contains saline solution. User places device in oral cavity; squeezes outer chamber to circulate cold saline around frozen inner chamber; integrated breathing tubes allow breathing during use. Used by patients at home or during infusion. Healthcare provider monitors patient outcomes; device provides prophylactic benefit.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-5, -10, -11; USP <151>), thermal performance (cooling capacity), mechanical integrity, and shelf-life/package integrity (24-month claim). Results demonstrated the device met design specifications and performed effectively under simulated worst-case conditions.

Technological Characteristics

Passive intraoral cooling device; materials include silicone, PVC, and polypropylene. Operates via conductive thermal heat exchange between frozen water inner chamber and circulating saline outer chamber. No electrical components, software, or firmware. Dimensions/form factor designed for portability and home use. Sterilization not specified; biocompatibility per ISO 10993 series.

Indications for Use

Indicated for adult patients undergoing chemotherapy to cool the oral mucosa and reduce the incidence and severity of chemotherapy-induced oral mucositis.

Regulatory Classification

Identification

The Cooral System is an intraoral cooling device, which is a prescription device intended to cool the oral mucosa during chemotherapy treatments to reduce the likelihood and severity of chemotherapy-induced oral mucositis in adult patients. The device consists of an energy control unit (ECU 200) with a computerized control system, plastic tubing, and a removable intraoral mouthpiece that circulates sterile water coolant to cool the oral mucosal surfaces.

Special Controls

In combination with the general controls of the FD&C Act, the intraoral cooling device is subject to the following special controls: - (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: - Thermal testing to evaluate cooling consistency and performance; and (i) - Physical Testing of the device to demonstrate material integrity. (ii) - (2) Electromagnetic compatibility (EMC) and electrical safety testing must be performed for any electrical components. - Software verification, validation, and hazard analysis must be performed for any software (3) components of the device. - (4) The patient contacting components of the device must be demonstrated to be biocompatible. - Labeling must include the following: (5) - (i) A summary of the device specifications, including temperature cooling range and duration of cooling; and - (ii) Instructions to stop the use of the device if skin irritation or sensitivities develop, or if the device leaks or does not maintain its material integrity.

Predicate Devices

• The Cooral System (DEN210027)

Submission Summary (Full Text)

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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.

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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 (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 ([e-mail]) or phone [phone] or 301-796-7100).

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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

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# 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)

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## 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 LLC<br>10 Railroad Avenue<br>Closter, NJ 07624<br>David Yoskowitz, CEO<br>[e-mail] |
| Contact Person: | Devjani Saha<br>Director, Neurology Regulatory Affairs<br>MCRA<br>803 7th St, NW 3rd Floor<br>Washington 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/ Regulation<br>Classification: | Class II |

#### 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.

### 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.

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### 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 Cooral<br>System<br>DEN210027 | Chemo<br>Mouthpiece<br>K232917 | Comparison<br>Discussion |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 CFR<br>872.5590<br>Intraoral cooling<br>device | 21 CFR 872.5590<br>Intraoral cooling<br>device | Same<br>21 CFR 872.5590 describes an intraoral<br>cooling device as "a prescription use device<br>that is intended to cool the mouth for<br>patients to reduce the likelihood of oral<br>mucositis. The device consists of a<br>removable mouthpiece that cools the oral<br>mucosal surfaces".<br>Similar to the proposed predicate, Chemo<br>Mouthpiece can be classified under this<br>regulation based on the following:<br>It is a prescription use deviceIt is intended to cool the mouth of<br>patients to reduce the likelihood of<br>oral mucositis.The device consists of a removal<br>mouthpiece that cools the oral<br>mucosa surface. |
| Intended Use | Cool the oral<br>mucosa to<br>reduce the<br>likelihood of<br>oral mucositis. | Cool the oral<br>mucosa to reduce<br>the likelihood of<br>oral mucositis. | Same |
| Indications for<br>Use (IFU) | The Cooral<br>System is<br>intended to cool<br>the oral mucosa<br>during<br>chemotherapy<br>treatments to<br>reduce the<br>likelihood and<br>severity of<br>chemotherapy<br>induced Oral | Chemo Mouthpiece<br>is an intraoral<br>cryotherapy device.<br>The Chemo<br>Mouthpiece is<br>intended to be used<br>to<br>cool the oral<br>mucosa to reduce<br>the incidence and<br>severity of<br>chemotherapy<br>induced oral | Similar:<br>The IFUs between the two devices are<br>identical except for the following:<br>The Chemo Mouthpiece indications<br>includes the statement that it is an<br>intraoral cryotherapy device. This<br>statement is in line with clinical<br>guidelines for oral mucositis (e.g.<br>Multinational Association of<br>Supportive Cancer Care for<br>Management of Patients with OM |
| | Mucositis in adult patients. | mucositis in adult patients. | [MASCC]¹ and the National<br>Comprehensive Cancer Network<br>[NCCN] Task Force²) which<br>categorizes treatments used to cool<br>the oral mucosa during<br>chemotherapy delivery as "oral<br>cryotherapy". This statement was<br>not included in the predicate device,<br>however it does not change the<br>intended use (e.g. cooling of the<br>oral mucosa for reducing the<br>likelihood of OM) and instead<br>further supports it.<br>- Cooral system specifies that the<br>device should be used during<br>chemotherapy treatments.<br>However, the footprint of the<br>Chemo Mouthpiece device is much<br>smaller and was designed to be<br>portable and easy to use by patients<br>in their own homes. As such the<br>Chemo Mouthpiece is intended to<br>be used not only when patients are<br>receiving their chemotherapy<br>regimens but also at home<br>following their infusion. This<br>difference in the indications for use<br>does not change the intended use.<br>- The proposed indications for<br>Chemo Mouthpiece replaces the<br>term likelihood (from the predicate<br>indications) with the word<br>incidence. The term incidence and<br>likelihood are synonymous and the<br>modification does not introduce a<br>new intended use. |
| Principal of Operation | cooling<br>technology that<br>allows for heat<br>transfer between<br>the mouthpiece<br>and the oral<br>mucosa thereby<br>cooling the oral<br>mucosa | cooling technology<br>that allows for heat<br>transfer between the<br>mouthpiece and the<br>oral mucosa thereby<br>cooling the oral<br>mucosa | Same:<br>Both devices use the same principal of<br>operation based on heat transfer and local<br>vasoconstriction thereby reducing<br>stomatotoxic levels of chemotherapy in the<br>oral mucosa. |
| | | | Different |
| Device Design | The Cooral<br>System is a<br>closed conduit<br>system which<br>continuously<br>circulates water<br>delivered by a<br>thermostat unit.<br>The water is<br>circulated<br>through a<br>removal<br>mouthpiece that<br>is inserted into<br>the patient's<br>mouth during<br>infusion. | The Chemo<br>Mouthpiece is a<br>passive device that<br>has no electrical<br>circuitry or<br>software/firmware<br>components.<br>Instead, patients<br>squeeze the outer<br>chamber of the<br>device to circulate<br>cold saline solution<br>over a frozen inner<br>chamber and<br>throughout the<br>mouthpiece that is<br>placed in patient's<br>mouth. | The Cooral System includes electronic<br>circuitry and firmware. In contrast the<br>Chemo Mouthpiece is a completely passive<br>device without any electrical or<br>software/firmware components. The<br>Chemo Mouthpiece also has a smaller form<br>factor than the predicate device which<br>allows the device to be used at home<br>following infusion.<br>These differences in device design do not<br>raise new questions of safety and<br>effectiveness since both devices operate<br>under the same principle of operation. The<br>ability of the Chemo Mouthpiece design to<br>result in sufficient cooling to reduce the<br>likelihood of oral mucositis is supported by<br>the results of performance testing. |
| Nonclinical<br>Performance<br>Testing | Biocompatibility<br>assessment<br>Thermal testing<br>to evaluate<br>cooling<br>consistency and<br>performance.<br>Testing to<br>demonstrate<br>material<br>integrity.<br>Device design<br>verification and<br>validation<br>testing.<br>Electromagnetic<br>compatibility<br>and Electrical<br>Safety testing<br>Software<br>verification and<br>validation | Biocompatibility<br>assessment<br>Thermal testing to<br>evaluate cooling<br>consistency and<br>performance.<br>Testing to<br>demonstrate<br>material integrity.<br>Device design<br>verification and<br>validation testing. | Different<br>Both devices underwent testing to<br>characterize the cooling consistency,<br>material integrity, and biocompatibility<br>risks associated with the device. However,<br>unlike the predicate device the Chemo<br>Mouthpiece does not include electrical<br>circuitry or software. As such, EMC,<br>electrical safety, and software verification<br>and validation were not needed for the<br>Chemo Mouthpiece. |
| Non-Clinical Performance Tests | | | |
| Test | Overview Summary | Results and Conclusions | |
| Device Cooling Test | Thermal testing was performed to<br>characterize the cooling capacity of<br>the Chemo Mouthpiece. | Pass - The results indicated that the Chemo<br>Mouthpiece met its design specifications and<br>demonstrated surface temperatures that were<br>cooler than that of the predicate device. | |
| Mechanical<br>Integrity Testing | Mechanical integrity testing was<br>conducted to evaluate the mechanical<br>durability of the device. | Pass – The results indicated that the Chemo<br>Mouthpiece device design met its mechanical<br>integrity requirements when used under<br>stimulated worst case conditions. | |
| Shelf Life and Package<br>Integrity Testing | Shelf life and package integrity testing<br>were conducted following accelerated<br>aging to support a 24 month shelf-life. | Pass: Results indicated that following<br>accelerated aging package seal met its<br>design requirements and thermal testing<br>on the aged samples indicated that the<br>device continued to meet its design<br>specifications in terms of its cooling<br>capacity. | |

#### Substantial Equivalence Summary

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^් 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.

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### 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> | |

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## 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.