(126 days)
Not Found
No
The device description explicitly states it is "completely passive" with "no electrical components" and relies on manual circulation of cold saline solution. There is no mention of AI, ML, or any computational processing in the device description or performance studies.
Yes
The device is intended to cool the oral mucosa to reduce the incidence and severity of chemotherapy-induced oral mucositis, which is a therapeutic purpose.
No
The device is designed to prevent or reduce the severity of a condition (oral mucositis) through cooling, not to diagnose a particular condition or disease.
No
The device description explicitly states it is a "completely passive" device with "no electrical components" and describes a physical mouthpiece that is frozen and manually squeezed to circulate cold saline. This indicates a hardware-based device, not software-only.
Based on the provided information, the Chemo Mouthpiece is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Chemo Mouthpiece Function: The Chemo Mouthpiece is a physical device that is placed inside the patient's mouth to cool the oral mucosa. It does not collect, prepare, or examine any specimens from the body. Its function is a direct physical intervention (cryotherapy) to reduce the incidence and severity of oral mucositis.
- Intended Use: The intended use clearly states it's for "cooling the oral mucosa to reduce the incidence and severity of chemotherapy induced oral mucositis." This is a therapeutic or preventative action, not a diagnostic one.
- Device Description: The description details a passive device that uses frozen water and cold saline solution for cooling. This aligns with a physical therapy or intervention device, not an IVD.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Chemo Mouthpiece falls under the category of a therapeutic or preventative medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
QUA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral mucosa / oral cavity
Indicated Patient Age Range
adult patients
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)
- Device Cooling Test: Thermal testing was performed to characterize the cooling capacity of the Chemo Mouthpiece. Results indicated that the Chemo Mouthpiece met its design specifications and demonstrated surface temperatures that were cooler than that of the predicate device.
- Mechanical Integrity Testing: Mechanical integrity testing was conducted to evaluate the mechanical durability of the device. Results indicated that the Chemo Mouthpiece device design met its mechanical integrity requirements when used under stimulated worst case conditions.
- Shelf Life and Package Integrity Testing: Shelf life and package integrity testing were conducted following accelerated aging to support a 24 month shelf-life. 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.
- Biocompatibility Assessment: Biocompatibility evaluation (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) was performed on patient contacting components made of Silicone, PVC, and polypropylene. The patient contacting component was found to be biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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)
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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 LLC |
| 10 Railroad Avenue | |
| Closter, NJ 07624 | |
| David Yoskowitz, CEO | |
| DYoskowitz@chemomouthpiece.com | |
| Contact Person: | Devjani Saha |
| Director, Neurology Regulatory Affairs | |
| MCRA | |
| 803 7th St, NW 3rd Floor | |
| 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 | |
| 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.
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 Cooral
System
DEN210027 | Chemo
Mouthpiece
K232917 | Comparison
Discussion |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 CFR
872.5590
Intraoral cooling
device | 21 CFR 872.5590
Intraoral cooling
device | Same
21 CFR 872.5590 describes an intraoral
cooling device as "a prescription use device
that is intended to cool the mouth for
patients to reduce the likelihood of oral
mucositis. The device consists of a
removable mouthpiece that cools the oral
mucosal surfaces".
Similar to the proposed predicate, Chemo
Mouthpiece can be classified under this
regulation based on the following:
It is a prescription use deviceIt is intended to cool the mouth of
patients to reduce the likelihood of
oral mucositis.The device consists of a removal
mouthpiece that cools the oral
mucosa surface. |
| Intended Use | Cool the oral
mucosa to
reduce the
likelihood of
oral mucositis. | Cool the oral
mucosa to reduce
the likelihood of
oral mucositis. | Same |
| Indications for
Use (IFU) | The Cooral
System is
intended to cool
the oral mucosa
during
chemotherapy
treatments to
reduce the
likelihood and
severity of
chemotherapy
induced Oral | 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 | Similar:
The IFUs between the two devices are
identical except for the following:
The Chemo Mouthpiece indications
includes the statement that it is an
intraoral cryotherapy device. This
statement is in line with clinical
guidelines for oral mucositis (e.g.
Multinational Association of
Supportive Cancer Care for
Management of Patients with OM |
| | Mucositis in adult patients. | mucositis in adult patients. | [MASCC]¹ and the National
Comprehensive Cancer Network
[NCCN] Task Force²) which
categorizes treatments used to cool
the oral mucosa during
chemotherapy delivery as "oral
cryotherapy". This statement was
not included in the predicate device,
however it does not change the
intended use (e.g. cooling of the
oral mucosa for reducing the
likelihood of OM) and instead
further supports it.
- Cooral system specifies that the
device should be used during
chemotherapy treatments.
However, the footprint of the
Chemo Mouthpiece device is much
smaller and was designed to be
portable and easy to use by patients
in their own homes. As such the
Chemo Mouthpiece is intended to
be used not only when patients are
receiving their chemotherapy
regimens but also at home
following their infusion. This
difference in the indications for use
does not change the intended use. - The proposed indications for
Chemo Mouthpiece replaces the
term likelihood (from the predicate
indications) with the word
incidence. The term incidence and
likelihood are synonymous and the
modification does not introduce a
new intended use. |
| Principal of Operation | cooling
technology that
allows for heat
transfer between
the mouthpiece
and the oral
mucosa thereby
cooling the oral
mucosa | cooling technology
that allows for heat
transfer between the
mouthpiece and the
oral mucosa thereby
cooling the oral
mucosa | Same:
Both devices use the same principal of
operation based on heat transfer and local
vasoconstriction thereby reducing
stomatotoxic levels of chemotherapy in the
oral mucosa. |
| | | | Different |
| Device Design | The Cooral
System is a
closed conduit
system which
continuously
circulates water
delivered by a
thermostat unit.
The water is
circulated
through a
removal
mouthpiece that
is inserted into
the patient's
mouth during
infusion. | The Chemo
Mouthpiece is a
passive device that
has no electrical
circuitry or
software/firmware
components.
Instead, patients
squeeze the outer
chamber of the
device to circulate
cold saline solution
over a frozen inner
chamber and
throughout the
mouthpiece that is
placed in patient's
mouth. | The Cooral System includes electronic
circuitry and firmware. In contrast the
Chemo Mouthpiece is a completely passive
device without any electrical or
software/firmware components. The
Chemo Mouthpiece also has a smaller form
factor than the predicate device which
allows the device to be used at home
following infusion.
These differences in device design do not
raise new questions of safety and
effectiveness since both devices operate
under the same principle of operation. The
ability of the Chemo Mouthpiece design to
result in sufficient cooling to reduce the
likelihood of oral mucositis is supported by
the results of performance testing. |
| Nonclinical
Performance
Testing | Biocompatibility
assessment
Thermal testing
to evaluate
cooling
consistency and
performance.
Testing to
demonstrate
material
integrity.
Device design
verification and
validation
testing.
Electromagnetic
compatibility
and Electrical
Safety testing
Software
verification and
validation | Biocompatibility
assessment
Thermal testing to
evaluate cooling
consistency and
performance.
Testing to
demonstrate
material integrity.
Device design
verification and
validation testing. | Different
Both devices underwent testing to
characterize the cooling consistency,
material integrity, and biocompatibility
risks associated with the device. However,
unlike the predicate device the Chemo
Mouthpiece does not include electrical
circuitry or software. As such, EMC,
electrical safety, and software verification
and validation were not needed for the
Chemo Mouthpiece. |
| Non-Clinical Performance Tests | | | |
| Test | Overview Summary | Results and Conclusions | |
| Device Cooling Test | Thermal testing was performed to
characterize the cooling capacity of
the Chemo Mouthpiece. | Pass - The results indicated that the Chemo
Mouthpiece met its design specifications and
demonstrated surface temperatures that were
cooler than that of the predicate device. | |
| Mechanical
Integrity Testing | Mechanical integrity testing was
conducted to evaluate the mechanical
durability of the device. | Pass – The results indicated that the Chemo
Mouthpiece device design met its mechanical
integrity requirements when used under
stimulated worst case conditions. | |
| Shelf Life and Package
Integrity Testing | Shelf life and package integrity testing
were conducted following accelerated
aging to support a 24 month shelf-life. | Pass: 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. | |
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 |
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.