The kallisio Stentra™ oral stent is intended to be used for repeat positioning and immobilization of a patient's tongue and jaw while undergoing a course of external beam radiation therapy for treatment of cancer and other diseases. The kallisio Stentra oral stent is intended to be used by or under the direction of a licensed physician.

Device Description

The Kallisio Stentra Oral Stent is a single patient, reusable custom tongue and jaw positioner used for repeat positioning and immobilization of a patient's tongue and jaw while receiving a course of external beam radiation therapy for treatment of cancer and other diseases. Q-bite bite block accessories are supplied separately. The Stentra Stent is a prescription device.

AI/ML Overview

The Kallisio Stentra™ oral stent is a medical device intended for repeat positioning and immobilization of a patient's tongue and jaw during external beam radiation therapy. The provided text, however, is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical performance acceptance criteria and study results for the subject device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document, nor can I describe a study proving the device meets those criteria, as such specific clinical performance validation is not the primary purpose of this type of submission.

The document primarily discusses non-clinical testing to demonstrate performance characteristics and material safety compared to a predicate device.

Here's an analysis of the provided information based on the requested categories, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as it would be for a clinical trial establishing efficacy for a new device. The document summarizes non-clinical performance data to demonstrate substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable in the context of clinical performance for this 510(k) submission. The non-clinical testing involved "test units" for biocompatibility, corrosion-resistance, mechanical strength, and attenuation, but specific sample sizes for these tests are not detailed beyond "test units."
Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer or contracted labs. Country of origin is not specified, and they are inherently not retrospective or prospective clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as there is no mention of a human-read test set or ground truth establishment by experts in the context of clinical performance within this document. The non-clinical tests rely on established scientific methods and instrumental measurements.

4. Adjudication method for the test set:

This information is not applicable as there is no human-read test set or ground truth establishment by experts for adjudication.

5. 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:

This information is not applicable. The device is an oral stent for physical positioning and immobilization during radiation therapy, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study with human readers and AI assistance is irrelevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The Kallisio Stentra is a physical medical device, not a software algorithm.

7. The type of ground truth used:

This information is not applicable in the context of clinical "ground truth" for diagnostic accuracy. For the non-clinical tests mentioned:

Biocompatibility: Ground truth is established by "acceptable biocompatibility... for its intended contact category and duration" based on ISO 10993-1 guidelines.
Corrosion-resistance: Ground truth is the "absence of corrosion or surface changes" after specific immersion tests.
Mechanical strength: Ground truth is "no cracks or fractures" after applying a compressive load.
Attenuation: Ground truth is "similar shielding performance" compared to the predicate device.

8. The sample size for the training set:

This information is not applicable as this is a physical medical device, not an AI or software system that requires a "training set."

9. How the ground truth for the training set was established:

This information is not applicable as this is a physical medical device.

Summary of Non-Clinical Performance Data Provided (from Section VII):

The document provides a summary of non-clinical testing performed to support substantial equivalence.

Acceptance Criteria / Test	Reported Device Performance
Biocompatibility (per ISO 10993-1)	Demonstrated acceptable biocompatibility (including cytotoxicity, irritation, and sensitization) for its intended contact category and duration.
Corrosion-resistance (Simulated saliva + boiling water)	No evidence of corrosion or surface changes observed via gross and microscopic (20x) examination.
Mechanical Strength (2x max human jaw force)	No cracks or fractures observed via gross and microscopic (20x) examination after applying a compressive load 2x the maximum force a human jaw can apply. The material is strong enough to withstand significant force without structural damage.
Attenuation (6 MV photon beam)	Demonstrated similar shielding performance to that of the predicate device. This suggests similar radiation blocking capabilities, which is important for protecting healthy tissue away from the treatment area.

Study Details (Non-Clinical):

Type of Study: Non-clinical laboratory testing.
Objective: To demonstrate the safety and performance characteristics of the Kallisio Stentra oral stent.
Methodology:
- Biocompatibility: Tested in accordance with FDA Guidance Use of International Standard ISO 10993-1, including cytotoxicity, irritation, and sensitization.
- Corrosion-resistance: Test units immersed in a simulated saliva solution at body temperature, followed by immersion in boiling water. Visual and microscopic (20x) examination performed.
- Mechanical Strength: A compressive load 2x the maximum force applicable by a human jaw was applied to test units. Visual and microscopic (20x) examination performed.
- Attenuation: Performed with a 6 MV photon beam to assess shielding.
Sample Size: "Test units" were used; specific numbers are not detailed.
Ground Truth: Industry standards (ISO 10993-1) for biocompatibility, and observational/measurement-based outcomes (absence of damage/corrosion, similar attenuation) for the other tests.
Experts/Adjudication: Not applicable in the context of clinical ground truth or human interpretation; testing relies on laboratory procedures and measurements.

In conclusion, the provided document focuses on demonstrating that the Kallisio Stentra is substantially equivalent to a previously cleared device (GrayDuck Stent K183374) through non-clinical performance data and comparison of technological characteristics. It does not contain information about clinical acceptance criteria or studies with human subjects that would typically involve many of the requested categories.

Summary

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December 22, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

Kallisio, Inc % Mary Lou Mooney Consultant 2925 Richmond Ave., Suite 1200 HOUSTON, TX 77098

Re: K232293

Trade/Device Name: kallisio stentra™ oral stent Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: July 31, 2023 Received: August 1, 2023

Dear Mary Lou Mooney:

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.

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

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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 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-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).

Sincerely,

Locan Weidner

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K232293

Device Name kallisio Stentra Oral Stent

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary (as required by 21CFR 807.92)

I. SUBMITTER

Kallisio, Inc 2925 Richmond Ave, Suite 1200 Houston, TX 77098 Phone: 650-464-5335

Contact Person:	Mary Lou Mooney (Consultant)
Date Prepared:	November 24, 2023

II. DEVICE

Name of Device:	Kallisio Stentra™ OralStent
Common or Usual Name:	Bite Block (positioner)
Classification Name:	Accessory to Accelerator, Linear, Medica
Regulatory Class:	892.5050
Product Code:	IYE
III. PREDICATE DEVICE
Predicate Device:	GrayDuck Stent™ (K183374)

IV. DEVICE DESCRIPTION

The Stentra Stent is a prescription device.

V. INDICATIONS FOR USE

The Kallisio Stentra™ oral stent is intended to be used for repeat positioning and immobilization of a patient's tongue and jaw while undergoing a course of external beam radiation therapy for treatment of cancer and other diseases. The Kallisio Stentra oral stent is intended to be used by or under the direction of a licensed physician.

The Indication for Use for the Stent is identical to the predicate device.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject and predicate device are based on the following same technological elements:
o A custom-fitted polymeric stent positioned inside the mouth.
Positioning of the device to open and immobilize the jaw and deviate the tongue away o from the radiation area.

The following technological differences exist between the subject device and the predicate device:

Use of a different polymeric material. o
Method of customization. o

Description	Kallisio Stentra(subject device)	GrayDuck StentK183374(predicate device)	Compared toSubjectDevice
Intended Use	Intended to providerepeat positioningand immobilizationof a patient'stongue and jaw.	Intended to providerepeat positioningand immobilizationof a patient'stongue and jaw.	Same
Indication forUse	Repeat positioningand immobilizationof a patient'stongue and jawwhile undergoing acourse of externalbeam radiationtherapy fortreatment of cancerand other diseases.	Repeat positioningand immobilizationof a patient'stongue and jawwhile undergoing acourse of externalbeam radiationtherapy fortreatment of cancerand other diseases.	Same
Target Population	Patientsundergoingexternal beamradiation therapyfor treatment ofcancer and otherdiseases.	Patients undergoingexternal beamradiation therapyfor treatment ofcancer and otherdiseases.	Same
Principles ofOperation	Device is insertedinto the mouth toopen andimmobilize the jawand deviate the	Device is insertedinto the mouth toopen andimmobilize the jawand deviate the	Same
Description	Kallisio Stentra(subject device)	GrayDuck Stent K183374(predicate device)	Compared to Subject Device
	tongue away from the treatment area.	tongue away from the treatment area.
Technology	Polymeric stent positioned inside the mouth	Polymeric stent positioned inside the mouth	Same
Clinical Setting/Site of Use	Prescription device for clinic/hospital use	Prescription device for clinic/hospital use	Same
Custom-fitted to Patient?	Yes	Yes	Same
Material	Polymeric material(nylon)	Polymeric material(Molded plastic, moldable EVA (ethylene vinyl acetate)	Similar
Patient Use	Single patient, multi-use	Single patient, multi-use	Same
Supplied Sterile/Non Sterile?	Supplied non-sterile	Supplied non-sterile	Same
Allows for jaw positioning?	Yes	Yes	Same
Positions the tongue?	Yes, allows the tongue to be positioned to the left, right, downward or upward.	Yes, allows tongue to be positioned to the left, right or downward.	Same, with the additional flexibility to position the tongue upward.
Attaches to a radiotherapy face mask?	Yes	Yes	Same
Shielding from backscatter radiation?	Yes	Yes	Non-clinical testing of subject device performed with 6MV photon beam. Predicate device non-clinical testing performed with 6MV and
Description	Kallisio Stentra(subject device)	GrayDuck StentK183374(predicate device)	Compared toSubjectDevice
			18 MVphoton beam.

Subject and Predicate Device Comparison

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VII. PERFORMANCE DATA

Non-Clinical Testing

Biocompatibility testing was conducted in accordance with FDA Guidance Use of International Standard ISO 10993-1. "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Biocompatibility testing included cytotoxicity, irritation and sensitization. Results demonstrated acceptable biocompatibility of the Stentra device for its intended contact category and duration.

Performance testing assessed corrosion-resistance and device mechanical strength. Test units were immersed in a simulated saliva solution at body temperature followed by immersion in boiling water. Gross and microscopic (20x) examination of the Stentra device showed no evidence of corrosion or surface changes. Device mechanical strength was demonstrated by applying a compressive load to the device that is 2x the maximum force that can be applied by a human jaw. Gross and microscopic (20x) examination of the Stentra device showed no cracks or fractures. Attenuation testing with a 6 MV photon beam demonstrated similar shielding performance to that of the predicate device.

CONCLUSIONS VIII.

The similarity of design, features, composition and the non-clinical test results demonstrate that the subject device is substantially equivalent to the predicate device for repeat positioning and immobilization of the jaw and tongue during external beam radiation for cancer and other diseases.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.