(82 days)
Not Found
No
The device description and performance studies focus on mechanical positioning and shielding, with no mention of AI or ML algorithms for analysis, prediction, or image processing.
No.
The device is used to position and immobilize a patient's tongue and jaw during external beam radiation therapy, and to provide shielding, but it does not directly treat or cure cancer or other diseases. It is an accessory to a therapeutic procedure rather than a therapeutic device itself.
No
The device is described as a custom tongue and jaw positioner used for immobilization during radiation therapy and for shielding. Its purpose is to facilitate treatment, not to diagnose a condition.
No
The device description clearly states it is a custom-fitted bite block made of injection molded plastic and EVA, which are physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or states of health by testing samples like blood, urine, tissue, etc.
- The GrayDuck Stent is a physical device used to position and immobilize a patient's tongue and jaw. It is used directly on the patient during radiation therapy.
The intended use and device description clearly indicate that the GrayDuck Stent is a medical device used for patient positioning and shielding during external beam radiation therapy, not for testing biological samples.
N/A
Intended Use / Indications for Use
The GrayDuck Stent™ custom tongue and jaw positioner from POLL Medical LLC is intended to be used for repeat positioning and immobilization of a patient's tongue and jaw while undergoing or receiving a course of external beam radiation therapy for treatment of cancer and other diseases. The GrayDuck Stent is intended to be used by or under the direction of a licensed physician.
Product codes
IYE
Device Description
The GrayDuck Stent™ custom tongue and jaw positioner from POLL Medical is design to provide reproducible opening of the jaw and positioning of the tongue for a patient undergoing external beam radiation therapy treatment. In addition, the GrayDuck Stent provides shielding against secondary low-energy backscatter radiation emitted from metal fillings and bridgework. The stent is a custom-fitted bite block with a boil-and-bite insert that allows for formation of dental impressions for repeatable positioning. The Stent is made of an injection molded plastic material with moldable EVA bite inserts. The GrayDuck Stent is available in two sizes. The patient's tongue can be deviated laterally left, laterally right, downward (depressed), or a combination of laterally left/depressing or laterally right/depressing by using one of the GrayDuck Stent tongue paddles, which allows many degrees of freedom in positioning the patient's tongue and jaw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's tongue and jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed physician / Clinic / Hospital Use
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
Non-Clinical Testing - The application includes detailed discussions of nonclinical testing. In all instances, the GrayDuck device preformed as intended. Biocompatibility testing was performed, demonstrating that the plastic polymer of the main stent body and the EVA thermoplastic insert are acceptable based on the contact category for the GrayDuck Stent. Attenuation testing was done to determine the GrayDuck Stent's backscatter shielding performance. The dose ratio for both high-energy photon beam levels tested (6 MeV and 18 MeV) were just below 1, demonstrating shielding performance similar to that of the predicate. An EVA dental impression depth comparison test was completed to verify that dental arch impression depth is not significantly affected by the bite timeframe. The GrayDuck Stent produces similar impression depth when comparing its current timeframe to the longer timeframe given in the predicate device's instructions for use. The nonclinical evaluates provide evidence of the GrayDuck Stent's safety and effectiveness when used as intended. Clinical Testing - Clinical testing is not included in this submission
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 26, 2019
POLL Medical LLC % Ms. Alyssa Thomas Principal Consultant Allegiance Regulatory Consulting LLC 16642 SW Lansford Ct. BEAVERTON OR 97007
Re: K183374
Trade/Device Name: GrayDuck Stent™ Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: February 6, 2019 Received: February 8, 2019
Dear Ms. Thomas:
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 (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D.'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name GrayDuck Stent™
Indications for Use (Describe)
The GrayDuck Stent™ custom tongue and jaw positioner from POLL Medical LLC is intended to be used for repeat positioning and immobilization of a patient's tongue and jaw while undergoing or receiving a course of external beam radiation therapy for treatment of cancer and other diseases. The GrayDuck Stent is intended to be used by or under the direction of a licensed physician.
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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5. 510(K) SUMMARY OR 510(K) STATEMENT
Please see the 510(k) Summary, as required by 21 CFR 807.92 (c), for the GrayDuck Stent device following this page.
4
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA (Safe Medical Devices Act) 1990 and 21 CFR 807.92.
K183374 The assigned 510(k) number is:
5.1. Submitter Contact Information
| Name: | POLL Medical |
|---|---|
| Address: | 8630 SW Scholls Ferry Road, Suite 22 |
| Beaverton, OR 97008, USA | |
| Phone: | 503-319-3096 |
| Fax: | 971-217-9004 |
| Contact: | Adrian Polliack, PhD |
| Date Prepared: | November 27, 2018 |
5.2. Device Identification
| Trade Name: | GrayDuck Stent™ |
|---|---|
| Common Name: | Bite Block (positioner) |
| Classification Name: | Patient Support Accessory to Accelerator, Linear, Medical |
| Regulatory Class: | 892.5050 |
| Product Code: | IYE |
5.3. Legally Marketed Predicate Device
K153270 Bionix Development Corporation's TruGuard Custom Tongue and Jaw Positioner
5.4. Device Description
The GrayDuck Stent™ custom tongue and jaw positioner from POLL Medical is design to provide reproducible opening of the jaw and positioning of the tongue for a patient undergoing external beam radiation therapy treatment. In addition, the GrayDuck Stent provides shielding against secondary low-energy backscatter radiation emitted from
5
metal fillings and bridgework. The stent is a custom-fitted bite block with a boil-and-bite insert that allows for formation of dental impressions for repeatable positioning. The Stent is made of an injection molded plastic material with moldable EVA bite inserts. The GrayDuck Stent is available in two sizes. The patient's tongue can be deviated laterally left, laterally right, downward (depressed), or a combination of laterally left/depressing or laterally right/depressing by using one of the GrayDuck Stent tongue paddles, which allows many degrees of freedom in positioning the patient's tongue and jaw.
5.5. Intended Use/Indications for Use
Intended Use: The GrayDuck Stent is intended to provide repeatable positioning and immobilization of a patient's tongue and jaw during external beam radiation therapy treatment.
Indication for Use: The GrayDuck Stent custom tongue and jaw positioner from POLL Medical LLC is intended to be used for repeat positioning and immobilization of a patient's tongue and jaw while undergoing or receiving a course of external beam radiation therapy for treatment of cancer and other diseases. The GrayDuck Stent is intended to be used by or under the direction of a licensed physician.
5.6. Summary of Technological Characteristics
The GrayDuck Stent is a custom-fitted bite block with a boil-and-bite insert that allows for the formation of dental impressions for repeatable positioning and immobilization of a patient's jaw and tongue. By using the patient's unique dental impressions of both upper and lower teeth (dental arches), the GrayDuck Stent is fit reproducibly for each successive radiation therapy treatment. The boil-and-bite insert material is used in both the subject device and the predicate (the TruGuard device). The GrayDuck Stent is available in multiple sizes and includes tongue paddles for positioning and immobilizing the patient's tongue. With the adjustable tongue paddles and variation in sizes, the GrayDuck sent allows the jaw to be held open at pre-set angles and the tongue to be deviated away from the treatment area. The TruGuard uses similar technology, a plastic indexing tab and tongue depressor to achieve the pre-set angle and tongue depression. The GrayDuck Stent provides additional range of tongue deviation through the selection of either a Right, Left or Depressing paddle. The additional flexibility create by the paddle options provides clinicians more choices to help ensure the patient's tongue is positioned away from the radiation treatment area. Similar to the TruGuard's indexing tab that allows the jaw to be held open at pre-set angles, the GrayDuck Stent size options
6
allow variation in the pre-set angle of the jaw. A table comparing the key features of the subject device and the predicate device is provided below (Error! Reference source not found.).
| Device | GrayDuck Stent | TruGuard Custom Tongue &
Jaw Positioner
(K153270) |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The GrayDuck Stent is intended to
provide repeatable positioning and
immobilization of a patient's
tongue and jaw during external
beam radiation therapy treatment. | Repeat positioning and
immobilization of patients
receiving external beam radiation. |
| Indication for Use | The GrayDuck Stent™ custom
tongue and jaw positioner from
POLL Medical LLC is intended to
be used for repeat positioning and
immobilization of a patient's
tongue and jaw while undergoing
or receiving a course of external
beam radiation therapy for
treatment of cancer and other
diseases. The GrayDuck Stent is
intended to be used by or under the
direction of a licensed physician. | The TruGuard Custom Tongue and
Jaw Positioner from Bionix
Development Corporation is
intended to be used for repeat
positioning and immobilization of
patients undergoing or receiving a
course of external beam radiation
therapy for treatment of cancer and
other diseases. It is intended to be
used by or under the direction of a
licensed physician. |
| Clinical Application | Radiation Therapy Treatment | Radiation Therapy Treatment |
| Clinical Setting/Site
of Use | Prescription Device for Clinic /
Hospital Use | Prescription Device for Clinic /
Hospital Use |
| Technology Characteristics | | |
| Material - Arch
Trays (Main Stent)
& Tongue
Deviation
Components | Molded Plastic | Molded Plastic |
| Material - Dental
Impression Insert | Moldable EVA (ethylene vinyl
acetate) Thermoplastic | Moldable EVA Thermoplastic |
| Dual Bite Trays | Yes | Yes |
| Allows for Open
Jaw Positioning | Yes | Yes |
| Principles of Operation & Performance | | |
| Procedure for Initial
Patient Fitting | Yes | Yes |
| Reproducible
Patient Positioning | Yes | Yes |
| Device | GrayDuck Stent
(Subject Device) | TruGuard Custom Tongue & Jaw Positioner
(K153270) |
| Positions the Tongue | Yes | Yes |
| Attaches to Face Mask | Yes | Yes |
| Shielding from Backscatter Radiation | Yes | Yes |
| MRI Safe | Yes | Yes |
Table 5-1 Subject & Predicate Device Comparison
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5.7. Performance Data
Non-Clinical Testing - The application includes detailed discussions of nonclinical testing. In all instances, the GrayDuck device preformed as intended. Biocompatibility testing was performed, demonstrating that the plastic polymer of the main stent body and the EVA thermoplastic insert are acceptable based on the contact category for the GrayDuck Stent. Attenuation testing was done to determine the GrayDuck Stent's backscatter shielding performance. The dose ratio for both high-energy photon beam levels tested (6 MeV and 18 MeV) were just below 1, demonstrating shielding performance similar to that of the predicate. An EVA dental impression depth comparison test was completed to verify that dental arch impression depth is not significantly affected by the bite timeframe. The GrayDuck Stent produces similar impression depth when comparing its current timeframe to the longer timeframe given in the predicate device's instructions for use. The nonclinical evaluates provide evidence of the GrayDuck Stent's safety and effectiveness when used as intended.
Clinical Testing - Clinical testing is not included in this submission
5.8. Substantial Equivalence
The GrayDuck Stent is as safe and effective as the predicate, the TruGuard Custom Tongue and Jaw Positioner. The GrayDuck Stent has the same intended uses and indications for use as the predicate device. The GrayDuck Stent has similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the GrayDuck Stent and its predicate devices raise no new issues of safety or effectiveness. The Performance data demonstrates that the GrayDuck is as safe and effective as the TruGuard. Thus, the GrayDuck is substantially equivalent.
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5.9. Conclusions
Conclusions drawn from the comparison to the predicate device and the nonclinical testing demonstrate that the GrayDuck Stent is as safe, as effective, and performs as well as or better than the predicate device.