(116 days)
Not Found
No
The summary describes a physical device for patient positioning and immobilization during radiation therapy. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The manufacturing process uses 3D printing, but this is a fabrication method, not an AI/ML application.
No.
The device is used for positioning and immobilization during radiation therapy, which is a treatment, but the device itself does not deliver the therapy or directly treat the disease. It facilitates the treatment.
No
Explanation: The device is described as a "BiteBlock" intended for repeat positioning and immobilization of patients during external beam radiation therapy. Its purpose is to physically aid in treatment delivery, not to diagnose a condition or disease.
No
The device description explicitly states it is a "multi-configuration, single patient reusable device" manufactured using 3D printing technology, indicating it is a physical object, not software.
Based on the provided information, the Lollipop BiteBlock from RadTec Medical Devices, Inc. is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "repeat positioning and immobilization of patients undergoing or receiving a course of external beam radiation therapy." This is a physical positioning and immobilization function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "multi-configuration, single patient reusable device intended to be used for the planning, positioning, and re-positioning of a patient's oral cavity." This further reinforces its role in physical manipulation and positioning during treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Performance Studies: The performance studies focus on physical properties like force resistance and radiation attenuation, which are relevant to its function as a positioning and shielding device during radiation therapy, not as a diagnostic tool.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Lollipop BiteBlock does not fit this description.
N/A
Intended Use / Indications for Use
The Lollipop BiteBlock from RadTec Medical Devices, Inc. is intended to be used for repeat positioning and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.
It is intended to be used by or under the direction of a licensed physician.
Product codes
IYE
Device Description
The Lollipop BiteBlock is a multi-configuration, single patient reusable device intended to be used for the planning, positioning, and re-positioning of a patient's oral cavity while they undergo or receive a course of external beam radiation therapy for the treatment of cancer and other diseases. The Lollipop BiteBlock is designed for use in radiation therapy departments in hospitals and/or free-standing treatment centers.
The Lollipop BiteBlock is available in four configurations: lateral tongue localization (LTL), mouth open tongue forward (MOTF), mouth open tongue depressed (MOTD), and mouth open tongue (forward) closed (MOTC). The choice of which configuration is appropriate to the patient is left to the physician's discretion.
The Lollipop BiteBlock is manufactured using 3D printing technology. At least one sample, per lot, from each of the four configurations is measured to ensure that it meets device specifications. The Lollipop BiteBlock is provided to the physician as the final finished device. The 3D electronic files are not sent to the physician at any time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used by or under the direction of a licensed physician.
radiation therapy departments in hospitals and/or free-standing treatment centers.
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
Vertical Tongue Force: A force of ≥ 175 lbF was applied to represent the worst-case scenario as it is 10-20% over the max force of the human tongue. Each construct was visually inspected for any internal or external fractures or cracks. None of the devices had any breaking, cracking, or fracturing therefore meeting the acceptance criteria and passing the test.
"Bite" Crush Force: The subject device was placed between the upper and lower jaws of an anthropomorphic jaw model with teeth to simulate a realistic treatment position and distribution of force. A force of ≥ 250 lbF was applied to represent worst-case scenario as it is 10-20% over the max force of the human jaw. Each construct was visually inspected for any internal or external fractures or cracks. None of the devices had any breaking, cracking, or fracturing therefore meeting the acceptance criteria and passing the test.
Backscatter Radiation Attenuation: The subject device was placed into a solid water phantom with sheets of GafChromic EBT3 film placed above and below the device. A dose of 4 Gy was used for irradiation. Irradiation was performed twice, once with a lead sheet (to generate back scatter) and once without. The lead sheet was used as a worstcase condition as it has a significantly higher backscatter than teeth, dental fillings, or other dental appliances. The test found that the subject device has a shielding efficacy just below "1" (0.962) demonstrating shielding performance similar to that of the predicate.
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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RadTec Medical Devices, Inc. % Michelle Rubin-Onur, Ph.D. Regulatory Specialist AcKnowledge Regulatory Strategies LLC. 2251 San Diego Ave, Suite B-257 SAN DIEGO CA 92110
July 6, 2020
Re: K200652
Trade/Device Name: Lollipop BiteBlock Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: June 11, 2020 Received: June 12, 2020
Dear Dr. Rubin-Onur:
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/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 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 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).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Lollipop BiteBlock
Indications for Use (Describe)
The Lollipop BiteBlock from RadTec Medical Devices, Inc. is intended to be used for repeat positioning and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.
It is intended to be used by or under the direction of a licensed physician.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary K200652
510(k) Summary
DATE PREPARED
May 5, 2020
MANUFACTURER AND 510(k) OWNER
RadTec Medical Devices, Inc. 131 Glenn Way #7, San Carlos, CA 94070 Telephone: Official Contact: Ross Holman, Founder and CEO
REPRESENTATIVE/CONSULTANT
Michelle Rubin-Onur, Ph.D. Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 Email: mrubin@acknowledge-rs.com, akomiyama@acknowledge-rs.com Website: www.acknowledge-rs.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Lollipop BiteBlock |
|---|---|
| Common Name: | Accelerator, Linear, Medical |
| Regulation Number: | 21 CFR 892.5050 |
| Class: | Class II |
| Product Code: | IYE |
| Premarket Review: | OPEQ/Division of Radiological Health (DRH) |
| Division of Radiological Health (DRH) |
PREDICATE DEVICE IDENTIFICATION
The Lollipop BiteBlock is substantially equivalent to the following predicate:
| 510(k)
Number | Predicate Device Name /
Manufacturer | Regulation
Number | Product
Code | Primary
Predicate |
|------------------|----------------------------------------------------------------------------------|----------------------|-----------------|----------------------|
| K153270 | TruGuard Custom Tongue and Jaw
Positioner /
Bionix Development Corporation | 21 CFR
892.5050 | IYE | ✓ |
The predicate device has not been subject to a design related recall.
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510(k) Summary DEVICE DESCRIPTION
The Lollipop BiteBlock is a multi-configuration, single patient reusable device intended to be used for the planning, positioning, and re-positioning of a patient's oral cavity while they undergo or receive a course of external beam radiation therapy for the treatment of cancer and other diseases. The Lollipop BiteBlock is designed for use in radiation therapy departments in hospitals and/or free-standing treatment centers.
The Lollipop BiteBlock is available in four configurations: lateral tongue localization (LTL), mouth open tongue forward (MOTF), mouth open tongue depressed (MOTD), and mouth open tongue (forward) closed (MOTC). The choice of which configuration is appropriate to the patient is left to the physician's discretion.
The Lollipop BiteBlock is manufactured using 3D printing technology. At least one sample, per lot, from each of the four configurations is measured to ensure that it meets device specifications. The Lollipop BiteBlock is provided to the physician as the final finished device. The 3D electronic files are not sent to the physician at any time.
INDICATIONS FOR USE
The Lollipop BiteBlock from RadTec Medical Devices, Inc. is intended to be used for repeat positioning and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.
It is intended to be used by or under the direction of a licensed physician.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
RadTec Medical Devices, Inc. believes that the Lollipop BiteBlock is substantially equivalent to the predicate device based on the information summarized here:
The subject device has a similar design and dimensions and uses similar or identical materials as the device cleared in K153270. The subject device has the same intended use and similar technological characteristics to the device cleared in K153270. The Lollipop BiteBlock has undergone testing to ensure that any differences in technological characteristics do not affect safety and effectiveness when compared to the predicate device.
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Lollipop BiteBlock.
Patient contacting material was subjected to biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing with a risk management process.
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Image /page/5/Picture/0 description: The image is a logo for a company called RADTEC Medical Devices. The logo is a blue shield with the company name at the top. Below the company name is a white silhouette of a head, and below the head is the text "Medical Devices". The logo is simple and professional, and it conveys the company's focus on medical devices.
510(k) Summary
The following tests were performed to demonstrate equivalence to the predicate device
- Vertical Tongue Force: A force of ≥ 175 lbF was applied to represent the worst-case . scenario as it is 10-20% over the max force of the human tongue. Each construct was visually inspected for any internal or external fractures or cracks. None of the devices had any breaking, cracking, or fracturing therefore meeting the acceptance criteria and passing the test.
- . "Bite" Crush Force: The subject device was placed between the upper and lower jaws of an anthropomorphic jaw model with teeth to simulate a realistic treatment position and distribution of force. A force of ≥ 250 lbF was applied to represent worst-case scenario as it is 10-20% over the max force of the human jaw. Each construct was visually inspected for any internal or external fractures or cracks. None of the devices had any breaking, cracking, or fracturing therefore meeting the acceptance criteria and passing the test.
- . Backscatter Radiation Attenuation: The subject device was placed into a solid water phantom with sheets of GafChromic EBT3 film placed above and below the device. A dose of 4 Gy was used for irradiation. Irradiation was performed twice, once with a lead sheet (to generate back scatter) and once without. The lead sheet was used as a worstcase condition as it has a significantly higher backscatter than teeth, dental fillings, or other dental appliances. The test found that the subject device has a shielding efficacy just below "1" (0.962) demonstrating shielding performance similar to that of the predicate.
CONCLUSION
Based on the testing performed it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed Lollipop BiteBlock are assessed to be substantially equivalent to the predicate device.