(116 days)
No
The device description focuses on 3D printing and physical dosimetry measurements, with no mention of AI or ML algorithms for analysis or processing.
No
The device is described as a "quality assurance" and "verification device" for radiation delivery systems and treatment planning, not for directly treating patients.
No
The device is described as a "quality assurance" and "verification device" for radiation therapy, intended to verify dose calculations and parts of the treatment chain. It is not used to diagnose a patient's medical condition.
No
The device description explicitly states that the device is a 3D printed physical model of a patient's CT-scan, made of bone equivalent material, and loaded with physical dosimeters like ion chambers or film inserts. This clearly indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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, treatment, or prevention of disease.
- Device Function: The Personalized PseudoPatient™ PV is a physical phantom used for quality assurance of external beam radiotherapy treatments. It is a model of a patient's anatomy and is used to verify dose calculations and the treatment delivery chain.
- Lack of Specimen Analysis: The device does not involve the collection, preparation, or analysis of any biological specimens from a patient. It is a tool used in the process of delivering radiation therapy, not for diagnosing or monitoring a patient's condition through laboratory testing.
The device's purpose is to ensure the accuracy and quality of the radiation treatment itself, not to provide diagnostic information about the patient's health status based on biological samples.
N/A
Intended Use / Indications for Use
The Personalized PseudoPatient™ PV is intended for the quality assurance of patient specific brain treatments done prior to and/or interfractionally to delivery by external beam radiotherapy, including IMRT and VMAT. It is also intended for quality assurance of the radiation delivery system.
Product codes
IYE
Device Description
The Personalized PseudoPatient™ PV is a precise model of a patient's CT-scan. Bone structure and external contour are 3D printed using bone equivalent material. The PseudoPatient™ is a pre-treatment end-to-end verification device. The device verifies the TPS dose calculations as well as the following parts of the treatment chain: patient immobilization, image guidance, and treatment delivery. The 3D printed, Personalized PseudoPatient™ PV is loaded with one of the following available types of dosimeters: ion chamber (IC) insert (or any kind of insert for point dosimetry), and/or film insert (FL). The insertcan be relocated depending on demands of treatment. The ion chamber inserts are specifically designed for the detector type indicated by the end user and constructed of Poly(methyl methacrylate) (PMMA). The PseudoPatient™ FL is equipped with a Real Water (RW3) insert to accommodate a dosimetry film (filled with water by the end-user).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT-scan
Anatomical Site
brain
Indicated Patient Age Range
Not Found
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)
Clinical testing is not necessary for this device type. This technology is well known and used in the field of dosimetry in radiation therapy. Validation of the calculated absolute dose and dose distribution using the device proved to be clinically acceptable.
The device is non-patient contacting and provided non-sterile, therefore, biocompatibility testing and sterility testing is not required.
Verification testing of the final device is performed for each unit produced to confirm accuracy of the printer and accuracy of the finished device to the patient anatomy. The basic specification is that the phantom is anatomically accurate and mimics the patient's morphological characteristics. A structure with known dimensions is printed simultaneously with the phantom. These dimensions are digitally and physically compared using validated software and calibrated equipment to ensure the finished device meets required specifications.
Verification testing is performed for each lot of material used for the finished device. This testing confirms the material is equivalent to bone by measuring the Hounsfield units of a 3D printed structure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 shows 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.
RTsafe, Inc. % Jennifer Palinchik President JALEX Medical, LLC. 30311 Clemens Rd. Suite #5D WESTLAKE OH 44145
Re: K180697
Trade/Device Name: Personalized PseudoPatient™ PV Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: June 15, 2018 Received: June 18, 2018
Dear Ms. Palinchik:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
July 10, 2018
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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. O'Hara For
Robert A. 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) K180697
Device Name Personalized PseudoPatient™ PV
Indications for Use (Describe)
The Personalized PseudoPatient™ PV is intended for the quality assurance of patient specific brain treatments done prior to and/or interfractionally to delivery by external beam radiotherapy, including IMRT and VMAT. It is also intended for quality assurance of the radiation delivery system.
| 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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Image /page/3/Picture/0 description: The image contains the logo for RTSafe. The logo consists of three blue circles in the upper left corner, followed by the text "RTsafe" in blue. The text is written in a sans-serif font, with the "R" and "T" being larger than the "safe".
510(k) Summary
| Submitted By: | RTsafe, Inc.
342 Regent Circle
San Antonio, TX 78231 |
|-----------------------------|-------------------------------------------------------------------------------------------|
| Date: | 06/27/2018 |
| Contact Person: | Jennifer Palinchik, President |
| Contact Telephone: | (440) 541-0060 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | Personalized PseudoPatient™ PV |
| Device Classification Name: | Accessory - Linear Accelerator (21 CFR 892.5050) |
| Device Classification: | Class II |
| Reviewing Panel: | Radiology |
| Product Code: | IYE |
| Primary Predicate Device: | ScandiDos AB Delta4 Phantom (K151426) This device has not
been subject to any recalls. |
Device Description:
The Personalized PseudoPatient™ PV is a precise model of a patient's CT-scan. Bone structure and external contour are 3D printed using bone equivalent material. The PseudoPatient™ is a pre-treatment end-to-end verification device. The device verifies the TPS dose calculations as well as the following parts of the treatment chain: patient immobilization, image guidance, and treatment delivery. The 3D printed, Personalized PseudoPatient™ PV is loaded with one of the following available types of dosimeters: ion chamber (IC) insert (or any kind of insert for point dosimetry), and/or film insert (FL). The insertcan be relocated depending on demands of treatment. The ion chamber inserts are specifically designed for the detector type indicated by the end user and constructed of Poly(methyl methacrylate) (PMMA). The PseudoPatient™ FL is equipped with a Real Water (RW3) insert to accommodate a dosimetry film (filled with water by the end-user).
Intended Use:
The Personalized PseudoPatient™ PV is intended for the quality assurance of patient specific brain treatments done prior to and/or interfractionally to delivery by external beam radiotherapy, including IMRT and VMAT. It is also intended for quality assurance of the radiation delivery system.
4
Image /page/4/Picture/0 description: The image contains the logo for RTSafe. The logo consists of three blue circles in a horizontal row, followed by the text "RTsafe" in a bold, blue font. The circles are slightly offset from each other, creating a sense of movement or connection. The overall design is simple and modern, with a focus on the company name.
Summary of Technological Characteristics:
The Personalized PseudoPatient™ PV and predicate have the same intended use. Both devices compare similarly in:
- Ease of alignment for positioning
- Accurate dose verification and absolute measurement
- Compatibility with any treatment planning systems (TPS)
- Patient quality assurance and machine quality assurance capabilities ●
- . Design features which allow the insertion of third party dosimeters that measure the placement and intensity of radiation treatment
- Tissue and bone equivalent materials that allow the radiation to transfer to the dosimeters ●
- . Overall size of cylinder to average patient anatomy
- Dosimeter usage
- Same intended use
- Biocompatibility (non-patient contacting)
- Sterility (non-sterile)
Clinical and Non-clinical Testing:
Clinical testing is not necessary for this device type. This technology is well known and used in the field of dosimetry in radiation therapy. Validation of the calculated absolute dose and dose distribution using the device proved to be clinically acceptable.
The device is non-patient contacting and provided non-sterile, therefore, biocompatibility testing and sterility testing is not required.
Verification testing of the final device is performed for each unit produced to confirm accuracy of the printer and accuracy of the finished device to the patient anatomy. The basic specification is that the phantom is anatomically accurate and mimics the patient's morphological characteristics. A structure with known dimensions is printed simultaneously with the phantom. These dimensions are digitally and physically compared using validated software and calibrated equipment to ensure the finished device meets required specifications.
Verification testing is performed for each lot of material used for the finished device. This testing confirms the material is equivalent to bone by measuring the Hounsfield units of a 3D printed structure.
Conclusion:
Based on the intended use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence and does not raise additional questions of safety or effectiveness.