(186 days)
Not Found
No
The summary describes standard treatment planning software functionalities like image import, ROI definition, dose calculation, and plan export. There is no mention of AI or ML terms, algorithms, or related concepts like training/test sets for model development. The performance studies focus on accuracy and equivalence to a predicate device, not on AI/ML performance metrics.
No
The device is a treatment planning system (TPS) that helps prepare treatment plans for patients. It does not directly administer therapy or provide a therapeutic effect. Its function is to determine the precise location of the target, define treatment beam locations, and visualize dose, which are preparatory steps for therapy.
No
The device is a treatment planning system that prepares treatment plans and calculates dose delivery parameters for radiation therapy based on imported images, rather than diagnosing a condition.
Yes
The device description explicitly states "The Explorer 4D™ Treatment Planning System software" and describes its function as processing images and creating treatment plans, which are software-based tasks. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this system works with medical images (CT and MR) of the patient's intracranial region. It does not analyze blood, urine, tissue samples, or any other biological specimens.
- The purpose of this device is treatment planning. It helps determine the precise location for radiation therapy and calculate dose delivery parameters. This is a therapeutic planning tool, not a diagnostic tool that analyzes biological samples to identify diseases or conditions.
The device is a medical device used in the planning of radiation therapy, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Explorer 4D™ Treatment Planning System software is intended for use in preparing treatment plans for patients who have intracranial diseases where neurological radio surgery has been prescribed.
The software is used to electronically import CT and MR images to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
Device Description
The Explorer 4D™ Treatment Planning System (TPS) provides individual treatment plans for patients undergoing gamma radiation therapy treatment. The TPS provides for the import of patient images and selecting a series of relevant patient images to create a treatment plan.
Precise calculation of the dose delivery parameters is supported by the registration of fiducial markers as a reference point between patient images. These images are then annotated with the region of interest (ROI) to be exposed to radiation. Several tools are provided to adjust the ROI based on the desired treatment area, within these regions "shots" (radiation sources) and associated treatment dose levels are defined as they related to a specified collimator size.
When the plan definition is completed the operator can save or export the treatment plan.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT and MR images
Anatomical Site
intracranial (diseases)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing for the Explorer 4D™ Treatment Planning System is the same as was performed for the r esting for the Explorer 12 - Freativent Planning System) with the difference that production and of no 9500 Enpress ware version 2.1 using MR images instead of CT images. In an tests were concacted with comparison tests were also conducted showing the results using MR images are equivalent to the results generated using CT images.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for American Radiosurgery. The logo consists of a series of black dots arranged in a semi-circular pattern on the left side of the image. To the right of the dots, the words "AMERICAN RADIOSURGERY" are written in a bold, sans-serif font. The text is aligned horizontally and is the main element of the logo.
510(k) Summary
NOW - 5 2010
| 510(k) | K101220 |
|---|---|
| Submitter/Applicant Name: | American Radiosurgery, Inc. |
| Address: | 16776 Bernardo Center Drive, Suite 203 |
| San Diego, CA 92128 | |
| Phone number: | 858-451-6173 |
| Fax number: | 858-487-0662 |
| Contact: | John Clark |
| Contact person: | Dan Olivier (CCS, Inc.) |
| Phone number: | (858) 675-8200 |
| Fax number: | (858) 675-8201 |
| Date prepared: | October 30, 2010 |
| Trade name: | Explorer 4D™ Treatment Planning System |
| Common name: | Radiation Therapy Treatment Planning System |
| Classification name: | System, Planning, Radiation Therapy Treatment |
| Classification: | 21 CFR Part 892.5050 Class II |
Substantial equivalence claimed to:
Substantial equivalence thanks as: "Treament Planning System is functionally and
substantially equivalent to the K093588 Explorer 4D™ Treatment Planning System with the subsumitially equility to import MR as well as CT images. Both systems share the same user interface and dose calculation algorithms; the only difference is the ability to import both CT and MR images.
Description
The Explorer 4D™ Treatment Planning System (TPS) provides individual treatment plans for patients undergoing gamma radiation therapy treatment. The TPS provides for the import of patient images and selecting a series of relevant patient images to create a treatment plan.
Precise calculation of the dose delivery parameters is supported by the registration of fiducial markers as a reference point between patient images. These images are then annotated with the region of interest (ROI) to be exposed to radiation. Several tools are provided to adjust the ROI based on the desired treatment area, within these regions "shots" (radiation sources) and associated treatment dose levels are defined as they related to a specified collimator size.
When the plan definition is completed the operator can save or export the treatment plan.
Intended Use
1
The Explorer 4D™ Treatment Planning System software is intended for use in preparing treatment plans for patients who have intracranial diseases where neurological radio surgery has been prescribed.
The software is used to electronically import CT and MR images to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
Substantial Equivalence
Substantial Explorer 4D™ Treatment Planning System include the capability to prepare treatment plans using MR images as well as CT images cleared under submission K093588 (version 2.0). Functional testing has demonstrated that version 2.1 is safe and effective and accuracy comparison tests have demonstrated equivalent performance using MR images as obtained using CT images.
| Equivalence Comparison | ||
|---|---|---|
| Item | Device | Predicate |
| Name | Explorer 4DTM Treatment | |
| Planning System version 2.1 | ||
| (K101220) | Explorer 4DTM Treatment | |
| Planning System version 2.0 | ||
| (K093588) | ||
| Indications for | ||
| Use | The Explorer 4DTM Treatment | |
| Planning System software is | ||
| intended for use in preparing | ||
| treatment plans for patients who | ||
| have intracranial diseases where | ||
| neurological radio surgery has | ||
| been prescribed. | ||
| The software is used to | ||
| electronically import CT and | ||
| MR images to determine the | ||
| precise location of the target, to | ||
| define and visualize treatment | ||
| beam locations, and to visualize | ||
| dose to the target and other | ||
| structures. | The Explorer 4DTM Treatment | |
| Planning System software is | ||
| intended for use in preparing | ||
| treatment plans for patients who | ||
| have intracranial diseases where | ||
| neurological radio surgery has | ||
| been prescribed. | ||
| The software is used to | ||
| electronically import CT images | ||
| to determine the precise | ||
| location of the target, to define | ||
| and visualize treatment beam | ||
| locations, and to visualize dose | ||
| to the target and other | ||
| structures. | ||
| System | ||
| Functions | The Explorer 4DTM Treatment | |
| Planning System (TPS) imports | ||
| patient images to determine the | ||
| precise location of the target for | ||
| gamma irradiation. | The Explorer 4DTM Treatment | |
| Planning System (TPS) imports | ||
| patient images to determine the | ||
| precise location of the target for | ||
| gamma irradiation. | ||
| Technological | ||
| characteristics | Technological characteristics | |
| include 3D imaging of | ||
| treatment beam locations to | ||
| visualize target dose overlaid on | ||
| CT and MR images. | Technological characteristics | |
| include 3D imaging of | ||
| treatment beam locations to | ||
| visualize target dose overlaid on | ||
| CT images. | ||
| Import data | CT and MR images | CT |
2
| Equivalence Comparison | ||
|---|---|---|
| Item | Device | Predicate |
| Data interfaces | TCP/IP network interface | TCP/IP network interface |
| User access | Secured through identification | |
| code and password | Secured through identification | |
| code and password | ||
| Safety Features | Requires physician approval of | |
| treatment plans | Requires physician approval of | |
| treatment plans | ||
| Non-clinical | ||
| testing | Testing includes functional | |
| coverage of all requirements | ||
| and accuracy comparison tests | ||
| using CT and MR images | Testing includes functional | |
| coverage of all requirements | ||
| Test results | Test results have been verified | |
| by physicist manual | ||
| calculations as accurate for CT | ||
| and MR images | Test results have been verified | |
| by physicist manual | ||
| calculations as accurate for CT | ||
| images | ||
| Software version | 2.1 | 2.0 |
Performance Data
Testing for the Explorer 4D™ Treatment Planning System is the same as was performed for the r esting for the Explorer 12 - Freativent Planning System) with the difference that production and of no 9500 Enpress ware version 2.1 using MR images instead of CT images. In an tests were concacted with comparison tests were also conducted showing the results using MR images are equivalent to the results generated using CT images.
production : : : : : : :
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
American Radiosurgery, Inc. c/o Mr. Dan Olivier President Certified Compliance Solutions. Inc. 11665 Avena Place, Suite 203 SAN DIEGO CA 92128
NOV - 5 2010
Re: K101220
Trade Name: Explorer 4DTM Treatment Planning System Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: October 24, 2010 Received: October 25, 2010
Dear Mr Oliver:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Dan
David G. Brown. Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
American Radiosurgery Explorer 4D™ Treatment Planning System Premarket Submission
Indications for Use 4.
510(k) Number: K101220 510(K) Namber : R101220 TM Treatment Planning System
NOV - 5 2010
Indications for Use:
The Explorer 4D™ Treatment Planning System software is intended for use in preparing The Exploier 4D - Treamfell Tiaming System Scoranial diseases where neurological radio surgery has been prescribed.
The software is used to electronically import CT and MR images to determine the precise I he "software" is asour to "elections and visualize treatment beam locations, and to visualize dose to the target and other structures.
Prescription Use (Per 21 CFR 801 Subpart D)
"AND/OR ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)
(Division Sign-Off)
510K K101220