(201 days)
No
The summary describes a radiation treatment planning system that uses a convolution algorithm and is an evolutionary successor to a predicate device. There is no mention of AI, ML, or related concepts.
No
The device is a treatment planning system; it does not directly treat the patient.
No
This device is a radiation treatment planning system that generates treatment plans and simulates dose delivery. It is used for therapeutic purposes, not for diagnosing medical conditions.
Yes
The device is described solely as a "software program" and its function is to generate treatment plans and simulate dose delivery, which are software-based tasks. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that iPlan RT Dose is a "stereotactic radiation treatment planning system" used for "radiation treatment of cranial, head and neck, and extracranial lesions." This describes a system used for planning and simulating medical treatment, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces that it's a "software program to generate treatment plans and to simulate the dose delivery for external beam radiotherapy." This is consistent with a treatment planning system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. iPlan RT Dose is a tool for planning and simulating radiation therapy, which is a medical treatment.
N/A
Intended Use / Indications for Use
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
Product codes
MUJ
Device Description
iPlan RT Dose is a software program to generate treatment plans and to simulate the dose delivery for external beam radiotherapy. The system is the evolutionary successor of the predicate device BrainSCAN (K994413). It is specialized for stereotactic procedures for cranial as well as extracranial lesions. It includes functions for all relevant steps from outer contract detection to quality assurance.
iPlan RT Dose incorporates most capabilities of the predicate device BrainSCAN. The device incorporates conformal beams, conformal IMRT beams, both static and dynamic arc treatments. The system calculates dose using a convolution algorithm similar to the predicate device BrainSCAN. The documentation & export allows producing printouts of all parameters and results for the creation of DICOM RT (RT Plan and RT Image) files.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial, head and neck, and extracranial lesions
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
Not Found
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.
0
JUL 1 2 2006
510 (k) Summary of Safety and Effectiveness for iPlan RT Dose
Manufacturer
| Address | BrainLAB AG
Ammerthalstrasse 8
85551 Heimstetten
Germany |
|----------------|-------------------------------------------------------------------|
| | Phone: +49 89 99 15 68 0
Fax: +49 89 99 15 68 33 |
| Contact Person | Mr. Rainer Birkenbach |
| Summary Date | December 21, 2005 |
Device Name
| Device Name |
|---|
| Common Name |
| Classification Name |
| Classification Number |
| Regulatory Class |
| FDA Establishment Registration Number |
iPlan RT Dose System, Planning, Radiation Therapy Treatment Medical charged-particle radiation therapy system 21 CFR 892.5050 Class Il 8043933
Predicate Device
BrainSCAN (K994413)
1
Intended Use
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
Device Description
iPlan RT Dose is a software program to generate treatment plans and to simulate the dose delivery for external beam radiotherapy. The system is the evolutionary successor of the predicate device BrainSCAN (K994413). It is specialized for stereotactic procedures for cranial as well as extracranial lesions. It includes functions for all relevant steps from outer contract detection to quality assurance.
iPlan RT Dose incorporates most capabilities of the predicate device BrainSCAN. The device incorporates conformal beams, conformal IMRT beams, both static and dynamic arc treatments. The system calculates dose using a convolution algorithm similar to the predicate device BrainSCAN. The documentation & export allows producing printouts of all parameters and results for the creation of DICOM RT (RT Plan and RT Image) files.
Substantial Equivalence
iPlan RT Dose has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device BrainSCAN (K994413).
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of an eagle or other bird-like figure, with its wings spread and tail feathers flowing.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL I 2 2006
Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstraße 8, 85551 Heimstetten GEMANY
Re: K053584
Trade/Device Name: iPlan RT Dose Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: June 14, 2006 Received: June 16, 2006
Dear Mr. Birkenbach:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows a logo with the text "1906-2006 FDA Centennial" in a circular design. The logo is for the Food and Drug Administration (FDA) and commemorates its centennial anniversary. The text "Protecting and Promoting Public Health" is written in a decorative font below the logo. The image appears to be a scan or reproduction of an older document or emblem.
3
Page 2 -
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K053584
Device Name: iPlan RT Dose
Indications For Use:
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planning system that is intended in
eropial, bood and post cranial, head and neck, and extracranial lesions.
David R. Syverson
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Prescription Use X (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 Device Evaluation (ODE)