(85 days)
Not Found
No
The summary lists image processing functions but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No.
The device is used for stereotactic radiation treatment planning, which is a step before the actual treatment. It processes imaging data for planning purposes rather than providing direct therapeutic action.
No
The device is used for radiation treatment planning and preparation, not for diagnosing medical conditions. It uses existing imaging data to plan treatment.
Unknown
The provided text describes the intended use and image processing capabilities of the device, which are software functions. However, it lacks a "Device Description" section, which would typically clarify whether the device is purely software or includes hardware components. Without this information, it's impossible to definitively determine if it's a software-only medical device.
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 the device is for stereotactic radiation treatment planning. This involves processing medical images to plan a therapeutic intervention (radiation treatment).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections.
- Lack of Biological Sample Analysis: The description focuses entirely on image processing and planning based on imaging data (CT, MR, etc.). There is no mention of analyzing biological samples.
Therefore, the device falls under the category of medical imaging software used for treatment planning, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
iPlan RT Image's indications for use are to prepare and present patient and image data based on CT, MR, angiographic and other imaging sources including
- image preparation -
- image localization
- n image fusion
- image segmentation "
- isocenter handling -
- plan review and approval -
where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.
Product codes
LHN
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, angiographic, PET
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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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JUN 2 4 2008
510 (k) Summary of Safety and Effectiveness for iPlan RT Image
Manufacturer:
| Address: | BrainLAB AG
Kapellenstrasse 12
85622 Feldkirchen
Germany | | |
|-----------------|-------------------------------------------------------------------|--------------------|--|
| | Phone: | +49 89 99 15 68 0 | |
| | Fax: | +49 89 99 15 68 33 | |
| Contact Person: | Mr. Per Persson | | |
| Summary Date: | March 25, 2008 | | |
Device Name:
Trade name:
iPlan RT Image
Common/Classification Name:
Planning System / Medical charged-particle radiation therapy system
Predicate Device: Intuition Image (K032511) iPlan RT FiberTracking (K052220) iPlan BOLD MRI (K053127)
Device Classification Name: Medical charged-particle radiation therapy system Regulatory Class: Class II
Intended Use:
iPlan RT Image's indications for use are to prepare and present patient and image data based on CT, MR, angiographic and other imaging sources including
- image preparation -
- image localization
- n image fusion
- image segmentation "
- isocenter handling -
- plan review and approval -
where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three wing-like shapes, representing the department's mission related to health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2008
Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Kapellenstraße 12, 85622 Feldkiechen GERMANY
Re: K080886
Trade/Device Name: iPlan RT Image Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: March 26, 2008 Received: March 31, 2008
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 (PMA), 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.
2
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. Your 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 logally 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely vours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: iPlan RT Image
Indications For Use:
iPlan RT Image's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic, PET to include standardized uptake values (SUV) and other imaging sources including
- image preparation .
- image localization .
- image fusion .
- image segmentation .
- isocenter handling .
- plan review and approval .
where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.
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 Device Evaluation (ODE)
Tonk Tithery
Division of Reproductive, Abdomina Radiological D 510(k) Number
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