(160 days)
Unknown
The description mentions "automatic or manual segmentation" and "automatic and/or manual re-segmentations," which could potentially be implemented using AI/ML, but the document does not explicitly state that AI/ML is used. The absence of mentions of AI, DNN, or ML, and the lack of details on training/test sets, make it impossible to definitively confirm the presence of AI/ML.
No
The device is a pre-planning software tool that assists in stereotactic radiation treatment planning, but it does not directly apply therapy or alter a patient's condition.
No
The device is described as a software tool for "pre-planning of treatments based on stereotactic systems" and for "stereotactic radiation treatment planning." Its use is to prepare and present data, perform tasks like image segmentation and fusion, and allow for plan review and approval for treatment. While it processes medical images, its primary output is a treatment plan, not a diagnostic interpretation of the patient's condition.
Yes
The device description explicitly states "Intuition Image is a software tool running on a standard, standalone computer workstation or being accessible via the intranet connection". It processes existing image data and does not include any hardware components for image acquisition or treatment delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as preparing and presenting patient and image data for stereotactic radiation treatment planning. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description reinforces its role in pre-planning treatments based on stereotactic systems and its use in conjunction with or as a pre-planning station for radiotherapy/radiosurgery treatment planning systems.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. Its purpose is to facilitate the planning of a medical treatment.
- Input Data: While it uses medical imaging data (CT, MR, Angiographic), this data is used for planning a treatment, not for making a diagnosis.
In vitro diagnostics (IVDs) are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such tests.
N/A
Intended Use / Indications for Use
Intuition Image's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including
- image preparation -
- image localization -
- image fusion -
- image segmentation -
- isocenter handling -
- plan review and approval
where in roomputer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.
Intuition Image's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic 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.
Product codes
90 LHN, MUJ
Device Description
Intuition Image is a software tool running on a standard, standalone computer workstation or being accessible via the intranet connection for pre-planning of treatments based on stereotactic systems.
The system provides e.g. tools for the automatic or manual segmentation of anatomical structures, which helps the user such as the radiologist or the neurosurgeon to quickly achieve the desired segmentation results through a variety of automatic and/or manual re-segmentations. Additionally anatomical and functional structures and segmentations of the human brain as defined and described by Talairach/Tournoux and/or Schaltenbrand/Wahren brain atlases can be correlated with the patient's brain data.
The created treatment plans of Intuition Image can be used on its own or in conjunction with other BrainLAB treatment planning systems such as Intuition Dose (to be developed) or BrainSCAN (K994413) for further planning of parameters, which are relevant for Radiotherapy/Radiosurgery. Intuition Image may also serve as a pre-planning station for various third party treatment planning systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, Angiographic and other imaging sources
Anatomical Site
cranial, head and neck and extracranial lesions.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologist or the neurosurgeon
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.
0
K$\phi$32511
510 (k) Summary of Safety and Effectiveness for Intuition Image
| Manufacturer: | BrainLAB AG |
|---|---|
| Address: | Ammerthalstrasse 8 |
| 85551 Heimstetten | |
| Germany | |
| Phone: | +49 89 99 15 68 0 |
| Fax: | +49 89 99 15 68 33 |
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | August 1, 2003 |
| Device Name: | |
| Trade name: | Intuition Image |
Common/Classification Name:
Planning System/X-ray radiation therapy system
Predicate Device: iPlan! (K020631) BrainSCAN (K994413)
Device Classification Name: X-ray radiation therapy system Regulatory Class: Class II
Intended Use:
Intuition Image's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including
- image preparation -
- image localization -
- image fusion -
- image segmentation -
- isocenter handling -
- plan review and approval ﯩ
plan forlow and applied. where in roomputer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.
1
K$\emptyset$32511
Device Description:
Intuition Image is a software tool running on a standard, standalone computer workstation or being accessible via the intranet connection for pre-planning of treatments based on stereotactic systems.
The system provides e.g. tools for the automatic or manual segmentation of anatomical structures, which helps the user such as the radiologist or the neurosurgeon to quickly achieve the desired segmentation results through a variety of automatic and/or manual re-segmentations. Additionally anatomical and functional structures and segmentations of the human brain as defined and described by Talairach/Tournoux and/or Schaltenbrand/Wahren brain atlases can be correlated with the patient's brain data.
The created treatment plans of Intuition Image can be used on its own or in conjunction with other BrainLAB treatment planning systems such as Intuition Dose (to be developed) or BrainSCAN (K994413) for further planning of parameters, which are relevant for Radiotherapy/Radiosurgery. Intuition Image may also serve as a pre-planning station for various third party treatment planning systems.
Substantial equivalence:
Intuition Image 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 devices iPlan! (K020631) and BrainSCAN (K994413).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2004
Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstraße 8 85551 Heimstetten GERMANY
Re: K032511
Trade/Device Name: Intuition Image Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 LHN, and MUJ Dated: December 5, 2003 Received: December 10, 2003
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 10 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 111 (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.
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.
3
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
510(k) Number (if known): K$\phi$32511
Device Name:
Intuition Image
Indications For Use:
Intuition Image's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Formal I-2-96)
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number