(120 days)
No
The description focuses on the mechanical and electronic components of a linear accelerator for radiation therapy, with no mention of AI or ML for image processing, treatment planning, or any other function.
Yes
The device produces beams of electrons used in radiation therapy treatment for malignant (cancer) and benign conditions, which is a therapeutic purpose.
No
The Mobetron is a treatment device that produces electron beams for radiation therapy, not for diagnosing conditions.
No
The device is a mobile electron linear accelerator, which is a hardware device used for radiation therapy. The description details physical components like the accelerator head, C-arm, applicators, and control system, indicating it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Mobetron's Function: The Mobetron is a linear accelerator used for radiation therapy. It directly treats patients with electron beams for therapeutic purposes (treating cancer and benign conditions). This is a form of in vivo treatment, not in vitro testing.
- Intended Use: The intended use clearly states it's for "radiation therapy treatment."
- Device Description: The description details the physical components and how it delivers radiation to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples, or providing diagnostic information based on laboratory results.
The Mobetron is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Mobetron is a mobile electron linear accelerator that produces beams of electrons used in the radiation therapy treatment of both malignant (cancer) and benign conditions. The Mobetron has four electron beam treatment energies and a set of electron applicators which provide a range of field sizes from 3 to 10 cm in diameter.
For delivery of electron beam radiation during a surgical procedure, known as Intraoperative Radiation Therapy (IORT), the Mobetron system includes a sterile cap and sterile drapes for each IORT procedure, IORT applicators, a QA system, a surgical table extender with added support leg, and bolus material.
Product codes
90 LHN
Device Description
The MOBETRON is a mobile electron beam accelerator designed specifically for use in the operating room (O.R.). Once in the OR, the accelerator head can be positioned in the horizontal plane, rotated about the coronal plane, and moved along the beam axis direction to facilitate docking with an electron applicator that is inserted into the patient. Together with the C-arm rotation, the accelerator head motion is designed to allow the accelerator to be easily and safely positioned for intraoperative treatments. All motorized motions are variable speed and are controlled by a lightweight hand-held control. The operator control system contains the dosimetry readout parameters, accelerator controls, machine interlock status, and a video output of the periscopic viewing system.
When the electrons emerge from the accelerator, they are scattered by a set of thin metallic foils and are pre-collimated to a circular field size of 10 cm. (at the standard treatment distance of 50 cm. SSD) by a primary tungsten collimator. The scattered electron beam passes through two independent transmission ion chambers and is further collimated to the desired field size by electron applicators which are inserted into the patient. The scattering foil and collimation technique and applicator systems used in the Mobetron is similar to techniques used for IORT in other electron accelerator systems. The Mobetron provides four (4) electron beams of energy 4, 6, 9 and 12 MeV, and a set of electron applicators of various diameters from 3 cm to enable the delivery of Intraoperative Radiotherapy (IORT) treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room (O.R.) / 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)
Performance tests were conducted and the results indicated that the Mobetron consistently performed within the design parameters and equivalently to the predicate device.
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
Accelerator, 510(k) Device
Number K852907
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS as required by section 807.92(c)
| 1. | Submitter's Information: | Dated March 24, 1998
Intraop Medical, Inc.
3170 De La Cruz Blvd., Suite 108
Santa Clara, CA 95054 |
|----|---------------------------------------|------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Donald A. Goer, Ph.D.
President & CEO
(408) 986-6020 (phone)
(408) 986-0222 (fax) |
| 2. | Common or Usual Name: | Electron Linear Accelerator (Linac) |
| | Proprietary and Trade Name of Device: | MOBETRON |
| | Device Classification: | System, Radiation Therapy, Charged-Particle, Medical |
| 3. | Predicate Device: | Siemens Mevatron ME Linear |
The MOBETRON is a mobile electron beam accelerator designed 4. Description of Device: specifically for use in the operating room (O.R.). Once in the OR, the accelerator head can be positioned in the horizontal plane, rotated about the coronal plane, and moved along the beam axis direction to facilitate docking with an electron applicator that is inserted into the patient. Together with the C-arm rotation, the accelerator head motion is designed to allow the accelerator to be easily and safely positioned for intraoperative treatments. All motorized motions are variable speed and are controlled by a lightweight hand-held control. The operator control system contains the dosimetry readout parameters, accelerator controls, machine interlock status, and a video output of the periscopic viewing system.
When the electrons emerge from the accelerator, they are scattered by a set of thin metallic foils and are pre-collimated to a circular field size of 10 cm. (at the standard treatment distance of 50 cm. SSD) by a primary tungsten collimator. The scattered electron beam passes through two independent transmission ion chambers and is further collimated to the desired field size by electron applicators which are inserted into the patient. The scattering foil and collimation technique and applicator systems used in the Mobetron is similar to techniques used for IORT in other electron accelerator systems. The Mobetron provides four (4) electron beams of energy 4, 6, 9 and 12 MeV, and a set of electron applicators of various diameters from 3 cm to enable the delivery of Intraoperative Radiotherapy (IORT) treatment.
Statement of Intended Use: The Mobetron is a mobile electron linear accelerator that న. produces beams of electrons used in the radiation therapy treatment of both malignant (cancer) and benign conditions. The Mobetron has four electron beam treatment energies and a set of electron applicators which provide a range of field sizes from 3 to 10 cm in diameter.
For delivery of electron beam radiation during a surgical procedure, known as Intraoperative Radiation Therapy (IORT), the Mobetron system includes a sterile cap and sterile drapes for each IORT procedure, IORT applicators, a QA system, a surgical table extender with added support leg, and bolus material.
The intended use is the same as the predicate device.
1
i ર. Statement of Technological Characteristics: The basic operation of the Mobetron is similar to that of any electron linear accelerator system, in that it employs a modulator, electron gun, rf-system and accelerator guide system. In the Mobetron, a lightweight electron beam linear accelerator is mounted on a motor driven gantry. The gantry is attached to a stand which is supported on a selfcontained transportation system. A modulator and operator control console complete the system. This system produces electron beams of energies, field size, and dose rate equivalent to other electron accelerators used for IORT.
The intended use and performance characteristics are equivalent to the predicate device and therefore we believe it is substantially equivalent to it.
Differences: The differences between the systems are minor and do not effect the safety and 7. efficacy of the treatment. The major difference between the Mobetron and the predicate device is that the predicate device is fixed in location and limited to a single O.R. The Mobetron is mobile and can be used in more than one O.R. Once it is in a specific O.R., its use is essentially identical to the predicate device. To assure that the Mobetron is performing correctly after it is moved to a new location, output and energy checks are made using a quality assurance device provided with the unit. The predicate device requires similar testing of output and energy prior to use even though the device is not moved. The Mobetron is thus substantially equivalent to the predicate device.
Performance Evaluation: Performance tests were conducted and the results indicated that 8. the Mobetron consistently performed within the design parameters and equivalently to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized image. The image is of a caduceus, a symbol of medicine, with a single snake winding around a staff. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 1998
Donald A. Goer, Ph.D. President Intraop Medical 3170 De La Cruz Blvd., Suite 108 Santa Clara, CA 95054
Re:
K981112 Mobetron (Electron Linear Accelerators) Dated: March 24, 1998 Received: March 26, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 LHN
Dear Dr. Goer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Cosmenc Act (Act). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INDICATIONS FOR USE
The Mobetron is a mobile electron linear accelerator that produces beams of electrons used in the radiation therapy treatment of both malignant (cancer) and benign conditions. The Mobetron has four electron beam treatment energies and a set of electron applicators which provide a range of field sizes from 3 to 10 cm in diameter.
For delivery of electron beam radiation during a surgical procedure, known as Intraoperative Radiation Therapy (IORT), the Mobetron system includes a sterile cap and sterile drapes for each IORT procedure, IORT applicators, a QA system, a surgical table extender with added support leg, and bolus material.
Daniel G. Symm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109)