(518 days)
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No
The summary describes a linear accelerator for radiation therapy and its mechanical and electrical features. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as "an electron linear accelerator used for radiation therapy," and its purpose is for "the treatment of malignant and benign conditions," indicating a direct therapeutic action.
No
The device is an electron linear accelerator used for radiation therapy, which is a treatment modality, not a diagnostic one. It delivers radiation to treat conditions rather than identifying or analyzing them.
No
The device description clearly outlines a physical electron linear accelerator with mobile and articulated components, applicators, and beam energies. While it mentions software development, the core device is hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- NOVAC7 Function: The NOVAC7 is a radiation therapy device. It directly delivers radiation to a patient's body during surgery to treat malignant and benign conditions. It does not analyze specimens taken from the body.
The description clearly states its purpose is for "radiation therapy during surgical procedures" and "delivery of high doses of radiation directly aimed at tumors or other sites." This is a therapeutic function, not a diagnostic one based on in vitro analysis.
N/A
Intended Use / Indications for Use
The NOVAC7 is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Know as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites while avoiding dosage to surgically mobilized normal tissues.
The NOVAC7 is a mobile and articulated machine that can be moved towards the patient and put in the appropriate position to carry out the necessary radiotherapy. Applicators direct the electron beam to the surgical area of interest.
Product codes
90 IYE
Device Description
The NOVAC7 is an electron accelerator for intraoperative radiation therapy that can be used in the operating room without making major adjustments to the room. Beam energies are 3, 5, 7, and 9 MeV. It is a mobile, hinged accelerator that can be moved to the patient's location and placed in the appropriate position for performing the required radiotherapy inside a surgical theatre. X-ray leakage into the environment and other related radiation protection problems have been minimized by eliminating diffusion filters which in conventional accelerators widen the beam.
Hard docking is performed in an easy way, reaching any site of the body. Two applicators are used, one is located over the patient area to be treated and the other is permanently mounted on the radiating head. Only the patient applicator comes in contact with the surgery site. The time required for performing docking and scanning irradiation is under five minutes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
tumors or other sites
Indicated Patient Age Range
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Intended User / Care Setting
surgical theatre, operating room
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)
The NOVAC7 has been designed and tested for electrical patient safety by conforming to applicable portions of IEC 60601-1, 60601-1-1, 60601-1-4, and 60601-2-1. The software is developed in accordance with a software development program plan and the software level of concern, as described in the document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 29, 1998.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/0 description: The image contains the logo for HITESYS. The logo consists of a geometric shape on the left and the word "HITESYS" on the right. The geometric shape is a square with diagonal lines inside, and the word "HITESYS" is written in a serif font.
JUN 2 2 2000
K990209
Page 1 of 3
510(k) Summary of Safety and Effectiveness as required by 21 CFR 807.92(c)
| 1. Submitter's Information: Dr. Pompilio Gatto |
|---|
| Hitesys S.p.A. |
| Via dell'Industria 1/A, |
| Aprilia (Latina), Italy |
| Telephone: (+39) 06 9281322 |
| Facsimile: (+39) 06 9281813 |
| E-Mail: hitesys.spa@flashnet.it |
| Date Summary Prepared: 12 January 1999 |
- Device Name:
Common or Usual Name: Electron linear accelerator (Linac) Proprietary and Trade Name: NOVAC7 Classification Name: Radiation Therapy, Charged-Particle, Medical System per 21 CFR 892.5050
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Predicate Device: MOBETRON, 510(k) number K981112 Intraop Medical Inc. Santa Clara, CA 95054
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Description of Device:
The NOVAC7 is an electron accelerator for intraoperative radiation therapy that can be used in the operating room without making major adjustments to the room. Beam energies are 3, 5, 7, and 9 MeV. It is a mobile, hinged accelerator that can be moved to the patient's location and placed in the appropriate position for performing the required radiotherapy inside a surgical theatre. X-ray leakage into the environment and other related radiation protection problems have been minimized by eliminating diffusion filters which in conventional accelerators widen the beam.
Hard docking is performed in an easy way, reaching any site of the body. Two applicators are used, one is located over the patient area to be treated and the other is permanently mounted on the radiating head. Only the patient applicator comes in contact with the surgery site. The time required for performing docking and scanning irradiation is under five minutes.
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K990209
Page 2 of 3
5. Statement of Intended Use:
The NOVAC7 is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Know as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites while avoiding dosage to surgically mobilized normal tissues.
The NOVAC7 is a mobile and articulated machine that can be moved towards the patient and put in the appropriate position to carry out the necessary radiotherapy. Applicators direct the electron beam to the surgical area of interest.
The intended use is the same as the predicate device.
6. Comparison with Predicate Device:
The NOVAC7 and the Mobetron differ in their accelerating structures. The NOVAC7 uses a simple and singular stationary wave structure in which the energy is varied by changing the level of peak power of the magnetron. On the other hand, the Mobetron is based on a collinear structure that is more complex and varies the energy by changing the phase of the power supply of the second structure. The NOVAC7 uses a normal accelerating magnetron in the S band, well known to radiotherapy departments worldwide. The Mobetron uses X band.
The Mobetron has significant attenuation of the electron beam by the use of a scattering filter. This approach provides a dose rate that is easily measured and the possibility of using very short applicators (50 cm). However, as a result, the machine must be heavily shielded and provided with a primary collimator to maintain acceptable levels of diffused radiation. In contrast, the NOVAC7 uses a beam produced by the accelerator without an intermediate structure. This means that longer applicators (80 - 100 cm) must be used and that the measurement of the instantaneous dose requires integrated dosimetry. However, this keeps the weight of the machine down and its diffused radiation to very low levels.
The Mobetron uses soft docking because of the high inertia and weight of the mobile parts of the machine. The radiating head of the NOVAC7 weighs less than 50 Kg and is moved very smoothly by electric motors that in no way allow pressure on the patient. Therefore, hard docking was used. This system ensures excellent mechanical repeatability and therefore an ideal uniformity of the field. The Mobetron requires that the patient always be moved toward the accelerator whereas the NOVAC7 does not require any movement of the patient. The machine is moved by its motors by means of a remote control unit to the operating field and therefore does not require any logistics beyond those usually required during surgery.
In spite of these differences, when considering the requirements of section 510(k) of the Federal Food Drug and Cosmetic Act, the two systems are substantially equivalent based on features such as the use of electron beams for intraoperative radiation therapy, the beam energies, and mobility within the surgical suite.
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Page 3 of 3
7. Performance Evaluation:
The NOVAC7 has been designed and tested for electrical patient safety by conforming to applicable portions of IEC 60601-1, 60601-1-1, 60601-1-4, and 60601-2-1. The software is developed in accordance with a software development program plan and the software level of concern, as described in the document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 29, 1998.
9. Conclusion:
Based on the analysis of the comparison in item 6 above and the performance evaluation results contained in item 7, Hitesys S.p.A. has concluded that the NOVAC7 is safe, effective, and performs as well as or better than the legally marketed device identified in item 3 above.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2000
Pompilio Gatto Managing Director Hitesys S.p.A. Via dell'Industria, 1/A 04011 Aprilia Italy
Dear Mr. Gatto:
and adulteration.
Re:
K990209 Hitesys NOVAC7 Linear Accelerator Dated: May 1, 2000 Received: May 1, 2000 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
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 legally marketed predicate devices marketed in interstate commerce pror 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 Cosmelic 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
lf 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 notfication submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 predication 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) 594-4591. Additionally, for question 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 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,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Statement of Indications for Use
To be assigned 510(k) Number (if known):
Device Name: NOVAC7
The NOVAC7 is an electron linear accelerator used for radiation therapy during surgical The NO VAOT is an operating room for the treatment of malignant and benign conditions. Know as procedures in an operating room of T), this technique allow delivery of high doses of radiation intractly aimed at tumors or other sites while avoiding dosage to surgically mobilized normal tissues.
The NOVAC7 is a mobile and articulated machine that can be moved towards the patient and put in the appropriate position to carry out the necessary radiotherapy. Applicators direct the electron beam to the surgical area of interest.
Concurrence of CDRH Office of Device Evaluation Division of Reproductive, Abdominal, ENT, and Radiological Devices
Prescription Use (Per 21CFR 801.109)
OR
Over-The-Counter Use
HHH
Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number