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.

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.

AI/ML Overview

The provided text describes the HITESYS NOVAC7 Electron Linear Accelerator and its comparison to a predicate device, the MOBETRON. However, it does not contain the specific information requested about acceptance criteria and a study proving device performance in the context of diagnostic accuracy, which would involve metrics like sensitivity, specificity, or reader performance.

The "Performance Evaluation" section (Item 7) focuses on safety and regulatory compliance, rather than diagnostic or treatment efficacy metrics typically associated with acceptance criteria for device performance. It mentions conformance to electrical patient safety standards (IEC 60601 series) and software development guidelines.

Therefore, I cannot provide a table of acceptance criteria, reported device performance (in terms of clinical efficacy), or details about a study evaluating such performance based on the provided document.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

Table of acceptance criteria and reported device performance: The document only mentions safety standards and software development processes, not performance metrics (e.g., accuracy, precision, error rates) or specific acceptance criteria for the therapeutic outcome of the radiation.
Sample size used for the test set and the data provenance: No test set or clinical data for performance evaluation is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for accuracy is not discussed.
Adjudication method for the test set: Not applicable as a test set for performance evaluation is not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No MRMC study is mentioned. The comparison is between the technical specifications and operational aspects of the NOVAC7 and the MOBETRON, not a comparative clinical effectiveness study involving human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is a linear accelerator for radiation therapy, not an AI algorithm.
The type of ground truth used: Not applicable as there's no discussion of diagnostic or therapeutic accuracy ground truth in the document.
The sample size for the training set: Not applicable as this is not an AI/ML device being "trained."
How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on:

Device description and intended use.
Comparison with a predicate device based on technical design and operational features.
Compliance with electrical safety and software development regulatory standards.
A conclusion of substantial equivalence to the predicate device based on these factors.

It does not provide evidence of performance against clinical acceptance criteria using patient data or expert evaluations.

Summary

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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

Predicate Device: MOBETRON, 510(k) number K981112 Intraop Medical Inc. Santa Clara, CA 95054
Description of Device:

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 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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K990209

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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.

Concurrence of CDRH Office of Device Evaluation Division of Reproductive, Abdominal, ENT, and Radiological Devices

Prescription Use (Per 21CFR 801.109)

Over-The-Counter Use

HHH

Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

Regulation Number and Section

§ 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.