(254 days)
The NOVAC 11 is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Known 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 device is a linear electron accelerator for intra-operative treatments. Thanks to its construction characteristics, it can be used directly in the operating room. NOVAC 11 is a reusable and non sterile electromedical device.
It is a mobile and articulated device. It can be moved towards the patient and put in the needed positions to carry out the necessary radiotherapy.
Radiation technique consists of administering a uniform and collimated dose of ionizing radiations to the tumor or other site. It is made through the surgical incision.
Collimation is performed by "Applicators" made of PMMA to minimize braking radiation.
Applicators are positioned according to the "Hard Docking" technique which ensures the maximum alignment accuracy, thus ensuring highly reproducible dosages.
The accelerator is equipped with an uninterruptible power supply which makes it completely independent during the radiation phase. Indeed, it ensures radiation continuity even if there are network power interruptions.
The provided documentation is a 510(k) summary for the NRT S.p.A. NOVAC 11, an electron linear accelerator for intra-operative radiation therapy (IORT). It does not contain specific details about acceptance criteria, device performance metrics, or a study design for evaluating these aspects. The document primarily focuses on establishing substantial equivalence to predicate devices and adherence to international safety and quality standards for medical electrical equipment.
Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from the given text, nor can I elaborate on specific study details as they are not present.
However, I can extract information about the regulatory context and the general nature of the performance data presented, and explain what is missing based on your request.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
- Information in document: The document explicitly states: "The New Radiant Technology S.p.A. NOVAC 11 device has been developed and tested according to the following international standards" and then lists several IEC and ISO standards. It also mentions "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - FDA - May 2005".
- Missing Information: The document does not provide specific, quantifiable acceptance criteria for performance metrics (e.g., accuracy of radiation dose, beam uniformity, consistency) or the reported device performance values against these criteria. Instead, it refers to compliance with general safety and performance standards. For a medical device like a radiation therapy system, acceptance criteria would typically include parameters like dose accuracy, beam energy stability, field size accuracy, and safety interlock effectiveness, each with specific pass/fail thresholds. The document does not provide these.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information in document: The document does not describe any specific clinical or performance test set, sample size, or data provenance. The "Performance Data" section refers to adherence to international standards and guidance documents, implying testing was done to meet these standards, but details of such testing (e.g., number of test cases, origin) are not provided.
- Missing Information: There is no mention of a test set size, its origin, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Information in document: The document does not mention any experts being used to establish ground truth for a test set, as no test set requiring such expert assessment is described.
- Missing Information: No information is provided regarding experts or their qualifications for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information in document: The document does not describe any adjudication method for a test set.
- Missing Information: No adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Information in document: The NOVAC 11 is an electron linear accelerator for radiation therapy, not a diagnostic imaging device with an AI component designed to assist human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device and is not mentioned.
- Missing Information: Not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information in document: The NOVAC 11 is a physical medical device (an electron linear accelerator) that delivers radiation therapy. It is operated by human users (medical professionals) and does not inherently function as a standalone "algorithm" in the typical sense of AI/software performance evaluations. The "Software life cycle processes" standard (IEC EN 62304) is mentioned, indicating software is part of the device, but its performance is integrated into the device's overall function, not evaluated as a standalone algorithm in isolation from the hardware components and human operation.
- Missing Information: Not applicable in the context of an "algorithm only" study as typically understood for AI-driven diagnostic tools. Performance of the device's software would be part of the overall device performance verification, not an "algorithm-only" standalone study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information in document: Since no specific clinical or performance study with a test set needing ground truth is described, no type of ground truth is mentioned. For a radiation therapy device, "ground truth" for performance would often refer to physical measurements of radiation output, beam characteristics, and geometric accuracy using phantoms and dosimetry equipment calibrated to established standards.
- Missing Information: No information on the type of ground truth specifically used for a performance study.
8. The sample size for the training set
- Information in document: This information is not provided. The document refers to development and testing according to standards, but does not detail any "training set" in the context of machine learning or AI.
- Missing Information: No sample size for a training set is mentioned.
9. How the ground truth for the training set was established
- Information in document: This information is not provided, as no training set is mentioned.
- Missing Information: No information on how ground truth for a training set was established.
Summary of Device and its "Performance Data" in the Document:
The NOVAC 11 is an electron linear accelerator for Intraoperative Radiation Therapy (IORT). Its "Performance Data" presented in this 510(k) summary focuses entirely on adherence to a list of international standards for medical electrical equipment safety, electromagnetic compatibility, software life cycle processes, risk management, and specific requirements for electron accelerators.
The document uses these standards as evidence of the device's "performance" in terms of safety, design, and manufacturing quality, rather than presenting results from a clinical efficacy or specific performance accuracy study with quantifiable metrics. This approach is common in 510(k) submissions where the device is substantially equivalent to existing predicate devices and is primarily evaluated based on meeting recognized industry standards and established safety profiles.
{0}------------------------------------------------
4112286
NOVAC 11
APR 1 9 2012
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------NRT S.p.A. 510(K) NOTIFICATION
- "
510(k) Summary
NOVAC 11
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
t
2.1. General Information
Submitter:
New Radiant Technology S.p.A. Via Dell'Industria, 1/A 04011 - Aprilia (LT) Italy
Establishment Registration Number: 3008058228
Contact Person in Italy:
Contact Person:
Guido Bonapace ISEMED srl Via Borgo Santa Cristina 12 40026 Imola (BO) Italy Mob.phone: +39-335-5378686 Telephone: +39-0542 683803 Fax: +39-0542 698456 Email: gbonapace(@jsemed.eu
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Telephone: 978-207-1245 Fax: 978-824-2541 Email: Maureen@OConnellRegulatory.com
Summary Preparation Date:
2.2. Names Device Name: Classification Name:
Product Code: Regulation number:
July 30, 2011
NOVAC I I Medical charged-particle radiation therapy system
IYE 892.5050
CONFIDENTIAL
Page 19
{1}------------------------------------------------
NRT S.p.A. 510(K) Notification
2.3. Predicate Devices
NOVAC 11 is substantially equivalent to the following devices:
| Applicant | Device name | 510(k) Number |
|---|---|---|
| Hytesis S.p.A. | NOVAC7 | K990209 |
| Intraop Medical Inc. | MOBETRON | K981112 |
NOVAC 11 and its predicate devices are electron linear accelerators used for radiation therapy (IORT) during surgical procedures in an operating room. They are used for the treatment of malignant and benign conditions.
NOVAC 11 and their predicate devices are also indicated for the same intended use and have the same operating principle (linear acceleration) and equivalent technical characteristics.
2.4. Device Description
The device is a linear electron accelerator for intra-operative treatments. Thanks to its construction characteristics, it can be used directly in the operating room. NOVAC 11 is a reusable and non sterile electromedical device.
It is a mobile and articulated device. It can be moved towards the patient and put in the needed positions to carry out the necessary radiotherapy.
Radiation technique consists of administering a uniform and collimated dose of ionizing radiations to the tumor or other site. It is made through the surgical incision.
Collimation is performed by "Applicators" made of PMMA to minimize braking radiation.
Applicators are positioned according to the "Hard Docking" technique which ensures the maximum alignment accuracy, thus ensuring highly reproducible dosages.
The accelerator is equipped with an uninterruptible power supply which makes it completely independent during the radiation phase. Indeed, it ensures radiation continuity even if there are network power interruptions.
2.5. Indications for Use
The NOVAC 11 is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Known 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.
Page 20
{2}------------------------------------------------
NRT S.D.A. . 510(K) NOTIFICATION
The NOVAC 11 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.
2.6. Performance Data
The New Radiant Technology S.p.A. NOVAC 11 device has been developed and tested according to the following international standards:
- IEC 60601-1 Medical Electrical Equipment Part.1: General requirements for . safety. I : Collateral standard : safety requirements for Medical Electrical Systems.
- . IEC 60601-1-2 Medical Electrical Equipment Part.1: General requirements for safety. 2- Collateral standard: electromagnetic compatibility - requirements and tests.
- IEC 60601-1-4 Medical electrical equipment Part 1-4: General requirements for . safety - Collateral standard: Programmable electrical medical systems.
- . IEC 60601-2-1 Medical electrical equipment -- Part 2-1: Particular requirements for the safety of electron accelerators in the range of I MeV to 50 MeV.
- ISO 14971 Medical Devices Application of risk management to medical ● devices.
- IEC EN 62304:2006 - Medical device software - Software life cycle processes.
Furthermore, New Radiant Technology has also used the guidance documents below:
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - FDA - May 2005
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three arms or extensions reaching upwards. The graphic is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-00002
APR 1 9 2012
New Radiant Technology S.p.A. % Mr. Guido Bonapace Consultant ISEMED srl Via Borgo Santa Cristina 12 IMOLA (BO) 40026 ITALY
Re: K112286
Trade/Device Name: NOVAC 11 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 10, 2012 Received: April 11, 2012
Dear Mr. Bonapace:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or any 1 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
{4}------------------------------------------------
Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
NOVAC 11
NRT S.p.A. 510(K) NOTIFICATION
Indications for Use
510(k) Number (if known) K112284
Device Name: NOVAC 11
Indications for Use:
The NOVAC 11 is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Known 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 NOVAC 11 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 involved surgical area of interest.
Prescription Use X (Part 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K112286
§ 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.