(85 days)
Not Found
No
The document describes image comparison and error detection based on comparing current treatment fraction data to a prior baseline fraction. There is no mention of AI, ML, or related concepts like training sets, test sets, or complex algorithms that would typically indicate the use of AI/ML. The description focuses on a direct comparison method.
No.
The device is used for quality assurance of radiation therapy delivery, not for directly treating a patient's disease or condition.
No
The device is described as a quality assurance tool for detecting errors in the delivery of radiation therapy treatment, rather than a tool for diagnosing a patient's medical condition. It performs consistency checks on the treatment delivery system and components.
No
The device description explicitly states that the software is installed on "standard, modern computing hardware (provided with the software)", indicating that hardware is included as part of the device.
Based on the provided information, PerFRACTION is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived 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").
- PerFRACTION's Function: PerFRACTION analyzes images generated during radiation therapy treatment delivery. It compares these images to detect errors in the delivery system (multi-leaf collimator, accelerator, etc.). It is not analyzing biological samples from the patient.
- Intended Use: The intended use clearly states it's for "detection of errors that can occur in the delivery of a patient's radiation therapy treatment," and for "providing a consistency check on the delivery of the treatment fraction." This focuses on the technical aspects of the treatment delivery, not on diagnosing a patient's condition based on biological samples.
Therefore, PerFRACTION falls under the category of a medical device used in the context of radiation therapy treatment delivery quality assurance, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PerFRACTION is intended to allow for the detection of errors that can occur in the delivery of a patient's radiation therapy treatment.
PerFRACTION allows for the comparison of the cumulative exit image(s) for one treatment fraction to the cumulative exit image(s) for another treatment fraction, thus providing a consistency check on the delivery of the treatment fraction.
Product codes
IYE
Device Description
PerFRACTION™ is a device that includes software installed on standard, modern computing hardware (provided with the software) that allows clinicians to perform quality assurance for each fraction of a radiotherapy treatment plan. PerFRACTION compares the beam-exit measurement data from a treatment fraction to data from a prior baseline fraction. This comparison allows for the detection of errors that may occur with the delivery system such as the multi-leaf collimator, accelerator, and collimating jaws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
electronic portal imaging device (EPID)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians / 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)
PerFRACTION™ has been tested in non-clinical and clinical settings, and it has been shown that this device performs within its design specifications. Performance testing involved assessment of the device when exposed to errors in the collimation jaws, multileaf collimator leaves, accelerator output, and gantry rotation of the treatment delivery device. Based on the results of this performance testing when evaluated against published data for the predicate, Model 1215 PerFRACTION is as safe, as effective, and performs as well or better than 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2014
Sun Nuclear Corporation % Mr. Jeff Kapatoes Sr. Director Product Management 3275 Suntree Boulevard MELBOURNE FL 32940
Re: K141800
Trade/Device Name: PerFRACTION (Model 1215) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 30, 2014 Received: July 3, 2014
Dear Mr. Kapatoes:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use Form
510(k) Number (if known):
Device Name: Model 1215 PerFRACTION
Indications for Use:
PerFRACTION is intended to allow for the detection of errors that can occur in the delivery of a patient's radiation therapy treatment.
PerFRACTION allows for the comparison of the cumulative exit image(s) for one treatment fraction to the cumulative exit image(s) for another treatment fraction, thus providing a consistency check on the delivery of the treatment fraction.
Perscription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K141800 510(k)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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510(k) Summary K141800
Provided in accordance with 21 CFR 807.92 (c)
1 General Provisions
Date Prepared:
June 30, 2014
Submitted by:
Sun Nuclear Corporation 3275 Suntree Blvd. Melbourne, FL 32940 Ph: 321-259-6862 Fax: 321-259-7979 Web: www.sunnuclear.com
Contact Person:
Jeff Kapatoes jeffkapatoes@sunnuclear.com
Common Name:
Quality Assurance for Patient Radiation Treatment
Trade Names:
Model 1215 PerFRACTION™
Establishment Registration Number:
1038814
Classification:
Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Product code: IYE
Predicate Device:
| Model Name: | COMPASS |
|---|---|
| Common Name: | Accelerator, linear, medical |
| 510(k) # | K072374 |
| Manufacturer: | Scanditronix Wellhdfer GmbH |
| Cleared: | Dec 7, 2007 |
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Image /page/4/Picture/1 description: The image is a logo for Sun Nuclear Corporation. The logo features a blue square with a yellow circle inside of it on the left side. The words "SUN NUCLEAR" are in large blue letters, and the word "corporation" is in smaller blue letters below it.
2 Description:
PerFRACTION™ is a device that includes software installed on standard, modern computing hardware (provided with the software) that allows clinicians to perform quality assurance for each fraction of a radiotherapy treatment plan. PerFRACTION compares the beam-exit measurement data from a treatment fraction to data from a prior baseline fraction. This comparison allows for the detection of errors that may occur with the delivery system such as the multi-leaf collimator, accelerator, and collimating jaws.
3 Intended Use Statement:
Model 1215 PerFRACTION is intended to allow for the detection of errors that can occur in the delivery of a patient's radiation therapy treatment.
PerFRACTION allows for the comparison of the cumulative exit image(s) for one treatment fraction to the cumulative exit image(s) for another treatment fraction, thus providing a consistency check on the delivery of the treatment fraction.
ব Technological Characteristics
PerFRACTION™ utilizes the output from the electronic portal imaging device (EPID) that is part of the treatment delivery device to perform a consistency check between fractions, while the predicate uses an array of ionization chambers. The EPID confers the advantage of having very high density detectors (0.4 mm spacing or less) while the predicate offers the use of ionization chambers. The latter item is not viewed as significant as PerFRACTION performs a consistency check fraction and does not convert EPID signal to dose.
5 Performance Data
PerFRACTION™ has been tested in non-clinical and clinical settings, and it has been shown that this device performs within its design specifications. Performance testing involved assessment of the device when exposed to errors in the collimation jaws, multileaf collimator leaves, accelerator output, and gantry rotation of the treatment delivery device. Based on the results of this performance testing when evaluated against published data for the predicate, Model 1215 PerFRACTION is as safe, as effective, and performs as well or better than the predicate device.