(41 days)
Not Found
No
The summary describes software for comparing predicted and measured radiation dose values, which is a standard quality control process in radiation therapy. There is no mention of AI, ML, or related concepts like training sets, test sets, or performance metrics typically associated with AI/ML models. The process is described as "automated and rapid comparison," which can be achieved through conventional algorithms.
No.
The device is a quality control tool for radiation therapy, comparing predicted and measured radiation dose values, and does not directly treat or diagnose a patient.
No
The device is a quality control tool for radiation therapy, comparing predicted and measured radiation dose values to verify the delivery process. It is used prior to patient treatment, not to diagnose a patient's medical condition.
Yes
The device is described as "software to aid in the verification of the delivery process" and "software is intended for the QC of external beam radiation treatments." While it interacts with external hardware (radiographic films, RTPS), the device itself is presented solely as software for data analysis and comparison.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this software is used for the quality control of external beam radiation treatments by comparing predicted and measured radiation dose values. The input data comes from radiographic films and a treatment planning system, not from patient specimens like blood, urine, or tissue.
- The purpose is to verify the delivery process of radiation therapy. This is a quality control tool for a medical procedure, not a diagnostic test performed on a biological sample to determine a patient's health status or diagnose a disease.
The software's function is entirely focused on ensuring the accuracy of the radiation delivery equipment and planning, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended purpose of the Protos Software is to provide a Radiation Therapy Quality Control (QC) tool that allows for the automated and rapid comparison of predicted and measured radiation dose values. The software is intended for the OC of external beam radiation treatments. Measured data will be acquired from radiographic films. Predicted data will be calculated in a Radiotherapy Treatment Planning System (RTPS) and transferred to the software via a Digital Imaging and Communications in Medicine (DICOM) protocol.
External Beam Radiation Therapy is typically delivered to patients from a linear External Beatli Rathanon Therapy is typically over from a radioactive source (high and accelerator with entire paoton of encircal Physics Corporation has designed and low dose rate valiants). "AIX FINAL Privation of the delivery process prior to manufactured software to and in the vermission is a compares the predicted data from a radiotherapy treatment. The software analyzes and compares the pressurer and radiotherapy treatment. The Software und.7200 and volupered dose measurements.
Product codes (comma separated list FDA assigned to the subject device)
90 IYE
Device Description
The Aktina Medical Physics' Protos Software has the same technological characteristics as the RIT 113 Film Analysis System (Radiological Imaging Technology, Inc., K935928). Both systems:
- Consist of Dosimetric Analysis software a.
- b. Import predicted radiation dosimetry data from treatment planning systems
- 0Import measured radiation dosimetry data imported from a film scanner; C. radiographic films are obtained from an IMRT phantom.
- d. Are used as Radiation Therapy Quality Control (OC) tools that allow for the automated and rapid comparison of predicted and measured radiation dose values
- Require personnel trained in the use of Radiation Therapy equipment. c.
- f. Require a Microsoft Windows or equivalent computer environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic films
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
personnel trained in the use of Radiation Therapy equipment.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KD40709
APR 2 8 2004
510(k) Summary Safety and Effectiveness Summary In Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
General Provisions 1.
Device Trade Name: Protos Software Common Name: Dosimetry Analysis Software
Applicant Name and Address:
AKTINA Medical Physics Corporation 360 North Route 9 W Congers, New York, 10920 Phone: 914-268-0101 FAX: 914-268-1700 Registration Number: 2436865
2. Name of Predicate Device
Radiological Imaging Technology, Inc., RIT 113 Film Analysis System, K935928
Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, "...a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977),
3. Classification
This device is classified as a class II device according to 21 CFR 892.5050
4. Performance Standards
The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this product.
1
Intended Use and Device Description 5.
The intended purpose of the Protos Software is to provide a Radiation Therapy Quality Control (QC) tool that allows for the automated and rapid comparison of predicted and measured radiation dose values. The software is intended for the OC of external beam radiation treatments. Measured data will be acquired from radiographic films. Predicted data will be calculated in a Radiotherapy Treatment Planning System (RTPS) and transferred to the software via a Digital Imaging and Communications in Medicine (DICOM) protocol.
Technological Characteristics 6.
The Aktina Medical Physics' Protos Software has the same technological characteristics as the RIT 113 Film Analysis System (Radiological Imaging Technology, Inc., K935928). Both systems:
- Consist of Dosimetric Analysis software a.
- b. Import predicted radiation dosimetry data from treatment planning systems
- 0Import measured radiation dosimetry data imported from a film scanner; C. radiographic films are obtained from an IMRT phantom.
- d. Are used as Radiation Therapy Quality Control (OC) tools that allow for the automated and rapid comparison of predicted and measured radiation dose values
- Require personnel trained in the use of Radiation Therapy equipment. c.
- f. Require a Microsoft Windows or equivalent computer environment.
7. Biocompatibility
The Aktina Medical Corporation Protos Software does not come into contact with the patient and therefore does not require biocompatibility testing.
8. Summary of Substantial Equivalence
This device is similar in design and intended use and performance characteristics to the predicate device. No new issues of safety or effectiveness are introduced by using this device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three heads, representing the department's focus on health and human well-being. The figure is positioned to the right of the department's name, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2004
Mr. Tony Spaccarotella Director. OA/RA Aktina Medical Corporation 360 North Route 9W CONGERS NY 10920
Re: K040709 Trade/Device Name: Protos Software (Model 11-860) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle Radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: March 15, 2004 Received: March 18, 2004
Dear Mr. Spaccarotella:
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 either class II (Special Controls) or class III (PMA), 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 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); 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.
3
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: にの中の709
Device Name: Protos Software
Indications for Use:
External Beam Radiation Therapy is typically delivered to patients from a linear External Beatli Rathanon Therapy is typically over from a radioactive source (high and accelerator with entire paoton of encircal Physics Corporation has designed and low dose rate valiants). "AIX FINAL Privation of the delivery process prior to manufactured software to and in the vermission is a compares the predicted data from a
radiotherapy treatment. The software analyzes and compares the pressurer and radiotherapy treatment. The Software und.7200 and volupered dose measurements.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: V or
Over-The Counter Use:
(Per 21 CFR 801.109)
David R. Segmen
(Division Sign-Off) (Division of Reproductive, Abdon and Radiological Devices 510(k) Number _