(152 days)
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No
The description focuses on algorithmic approaches, standard image processing techniques, and static radiation beams, with no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML models.
No.
AccuSoft is a radiation treatment planning system that calculates and displays radiation dose estimations. It is intended to guide a physician in selecting the optimum patient treatment plan rather than directly treating a disease or condition itself.
No
The device is a radiation treatment planning system that computes radiation dose estimations and aids in selecting optimal patient treatment plans. It does not diagnose medical conditions.
Yes
The device description explicitly states "It consists of a software package" and describes functionalities typical of radiation treatment planning software, without mentioning any accompanying hardware components that are part of the device itself. While it interacts with other systems (image acquisition, radiation delivery), the device being described is the software.
Based on the provided information, this device, AccuSoft, is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description of AccuSoft clearly indicate it is a radiation treatment planning system that uses image acquisition and processing to plan radiation delivery to a patient's body. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The purpose of AccuSoft is to plan and estimate radiation dose for therapeutic treatment. IVDs are used for diagnostic purposes, such as detecting diseases, monitoring health conditions, or determining compatibility.
AccuSoft falls under the category of a medical device, specifically a radiation treatment planning system. Its function is to assist healthcare professionals in planning and delivering radiation therapy, which is a therapeutic intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
AccuSoft is intended to be used for the computation, display, evaluation, and output documentation of radiation dose estimations that are to be submitted for independent clinical review and verification by a physicist or physician prior to use.
The application provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.
Product codes (comma separated list FDA assigned to the subject device)
90 IYE
Device Description
AccuSoft is a radiation treatment planning system. It consists of a software package that executes accepted algorithmic approaches to produce radiation dose estimations and of extensive verification and quality assurance (QA) procedures to enable the proper system and patient setup and adequate radiation delivery. It includes the same image acquisition, localizing, delineation and beam planning techniques. AccuSoft is designed with stationary or "static" radiation beams. These beams can be shaped with a shaping device, a Micro-Multi-Leaf Collimator (MMLC), such that the shape of the radiation beam conforms to the irregular shape of the lesion. The ability to shape the radiation beam enables the user to treat irregularly shaped lesions, maximizing the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures.
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
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Indicated Patient Age Range
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Intended User / Care Setting
competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
PerMedics' OptiRad K993895
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.
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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).
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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.
0
510(K) SUMMARY AccuSoft 510(k) Number K_03217/
Applicant's Name:
Direx Systems Corp. 11 Mercer Road, Natick Business park Natick, MA 01760 United States of America Tel: (508) 6510900 Fax: (508) 6518125
Contact Person:
Larisa Gershtein Direx Systems Corp. 11 Mercer Road Natick, MA 01760 Tel: (888) 874 7837 Fax: (508) 651-8125 E-mail: lgershtein@direxusa.com
Trade Name:
AccuSoft™
Model:
AccuSoft
Classification Name:
System, Planning, Radiation Therapy Treatment
Classification:
The FDA has classified this type of devices as class II (product code 90 IYE, Regulation No. 892.5050) and they are reviewed by the Radiology Panel.
Predicate Devices:
PerMedics' OptiRad K993895
Performance Standards:
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act.
1
KØ32171
However, AccuSoft complies with the following voluntary standards: Guidance for FDA Reviewers and Industry - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. IEC 601-1-4, Medical electrical equipment - Part 1:General requirements for safety - 4. Collateral Standard: Programmable electrical medical systems."
FDA/CDRH/ODE Draft Document - Guidance for Off-the-Shelf Software Use in Medical Devices (June 4, 1997).
EN 1441 (1997) - Medical Devices: Risk analysis;
Collateral Standard: Programmable electrical medical systems and IEC 60812 (1985) - Failure Mode and Effects Analysis.
Intended Use:
AccuSoft is intended to be used for the computation, display, evaluation, and output documentation of radiation dose estimations that are to be submitted for independent clinical review and verification by a physicist or physician prior to use.
The application provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.
Device Description:
AccuSoft is a radiation treatment planning system. It consists of a software package that executes accepted algorithmic approaches to produce radiation dose estimations and of extensive verification and quality assurance (QA) procedures to enable the proper system and patient setup and adequate radiation delivery. It includes the same image acquisition, localizing, delineation and beam planning techniques. AccuSoft is designed with stationary or "static" radiation beams. These beams can be shaped with a shaping device, a Micro-Multi-Leaf Collimator (MMLC), such that the shape of the radiation beam conforms to the irregular shape of the lesion. The ability to shape the radiation beam enables the user to treat irregularly shaped lesions, maximizing the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures.
Substantial Equivalence:
Based on validations and performance testing results, Direx Systems Corp. believes that AccuSoft is substantially equivalent to the predicate device cited above without raising new safety and/or effectiveness issues.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2003
Ms. Larisa Gershtein QA Manager DiREX Systems Corporation 11 Mercer Road NATICK MA 01760
Re: K032171 Trade/Device Name: AccuSoft Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: November 6, 2003 Received: November 10, 2003
Dear Ms. Gershtein:
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 (OS) 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)
I his lotter will and in your your 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 11 you toon 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
Page 2
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: AccuSoft Indications for Use:
AccuSoft is to be used for the computation, display, evaluation, and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment by a physicist or physician prior to use. The device provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use __
Daniela. bezzam
(Division Sign-Off) Division of Reproductive, Abdomis and Radiological Devic 5 10(k) Number