(120 days)
Not Found
No
The summary describes algorithmic approaches for dose calculation and planning, but does not mention AI or ML.
No.
The device is a radiation treatment planning system intended for computation, display, evaluation, and documentation of radiation treatments. It does not directly provide a therapeutic effect but rather supports the planning of such treatments.
No
The device is a radiation treatment planning system used for computing and evaluating radiation dose calculations for cancer treatment, not for diagnosing medical conditions.
Yes
The device description explicitly states "AccuSoft is a radiation treatment planning system. It consists of a Software package...". While it interacts with other systems for radiation delivery, the core device being described and cleared is the software itself for planning.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that AccuSoft is for the computation, display, evaluation, and output documentation of radiation treatment planning. This is a process related to delivering therapy, not diagnosing a condition based on in vitro samples.
- Device Description: The description confirms it's a "radiation treatment planning system" used for calculating radiation dose distributions and planning radiation delivery. This aligns with therapeutic planning, not in vitro diagnostics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. AccuSoft's function is entirely focused on planning the delivery of radiation therapy.
N/A
Intended Use / Indications for Use
AccuSoft is intended to be used for the computation, display, evaluation, Accusoft is intended to be accurion dose estimations including and output documentation of radiation Treatment (IMRT) that thise for Thrensity arounded and clinical review and verification by a physicist or physician prior to use.
The application provides output data in the form of displays or The application provides output a physician in selecting the bound by natucopy printouts to garao a personal provide a report to be used by patient treathent professional such as a radiation oncologist, a comportist, radiation therapist or dosimetrist.
AccuSoft is to be used for the computation, display, evaluation, and output Accumentation of radiation dose estimations including those for Intensity Modulated Radiation Treatment (IMRT), to be submitted for independent clinical review and judgment by a physicist or physician much to use. The device provides output data in the form of displays or prior to abores.
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 tratifies 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, 90 MUJ
Device Description
AccuSoft is a radiation treatment planning system. It consists of a AccuSoft is a factation treatment proxected algorithmic approaches to Soltware package that aloous and of extensive verification and produce radiation dose coundations to enable the proper system and patient setup and adequate radiation delivery.
It includes the image, delineation and beam planning techniques. The it includes the miage, delineation 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
It includes the image, delineation and beam planning techniques.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologist, radiation oncologist, a comportist, radiation therapist or dosimetrist.
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
JUN 2 3 2004
510(K) Summary
AccuSoft 510(k) Number K (40474
Applicant's Name:
Direx Systems Corp. 11 Mercer Road, Natick Business park Natick, MA 01760 United States of America
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); they are reviewed by the Radiology Panel.
Applicable Standards:
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act.
However, AccuSoft complies with the following consensus standards:
-
IEC 60812 (1985) Failure Mode and Effects Analysis.
IEC 60601-1-4 - Consol. Ed. 1.1 (2000-04) Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral Standard: Programmable electrical medical systems.
- IEEE Std 829 (1998) Standard for Software Test Documentation A
- IEEE Std 830 (1998) Recommended Practice for Software Requirements Specifications A
- ISO 14971 (2000) Medical devices Application of risk management to medical devices A
- Guidance on Medical Device Patient Labeling; Final Guidance for Industry and
1
FDA Reviewers, April 19, 2001
-
An Introduction to Human Factors in Medical Devices, December 1996
-
An ma oduction is = " = " = " = " = " = " = " = " = " = " = " = " = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = > Guidance for FDA Keviewers and Industry, Cartical Devices May 29, 1998
- Chiarter Buonnestone Software Validation; Final Guidance for Industry and FDA A Staff January 11, 2002
- Start July 21, 2017 11:41
Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices September 9, 1999
Intended Use:
AccuSoft is intended to be used for the computation, display, evaluation, Accusoft is intended to be accurion dose estimations including and output documentation of radiation Treatment (IMRT) that thise for Thrensity arounded and clinical review and verification by a physicist or physician prior to use.
The application provides output data in the form of displays or The application provides output a physician in selecting the bound by natucopy printouts to garao a personal provide a report to be used by patient treathent professional such as a radiation oncologist, a comportist, radiation therapist or dosimetrist.
Device Description:
AccuSoft is a radiation treatment planning system. It consists of a AccuSoft is a factation treatment proxected algorithmic approaches to Soltware package that aloous and of extensive verification and produce radiation dose coundations to enable the proper system and patient setup and adequate radiation delivery.
It includes the image, delineation and beam planning techniques. The it includes the miage, delineation 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.
Predicate Devices:
Based on validations and performance testing results, Direx Systems Corp. Dascu on valuations and pubstantially equivalent to the following belleves that hecabor is backening new safety and/or effectiveness issues.
- AccuSoft, v2.02., radiation treatment planning system cleared on . Accurson, V2.02., Facking number K032171), manufacturer Direx Systems Corp.
- DMLC IV ERGO cleared on October 23, 2000 (Tracking number . K001163). Manufacturer 3D Line
2
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-like symbol with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2004
Ms. Larisa Gershtein QA Manager Direx Systems Corp. 11 Mercer Road NATICK MA 01760 Re: K040474 Trade/Device Name: AccuSoft Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: May 18, 2004 Received: May 21, 2004
Dear Ms. Gershtein:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bection 310(t) promotion is substantially equivalent (for the indications felerenced above and nave coloring to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manated posice Americal Device Americal processor of Coast Drug commerce prior to May 20, 1970, the excordance with the provisions of the Federal Food, DNA devices that have been recuassincs in accordance wal of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ap and Cosment Act (Act) that do not require apper o the general controls provisions of the Act. The You may, therefore, thanker the device, only of equirements for annual registration, listing of general Controls provisions of the rice, 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 If your device is classince (see above) nits. Existing major regulations affecting your device can may be subject to sach additional ochilonial official of the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pouchar Eng
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
that FDA has made a determination that your device complies with one waters and that FDA has made a Gecermanation that Jointer Federal agencies. You must comply of CCP Post or any Federal statutes and regulations administry of the orders and listing (2) CFR Part with all the Act $ requirements, moractice requirements as set forth in the 807), labeling (21 CFR Part 820), and if applicable, the electronic product quality systems (QB) regulation (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 letter will anow you to ocgin hanceling your ever of your device of your device to a legally premarket notification. The PDA miding of bactiation 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 If you desire specific advice for your dones on our 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 Adultionally, for questions on the promotions. Also, please note the regulation entitled, "Misbranding Othece of Compliance at (301) 59 1-100 (21CFR Part 807.97) you may obtain. Other general by reletence to premarket notified.com (Dr of Act may be obtained from the Division of Strail information on your responsionalism 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 STATEMENT
510(k) Number (if known): K040474 Device Name: AccuSoft Indications for Use:
AccuSoft is to be used for the computation, display, evaluation, and output Accumentation of radiation dose estimations including those for Intensity Modulated Radiation Treatment (IMRT), to be submitted for independent clinical review and judgment by a physicist or physician much to use. The device provides output data in the form of displays or prior to abores.
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 tratifies 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)
y Prescription Use _____________________________________________________________________________________________________________________________________________________________
Daniel A. Sprem
(Division Sign-Off) Division of Reproductive, Abdon ann Radiological Devices 51(Jik) Number _