(27 days)
Not Found
No
The summary describes a radiation treatment planning system that uses algorithms for dose estimation and beam shaping. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is a radiation treatment planning system (RTPS) used for dose estimation, not for direct therapeutic intervention.
No
Explanation: The device is a radiation treatment planning system (RTPS) used for calculating and displaying radiation dose estimations for therapy, not for diagnosing a condition.
Yes
The device description explicitly states that it "consist[s] of a collection of software modules that execute algorithms". While it interacts with hardware (Linac, MMLC, DICOM server), the device itself is described solely as software. The performance studies section also references software-specific guidance documents.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy." This describes a device used in the planning and delivery of radiation treatment, which is a therapeutic procedure performed on a patient.
- Device Description: The device is described as a "radiation treatment planning system (RTPS)" that "executes algorithms to produce estimates of beam radiation dose distribution in body tissues." This further reinforces its role in radiation therapy planning.
- Lack of In Vitro Activity: IVD devices are designed to perform tests on specimens taken from the human body (like blood, urine, tissue samples) to provide information about a person's health. This device does not interact with or analyze such specimens. It uses imaging data (CT Images) to plan treatment on the patient.
Therefore, the function and purpose of this device clearly fall outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CrossPlan / AccuSoft-XL v. 4.04 is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.
Product codes
90 MUJ
Device Description
CrossPlan / AccuSoft-XL v. 4.04 is an upgraded version of the Company's proprietary AccuSoft-XL. CrossPlan / AccuSoft-XL v. 4.04 is a radiation treatment planning system (RTPS), consisting of a collection of software modules that execute algorithms to produce estimates of beam radiation dose distribution in body tissues. It includes the image, delineation and beam planning techniques.
CrossPlan / AccuSoft-XL v. 4.04 is designed to operate with Cones, Blocks and Wedges, as well as with 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 maximization of the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures.
CrossPlan / AccuSoft-XL v. 4.04 is used for computation, display, evaluation, and output of dose estimations, including those for several modes of treatment, such as Conformal, Blocks and Wedges, Cones and Intensity Modulated Radiation Therapy (IMRT). There are several IMRT treatment modes: (1) Intensity Modulated Arc Therapy (IMAT) - in which an irradiating Linac rotates while leaves form a sequence of apertures (arcs), (2) Dynamic Intensity Modulated Radiation Therapy (DIMRT) – in which irradiating Linac is stationary while leaves form a sequence of apertures, as well as (3) Intensity Modulated Radiation Therapy (also called Step-and-Shoot), during which apertures are formed prior to irradiation
As an option, some of the data can be imported via DICOM server that will include information of RT objects (RT Plan, RT Structure Set, RT Images) and CT Images.
CrossPlan / AccuSoft-XL v. 4.04 is able to combine two registered images to create a fusion image. This is often used to combine two images acquired differently but from a single source to enhance the display of various materials or tissues.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
RT Objects (RT Plan, RT Structure Set, RT Images), CT Images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, CrossPlan / AccuSoft-XL v. 4.04 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: May 11, 2005.
- IEC 60601-1-4 Consol. Ed. 1.1 Medical Electrical Equipment Part 1-4: . General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems (1996) + A1 (1999).
- . Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices; September 9, 1999.
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.
0
SECTION 5 -- 510(k) SUMMARY
K 0634/82
[Submitted pursuant to 21 CFR 807.92(a). All data included in this document are accurate and complete to the best of DSC's knowledge.]
| 1. Submitter Information | DEC 14 2006 | |
|---|---|---|
| Date: | ||
| Submitter: | November 3, 2006 | |
| Direx Systems Corporation | ||
| 437 Turnpike Street | ||
| Canton | ||
| MA 02021 | ||
| Telephone: | ||
| Fax: | ||
| Contact Person | (339) 502-6013 | |
| (339) 502-6018 | ||
| Larisa Gershtein | ||
| QA Manager | ||
| Contact Person e-mail address: | lgershtein@direxusa.com | |
| 2. Device | ||
| Trade/Proprietary Name: | AccuSoft-XL v. 4.04, will also be | |
| marketed as CrossPlan | ||
| Classification Name: | System, Planning, Radiation | |
| Therapy Treatment | ||
| Regulation Number: | 21 CFR 892.5050 | |
| Regulatory Class: | Class II (special controls) | |
| Product code: | 90 MUJ | |
| Panel: | Radiology Devices |
3. Predicate Devices
| Direx Systems Corp | AccuSoft-XL v. 4.01 | (K062032) |
|---|---|---|
| ADAC Laboratories Inc, | Pinnacle3 RTP v. 6.6 | (K032724) |
1
4. Intended Use:
CrossPlan / AccuSoft-XL v. 4.04 is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.
5. Device Description
CrossPlan / AccuSoft-XL v. 4.04 is an upgraded version of the Company's proprietary AccuSoft-XL. CrossPlan / AccuSoft-XL v. 4.04 is a radiation treatment planning system (RTPS), consisting of a collection of software modules that execute algorithms to produce estimates of beam radiation dose distribution in body tissues. It includes the image, delineation and beam planning techniques.
CrossPlan / AccuSoft-XL v. 4.04 is designed to operate with Cones, Blocks and Wedges, as well as with 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 maximization of the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures.
CrossPlan / AccuSoft-XL v. 4.04 is used for computation, display, evaluation, and output of dose estimations, including those for several modes of treatment, such as Conformal, Blocks and Wedges, Cones and Intensity Modulated Radiation Therapy (IMRT). There are several IMRT treatment modes: (1) Intensity Modulated Arc Therapy (IMAT) - in which an irradiating Linac rotates while leaves form a sequence of apertures (arcs), (2) Dynamic Intensity Modulated Radiation Therapy (DIMRT) – in which irradiating Linac is stationary while leaves form a sequence of apertures, as well as (3) Intensity Modulated Radiation Therapy (also called Step-and-Shoot), during which apertures are formed prior to irradiation
As an option, some of the data can be imported via DICOM server that will include information of RT objects (RT Plan, RT Structure Set, RT Images) and CT Images.
5-2
2
CrossPlan / AccuSoft-XL v. 4.04 is able to combine two registered images to create a fusion image. This is often used to combine two images acquired differently but from a single source to enhance the display of various materials or tissues.
6. Performance Testing
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, CrossPlan / AccuSoft-XL v. 4.04 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: May 11, 2005.
- IEC 60601-1-4 Consol. Ed. 1.1 Medical Electrical Equipment Part 1-4: . General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems (1996) + A1 (1999).
- . Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices; September 9, 1999.
7. Substantial Equivalence
CrossPlan / AccuSoft-XL v. 4.04 is a modification of its predicate AccuSoft-XL (K062032).
CrossPlan / AccuSoft-XL v. 4.04 differences relative to its predicate devices do not raise additional safety or effectiveness issue as evidenced by performance validation.
Based on the descriptive information and the performance testing we believe that CrossPlan / AccuSoft-XL v. 4.04 is substantially equivalent to its predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUM." written around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Larisa Gershtein QA Manager DIREX System Corporation 437 Turnpike Street CANTON MA 02021
DEC 1 4 2006
Re: K063482
Trade/Device Name: Accusoft-XL v.4.04 (also be marketed under the name CrossPlan) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: November 15, 2006 Received: November 17, 2006
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 (Premarket Approval), 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.
Image /page/3/Picture/10 description: The image is a circular seal with text and symbols. The text "1906-2006" is at the top of the seal. The letters "FDA" are in the center of the seal. The word "Centennial" is at the bottom of the seal. There are three stars below the word "Centennial".
oting Public S.
4
Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the logo for Direx Systems Corp. The word "Direx" is in large, bold, black letters with a line underneath. Below the line, the words "SYSTEMS CORP." are in smaller, black letters.
Section 4: Indications for Use Statement
Indications for Use STATEMENT
510(k) Number (if known): K063482
Device Name:
Accusoft-XL v.4.04 (also be marketed under the name CrossPlan)
Indications for Use:
Accusoft-XL v.4.04 / CrossPlan is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.
Prescription Use ✔ (Per 21 CFR § 801.109)
OR
Over the Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Nancy Broadon
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number _
437 Turnpike Street ♦ Canton, MA 02021 Phone: (339) 502-6013 ♦ Fax: (339) 502-6018 e - mail p r o m o @ @ d i r e x u s a . c o m