← Product Code [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE) · K052705 # DART-12 (K052705) _Direx Systems Corp. · IYE · Feb 21, 2006 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K052705 ## Device Facts - **Applicant:** Direx Systems Corp. - **Product Code:** [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE.md) - **Decision Date:** Feb 21, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.5050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Therapeutic ## Indications for Use DART-12 is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. ## Device Story DART-12 is a LINAC-based Micro-Multi-Leaf-Collimator (MMLC) system used in radiation therapy. It shapes the linear accelerator (Linac) beam to match target volumes while sparing healthy tissue. The system comprises an MMLC module, Linac interface, workstation with control software, and distribution module. It operates in conjunction with a Linac and treatment couch. The software calculates leaf motion based on current measured positions and desired destinations from treatment plans. It supports three modes: Step-and-Shoot (apertures modified prior to irradiation), Dynamic Arc (apertures formed at set gantry angles during arc), and Dynamic IMRT (apertures modified while Linac is stationary). The workstation displays leaf positions and provides numeric feedback to the clinician. By automating precise leaf positioning, the device enables complex conformal radiation delivery, potentially improving treatment accuracy and patient outcomes. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics LINAC-based MMLC system. Components: MMLC module, Linac interface, workstation, distribution module. Motor-driven leaves for beam shaping. Complies with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-4. Software-controlled sequential linear process for aperture formation. ## Regulatory 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. ## Predicate Devices - AccuLeaf v 2.1 (k040553) - BrainLAB MMLC (k020860) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Page 1 of 3 ## SECTION 7 - 510(K) SUMMARY ## DART-12 #### 510(k) Number K052705 ## Applicant's Name: Direx Systems Corp. 11 Mercer Road Natick, MA 01760 United States of America Tel: (888) 874 7837 Fax: (508) 651 8125 ## Contact Person: Ms. Larisa Gershtein Direx Systems Corp. 11 Mercer Road Natick, MA 01760 Tel: (888) 874 7837 Fax: (508) 651-8125 E-mail: Igershtein@direxusa.com ## Trade Name: #### DART-12 Model: DART-12 #### Classification Name: Accelerator, Linear, Medical #### Classification: The FDA has classified this type of devices as class II (product code IYE, Regulation No. 892.5050). They are reviewed by the Radiology Panel. ## Establishment Registration Number 1224828 ## Predicate Devices: - 1. AccuLeaf v 2.1 (k040553) cleared on April 01, 2004 - 2. BrainLAB MMLC (k020860) {1}------------------------------------------------ K052705 Page 2 of 3 ## Performance Standards: No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, DART-12 complies with these voluntary standards: - IEC 60601-1(1988) +A1 (1991) +A2 (1995) . - IEC 60601-1-1 (2000) . - . IEC 60601-1-2 (2004) - IEC 60601-1-4 (2000) . ## Intended Use: DART-12 is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. #### Device Description: DART-12 is a LINAC based Micro-Multi-Leaf-Collimator (MMLC), used in radiation treatment. It enables shaping the Linac beam according to target geometrical and clinical requirements. The device is composed of the MMLC module, the Linac interface module, the Workstation (with DART-12 Control Software), and the Distribution module. The device operates in conjunction with a Linac, a treatment couch, and any additional equipment required in radiation treatment. The MMLC apertures, (defined in treatment data file), are generated by positioning the motor-driven leaves. The motors, controlled by DART-12, bring the leaves to specified positions. The DART-12 control software operates as a sequential linear process, where the apertures are performed one by one. To form a desired aperture, DART-12 Control Software calculates leaves motion from knowledge of their current positions (measured) and desired destination (delivered by treatment plan). DART-12 displays an image reflecting the leaves current position. Numeric indication of each leaf position is available. DART-12 three operation modes are: Step-and-Shoot, Dynamic Arc. and dynamic IMRT. {2}------------------------------------------------ K052705 Page 3 of 3 - Step-and-Shoot: MMLC modifies the apertures prior to irradiation. - Dynamic Arc: Irradiating Linac forms an arc while DART-12 forms apertures at a set of Gantry angles. - DIMRT: Irradiating Linac is stationary while DART-12 modifies the apertures. ## Substantial Equivalence: The predicate devices for substantial equivalence are: - 1. AccuLeaf v2.1 (k040553) - 2. BrainLAB MMLC (k020860) The Dart-12 is substantially equivalent to its predicate devices as the basic features design and intended use are the same or similar. The minor differences in design dimensions and features between the Dart-12 and its predicate devices raise no issues of safety and efficacy as these differences have no effect on the performance, function or intended use of DART-12. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 1 2006 Ms. Larisa Gershtein Quality Assurance Manager Direx Systems Corp. 437 Turnpike Street CANTON MA 02021 K052705 Re: Trade/Device Name: DART-12 Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: January 18, 2006 Received: January 20, 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. Please be advised that FDA `s issuance of a substantial equivalence determination docs 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 (0S) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) This leter with anow you to begin maneting of substantial equivalence of your device to a legally premarket nothleation: "The I DA mading of based. 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 If you desire specific advice for your downer car and one of the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note tic regulation chated, "Prisettan" - " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " 807.97). You may outlain other general informations of its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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 {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. Below the word "Direx" is a thick black line, and below that is the text "SYSTEMS CORP." in smaller, black letters. Attachment 4-1 # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K052705 Device Name: DART-12 Indications for Use: DART-12 is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. DART-12 is a tertiary Micro Multi Leaf Collimating (MMLC) system. It performs the same functions as beam shaping blocks, circular or cut blocks collimators for Conformal and "step and shoot IMRT" treatments, and it also performs "dynamic arcs" and "dynamic IMRT" treatments. (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) 510(k) Number_ V Prescription Use (Per 21 CFR § 801.109) OR Over the Counter Use Nancy C. Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number 11 Mercer Road ♦ Natick, Ma 01760 Phone: 1-888-TRIPTER ♦ Fax: 508-651-8125 e-mail:promo@direxusa.com 4-2 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K052705](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K052705) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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