(146 days)
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.
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.
The provided 510(k) summary for DART-12, K052705, does not contain information about specific acceptance criteria or a dedicated study demonstrating the device's performance against such criteria.
Instead, the document focuses on:
- Substantial Equivalence: The primary strategy for clearance is to demonstrate substantial equivalence to previously cleared predicate devices (AccuLeaf v2.1 (K040553) and BrainLAB MMLC (K020860)). The summary states that "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."
- Compliance with Voluntary Standards: The device complies with several IEC (International Electrotechnical Commission) standards, which are general safety and performance standards for medical electrical equipment.
Therefore, I cannot provide the requested table or detailed study information because it is not present in the provided text.
Here's a breakdown of why each specific point you requested cannot be fully addressed based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Information in text: The text mentions "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act." It then lists voluntary standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4).
- Missing Information: There are no specific acceptance criteria (e.g., leaf positioning accuracy within X mm, repetition accuracy within Y, etc.) or quantitative performance metrics reported for DART-12. The IEC standards are general safety and performance standards, not specific acceptance criteria for the clinical performance of an MMLC in terms of radiation delivery accuracy.
2. Sample size used for the test set and the data provenance
- Information in text: Not found.
- Missing Information: No details are provided about any test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Information in text: Not found.
- Missing Information: This information would typically be part of a clinical performance study, which is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information in text: Not found.
- Missing Information: As no test set or expert review (ground truth establishment) is mentioned, no adjudication method would be detailed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Information in text: Not found.
- Missing Information: DART-12 is described as a LINAC based Micro-Multi-Leaf-Collimator. It is a hardware and software system for shaping radiation beams, not an AI-assisted diagnostic or decision-support tool for human readers. Therefore, an MRMC study related to human reader improvement with AI assistance would not be applicable to this device's function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information in text: Not found.
- Missing Information: While DART-12 has control software that calculates leaf motion, the document does not describe a standalone performance study in isolation from the LINAC or clinical use. The "performance" assessment relies on substantial equivalence and compliance with engineering standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Information in text: Not found.
- Missing Information: Since no specific performance study establishing a ground truth is described, this information is not available.
8. The sample size for the training set
- Information in text: Not found.
- Missing Information: The description of DART-12 doesn't indicate it utilizes machine learning models that would require a "training set" in the common sense (e.g., for AI/deep learning). Its software appears to be based on deterministic algorithms for leaf motion calculation.
9. How the ground truth for the training set was established
- Information in text: Not found.
- Missing Information: As no training set is indicated, this information is not applicable.
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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:
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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.
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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:
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.
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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.
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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
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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
§ 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.