(32 days)
Not Found
No
The summary describes a hardware-based multi-leaf collimator system with associated control software for shaping radiation beams. There is no mention of AI or ML in the device description, intended use, or any other section. The operation is described as a "sequential process of forming apertures" based on data files and potential input from an IGRT system, which is a deterministic process, not indicative of AI/ML.
No
The device is a component used in radiation treatment delivery (a LINAC based Micro-Multi-Leaf-Collimator) and assists in shaping the radiation beam. While it plays a crucial role in radiation therapy, which is a therapeutic process, the device itself is a tool or accessory used during the therapy, rather than being the therapeutic agent or device that directly treats the patient.
No
The device is a Micro Multi Leaf Collimating (MMLC) system used in radiation therapy to shape the Linac beam, which is a treatment function, not a diagnostic one.
No
The device description explicitly states that the device is composed of hardware components including MMLC modules, Linac interface modules, a Workstation, and a Power Distribution module, in addition to software.
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 the device is used 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." This describes a device used in the treatment of a patient, not for the diagnosis of a condition using in vitro methods.
- Device Description: The description details a "LINAC based Micro-Multi-Leaf-Collimator (MMLC)" that shapes a radiation beam. This is a physical device used to modify radiation delivery, not a test performed on biological samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is a component of a radiation therapy system, which is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
TrackLeaf-10 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.
TrackLeaf-10 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.
Product codes
IYE
Device Description
TrackLeaf 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 modules the Linac interface modules the v Workstation (with TrackLeaf. Control. Software), and the Power Distribution module. »
The device operates in conjunction with a Linac, a treatment couch, a data file that contains the desired aperture parameters, and any additional equipment required in radiation treatment. In addition, means are provided to receive aperture offset data from an Image Guided Radiation Therapy (IGRT) system in order to perform leaves position adjustments.
MMLC apertures are generated by positioning the motor-driven leaves. TrackLeaf software operates as a sequential process of forming apertures.
TrackLeaf operation modes are: Step-and-Shoot, Dynamic Arc, and dynamic IMRT (DIMRT).
- Step-and-Shoot: TrackLeaf forms apertures while irradiation is off and gantry is stationary.
- Dynamic Arc: TrackLeaf forms apertures while irradiation is on and the gantry rotates.
- DIMRT: TrackLeaf forms apertures while irradiation is on and the gantry is stationary.
Mentions image processing
Not Found
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
radiation oncologist
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)
Reference Device(s)
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
SECTION 5 - 510(K) SUMMARY
TrackLeaf-10
510(k) Number K 07 l 701
Applicant's Name:
Direx Systems Corp. 437 Turnpike Street Canton, MA 02021 United States of America Tel: (339) 502 6013 Fax: (339) 502 6018
Contact Person:
Ms. Larisa Gershtein E-mail: lgershtein@direxusa.com
Trade Name:
TrackLeaf
Model:
TrackLeaf-10
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
1
Predicate Devices:
Performance Standards:
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act.
However, TrackLeaf complies with these voluntary standards:
- IEC 60601-1(1988) +A1 (1991) +A2 (1995) .
- . IEC 60601-1-1 (2000)
- IEC 60601-1-2 (2001) ●
- IEC 60601-1-4 (1996)+A1(1999) .
Intended Use:
TrackLeaf-10 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.
TrackLeaf-10 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.
Device Description:
:
TrackLeaf 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 modules the Linac interface modules the v Workstation (with TrackLeaf. Control. Software), and the Power Distribution module. »
The device operates in conjunction with a Linac, a treatment couch, a data file that contains the desired aperture parameters, and any additional equipment required in radiation treatment. In addition, means are provided to receive aperture offset data from an Image Guided Radiation Therapy (IGRT) system in order to perform leaves position adjustments.
2
MMLC apertures are generated by positioning the motor-driven leaves. TrackLeaf software operates as a sequential process of forming apertures.
TrackLeaf operation modes are: Step-and-Shoot, Dynamic Arc, and dynamic IMRT (DIMRT).
- Step-and-Shoot: TrackLeaf forms apertures while irradiation is off and gantry is stationary.
- Dynamic Arc: TrackLeaf forms apertures while irradiation is on and the gantry rotates.
- DIMRT: TrackLeaf forms apertures while irradiation is on and the gantry is stationary.
Substantial Equivalence:
TrackLeaf is substantially equivalent to its predicate devices since the intended use is unchanged and the basic features are the same or similar. The differences ! in added features between TrackLeaf and its predicate devices raise no issue of safety and efficacy .
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 2 3 2007
Ms. Larisa Gershtein QA Manager Direx Systems Corporation 437 Turnpike Street CANTON MA 02021
Re: K071701
Trade/Device Name: TrackLeaf-10 Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 14, 2007 Received: June 21, 2007
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 shows a circular logo with the text "1906-2006 FDA Centennial" in it. The logo is black and white and has a star pattern around the edge. The text "FDA" is in large, bold letters in the center of the logo. The logo appears to be a commemorative emblem for the 100th anniversary of the Food and Drug Administration.
Protecting and Promoting Public Health
4
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.xxxx 21 CFR 884.xxxx 21 CFR 892.xxxx Other
240-276-0115 (Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology);
240-276-0115 240-276-0120 240-276-0100
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
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 "Direx" is a horizontal line, and below that is the text "SYSTEMS CORP." in smaller, black letters. The "X" in "Direx" has a textured pattern.
SECTION 4: INDICATIONS FOR USE STATEMENT
Indications for Use Statement
510(k) Number (if known): Ko71701
Device Name:
TrackLeaf-10
Indications for Use:
TrackLeaf-10 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.
TrackLeaf-10 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.
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
Huluthener
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal 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