(146 days)
Not Found
No
The device description explicitly states that a lookup table is used to determine the appropriate collimator pair, which is a deterministic approach and does not involve AI/ML.
Yes
The device is intended to assist in the delivery of radiation for Stereotactic Radio Surgery (SRS) and Stereotactic Radio Therapy (SRT) treatments, which are medical treatments for diseases like cancer.
No
The device is intended to assist radiation oncologists in the delivery of radiation therapy by shaping the radiation beam. It is used for treatment delivery, not for diagnosing medical conditions.
No
The device description explicitly states that AccuChanger is an "add-on to a Linac used for automatic switching of circular collimators during treatments without entering the treatment room." It describes physical components like "two-level circular-collimator set" and "two drums," indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in the delivery of radiation therapy to target volumes in patients. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is an add-on to a Linac (Linear Accelerator) used for shaping the radiation beam during treatment. It manipulates physical collimators to control the radiation field. This is a physical manipulation of a therapeutic device, not a test performed on biological samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The AccuChanger does not fit this description. It is a device used in the delivery of a medical treatment.
N/A
Intended Use / Indications for Use
AccuChanger 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. It is intended to be used for the collimation of megavoltage photon beams in conjunction with Stereotactic Radio Surgery (SRS) and Stereotactic Radio Therapy (SRT) treatments.
Product codes (comma separated list FDA assigned to the subject device)
IXI, IYE
Device Description
AccuChanger device is designed to be used for the Linac beam shaping during radiotherapy. It constitutes an add-on to a Linac used for automatic switching of circular collimators during treatments without entering the treatment room.
AccuChanger uses a two-level circular-collimator set. It has two drums one mounted on top of the other. Each drum has nine drumb one mounted in a descending order of radius. Although it is possible for the collimation to combine any pair of collimators lo possible as a drum, only seventeen combinations are deemed valid. Each valid combination is forming a circular aperture valia. Back value of the circular collimators (upper/lower) is set as the beam shaping collimator, the other (lower/upper respectively) is set as a post/pre bounding "protecting" collimator to reduce radiation transmission.
To start a treatment, a treatment file is needed specifying the aperture diameter at the isocenter for each of the treatment beams (defined input format). AccuChanger-CS calculates the fitting collimator size on one drum and chooses the best match on the other. Since the matching pairs are known in advance, a lookup table is used obviating the need of re-calculating the appropriate collimators pair.
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): 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
510(K) SUMMARY
AccuChanger
MAY - 5 2005
510(k) Number K 043409
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 Business park Natick, MA 01760 United States of America Tel: (508) 6510900 Fax: (508) 6518125
Trade Name:
AccuChanger
Model:
AccuChanger
Classification Name:
Accelerator, Linear, Medical
Classification:
The FDA has classified this type of devices as class II (product code IXI, Regulation No. 892.5710). They are reviewed by the Radiology Panel.
Establishment Registration Number
1224828
Predicate Devices:
The predicate devices for substantial equivalence are:
-
- AccuLeaf K040553, DIREX Systems Corp.
-
- Cranial Stereotactic Equipment, K010065 Arplay/ BrainLab
-
- XKnife K912630, Radionics Software Applications, Inc.,
Performance Standards:
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act.
However, AccuChanger complies with these voluntary standards:
IEC 60601-1 (2000); IEC 60601-1-1 (2000); IEC 60601-1-2 (2001);
1
IEC 60601-1-4, Ed. 1.1 (2000).
.
2
Intended Use:
AccuChanger is intended to assist the radiation oncologist in the Accuentanys is in the well defined target volumes while sparing delively of radiation to won and critical organs from excess radiation.
In this application the AccuChanger performs the same function i in this application shaping blocks, and circular or cut blocks collimators, which have been used for many years.
Device Description:
AccuChanger device is designed to be used for the Linac beam shaping during radiotherapy. It constitutes an add-on to a Linac used for automatic switching of circular collimators during treatments without entering the treatment room.
AccuChanger uses a two-level circular-collimator set. It has two drums one mounted on top of the other. Each drum has nine drumb one mounted in a descending order of radius. Although it is possible for the collimation to combine any pair of collimators lo possible as a drum, only seventeen combinations are deemed valid. Each valid combination is forming a circular aperture valia. Back value of the circular collimators (upper/lower) is set as the beam shaping collimator, the other (lower/upper respectively) is set as a post/pre bounding "protecting" collimator to reduce radiation transmission.
To start a treatment, a treatment file is needed specifying the aperture diameter at the isocenter for each of the treatment beams (defined input format). AccuChanger-CS calculates the fitting collimator size on one drum and chooses the best match on the other. Since the matching pairs are known in advance, a lookup table is used obviating the need of re-calculating the appropriate collimators pair.
Substantial Equivalence:
We claim AccuChanger to be SE to:
-
AccuLeaf K040553, DIREX Systems Corp. 1.
It has identical intended use and indications for use as AccuLeaf. -
Cranial Stereotactic Equipment, K010065 Arplay/BrainLab 2.
-
XKnife K912630, Radionics Software Applications, Inc., 3.
All compared devices have similar principles of operation and technological characteristics. Furthermore, AccuChanger does not present any new method of treatment other than its predicate devices. Any minor differences between the systems do not raise new types of safety or effectiveness issues, as further discussed below.
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MAY - 5 2005
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Larisa Gershtein QA Manager DiREX Systems Corp. 11 Mercer Road
NATICK MA 01760
Re: K043409 Trade/Device Name: AccuChanger Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 14, 2005 Received: April 18, 2005
Dear Ms. Gershtein:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have and have determined the device is substantially equivalent (for the indications for use stated in above una nave determinerarketed predicate devices marketed in interstate commerce prior to the cholore) to regardy mant date of the Medical Device Amendments, or to devices that have been May 20, 1770, the charanteness 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 do not require approval or a ve visions of the Act. The general controls provisions of the Act device, subjoct to the general 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 If your de rever is elabelied (500 acch additional controls. Existing major regulations affecting your Apploval), it the you sable 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 does not mean that I toase oe advisou that your device complies with other requirements of the Act or any I DA has made a acteriminations administered by other Federal agencies. You must comply with all the I cacan states and regulating, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, moraling practice requirements as set forth in the quality systems (QS) (21 CFR Part 80 7), good mo 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) 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 | (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 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 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
AccuChanger
510(k) Number (if known): K043409
AccuChanger 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. It is intended to be used for the collimation of megavoltage photon beams in conjunction with Stereotactic Radio Surgery (SRS) and Stereotactic Radio Therapy (SRT) treatments.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V And (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Nancy C. Brogdon
(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number