(107 days)
DMLC IV (K001163)
Not Found
No
The document describes a hardware modification to a medical device (improved leaf resolution in a microMLC system) and does not mention any software or algorithmic components related to AI or ML.
No
The device is described as an "add-on microMLC system" and an "accessory to the linear accelerator used for radiation therapy." Its purpose is to "shape the X-ray field" to "assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues." This indicates it is a component of a therapeutic system, rather than a standalone therapeutic device itself.
No
Explanation: The device is described as an accessory for a linear accelerator used in radiation therapy, intended to shape the X-ray field for treatment delivery. Its purpose is to assist in shaping radiation beams during therapy, not to provide diagnostic information about a patient's condition.
No
The device description explicitly states it is an "add-on MLC Apel M consist of a 112 leaves individually controlled and monitored having a 2.5mm thickness at the isocenter and a field size of 120 mm x 140 mm," indicating it is a hardware component with physical leaves.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Apex is an accessory to a linear accelerator used for radiation therapy. Its purpose is to shape the X-ray field to deliver radiation to target tissue and spare normal tissue. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a physical device (an add-on microMLC system) that manipulates radiation beams. This aligns with a therapeutic device, not a device used to examine specimens from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
Therefore, based on the provided information, Apex is a therapeutic device accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Apex™ is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.
Product codes (comma separated list FDA assigned to the subject device)
IXI
Device Description
This Traditional 510(k) describes modifications made to the add-on DMLC accessory for the Elekta range of digital linear accelerators. The primary reason for these enhancements is to improve the leaf resolution - Apex 11 has a reduced leaf width of 2.5mm and increased field size.
The add-on MLC Apel M consist of a 112 leaves individually controlled and monitored having a 2.5mm thickness at the isocenter and a field size of 120 mm x 140 mm.
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.
DMLC IV (K001163)
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
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.
0
510(k) SUMMARY
SEP 3 0 2011
Date of preparation of summary: May 10th 2011
Submitted by:
Trade Name:
Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH10 9RR, United Kingdom Fax: +44 (0) 1293 654260 Telephone: +44 (0) 1293 654201
Contact name:
Mr Patrick Hull Apex TM
Common Name: Add-on microMLC
Classification Name:
5710, Product Code IXI)
Predicate Device: DMLC IV (K001163)
Product Description:
This Traditional 510(k) describes modifications made to the add-on DMLC accessory for the Elekta range of digital linear accelerators. The primary reason for these enhancements is to improve the leaf resolution - Apex 11 has a reduced leaf width of 2.5mm and increased field size.
BLOCK, BEAM-SHAPING, RADIATION THERAPY (21CFR 892
Intended Use Statement:
Apex™ is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.
Indication for Use Statement:
Apex ™ is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.
Summary of Technological Characteristics:
The add-on MLC Apel M consist of a 112 leaves individually controlled and monitored having a 2.5mm thickness at the isocenter and a field size of 120 mm x 140 mm.
There has been no substantial change made to the underlying technological characteristics of the product.
Substantial Equivalence
The functionality for the Apex™ is equivalent to its predicate device DMLC IV (K001163) in safety and effectiveness. The fundamental technical characteristics are the same as those of the predicate device and differences in operation are described in the comparison as and discussion provided elsewhere in this 510(k) submission.
| 2011/05/10 | Apex | Document 05-01 |
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| © 2011 Elekta Limited, Crawley, UK. All rights reserved. | Page 1 of 1 |
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in blue text. To the left of the text is an emblem featuring a stylized human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JUL 2 4 2012
Mr. Patrick Hull Regulatory Affairs Engineer Elekta Limited Linac House, Fleming Way CRAWLEY, WEST SUSSEX RH10 9RR UNITED KINGDOM
Re: K111676
Trade/Device Name: Apex Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation Therapy beam-shaping block Regulatory Class: II Product Code: IXI Dated: May 10, 2011 Received: June 15, 2011
Dear Mr. Hull:
This letter corrects our substantially equivalent letter of September 30. 2011. 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 Parts 801 and 809); medical device reporting (reporting of
2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Section 4 - Indications for Use Statement and Technical Description of Apex
Apex
510(k) Number (if known): _ KII I676
Device Name:
Indications for Use:
Apex is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Mary S Potts
Concurrence of CDRH, Office of Device Evaluation of
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