(32 days)
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No
The summary describes mechanical and performance improvements to a multileaf collimator, with no mention of AI or ML.
No.
The device is described as a multileaf collimator, which is an accessory used for conforming a radiation beam during exposure, rather than directly treating a condition. Its function is to modify the radiation beam from a therapeutic device (linear accelerator) but is not itself a therapeutic device.
No
Explanation: The device is a multileaf collimator, which is an accessory for linear accelerators used in radiation therapy. Its function is to conform the radiation beam to the anatomy, not to diagnose a condition.
No
The device description explicitly states it is a "Multileaf collimator," which is a hardware component used in radiation therapy. The modifications described are improvements to the physical performance of this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "conform the radiation beam to the anatomy to be exposed." This describes a function related to radiation therapy, which is a treatment modality, not a diagnostic process performed on in vitro samples.
- Device Description: The description details modifications to a "multileaf collimator for use as an accessory for the Elekta range of medical digital linear accelerators." Linear accelerators are used for delivering radiation therapy, further reinforcing its role in treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information.
Therefore, the MLCi2 Multileaf collimator is a medical device used in radiation therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MLCi2 Multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
Product codes
IYE
Device Description
This Special 510(k) describes modifications to the MLCi multileaf collimator for use as an accessory for the Elekta range of medical digital linear accelerators. These modifications provide the following improvements;
- . Improved x-ray performance (peak and average leakage).
- Improved repeatability of leaf edge position.
- . The ability for leaves to interdigitate.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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
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.
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Image /page/0/Picture/0 description: The image shows the logo for Elekta. The logo consists of a black circle with a white line extending from the center to the edge, resembling a dial. Below the circle, the word "ELEKTA" is written in capital letters.
Kös2122
AUG 2 9 2008
510(k) SUMMARY
Date of preparation of summary: 18th July 2008
Submitted by:
Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH20 9RR, United Kingdom Telephone: +44 (0) 1293 544422 Fax: +44 (0) 1293 654260
Contact name: Mr. Patrick Hull
| Trade Name: | MLCi2 |
|---|---|
| Common Name: | Multileaf Collimator |
| Classification Name: | Medical Linear Accelerator Accessory, IYE |
| Predicate Device: | MLCi (K963624) |
Product Description:
This Special 510(k) describes modifications to the MLCi multileaf collimator for use as an accessory for the Elekta range of medical digital linear accelerators. These modifications provide the following improvements;
- . Improved x-ray performance (peak and average leakage).
- Improved repeatability of leaf edge position.
- . The ability for leaves to interdigitate.
Intended Use Statement:
The MLCi2 Multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
Summary of Technological Characteristics:
The MLCi multileaf collimator has been modified to improve leaf design. The changes made result in the following characteristics;
- Leaf height increased by 6.5%. .
- ◆ Leaf profile and attitude changed to reduce leakage.
- Leaf guidance improved to allow interdigitation. ●
Substantial Equivalence
The functionality for the MLCi2 is equivalent to its predicate device the MLCi (K963624) 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 chart and discussion provided elsewhere in this 510(k) submission.
| 2008/07/18 | MLCi2 | Document 05 - 01 |
|---|---|---|
| © 2008 Elekta Limited, Crawley, UK. All rights reserved. | Page 1 of 1 |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 2 9 2008
Mr. Patrick T. M. Hull Regulatory Affairs Engineer Elekta Limited Linac House, Fleming Way Crawley, West Sussex RH10 9RR UNITED KINGDOM
Re: K082122
Trade/Device Name: MLCi2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 23, 2008 Received: July 28, 2008
Dear Mr. Hull:
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/1/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" in cursive font in the middle. The letters "FDA" are prominently displayed in a bold, stylized font. The logo is surrounded by text that appears to be part of a circular border, but the text is not fully legible. The logo seems to commemorate a centennial, likely related to the FDA.
Promoting Public -
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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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Nancy 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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Indications for Use
510(k) Number (if known):
Device Name ...................... MLCi2
The MLCi2 Multileaf collimator is indicated for use when additional Indication for Use: flexibility is required in conforming the radiation beam to the anatomy to be exposed.
Prescription Use - YES AND/OR Over-The-Counter Use - NO (Per 21 CFR 801.109 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _______________________________________________________________________________________________________________________________________________________________
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