(184 days)
No
The description focuses on the mechanical and software control of the multileaf collimator based on a treatment planning system, with no mention of AI or ML technologies.
Yes.
The device is intended to assist in the delivery of radiation therapy, which is a therapeutic treatment.
No
Explanation: The device is a dynamic multileaf collimator intended to shape radiation fields for therapeutic purposes (radiation delivery), not to diagnose diseases or conditions.
No
The device description explicitly states it comprises "multiple motorized tungsten leafs," indicating it includes physical hardware components in addition to software control.
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 designed to "shape the specific fields... to assist the radiation oncologist in the delivery of radiation." This describes a device used in the treatment of patients, specifically in radiation therapy.
- Device Description: The description reinforces this by explaining how the device works with a linear accelerator and a treatment planning system to shape radiation fields.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such activities.
Therefore, the TOPSLANE DMLC is a medical device used in radiation therapy for treatment delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, 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.
Product codes
IYE, IXI
Device Description
TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the various linear accelerator. It comprises multiple motorized tungsten leafs and By controlling each leaf to the designed position according to the software. treatment planning system (TPS), TOPSLANE DMLC is intended to shape the specific field, either in static or dynamic mode. TOPSLANE DMLC can perform different field shaping methods, such as Static Field Shaping, or Step and Shoot IMRT Field Shaping or Sliding Window IMRT Field Shaping.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SUMMARY OF SAFETY AND EFFECTIVENESS
Compliance with 513(i) of the Federal Food, Drug and Cosmetic Act
660187
January 18, 2006
JUL 27 2006
1. Submitter's Information
| Common/Usual Name: | DYNAMIC MULTILEAF COLLIMATOR |
|---|---|
| Proprietary Name: | TOPSLANE DMLC |
| Applicant Address: | Topslane International, LLC |
| 15375 Roosevelt Blvd. Suite #300, | |
| Clearwater, FL 33760 | |
| Contact Person: | Jim Marsh, President |
| Telephone: | 727-507-8500 |
| Fax: | 727-507-9192 |
2. Predicate Devices
m3 (micro-Multileaf Collimator) (K004022, K020860)
Therapeutic X-Ray Collimator Device Classification Name: Regulatory Class: Class II (according to 21 CFR 892.5050)
3. Performance Standards
No applicable standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.
1
4. Device Description
K60187
TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the various linear accelerator. It comprises multiple motorized tungsten leafs and By controlling each leaf to the designed position according to the software. treatment planning system (TPS), TOPSLANE DMLC is intended to shape the specific field, either in static or dynamic mode. TOPSLANE DMLC can perform different field shaping methods, such as Static Field Shaping, or Step and Shoot IMRT Field Shaping or Sliding Window IMRT Field Shaping.
5. Intended Use
TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, 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.
The intended use is the same as the predicate device.
6. Summary of Substantial Equivalence
This device is similar in design and construction, and has the same intended use and performance characteristics to the predicate device. It utilizes materials that are already in use in other medical devices. No new issues of safety or effectiveness are introduced by using this device.
2
Image /page/2/Picture/1 description: The image is a circular seal with the logo of the Department of Health & Human Services (HHS). The seal features the HHS emblem, which consists of a stylized caduceus-like symbol with three wavy lines representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 27 2006
Mr. James N. Marsh President TOPSLANE International. LLC 15375 Roosevelt Blvd.. Suite #300 CLEARWATER FL 33760
Re: K060187
Trade/Device Name: TOPSLANE DMLC Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE. IXI Dated: June 16. 2006 Received: June 20, 2006
Dear Mr. Marsh:
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/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "PA" are in the center of the logo in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
3
Page 2 -
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.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C.Bogdon
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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Page 1 of 1
510(k) Number (if known): K[60187]
Device Name:
Indications for Use:
TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, 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.
(PLEASE DO NOT WRITE BELLOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98) Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109) (Division Sign-Off), Division of Reproductive, Ab
and Padiological Devices 510(k) Number _