(105 days)
Not Found
No
The summary describes a mechanical device (multileaf collimator) for shaping radiation fields and does not mention any AI/ML components or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
Yes
The device assists in the delivery of radiation to treat well-defined target volumes (e.g., tumors), which is a therapeutic function.
No
The device is described as a multileaf collimator intended to shape radiation fields for therapeutic delivery, not to diagnose a condition.
No
The device description explicitly states it is a "dynamic multileaf collimator designed to be mounted on the linear accelerator," indicating it is a hardware component.
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 "shape the specific fields... 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 patients, specifically in radiation therapy.
- Device Description: The description reinforces this by stating it's a "dynamic multileaf collimator designed to be mounted on the linear accelerator," which is a piece of equipment used for delivering radiation treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is used to physically shape the radiation beam during treatment.
N/A
Intended Use / Indications for Use
TIGRT MLC 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
Device Description
TIGRT MLC 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.
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
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
KO90802
JUL - 7 2009
Summary of Safety and Effectiveness
March 20, 2009
1. Submitter's Information
DYNAMIC MULTILEAF COLLIMATOR Common/Usual Name:
Proprietary Name:
TiGRT MLC, TiGRT DMLC
Applicant Name and Address:
LinaTech, LLC 1294 Kifer Road, #705 Sunnyvale, CA 94086 Telephone: 408-733-2051 Fax: 408-733-2045
2. Predicate Devices
DMLC (K060187)
3. Classification
This device is classified as a Class II device according to 21 CFR 892:5050
4. Performance Standards
No applicable standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.
Image /page/0/Picture/16 description: The image is a black and white picture that appears to be a scan of a document or a textured surface. The image is mostly white with a scattering of black spots and marks across the surface. The distribution of the black marks is somewhat uneven, with some areas having a higher concentration than others. There are also some vertical lines or streaks present, particularly along the edges of the image.
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5. Device Description and Intended Use
TIGRT MLC 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. Biocompatibility
No new issues of biocompatibility are raised with regard to this device.
7. 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.
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| Characteristic | Current Modified Device | Predicate Device |
|---|---|---|
| TiGRT MLC | DMLC (K061087) | |
| Operating | ||
| System | MS Windows XP and Vista | MS Windows XP |
| Intended Use | TIGRT MLC 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. | 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. | ||
| Application(Use) | Static Field Shaping; | |
| Step and Shoot IMRT Field | ||
| Shaping; | ||
| Sliding Window IMRT Field | ||
| Shaping; | ||
| SRS and SRT Field Shaping; | ||
| Dynamic (Arc) field shaping. | Static Field Shaping; | |
| Step and Shoot IMRT Field | ||
| Shaping; | ||
| Sliding Window IMRT Field | ||
| Shaping; | ||
| SRS and SRT Field Shaping; | ||
| Dynamic (Arc) field shaping. | ||
| Beam Shaping | Linac with Photon and Electron | |
| beam, and C60 beam | Linac with Photon and Electron | |
| beam, and C60 beam | ||
| Communication | DICOM RT | DICOM RT |
| COM ports | ||
| support | 8 COM ports, reserved for Arc RT, | |
| R/V, IGRT, Breathing Signal Input | 6 COM ports, reserved for Arc | |
| RT, R/V, IGRT Signal Input | ||
| Leaf Pairs | 27 pairs- 53 pairs (selectable) | 27 pairs |
| Networking | TCP/IP | TCP/IP |
.
.
: .
Table 1: Comparison of Modified Device TiGRT MLC with Predicate Device
. ,
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three wing-like shapes. The image is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2009
Mr. Jonathan Yao President and CEO LinaTech, LLC 1294 Kifer Road, #705 SUNNYVALE CA 94086
Re: K090802
Trade/Device Name: TIGRT MLC Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 10, 2009 Received: June 11, 2009
Dear Mr. Yao:
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. Ilsting 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 (PMA). it may be subject to 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.
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); medical device reporting (reporting of medical
4
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting 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
K090802 510(k) Number (if known):_
Device Name: ___ TIGRT MLC
Indications for Use:
TIGRT MLC 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
OR Over-The-Counter Use
. (Per 21 CFR 801.109)
Hulda Russo
(Division Sign (Division Sign-On)
Division of Reproductive, Abdominal, Division ological Devices 510(k) Number