(87 days)
Not Found
No
The summary describes a hardware accessory and software that enables IMRT functionality by controlling a multileaf collimator and suspending the radiation beam. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions. The performance studies focus on system functionality testing, not AI/ML model performance.
Yes
The device is described as assisting in the delivery of radiation to target volumes while sparing normal tissue, which is a therapeutic function for conditions like cancer.
No
The device is an accessory for a linear accelerator used in radiation therapy, assisting in the delivery of radiation. It does not diagnose medical conditions.
No
The device is described as an "optional accessory" for a hardware component (Radionics Mini-Multileaf Collimator) and is mounted on a Linear Accelerator. It also utilizes a "Varian gating board" to interact with the Linac, indicating a direct hardware interface and control function.
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 assist in the delivery of radiation therapy to patients. It is a component of a radiation delivery system.
- Device Description: The description confirms it's an accessory for a linear accelerator, which is a device used for external beam radiation therapy. It facilitates the shaping and modulation of the radiation beam.
- Lack of In Vitro Activity: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue). This device does not interact with patient samples in this way. It interacts with the radiation beam and the patient's body externally.
Therefore, the VariLink 2 MMLC is a therapeutic device or an accessory to a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VariLink 2 MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics' Treatment Planning Software, the MMLC enables static conformal treatments to be performed with finely shaped field patterns.
The VariLink 2 MMLC is intended to assist the radiation oncologist team in the The Varithe 2 Wirise 15 method target volumes while sparing surrounding normal the world critical organs from excess radiation. The Varilink 2 MMLC can be used s part of IMKT (Intensity Modulated Radiotherapy) or general conformal radiation.
Product codes
90 IYE
Device Description
The device is an optional accessory for the Radionics Mini-Multileaf Collimator (MMLC), mounted on a Varian C-Series Linear Accelerator (Linac). VariLink 2 allows Intensity Modulation Radiation Therapy (IMRT) functionality to be used on a Varian Linac. The Radionics' Treatment Planning software generates treatment plans with segmented beams, in which the intensity within the irradiation field is not constant (as in conventional treatments) but varies across the field. This requires the LINAC to suspend the beam between segments to allow the MMLC to change fields. VariLink 2 uses the Varian gating board to suspend the beam to allow MMLC to change the shape of the field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
well defined target volumes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation oncologist team
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
A rigorous test of the functionality of VariLink 2 was conducted using a Varian C-Series Linac with the Gating Board Interface.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
System testing verifies that the device is ready for clinical use. A rigorous test of the functionality of VariLink 2 was conducted using a Varian C-Series Linac with the Gating Board Interface.
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
K023519
12 510(k) Summary
JAN 1 6 2003
Radionics VariLink 2 510(k) Summary
This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.
1.0 The submitter of this premarket notification is:
Kevin J. O'Connell Senior Regulatory Associate Radionics, a division of Tyco Healthcare Group LP 22 Terry Avenue Burlington, MA 01803 Tel .: (781) 272-1233 Fax: (781) 272-2428
This summary was prepared on October 16, 2002.
- 2.0 The name of the device is the Radionics VariLink 2. The common name is Radiotherapy beam shaping block, and its classification name is Medical charged-particle radiation therapy system.
- 3.0 The above device is substantial equivalent to the Radionics ConforMAX MMLCVR1 was cleared via 510(k), K993594, on December 15, 1999.
- 4.0 The device is an optional accessory for the Radionics Mini-Multileaf Collimator (MMLC), mounted on a Varian C-Series Linear Accelerator (Linac). VariLink 2 allows Intensity Modulation Radiation Therapy (IMRT) functionality to be used on a Varian Linac. The Radionics' Treatment Planning software generates treatment plans with segmented beams, in which the intensity within the irradiation field is not constant (as in conventional treatments) but varies across the field. This requires the LINAC to suspend the beam between segments to allow the MMLC to change fields. VariLink 2 uses the Varian gating board to suspend the beam to allow MMLC to change the shape of the field.
- 5.0 The device is intended for use in stereotactic, conformal, computer planned, LINAC (linear accelerator) based radiation. The indications for use are: The VariLink 2 MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics' Treatment Planning Software, the MMLC enables static conformal treatments to be performed with finely shaped field patterns.
1
- 6.0 System testing verifies that the device is ready for clinical use. A rigorous test of the functionality of VariLink 2 was conducted using a Varian C-Series Linac with the Gating Board Interface.
2
Image /page/2/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 a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three lines that form the shape of a snake wrapped around a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2003
Mr. Kevin J. O'Connell Senior Regulatory Associate Radionics. A Division of Tyco Healthcare 22 Terry Avenue BURLINGTON MA 01803-2516 USA
Re: K023519
Trade/Device Name: Radionics VariLink 2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system
Regulatory Class: II Product Code: 90 IYE Dated: October 17, 2002 Received: October 21, 2002
Dear Mr. O'Connell:
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 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); 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.
3
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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.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
Page 2
4
ODE Indications for Use Statement
510(k) Number (if known): K023519
Device Name: Radionies VariLink 2 MMLC
indicalions for Use:
The Varilink 2 MMLC is intended to assist the radiation oncologist team in the The Varithe 2 Wirise 15 method target volumes while sparing surrounding normal the world critical organs from excess radiation. The Varilink 2 MMLC can be used s part of IMKT (Intensity Modulated Radiotherapy) or general conformal radiation цていたけどのし
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prevengstion Use (ther 21 CFR $ 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
David A. Seymon
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number