(88 days)
Not Found
No
The summary describes a mechanical head holder system for radiation therapy and imaging, with no mention of AI or ML capabilities.
No
The device is a re-locatable head holder system that serves as a stereotactic platform for radiation treatments and imaging, but it is not directly administering therapeutic energy or substances. It is an accessory to the therapeutic LINAC system.
No
The device is described as a "stereotactic platform" and a "Re-locatable Head Holder System" used for positioning pediatric patients during radiation treatments and imaging. Its function is to hold the head in place, not to diagnose a condition.
No
The device description clearly outlines physical components like a base frame, occipital head cups, earplug tips, and a mold, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing a stereotactic platform for radiation treatments and imaging in the cranium of pediatric patients. This is a direct interaction with the patient's body for therapeutic and imaging purposes.
- Device Description: The device is a physical head holder system designed to position and stabilize the patient's head. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The TLC Pediatric Frame is intended for use as a stereotactic platform for fractionated (multiple, lower dose) LINAC-based radiation treatments and related CT and angiographic imaging in the cranium for the treatment of pediatric patients.
The TLC Frame is indicated for use as a stereotactic platform for fractionated (multiple, lower dose) LINAC-based radiation treatments and related CT and angiographic imaging in the cranium for the treatment of pediatric patients.
Product codes
90 IYE
Device Description
The TLC Pediatric Frame is a Re-locatable Head Holder System. The device consists of a base frame that combines the attachment of various sized plastic occipital head cups, left and right earplug tips, and a mold of the patient's frontal, nasion and lateral of eyes. The Radionics' Depth Helmet attaches to the frame and depth measurements are maintained to allow the operator to re-locate the patient for each radiation therapy treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and angiographic imaging
Anatomical Site
cranium
Indicated Patient Age Range
pediatric patients
Intended User / Care Setting
Not Found
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)
Non-clinical tests were conducted to demonstrate that the TLC Pediatric Frame meets all product requirements. This testing also demonstrates that the performance is substantially equivalent to the predicate device cited above.
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
510(k) Summary of Safety & Effectiveness for the Radionics TLC Pediatric Frame
1. Sponsor
Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803
| Contact Person: | Nancy C. MacDonald |
|---|---|
| Sr. Regulatory Engineer | |
| (781) 272-1233 |
2. Device Name
| Proprietary Name: | TLC Pediatric Frame |
|---|---|
| Common/Usual Name: | Stereotactic Radiation Treatment Planning |
| System and Accessories | |
| Classification Name: | X-ray Radiation Therapy System |
3. Predicate Device
Radionics Software Applications, Inc. believes that within the meaning of the Medical Devices Amendments of 1976, the TLC Pediatric Frame addressed in this premarket notification is substantially equivalent to the following medical device:
The Radionics Gill-Thomas-Cosman (GTC) Re-locatable Head Holder System, cleared under 510(k) #K934523.
4 . Device Description
The TLC Pediatric Frame is a Re-locatable Head Holder System. The device consists of a base frame that combines the attachment of various sized plastic occipital head cups, left and right earplug tips, and a mold of the patient's frontal, nasion and lateral of eyes. The Radionics' Depth Helmet attaches to the frame and depth measurements are maintained to allow the operator to re-locate the patient for each radiation therapy treatment.
1
5. Intended Use
The TLC Pediatric Frame is intended for use as a stereotactic platform for fractionated (multiple, lower dose) LINAC-based radiation treatments and related CT and angiographic imaging in the cranium for the treatment of pediatric patients.
General Safety and Effectiveness 6 .
The TLC Pediatric Frame labeling contains Instructions for Use. The Operator's Manual includes: indications for use, cautions, warnings and user quality assurance procedures. This information promotes safe and effective use of this device.
Comparison of Technological Characteristics 7 .
Radionics Software Applications, Inc. believes that the information and testing provided in this submission clearly describes the technological characteristics of the TLC Pediatric Frame and demonstrates that the TLC Frame is substantially equivalent to the commercially available GTC Re-locatable Head Holder System.
8. Performance Testing
Non-clinical tests were conducted to demonstrate that the TLC Pediatric Frame meets all product requirements. This testing also demonstrates that the performance is substantially equivalent to the predicate device cited above.
9. Safety Summary
The TLC Pediatric Frame has quality assurance equipment and procedures to verify, prior to patient treatment, that the TLC Frame is accurately positioned with respect to the patient's cranium.
10. Basis for Substantial Equivalence
The TLC Frame, addressed in this premarket notification, has the same technological characteristics as the commercially available Radionics GTC Relocatable Head Holder System. Like the GTC, the TLC Frame ins non-invasive, and allows repeat positioning for lower dose multiple fractionated stereotactic LINAC-based radiation treatments and related CT and angiographic imaging,
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.
JUL 30 1999
Nancy macDonald Senior Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K991523 TLC Pediatric Frame Dated: April 30, 1999 Received: May 3, 1999 Regulatory Class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Ms. MacDonald:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
Re:
If your device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page of
510(k) Number (if known):
TLC Pediatric Frame Device Name:
Indications for Use:
The TLC Frame is indicated for use as a stereotactic platform for fractionated (multiple, lower dose) LINAC-based radiation treatments and related CT and angiographic imaging in the cranium for the treatment of pediatric patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thind A. beymm
(Division Sign-Off)
( Division of Reproductive, Abdominal, ENT,
and Radiological Devices and Radiological Devi 510(k) Number
Prescription Use:
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________