(88 days)
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 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.
The provided text describes the 510(k) summary for the Radionics TLC Pediatric Frame, a re-locatable head holder system for pediatric radiation therapy. However, it does not contain a specific study with detailed acceptance criteria and reported device performance metrics in the format requested.
The document focuses on demonstrating substantial equivalence to a predicate device (Radionics Gill-Thomas-Cosman (GTC) Re-locatable Head Holder System, K934523), rather than presenting a standalone performance study with quantitative acceptance criteria.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the TLC Pediatric Frame. Instead, it relies on demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated, inferred from 'substantial equivalence') | Reported Device Performance |
|---|---|---|
| Relocatable Accuracy | (Implied to be comparable to predicate's established accuracy for LINAC-based radiation treatments and imaging) | Not Quantified |
| Patient Comfort/Fit | (Implied acceptability for pediatric use, similar to predicate's adult use with pediatric adaptations) | Not Quantified |
| Image Compatibility | (Implied compatibility with CT and angiographic imaging, similar to predicate) | Not Quantified |
| Safety | (Implied to be safe, with "quality assurance equipment and procedures to verify, prior to patient treatment, that the TLC Frame is accurately positioned".) | Not Quantified |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Non-clinical tests were conducted to demonstrate that the TLC Pediatric Frame meets all product requirements." However, it does not specify the sample size used for these tests, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a mechanical device like a head frame, the "test set" would likely refer to a series of physical measurements and experiments conducted in a lab setting, rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish ground truth for the "test set" in the context of clinical accuracy or diagnosis. The testing described appears to be engineering verification and validation against product requirements, likely performed by the manufacturer's internal engineering team.
4. Adjudication Method:
Since no expert input for ground truth is mentioned, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. This type of study is more relevant for diagnostic AI tools where human readers interpret images. The TLC Pediatric Frame is a physical medical device.
6. Standalone Performance Study:
The document states: "Non-clinical tests were conducted to demonstrate that the TLC Pediatric Frame meets all product requirements." This implies a standalone (algorithm only, though in this case, device only) performance assessment against pre-defined engineering requirements. However, no quantitative performance metrics from such a study are provided in the summary. The focus is on substantial equivalence to the predicate device.
7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" would be the engineering specifications and design requirements for the device (e.g., dimensional accuracy, stability, material properties, repeatability of positioning). There is no mention of clinical ground truth derived from pathology, outcomes data, or expert consensus in this summary.
8. Sample Size for the Training Set:
Not applicable. The TLC Pediatric Frame is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. (See point 8).
In summary:
The provided 510(k) summary for the Radionics TLC Pediatric Frame is focused on demonstrating substantial equivalence to an existing predicate device based on technological characteristics and non-clinical performance testing. It does not provide the detailed quantitative acceptance criteria and study results typically found in performance studies for diagnostic or AI-driven medical devices. The "study" mentioned is general non-clinical testing to ensure the device meets its product requirements and is comparable to the predicate.
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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 PlanningSystem 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.
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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,
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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
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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.
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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 _________________________________________________________________________________________________________________________________________________________
§ 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.