(90 days)
No
The summary describes a radiation therapy planning and delivery system with dynamic capabilities but does not mention AI or ML. The performance studies focus on physics and clinical testing, not AI/ML model validation.
Yes
The device is described as an "integrated system for the planning and delivery of dynamic conformal radiation therapy," indicating it is used for treatment.
No
The device is described as an integrated system for the planning and delivery of dynamic conformal radiation therapy, focused on producing a radiation field to conform to tumor volume for treatment, not for diagnosing a condition.
No
The device is described as an "integrated system" and a "radiation therapy treatment planning and delivery system," implying the inclusion of hardware components for radiation delivery, not just software for planning.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for planning and delivering radiation therapy to treat tumors. This is a therapeutic intervention performed on a patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description "Integrated radiation therapy treatment planning and delivery system" further reinforces its role in treatment, not diagnosis.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, this device falls under the category of a therapeutic medical device used for radiation oncology.
N/A
Intended Use / Indications for Use
This device is intended to be used as an integrated system for the planning and delivery of dynamic conformal radiation therapy to produce a radiation field which is modulated to conform to the projected tumor volume plus margins by means of a dynamic (moving) multileaf collimator, while simultaneously moving the accelerator gantry.
Product codes
Not Found
Device Description
Integrated radiation therapy treatment planning and delivery system
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
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
Physics and clinical testing has demonstrated that the Peacock System performs as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Premarket Notification - Peacock™ System
NOV 1 8 1995
Kqb 3258
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act August 19, 1996
- General Provisions
Trade/Proprietary Name
NOMOS PEACOCK System consisting of:
CORVUS (cleared as Peacock™ Plan; K940663) MIMIC™ (K940412)
Common/Usual Name
Integrated radiation therapy treatment planning and delivery system
Radiation therapy treatment planning system (CORVUS)
Linear accelerator mounted treatment delivery system (MIMiC)
Applicant Name and Address
NOMOS Corporation 2591 Wexford Bayne Road Sewickley, PA 15143
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- Names of Predicate Devices'
Integrated PEACOCK Treatment Planning and Delivery System:
- Names of Predicate Devices'
Varian Varisource HDR Afterloader with integrated planning system (K852842) GE Target Planning System (K896353) & Arc Therapy (K802809)
These systems were marketed prior to and/or following enactment of the Medical Device Amendments on May 28, 1976.
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- Classification
Radiation therapy simulation systems were reviewed by the Radiological Devices Classification Panel and placed in Class II (21 CFR 892.5050); an accessory to a medical charged particle radiation therapy system.
- Classification
MIMIC, a radiation therapy beam-shaping block, is classified as class II according to 21 CFR 892.5710; a radiation therapy beam shaping block.
These devices are reviewed by the Radiological Devices Panel of the Division of Reproductive, Abdominal, ENT, and Radiological Devices.
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- Performance Standards
Not applicable.
- Performance Standards
1
5. Intended Use and Device Description
This device is intended to be used as an integrated system for the planning and delivery of dynamic conformal radiation therapy to produce a radiation field which is modulated to conform to the projected tumor volume plus margins by means of a dynamic (moving) multileaf collimator, while simultaneously moving the accelerator gantry.
6. Summary of Substantial Equivalence
The Peacock System is similar in design, construction, materials, intended use and performance characteristics to the predicate treatment planning systems and multileaf collimators. Physics and clinical testing has demonstrated that the Peacock System performs as intended. No new issues of safety or effectiveness are introduced by using this device.