(781 days)
No
The description focuses on traditional radiation treatment planning algorithms and does not mention AI or ML.
No
This device is a treatment planning system for radiation therapy, designed to guide the delivery of radiation, not to deliver the therapy itself.
No
Explanation: This device is a radiation treatment planning package, which creates treatment simulations and defines beam intensities for delivering radiation therapy. It does not diagnose, detect, or monitor a disease or condition.
Yes
The device is described as a "radiation treatment planning package" and its function is to create treatment plans based on CT data. The description focuses entirely on the software algorithms and processes used for planning, without mentioning any specific hardware components included with the device itself. While it interacts with CT data and is used in conjunction with radiation therapy machines (hardware), the device being cleared is the software package for planning.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The NOMOS Peacock Plan is a software package used for radiation treatment planning. It takes imaging data (CT scans) and user input to calculate and visualize radiation dose distributions for external beam radiation therapy.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is entirely focused on planning the delivery of external radiation based on anatomical information and desired treatment parameters.
Therefore, the device falls under the category of medical devices used for treatment planning, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The NOMOS Peacock Plan is a radiation treatment planning package designed to allow medical physicists, dosimetrists and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by Peacock are based upon treatment machine specific data and are intended to provide a quide to delivering exrernal beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
Peacock Plan has been designed to generate plans for the implementation of 3-D Conformal Radiation Therapy (3-D-CRT) in a manner similar to the predicate devices listed above (Small Systems Group: Prowess 2000, K884261/A/B; GE Target Series 2, K896353; University of Michigan/Scanditronix: Scandiplan K903403). The basis for 3-D-CRT and its implementation is the mirror image of computerized tomography (General Electric K841997, Siemens K910859/A). The Peacock Plan and CT both use variations on computer implementations of filtered backprojection algorithms. In CT, a spatially-uniform-radiation exposure is delivered to the patient and the spatially non-uniform attenuation of the exit beam is measured. Peacock Plan creates treatment simulations based upon user annotated CT information. This information describes the desired shape of the isodose distribution and location of the desired dose. Peacock Plan then defines the beam intensities and shapes to produce this desired dose distribution at the target site. With Peacock Plan, a multileaf collimator, partial-attenuation block or other beam-blocking mechanisms may be employed to generate a spatially, non uniform beam which, when directed at the tumor, will form a spatially- uniform dose around the target volume.
The current version of Peacock Plan is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.
Product codes
Not Found
Device Description
The NOMOS Peacock Plan is a radiation treatment planning package designed to allow medical physicists, dosimetrists and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by Peacock are based upon treatment machine specific data and are intended to provide a quide to delivering exrernal beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
Peacock Plan has been designed to generate plans for the implementation of 3-D Conformal Radiation Therapy (3-D-CRT) in a manner similar to the predicate devices listed above (Small Systems Group: Prowess 2000, K884261/A/B; GE Target Series 2, K896353; University of Michigan/Scanditronix: Scandiplan K903403). The basis for 3-D-CRT and its implementation is the mirror image of computerized tomography (General Electric K841997, Siemens K910859/A). The Peacock Plan and CT both use variations on computer implementations of filtered backprojection algorithms. In CT, a spatially-uniform-radiation exposure is delivered to the patient and the spatially non-uniform attenuation of the exit beam is measured. Peacock Plan creates treatment simulations based upon user annotated CT information. This information describes the desired shape of the isodose distribution and location of the desired dose. Peacock Plan then defines the beam intensities and shapes to produce this desired dose distribution at the target site. With Peacock Plan, a multileaf collimator, partial-attenuation block or other beam-blocking mechanisms may be employed to generate a spatially, non uniform beam which, when directed at the tumor, will form a spatially- uniform dose around the target volume.
The current version of Peacock Plan is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computerized tomography
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical physicists, dosimetrists and radiation oncologists
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Prowess 2000, K884261/A/B, GE Target Series 2, K896353, Scandiplan K903403
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
General Electric K841997, Siemens K910859/A
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
APR - 9 1996
APPENDIX IV
SUMMARY OF SAFETY AND EFFECTIVENESS
Peacock Plan
K-940663
Pursuant to Section 513(i) of the Federal Food, Drug, and Cosmetic Act
l, General Information
Classification Name: Radiation Therapy Simulation System
Common/Usual Name: Radiation therapy treatment planning computer program
Trade/Proprietary Name: Peacock Plan
Applicant's Name and Address:
Harris S. Targovnik, Ph.D. Vice President, Director of Clinical Affairs NOMOS Corporation (NOMOS) 2593 Wexford Bayne Road Sewicklev, PA 15143 (412)-934-5477
11. Name of predicate device(s):
1.Small Systems Group: Prowess 2000, K884261/A/B 2.GE Target Series 2, K896353 3.University of Michigan/Scanditronix: Scandiplan K903403
lll. Classification:
Radiation Therapy Simulation Systems were reviewed by the Radiological Devices Classification Panel and placed in Class II (21 CFR 892.5840).
IV. Performance Standards:
No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.
1
V. Intended Use and Device Description:
The NOMOS Peacock Plan is a radiation treatment planning package designed to allow medical physicists, dosimetrists and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by Peacock are based upon treatment machine specific data and are intended to provide a quide to delivering exrernal beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
Peacock Plan has been designed to generate plans for the implementation of 3-D Conformal Radiation Therapy (3-D-CRT) in a manner similar to the predicate devices listed above (Small Systems Group: Prowess 2000, K884261/A/B; GE Target Series 2, K896353; University of Michigan/Scanditronix: Scandiplan K903403). The basis for 3-D-CRT and its implementation is the mirror image of computerized tomography (General Electric K841997, Siemens K910859/A). The Peacock Plan and CT both use variations on computer implementations of filtered backprojection algorithms. In CT, a spatially-uniform-radiation exposure is delivered to the patient and the spatially non-uniform attenuation of the exit beam is measured. Peacock Plan creates treatment simulations based upon user annotated CT information. This information describes the desired shape of the isodose distribution and location of the desired dose. Peacock Plan then defines the beam intensities and shapes to produce this desired dose distribution at the target site. With Peacock Plan, a multileaf collimator, partial-attenuation block or other beam-blocking mechanisms may be employed to generate a spatially, non uniform beam which, when directed at the tumor, will form a spatially- uniform dose around the target volume.
The current version of Peacock Plan is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.
VI. Summary of Substantial Equivalence:
Indications: The indications for the NOMOS Peacock Plan are the same as those for the predicate devices with external beam radiation: Present a graphical display of the resultant dose distribution around a target which is based upon the size, shape and position of the radiation treatment fields.
Design: The design of the NOMOS Peacock Plan is similar to those used in the predicate devices.
Materials: The materials used in the NOMOS Peacock Plan is similar to that of the predicate devices.
Manufacturing: The manufacturing processes used in the NOMOS Peacock Plan are similar to those used in the manufacture of predicate devices.
2
Specifications: The specifications of the NOMOS Peacock Plan are similar to those of the predicate devices.
Conclusions: The indications, design, materials, manufacturing, and specifications of Peacock Plan do not raise any new issues relating to safety and effectiveness.
NOMOS thus considers the Peacock Plan to be substantially equivalent to the predicate devices.