(311 days)
The AcQPlan 5.0 is an integrated 3-D RTP and simulation system embedded in a volumetric image processing computer environment. AcQPlan 5.0 is intended to be used to plan radiation therapy treatments on linear accelerators and other similar teletherapy devices with x-ray beams of energies from 4 to 50 MV, cobalt-60, and electron beams with energies from 4 to 50 MeV of the entire human anatomy. It allows the treatment planner to employ such techniques as asymmetrically collimated fields, irregular fields, multi-leaf collimators, non-coplanar fields, bolus, and fixed wedges. It allows the treatment planner to take heterogeneities into account (CT only) for photon beams using two versions of the Batho method or the Equivalent TAR (ETAR) method, and it uses a generalized Gaussian pencil beam model for electron beams. Using AcOPlan 5.0. the treatment planner can simultaneously visualize target and normal tissues and the computed 3-D dose distributions in great detail, on a real-time basis. The treatment planner develops treatment plans in a coordinate system accurately fixed to set-up marks on the patient made possible by volumetric 3-D image processing. Tools for managing competing and complementary plans are provided. Tools, based on DVH plots, are provided for comparing competing plans. High quality DRS and DCS (digitally reconstructed or composited simulation) images, with BEV and beam graphics superimposed, are generated to replace conventional simulator films. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
The AcQPlan 5.0 provides three-dimensional, external beam radiotherapy treatment planning (RTP) based on Philips Computed Tomography and Magnetic Resonance volume datasets. AcQPlan 5.0 is a fully integrated software package option to AcQSim virtual simulation software for dose calculation and evaluation. When used with the geometricplanning functionality of Philips AcQSim virtual simulation package, AcQPlan 5.0 users can simulate and plan a comprehensive course of radiotherapy in a single episode of patient care on a single workstation
The provided text does not contain detailed information about specific acceptance criteria, a standalone study to prove meeting those criteria, or a multi-reader multi-case (MRMC) comparative effectiveness study. The submission focuses on demonstrating substantial equivalence to a predicate device, AcQPlan (K974770), based on safety and effectiveness considerations rather than specific performance metrics against pre-defined acceptance criteria.
The information provided outlines:
- Device Description: AcQPlan 5.0 is a 3-D external beam radiotherapy treatment planning (RTP) system embedded in a volumetric image processing environment. It integrates with AcQSim virtual simulation software for dose calculation and evaluation.
- Intended Use: To plan radiation therapy treatments using various beam energies and techniques for the entire human anatomy. It allows visualization of target and normal tissues, 3-D dose distributions, and provides tools for plan management and comparison.
- Safety and Effectiveness Considerations: Safety is assured by adherence to FDA GMPs, IEC 60601-1, UL 187, and 21 CFR Subchapter "J" Performance Standards. Software safety is managed through Philips' LCM Procedures. Effectiveness is established by Philips's evaluation demonstrating performance according to development specifications.
- Substantial Equivalence Statement: The device is considered substantially equivalent to the predicate device, AcQPlan (K974770), and represents current state-of-the-art technology.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth types based on the provided document.
The document describes a 510(k) submission, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed clinical trial results or performance metrics against pre-defined acceptance criteria for a novel device. The "Effectiveness" section states that it's "established by Philips's evaluation throughout all phases of the AcQPlan 5.0 development" and that "The product will perform in accordance with the development specifications," but it does not provide the specifics of these evaluations or specifications.
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Philips 510(k) Notice
AcQPlan 5.0
SUMMARY
The following information is being supplied in accordance with 21CFR 807.92(a) and in the order specified in that section.
| 1. Submitter | Philips Medical Systems, Inc.595 Miner RoadCleveland, OH 44143(440) 483-3000 |
|---|---|
| -------------- | ------------------------------------------------------------------------------------------ |
Contact Robert L. Turocy Philips Medical Systems 595 Miner Road Cleveland, OH 44143 Telephone: 440 483 3528 FAX: 440 483 1116
Summary Date: November 1, 2001
2. Device Name and Classification
Device Name: AcQPlan 5.0 Classification Name: Radiation Therapy Planning System Common Name: Radiation Therapy Planning System
The FDA has classified the AcQPlan 5.0 as Class II in 21 CFR 892.5840 (Product Code 90KPQ).
3. Comparison to Predicate Device
In the opinion of Philips, the AcQPlan 5.0 is Radiation Therapy Planning System is of comparable type and substantially equivalent to the legally marketed device, AcQPlan currently in commercial distribution under 510(k) Document control Number K974770.
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4. Device Description
The AcQPlan 5.0 provides three-dimensional, external beam radiotherapy treatment planning (RTP) based on Philips Computed Tomography and Magnetic Resonance volume datasets. AcQPlan 5.0 is a fully integrated software package option to AcQSim virtual simulation software for dose calculation and evaluation. When used with the geometricplanning functionality of Philips AcQSim virtual simulation package, AcQPlan 5.0 users can simulate and plan a comprehensive course of radiotherapy in a single episode of patient care on a single workstation
5. Intended Use of the Device
The AcQPlan 5.0 is an integrated 3-D RTP and simulation system embedded in a volumetric image processing computer environment. AcQPlan 5.0 is intended to be used to plan radiation therapy treatments on linear accelerators and other similar teletherapy devices with x-ray beams of energies from 4 to 50 MV, cobalt-60, and electron beams with energies from 4 to 50 MeV of the entire human anatomy. It allows the treatment planner to employ such techniques as asymmetrically collimated fields, irregular fields, multi-leaf collimators, non-coplanar fields, bolus, and fixed wedges. It allows the treatment planner to take heterogeneities into account (CT only) for photon beams using two versions of the Batho method or the Equivalent TAR (ETAR) method, and it uses a generalized Gaussian pencil beam model for electron beams. Using AcOPlan 5.0. the treatment planner can simultaneously visualize target and normal tissues and the computed 3-D dose distributions in great detail, on a real-time basis. The treatment planner develops treatment plans in a coordinate system accurately fixed to set-up marks on the patient made possible by volumetric 3-D image processing. Tools for managing competing and complementary plans are provided. Tools, based on DVH plots, are provided for comparing competing plans. High quality DRS and DCS (digitally reconstructed or composited simulation) images, with BEV and beam graphics superimposed, are generated to replace conventional simulator films. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Warning: In the United States, Federal law restricts this device to sale, distribution and use by or on the order of a physician.
6. Safety and Effectiveness Considerations
The safety of the AcOPLan 5.0 is assured by Philip's adherence to FDA GMPs designed to conform with International Standards. Potential hazards are identified in the Hazard Analysis (Attachment "F") and these hazards are controlled in the following manner:
Electrical and Mechanical safety is assured by adherence to IEC 60601-1 and UL 187 Radiation safety is assured by conformance to 21 CFR Subchapter "J" Performance Standards.
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Radiation safety is assured by conformance to 21 CFR Subchapter "J" Performance Standards.
Software safety is assured by the Philip's LCM Procedures that conform to accepted practiccs. Ouality assurance procedures and test results demonstrate that the AcOPlan 5,0 specifications and functional requirements functional are met. See Attachment "H" Software Lifecycle Management Process.
Effectiveness is established by Philips's evaluation throughout all phases of the AcOPlan 5.0 development. The product will perform in accordance with the development specifications.
7. Substantial Equivalence Statement
Based on the above considerations, it is the opinion of Philip's that the AcOPlan 5.0 Radiation Therapy Planning System is substantially equivalent to the predicate device the AcOPlan granted marketing permission in K974770. The AcQPlan 5.0 represents the current state-of- the-art technology, therefore, is equivalent to legally marketed devices.
The AcQPlan 5.0 is substantially equivalent to legally marketed devices referenced above. The AcQPlan 5.0 is under control of health care professionals who are trained and responsible for radiation therapy planning. Labeling (Product Specification and Operator's Manual) will be provided to the user of the equipment.
Philips has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the AcQPlan 5.0. In addition, all information contained in this 510(k) Notice is accurate and complete.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" written around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard . Rockville MD 20850
Mr. Robert L. Turocy Regulatory Affairs Manager Philips Medical Systems 595 Miner Road CLEVELAND OH 44143
Re: K013644
Trade/Device Name: AcQPlan 5.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system
Regulatory Class: II Product Code: 90 MUJ Dated: June 21, 2002 Received: June 24, 2002
Dear Mr. Turocy:
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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
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.
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Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) Number (if known): K0_13 64 Y
Device Name: AcQPlan 5.0
Indications for Use:
The AcQPlan 5.0 is an integrated 3-D RTP and simulation system embedded in a volumetric image processing computer environment. AcQPlan 5.0 is intended to be used to plan radiation therapy treatments on linear accelerators and other similar teletherapy devices with x-ray beams of energies from 4 to 50 MV, cobalt-60, and electron beams with energies from 4 to 50 MeV of the entire human anatomy. It allows the treatment planner to employ such techniques as asymmetrically collimated fields, multileaf collimators, non-coplanar fields, bolus, and fixed wedges. It allows the treatment planner to take heterogeneities into account (CT only) for photon beams using two versions of the Batho method or the Equivalent TAR (ETAR) method, and it uses a generalized Gaussian pencil beam model for electron beams. Using AcQPlan 5.0, the treatment planner can simultaneously visualize target and normal tissues and the computed 3-D dose distributions in great detail, on a real-time basis. The treatment planner develops treatment plans in a coordinate system accurately fixed to set-up marks on the patient made possible by volumetric 3-D image processing. Tools for managing competing and complementary plans are provided. Tools, based on DVH plots, are provided for comparing competing plans. High quality DRS and DCS (digitally reconstructed or composited simulation) images, with BEV and beam graphics superimposed, are generated to replace conventional simulator films. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
Over-The Counter Use
(Per 21 CFR 801.109)
OR
(Optional Format 1-2-9G)
Thind A. Seymon
(Division Sign-Off)-
Division of Reproductive, Abdominal,mal
and Radiological Devices
510(k) Number K013644
§ 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.