(34 days)
No
The document describes a change to the operating system and explicitly states that the fundamental scientific technology of the design was not modified. There is no mention of AI or ML.
No
The CORVUS system is a "radiation treatment planning package" that generates plans to guide therapy, but it does not directly deliver the therapy itself. Therefore, it is not a therapeutic device.
No
Explanation: The device is a radiation treatment planning system, which is used to plan a treatment, not to diagnose a condition.
Yes
The device is described as a "radiation treatment planning package" and the modification is a change to the operating system, indicating it is primarily software. There is no mention of hardware components being part of the device itself.
Based on the provided text, the CORVUS Radiation Therapy Planning System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CORVUS Function: The description clearly states that CORVUS is a "radiation treatment planning package" used by medical professionals to "create conformal treatment plans using photon (x-ray) external beam radiation therapy." It takes machine-specific data and helps guide the delivery of radiation to a target volume within the patient's body.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens from a patient. Its function is focused on planning and guiding external radiation delivery.
Therefore, the CORVUS system falls under the category of a medical device used for treatment planning, not an IVD.
N/A
Intended Use / Indications for Use
The CORVUS system 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 CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.
Product codes
90 MUJ
Device Description
The CORVUS system 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 CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.
The modification described in this premarket notification consists of a change to the operating system upon which the device operates. The currently-marketed CORVUS System utilizes the NextStep operating system, while the modified device runs on the Macintosh OS X (Mac OSX) operating system. This change did not modify the intended use of the device or the fundamental scientific technology of its design. Testing performed demonstrates that the modified device produces clinically equivalent results. Therefore, this change does not affect the safe and effective use of the device within its prescribed indications.
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
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
Testing performed demonstrates that the modified device produces clinically equivalent results.
Key Metrics
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.
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AUG 2 1 2003
Image /page/0/Picture/1 description: The image shows handwritten text, with "K032209" at the top. Below that, the text "page 1 of 3" is written in cursive. The handwriting appears to be somewhat rough, with thick strokes and varying letter sizes.
Image /page/0/Picture/2 description: The image shows the word "nomos" in a stylized, bold font. Below the word "nomos" is the phrase "HOW WILL WE CHANGE RADIATION NEXT" in a smaller, sans-serif font. The text is all in black and white.
Section 2 - 510(k) Summary
Summary of Safety and Effectiveness NOMOS Motorized CRANE® II
Pursuant to Section 513(i) of the Federal Food, Drug, and Cosmetic Act
A. General Information:
| Classification Name: | Medical charged-particle radiation therapy
system accessory: Treatment Planning
System
(Sec. 892.5050) |
| ---------------------- | ----------------------------------------------------------------------------------------------------------------- |
|---|
Common/Usual Name: Radiation Therapy Treatment Planning System
Trade/Proprietary Name: CORVUS® 5.0M System
Applicant's Name and Address: Francis X. Dobscha Director of Quality
NOMOS Corporation 200 West Kensinger Drive Cranberry Township, PA 16066
| Phone: | 724-741-8242 |
|---|---|
| FAX: | 724-741-0778 |
| Email: | fdobscha@nomos.com |
- B. Name of predicate device: NOMOS CORVUS System (K940663, K963258, K972451)
- Class II C. Classification:
- None established D. Performance Standards:
E. Intended Use and Device Description:
The CORVUS system 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 CORVUS are based upon
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K03209
page 208
treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.
The modification described in this premarket notification consists of a change to the operating system upon which the device operates. The currentlymarketed CORVUS System utilizes the NextStep operating system, while the modified device runs on the Macintosh OS X (Mac OSX) operating system. This change did not modify the intended use of the device or the fundamental scientific technology of its design. Testing performed demonstrates that the modified device produces clinically equivalent results. Therefore, this change does not affect the safe and effective use of the device within its prescribed indications.
F. Summary of Substantial Equivalence
Indications for Use:
The indications for use for the CORVUS Radiation Therapy Planning System have not changed as a result of this modification.
Materials:
The materials used in the CORVUS 5.0M are equivalent to those used in the currently marketed device. The only difference is the use of computer hardware and peripherals supporting the Mac OSX operating system (versus hardware supporting the NextStep operating system).
Manufacturing:
The manufacturing processes used in the production of the CORVUS 5.0M System has not changed from that used to produce the currently-marketed predicate device. The device is manufactured at the same facility under the same process controls.
Specifications and Fundamental Scientific Technology:
The performance specifications of the CORVUS 5.0M System are the same as the currently-marketed CORVUS System. The design and the fundamental scientific technology upon which the CORVUS System operates have not changed.
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Image /page/2/Picture/0 description: The image shows a close-up of handwritten text on a white background. The text includes the characters 'K0322', 'page', '3 of 3'. The writing appears to be in black ink and has a slightly rough or uneven texture, suggesting it may have been written quickly or with a worn pen.
Design Controls:
The modification to the CORVUS System were developed, tested, and implemented following NOMOS Corporation's established processes for design control. NOMOS Corporation's design control processes conform to all applicable requlatory and industry requirements. A hazard analysis and testing were performed to assess the impact of the modification, which resulted in a determination that the modification does not raise any new issues of safety or efficacy for the device.
Conclusions:
Based on the above information, and on NOMOS Corporation's commitment to provide safe, reliable, and effective products, NOMOS considers the CORVUS 5.0M Radiation Therapy Planning System to be substantially equivalent to the currently-marketed CORVUS System.
Note:
Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be legally marketed according to FDA regulations and is not relevant evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, ". . a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without premarket approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. (1977).
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or bird in flight, composed of three curved lines. The text is arranged around the top and left side of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2003
Ms. Francis X. Dobscha VP, Quality and Regulatory Affairs NOMOS Corporation 200 West Kensinger Drive CRANBERRY TOWNSHIP PA 16066 Re: K032209
Trade/Device Name: CORVUS Radiation Therapy Planning System · Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: July 14, 2003 Received: July 22, 2003
Dear Ms. Dobscha:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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.
4
This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number: Not Assigned
Page 1 of 1
CORVUS® 5.0M Radiation Therapy Planning System Device Name:
Indications for Use:
The indications for use for the CORVUS Radiation Therapy Planning System have not changed as a result of this modification.
The CORVUS system 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 CORVUS are based upon treatment machinespecific data and are intended to provide a quide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
| 510(k) Number | K032209 |
|---|---|
| --------------- | --------- |
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