CadPlan 6.0 is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1-50 MV, as well as Cobalt-60, and electron energies from 1 to 50 MeV, and to plan brachytherapy treatments. CadPlan will plan the 3D radiotherapy treatment approaches to combined modality plans, asymmetric and non-coplanar field, total body irradiation, multileaf collimators, motorized and dynamic wedges, customized blocking, compensating filters, and bolus.

CadPlan 6.0 includes export capabilities to verify beam and patient date, dose-planning results, and provide on-line information to block-cutting devices.

Device Description

CadPlan 6.0 is a comprehensive 3D Treatment Modeling Workstation for external beam and brachytherapy planning.

AI/ML Overview

This 510(k) summary for CadPlan 6.0 primarily focuses on demonstrating substantial equivalence to a predicate device (CadPlan ver. 2.62 Radiation Therapy Treatment Planning) based on technological characteristics and intended use. It does not describe specific acceptance criteria and a study proving the device meets those criteria in the way you've outlined for clinical performance studies.

Here's an analysis based on the provided text, highlighting what's not present:

Table of acceptance criteria and reported device performance:
- Not provided. The document states "See the attached 'Specification Comparison Chart', Tab F" for technological characteristics, but this chart itself is not included in the provided text. Therefore, we cannot extract specific performance metrics or acceptance criteria.
Sample size used for the test set and the data provenance:
- Not provided. There is no mention of a clinical test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective). This submission focuses on demonstrating equivalence through technical specifications rather than a clinical performance study with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. As there's no described test set, there's no mention of experts or their qualifications for establishing ground truth.
Adjudication method:
- Not provided. No adjudication method is described, as there's no performance study involving independent expert review.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not provided. This document predates common AI/MRMC studies for medical devices. CadPlan 6.0 is described as a "3D Treatment Modeling Workstation" for planning radiation therapy, not an AI-assisted diagnostic or assistive device that would typically undergo MRMC studies comparing human readers with and without AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not provided. The device is a "Treatment Modeling Workstation," implying intended use with a human operator. There's no discussion of standalone algorithmic performance.
The type of ground truth used:
- Not provided. If a performance study were conducted, common ground truths for radiation therapy planning software might include dosimetric measurements, comparison to established phantoms, or expert physicist review of plans. However, none of this is described in the provided text.
The sample size for the training set:
- Not applicable/Not provided. This device is a software planning tool, not an AI/ML device that requires a "training set" in the modern sense. Its functionality would be based on underlying physics models and algorithms, not trained on patient data in the same way.
How the ground truth for the training set was established:
- Not applicable/Not provided. (See point 8).

Summary of what is present:

The document is a Premarket Notification [510(k)] Summary for CadPlan 6.0, indicating its submission date, contact person, device name, classification, and predicate device. It briefly describes the product as a "comprehensive 3D Treatment Modeling Workstation" for external beam and brachytherapy planning and lists its intended uses, including planning various radiotherapy treatment approaches and export capabilities. The FDA's response letter confirms the 510(k) clearance based on substantial equivalence.

Conclusion regarding acceptance criteria and performance study:

The provided text does not contain the information requested regarding specific acceptance criteria, a clinical performance study, sample sizes, expert involvement, adjudication methods, or ground truth establishment. This is typical for 510(k) submissions of this era for a software planning tool where substantial equivalence is demonstrated primarily through comparison of technical specifications and intended use against a legally marketed predicate device, rather than through a de novo clinical performance study with defined acceptance criteria. The requested information would typically be found in detailed verification and validation reports, which are part of the full 510(k) submission but not routinely included in the publicly available summary.

Summary

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K992753

SEP , 3 1999

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Premarket Notification [510K] Summary as required by 21 CFR 807.92

Date Summary was prepared:

August 12,1999

Submitter's Name:

Varian Medical Systems 3100 Hansen Way M/S H-055 Palo Alto, CA 94304

Contact Person:

Linda S. Nash Regulatory Affairs and Quality Assurance Manager Phone (650) 424-6990 FAX (650) 855-7364 E-mail linda.nash@os.varian.com

Device Name:

CadPlan 6.0

Classification Name: Medical charged-particle radiation therapy system

Predicate Device: CadPlan ver. 2.62 Radiation Therapy Treatment Planning

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Page 1 of 2

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Product Description:

CadPlan 6.0 is a comprehensive 3D Treatment Modeling Workstation for external beam and brachytherapy planning.

Intended Use

Technological Characteristics:

See the attached "Specification Comparison Chart", Tab F.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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SEP 1999

Ms. Linda Nash Requlatory Affairs and Quality Assurance Manager Varian Associates, Inc. 3045 Hanover Street Palo Alto, CA 94304-1129

Dear Ms. Nash:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K992753 CadPlan 6.0 Radiation Therapy Treatment Planning System Dated: August 13, 1999 Received: August 16, 1999 Regulatory Class: Il (two) Product Code: 90 MUJ 21 CFR 892.5050

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.

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 regulation (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 requlatory 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 requlation 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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varian® oncology systems

Indications for Use

510(k) Number (if known):

Device Name: CadPlan 6.0

Indications for Use:

CadPlan 6.0 includes export capabilities to verify beam and patient date, dose-planning results, and provide on-line information to block-cutting devices.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V OR (per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

David A. Seaymm

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Deyic

510(k) Number

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Varian Associates, Inc. 3045 Hands &: Care . . . . Alle, C ... Jinia 94304-1129 U.S.A. 650.493.4000 FAX: 650.424.4830

Regulation Number and Section

§ 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.