PREFERNCE IMRT TREATMENT PLANNING MODULE by NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.

The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.

The expanded indications for use are also applicable as previously presented for pReference Treatment System (K983793), including hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.

The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

Device Description

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AI/ML Overview

I apologize, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "pReference IMRT Treatment Planning Module" and its indications for use. It primarily focuses on the regulatory approval and substantial equivalence to predicate devices.

The document does NOT contain information about specific acceptance criteria, a study proving the device meets those criteria, or the detailed methodology of such a study.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported performance, nor can I answer questions about:

Sample sizes (test, training) or data provenance
Number of experts or their qualifications
Adjudication methods
MRMC comparative effectiveness study or effect size
Standalone performance
Type of ground truth used
How ground truth for training was established

The letter only states that the device is "substantially equivalent" to legally marketed predicate devices for its stated indications for use. This means the FDA determined it performs as safely and effectively as existing, legally marketed devices, but it does not detail the specific performance metrics or studies that would typically be associated with defined acceptance criteria.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2002

Lee Myers, MD Director of Operations Northwest Medical Physics Equipment, Inc. 21031 67th Ave W LYNNWOOD WA 98036

Re: K012575

Trade/Device Name: pReference IMRT Treatment Planning Module Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system

Regulatory Class: II Product Code: 90 MUJ Dated: December 20, 2001 Received: December 21, 2001

Dear Dr. Myers:

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.

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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 notheation. The I Dri Imaling of sossion 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 If you desire spective 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 Additionally, for questions on and please note the regulation entitled, "Misbranding Other of Compinated to premarket notification" (21 CFR Part 807.97). Other general information on by received to premained from the Division of Small Manufacturers, your responsional 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

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Section D- Statement of Indications for Use

Page of

K0/2575

510 (k) Number (if known):

Device Name: pReference IMRT Treatment Planning Module .

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K012575

Prescription Use		OR	Over-The-Counter Use __________
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

pReference IMRT Treatment Planning Module DRAERD Premarket Notification 510(k) D-1

08/07/01 a1620_imrt_510k.ms.doc

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.