The PIPSpro QA Software System displays, enhances and analyses portal images, and is used in conjunction with commercially available electronic portal imaging detectors (EPIDs). PIPSpro provides numerous measurement tools, image processing routines, statistical analysis and capabilities that are not available in the standard software provided by the EPID suppliers. These include the processing of simulator and portal verification images, analyzing patient registration errors, measuring of image quality from an EPID during installation tests, providing a platform for quality assurance programs in radiation therapy, and tools for writing and editing notes attached to images for easy communication. In this capacity, it can only import images and information.

Device Description

PIPSpro QA Software System (Portal Imaging Processing System, professional version) is a stand-alone software program for use on PC computers running under Microsoft Windows 9x/Me/2000/NT/XP. The PC is not supplied with PIPSpro, and must be provided by the user. PIPSpro is supplied on a CD together with a software security key ("dongal" or hard lock) which is inserted into a parallel or USB port on the computer to allow the software to work. PIPSpro does not use, control, or operate any hardware, it is purely a stand-alone software program.

AQUA is also a stand-alone software program, consisting of a small part of the PIPSpro system. AQUA includes only those routines required for the analysis of images acquired with the QC-3 phantom, and used for quality control of electronic portal imaging devices

The PIPSpro OA Software System, which displays, enhances and analyses portal images, and is used in conjunction with commercially available electronic portal imaging detectors (EPIDs). PIPSpro provides numerous measurement tools, image processing routines, statistical analysis and capabilities that are not available in the standard software provided by the EPID suppliers. These include the processing of simulator and portal verification images, analyzing patient registration errors, measuring of image quality from an EPID during installation tests, providing a platform for quality assurance programs in radiation therapy, and tools for writing and editing notes attached to images for easy communication. In this capacity, it can only import images and information.

AI/ML Overview

The provided document is a 510(k) Summary of Safety and Effectiveness Information for the Standard Imaging PIPSpro QA Software System. It describes the software's functionality and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria with quantitative values.

The document states: "The Standard Imaging PIPSpro QA Software System has met its predetermined design specifications, risk analysis and validation objectives." It also mentions "nearly 10 years of evolving development and use" and lists validation activities such as "Algorithm and image transfer," "Results presentation and graphing," "Beta testing," "Interface, compatibility, use and misuse," and "Bug, Modification and/or Addition change testing." However, these are general statements about development and validation processes, not a detailed account of specific performance metrics or a study.

Therefore, I cannot provide the requested information from this document.

Summary of missing information:

Table of acceptance criteria and reported device performance: Not provided. The document states validation objectives were met, but does not list specific criteria or performance metrics.
Sample size used for the test set and data provenance: Not provided.
Number of experts used to establish ground truth for the test set and qualifications: Not provided.
Adjudication method for the test set: Not provided.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
Standalone (algorithm only) performance study: Not detailed, although the software is described as "standalone."
Type of ground truth used: Not specified.
Sample size for the training set: Not provided.
How the ground truth for the training set was established: Not provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Standard Imaging. The logo is in black and white and features the words "Standard Imaging" in a stylized font. The word "Standard" is above the word "Imaging", and there is a trademark symbol to the right of the word "Imaging". Below the words is a graphic of lines radiating out from a central point.

K042733

NOV 1 5 2004

Subject:	510(k) Summary of Safety and Effectiveness Information for theStandard Imaging PIPSpro QA Software System
Proprietary Name:	Standard Imaging PIPSpro QA Software System
Common Name:	Portal Imaging Processing System
Classification Name:	Multiple
Classification:	Class I, 21CFR892.1940 – LHO, Radiologic Quality Assurance InstrumentClass I, 21CFR892.1950 – IXG, Radiographic Anthropomorphic PhantomClass I, 21CFR892.2010 – LMB, Medical Image Storage DeviceClass I, 21CFR892.2020 – LMD, Medical Image Communications DeviceClass II, 21CFR892.5050 – MUJ, Accessory to a Medical Charged-Particle Therapy SystemClass II, 21CFR892.2050 – LLZ, Picture Archiving and CommunicationsSystem
Panel:	Radiology
Contact Person:	Raymond Riddle, Vice President, Regulatory Affairs

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

The Standard Imaging PIPSpro QA Software System is substantially equivalent to selected functions of the following predicate devices for classifications 21CFR892.5050 -- MUJ and 21CFR892.2050 - LLZ:

ProductName	ManufacturerName	FDA 510(k)Clearance	FDA 510(k)Number
Elekta iView/iView+ ElectronicPortal Imaging Device	Elekta Oncology Systems, Ltd.	Yes	K012289 K981790
Portalvision Electronic PortalImaging Device	Varian Medical Systems, Inc.	Yes	K003636 K955774
RIT113 Radiation FilmDosimetry Software	Radiological ImagingTechnology, Inc.	Yes	K935928

Radiation Calibration and QA Instruments
for health care
COMPLETE SOLUTIONS PROVIDED

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Image /page/1/Picture/0 description: The image shows the logo for "Standard Imaging". The logo is in black and white and features a stylized font. There is a design element below the text that looks like lines radiating from a central point.

The Standard Imaging PIPSpro QA Software System was designed to comply with the applicable portions of the following voluntary standard:

IEC 60601-1-4 (Edition 1.1 2000-04) Collateral standard for programmable medical 1 . systems
The Standard Imaging PIPSpro QA Software System has been validated through nearly 10 years of evolving development and use. This validation included the following:
Algorithm and image transfer 1.
1. Results presentation and graphing
1. Beta testing
1. Interface, compatibility, use and misuse
1. Bug, Modification and/or Addition change testing

The Standard Imaging PIPSpro QA Software System has met its predetermined design specifications, risk analysis and validation objectives.

Radiation Calibration and OA Inst COMPLETE SOLUTIO

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 5 2004

Raymond T. Riddle, PE, RAC Vice President, Regulatory Affairs Standard Imaging, Inc. 7601 Murphy Drive MIDDLETON WI 53562-2532

Re: K042733
Trade/Device Name: Standard Imaging PIPSpro QA Software System Regulation Number: 21 CFR 892.1940 Regulation Name: Radiologic quality assurance instrument Product Code: 90 LHO Regulatory Class: I Regulation Number: 21 CFR 892.1950 Regulation Name: Radiographic anthropomorphic phantom Product Code: 90 IXG Regulatory Class: I Regulation Number: 21 CFR 892.2010

Regulation Name; Medical image storage device

Product Code: 90 LMB
Regulatory Class: I
· Regulation Number: 21 CFR 892.2020 Regulation Name: Medical image communications device Product Code: 90 LMD Regulatory Class: I Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system
Product Code: 90 LLZ
Regulatory Class: II

Regulation Number: 21 CFR 892.5050

Regulation Name: Medical charged-particle radiation therapy system Product Code: 90 IYE

Regulatory Class: II

Dated: September 29, 2004 Received: October 1, 2004
Dear Mr. Riddle:

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

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Page 2 – Mr. Riddle

Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, I to: "The Entraining practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it your device to such 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 overrination 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket I mis lotto will and my 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:

(Gastroenterology/Renal/Urology) 240-276-0115 21 CFR 876.xxxx 240-276-0115 (Obstetrics/Gynecology) 21 CFR 884.xxxx 240-276-0120 (Radiology) 21 CFR 892.xxxx 240-276-0100 Other

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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

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Indications for Use

510(k) Number (if known): 16042733

Device Name:

Standard Imaging PIPSpro QA Software System

Indications For Use:

PIPSpro QA Software System (Portal Imaging Processing System, professional version) is a stand-alone software program for use on PC computers running under Microsoft Windows 9x/Me/2000/NT/XP. The PC is not supplied with PIPSpro, and must be provided by the user. PIPSpro is supplied on a CD together with a software security kev ("dongal" or hard lock) which is inserted into a parallel or USB port on the computer to allow the software to work. PIPSpro does not use, control, or operate any hardware, it is purely a stand-alone software program.

Prescription Use (Part 21 CFR 801 Subpart D)

and/or

Over-the-Counter-Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

Page 1 of 1

Regulation Number and Section

§ 892.1940 Radiologic quality assurance instrument.

(a)
Identification. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.