(45 days)
Not Found
No
The description focuses on standard image processing, measurement tools, statistical analysis, and data management, with no mention of AI or ML techniques. The validation process described is also typical for traditional software, not AI/ML.
No
The device is a software system used for quality assurance of electronic portal imaging devices and processing of images in radiation therapy. It does not directly provide therapy.
No
The device is a QA software system used for quality control of electronic portal imaging devices and for quality assurance programs in radiation therapy, not for diagnosing patient conditions. It processes and analyzes existing images to evaluate system performance and patient registration errors, rather than directly diagnosing disease.
No
The device is described as a stand-alone software program, but it requires a physical software security key ("dongle" or hard lock) to function. This physical component, while not directly processing medical data, is a necessary hardware element for the software's operation and is supplied with the software. Therefore, it is not purely software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PIPSpro QA Software System is described as a stand-alone software program that processes and analyzes images acquired from electronic portal imaging detectors (EPIDs) and other imaging sources used in radiation therapy. Its purpose is for quality assurance of the imaging equipment and analysis of patient registration errors, not for analyzing biological samples from a patient.
- Intended Use: The intended use clearly states its function in the context of radiation therapy quality assurance and image analysis, not for diagnostic testing of patient samples.
Therefore, the PIPSpro QA Software System falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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 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.
Product codes
LHO, IXG, LMB, LMD, MUJ, LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
portal images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
-
- Results presentation and graphing
-
- Beta testing
-
- Interface, compatibility, use and misuse
-
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K012289, K981790, K003636, K955774
K935928
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
O
NOV 1 5 2004
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the
Standard 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 Instrument
Class I, 21CFR892.1950 – IXG, Radiographic Anthropomorphic Phantom
Class I, 21CFR892.2010 – LMB, Medical Image Storage Device
Class I, 21CFR892.2020 – LMD, Medical Image Communications Device
Class II, 21CFR892.5050 – MUJ, Accessory to a Medical Charged-
Particle Therapy System
Class II, 21CFR892.2050 – LLZ, Picture Archiving and Communications
System |
| 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:
| Product
Name | Manufacturer
Name | FDA 510(k)
Clearance | FDA 510(k)
Number |
|---------------------------------------------------------|------------------------------------------|-------------------------|----------------------|
| Elekta iView/iView+ Electronic
Portal Imaging Device | Elekta Oncology Systems, Ltd. | Yes | K012289
K981790 |
| Portalvision Electronic Portal
Imaging Device | Varian Medical Systems, Inc. | Yes | K003636
K955774 |
| RIT113 Radiation Film
Dosimetry Software | Radiological Imaging
Technology, Inc. | Yes | K935928 |
Radiation Calibration and QA Instruments
for health care
COMPLETE SOLUTIONS PROVIDED
1
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.
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.
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.
-
- Results presentation and graphing
-
- Beta testing
-
- Interface, compatibility, use and misuse
-
- 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
2
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
3
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
4
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.
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 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.
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