(36 days)
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No
The document describes software for controlling a patient positioning couch in radiation therapy. It focuses on interfacing with other systems and controlling movement based on user input or data from imaging systems, but there is no mention of AI or ML being used for decision-making, image analysis, or automated adjustments beyond direct control.
No
The device is patient positioning software that interfaces with hardware for radiation treatments, but it does not directly treat or diagnose a disease or condition.
No
Explanation: The device is described as "patient positioning software used in radiation treatments" and "intended to position the patient after diagnostic decisions have been made." It helps in treatment delivery, not in making diagnostic decisions.
No
The device description explicitly states that the software interfaces with "Protura Couch Hardware" and is intended to position the patient using this hardware. The performance studies also include testing related to the "Movement of the Protura Couch," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Protura Couch Software is described as patient positioning software used in radiation treatments. Its primary function is to control the movement of a patient couch based on information from imaging systems (like IGRT) and other treatment planning systems.
- Lack of Specimen Analysis: There is no mention of this software analyzing any biological specimens from the patient. Its input comes from imaging and treatment planning data, not from in vitro tests.
Therefore, the Protura Couch Software falls under the category of a medical device used in treatment delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Protura Couch Software is intended to interface between a record and verify system. linear accelerator (Linac) software, Linac safeguard systems, and/or image guidance systems and the Protura Couch. The Protura Couch Software is also capable of operating the Protura Couch (6 Degree Axis Couch).
Product codes (comma separated list FDA assigned to the subject device)
JAI
Device Description
The proposed device, the Protura Couch Software (MT6XSMEU), is patient positioning software used in radiation treatments in conjunction with an Image Guided Radiation Therapy (IGRT) system. The Protura Couch Software interfaces with the Protura Couch Hardware (K031866) and is intended to position the patient after diagnostic decisions have been made based on results from an IGRT system. The Protura Couch Software allows the user to control patient positioning with six degrees of freedom from outside of the treatment room. The Protura Couch Software also includes the ability to interface with a record and verify system, Linac software, Linac safeguard systems, and/or image guidance systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was conducted for the following characteristics:
- Movement of the Protura Couch.
- Interfacing with External Systems.
- Couch Pedestal and Isocenter Alignment
- Patient Record Handling
All testing confirmed that the Protura Couch Software is safe and effective for its intended use.
No clinical testing was performed in the evaluation of this medical device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, followed by the text "CIVCO" in bold, sans-serif font. Below the company name, the words "MEDICAL SOLUTIONS" are printed in a smaller, sans-serif font, with spacing between the letters. The overall design is clean and professional.
AUG 30 2012
Section 5 - 510(k) Summary
| A. Submitter Information | Submitter Name & Address: MED-TEC, Inc. d/b/a CIVCO Medical Solutions
1401 8th Street SE
Orange City, lowa 51041 |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amanda Stahle, Regulatory Affairs Specialist
Telephone: 319-248-6628, Fax: 877-218-0324
amanda.stahle@civco.com |
| Date Summary Prepared: | July 10, 2012 |
| Trade Name:
Common Name:
Classification Name:
Classification Number:
Product Code: | Protura Couch Software
Treatment Couch Software
Powered radiation therapy patient support assembly
892.5770
JAI |
B. Predicate Device
MED-TEC, Inc. d/b/a CIVCO Medical Solutions claims the proposed device to be substantially equivalent to the following device:
| 510(k) Number | Device Name | Product
Classification/
Code | Submitter
Name |
|---------------|---------------------------------------------------|------------------------------------|-------------------|
| K034054 | PRO SERIES COUCH
SOFTWARE, MODEL MT-
PRO100 | 892.5770/JAI | MED-TEC, Inc. |
Both the proposed device and the predicate device are patient positioning software systems that interface with the Couch Hardware (K031866). Six degrees of freedom patient positioning corrections are sent from the software to the Couch Hardware for implementation. The predicate device also interfaces with a treatment planning system whereas the proposed device interfaces with a record and verify system, linear accelerator (Linac) software, Linac safeguard systems, and/or image guidance systems. Testing has demonstrated that the proposed device is substantially equivalent to the predicate device in regards to safety, effectiveness, and performance, and the additional interfaces provided by the proposed device did not diminish the safety or effectiveness of the device.
| Corporate Headquarters | 102 First Street South | Kalona, IA 52247 | USA | 0 319.248.6757 | 3 319.248.6660 | ||
|---|---|---|---|---|---|---|---|
| Coralville Office | 2301 Jones Blvd. | Coralville, IA 52241 | USA | 0 319.248.6757 | 3 319.248.6660 | ||
| Europe Office | Pasteurstraat 6 | 2811 DX Reeuwijk | The Netherlands | 0 +31(0) 182.394495 | 1 +31(0) 182.395014 | ||
| Orange City Office | 1401 8th Street SE | Orange City, IA 51041 | USA | 1 712.737.8688 | 9 712.737.8654 |
1
C. Device Description
The proposed device, the Protura Couch Software (MT6XSMEU), is patient positioning software used in radiation treatments in conjunction with an Image Guided Radiation Therapy (IGRT) system. The Protura Couch Software interfaces with the Protura Couch Hardware (K031866) and is intended to position the patient after diagnostic decisions have been made based on results from an IGRT system. The Protura Couch Software allows the user to control patient positioning with six degrees of freedom from outside of the treatment room. The Protura Couch Software also includes the ability to interface with a record and verify system, Linac software, Linac safeguard systems, and/or image guidance systems.
D. Indications for Use/Intended Use
The Protura Couch Software is intended to interface between a record and verify system. linear accelerator (Linac) software, Linac safeguard systems, and/or image guidance systems and the Protura Couch. The Protura Couch Software is also capable of operating the Protura Couch (6 Degree Axis Couch).
E. Technological Characteristics
Both the Protura Couch Software and the predicate device are interface software systems that are intended to operate the Couch Hardware (K031866). The predicate device interfaces with a treatment planning system whereas the Protura Couch Software interfaces with a record and verify system, Linac software, Linac safeguard systems, and/or image guidance systems. The Protura Couch Software is programmed in C#; the predicate device is programmed in C, C#, C++, and Java. The Protura Couch Software runs on Windows XP SP3 (32 bit), Windows 7 (32 bit), and Windows 7 (64 bit); the predicate runs on Windows 2000.
F. Non-Clinical Performance Data
Non-clinical performance testing was conducted for the following characteristics:
- Movement of the Protura Couch .
- Interfacing with External Systems .
- . Couch Pedestal and Isocenter Alignment
- . Patient Record Handling
All testing confirmed that the Protura Couch Software is safe and effective for its intended use.
G. Clinical Performance Data
No clinical testing was performed in the evaluation of this medical device.
H. Non-Clinical and Clinical Performance Data Conclusions
The conclusions drawn from the tests are that the Protura Couch Software is substantially equivalent to the predicate device in regards to safety, effectiveness, and performance, and the additional interfaces have not diminished the safety or effectiveness of the device.
| Corporate Headquarters | 102 First Street South | Kalona, IA 52247 | USA | ⓟ 319.248.6757 | Ⓕ 319.248.6660 | ||
|---|---|---|---|---|---|---|---|
| Coralville Office | 2301 Jones Blvd. | Coralville, IA 52241 | USA | ⓟ 319.248.6757 | Ⓕ 319.248.6660 | ||
| Europe Office | Pasteurstraat 6 | 2811 DX Reeuwijk | The Netherlands | ⓟ +31(0) 182.394495 | Ⓕ +31(0) 182.395014 | ||
| Orange City Office | 1401 8th Street SE | Orange City, IA 51041 | USA | ⓟ 712.737.8688 | Ⓕ 712.737.8654 |
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, black and white design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms.` Amanda Stahle Regulatory Affairs Specialist MED-TEC, Inc. d/b/a CIVCO Medical Solutions 1401 8th Street SE ORANGE CITY IA 51041
AUG 30 2012
Re: K122201
Trade/Device Name: Protura Couch Software Regulation Number: 21 CFR 892.5770 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: JAI Dated: July 17, 2012 Received: July 25, 2012
Dear Ms. Stahle:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We nave reviewed your Section 910(t) premains is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Electosule for tegarry manation that of the Medical Device Ameral Food Truc commerce prior to May 26, 1977, the excordance with the provisions of the Federal Food. Drug, devices that have been reciassified in accordines while premarket approval application (PMA). and Cosmetic Act (Act) that to not require approval controls provisions of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, saojeet to decidents for annual registration, listing of
general controls provisions of the Act include requirements for annual regist general controls provisions of the receives and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (Scc above) into eason affecting your device can be found in Title 21, 2011 additional controls. Existing major regulations a 195. In addition, FDA may publish further
Code of Federal Regulations (CFR), Parts 800 to 1995. In addition, FDA may publ Code of Poderal regarning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuality of a succession with other requirements of the Act
that FDA has made a determination that your devices associes. You must that FDA has made a decemmation that your corred by other Federal agencies. You must or any Federal statutes and regulations and including, but not to: registing (21)
comply with all the Act's requirements, including, but not includes areasting (reporting of comply with all the Act s requirements, therauling, our not many of the one of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice mediem as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as bet form inrketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonicate 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 Parts 801 and 11 you desire possible ad res to: Jon Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Four may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Protura Couch Software
Indications for Use: The Protura Couch Software is interface between a record and verify system, linear accelerator (Linac) software, Linac safeguard systems, and/or image guidance systems and the Protura Couch. The Protura Couch Software is also capable of operating the Protura Couch (6 Degree Axis Couch).
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Arland D. Johns
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KLaaaøl
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