The Protura Couch Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, 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).

Device Description

The proposed device, the Protura Couch Software 1.3.0 (Part No. MT6XSM1.3.0), 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 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 record and verify systems, Linac software systems, Linac safeguard systems, and/or image guidance systems.

AI/ML Overview

The provided document is a 510(k) summary for the Protura Couch Software 1.3.0, a patient positioning software used in radiation treatments. It states that non-clinical performance testing was conducted, but no clinical testing was performed. Therefore, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance based on a study, nor does it provide details about patient data, expert reviews, or comparative effectiveness studies.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "Non-Clinical Performance Data" areas tested and states "All testing confirmed that the Protura Couch Software 1.3.0 is safe and effective for its intended use." However, it does not provide specific acceptance criteria (e.g., numerical thresholds, error limits) or quantitative results of the device's performance against such criteria.

Acceptance Criterion (Inferred from testing areas)	Reported Device Performance (General Statement)
Movement of the Protura Couch	Confirmed safe and effective
Interfacing with External Systems	Confirmed safe and effective
Couch Pedestal and Isocenter Alignment	Confirmed safe and effective
Patient Record Handling	Confirmed safe and effective

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable. No clinical testing with patient data was performed. The testing described is non-clinical performance testing of the software and hardware interfaces.
Data Provenance: Not applicable, as no patient data was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts: Not applicable. No clinical testing or expert review of patient data was conducted.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. No clinical testing or expert review requiring adjudication was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No. The document explicitly states: "No clinical testing was performed in the evaluation of this medical device." Therefore, no MRMC study, human reader improvement analysis, or AI assistance effect size was reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: The non-clinical performance testing focused on the device's functionality, interfacing, and mechanical aspects. While this could be considered a form of "standalone" testing for the software's operational characteristics, it's not in the context of diagnostic or interpretive performance where "standalone" typically refers to an AI algorithm's accuracy in analysis without human input. The document describes testing of the software's technical operation (e.g., couch movement, interfacing), not its interpretation of data.

7. The Type of Ground Truth Used:

Ground Truth: For the non-clinical performance tests, the "ground truth" would have been established by engineering specifications, calibration standards, and expected operational parameters for the couch movement, interface communication, and alignment accuracy. For example, for "Movement of the Protura Couch," the ground truth would be the programmed movement patterns and expected physical responses of the couch hardware. For "Couch Pedestal and Isocenter Alignment," it would be the precise physical alignment specifications.

8. The Sample Size for the Training Set:

Sample Size: Not applicable. This device is software that controls a medical device (a radiation therapy couch). It is not an AI/ML algorithm that requires a training set in the typical sense (i.e., for learning from data to perform a diagnostic or predictive task). The software is programmed based on engineering principles and specifications, not trained on a dataset of patient cases.

9. How the Ground Truth for the Training Set was Established:

Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device. The software functions based on its coded logic and interface protocols, not on learned patterns from a dataset.

Summary

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Image /page/0/Picture/1 description: The image shows handwritten text on a white background. The text at the top reads "K132084", which appears to be a reference or identification number. Below this, the text "Page 1 of 2" indicates that this is the first page of a two-page document. The handwriting is clear and legible, with a simple, straightforward style.

www.civco.com

Section 5 -- 510(k) Summary

SEP 2 6 2013

A. Submitter Information

Submitter Name & Address:	MEDTEC, Inc. d/b/a CIVCO Medical Solutions1401 8th Street SEOrange City, lowa 51041
Contact Person:	Amanda Stahle, Regulatory Affairs SpecialistTelephone: 319-248-6628, Fax: 877-218-0324amanda.stahle@civco.com
Date Summary Prepared:	June 28, 2013
Trade Name:	Protura Couch Software 1.3.0
Common Name:	Treatment Couch Software
Classification Name:	Powered radiation therapy patient support assembly
Classification Number:	Class II under 21 CFR 892.5770
Review Panel:	Radiology
Product Code:	JAI

B. Predicate Device

MEDTEC, Inc. d/b/a CIVCO Medical Solutions claims the proposed device to be substantially equivalent to the following device:

510(k) Number	Device Name	ProductClassification/Code	Submitter Name
K122201	PROTURA COUCHSOFTWARE	892.5770/JAI	MED-TEC, Inc.D/B/A CIVCOMEDICALSOLUTIONS

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 Protura Couch Software to the Couch Hardware for implementation. Both the proposed device and the predicate device may interface with a record and verify system (Elekta MOSAIQ), Linac software (Elekta iCOM), Linac safeguard systems (Elekta touch guard and External Inhibit), and/or image guidance systems (Elekta XVI and VisionRT AlignRT). The proposed device adds interface capability with the following Varian systems: record and verify system (Varian ARIA), Linac software system (Varian 4DTC), Linac safeguard system (Varian 4DTC beam authorization), and image guidance system (Varian OBI). The proposed device also includes bug fixes and other functionality improvements. Testing has demonstrated that the proposed device is substantially equivalent

Corporate Headquarters		1 102 First Street South 1 - Kalona: A 52247 - 1 - 2 - 5 19.248.6757.			0 319.248.6660 - 19.248.6660 - 19.2
Coralville Office	2301 Jones Blvd.	Coralville, IA 52241	USA	2 319.248.6757	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	2 712.737.8688	3 712.737.8654

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Image /page/1/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe-like graphic on the left, followed by the word "CIVCO" in bold, sans-serif font. Below "CIVCO" are the words "MEDICAL SOLUTIONS" in a smaller, sans-serif font, with a wider letter spacing.

K132084
Page 2 of 2

www.civco.com

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.

C. Device Description

D. Indications for Use/Intended Use

The Protura Couch Software is interface between record and verify systems, linear accelerator (Linac) software systems, 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 proposed device and the predicate device are interface software systems that are intended to operate the Couch Hardware (K031866). Both the proposed device and the predicate device interface with a record and verify system, Linac software, Linac safeguard systems, and/or image guidance systems. The proposed device interfaces with an additional record and verify system, Linac software system, Linac safeguard system, and image guidance system. The proposed device and the predicate device are programmed in C#. The proposed device operates on Windows 7 (64 bit) whereas the predicate device operates on Windows XP SP3 (32 bit), Windows 7 (32 bit), and Windows 7 (64 bit).

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 1.3.0 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 Performance Data Conclusions

The conclusions drawn from the tests are that the Protura Couch Software 1.3.0 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

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized, and the overall appearance is clean and professional.

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 26, 2013

MED-TEC, Inc. d/b/a CIVCO Medical Solutions % Ms. Amanda Stahle Regulatory Affairs Specialist 1401 8th Street SE ORANGE CITY IA 51041

Re: K132084

Trade/Device Name: Protura Couch Software 1.3.0 Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: JAI Dated: July 3, 2013 Received: July 5, 2013

Dear Ms. Stahle:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Ms. Stahle

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Division 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.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K132084

Device Name: Protura Couch Software 1.3.0

Indications for Use: The Protura Couch Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, 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 X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k)________________________________________________________________________________________________________________________________________________________________________

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Regulation Number and Section

§ 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.