PROTURA COUCH SOFTWARE

K122201 · Med-Tec, Inc. D/B/A Civco Medical Solutions · JAI · Aug 30, 2012 · Radiology

Device Facts

• Record ID: K122201
• Device Name: PROTURA COUCH SOFTWARE
• Applicant: Med-Tec, Inc. D/B/A Civco Medical Solutions
• Product Code: JAI · Radiology
• Decision Date: Aug 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5770
• Device Class: Class 2

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).

Device Story

Protura Couch Software is a patient positioning interface for radiation therapy. It connects record and verify systems, Linac software, Linac safeguard systems, and image guidance systems to the Protura Couch hardware. The software enables clinicians to control patient positioning with six degrees of freedom from outside the treatment room. By integrating with image guidance systems, it allows for precise patient adjustments based on diagnostic decisions. The system facilitates accurate patient alignment for radiation delivery, potentially improving treatment precision and patient outcomes. It is intended for use in clinical radiation therapy environments.

Clinical Evidence

No clinical data. Bench testing only, covering couch movement, external system interfacing, couch pedestal/isocenter alignment, and patient record handling.

Technological Characteristics

Interface software for radiation therapy couch hardware. Programmed in C#. Runs on Windows XP SP3 (32-bit), Windows 7 (32-bit), and Windows 7 (64-bit). Enables 6-degree-of-freedom positioning control. Connectivity includes record and verify systems, Linac software, and image guidance systems.

Indications for Use

Indicated for use as an interface between radiation therapy systems (record and verify, Linac, safeguard, and image guidance systems) and the Protura 6-degree-of-freedom patient positioning couch to facilitate patient positioning during radiation therapy.

Regulatory Classification

Identification

A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.

Predicate Devices

• PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 (K034054)

Reference Devices

• Protura Couch Hardware (K031866)

Submission Summary (Full Text)

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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.

WWW.CIVCO.COM

AUG 30 2012

## Section 5 - 510(k) Summary

| A. Submitter Information | Submitter Name & Address: MED-TEC, Inc. d/b/a CIVCO Medical Solutions<br>1401 8th Street SE<br>Orange City, lowa 51041 |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amanda Stahle, Regulatory Affairs Specialist<br>Telephone: [phone], Fax: [phone]<br>[e-mail] |
| Date Summary Prepared: | July 10, 2012 |
| Trade Name:<br>Common Name:<br>Classification Name:<br>Classification Number:<br>Product Code: | Protura Couch Software<br>Treatment Couch Software<br>Powered radiation therapy patient support assembly<br>892.5770<br>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<br>Classification/<br>Code | Submitter<br>Name |
|---------------|---------------------------------------------------|------------------------------------|-------------------|
| K034054 | PRO SERIES COUCH<br>SOFTWARE, MODEL MT-<br>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 |

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WWW.CIVCO.COM

### 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 | | <span style="font-family: sans-serif;">ⓟ</span> 319.248.6757 | | <span style="font-family: sans-serif;">Ⓕ</span> 319.248.6660 |
|------------------------|------------------------|-----------------------|-----------------|--|-------------------------------------------------------------------|--|-------------------------------------------------------------------|
| Coralville Office | 2301 Jones Blvd. | Coralville, IA 52241 | USA | | <span style="font-family: sans-serif;">ⓟ</span> 319.248.6757 | | <span style="font-family: sans-serif;">Ⓕ</span> 319.248.6660 |
| Europe Office | Pasteurstraat 6 | 2811 DX Reeuwijk | The Netherlands | | <span style="font-family: sans-serif;">ⓟ</span> +31(0) 182.394495 | | <span style="font-family: sans-serif;">Ⓕ</span> +31(0) 182.395014 |
| Orange City Office | 1401 8th Street SE | Orange City, IA 51041 | USA | | <span style="font-family: sans-serif;">ⓟ</span> 712.737.8688 | | <span style="font-family: sans-serif;">Ⓕ</span> 712.737.8654 |

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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

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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 [phone]. 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 [phone] or [phone] 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

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#### 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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