IDENTIFY

K112692 · Humediq GmbH · IYE · Aug 3, 2012 · Radiology

Device Facts

• Record ID: K112692
• Device Name: IDENTIFY
• Applicant: Humediq GmbH
• Product Code: IYE · Radiology
• Decision Date: Aug 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The intended use of the device is to identify the patient specific accessories and to guide the positioning of patients and accessories for radiotherapy procedures. The system uses optical tracking of optical markers and RFID tracking of RFID tags as the method of identifying the patient and the accessories. The system consists of an optical tracking system with optical markers and RFID tracking system including RFID tags, a RFID identification system, a computer workstation, an interlock unit, a handheld controller, Wireless LAN access points, a video camera and calibration tools.

Device Story

Identify system aids radiotherapy patient/accessory positioning; identifies patient-specific accessories. Inputs: optical tracking of retro-reflective disk markers; RFID tag data from patients/equipment. Components: PC, GUI, NDI Polaris 3D tracking system, video camera, RFID reader, interlock unit, handheld controller, WLAN access points. Operation: system tracks markers/reads RFID tags to display position/ID information to user. Used in radiologic diagnostic/radiation therapy departments. Output: visual display of position/identification data on GUI. Clinical utility: assists clinicians in accurate patient/accessory alignment during radiation therapy; ensures correct patient/accessory identification; potentially improves treatment precision.

Clinical Evidence

Bench testing only. Compliance with safety standards EN 60601-1, UL 60601-1, and EN 60601-1-2 (electromagnetic compatibility) provided.

Technological Characteristics

System includes PC workstation, NDI Polaris 3D optical tracking system, video camera, RFID reader, interlock unit, handheld controller, and WLAN access points. Uses optical tracking of retro-reflective markers and RFID tag identification. Complies with EN 60601-1 and UL 60601-1 safety standards and EN 60601-1-2 for electromagnetic compatibility.

Indications for Use

Indicated for patients undergoing radiotherapy procedures requiring identification of patient-specific accessories and guidance for patient and accessory positioning.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• iGuide System (K062611)

Reference Devices

• Civco RFSuite
• Xecan EMR RFID plug-in

Submission Summary (Full Text)

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# 510(K) Summary Identify

## General information

510(K) number: K112692 Owner's name: humediQ GmbH Address: Bahnhofstraße 108, 82166 Gräfelfing, Germany Phone: [phone] Fax number: [phone] Name of contact person: Christian Hieronimi Date: 12th Sep. 2011

Name of device: Identify System trade name: Identify Regulation number: 21 CFR §892.5050 Regulation name: Medical charged-particle radiation therapy system Regulatory class: II Product code: IYE

### Predicated Devices

Product: iGuide System Manufacturer: Medical Intelligence Medizintechnik GmbH 510(k) number: K062611 Substantial Equivalence Date: 31. Aug. 2006

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#### Description

ldentify displays position and identification information during radio therapy treatment to the user.

The system uses optical tracking of retro reflective disk markers to find the position of the patient and radiotherapy equipment and radio frequency identification (RFID) to obtain identification information from the patient and radiotherapy equipment.

The system consists of a PC, a graphical user interface, a NDI Polaris 3D tracking system, a video camera and a RFID reader.

#### Indications for Use

The intended use of the device is to identify the patient specific accessories and to aid in the positioning of a patient during radiation therapy.

## Substantially Equivalence Claim

Identify has the same intended use as the predicate device. It uses the same optical 3D tracking technology to locate the position of the patient and accessories.

In addition to the predicate device it uses RFID identification to read the ID of the patient and the accessories during radiotherapy from an RFID tag. This technology is used by systems which are not subject to FDA approval (Civco RFSuite, Xecan EMR RFID plug-in).

For a detailed discussion of the substantial equivalence see the document "Detailed Substantial Equivalence Claim".

ldentify and its components are as safe and effective as the above-mentioned predicated device. It meets safety requirements, EN 60601-1: Medical Electrical Equipment — Part 1: General Requirements for Safety, UL 60601-1: Medical Electrical Equipment – Part 1: General Requirements for Safety and EN 60601-1-2:2007: Medical Electrical Equipment – Part 1-2: General Requirements for Safety. Collateral standard: Electromagnetic compatibility. It bears the CE mark in accordance to the Medical Device Directive 93/42/EEC.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four abstract shapes that resemble a human figure, with the top shape representing the head and the other shapes representing the body.

#### 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. Gundula Gehrmann Director Quality & Operations humediQ GmbH Bahnhofstrabe 108 GRAFELFING 82166 GERMANY

Re: K112692

Trade/Device Name: Identify Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 9, 2012 Received: July 12, 2012

#### Dear Ms. Gehrmann:

'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 reay, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, dictore, mainer are act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r 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 or any i with all the Act's requirements, including, but not limited to: registration and listing (21 fCFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

AUG 3 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding 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 Parts 801 and 809), please contact the Office of In 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 Division 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

Acting 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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Identify - Device Master Record

Image /page/4/Picture/2 description: The image shows the word "humediQ" in a simple, sans-serif font. The letters are black against a white background. Above the "i" in "humediQ" is a small icon resembling radio waves, suggesting a connection or communication aspect to the brand.

#### Indications for Use Form

510(k) Number (if known):

Device Name: Identify

Indications for Use:

The intended use of the device is to identify the patient specific accessories and to guide the positioning of patients and accessories for radiotherapy procedures. The system uses optical tracking of optical markers and RFID tracking of RFID tags as the method of identifying the patient and the accessories. The system consists of an optical tracking system with optical markers and RFID tracking system including RFID tags, a RFID identification system, a computer workstation, an interlock unit, a handheld controller, Wireless LAN access points, a video camera and calibration tools.

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The only location where the device is used is the radiologic diagnostic and radiation therapy department.

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)

Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 112692

File location: https://james.se.surgiceye.com/product/Confident Surgery Suite CSS/PinPoint/01IntendedUseIdentify.docx

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