CONFIDENT SURGERY SUITE 300, MODEL CSS300

K101887 · Surgiceye GmbH · IZD · Mar 22, 2011 · Radiology

Device Facts

• Record ID: K101887
• Device Name: CONFIDENT SURGERY SUITE 300, MODEL CSS300
• Applicant: Surgiceye GmbH
• Product Code: IZD · Radiology
• Decision Date: Mar 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1320
• Device Class: Class 1

Indications for Use

Confident Surgery Suite 300 (CSS300) works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. CSS300 is intended to extend the said detector and generate images of the distribution of radionuclides in the human body by means of tracking technologies and image reconstruction techniques. CSS300 extends currently all nuclear uptake detectors by Crystal Photonics. CSS300 may also be used intraoperatively or on pathological specimens if a protective sheath is used to cover the nuclear uptake detector. CSS300 may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.

Device Story

CSS300 is an extension system for nuclear uptake detectors (e.g., Crystal Photonics probes) to enable 3D imaging of radionuclide distribution. System includes an optical camera, positioning sensor, ergonomic arm, and analysis/display equipment. Operator moves the detector freely over the target area; infrared tracking system monitors probe position/orientation. Data from the detector and tracking system are processed via image reconstruction techniques to produce 3D images. Used intraoperatively, at bedside, in ER, or ICU by trained personnel. Output provides visual representation of radionuclide uptake for clinical documentation, reporting, and decision-making. Benefits include more intuitive use of nuclear probes and enhanced patient treatment through spatial visualization of radioactivity.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and bench testing for safety and electromagnetic compatibility (EN 60601-1, UL 60601-1, EN 60601-1-2).

Technological Characteristics

System includes nuclear uptake detector interface, optical camera, positioning sensor, and ergonomic arm. Utilizes infrared tracking technology for spatial localization. Employs image reconstruction algorithms to convert probe signals and tracking data into 3D images. Complies with EN 60601-1 (safety) and EN 60601-1-2 (EMC).

Indications for Use

Indicated for use with nuclear uptake detectors to generate 3D images of radionuclide distribution in human organs or body regions. Applicable for intraoperative use, pathological specimens, bedside, ER, or ICU settings. Intended for use by trained personnel.

Regulatory Classification

Identification

A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Neoprobe Model 1500 Portable Radioisotope Detector and Accessories (K971167)
• SI-Handheld Gamma Finder (HGF) (K013751)
• VectorVision2 (K983831)
• Nexstim Eximia navigated brain stimulation system (K091457)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Surgic Eye. The logo consists of the word "SURGICeye" with the word "eye" in a smaller font size. Above and below the word are curved lines that resemble an eye. Below the logo is the text "Vision for Tomorrow's Surgery".

MAR 2 2 2011

# 510(K) Summary < Revised in S2 > Confident Surgery Suite 300 (CSS300)

#### General information

510(K) number: K101887 Owner's name: SurgicEye GmbH Address: Friedenstr. 18A, 81671 München, GERMANY Phone: [phone] Fax number: [phone] Name of contact person: Dr. Joerg Traub Date: 18th Dec 2011

Name of device: Confident Surgery Suite 300 (CSS300) System trade name: Confident Surgery Suite Common name: Extension of nuclear uptake probe Classification name: Nuclear uptake probe, Class I. 21 CFR 3 892.1320 (2010)

#### Predicated Devices

Product: Neoprobe Model 1500 Portable Radioisotope Detector and Accessories Manufacturer: Neoprobe Corporation 510{k} number: K971167

Substantial Equivalence Date: 1997/6/26 Product: SI-Handheld Gamma Finder (HGF) Manufacturer: Silicon Instruments, GmbH 510{k} number: K013751 Substantial Equivalence Date: 2002/2/6

Product: VectorVision2 Manufacturer: Brainlab, AG 510(k) number: K983831 Substantial Equivalence Date: 1999/05/19

Product: Nexstim Eximia navigated brain stimulation system Manufacturer: Nexstim, OY 510(k) number: K091457 Substantial Equivalence Date: 2009/12/08

#### Confidential.

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File location: http://james/product/Confident Surgery Suite CSS/CSS300/FDA Notification/510(k)SummaryCSS300_ProbeExtention.docx

Document version: 1.0

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Image /page/1/Picture/0 description: The image shows the logo for Surgic Eye. The logo consists of the word "SURGICeye" in a sans-serif font, with the "eye" portion of the word in a slightly different style. Above and below the word are curved lines that resemble an eye shape. Below the logo is the tagline "Vision for Tomorrow's Surgery" in a smaller font.

#### Description

CSS300 is an extension for nuclear uptake detectors designed to obtain 3D images from small organs and structures labeled using radionuclides emitting gamma rays by acquiring data while moving freely with the hand the said detectors.

Examples of nuclear uptake detectors compatible with CSS300 are the nuclear uptake detectors by Crystal Photonics.

CSS300 includes also analysis and display equipment, an optical camera, a cart and an ergonomic arm which allows positioning the required positioning sensor and camera in a suitable position while using the device.

#### Indications for Use

Confident Surgery Suite 300 (CSS300) works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. CSS300 is intended to extend the said detector and generate images of the distribution of radionuclides in the human body by means of tracking technologies and image reconstruction techniques. CSS300 extends currently all nuclear uptake detectors by Crystal Photonics. CSS300 may also be used intraoperatively or on pathological specimens if a protective sheath is used to cover the nuclear uptake detector. CSS300 may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.

### Substantially Equivalence Claim

CSS300 has the same intended use as the legally marketed predicated devices Neoprobe Model 1500 Portable Radioisotope Detector and Accessories (Neoprobe Corporation), K971167, and SI-Handheld Gamma Finder (Silicon Instruments GmbH), K013751. CSS300 extends a nuclear uptake probe like said predicated devices by further incorporating an infrared tracking system substantially equivalent to the ones included in the cleared VectorVision2 (Brainlab AG), K983831 and Nexstim Eximia Navigated Brain Stimulation System (Nexstim OY), K091457. By combining both technologies and image reconstruction technique, CSS300 is capable of generating images of the radioactivity taken up by a particular organ or body region. CSS300 can be considered an extension to nuclear uptake detectors that make their use more intuitive and thus enable better patient treatment.

CSS300 is as safe and effective as the above-mentioned predicated devices. 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

Confidential.

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File location: http://james/product/Confident Surgery Suite CSS/CSS300/FDA Notification/510(k)SummaryCSS300_ProbeExtention.docx

Document version: 1.0

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Image /page/2/Picture/0 description: The image shows the logo for "SURGICeye". The word "SURGICeye" is in bold, black letters, with the "eye" portion of the word in a slightly smaller font size. Above and below the word are curved lines that resemble an eye shape. Below the logo is the tagline "Vision for Tomorrow's Surgery".

standard: Electromagnetic compatibility. It bears the CE mark in accordance to the Medical Device Directive 93/42/EEC.

Confidential.

File location: http://james/product/Confident Surgery Suite CSS/CSS300/FDA Notification/510(k)SummaryCSS300_ProbeExtention.docx

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Document version: 1.0

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

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

MAR 2 2 2011

Mr. Moritz Hoyer QM & Regulatory Affairs SurgicEve GmbH Friedenstrabe, 18a D-81671 Munich GERMANY

Re: K101887

Trade/Device Name: CSS300 Regulation Number: 21 CFR 892.1320 Regulation Name: Nuclear uptake probe Regulatory Class: I Product Code: IZD Dated: January 20, 2011 Received: February 8, 2011

Dear Mr. Hoyer:

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 of medical device-related

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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 200). This letter will allow you to begin marketing your device as described in your Section 510(l). This ket notification. The FDA finding of substantial equivalence of your device to a legal y renaketed 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 tolloffree mobile [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

Mary S. Pastel, Sc.D. 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): K101887 Device Name: CSS300

Indications for Use:

Confident Surgery Suite 300 (CSS300) works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. CSS300 is intended to extend the said detector and generate images of the distribution of radionuclides in the human body by means of tracking technologies and image reconstruction techniques. CSS300 extends currently all nuclear uptake detectors by Crystal Photonics. CSS300 may also be used intraoperatively or on pathological specimens if a protective sheath is used to cover the nuclear uptake detector. CSS300 may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.

Prescription Use ਮ (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 Diagnostic Devices (OIVD)

Mary S. Potts
(Division Sign Off)

Office of In Vitro

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510K K101882