DISCOVERY NM 630

K111445 · GE Healthcare · KPS · Jun 3, 2011 · Radiology

Device Facts

• Record ID: K111445
• Device Name: DISCOVERY NM 630
• Applicant: GE Healthcare
• Product Code: KPS · Radiology
• Decision Date: Jun 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.

Device Story

Discovery NM 630 is a dual-detector SPECT nuclear medicine imaging system; captures radioisotope tracer uptake in patient body. Inputs: gamma radiation signals; processed via various scanning modes (planar, SPECT, gated SPECT, whole body). Features: collimators, physiological gating, real-time automatic body contouring. Operated by trained healthcare professionals in clinical settings. System produces diagnostic images for physician review; aids in disease detection, localization, diagnosis, organ function assessment, and therapy planning. Benefits: provides functional imaging data for clinical decision-making across diverse patient populations.

Clinical Evidence

Bench testing only. No clinical studies required for substantial equivalence. Verification and validation performed via module, integration, and system-level testing.

Technological Characteristics

Dual-detector NM gantry; patient table; remote control unit; operation console. Supports planar and tomographic (SPECT) modes. Features: collimators, physiological gating, real-time automatic body contouring. Connectivity: signal analysis and display equipment. Developed under GE Quality System.

Indications for Use

Indicated for patients of all ages for general nuclear medicine imaging procedures to detect radioisotope tracer uptake, aid in diagnosis, assess organ function, and evaluate diseases, trauma, abnormalities, and disorders including cardiovascular disease, neurological disorders, and cancer. Used for tumor staging/restaging and therapy planning/monitoring.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• Discovery NM/CT 670 (K093514)

Submission Summary (Full Text)

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K111445

JUN - 3 2011

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## GE Healthcare 510(k) Premarket Notification Submission

### 510(k) Summary

| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Date: | [April 12, 2011] |
| Submitter: | GE Healthcare, GE Medical Systems Israel, Functional Imaging |
| | 4 HAYOZMA St |
| | TIRAT HACARMEL, 30200, ISRAEL |
| Primary Contact Person: | Tal Bresler-Stramer |
| | Regulatory Affairs Leader |
| | GE Healthcare, GE Medical Systems Israel, Functional Imaging |
| | (972) 4-8563666 |
| | (972) 4-8577664 |
| Secondary Contact Person: | John Jaeckle |
| | Regulatory Affairs Manager, MI&CT |
| | GE Healthcare, |
| | 262-424-9547 |
| Device:<br>Trade Name: | Discovery NM 630 |
| Common/Usual Name: | Single Photon Emission Computed Tomography (SPECT ) |
| Classification Names: | 21CFR 829.1200 |
| Product Code: | KPS |
| Predicate Device(s): | Discovery NM/CT 670 (k093514) |
| Device Description: | The Discovery NM 630 is an all-purpose dual detector nuclear |
| | imaging system intended for general nuclear medicine imaging |
| | procedures for detection of radioisotope tracer uptake in the |
| | patient body, using a variety of scanning modes supported by |
| | various acquisition types and imaging features designed to |
| | enhance image quality. The main components of the Discovery |
| | NM 630 system are: NM Gantry with Dual detector heads, patient |
| | table. Remote Control Unit and NM operation console. The |
| | Discovery NM 630 is a subsystem of its predicate device |
| | Discovery NM/CT 670 (K093514). |
| Indications for Use: | The GE Discovery NM 630 system is a medical tool intended for |
| | use by appropriately trained healthcare professionals to aid in |
| | detecting, localizing, diagnosing of diseases and in assessment of |
| | organ function for the evaluation of diseases, trauma, |
| | abnormalities, and disorders such as, but not limited to, |
| | cardiovascular disease, neurological disorders and cancer. The |
| | system output can also be used by the physician for staging and |
| | restaging of tumors, planning, guiding, and monitoring therapy. |

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Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters and the inner part of the circle are black, while the outer part of the circle is white.

#### GE Healthcare 510(k) Premarket Notification Submission

The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multiisotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.

The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.

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Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white.

#### GE Healthcare 510(k) Premarket Notification Submission

Technology: The Discovery NM 630 is a subset of its predicate device the NM/CT hybrid system Discovery NM/CT 670 (k093514). The Discovery NM 630 employs the same fundamental scientific technology as the NM subsystem of its predicate device the NM/CT hybrid system Discovery NM/CT 670 (k093514).

Summary of Non-Clinical Tests: Determination of Substantial Equivalence:

> The Discovery NM 630 and its applications are designed to comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. It was developed in accordance with GE's Quality System. The following quality assurance measures were applied to the development of the system:

Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Final acceptance testing (Validation) Performance testing (Verification) Safety testing (Verification) The Discovery NM 630 did not require clinical studies to support substantial equivalence. The Discovery NM 630 is the stand-alone nuclear medicine Conclusion: functionality/components of its predicate device. It does not introduce and new safety risks, or intended uses. It performs as well or better than similar devices currently on the market and conforms to the recognized standards for NM. GE Healthcare considers the Discovery NM 630 to be as safe, as effective, and is

substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.

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

GE Healthcare GE Medical Systems Israel, Functional Imaging c/o Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

JUN - 3 2011

Re: K111445

Trade/Device Name: Discovery NM 630 Regulation Number: 21 CFR §892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: May 20, 2011 Received: May 24, 2011

Dear Mr. Devine:

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.

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 issuarice 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, Parts 801 and 809); medical device reporting (reporting of

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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 5.10(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.

Mary Patel

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 Form

510(k) Number (if known):

Device Name: Discovery NM 630

Indications for Use:

The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.

The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring,

The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

Mary Spatil

Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111445

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