VENTRI 1.1

K080124 · Ge Medical Systems F.I. Haifa · KPS · Jan 31, 2008 · Radiology

Device Facts

• Record ID: K080124
• Device Name: VENTRI 1.1
• Applicant: Ge Medical Systems F.I. Haifa
• Product Code: KPS · Radiology
• Decision Date: Jan 31, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The intended use of the Ventri 1.1 system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes. Ventri 1.1 is primarily intended for cardiac applications.

Device Story

Ventri 1.1 is a high-performance Single Photon Emission Computed Tomography (SPECT) system for nuclear cardiology. It captures radioisotope tracer uptake within the patient body to produce diagnostic images. The system features a specialized scanning geometry and updated detection assembly/electronic boards compared to its predecessor, enabling shorter scan times. It utilizes a stationary gantry design with no moving parts during patient scanning, reducing the need for automatic gantry motion. The system is operated by clinical staff in a diagnostic imaging environment. The user interface is identical to the predicate Ventri system. Healthcare providers use the resulting images to assess cardiac function and pathology, aiding in clinical decision-making and patient diagnosis.

Clinical Evidence

No clinical trial data provided. Evidence consists of bench testing for compliance with safety standards (IEC60601 series) and performance standards (NEMA NU-1), alongside software validation and clinical image comparisons to the predicate device.

Technological Characteristics

SPECT system; specialized scanning geometry; updated detection assembly and electronic boards; stationary gantry design (no moving parts during scan); acquisition station adapted from predicate; UI identical to predicate. Complies with IEC60601 and NEMA NU-1 standards.

Indications for Use

Indicated for patients requiring nuclear imaging procedures for the detection and imaging of radioisotope tracer uptake for clinical diagnostic purposes, with a primary focus on cardiac applications.

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

• Ventri (K051855)
• D-SPECT™ Cardiac Scanner System (K062450)
• APEX Helix- A (K914807)

Submission Summary (Full Text)

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GE Medical System, F.I. , Haifa 4, Hayozma St. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL

K080124

JAN 31 2008

#### 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b)) 10.

#### Summary date

December 27, 2007

Device Name Proprietary Device Name: Ventri 1.1

# Establishment Name and Registration Number of Submitter

Name: Registration Number: Corresponding Official:

GE Medical Systems F.I. Haifa 6613299 Laurence Bigio; Site QA Manager GE Medical Systems F.I. Haifa 4 Hayozma St. P.O. Box 170 Tirat Hacarmel 30200, ISRAEL [e-mail] [phone] (Tel) [phone] (Fax)

#### Device Classification

Classification Name:

Common Name: Classification Code: Panel Identification: Classification Class:

System Emission Computed Tomography (per 21CFR 892.1200) Single Photon Emission Computed Tomography 90 KPS Radiology Class II Product

Type of Submission

Traditional

#### Reason for 510(k) Submission

Modification of legally marketed devices.

| Identification of Legally Marketed Equivalent Devices | |
|-------------------------------------------------------|---------|
| Ventri | K051855 |
| D-SPECT™ Cardiac Scanner System | K062450 |
| APEX Helix- A | K914807 |

FDA CDRH DMC

JAN 1 7 2008

Received

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a circle. The circle has decorative swirls or flourishes at the top and bottom, giving it a classic or vintage appearance.

GE Medical System, F.I. , Haifa 4, Hayozma St. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL

510(k) Summary of Safety and Effectiveness, Ventri 1.1, Page 2

### Device Description

The Ventri 1.1 is a high-performance Single Photon Emission Computed Tomography system, mainly for nuclear cardiology imaging.

#### Description of Change or Modification

The following modifications have been made to the Ventri 1.1 system relative mainly to the predicate device "Ventri" Nuclear Medicine System (K051855).

- 1. Gantry the gantry structure is the same as Ventri (K051855). Relevant changes have been introduced in order to carry a new type of detection assembly.
- 2. Detection assembly new type of detection assembly and electronic boards have been introduced. The special scanning geometry and detector technology, enable shorter scan times.
- 3. Table the patient table is the same as Ventri (K051855).
- 4. Acquisition station the acquisition station has been adapted from the Ventri system (K051855) with minimum configuration changes. Automatic gantry motion were reduced to minimum due to the fact that there are no moving parts during patient scanning. User interface (UI) is identical to that of the Ventri System (K051855).

#### Intended Use of Device

The intended use of the Ventri 1.1 system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes.

Ventri 1.1 is primarily intended for cardiac applications.

#### Summarv of Studies

The system was tested to comply with safety industry standards (IEC60601 series) and its performance was tested according to industry performance standards (relevant parts in NEMA NU-1).

SW validation tests, Bench data and clinical images show that the Ventri 1.1 performance is substantially equivalent to the performance of the predicate devices.

#### Conclusion

In the opinion of GE Medical Systems F.I. Haifa, the Ventri 1,1 system is substantially equivalent in terms of safety and effectiveness to the legally marketed the Ventri Nuclear Medicine System (K051855).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 31 2008

GE Medical Systems F.I. Haifa % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

Re: K080124

Trade/Device Name: Ventri 1.1 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: January 11, 2008 Received: January 17, 2008

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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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); 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.

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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The letters and the border are black, while the background is white. There are decorative swirls or flourishes around the inside of the border, adding a touch of elegance to the design.

GE Medical System, F.I. , Haifa 4, Hayozma St. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL

Indications for Use

2080124 510(k) Number (if known): _

Device Name: Ventri 1.1

Indications for Use:

The intended use of the Ventri 1.1 system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes.

Ventri 1.1 is primarily intended for cardiac applications

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 Device Evaluation (ODE)

Page / of /

(Posted November 13, 2003)

Arun M. Thayan

(Disic Division of Reproductive, Abdominal and Radiological Device 510(k) Number

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