MYOLIGHT

K033874 · Ge Medical Systems F.I. Haifa · KPS · Dec 30, 2003 · Radiology

Device Facts

• Record ID: K033874
• Device Name: MYOLIGHT
• Applicant: Ge Medical Systems F.I. Haifa
• Product Code: KPS · Radiology
• Decision Date: Dec 30, 2003
• 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 MyoLIGHT system is to perform Nuclear imaging procedures for detection and imaging of single photon radioisotope tracer uptake in the patient body for clinical diagnostic purposes.

Device Story

MyoLIGHT is a dedicated dual-head gamma camera for nuclear cardiology; performs nuclear imaging procedures to detect/image radioisotope tracer uptake. System features reduced-size gantry with lightweight construction; detectors move in enclosed space on fixed radius at 90-degree orientation; integrated patient table; integrated acquisition station and operator console. Includes built-in cardiac gating circuitry for gated planar and gated SPECT studies. Used in clinical settings by healthcare professionals to acquire diagnostic images; output assists clinicians in evaluating tracer distribution and cardiac function. Benefits include improved workflow through integrated components and built-in gating capabilities compared to external predicate configurations.

Clinical Evidence

No clinical data. Bench testing and image data comparisons were performed to demonstrate that MyoLIGHT images are similar to those produced by the predicate CARDIOSPECT D90 system.

Technological Characteristics

Dual-head gamma camera for nuclear medicine imaging. Features include a reduced-size gantry, lightweight construction, fixed-radius detector movement at 90-degree orientation, integrated patient table, and integrated acquisition station. Includes built-in cardiac gating circuitry for gated planar and SPECT studies. Operates as an emission computed tomography system.

Indications for Use

Indicated for patients requiring nuclear imaging procedures for the detection and imaging of single photon radioisotope tracer uptake for clinical diagnostic purposes.

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

• CARDIOSPECT D90 (K021823)

Submission Summary (Full Text)

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Image /page/0/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 and the border are black, contrasting with the white background.

DEC 3 0 2003

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

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

#### Summary date

Dec- 08- 2003

Device Name Proprietary Device Name: MyoLIGHT

## Establishment Name and Registration Number of Submitter

| Name: | GE Medical Systems F.I. Haifa |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number: | 9613299 |
| Corresponding Official: | Laurence Bigio; Quality, Safety and Regulatory<br>Manager<br>GE Medical Systems F.I. Haifa<br>4 Hayozma St. P.O. Box 170<br>Tirat Hacarmel 30200, ISRAEL<br>[e-mail]<br>[phone] (Tel)<br>[phone] (Fax) |

# Device Classification Classification Code: Panel Identification: Classification Name:

90 KPS Radiology Emission computed tomography system (per 21CFR 892.1200) Nuclear Medicine Imaging system Class II Product

Type of Submission

Classification Class:

Common Name:

Traditional

Reason for 510(k) Submission

Modification of legally marketed device.

## Identification of Legally Marketed Equivalent Devices

Nuclear Cardiology System: CARDIOSPECT D90 - K021823 (Manufactured by MEDISO Budapest)

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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 letters and the circle are black, and the background is white.

·

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

### 510(k) Summary of Safety and Effectiveness, MyoLIGHT, Page 2

#### Device Description

The MyoLIGHT system is a dedicated Gamma Camera for nuclear cardiology, highperformance dual-head nuclear medicine imaging system. It is based on the following legally marketed device: CARDIOSPECT D90 - K021823

#### Description of Change or Modification

The following modifications have been made to the MyoLIGHT system relative to the predicate device, CARDIOSPECT D90 (K021823):

- 1. Gantry: The gantry size has been reduced and adapted for the new patient table. The new system utilizes lightweight construction relative to the predicate device.
- 2. Detectors: The detectors move in an enclosed space on a fixed radius, and are set at 90 degrees to each other.
- 3. Table: The simplified patient table system is integrated to the gantry.
- 4. Acquisition station: The Acquisition station has been integrated into the gantry structure, including its operator console.
- 5. Built-in Gating Capability: The system includes built-in cardiac gating circuitry used for both gated planar and gated SPECT studies. This capability was provided externally in the predicate device. The two are functionally equivalent for nuclear medicine studies.

#### Intended Use of Device

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

#### Summary of Studies

Bench and images data show that the MyoLIGHT images are similar to the CARDIOSPECT D90 (K021823) images.

#### Conclusion

In the opinion of GE Medical Systems F.I. Haifa, the MyoLIGHT system is substantially equivalent in terms of safety and effectiveness to the legally marketed the CARDIOSPECT D90 (K021823) system.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 2003

GE Medical Systems F.I. Haifa % Ms. Chantel Carson Engineering Group Leader Underwriters Laboratories, Inc. Northbrook Division 333 Pfingsten Road NORTHBROOK IL 60062-2096 Re: K033874 Trade/Device Name: MyoLIGHT Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: December 11, 2003 Received: December 15, 2003

Dear Ms. Carson:

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. Iisting 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.

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,

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincercly 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

Enclosure

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Attachment 1 b Page 1 of 1

| 510(k) Number (if known): | |
|---------------------------|--|
| Device Name: | |
| Indications For Use: | |

| K033874 | |
|----------|--|
| MyoLIGHT | |

The intended use of the MyoLIGHT system is to perform Nuclear imaging procedures for detection and imaging of single photon radioisotope tracer uptake in the patient body for clinical diagnostic purposes.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div> <img alt="Signature" src="signature.png"/> </div> |
|---------------------------------------------------------------|---------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K033874 |

| Prescription Use (Per 21CFR 801.109) | OR | Over-The-Counter Use |
|--------------------------------------|----|----------------------|
|--------------------------------------|----|----------------------|

(Optional Format 1-2-96