C.CAM

K031825 · Danish Diagnostic Development A/S · KPS · Jun 20, 2003 · Radiology

Device Facts

• Record ID: K031825
• Device Name: C.CAM
• Applicant: Danish Diagnostic Development A/S
• Product Code: KPS · Radiology
• Decision Date: Jun 20, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

Virgo is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. Virgo is primarily intended for cardiac applications but the Virgo design also supports non-cardiac procedures of the patient's chest region and body extremities. Virgo supports radionuclides within the energy range of 60 - 170 keV

Device Story

Virgo is an emission computed tomography (ECT) system; detects gamma ray radionuclides in body; produces cross-sectional images via computer reconstruction. System comprises gantry with fixed 90-degree dual-head detector and patient chair. Operator uses acquisition PC and hand controller to position detectors and chair. Detectors capture gamma photons; determine energy and 2D position; perform uniformity/linearity corrections. Data sent to acquisition PC for image framing and storage; export via DICOM to external processing station. Used in clinical settings; operated by trained personnel. Benefits include diagnostic imaging for cardiac and non-cardiac (chest/extremities) procedures.

Clinical Evidence

Bench testing only. Performance verified against NEMA Standard NU 1-1994, including intrinsic spatial resolution (≤ ± 3.7mm), energy resolution (≤ 9.4% @ Tc-99m), spatial linearity (< ± 0.5 mm), and flood field uniformity (< ± 2.5%).

Technological Characteristics

Emission computed tomography system. Detectors: NaI crystal, 24 3" square PMTs, copper/zinc/lead alloy housing (UNS C94300). Energy range: 60-170 keV. Patient support: S-shaped iron frame chair with tilt/height adjustment. Connectivity: IEEE 1394 Firewire to acquisition PC; DICOM export. Power: 100-240 VAC. Software: Windows-based acquisition package.

Indications for Use

Indicated for patients requiring emission computed tomography imaging for cardiac applications, as well as non-cardiac procedures of the chest region and body extremities, using radionuclides in the 60-170 keV energy range.

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

• CardioMD (K011611)
• Unicorn (K001888)

Submission Summary (Full Text)

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10 June 2003

1PMN0397-C04

DDD

### ADMINISTRATIVE INFORMATION в

# B-1 Summary of Safety and Effectiveness Statement

#### Ref. CFR 807.92 B-1-1

| 1 | Submitted by: | 3D, Danish Diagnostic Development A/S<br>Dr. Neergaardsvej 5F<br>2970 Horsholm, Denmark<br>Tel: [phone]<br>Fax: [phone] | |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | Contact person: | Niels Sorensen<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| | Preparation date: | 29 April 2003 | |
| 2 | Device Trade Name: | Virgo | |
| | Common Name: | Gamma Camera System | |
| | Classification name: | Emission computed tomography system | |
| 3 | Predicate Device: | 3D, Danish Diagnostic Development A/S, CardioMD | |
| | 510(K) Number: | K011611 | |
| | | 3D, Danish Diagnostic Development A/S, Unicorn (K001888)<br>Refer to section C3 Comparison of the New and Predicate Device, subpart;<br>Indications for use statement. | |
| 4 | Device description: | The Virgo system design comprises a gantry supporting a fixed 90 degree<br>dual head detector and a patient chair. The Virgo system is operated through<br>interaction with a graphical user interface situated on the acquisition PC and a<br>dedicated Virgo hand controller. | |
| | Functional description: | The patient ascends the chair. When the acquisition setup has been completed<br>on the acquisition PC, preprogrammed motions declines the chair and patient<br>to slanted position and the detectors brought to a predetermined position. | |
| | | When a tomography is acquired, the handset is used to position the detector in<br>close proximity to the patient to enter contour marks to determine the detector<br>orbit for the acquisition. | |
| | | For planar imaging, the handset is used to position the detectors. | |
| | | When the detectors are in position, the acquisition is started. During<br>acquisition, the detector detects gamma photons emitted from the patient. For<br>each photon detected, the detector determines the energy and position (two-<br>dimensional) from where the photon originated within the patient. The<br>detector corrects for uniformity and linearity errors before sending energy and | |
| DDD | | VIRGO 510(K) SUBMISSION | |
| 1PMN0397-C04 | | 10 June 2003 | |
| | position data to the acquisition PC. The acquisition PC frames the received<br>data into images. Once the acquisition terminates, the resulting images and<br>data is stored in the acquisition PC database for later reviewing and export via<br>DICOM to the OEM customer provided processing station. | | |
| 5 | Intended use: | Virgo is an emission computed tomography system intended to detect the<br>location and distribution of gamma ray radionuclides in the body and produce<br>cross-sectional images through computer reconstruction of the data. The<br>device includes display equipment, patient and equipment supports,<br>component parts, and accessories.<br>Virgo is primarily intended for cardiac applications but the Virgo design also<br>supports non-cardiac procedures of the patient's chest region and body<br>extremities.<br>Virgo supports radionuclides within the energy range of 60 - 170 keV | |
| 6<br>a | Summary of technological<br>characteristics: | The device has the same technological and functional characteristics as the<br>predicate device. However, the gantry with patient support device is in design<br>significantly different: | |
| | Submitted device: Virgo | Predicate device: CardioMD | |
| | Design: | A gantry base on the floor supports a<br>console with electronics and a<br>robotic detector arm. The detector<br>arm serves as detector support in an<br>unbalanced design.<br>Detector motions for positioning the<br>detectors and for orbiting the<br>detectors circularly and non-<br>circularly around the patient is<br>achieved by a combination of:<br>Horizontal translation of the<br>console with detector arm and<br>detector towards the patient.<br>Rotation of the robotic arm with<br>the detector.<br>Rotation of the detector on the<br>robotic arm.<br>Further the gantry base supports a<br>patient chair in which the patient is<br>seated during acquisition and a stand<br>for the acquisition PC. | |
| | | A gantry base on the floor supports a<br>tower that holds the detector in an<br>unbalanced design.<br>Detector motions for positioning the<br>detectors and for orbiting the detectors<br>circularly and non-circularly around<br>the patient is achieved by a<br>combination of:<br>Horizontal translation of the tower<br>with the detector towards the<br>patient.<br>Vertical translation of the detector.<br>Rotation of the detector on the<br>tower.<br>Further the gantry base supports a<br>table console with electronics that acts<br>as support for a patient table on which<br>the patient is lying during acquisition.<br>The acquisition PC is located on a<br>separate rollable PC cart. | |
| | Material: | Painted and cromated iron and<br>aluminum plates and casts.<br>Aluminum plate covers. | |
| | | Painted and cromated iron and<br>aluminum plates and casts.<br>Aluminum plate covers. | |
| Energy source: | Mains supply.<br>100 VAC - 240 VAC | Mains supply.<br>100 VAC - 240 VAC | |
| Patient Support: | The patient support comprises a chair mounted on the gantry base in which the patient is seated supine during acquisition.<br><br>The chair consists of a back pad and a seat pad mounted onto an S-shaped iron frame.<br><br>The back pad has a cutout towards the detector to enable close detector proximity to small patients.<br><br>The chair includes a rotate motion capable of tilting the entire chair with patient between upright position (patient load) and a declined scan position about 20 degrees from horizontal.<br><br>By manual control, the seat of the chair (with patient) can be moved up and down to position the heart of both tall and short patients within the detector field of view. | The patient support comprises a table mounted on the table console on which the patient is lying horizontally supine or prone during acquisition.<br><br>The table consists of a thin aluminum plate with a mattress. The aluminum table has a cutout towards the detector to enable close detector proximity to small patients.<br><br>By manual control, the table can be translated manually to position patient's heart within the detector field of view. | |
| Detector: | The two fixed 90 degrees detector heads are mounted into a single copper/ zinc/lead alloy (UNS designation; C94300) casting covered by aluminum plate covers with collision sensors and pads.<br><br>Each detector comprises a NaI crystal and 24 3" square photomultiplier tubes and electronics for position determination and correction for uniformity and linearity errors. The detector outputs corrected events as energy and position data embedded in an IEEE 1394 Firewire bus to the connected acquisition PC. | The two fixed 90 degrees detector heads are mounted into a single copper/ zinc/lead alloy (UNS designation; C94300) casting covered by aluminum plate covers with collision sensors and pads.<br><br>Each detector comprises a NaI crystal and 24 3" square photomultiplier tubes and electronics for position determination and correction for uniformity and linearity errors. The detector outputs corrected events as energy and position data embedded in an IEEE 1394 Firewire bus to the connected acquisition PC. | |
| | Software: | The Virgo acquisition station is<br>based on a Windows PC platform<br>running a dedicated acquisition<br>software package. | The CardioMD acquisition station is<br>based on a Windows PC platform<br>running a dedicated acquisition<br>software package. |
| | | This software is formed by: | This software is formed by: |
| | | A graphical user interface package<br>including the patient database and<br>DICOM interface | A graphical user interface package<br>including the patient database and<br>DICOM interface |
| | | A camera control package designed<br>for the purpose of controlling system<br>setup, gantry/chair motions and<br>image framing. | A camera control package designed<br>for the purpose of controlling system<br>setup, gantry/patient table motions and<br>image framing. |
| 6<br>b | Description of how the non<br>clinical test results have<br>been collected. | In general, all non clinical test results have been collected following<br>documented verification plans. Whenever possible, these plans are following<br>relevant and recognized standards and guidelines like the NEMA Standard<br>NU 1-1994. Below is a list of a subset of the more important specifications<br>with a description of how these test results are collected. | |
| | Intrinsic Spatial Resolution,<br>FWHM, UFOV: $\leq \pm 3.7mm$ | Test equipment used, test setup and all calculations have all been performed<br>according to the NEMA Standard NU 1-1994. | |
| | Spatial Resolution, FWHM,<br>LEGP collimator @ 10cm,<br>Tc-99m: $< 9.2 mm$ | Test equipment used, test setup and all calculations have all been performed<br>according to the NEMA Standard NU 1-1994.<br>(section 3.5.3) | |
| | Energy Resolution,<br>@Tc-99m: $\leq9.4%$ | Test equipment used, test setup and all calculations have all been performed<br>according to the NEMA Standard NU 1-1994. | |
| | Spatial Linearity, UFOV:<br>$<\pm 0.5$ mm absolute. | Test equipment used, test setup and all calculations have all been performed<br>according to the NEMA Standard NU 1-1994. | |
| | Intrinsic Flood Field<br>Uniformity, UFOV Integral:<br>$< \pm 2.5 %$ | Test equipment used, test setup and all calculations have all been performed<br>according to the NEMA Standard NU 1-1994. | |
| | Maximum Count rate:<br>> 180k cps with scatter<br>> 290k cps w/o scatter | Test equipment used, test setup and all calculations have all been performed<br>according to the NEMA Standard NU 1-1994. | |
| | Count rate @ 20 % loss.<br>> 225k cps | Test equipment used, test setup and all calculations have all been performed<br>according to the NEMA Standard NU 1-1994. | |
| | Detector Background<br>Sensitivity, @180 °,<br>140 keV: $< 2.0 %$ | The Virgo detector was mounted with a Low Energy General Purpose<br>collimator (LEGP). A 140 keV source in source holder (NEMA standard fig.<br>2-4) was placed 10 cm in front of the collimator. With 20% symmetric energy<br>window setting the count rate was verified (less than 10 k cps). Moving the<br>source 360 ° around the Detector in X- and Y direction the position of the<br>maximum count rate was found. | The maximum % was calculated according to |

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## VIRGO 510(K) SUBMISSION

## DDD 1PMN0397-C04

10 June 2003

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## 1PMN0397-C04

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Danish Diagnostic Development A/S % Ms. Susan Gill Senior Project Engineer Underwriters Lanoratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709-3995

Re: K031825 Trade/Device Name: "Virgo" Model 9VIR1200 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: June 12, 2003 Received: June 13, 2003

Dear Ms. Gill:

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.

JUN 2 0 2003

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); 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.

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

Enclosure

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1PMN0397-C04

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10 June 2003

B-2 FDA Indications for Use Form

## Indications for Use Form

510(k) Number (if known): K031825
Device Name: Virgo
Indications For Use:

Virgo is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment parts, and accessories.

Virgo is primarily intended for cardiac applications but the Virgo design also supports non-cardiac procedures of the patient's chest region and body extremities. Virgo supports radionuclides within the energy range of 60 -170 keV

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. KL31825