HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4

K021656 · Nuclear Diagnostics · KPS · Jun 13, 2002 · Radiology

Device Facts

• Record ID: K021656
• Device Name: HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
• Applicant: Nuclear Diagnostics
• Product Code: KPS · Radiology
• Decision Date: Jun 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The HERMES HDAQ Acquisition Station is a system designed to acquire nuclear medicine image data using a compatible gamma camera system. The HERMES Workstation is a system designed to process, display, analyze, and manage nuclear medicine and other medical imaging data transferred from other workstations or HDAQ acquisition stations.

Device Story

HERMES HDAQ Acquisition Station and HERMES Workstation (Ver. 3.4) function as accessories to commercially available gamma cameras. The system acquires nuclear medicine image data via the HDAQ station; the workstation processes, displays, analyzes, and manages this data, as well as data transferred from other imaging sources. The system supports networking with other vendors' medical imaging workstations. Operated by clinical staff, the device provides processed images and analysis tools to assist healthcare providers in clinical decision-making. The modification involves the addition of six software applications operating independently on the workstation and acquisition station to enhance data management and analysis capabilities.

Clinical Evidence

Bench testing only. The manufacturer utilized internal procedures and automated test tools to verify the performance of the six additional software applications. No clinical data was required or provided.

Technological Characteristics

System consists of a data acquisition station and a computer workstation. Software-based applications for nuclear medicine image processing, display, and analysis. Network-compatible with other vendors' imaging systems. Technological characteristics are identical to the predicate device, with the addition of six independent software modules.

Indications for Use

Indicated for acquisition, processing, display, analysis, and management of nuclear medicine and other medical imaging data in a clinical setting.

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

• HERMES HDAQ Acquisition Station and HERMES Workstation (K002782)

Submission Summary (Full Text)

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# K021656

HERMES HDAQ Acquisition Station and HERMES Workstation, Ver. 3.4

6/3/02

### 510(K) SUMMARY

#### GENERAL INFORMATION I.

| A. | Submitted By: | Nuclear Diagnostics AB<br>Söder Mälarstrand 13<br>S-118 20 Stockholm, SWEDEN | |
|----|----------------------|------------------------------------------------------------------------------|------------------|
| | | Tel: | [phone] |
| | | Fax: | [phone] |
| | Contact Person: | Jan Bertling<br>At address above | |
| B. | Device Trade Name: | HERMES HDAQ Acquisition Station and<br>HERMES Workstation, Ver. 3.4 | |
| | Common Name: | Accessory to a Nuclear Scanner | |
| | Classification Name: | Emission Computed Tomography System | |

#### II. DEVICE DESCRIPTION

The base product design for the HERMES HDAQ Acquisition Station and HERMES Workstation, Ver. 3.4 is the same as the one for the HERMES HDAQ Acquisition Station and HERMES Workstation (K002782). The HERMES system consists of two components, a data acquisition station and a computer workstation. The HERMES HDAQ acquisition station and workstation are designed for use with commercially available gamma cameras. Software applications control acquisition, processing, display, analysis, and management of data and can be connected via network to other vendors' medical imaging workstations.

#### INTENDED USE III.

The HERMES HDAO Acquisition Station is a system designed to acquire nuclear medicine image data using a compatible gamma camera system. The HERMES Workstation is a system designed to process, display, analyze, and manage nuclear medicine and other medical imaging data transferred from other workstations or HDAQ acquisition stations.

#### TECHNOLOGICAL CHARACTERISTICS IV.

The technological characteristics of the modified device are the same as the original device. The proposed modification is the addition of six additional software applications as described in the 510(k) submission. These software applications operate as independent applications on the workstation and the acquisition station.

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6/3/02

#### V. TESTING

Testing of the modified device followed Nuclear Djagnostic AB's normal procedures. A test plan was developed containing a description of relevant test procedures. Test results were documented, including what was tested, expected results, who performed the test, and which resources were used (i.e., automated test tools).

#### CONCLUSIONS VI.

In summary, Nuclear Diagnostics AB has demonstrated that the intended use for the HERMES HDAQ Acquisition Station and HERMES Workstation, Ver. 3.4 is the same as the original device. The technological characteristics have been described insufficient detail to demonstrate that they are the same as the original device. Therefore, this premarket notification has demonstrated substantial equivalence as defined and understood in the Federal Food, Drug, & Cosmetic Act and its amendments.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 3 2002

Nuclear Diagnostics AB % Mr. Jim Howard Bio-Reg Associates, Inc. 11800 Baltimore Avenue, Suite 105 BELTSVILLE MD 20705

Re: K021656

Trade/Device Name: HERMES HDAO Acquisition Station and HERMES Workstation Ver. 3.4 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system

Regulatory Class: II Product Code: 90 KPS Dated: May 17, 2002 Received: May 20, 2002

Dear Mr. Howard:

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 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 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 this 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" (21 CFR Part 807.97). 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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## INDICATIONS FOR USE STATEMENT

Ku21456 510(k) Number (if known): HERMES HDAQ Acquisition Station and HERMES Device Name: Workstation, Ver. 3.4

Nuclear Diagnostics AB Sponsor Name:

Indications for Use:

The HERMES HDAQ Acquisition Station is a system designed to acquire nuclear medicine image data using a compatible gamma camera system. The HERMES Workstation is a system designed to process, display, analyze, and manage nuclear medicine and other medical imaging data transferred from other workstations or HDAQ acquisition stations.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

വും പ്രവുത്തിച്ചു. പ്രവരിച്ചു പ്രവരിച്ചു. പ്രവരിച്ചു വിവ്യത്തിന്റെ വിശ്വാസം പ്രവരിച്ചു. പ്രവരിച്ചു. പ്രവരിച്ചു. പ്രവരിച്ചു വിവ്യത്തിന്റെ വിശ്വാസം പ്രവരിച്ചു. പ്രവരിച്ചു. പ്ര

Prescription Use Over-The-Counter Use

David A. Kellogg
(Division Sign-Off)

Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _