(24 days)
No
The document describes standard image acquisition, processing, display, analysis, and management software for nuclear medicine images. There is no mention of AI, ML, deep learning, or any related terms or concepts in the intended use, device description, or testing sections. The predicate device is also the same system, suggesting no significant technological change related to AI/ML.
No
The device is described as a system designed to acquire and process nuclear medicine image data, not to directly treat or diagnose a patient. Therapeutic devices are typically used in the treatment of a disease or condition.
Yes
Explanation: The device is described as an "Acquisition Station" and "Workstation" designed to "acquire nuclear medicine image data" and "process, display, analyze, and manage nuclear medicine and other medical imaging data." This indicates its role in obtaining and interpreting medical images, which is a diagnostic function.
No
The device description explicitly states the system consists of two components, a data acquisition station and a computer workstation, and mentions the acquisition station is designed for use with commercially available gamma cameras, indicating hardware components are involved.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is designed to acquire, process, display, analyze, and manage nuclear medicine image data. This involves imaging the patient directly, not analyzing samples taken from the patient (which is the core of IVD).
- Device Description: The description reinforces this by mentioning its use with gamma cameras, which are used for in-vivo imaging.
- No mention of biological samples: There is no mention of analyzing blood, urine, tissue, or any other biological samples, which are characteristic of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device deals with imaging data obtained from the patient's body directly.
N/A
Intended Use / 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.
Product codes
90 KPS
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
nuclear medicine image data
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.
0
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
Söder Mälarstrand 13
S-118 20 Stockholm, SWEDEN | |
|----|----------------------|------------------------------------------------------------------------------|------------------|
| | | Tel: | +46 (0) 8-190325 |
| | | Fax: | +46 (0) 8-184354 |
| | Contact Person: | Jan Bertling
At address above | |
| B. | Device Trade Name: | HERMES HDAQ Acquisition Station and
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.
1
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.
2
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.
3
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
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.
Do Not Write Below This Line - Continue on Another Page if Needed
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 _