(15 days)
Not Found
No
The document describes a standard image processing and display workstation for nuclear medicine, with no mention of AI, ML, or related concepts.
No.
The device is used for image processing and display to aid physicians in diagnosis, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" states that "When interpreted by a nuclear physician, the results obtained by using the ENsphere Tempo applications may be used as a tool in determining a patient's diagnosis." This explicitly indicates its role in diagnosis.
No
The device description explicitly states that the system will consist of a Hewlett Packard XW4100 workstation or equivalent, indicating it includes hardware components beyond just software.
Based on the provided information, the ENsphere™ Tempo device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- ENsphere™ Tempo processes medical images: The primary function of ENsphere™ Tempo is to process, analyze, and display medical images obtained from nuclear medicine scans. It does not directly analyze biological samples.
- Intended Use focuses on image interpretation: The intended use clearly states that the results obtained are used as a "tool in determining a patient's diagnosis" when interpreted by a physician, based on the image data.
Therefore, ENsphere™ Tempo falls under the category of a medical image processing and display workstation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ENsphere™ Tempo is a nuclear medicine image processing and display workstation that provides cardiology specific software applications used to process, analyze, and display medical images. When interpreted by a nuclear physician, the results obtained by using the ENsphere Tempo applications may be used as a tool in determining a patient's diagnosis. ENsphere Tempo should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
Product codes
90 LLZ
Device Description
ENsphere™ Tempo is a Windows®-based Nuclear Mcdicine workstation specific for the Cardiology market segment. The computer system will consist of a Hewlett Packard XW4100 workstation or equivalent. The comprehensive tools and features provided with this product, will allow the technologist and/or physician to perform image review, processing of source data, post processing, hardcopy production, interpretation, report gencration and contains the utilities necessary to support the workflow and data management between those activities. The system will support connectivity aspects necessary to import and export data as required to accomplish daily work scenarios.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
nuclear medicine
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This workstation is intended to be operated in a hospital, clinic, or doctor's office. Patient data may be transferred via DICOM over Local Area Networks (LAN), or Wide Area Networks WAN. The primary users of this product include nuclear medicine technologists who process the data and physicians who display, review, and interpret the processed image data.
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)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
CONFIDENTIAL
510(k) Premarket Notification Section B. Administrative Information
ADMINISTRATIVE INFORMATION
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS I.
| A. | Submitted By: | ADAC Laboratories A Philips Medical
Systems Company
540 Alder Drive
Milpitas, California 95035 | |
|----|----------------------|---------------------------------------------------------------------------------------------------------|---------------|
| | | Tel: (408) 468-3051
Fax: (408) 468-3050 | |
| | Contact Person: | Coleen Coleman
At address above | |
| B. | Device Trade Name: | ENsphere™ Tempo Cardiology Workstation | |
| | Common Name: | Picture Archive and Communication
Systems (PACS) | |
| | Classification Name: | Image Processing System | |
| C. | Predicate Device(s): | | |
| | Manufacturer | Product Name | 510(k)
No. |
| ADAC Laboratories | Pegasys Ultra™ | K993940 |
|---|---|---|
| ADAC Laboratories | ENsphere™ (Physician Desktop Review) | K021669 |
D. Device Description:
ENsphere™ Tempo is a Windows®-based Nuclear Mcdicine workstation specific for the Cardiology market segment. The computer system will consist of a Hewlett Packard XW4100 workstation or equivalent. The comprehensive tools and features provided with this product, will allow the technologist and/or physician to perform image review, processing of source data, post processing, hardcopy production, interpretation, report gencration and contains the utilities necessary to support the workflow and data management between those activities. The system will support connectivity aspects necessary to import and export data as required to accomplish daily work scenarios.
- E. Intended Use:
ENsphere™ Tempo is a nuclear medicine image processing and display workstation that provides cardiology specific software applications used to
1
process, analyze, and display medical images. When interpreted by a nuclear physician, the results obtained by using the ENsphere Tempo applications may be used as a tool in determining a patient's diagnosis. ENsphere Tempo should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
This workstation is intended to be operated in a hospital, clinic, or doctor's office. Patient data may be transferred via DICOM over Local Area Networks (LAN), or Wide Area Networks WAN. The primary users of this product include nuclear medicine technologists who process the data and physicians who display, review, and interpret the processed image data.
- Technological Comparison: F.
The ENsphere™ (Physician Desktop Review K021669), Pegasys Ultra™ (K993946), and ENsphere™ Tempo have similar indications for use and overall function and perform in a similar manner with respect to, display, review and processing applications, data storage, and system utilities.
II. CONCLUSION
ENsphere™ Tempo is substantially equivalent to the following predicate devices, Pegasys Ultra™ (K993946) and ENsphere™ (Physician Desktop Review K021669) based on similar intended use, technological comparison, and system performance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle with three lines representing its wings. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 6 2004
ADAC Laboratories % Ms. Ellen Fickewirth Reviewer Underwriters Laboratoies, Inc. Santa Clara Division 1655 Scott Boulevard SANTA CLARA CA 95050-4169 Re: K040142 Trade/Device Name: ENsphere™ Tempo Cardiology Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: January 21, 2004 Received: January 22, 2004
Dear Ms. Fickewirth:
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.
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 | (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" (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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.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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Enclosure
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INDICATIONS FOR USE STATEMENT
510 (k) NUMBER (if KNOWN): _ K 040142
DEVICE NAME:
ENsphere™ Tempo Processing Workstation
SPONSOR NAME:
ADAC Laboratories
INDICATIONS FOR USE:
ENsphere™ Tempo is a nuclear medicine image processing and display workstation that provides cardiology specific software applications used to process, analyze, and display medical images. The applications included with ENsphere Tempo may be used as a tool, by the Physician in interpreting Nuclear Cardiology procedures. ENsphere Tempo should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
(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)
000013
Nancy C. Hoddon
Division Sign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040142