(78 days)
Not Found
No
The description focuses on data viewing, playback, and report generation features of existing ultrasound data, with no mention of AI/ML terms or functionalities like image processing beyond simple display.
No
The software is for off-line data viewing, playback, and report generation of ultrasound studies, not for direct therapeutic intervention.
No
The PMD Viewer Software is described as intended for "data viewing, playback, and report generation" of previously acquired Doppler ultrasound studies, and explicitly states it is "NOT intended to replace any means of evaluating vital patient physiological processes." This indicates it is for post-processing and display of diagnostic data, not for performing diagnosis itself.
Yes
The device description explicitly states "This device is a software-only version..." and "PMD Viewer may only be operated independently, as a software-only product." The functionality described (data viewing, playback, report generation) is purely software-based and runs on a standard PC.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PMD Viewer Software is designed to view, playback, and generate reports from transcranial Doppler ultrasound studies. This involves using ultrasound waves to assess blood flow in the brain, which is an in vivo (within the living body) diagnostic method, not an in vitro one.
- Intended Use: The intended use clearly states it's for "off-line data viewing, playback, and report generation features of transcranial TCD100M/PMD150 Doppler ultrasound studies." This reinforces its role in processing data from an in vivo procedure.
- No Mention of Samples: There is no mention of the device interacting with or analyzing samples taken from the body.
Therefore, the PMD Viewer Software is a medical device used in conjunction with an in vivo diagnostic procedure (Doppler ultrasound), but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
PMD Viewer is intended to provide the same data viewing, playback, and report generation features of its predicate (parent) device, TCD100M/PMD150, Doppler ultrasound studies, offline on a standard PC. The data consists of previously acquired information on cerebral arterial blood flow velocity measurements and the occurrence of micro-embolic signals in the cerebral arterial blood flow. PMD Viewer operates exclusively as a stand-alone software product on a standard PC. PMD Viewer is intended for use by a technologist or physician trained in the use of Doppler ultrasound. PMD Viewer is NOT intended to replace any means of evaluating vital patient physiological processes. No new intended uses are claimed.
The PMD Viewer Software is intended to provide off-line data viewing, playback, and report generation features of transcranial TCD100M/PMD150 Doppler ultrasound studies on a PC. PMD Viewer may only be operated independently, as a software-only product. PMD Viewer is intended for use by a technologist or physician trained in the use of Doppler ultrasound. PMD Viewer is NOT intended to replace any means of evaluating vital patient physiological processes. No new intended uses are claimed.
Product codes
LLZ
Device Description
This device is a software-only version of the Spencer Technologies digital Transcranial Doppler ultrasound system, the TCD100M/PMD150, and is described as the PMD Viewer.
The modification of the TCD100M/PMD150 implemented in the PMD Viewer provides physicians and technologists with the same data viewing, playback, and report generation features of the TCD100M/PMD150 off-line on a standard PC utilizing Windows XP SP2 or VISTA. All software features can be controlled with a standard keyboard and wheel mouse. Because it can read the proprietary binary file formats of the predicate (parent) device, the TCD100M/PMD150, the PMD Viewer displays images without any compression, duplicating the original quality of the images on the TCD100M/PMD150.
PMD Viewer is a medical image device that is used with computer hardware in a picture archiving and communications system user environment. It has the same intended use and technical characteristics as the predicate device, the Acuson Corporation CSV12 Software Viewer, listed above. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, interprets the images and information being displayed and printed.
PMD Viewer utilizes commercially available computer platforms and operating systems (Microsoft Windows XP/Vista) as does the predicate CSV12 Software Viewer. PMD Viewer does not produce any original medical images. All functions for the review of the PMD device files are the same as reviewing the files on the predicate (parent) device, TCD100M/PMD150, with respect to intended use and indications for use, principles of operation, and technological characteristics and design. It is comparable in key safety and effectiveness features. Studies may be transmitted in DICOM or native TCD100M/PMD150 format, to an integrated magnetooptical drive, or over a network.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound
Anatomical Site
cerebral arterial blood flow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
technologist or physician trained in the use of Doppler ultrasound; offline on a standard PC
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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5. 510(K) SUMMARY
A. Submitter
Spencer Technologies 701 16th Avenue Seattle, WA 98122 USA 206-329-7220
B. Establishment Registration Number: 3033518
C. Contact
OCT - 8 2009
| Name | Tony Williams |
|---|---|
| Title | VP Quality Assurance/Regulatory Affairs |
| Telephone: | 206-329-7220 x118 |
| FAX: | 206-329-7230 |
| Email: | williamstc@spencertechnologies.com |
D. Submission Date: 16 July 2009
E. Trademark and Common Name
Spencer Technologies PMD Viewer
F. Classification of the device
| Classification Name | Picture Archival and Communications System |
|---|---|
| Classification Panel | Radiology |
| CFR Number | 21 CFR 892.2050 |
| Device Class | Class II |
| Product Code | LLZ |
G. Predicate Device
The PMD Viewer, addressed in this premarket notification, is substantially equivalent to the following commercially available devices:
| Manufacturer | Trade Name | 510(k) No | Product Code |
|---|---|---|---|
| Acuson Corporation | CSV12 Software Viewer | K022896 | 90 LLZ |
| Spencer Technologies | TCD 100M/PMD150 Diagnostic | ||
| Ultrasound System | K002533 | 90 IYN |
Note: In this document we refer to the Acuson Viewer as the "predicate device", and to the PMD Viewer as the "predicate (parent) device".
H. Device Description
This device is a software-only version of the Spencer Technologies digital Transcranial Doppler ultrasound system, the TCD100M/PMD150, and is described as the PMD Viewer.
The modification of the TCD100M/PMD150 implemented in the PMD Viewer provides physicians and technologists with the same data viewing, playback, and report generation features of the TCD100M/PMD150 off-line on a standard PC utilizing Windows XP SP2 or VISTA. All software features can be controlled with a standard keyboard and wheel mouse. Because it can read the proprietary binary file formats of the predicate (parent) device, the TCD100M/PMD150, the PMD Viewer displays images without any compression, duplicating the original quality of the images on the TCD100M/PMD150.
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-Intended Use
PMD Viewer is intended to provide the same data viewing, playback, and report generation features of its predicate (parent) device, TCD100M/PMD150, Doppler ultrasound studies, offline on a standard PC. The data consists of previously acquired information on cerebral arterial blood flow velocity measurements and the occurrence of micro-embolic signals in the cerebral arterial blood flow. PMD Viewer operates exclusively as a stand-alone software product on a standard PC. PMD Viewer is intended for use by a technologist or physician trained in the use of Doppler ultrasound. PMD Viewer is NOT intended to replace any means of evaluating vital patient physiological processes. No new intended uses are claimed.
J. Technological Characteristics and Substantial Equivalence
PMD Viewer is a medical image device that is used with computer hardware in a picture archiving and communications system user environment. It has the same intended use and technical characteristics as the predicate device, the Acuson Corporation CSV12 Software Viewer, listed above. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, interprets the images and information being displayed and printed.
PMD Viewer utilizes commercially available computer platforms and operating systems (Microsoft Windows XP/Vista) as does the predicate CSV12 Software Viewer. PMD Viewer does not produce any original medical images. All functions for the review of the PMD device files are the same as reviewing the files on the predicate (parent) device, TCD100M/PMD150, with respect to intended use and indications for use, principles of operation, and technological characteristics and design. It is comparable in key safety and effectiveness features. Studies may be transmitted in DICOM or native TCD100M/PMD150 format, to an integrated magnetooptical drive, or over a network.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Tony Williams VP Quality Assurance/Regulatory Affairs Spentech, Inc. Doing Business as Spencer Technologies 701 16th Avenue SEATTLE WA 98122
OCT = 8 2009
Re: K092204
Trade/Device Name: PMD Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 16, 2009 Received: July 22, 2009
Dear Mr. Williams:
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); medical device reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATION FOR USE
510(k) Number (if known): K092204
Device Name: PMD Viewer
Indications for Use:
The PMD Viewer Software is intended to provide off-line data viewing, playback, and report generation features of transcranial TCD100M/PMD150 Doppler ultrasound studies on a PC. PMD Viewer may only be operated independently, as a software-only product. PMD Viewer is intended for use by a technologist or physician trained in the use of Doppler ultrasound. PMD Viewer is NOT intended to replace any means of evaluating vital patient physiological processes. No new intended uses are claimed.
Prescription Use X (Part 21 CFR 801 Subpart D)
V
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arvin M. White
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number K092204