(122 days)
Not Found
No
The summary describes standard image processing and data acquisition, with no mention of AI, ML, or related concepts. The performance studies focus on traditional imaging metrics.
No
The device is described as an imaging device for detecting radionuclides in the human body, not for treating conditions.
Yes
The device is indicated for "imaging the distribution of radionuclides in the human body," which is a diagnostic purpose to visualize and analyze the presence and activity of radionuclides within the body, typically to identify or characterize medical conditions.
No
The device description explicitly states it consists of hardware components: a detector module, high-voltage power supply, and a handheld enclosure integrating these components, in addition to the computer and software.
Based on the provided information, the ProxiScan™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "imaging the distribution of radionuclides in the human body using planar imaging techniques." This describes an in vivo imaging procedure, where the device interacts with the living human body.
- Device Description: The description details an imaging system with a detector module, power supply, and computer. This aligns with the components of a gamma camera used for nuclear medicine imaging, which is an in vivo technique.
- Input Imaging Modality: The input imaging modality is listed as "Gamma Camera," which is an in vivo imaging modality.
- Anatomical Site: The anatomical site is the "human body," further supporting an in vivo application.
In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes. The ProxiScan™ does not operate on such specimens; it directly images the distribution of radionuclides within the living body.
N/A
Intended Use / Indications for Use
The ProxiScan™ is indicated for use in imaging the distribution of radionuclides in the human body using planar imaging techniques. ProxiScan™ may also be used intraoperatively, on pathological specimens and for endocavity applications if a protective sheath is used.
Product codes
IYX
Device Description
The ProxiScan™ is an imaging device consisting of the imaging system: detector module, high-voltage power supply and computer. The detector module and highvoltage power supply are integrated into a small handheld enclosure, which works in conjunction with an external low-voltage power supply and a computer for data acquisition and processing.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scintillation (gamma)
Anatomical Site
human body
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)
Appropriate performance testing was performed. All specifications were met. It was also tested in accordance with the requirements of the IEC-60601-1 for electrical safety and in accordance with the ISO-10993 standard for biocompatibility.
ProxiScan™ was subjected to functional testing including system energy linearity, intrinsic energy resolution, spatial resolution, contrast evaluation, uniformity, count rate characteristics and sensitivity. All specifications were met.
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
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).
0
APR - 2 2010
Hybridyne Imaging Technologies, Inc. ProxiScan™
510(k) Premarket Notification November 30, 2009
510(k) SUMMARY
SUBMITTER:
CONTACT PERSON:
DATE PREPARED:
DEVICE TRADE NAME:
COMMON NAME:
CLASSIFICATION NAME:
PREDICATE DEVICE(S):
DEVICE DESCRIPTION:
Hybridyne Imaging Technologies, Inc.
Terrence Lall
October 30, 2009
ProxiScan™
Handheld Gamma Camera
Gamma Camera (21 CFR 892.1100 Product Code: IYX)
Anzai Medical Company, Ltd. Anzai eZScope AN Portable Gamma Camera (K022342) and the Siemens Medical Solutions USA, Inc EC9-4 Ultrasound Transducer (K060879)
The ProxiScan™ is an imaging device consisting of the imaging system: detector module, high-voltage power supply and computer. The detector module and highvoltage power supply are integrated into a small handheld enclosure, which works in conjunction with an external low-voltage power supply and a computer for data acquisition and processing.
INDICATION FOR USE:
The ProxiScan™ is indicated for use in imaging the distribution of radionuclides in the human body using planar imaging techniques. ProxiScan™ may also be used intraoperatively, on pathological specimens and for endocavity applications if a protective sheath is used.
TECHNOLOGICAL CHARACTERISTICS:
The ProxiScan™ is an imaging device consisting of the imaging system: detector module, high-voltage power supply and computer. The detector module and highvoltage power supply are integrated into a small handheld enclosure. which works in conjunction with an external low-voltage power supply and a computer for data acquisition and processing. Signals from CZT detectors are transferred frame to the display computer. A software program in the computer reads the data and displays the images.
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NON CLINICAL TEST RESULTS:
Appropriate performance testing was performed. All specifications were met. It was also tested in accordance with the requirements of the IEC-60601-1 for electrical safety and in accordance with the ISO-10993 standard for biocompatibility.
FUNCTIONAL TEST RESULTS:
ProxiScan™ was subjected to functional testing including system energy linearity, intrinsic energy resolution, spatial resolution, contrast evaluation, uniformity, count rate characteristics and sensitivity. All specifications were met.
CONCLUSIONS:
This pre-market notification has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes on its wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
APR - 2 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Hybridyne Imaging Technologies, Inc. % Mr. Barry S. Sall, RAC Principal Consultant PAREXEL Consulting 195 West Street WALTHAM MA 02451
Re: K093706
Trade/Device Name: ProxiScan™ Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: II Product Code: IYX Dated: March 8, 2010 Received: March 9, 2010
Dear Mr. Sall:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely yours.
Amell Joff
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K093706
Device Name: ProxiScan™
Indications for Use:
The ProxiScan™ is indicated for use in imaging the distribution of radionuclides in the human body using planar imaging techniques. ProxiScan™ may also be used intraoperatively, on pathological specimens and for endocavity applications if a protective sheath is used.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Office of In
510K to93701
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