(87 days)
No
The document describes image acquisition and processing but does not mention AI, ML, or related terms like deep learning or neural networks. The processing described appears to be standard nuclear medicine image processing for quantitative analysis.
No.
The device is clearly stated as intended for diagnostic imaging, specifically to produce images depicting the anatomical distribution of radioisotopes and to assess left and right ventricular function, which are diagnostic purposes, not therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device." It also mentions that it "produces images that depict the anatomical distribution of radioisotopes within the human body," which is a diagnostic function, and that "First-pass radionuclide angiography (FPRNA) is used to assess left and right ventricular function," which is also a diagnostic assessment.
No
The device description explicitly mentions hardware components like a detector, articulating arm, and vertical lift, indicating it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- OnePass function: The OnePass system directly images the distribution of radioisotopes within the human body. It does not analyze samples taken from the body.
The OnePass system is a diagnostic imaging device that uses nuclear medicine techniques to visualize and assess the function of the heart.
N/A
Intended Use / Indications for Use
The OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images that depict the anatomical distribution of radioisotopes within the human body. The OnePass system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.
The OnePass system's design is optimized for acquiring and processing cardiac first pass data. First-pass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.
Product codes
90 IYX
Device Description
The OnePass Nuclear Medicine Imaging Systems acquires and processes gated First Pass Radionuclide Angiography (FPRNA) images. After completion of acquisition, both qualitative and quantitative results are available to the physician for analysis.
The acquisition system consists of a single small field-of-view detector mounted on an articulating arm to allow precise positioning of the detector over the patient's heart. In addition, a vertical lift adjusts the detector height position to track changes in the incline of the treadmill to ensure camera remains positioned directly over the patient's heart during acquisition.
Mentions image processing
Acquires and processes gated First Pass Radionuclide Angiography (FPRNA) images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear Imaging
Anatomical Site
Human body, specifically the heart for cardiac first pass data/FPRNA studies.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Facility lacking adequate floor space for a typical nuclear medicine imaging system.
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
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
510(k) Summary of Safety and Effectiveness D
Image /page/0/Picture/3 description: The image shows the logo for "GI Medical Devices". The logo consists of a stylized "GI" in a bold, black font. To the right of the "GI" is the text "MEDICAL DEVICES", also in a bold, black font. The logo is simple and professional, and it is likely used to represent a company that manufactures or distributes medical devices.
Date Prepared
Contact:
Fax:
E-mail:
Telephone:
Registration Number:
Device Name and Classification
CDRH Product Code:
Classification Panel:
Proprietary Name:
Regulatory Device Class:
21 CFR Number:
1-October-2002
Establishment Name and Registration Number
Manufacturer Name and Address:
GVI Medical Devices 1470 Enterprise Parkway Twinsburg, Ohio 44087 Kevin Murrock 330-963-4083 330-963-4084 mailto:kevin.murrock@gvitp.com None 892.1100 90 IYX -Radiology OnePass Nuclear Imaging System Gamma Camera System Camera, Scintillation (Gamma)
Common Name: Classification Name:
Reason for 510(k) Submission
New Device
Predicate Device
SIM-400 System, Scinticor, Inc. 510(k) Number: K931193
Device Description
The OnePass Nuclear Medicine Imaging Systems acquires and processes gated First Pass Radionuclide Angiography (FPRNA) images. After completion of acquisition, both qualitative and quantitative results are available to the physician for analysis.
The acquisition system consists of a single small field-of-view detector mounted on an articulating arm to allow precise positioning of the detector over the patient's heart. In addition, a vertical lift adjusts the detector height position to track changes in the incline of the treadmill to ensure camera remains positioned directly over the patient's heart during acquisition.
1470 Enterprise Parkway Twinsburg, Ohio 44087 Phone: (330) 963-4083 Fax: (330) 963-4084
JAN 0 3 2003
1
Intended Use
The OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images that depict the anatomical distribution of radioisotopes within the human body. The OnePass system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.
The OnePass system's design is optimized for acquiring and processing cardiac first pass data. First-pass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.
Substantial Equivalence
The OnePass is of a comparable type and substantially equivalent to the Scinticor SIM-400 System (510(k) Number K931193). Both devices are used to perform First-Pass Radionuclide Angiography (FPRNA) studies and contain similar performance characteristics. The primary difference between the devices is that the OnePass is optimized for performing only FPRNA studies, while the SIM-400 is capable of performing additional study types such as cardiac SPECT.
Conclusion
The OnePass does not result in any new potential safety risks and performs as well as the SIM-400 for performing FPRNA studies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
00 Corporate Boulevard ockville MD. 20850
JAN 03 2003
Mr. Kevin M. Murrock GVI Medical Devices 1470 Enterprise Parkway TWINSBURG OH 44087 Re: K023373
Trade/Device Name: OnePass Nuclear Medicine Imaging System Regulation Number: 21 CFR 892:1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: 90 IYX Dated: October 1, 2002 Received: October 8, 2002
Dear Mr. Murrock:
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 | (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
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OnePass Nuclear Medicine Imaging System Section C. Indications for Use Statement
Indications for Use Statement C
510(k) Number (if known):
Device Name: OnePass Nuclear Medicine Imaging System
Indications for Use: The OnePass nuclear medicine imaging system is intended for use as a diagnostic imaging device. Used with appropriate radiopharmaceuticals, it produces images that depict the : anatomical distribution of radioisotopes within the human body. The OnePass system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.
The OnePass system's design is optimized for acquiring and processing cardiac first pass data. First-pass radionuclide angiography (FPRNA) is used to assess left and right ventricular function at rest or during stress.
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
510(k) Notificatio
Nancy C. Brogdon
(Division Sign-Off) Division of Fi-productive, Abdominal, and Radiological Devices 5 1 (k) Number