(25 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and there are no other indicators of AI/ML use in the provided text.
No
The device is described as a nuclear imaging system for diagnostic purposes, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the VENTRi system is used "for clinical diagnostic purposes."
No
The device description explicitly states it is a "high-performance dual-head Single Photon Emission Computed Tomography system," which is a hardware-based imaging system.
Based on the provided information, the VENTRi system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens taken from the human body. The intended use of the VENTRi system is to perform nuclear imaging procedures on the patient body to detect radioisotope tracer uptake. This is an in-vivo (within the living body) procedure, not an in-vitro (outside the living body) procedure.
- The device description confirms it's a SPECT system. SPECT systems are imaging devices that work by detecting radiation emitted from a radioactive tracer administered to the patient. This is a form of medical imaging, not laboratory testing of specimens.
Therefore, the VENTRi system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the VENTRi system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes. VENTRi is primarily intended for cardiac applications but also supports non-cardiac procedures of the patient's head, chest and body extremities.
Product codes
KPS
Device Description
The VENTRi is a high-performance dual-head Single Photon Emission Computed Tomography system dedicated mainly for nuclear cardiology imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Single Photon Emission Computed Tomography
Anatomical Site
patient's head, chest and body extremities
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
Bench and images data show that the VENTRi images are similar to the images of The predicate devices.
Key Metrics
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
05/855
AUG 2 - 2005 GE Medical System, F.I. , Haifa 4, Hayozma St. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL
10. 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Summary date
May- 16- 2005
Device Name Proprietary Device Name: VENTRi
Establishment Name and Registration Number of Submitter
| Name: | GE Medical Systems F.I. Haifa |
|---|---|
| Registration Number: | 9613299 |
| Corresponding Official: | Laurence Bigio; Quality, Safety and Regulatory |
| Manager | |
| GE Medical Systems F.I. Haifa | |
| 4 Hayozma St. P.O. Box 170 | |
| Tirat Hacarmel 30200, ISRAEL | |
| Laurence.bigio@med.ge.com | |
| +972-4-8563633 (Tel) | |
| +972-4-857-7664 (Fax) |
Device Classification
| Classification Name: | System Emission Computed Tomography
(per 21CFR 892.1200) |
|-----------------------|-------------------------------------------------------------|
| Common Name: | Single Photon Emission Computed Tomography |
| Classification Code: | 90 KPS |
| Panel Identification: | Radiology |
| Classification Class: | Class II Product |
Type of Submission
Traditional
Reason for 510(k) Submission
Modification of legally marketed devices.
| Identification of Legally Marketed Equivalent Devices | |
|---|---|
| GE Quasar Nuclear Medicine System ("Infinia") | K022960 |
| Optima Nuclear Medicine System | K915470 |
| Millennium MT and Millennium MG Nuclear Medicine Systems | K962738 |
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510(k) Summary of Safety and Effectiveness, VENTRi, Page 2
Device Description
The VENTRi is a high-performance dual-head Single Photon Emission Computed Tomography system dedicated mainly for nuclear cardiology imaging.
Description of Change or Modification
The following modifications have been made to the VENTRi system relative to the predicate devices. Quasar ("Infinia") Nuclear Medicine System (K022960), Optima Nuclear Medicine System (K915470), and Millennium MT and Millennium MG Nuclear Medicine Systems (K962738).
-
- Gantry: Gantry aperture has been expanded. A computer-controlled radial motion during the scan enables the detectors to perform non-circular SPECT orbiting for higher resolution scans. The new system utilizes lightweight construction relative to the predicate devices.
-
- Detectors: The detectors contain PMT & electronics circuits that are similar to the Infinia (K022960) Elite™ Detector system, but with fewer PMTs. Twenty two 3" PM tubes and six 1.5" PM tubes are arranged above a Nal Crystal to create an acquisition F.O.V of 365x185mm. The front-end electronics of the Infinia (K022960) have been configured to adapt to the new number of PMT's with minor changes.
-
- Table: Table designed to reduced size and includes telescopic mode motion in horizontal axis.
-
- Acquisition Station: The Acquisition station has been adapted from the Infinia system (K022960), working in windows 2000 operating system and minor changes have been made to the SW.
Intended Use of Device
The intended use of the VENTRi system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes.
VENTRi is primarily intended for cardiac applications but also supports non-cardiac procedures of the patient's head, chest and body extremities.
Summary of Studies
Bench and images data show that the VENTRi images are similar to the images of The predicate devices.
2
GE Medical System, F.I. , Haifa 4, Hayozma St. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL
Conclusion
In the opinion of GE Medical Systems F.I. Haifa, the VENTRi system is substantially equivalent in terms of safety and effectiveness to the legally marketed the Quasar Nuclear Medicine System (K022960), Optima Nuclear Medicine System (K915470), and Millennium MT and Millennium MG Nuclear Medicine Systems (K962738).
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular with text around the perimeter. In the center of the logo is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 - 2005
GE Medical Systems F.I. HAIFA % Mr. Alex Grob Senior Project Engineer Underwriters Laboratories, Inc. Northbrook Division 333 Pfingsten Road NORTHBROOK IL 60062-2096 Re: K051855 Trade/Device Name: Ventri Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: July 23, 2005 Received: July 25, 2005
Dear Mr. Grob:
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 (Premarket Approval), 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.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you're substantial equivalence of your device of your device to a legally promance notification - wees ification 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 rryou don't appoints as no of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 77). I Canall 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/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
GE Medical System, F.I. , Haifa 4, Hayozma St. P.O. Box 170 Tirat HaCarmel 30200, ISRAEL
STATEMENT OF INTENDED USE
510(k) Number (if known): __
Device Name: VENTRi
Indications for Use
The intended use of the VENTRi system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes. VENTRi is primarily intended for cardiac applications but also supports non-cardiac procedures of the patient's head, chest and body extremities.
(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_______________________________________________________________________________________________________________________________________________________
Nancy C. Hoadon
Division Sign-Off
(Division Sign-C Division of Reprodu and Radiological De 510(k) Number