(15 days)
No
The summary describes a combined PET/CT system that integrates existing, predicate devices. There is no mention of AI, ML, or advanced image processing techniques beyond standard image registration and display. The performance studies focus on compliance with standards and phantom evaluations, not AI/ML performance metrics.
No
The device is an imaging system designed to produce images for diagnostic interpretation, not to treat a condition or disease.
Yes
Explanation: The device is an imaging system (PET/CT) that produces images for interpretation by trained health professionals. These images of the distribution of PET radiopharmaceuticals and X-ray transmission are used to aid in the diagnosis of various conditions.
No
The device description explicitly states it is a "hybrid PET/CT system" and describes the integration of two physical scanner systems (ADAC ALLEGRO PET and Marconi MX8000-v5.0 CT) within a common integrated housing. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The GEMINI system is an imaging system that visualizes the distribution of radiopharmaceuticals within the body and produces X-ray transmission images. It does not analyze biological samples.
- The intended use describes imaging and visualization. The description focuses on producing and displaying images of the distribution of substances within the body and anatomical structures.
- The device description details imaging components. The description highlights the integration of PET and CT scanners, which are imaging modalities.
Therefore, the GEMINI system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
GEMINI is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. - The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as x-ray transmission images of these areas. The PET and CT images are registered and displayed in a transmission images of these areas. The PET and CT images are registered and displayed in a combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone CT portions on the system can or around provide CT data suitable for use in attenuation correction.
Product codes (comma separated list FDA assigned to the subject device)
90 KPS, 90 JAK
Device Description
The GEMINI hybrid PET/CT system is a combined positron emission tomography and X-ray Computed Tomography Scanner. This system uses the ADAC ALLEGRO PET system, K003434, and the Marconi MX8000-v5.0 CT, K010817. The GEMINI integrates the two systems into a common integrated housing operated from a single workstation to allow straightforward planning and system operation. The PET and CT system gantries remain intact as major sub-system components are integrated within a common integrated housing. It can be used in any procedures, which have been clinically conducted in a separate CT system and/or a PET system. No modifications have been made to either system that would affect system performance.
GEMINI is intended for use primarily as a clinical whole body oncology scanner with high-end dual slice CT capability and high-end GSO based PET performance. It mechanically might one data. Biros of capreater flexibility for above three operation modes. The availability of low dose tomographic data sets implies that a natural extension of the ALLEGRO based cesium source attenuation correction to a CT transmission map attenuation correction exists. The primary purpose, however, of the CT is to provide precise anatomical localization for the metabolically significant positron emission distributions imaged on the PET system. These images when properly registered and displayed as a fused image, provide both functional and anatomical information with reliable spatial correspondence in a single image.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET), X-ray Computed Tomography (CT)
Anatomical Site
head, body and total body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained health professionals
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)
System Performance Test:
- The MX 8000 v.5.0 is manufactured in accordance with Performance Standards in 21 CFR 1020.30 -- 33.
- ALLEGRO system performance was measured according to the NEMA-NU2 standard. In addition, clinical phantoms with clinical protocols were used to evaluate ALLEGRO image quality in terms of the noise texture and contrast of the image.
- The GEMINI complies with voluntary standards for safety and effectiveness (IEC 60601-1, IEC 60601-2, IEC 60825-1, UL 2601-1, & CAN/CSA-C22.2 and is tested to demonstrate the hazards, i.e., electrical, mechanical, and radiation have been minimized.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
GE CT-PET (K010641), EXACT CT-PET (K002715)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
ADAC Allegro PET, K003434, Marconi MX 8000 CT, K010817
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
(012 510(k) SUMMARY OF SAFETY AND EFFECTIVENES
General Information
| A. | Submitted By:
ADAC Laboratories
540 Alder Dr.
Milpitas, CA 95035 | Contact: Coleen Coleman
Tel: (408) 468-3051
Fax: (408) 468-3050 |
|----|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| B. | Device Trade Name:
Common Name: | GEMINI
Positron Emission Tomography |
| | Classification Name: | Computed Tomography X-Ray
System, Emission Computed Tomography, (892.1200)
System, Computed Tomography X-Ray, (892.1750) |
| | Device Class: | 21CFR 892.1200, Class II
21 CFR 892.1750, Class II |
| | Product Code: | 90 KPS and 90 JAK |
| C. | Date prepared: | October 5, 2000 |
| D. | Predicate Device: | GE CT-PET (K010641) ADAC Allegro PET, K003434
EXACT CT PET (K002715) Marconi MX 8000 CT, K010817 |
| E. | | Performance Standards 21 CFR 1020.30 – 1020.33 as applicable |
for Computed Tomography X-Ray, (892.1750)
Intended Use: E.
GEMINI is an imaging system that combines positron emission tomography (PET) and X-ray OLMINI is an imaging System that other attenuation and non-attenuation corrected images computed toniography. - The OEMIX in the head, body and total body as well as x-ray of the distribution of I ET radiophalmater The PET and CT images are registered and displayed in a transmission mages of these arcas: "XX" and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an by transd health professionals: "The RET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.
F. Device Description:
The GEMINI hybrid PET/CT system is a combined positron emission tomography and X-100 The OLMIN Hyorathy scanner. This system uses the ADAC ALLEGRO PET system, K003434, Computed tonlogiaply Seather. "This Systems MX8000-v5.0 CT, K010817. The GEMINI integrates the two and the Marcon Meanen of on a single workstation to allow straightforward planning and system system operator consores mo the MX8000 CT system gantries remain intact as major operation. The PEEDOricated within a common integrated housing. It can be used in any subsydent components rocedures, which have been clinically conducted in a separate CT system end/or a PET system. No modifications have been made to either system, which would affect system performance.
performanos:
GEMINI is intended for use primarily as a clinical whole body oncology scanner with high-end dual slice CT capability and high-end GSO based PET performance. It mechanically might one data. Biros of capreater flexibility for above three operation modes. The availability of
GEMINI 510(k) Notification ADAC Laboratories
Section X.-1-1
1
K013521
-Page 2 of 2
low dose tomographic data sets implies that a natural extension of the ALLEGRO based cesium source attenuation correction to a CT transmission map attenuation correction exists. The primary purpose, however, of the CT is to provide precise anatomical localization for the metabolically significant positron emission distributions imaged on the PET system. These images when properly registered and displayed as a fused image, provide both functional and anatomical information with reliable spatial correspondence in a single image.
Comparison to Predicate Device: G.
The predicate devices, GE CT-PET (Discovery LS) and the ECAT CT-PET (Biograph) are similar to the GEMINI in that all of the devices consist of a full functional CT and PET. The patient may have a diagnostic CT and PET scan performed consecutively without having to move the patient. The GEMINI provides a mean to reach the diagnostic decision faster than the conventional way of imaging patients with both CT and PET systems in separate locations. The differences are the area of overall system dimensions, room size requirements, scanning length, and ease of use.
The GEMINI CT-PET is designed so that the system can operate in three modes: CT only, PET only and combined CT/PET. The major difference is that the GEMINI imaging system has a separation system that allows the distance of the CT and PET units to be increased. This feature provides easy access to the patient. GEMINI provides a newly developed dedicated PET/CT table to minimize the system room requirements
H. System Performance Test:
- The MX 8000 v.5.0 is manufactured in accordance with Performance Standards in 21 ● CFR 1020.30 -- 33.
- ALLEGRO system performance was measured according to the NEMA-NU2 standard. . In addition, clinical phantoms with clinical protocols were used to evaluate ALLEGRO image quality in terms of the noise texture and contrast of the image.
- The GEMINI complies with voluntary standards for safety and effectiveness (IEC 60601-. 1, IEC 60601-2, IEC 60825-1, UL 2601-1, & CAN/CSA-C22.2 and is tested to demonstrate the hazards, i.e., electrical, mechanical, and radiation have been minimized.
I. Conclusion:
The GEMINI Imaging System is substantially equivalent to the predicate devices, the GE CT-PET (K010641) and the EXACT CT-PET (K002715) based upon similar intended use, technological comparison, and system performance.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 7 2001
ADAC Laboratories % Michael Kwan, Ph.D. Principal Reviewer/Office Coordinator Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169
Re: K013521
Trade/Device Name: GEMINI PET-CT Device Combined PET/CT System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 KPS Product Code: 90 JAK Dated: October 22, 2001 Received: October 23, 2001
Dear Dr. Kwan:
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.
3
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
4
NOV 0 7 2001
INDICATIONS FOR USE STATEMENT
510 (k) NUMBER (if KNOWN): _ KO1352 / 1
DEVICE NAME:
GEMINI
ADAC Laboratories SPONSOR NAME:
INDICATIONS FOR USE:
GEMINI is an imaging system that combines positron emission tomography (PET) and CEMINI is an inflaging system that como produces attenuation and non-attenuation A-1ay computed tonlography. corrected images of the distribution of I D F ranspition images of the PET and CT images tolal body as well as x-ray transmission. Integories combined PET and anatomical all registered and displayed in a etation by trained health professionals. The PET and data at different angles for merpretained by ther as an integrated system or as a stand-alone CT portions on the system can or arouvide CT data suitable for use in attenuation correction.
(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) | _________________ |
|---|---|
| ----------------------------------------------- | ------------------- |
✓
Nancy C brigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,