(15 days)
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: "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 trained health professionals: "The RET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.
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 on a single workstation to allow straightforward planning and system operation. The PET and the MX8000 CT system gantries remain intact as major subsydent components fabricated within a common integrated housing. It can be used in any procedures, 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.
The provided document is a 510(k) summary for the GEMINI PET/CT system. It does not contain a detailed study with acceptance criteria and reported device performance metrics in the format requested.
The document focuses on:
- Device Description and Intended Use: Explaining what the GEMINI system is and what it's used for (combining PET and X-ray computed tomography for imaging).
- Comparison to Predicate Devices: Stating that the GEMINI is similar to existing GE CT-PET and ECAT CT-PET systems.
- System Performance Test (General): This section mentions that the component CT system (MX 8000) and PET system (ALLEGRO) meet certain performance standards (21 CFR 1020.30-33 for CT, NEMA-NU2 for PET) and that "clinical phantoms with clinical protocols were used to evaluate ALLEGRO image quality in terms of the noise texture and contrast of the image." It also states the GEMINI complies with voluntary safety and effectiveness standards.
- Conclusion: The device is substantially equivalent to predicate devices.
Missing Information:
The document lacks the specific details required to complete many sections of your request, such as a table of acceptance criteria with measured device performance, sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
Based on the provided text, here is what can be extracted and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| CT System (MX 8000 v.5.0): Compliance with Performance Standards in 21 CFR 1020.30 - 33. | "The MX 8000 v.5.0 is manufactured in accordance with Performance Standards in 21 CFR 1020.30 -- 33." (Confirms compliance, but specific performance metrics are not detailed). |
| PET System (ALLEGRO): Performance measured according to NEMA-NU2 standard. Evaluate image quality in terms of noise texture and contrast using clinical phantoms and protocols. | "ALLEGRO system performance was measured according to the NEMA-NU2 standard." "clinical phantoms with clinical protocols were used to evaluate ALLEGRO image quality in terms of the noise texture and contrast of the image." (Confirms methods used, but specific performance metrics - e.g., spatial resolution, sensitivity, noise reduction values - are NOT provided). |
| GEMINI System (Overall): Compliance with voluntary standards for safety and effectiveness (IEC 60601-1, IEC 60601-2, IEC 60825-1, UL 2601-1, & CAN/CSA-C22.2) and demonstration of minimized hazards (electrical, mechanical, radiation). | "The GEMINI complies with voluntary standards for safety and effectiveness... and is tested to demonstrate the hazards, i.e., electrical, mechanical, and radiation have been minimized." (Confirms compliance, but specific test results are not detailed). |
| Substantial Equivalence: Similar intended use, technological comparison, and system performance to predicate devices (GE CT-PET K010641, EXACT CT-PET K002715). | "The GEMINI Imaging System is substantially equivalent to the predicate devices... based upon similar intended use, technological comparison, and system performance." (This is the ultimate conclusion, not a specific performance metric). |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document mentions "clinical phantoms" for the ALLEGRO PET system but does not provide a number or mention human subject data for testing the combined GEMINI system's performance metrics.
- Data Provenance: Not specified for any performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The document states that the system produces images for "interpretation by trained health professionals," but it does not describe how ground truth was established for any performance evaluation.
4. Adjudication method for the test set
- This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study mentioned. The document describes a medical imaging device (PET/CT scanner) rather than an AI-enabled diagnostic algorithm. There is no mention of AI or reader improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / No standalone algorithm performance provided. This document describes a hardware imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. The document mentions "clinical phantoms" for PET system evaluation, implying a known simulated pathology or reference standard for those tests, but the specific type of ground truth for a test set is not detailed for the integrated system.
8. The sample size for the training set
- Not applicable / Not specified. This document describes a medical imaging hardware system. If any internal algorithms were developed, their training data is not discussed.
9. How the ground truth for the training set was established
- Not applicable / Not specified. As above, this information is not relevant to or provided in the context of this 510(k) for a hardware imaging system.
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(012 510(k) SUMMARY OF SAFETY AND EFFECTIVENES
General Information
| A. | Submitted By:ADAC Laboratories540 Alder Dr.Milpitas, CA 95035 | Contact: Coleen ColemanTel: (408) 468-3051Fax: (408) 468-3050 |
|---|---|---|
| B. | Device Trade Name:Common Name: | GEMINIPositron Emission Tomography |
| Classification Name: | Computed Tomography X-RaySystem, Emission Computed Tomography, (892.1200)System, Computed Tomography X-Ray, (892.1750) | |
| Device Class: | 21CFR 892.1200, Class II21 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, K003434EXACT 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
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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.
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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.
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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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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,
§ 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.