(78 days)
The Mx8000 IDT is a Whole Body Computed Tomography 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 device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.
The Mx8000 IDT is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability of up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.
The provided text is a 510(k) Summary for the Marconi Medical Systems Inc. Mx8000 IDT CT Scanner. This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with detailed acceptance criteria and supporting data as might be found in a clinical trial report or a performance validation study for an AI/CAD device.
Based on the content provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The 510(k) summary for this CT scanner focuses on comparing it to predicate devices (Mx8000 K982060 and Mx8000 v5.0 K010817) and demonstrating substantial equivalence based on device description, intended use, and adherence to safety standards (GMP, IEC 60601-1, 21 CFR Subchapter J for radiation safety). There are no specific performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic task) or quantitative acceptance criteria listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided. As this is a 510(k) for a CT scanner system and not a diagnostic algorithm or AI product, an independent performance test set with associated data provenance would not typically be part of this type of submission. The safety and effectiveness are established through adherence to standards and comparison to predicate hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided. There is no mention of a test set requiring expert ground truth in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. There is no mention of a test set, and therefore no adjudication method.
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:
This information is not provided. An MRMC study is relevant for AI-assisted diagnostic tools. This 510(k) is for a CT scanner hardware system, not an AI or CAD software, so such a study would not be expected or relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided. No specific ground truth methodology is mentioned as it's not relevant to this type of 510(k) submission for a CT scanner.
8. The sample size for the training set:
This information is not provided. This is not an AI/ML product, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
This information is not provided. Not applicable for this device.
Summary of what CAN be extracted:
The document focuses on demonstrating substantial equivalence to previously cleared predicate devices (Mx8000 K982060 and Mx8000 v5.0 K010817) based on:
- Device Description: Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry, multi-slice capability (up to 16 slices simultaneously), and computer reconstruction of x-ray transmission data.
- Intended Use: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
- Safety and Effectiveness: Assured by adherence to GMP practices, company procedures for software safety, IEC 60601-1 for electrical and mechanical safety, and 21 CFR Subchapter J for radiation safety.
The acceptance criteria for this type of submission are primarily regulatory: demonstrating that the device is as safe and effective as a legally marketed predicate device, satisfying the requirements for general controls under the Federal Food, Drug, and Cosmetic Act. The "study" proving this is the 510(k) submission itself, where the manufacturer presents a detailed comparison to predicate devices and asserts compliance with relevant safety standards. No specific performance study with quantitative acceptance criteria and results as typically seen for diagnostic devices is described.
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SEP 1 3 2001
Marconi Medical Systems Inc. 510(k) Summary
Mx8000 IDT CT Scanner
1. Submitter
Marconi Medical Systems, Inc. 595 Miner Road Cleveland, OH 44143 (440) 483-3000
Contact:
Robert L. Turocy Marconi Medical Systems 595 Miner Road Cleveland. OH 44143 Telephone: 440 483 3528 440 483 1116 FAX:
Date of Summary: June 19, 2001
2. Device Name and Classification
Mx8000 IDT CT Scanner Device Name:
Classification Name: Computed Tomography X-Ray System
The FDA has classified the Computed Tomography X-Ray System as Class II in 21 CFR 892.1750 (Product Code 90JAK)
3. Device Description
The Mx8000 IDT is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability of up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.
4. Intended Use Of The Device
The Mx8000 IDT is a Whole Body Computed Tomography 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.
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5. Comparison to Predicate Devices
In the opinion of Marconi Medical Systems Inc., the Mx8000 IDT CT scanner is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely:
6. Safety and Effectiveness Considerations
The safety of the device is assured by adherence to GMP practices and to International Standards. Potential hazards are identified in a hazard analysis and controlled in the following manner:
Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures were adhered to, and test results demonstrate that the option specifications and functional requirements were met.
Electrical and Mechanical safety is assured by adherence to IEC 60601-1 standards. Radiation safety is assured by compliance with 21 CFR, Subchapter J performance standards.
7. Substantial Equivalency Statement
Based on the above considerations, it is Marconi's opinion that the Mx8000 IDT CT scanner is substantially equivalent in safety and effectiveness to the predicate devices, Mx8000 (initially identified as Volumax), K982060 and Mx8000 v5.0, K010817
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined strands and a stylized bird-like shape at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert L. Turocy Regulatory Affairs & Quality Control Marconi Medical Systems, Inc. 595 Miner Road HIGHLAND HEIGHTS OH 44143
Re: K012009 Trade/Device Name: Mx8000 IDT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: 90 JAK Dated: June 19, 2001 Received: June 27, 2001
Dear Mr. Turocy:
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 for associated in the encreases 776 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.
SEP 1 3 2001
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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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K 612009 510(k) Number (if known):
Page of
Mx8000 IDT Device Name:
The Mx8000 IDT is a Computed Tomography X-Ray Indications for Use: firdleations for Obe. Bystem intention of x-ray transmission data from the same axial plane taken at rcconsultion of A Ta) addisisess include signal analysis and display equipment, patient, and equipment supports, components and accessories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K012009 |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | _________________ |
|---|---|
| (Optional Format 1-2-96) |
§ 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.