(90 days)
The CT device with Sliding Gantry Option is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*Spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous movement of the Sliding Gantry).
The Sliding Gantry option is designed to allow whole body x-ray computed tomography scanning on a single patient that can be performed on different types of patient tables in different environments. The Sliding Gantry Option integrates the function of precise scan control driven horizontal movement, which is usually a function of the dedicated CT-table, into the CT gantry itself. The original CT gantry is mounted on a rail system and a scan control system moves the gantry relative to the table, instead of moving the table relative to the gantry.
This 510(k) summary focuses on establishing substantial equivalence for the "Sliding Gantry Option for CT Devices" by comparing it to predicate devices. It does not contain information regarding specific acceptance criteria, performance studies, or details on ground truth establishment for a new device's performance claims. Therefore, I cannot provide the requested information based solely on the provided text.
The document states that the new device is "substantially equivalent" to predicate devices, meaning it has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness. The FDA's clearance is based on this substantial equivalence, not on independent performance studies for novel acceptance criteria.
However, I can extract the following relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly define acceptance criteria or report specific device performance metrics in the way a clinical study would. The basis for clearance is "substantial equivalence" to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document does not describe a performance study with a test set.
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):
Not applicable. The document does not describe a performance study with a test set or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The document does not describe a performance study with a test set.
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:
Not applicable. This device is an optional hardware component for CT scanners, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a hardware component, not an algorithm, and no standalone performance study is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The document does not describe a performance study with an explicit ground truth. The substantial equivalence relies on the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
Summary of what is present in the document:
- Identified Device: Siemens Sliding Gantry Option for CT Devices
- Intended Use: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
- Basis for Clearance: Substantial Equivalence to previously cleared predicate devices (Siemens Angio-CT MIYABI K990491 and Siemens Plus 4 with Sliding Gantry Option K991600).
- Device Description: The Sliding Gantry option integrates the function of precise scan control driven horizontal movement into the CT gantry itself, moving the gantry relative to the table instead of the table relative to the gantry.
To answer your full request, a different type of submission (e.g., a PMA or a more detailed 510(k) for a novel device with new performance claims) would be needed. This document primarily focuses on demonstrating that the Sliding Gantry Option is a modification to an existing CT system that maintains the safety and effectiveness of the predicate devices.
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510(K) SUMMARY FOR THE SLIDING GANTRY OPTION FOR CT DEVICES
Submitted by:
Siemens Medical Solutions, Inc. 51Valley Stream Parkway Malvern, PA 19355
July XX, 2003
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Contact Person: 1.
Ms. Nealie Hartman 51 Valley Stream Parkway Malvern, PA 19355 Phone: (610) 448-1769 Fax: (610) 448-1787
Device Name and Classification 2.
Product Name: Common Name Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
Sliding Gantry Option for CT Devices Computed Tomography X-ray system Accessory to Computed Tomography System Radiology 21 CFR §892.1750 Class II 90 JAK
Importer/Distributor Establishment: 3.
Registration Number: 2240869 Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355
Manufacturing Facility: 4.
Siemens AG Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany
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5. Substantial Equivalence
The Sliding Gantry Option for CT Devices, addressed in this premarket notification, is substantially equivalent to the following commercially available systems
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Siemens Angio-CT MIYABI | K990491 | 04/05/99 |
| Siemens Plus 4 with Sliding GantryOption | K991600 | 06/09/99 |
6. Device Description
The Sliding Gantry option is designed to allow whole body x-ray computed tomography scanning on a single patient that can be performed on different types of patient tables in different environments. The Sliding Gantry Option integrates the function of precise scan control driven horizontal movement, which is usually a function of the dedicated CT-table, into the CT gantry itself. The original CT gantry is mounted on a rail system and a scan control system moves the gantry relative to the table, instead of moving the table relative to the gantry.
7. Intended Use
The CT device with Sliding Gantry Option is intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*Spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous movement of the Sliding Gantry).
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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 consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. 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
Ms. Nealie Hartman Technical Specialist Siemens Medical Systems, Inc. 51 Valley Stream Parkway MALVERN PA 19355
NOV 1 0 2003
Re: K032475
Trade/Device Name: SOMATOM Computed Tomography X-ray Systems with Sliding Gantry Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system
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x-ray syste
Regulatory Class: II Product Code: 90 JAK Dated: August 8, 2003 Received: August 16, 2003
Dear Ms. Hartman:
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 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.
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This letter will allow you to begin marketing your device as described in your Section 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
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 the 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" (21CFR Part 807.97) you may obtain. 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
Page 2
to proceed to the market.
Enclosure
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SECTION 2
INDICATIONS FOR USE
1032475 510(k) Number (if known): _ Sliding Gantry Option for Siemens CT systems Device Name:
The CT device with Sliding Gantry Option is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*Spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous movement of the Sliding Gantry).
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR §801.109)
Over-The-Counter Use OR
Nancy C. Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032475
510(k) for SIEMENS "Sliding Gantry Option" for
CONFIDENTIAL
§ 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.