(87 days)
The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems is indicated for head and whole body x-ray computed tomography applications.
The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems consists of a gantry, patient table, console, computer and associated accessories.
The provided text is a 510(k) summary for the GE Medical Systems HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems. This document is a premarket notification to the FDA for a medical device and typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.
Based on the provided text, the following information can be extracted regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria and a detailed table of device performance against those criteria in the way a clinical study report would. Instead, the submission relies on demonstrating substantial equivalence to existing, legally marketed Computed Tomography (CT) X-ray Systems.
- Acceptance Criterion (Implicit): Substantial equivalence to currently marketed Computed Tomography X-ray Systems regarding design, material composition, energy source, radiation characteristics, and safety.
- Reported Device Performance (Implicit): The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems perform "as well as or better than devices currently on the market" and do not introduce "any new potential safety risks." This is a qualitative statement of performance relative to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective or prospective) for a performance study. The evaluation appears to be based on system verification and validation to specifications, rather than a clinical trial with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The document does not describe a test set or ground truth established by experts.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of a test set or an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. The document does not indicate that an MRMC comparative effectiveness study was performed. The focus is on demonstrating substantial equivalence to existing devices, not on comparing reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
The device described is a CT scanner system, not an AI algorithm. Therefore, a standalone algorithm-only performance study is not relevant in this context. The evaluation is for the entire hardware and software system.
7. The Type of Ground Truth Used:
Not applicable. The document does not describe a performance study involving ground truth derived from clinical data (like pathology or outcomes data). The "ground truth" for the substantial equivalence claim is the performance and safety profile of the predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This document describes a CT imaging system, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, the device is a CT imaging system, not an AI model.
In summary, this 510(k) submission is for a new generation of CT scanners demonstrating substantial equivalence to previously cleared devices. It relies on internal verification and validation against specifications and adherence to standards rather than detailed clinical performance studies with specific acceptance criteria, ground truth, and expert evaluation to prove performance in the context of advanced diagnostic algorithms.
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GE Medical Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------0x 414 11 Marikee NI 5320
APR 1 3 1998
510(k) Summary of Safety & Effectiveness
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)
Submitter: Larry A. Kroger, Ph.D.
Regulatory Programs Manager Who may be contacted by telephone at 414-544-3894 or by FAX at 414-544-3863. Summary prepared 24 December 1997
Summary prepared 24 December 1999
Product Identification
Name: HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems Classification Name: Computed Tomography X-ray System
| Manufacturer: | GE-YMS7-127 Asahigaoka 4-ChomeHino-Shi, Tokyo, Japan 191 | Distributor: | GE Medical Systems3000 GrandviewWaukesha, Wi 53188 |
|---|---|---|---|
| --------------- | ------------------------------------------------------------------ | -------------- | ------------------------------------------------------------ |
Marketed Devices:
The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems is of comparable type and substantially equivalent to currently marketed Computed Tomography X-ray Systems that comply with the same or equivalent standards and have the same intended uses.
Device Description:
The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems consists of a gantry, patient table, console, computer and associated accessories.
Materials: Materials and construction are equivalent to the HiSpeed CT/i (K940606) and are compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J.
Design: The System is designed to be a head and whole body CT scanner utilizing a solid state detector, and an intuitive Operator Console with similar features to the HiSpeed CT / i (K940606).
Indications for Use:
The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems is indicated for head and whole body x-ray computed tomography applications.
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Comparison with Predicate:
It is the opinion of GE Medical Systems that the HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems is of a comparable type and substantially equivalent to currently marketed head and whole body x-ray computed tomography systems with respect to design, material composition, energy source, and radiation characteristics.
Adverse Effects on Health:
Potential electrical, mechanical and radiation hazards are identified in a hazard analysis and controlled by:
- . System verification and validation to insure performance to specifications, Federal Regulations, and user requirements.
- Adherence to Industry and International Standards. (UL and IEC) .
Conclusions:
Use of the HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems does not result in any new potential safety risks and performs as well as or better than devices currently on the market.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, resembling a bird in flight. The figure is composed of three curved lines that create the impression of movement and dynamism. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 1998
Larry A. Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems. Inc. P.O. Box 414, W-709 Milwaukee, WI 53201
Re:
K980169 HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems Dated: January 12, 1998 Received: January 13,1 998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Kroger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems
Indications For Use:
The HiSpeed LX/i, HiSpeed FX/i, and HiSpeed DX/i Family of Systems are indicated for head and whole body x-ray computed tomography applications.
(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 CER 801-109)
Over-The Counter Use_ OR
Yand A. Hymm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
§ 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.