(103 days)
The GE LightSpeed Xtra CT Scanner System is indicated for head and whole body Xray Computed Tomography applications.
The system is capable of generating images for the guidance of minimally invasive procedures such as biopsy and ablation of tumors and pathology.
The system allows imaging of obese patients, up to and including the morbidly obese population (BMI > 40).
When used in the LightSpeed RT Pro16 configuration:
The system acquires CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.
The LightSpeed Xtra CT Scanner System is composed of a gantry, patient table, operator console, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
The system generates images through the computer reconstruction of data acquired at different angles of the same axial plane. The gantry can rotate at up to 0.5 seconds per rotation, and can acquire up to 16 slices of data with a maximum total coverage of 20mm in the axial direction. The system may be operated in both axial and helical scan modes.
The system features an 80cm diameter wide bore to accommodate large patients and radiation therapy planning immobilization devices, to allow easy access during interventional procedures, and for ease of patient positioning.
The LightSpeed Xtra system is also available as the LightSpeed RT ProJ6, which features a unique accessory package designed to assist planning of radiation therapy procedures.
The provided text is a 510(k) summary for the GE LightSpeed Xtra CT Scanner System. This document is primarily focused on demonstrating substantial equivalence to a predicate device and discussing the device's technical specifications and intended use. It does not contain information about specific acceptance criteria for device performance, nor details of a study that proves the device meets such criteria in terms of clinical accuracy or diagnostic efficacy.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for clinical outcomes or diagnostic accuracy. It focuses on technical specifications and safety standards.
- Sample size used for the test set and the data provenance: No test set data or provenance is mentioned for device performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for a clinical test set is not described.
- Adjudication method for the test set: No test set adjudication method is mentioned.
- 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, AI component, or human improvement metrics are discussed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is discussed as this is a CT scanner, not an AI diagnostic algorithm.
- The type of ground truth used: No ground truth for clinical performance or diagnostic accuracy is described.
- The sample size for the training set: No training set information is provided.
- How the ground truth for the training set was established: No training set information is provided.
The document states:
- "LightSpeed Xtra is an evolutionary modification to the LightSpeed 5.0 scanner (K030420), does not result in any new potential safety risks, and performs as well as or better than devices currently on the market." This is a general claim of equivalence and performance, not a report of specific acceptance criteria met.
- "LightSpeed Xtra will be certified to comply with the X-ray requirements of 21CFR1020.30 and 1020.33, as well as the safety requirements of UL 60601-1, and IEC 60601-1 and associated collateral and particular standards." These are safety and technical compliance standards, not clinical performance acceptance criteria.
To obtain the information you are requesting, you would typically need a clinical study report or performance evaluation document, which is not included in this 510(k) summary.
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Image /page/0/Picture/1 description: The image shows a black and white logo of the company General Electric (GE). The logo is a circular shape with the letters "GE" in a stylized font in the center. The letters are connected and appear to be handwritten. The background of the circle is filled with a pattern of dots, giving it a textured appearance.
APR 1 9 2006
GE Healthcare Technologies
510(k) Summary of Safety and Effectiveness
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).
Submitter:
| Name: | GE Medical Systems, LLC (GE Healthcare) |
|---|---|
| Address: | 3000 N. Grandview Blvd., W-1140Waukesha, WI 53188 |
| Contact: | Glen E. SabinFCT Safety and Regulatory EngineerTel: 262-312-7703, Fax: 262-312-7144e-mail: glen.sabin@med.ge.com |
| Date Prepared: | 11 November 2005 |
| Product Identification: | |
| Proprietary Device Names: | GE LightSpeed Vtra CT Scanner System |
Proprietary Device Names:
GE LightSpeed Xtra CT Scanner System Available also as GE LightSpeed RT Pro16
Common Name: Classification Name:
CT Scanner Computed Tomography X-ray System (21 CFR 892.1750, Product Code JAK)
Predicate Device(s):
GE LightSpeed 5.0 CT Scanner System
Device Description:
The LightSpeed Xtra CT Scanner System is composed of a gantry, patient table, operator console, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
The system generates images through the computer reconstruction of data acquired at different angles of the same axial plane. The gantry can rotate at up to 0.5 seconds per rotation, and can acquire up to 16 slices of data with a maximum total coverage of 20mm in the axial direction. The system may be operated in both axial and helical scan modes.
The system features an 80cm diameter wide bore to accommodate large patients and radiation therapy planning immobilization devices, to allow easy access during interventional procedures, and for ease of patient positioning.
E. Medical Systems, LLC
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The LightSpeed Xtra system is also available as the LightSpeed RT ProJ6, which features a unique accessory package designed to assist planning of radiation therapy procedures.
Intended Use:
The GE LightSpeed Xtra CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
The system is capable of generating images for the quidance of minimally invasive procedures such as biopsy and ablation of tumors and pathology.
The system allows imaging of obese patients, up to and including the morbidly obese population (BMI > 40).
When used in the LightSpeed RT Pro16 configuration:
The system acquires CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.
Comparison with Predicate:
The LightSpeed Xtra CT Scanner System represents a modification to the legally marketed LightSpeed 5.0 scanner (510lk) number K030420). The LightSpeed Xtra is an evolutionary change to the LightSpeed product line, and includes many features, functions, software, and hardware that are common to previous generations, including the LightSpeed 4.0 (K013561) 16 slice system. the LightSpeed 3.0 (K002978) 8 slice system, and LightSpeed 2.0 (K000300) 4 slice system. It has the same technological characteristics and operating principles, is comparable in key safety and effectiveness features, and uses the same basic design, construction, and materials.
ln the opinion of GE Healthcare, the LightSpeed Xtra CT Scanner System is of comparable type and is substantially equivalent to currently marketed head and whole body X-ray computed tomography systems that comply with the same or equivalent standards and have similar intended uses.
Conclusion:
LightSpeed Xtra is an evolutionary modification to the LightSpeed 5.0 scanner (K030420), does not result in any new potential safety risks, and performs as well as or better than devices currently on the market. LightSpeed Xtra will be certified to comply with the X-ray requirements of 21CFR1020.30 and 1020.33, as well as the safety requirements of UL 60601-1, and IEC 60601-1 and associated collateral and particular standards. GE considers the LightSpeed Xtra CT Scanner System to be equivalent to other marketed devices with similar indications for use and meeting similar standards.
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DEPARTMENT OF HEALTH & HUMAN SERVICES .
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 9 2006
GE Medical Systems, LLC (GE Healthcare) % Mr. Tamas Borsai Program Manager, Third Party Review Program TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K060052
Trade/Device Name: GE LightSpeed Xtra CT Scanner System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: JAK and KPQ Dated: April 3, 2006 Received: April 4, 2006
Dear Mr. Borsai:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. The logo is surrounded by text that reads "U.S. Department of Health & Human Services". Below the logo is the text "Protecting and Promoting Public Health" in a decorative font. The image appears to be a promotional or commemorative item related to the FDA's centennial anniversary.
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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.
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 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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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Indications for Use
510(k) Number (if known):
Kobosz
Device Name:
GE LightSpeed Xtra CT Scanner System
Indications for Use:
The GE LightSpeed Xtra CT Scanner System is indicated for head and whole body Xray Computed Tomography applications.
The system is capable of generating images for the guidance of minimally invasive procedures such as biopsy and ablation of tumors and pathology.
The system allows imaging of obese patients, up to and including the morbidly obese population (BMI > 40).
When used in the LightSpeed RT Pro16 configuration:
The system acquires CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.
Prescription Use >> AND/OR (21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060052
§ 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.