(13 days)
No
The document describes standard image processing and reconstruction techniques for a CT scanner, with no mention of AI or ML algorithms.
No
The device is described as an X-ray system intended to produce cross-sectional images for diagnostic purposes, and its output is a valuable medical tool for the "diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy" - it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy." This indicates its use in diagnosing conditions.
No
The device description explicitly states it is composed of hardware components such as a gantry, patient table, operator console, computer, and PDU, in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The GE BrightSpeed Delight Series Computed Tomography X-ray system is an imaging device that uses X-rays to create cross-sectional images of the body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states that the device produces images of the body for diagnosis, planning, guiding, and monitoring therapy. This is a function of an in vivo imaging device, not an in vitro diagnostic device.
The device description and intended use consistently describe a system that interacts directly with the patient's body using X-rays to generate images, which is the core function of a CT scanner, not an IVD.
N/A
Intended Use / Indications for Use
The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.
The GE BrightSpeed Delight Series CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Product codes
JAK
Device Description
The GE BrightSpeed Delight Series CT Scanner System (aka GE BrightSpeed Elite, BrightSpeed Elite Select, BrightSpeed Edge Select, and BrightSpeed Excel Select) is composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. The GE BrightSpeed Delight Series CT Scanner System is an evolutionary modification to StarSpeed Series CT system (K052855). It is developed from the hardware platform of StarSpeed system by adding new application features that involve changes in hardware, software, firmware, recon, and scan mode.
The GE BrightSpeed Delight Series CT Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and similar Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21CFR Subchapter J.
Mentions image processing
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray Computed Tomography
Anatomical Site
Body, head, whole body, cardiac and vascular
Indicated Patient Age Range
all ages
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
OCT 0 8 2008
Image /page/0/Picture/1 description: The image shows a handwritten text string that appears to be "Ko 2814". The characters are written in a cursive style, with some variations in stroke thickness. The text is slightly tilted, and the overall impression is that of a quick, informal note.
GE Healthcare
3000 N. Grandview Blvd. W-1140 Waukesha, WI 53188
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 807.07(h).
| Submitter: | |
|---|---|
| Name: | GE Medical Systems, LLC (GE Healthcare) |
| Address: | 3000 N. Grandview Blvd., W-1140 |
| Waukesha, WI 53188 | |
| Contact: | Steve Kachelmeyer |
| Premarket Regulatory Affairs Program Manager | |
| Tel: 262-548-2432, Fax: 262-997-1080 | |
| e-mail: Steven.Kachelmeyer@med.ge.com | |
| Date Prepared: | August 11, 2008 |
| PRODUCT IDENTIFICATION | |
| Name: | GE BrightSpeed Series CT |
| (Also known as BrightSpeed Delight Series CT | |
| Scanner System) | |
| Classification Name: | Computed Tomography X-ray System |
| 21CFR892.1750, 90-JAK | |
| Manufacturer: | GE Yokogawa Medical Systems |
| 7-127 asahigaoka 4-chome | |
| Hino-shi, Tokyo, Japan 191-8503 |
GE Hangwei Medical Systems Co. Ltd.
No 1 Young Change North Rd
Beijing Economic and Tech Development Zone
Beijing, China 100176
Future Production may also be accomplished at one of our
other registered CT Manufacturing facilities. |
| Distributor: | GE Medical Systems LLC. (GE Healthcare)
3000 N. Grandview Blvd.
Waukesha, WI 53188 |
1
Marketed Devices: The GE BrightSpeed Delight series CT Scanner System (aka GE BrightSpeed Elite, BrightSpeed Elite Select, BrightSpeed Edge Select, and BrightSpeed Excel Select) is of comparable type and substantially equivalent to GE's currently marketed Computed Tomography X-ray Systems that comply with the same or equivalent standards and have similar intended uses, such as the previous StarSpeed CT Scanners.
Predicate Device(s):
GE StarSpeed Series CT Scanner System (K052855)
DEVICE DESCRIPTION
The GE BrightSpeed Delight Series CT Scanner System (aka GE BrightSpeed Elite, BrightSpeed Elite Select, BrightSpeed Edge Select, and BrightSpeed Excel Select) is composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. The GE BrightSpeed Delight Series CT Scanner System is an evolutionary modification to StarSpeed Series CT system (K052855). It is developed from the hardware platform of StarSpeed system by adding new application features that involve changes in hardware, software, firmware, recon, and scan mode.
The GE BrightSpeed Delight Series CT Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and similar Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21CFR Subchapter J.
Indications for Use:
The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.
The GE BrightSpeed Delight Series CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
2
The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
Comparison with Predicate:
The GE BrightSpeed Delight Series CT Scanner System is developed from the hardware platform of our StarSpeed system (K052855). The GE BrightSpeed Delight Series CT involves changes from the StarSpeed CT system to add new application features that involve changes in hardware, application software, firmware, recon, and scan mode. The GE BrightSpeed Delight Series CT Scanner System uses virtually the same materials and identical operating principle as our existing marketed product, StarSpeed CT system as well as having similar indications for use. We believe the GE BrightSpeed Delight Series CT Scanner System is of comparable type and substantially equivalent to our currently marketed system listed above and complies with the same or equivalent standards and have the same intended uses.
The GE BrightSpeed Delight Series CT Scanner System will be certified to comply with the X-ray requirements of 21CFR1020.30 and1020.33, as well as the safety requirements of UL 60601-1, and IEC 60601-1 and associated collateral and particular standards.
Adverse Effects on Health:
Potential electrical, mechanical and radiation hazards are identified in a risk management including hazard analysis and controlled by:
- System verification and validation to ensure performance to specifications, . Federal Regulations, and user requirements.
- . Adherence and certification to industry and international standards. (UL/CSA and IEC).
- . Compliance to applicable CDRH 21CFR subchapter J requirements.
The device is designed and manufactured under the Quality System Regulations of 21CFR820.
Conclusions:
The GE BrightSpeed Delight Series CT Scanner System is an evolutionary modification to the StarSpeed Series CT system (K052855). It does not result in any new potential safety risks and performs as well as or better than devices currently on the market. The GE BrightSpeed Delight Series CT system will be certified to comply with the X-ray requirements of 21CFR 1020.30 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 GE BrightSpeed Delight Series CT Scanner System to be equivalent to other marketed devices with similar indications for use and meeting similar standards.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 8 2008
GE Medical Systems, LLC % Mr. James W. Monroe Official Correspondent Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K082816
Trade/Device Name: GE BrightSpeed Delight Series CT Scanner Systems (aka GE BrightSpeed Elite, BrightSpeed Elite Select, BrightSpeed Edge Select, and BrightSpeed Excel Select)
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 24, 2008 Received: September 25, 2008
Dear Mr. Monroe:
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.
4
Page 2
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 (OS) 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jorque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: GE BrightSpeed Delight Series CT Scanner Systems (aka GE BrightSpeed Elite, BrightSpeed Elite Select, BrightSpeed Edge Select, and BrightSpeed Excel Select)
Indications for Use:
The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.
The GE BrightSpeed Delight Series CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helmut Leman
Page 1 of 1
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devic 510(k) Number
4-2