(81 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on image processing for gated CT images.
No.
The device is used for image scoring and processing, specifically "Heart calcium scoring," which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states "Heart calcium scoring for gated CT images," which is a diagnostic purpose. The device also processes CT images of the heart to minimize the effects of heart movements for this scoring, indicating it aids in diagnosis.
Yes
The device is described as a "Software Upgrade" and "Tool enhancement" for an existing imaging workstation, focusing on image processing for heart calcium scoring. There is no mention of new hardware components being introduced or modified.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a software upgrade for a CT imaging workstation. Its intended use is "Heart calcium scoring for gated CT images." This involves processing medical images (CT scans) taken from a patient's body, not analyzing samples taken from the body.
- Input: The input is CT images, not biological samples.
- Output: The output is a score based on the analysis of the images, not a result from a laboratory test on a biological sample.
The device falls under the category of medical imaging software used for diagnostic purposes, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Heart calcium scoring for gated CT images to minimize effects of heart movements.
Product codes
90JAK
Device Description
The Acculmage Smartgate Upgrade for AccuScore 1.0 is an additional The Accumlage Onlangate Openalic Imaging Workstation with AccuScore, AccuAnalyze, AccuShade, AccuVRT and AccuMIP plugwin 7 locaboore, Accuring is not currently marketed, and the AccuMIP ins. The Accuremade play ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . play-in-15-ourrently-our-en-in-stating Tool enhancement for AccuScore Accumage Onlangulo Opgrado Stimas scoring for gated images, thus minimizing adverse effects of heart movement.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
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)
The software was designed, developed, verified and validated according The soltware was assigned procedures specify individuals within the to which procedule for developing and approving product organizations, software colling and testing, validation testing and field maintenance. All software testing specified in the Software Product Development Plan will be successfully completed prior to market release.
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
SEP 2 5 2001
510(k) Summary
K 012/06
Company Identification 1.
Acculmage Diagnostics Corporation 400 Grandview Drive South San Francisco, CA 94080 Phone (650) 875-0192 Fax (650) 875-0194 Contact Person: Oscar Gils Carbó Email oscar@accuimage.com Establishment Registration No. 2953774
2. Official Correspondent
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro CA 94578-1116 Phone (510) 276-2648 Fax (510) 276-3559 Email: regman1@home.com
3. Date of Submission July 3, 2001
-
- Device Name
| Proprietary Name: | Acculmage SmartGate Upgrade: Acculmage
EKG Gating Tool Enhancement for AccuScore
1.0. |
|----------------------|---------------------------------------------------------------------------------------------|
| Classification Name: | 90JAK – CT, Image Processing |
| Device/Usual Name: | Gated Calcification Scoring of CT images. |
5. Substantial Equivalence
The Acculmage Smartgate Upgrade Option is Substantially Equivalent to GE Medical Systems HiSpeed Lxi with SmartScore and the Vital Images Vscore with Gating options.
Page 1 of 3
1
KO12106
Page 2 of 3
Device Description and Intended Use 6.
Device Description
The Acculmage Smartgate Upgrade for AccuScore 1.0 is an additional The Accumlage Onlangate Openalic Imaging Workstation with AccuScore, AccuAnalyze, AccuShade, AccuVRT and AccuMIP plugwin 7 locaboore, Accuring is not currently marketed, and the AccuMIP ins. The Accuremade play ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . play-in-15-ourrently-our-en-in-stating Tool enhancement for AccuScore Accumage Onlangulo Opgrado Stimas scoring for gated images, thus minimizing adverse effects of heart movement.
Intended Use
Heart calcium scoring for gated CT images to minimize effects of heart movements.
Software Development: 7.
The software was designed, developed, verified and validated according The soltware was assigned procedures specify individuals within the to which procedule for developing and approving product organizations, software colling and testing, validation testing and field maintenance.
Performance Testing:
All software testing specified in the Software Product Development Plan will be successfully completed prior to market release.
8. Hazard Analysis
Hazard analysis on this product has been performed throughout the l definition, design, coding and testing phases of product development and implementation. This process has emphasized:
- identification of potential hazards, their causes, and their effects; .
- development of methodologies to control the occurrence of hazards . and to constrain their effects; and
- Determine any effect on patient safety and system effectiveness. .
The potential hazards associated with this software product are no different The potomian nazar PACS components . These are primarily related to than those of computer system components, and may be variously obviated by
2
Koi2106
Page 3 of 3
decisions taken by the customers of this product. None of these failures are expected to materially contribute to patient death or injury.
It is our conclusion that there is no hardware or software component, operating in a properly configured environment, whose failure or latent design defect would be expected to result in death or injury of a patient. Thus the "Level of Concern" is "Minor".
Safety Concerns 9.
The hardware is "off-the-shelf" and complies with applicable electrical safety standards for standard PC hardware and peripherals.
Substantial Equivalence Comparison Chart 10.
The following product(s) provides functions, which are substantially equivalent to this product:
| Manufacturer | GE Medical
Systems | Vital Images | Acculmage |
|---------------------------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Name | HiSpeed LX/i
with SmartScore | Vscore with
AutoGate option | Acculmage
Smartgate Upgrade |
| 510(k)
Number | K980169 | K003230 | |
| Computer
Platform | Not Known | PC / Windows
workstation | Pentium / Windows
workstation |
| Gating Option
for Calcium
Scoring | HiSpeed LX/i
with SmartScore
option | Match cardiac CT
images with the
corresponding EKG
signal. This allows
the physician to
select images
acquired when the
heart was still. | Match cardiac CT
images with the
corresponding EKG
signal. This allows
the physician to
select images
acquired when the
heart was still. |
| Type of CT
scanners for
which it is
applicable | LightSpeed and
HiSpeed GE CT
scanners | EBCT and
standard CT | EBCT and
standard CT |
| Types of
Gating | Prospective and
Retrospective
Gating | Images with either
associated EKG
signal or image-
derived cardiac
motion signal | Images with either
associated EKG
signal or image-
derived cardiac
motion signal |
3
Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines. The symbol is black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2001
AccuImage Diagnostics Corporation % Mr. Gary Allsebrook Official Correspondent Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116
Re: K012106
Trade/Device Name: AccuImage SmartGate Upgrade Gated Calcification Scoring for CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: 90 JAK Dated: July 3, 2001 Received: July 6, 2001
Dear Mr. Allsebrook:
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 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.
4
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 vours.
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
5
510(k) Number (if known): KO12106
Device Name:
AccuImage SmartGate Upgrade: AccuImage EKG Gating Tool Enhancement for Accuscore 1.0
Indications For Use:
Heart calcium scoring for gated CT images to minimize effects of heart movements.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 901.109)
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012106