(51 days)
Not Found
No
The document describes standard quantitative analysis software for nuclear medicine images and does not mention AI, ML, or related concepts.
No
The device is described as software used for quantitative analysis and display of images obtained from a scintillation gamma camera to assess liver and gallbladder function. It processes data and generates time-activity curves and quantitative results for diagnostic purposes, rather than directly treating or mitigating a disease or condition.
Yes
The device is described as "software used for quantitative analysis of liver and gallbladder function studies" and "generates time activity/curves and provides quantitative results of the liver and gallbladder function," which are activities consistent with a diagnostic device.
Yes
The device is described as "Off the Shelf" software written on a JAVA platform that can be loaded onto a PC. Its function is the quantitative analysis and display of image data acquired from a separate hardware device (scintillation gamma camera). The description focuses solely on the software's capabilities and does not mention any accompanying hardware components or hardware-specific validation.
Based on the provided information, it is highly likely that this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: IVDs are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that KHBS is software used for the quantitative analysis of image data obtained from a scintillation gamma camera. This camera acquires images of the liver and gallbladder after a radioactive tracer is administered to the patient.
- Input Data: The input data is image data from a medical imaging modality (scintillation gamma camera), not biological specimens.
- Analysis: The software analyzes the spatial and temporal distribution of the radioactive tracer within the organs, generating time-activity curves and quantitative results related to organ function. This is a form of in vivo (within the living body) analysis, not in vitro (outside the living body).
In summary, the device processes and analyzes medical images acquired from a patient, which falls under the category of medical imaging software, not In Vitro Diagnostics.
The fact that it analyzes "liver and gallbladder function studies" might initially sound like it could be related to laboratory tests, but the context of using a scintillation gamma camera and analyzing image data firmly places it outside the realm of IVDs.
N/A
Intended Use / Indications for Use
KHBS is accessory for quantitative analysis of planar liver and gallbladder function studies acquired in a scintillation gamma camera system. It processes the data and displays images in a format desired by the user. KHBS should be operated only by qualified health care professionals trained with the use of muclear medicine equipments.
KHBS is an "Off the Shelf" software used for quantitative analysis of liver and gallbladder function studies obtains with a scintillation is treaters. The Dicom image data obtained with the scintillation gaments camera is transferred to the software loaded on to a network PC and analyzed by a person familiar with the use of nuclear medicine equipment.
Product codes (comma separated list FDA assigned to the subject device)
IYX, LLZ
Device Description
KHBS is an Off the Shelf nuclear hepatology software written on JAVA platform that can be loaded on to a PC. It is used for quantitative analysis and display of planar dicom image data acquired using scintillation gamma camera. The system generates time activity/curves and provides quantitative results of the liver and gallbladder function. It displays images, curves and texts in grey scale or color.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scintillation gamma camera (Dicom image data)
Anatomical Site
Liver and Gallbladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified health care professionals trained with the use of muclear medicine equipments.
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 studies obtained with the scintillation gamma camera and Device Comparison. The nampared with the results obtained with Siemens nuclear medicine software (E.Soft) in our department. Since we do not have GE or Phillips mome sonware (2.000.1) in compare our results with these two systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K992731, K903315B, K892358, K991841
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).
0
JUN 2 0 2007
510(k) SUMMARY
Prepared as required by CFK 892.1100
Device Name: KHBS verses.1.1 (Krislanmurthy Hegato-Biliary Software)
Common Name: Sciatillation Gamma Camera-Accessory
Product Code: IYX
510(k) Number: K071195
Submitter Name ANI-KAL U, LLC
Contact Person: Gerbail T. Krishnamurthy
Contact Person telephone Number: (503)245-9029 or 503)681-1745, E-mail address GTK ristmataol.com
Submitter address: 7570 SW Westgate way Portland, OR 97225 Telephone (503)245-9029, Fax (503)245-4979.
Device Deserintion: KHBS is an Off the Shelf nuclear hepatology software written on JAVA platform that can be loaded on to a PC. It is used for quantitative analysis and display of planar dicom image data acquired using scintillation gamma camera. The system generates time activity/curves and provides quantitative results of the liver and gallbladder function. It displays images, curves and texts in grey scale or color.
Intended use: KHBS is accessory for quantitative analysis of planar liver and gallbladder function studies acquired in a scintillation gamma camera system. It processes the data and displays images in a format desired by the user. KHBS should be operated only by qualified health care professionals trained with the use of muclear medicine equipments.
Device Comparison:
| Predicate Device | Manufacturer | 510(k) Number |
|---|---|---|
| E.CAM/E.Soft | Siemens Medical Solutions USA, Inc | K992731 |
| ICON Computer | ||
| System | Siemens Medical Solutions USA, Inc | K903315B |
| ADAC Pegasys | Phillips Medical System | K892358 |
| Hawkeye Option | EL GEMS Ltd/GE Medical | K991841 |
1
KHBS is produced specifically for analysis of liver and gallbladder function and incorporates many of known functional parameters. Although many of the functional parameters can be obtained with the Siemens predicate device, it is labor intensive and prone to extors of momual calculations. Similar comments apply to other predicate device from Phillips and GE.
Summary of design control. Risk analysis method includes impact of calculation errors. Since the gamma camera Dicom data provides an organ image to compare to the quantitative results from KHBS, the clinician will be able to pick up any error in calculations. For example, a low gallbladder ejection fraction (GBEF) value should have minor reduction in gallbladder size on the image, and a normal HF should have major reduction in image size. Detailed risk analysis is also incorporated in the original submission.
2
Device Comparison: The studies obtained with the scintillation gamma camera and Device Comparison. The nampared with the results obtained with Siemens nuclear medicine software (E.Soft) in our department. Since we do not have GE or Phillips mome sonware (2.000.1) in compare our results with these two systems. However, both of these systems (Phillips K892358 and GE K991841) were quoted as equivalent in the Siemens application for 510(k) submission to the FDA for Software enable analysis of data obtained with a scintillation gamma camera system. Siemens E.Soft and other prodicate devices provide basic means of data analysis and most of liver and gallbladder procious developments have to be calculated manually. It is time consuming and may lead to errors of manual calculation. The following table provides some important similarities and differences between KHBS and Siemens E. Soft system
| Parameter | KHBS | Siemens |
|---|---|---|
| Requires | PC | PC |
| Platform | Java | MS DOS |
| Deconvolutional analysis | yes | no |
| HEF | yes | no |
| T1/2 measurement | auto | manual |
| GBEF | yes | yes |
| GBEP | auto | manual |
| GBER | auto | manual |
| DGBR Basal | auto | manual |
| DGBR-CCK | auto | manual |
| Segmental GBEF | auto | manual |
| Lobar liver function | auto | manual |
| Segmental liver function | yes | no |
| HPS | auto | manual |
Table 1. Comparison of parameters between KHBS and Siemens E.Soft system
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Image /page/3/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three curved lines that form a bird-like shape. The logo is black and white and appears to be a scanned image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
G.T. Krishnamurthy, M.D. Manager ANI-KAL II, LLC 7570 SW West Gate Way PORTLAND OR 97225
JUN 20 2007
Re: K071195
Trade/Device Name: KHBS v 1.1 (Nuclear Hepatology Software) Regulation Number: 21 CFR 892,1100 Regulation Name: Scintillation (gamma) camera Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: IYX and LLZ Dated: April 26, 2007 Received: May 2, 2007
Dear Dr. Krishnamurthy:
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 (fact 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 device that have been reclassified in accordance with the provisions of the Federal Food, Drue, and Comentatio Act (Act) that do not require approval of a premarket approval application (PMA). Your costi. therefore, market the device, subject to the general controls provisions of the Act. The grateral 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 affective 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/3/Picture/10 description: The image shows a logo with the letters "FDA" in the center, surrounded by the words "Centennial" and "***". Above the logo, the numbers "506-XXX" are visible. Below the logo, the words "Protecting and Promoting Public Health" are written in a decorative font.
4
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 nf 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.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" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Chogdon
Nancy C. Brogdon 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): K071195
Device Name:KHBS v 1.1 (Nuclear Hepatology software)
Indications for Use: KHBS is an "Off the Shelf" software used for quantitative analysis of liver and gallbladder function studies obtains with a scintillation is treaters. The Dicom image data obtained with the scintillation gaments camera is transferred to the software loaded on to a network PC and analyzed by a person familiar with the use of nuclear medicine equipment.
Prescription Use V x AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(FEEASE INO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED)
Concurrence of CDRB~ Office of Device Evaluation (ODE)
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Hulu Remmers
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number