(51 days)
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.
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.
The provided text describes the KHBS v1.1 (Nuclear Hepatology Software) and its 510(k) submission. However, it does not contain a detailed study or specific acceptance criteria and reported device performance in the format requested.
The document focuses on:
- Device description and intended use.
- Comparison to predicate devices, highlighting features that KHBS automates that were manual in predicate devices.
- Safety considerations (risk analysis for calculation errors).
- FDA's 510(k) clearance letter.
Therefore, for most of the requested information, the answer will be that it is not available in the provided text.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided. The document states that "The studies obtained with the scintillation gamma camera and 1.1 were compared with the results obtained with Siemens nuclear medicine software (E.Soft) in our department." This implies a comparison was done, but no specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or agreement rates) or detailed reported performance metrics are given. The comparison table (Table 1) only lists features and whether they are present/manual/auto, not performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly provided. The text refers to "studies obtained with the scintillation gamma camera," but no details on the number of cases (sample size) or their provenance (country, retrospective/prospective) are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not explicitly provided. The document does not mention the establishment of a ground truth for a test set or the number/qualifications of experts involved. The comparison was against results from the Siemens E.Soft software.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not explicitly provided. There is no mention of an adjudication method.
5. 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 was described. The comparison was between the KHBS software and the Siemens E.Soft software, not involving human readers directly comparing performance with and without AI assistance to measure improvement in human interpretation. The software "provides quantitative results" and automates calculations, which can reduce manual calculation errors, but an MRMC study demonstrating reader improvement is not detailed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Implied, but not explicitly detailed as a standalone study. The device itself is a software for quantitative analysis and display. The comparison mentioned ("studies obtained with... KHBS v1.1 were compared with the results obtained with Siemens nuclear medicine software (E.Soft)") seems to be a comparison of the software's outputs (quantitative results) against the outputs of a predicate software. This functions as a standalone performance check against a reference method, but it is not described as a formal 'standalone study' with specific metrics. The software is intended to be "operated only by qualified health care professionals," indicating a human-in-the-loop for interpretation and use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Reference standard was a predicate device's output. The "ground truth" or reference for comparison was the "results obtained with Siemens nuclear medicine software (E.Soft)." This is a comparison against an existing, legally marketed device's output, rather than an independent clinical ground truth like pathology or expert consensus on clinical outcomes.
8. The sample size for the training set
- Not applicable / Not provided. The document does not describe the development of a machine learning or AI model that would typically require a training set. KHBS is described as "an Off the Shelf nuclear hepatology software" that performs "quantitative analysis and display." The primary benefit highlighted is the automation of calculations that were previously manual.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As no training set for an AI/ML model is mentioned, this information is not relevant to the provided text.
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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 ComputerSystem | Siemens Medical Solutions USA, Inc | K903315B |
| ADAC Pegasys | Phillips Medical System | K892358 |
| Hawkeye Option | EL GEMS Ltd/GE Medical | K991841 |
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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.
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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.
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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 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
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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
§ 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).