KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5

K071195 · Ani-Kal Ii, LLC · IYX · Jun 20, 2007 · Radiology

Device Facts

• Record ID: K071195
• Device Name: KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5
• Applicant: Ani-Kal Ii, LLC
• Product Code: IYX · Radiology
• Decision Date: Jun 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1100
• Device Class: Class 1
• Attributes: Software as a Medical Device

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.

Device Story

KHBS is off-the-shelf nuclear hepatology software for PC; processes planar DICOM image data from scintillation gamma cameras. Transforms raw image data into quantitative results for liver and gallbladder function; generates time-activity curves; displays images/curves/text in grayscale or color. Operated by qualified nuclear medicine professionals in clinical settings. Automates calculations (e.g., GBEF, T1/2, HPS, segmental liver function) previously performed manually. Clinicians use output to assess liver/gallbladder function; visual comparison between organ images and quantitative results allows verification of calculation accuracy. Benefits include reduced manual labor, improved efficiency, and decreased risk of calculation errors compared to manual methods.

Clinical Evidence

No clinical data. Bench testing only. Comparison of quantitative results performed against Siemens E.Soft system in-house. Risk analysis conducted to evaluate impact of calculation errors.

Technological Characteristics

Java-based software for PC; processes planar DICOM image data. Features automated deconvolutional analysis, HEF, T1/2, GBEF, GBEP, GBER, DGBR, segmental GBEF, lobar/segmental liver function, and HPS. Connectivity via network PC. No specific hardware materials or sterilization required as it is software-only.

Indications for Use

Indicated for quantitative analysis of liver and gallbladder function studies in patients undergoing scintillation gamma camera imaging. Intended for use by qualified healthcare professionals trained in nuclear medicine equipment.

Regulatory Classification

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.

Predicate Devices

• E.CAM/E.Soft (K992731)
• ICON Computer System (K903315B)
• ADAC Pegasys (K892358)
• Hawkeye Option (K991841)

Submission Summary (Full Text)

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K071195

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: [phone] or 503)681-1745, E-mail address GTK ristmataol.com

Submitter address: 7570 SW Westgate way Portland, OR 97225 Telephone [phone], Fax [phone].

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<br>System | 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.

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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 [phone] or [phone]

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)

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Concurrence of CDRB~ Office of Device Evaluation (ODE)

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