LODOX, MODEL BASELINE

{0}------------------------------------------------ # AUG 0 6 2002 Image /page/0/Picture/1 description: The image shows the logo for Lodox, a company specializing in diamond sharp imaging. The logo features the word "LODOX" in large, bold letters, with the tagline "DIAMOND SHARP IMAGING" underneath. The company's website address, "WWW.LODOX.COM," is displayed below the tagline. The logo is simple and professional, conveying the company's focus on high-quality imaging. KOI.3999 LODOX SYSTEMS (PTY) LTD P O Box 784055 Sandton South Africa 2146 Registration Number 2000/024615/07 +27 11 2693791 Tel: +27 11 2693792 Fax: E-mail: herman@lodox.com ### 510(K) SUMMARY [As required by 21CFR807.92] #### Date Prepared [21CFR807.92(a)(1)] 5.1 November, 2001 ### 5.2 Submitter's Information [21CFR807.92(a)(1)] | Company Name: | Centric Capital Ventures LLC (a<br>Delaware Limited Liability<br>Company) | |-----------------|---------------------------------------------------------------------------| | Establishment | | | Registration | | | Number: | 13-4104540 | | Street Address: | 177 East 79th Street, Suite 4 | | City: | New York | | State/Province: | New York, 10021 | | Country: | USA | | Telephone: | 212-439-0746 | | Facsimile: | 212-452-0756 | | Contact Person: | Bradley Sacks | | Contact Title: | Managing Partner | | Contact email: | bradsacks@earthlink.net | {1}------------------------------------------------ ### 5.3 Trade Name, Common Name, Classification [21CFR807.92(a)(2)] - Trade Name: Common Name: Classification Name: Device Class: Product Code: Lodox Digital Radiography System Solid State X-ray Imager (SSXI) Class II 90MQB #### Identification of Predicate Device(s) [21CFR807.92(a)(3)] 5.4 - Equivalency is based on the Elscint EXCEL 2000 ELITE CT system (K884671) and the Siemens Polydoros 80 system (K950883) and bucky (x-ray film holder) using conventional radiographic film (21CFR892.1840). #### Description of the Device [21CFR807.92(a)(4)] 5.5 Lodox is a whole-body x-ray scanner that produces x-ray images that can be used for diagnostic purposes. It is an optical-based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of a fluorescent screen optically coupled to a number of CCD cameras, which produce a digital image. The captured diagnostic image is stored in a database and is displayed on a highresolution, medical-quality monitor, where the diagnosis can be performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing. The imaging area can be set from 100 mm x 100 mm x 680 mm on a special purpose patient trolley. #### 5.6 Intended Use [21CFR807.92(a)(5)] Lodox is a digital x-ray imager intended as a replacement for x-ray film for general human radiography (excluding fluoroscopy, angiography, and mammography). It is specifically aimed at emergency room use. Lodox allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, and extremities. Radiographic exposures may be taken of a patient lying on the patient trolley in any angle from the Anterior-Posterior view to the lateral view, or with the patient in the standing or prone positions. {2}------------------------------------------------ #### Technological Characteristics [21CFR807.92(a)(6)] 5.7 | Feature | Lodox | Elscint<br>EXCEL<br>2000<br>ELITE CT<br>K884671 | Siemens<br>Polydoros<br>80<br>K950883 | Bucky with<br>Film /<br>Screen<br>892.1840 | |--------------------------------------------------------|---------------------------|-------------------------------------------------|---------------------------------------|--------------------------------------------| | 510(k)<br>Regulation | Pending | | | | | Intended Use | General Human Radiography | | | | | Fluorescent<br>screen to<br>convert x-rays<br>to light | Yes | Yes | No | Yes | | Whole body<br>radiograph | Yes | Yes 1 | | No | | Whole body<br>exposure 2 | 25 μGy | 80,5 μGy 1 | | - | | Chest<br>exposure 3 | 0,21 mGy | - | | 2,57 mGy | | CCD to<br>capture image | Yes | Yes | | No | | CCD Pixel<br>Size | 26 x 26 μm | Not Available | | - | | Half-Value<br>Layer | 4,35 mm | - | | 4,73 mm | | Signal-to-<br>Noise Ratio | 2,57 | - | | 2,16 | | Modulation<br>Transfer<br>Function 4 | 1,67 lp/mm 5 | - | | 2,34 lp/mm 4 | | Detective<br>Quantum<br>Efficiency | TBD 6 | - | | TBD 6 | | External<br>Connectivity | DICOM 3.0 | None | None | None | | Image Storage | Hard Drive | Hard Drive | | X-ray film | ### NOTE - 1. CT in scan mode. - 2._ Measured on bed with no patient present. - 3. An average taken of 10 chest x-ray cases. - - 4_ Measured on bed, along its width, at 3% contrast. 5_ In normal resolution mode (5 x 5 binning) and perpendicular to scan direction. - 6_Work Group (WG33) in IEC/SC62B is currently developing a new IEC standard for measurement of the DQE of digital x-ray imaging detectors. This is due to be published within the first quarter of 2002. Lodox DQE performance will be determined according to this standard once it is published. {3}------------------------------------------------ #### Non-clinical Testing [21CFR807.92 (b)(1)] 5.8 Lodox uses a fluorescent screen of the type used in film/screen radiography to convert xrays to light. A high-resolution, CCD-based, sensor captures this light. To verify the spatial resolution and determine its equivalence to film, tests were performed using line-pair resolution and high and low contrast targets. Resolution was found to substantially equivalent to the predicate. #### Clinical Testing [21CFR807.92 (b)(2)] 5.9 In an image quality study, 39 human subjects were x-rayed both conventionally and with Lodox. A range of anatomy was covered representative of general radiography. The results were examined by a panel of two radiologists and found substantially equivalent to film. ### 5.10 Conclusions [21CFR807.92 (b)(3)] Images taken using the digital technology of Lodox were substantially equivalent to images taken on the Elscint EXCEL 2000 ELITE CT system based on the following: - 1. Whole-body radiographs could be taken on both systems. Images taken using the digital technology of Lodox were substantially equivalent to standard film images based on the following: - 1. The results from studies showed that the digital images were comparable to film. - 2. Laboratory test results also supported the equivalence to standard film images shown in clinical studies. This clinical outcome supported the diagnostic imaging quality of the digital system as being equal to film/screen. It was concluded that Lodox is equivalent to the Elscint EXCEL 2000 ELITE CT system (K884671) and the Siemens Polydoros 80 system (K950883) and bucky (x-ray film holder) using conventional radiographic film (21CFR892.1840) based upon the following criteria: - Lodox has the same intended use as the predicate devices; and, ● - Lodox has radiographic performance equivalent to the predicate devices. . {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all connected by a single line that runs from the top of the top profile to the bottom of the bottom profile. The logo is surrounded by the words "DEPARTMENT OF HUMAN SERVICES - USA" in a circular pattern. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Lodox Systems (Pty) LTD % Mr. Bradley Sacks Managing Partner Centric Capital Ventures, LLC 177 East 79th Street, Suite 4 NEW YORK NY 10021 Re: K013999 AUG 0 6 2002 Trade/Device Name: Lodox Whole Body X-ray Scanner Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomographic x-ray system Regulatory Class: II Product Code: 90 JAK Dated: May 10, 2002 Received: May 13, 2002 Dear Mr. Sacks: 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. {5}------------------------------------------------ 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 vour 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 {6}------------------------------------------------ ## 4. SECTION D - STATEMENT OF INDICATIONS FOR USE | Applicant | Lodox Systems (Pty) LTD | |--------------------------|-------------------------| | 510(k) Number (if known) | N/A K013999 | | Device Name | Lodox X-ray Scanner | Indications for use: The Lodox whole-body x-ray scanner is mainly intended for use in trauma wards where multiple injuries can be medically diagnosed in a very short time. It can also be used for normal x-ray examinations as is currently practised with general-purpose single-shot x-ray machines. A full image area is 1800 mm by 680 mm, and can be reduced to any size down to 100 mm by 100 mm anywhere within the image area. Prescription Use Yorind A. higrom (Division Sign-Off) Division of Reproductive, Abdon and Radiological Device 510(k) Number