CERETOM, MODEL NL3000

{0}------------------------------------------------ K051765 JUL 1 4 2005 NeuroLogica # 510(k) SUMMARY For NeuroLogica Corporation NL3000 CereTom™ Computed Tomography System This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h) | (1) | Submitter: | NeuroLogica Corporation | |-----|------------|-------------------------| | | | 14 Electronics Avenue | | | | Danvers, Ma, 01923 | Establishment Registration number: Not yet applied for Contact person: Brahim Hadri Manager for Regulatory Affairs and Quality Systems Telephone 978-564-8520 FAX 978-564-8677 e-mail: bhadri@neuro-logica.com ## Date this summary was prepared: June 1, 2005 #### (2) Device Name: Proprietary or Trade Name: CereTom Device Model: NL3000 Classification Name: Computed Tomography X-ray System Product code: 90JAK Device classification: Class II Regulation number: 21 CFR 892.1750 NeuroLogica Corporation NL3000 CereTom Computed Tomography System 510(k) Summary {1}------------------------------------------------ ### (3) Predicate device: The legally marketed devices to which substantial equivalencies are being claimed are as follows: - Philips Tomoscan M/EG CT. This predicate device was cleared under pre-. market Notification K964890. - . GE LightSpeed Ultra CT. This predicate device was cleared under premarket Notification K000300 - Siemens SOMATOM Plus 4 with sliding Gantry Option. This predicate . device was cleared under pre-market Notification K991600 #### (4) Device Description: The NL3000 CereTom is a high resolution, 8 row, 32 cm bore, 25cm field of view, Computed Tomography System. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, 3264-element solid state detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, touch screen LCD display, power system, brushless DC servo drive system (disk rotation), and stepper drive system (translation). The power system consists of dry sealed batteries which provide system power while unplugged from the charging outlet. When plugged into an outlet the system charges the batteries with a line power drain of less than 1300 watts. The work station consists of a Sony Vaio laptop computer. The workstation software consists primarily of a certified off-the-shelf CT viewing system from a third party vendor. In addition the system has the necessary safety features such as emergency stop switch, x-ray indicators, interlocks, patient alignment laser, and 110 percent x-ray timer. It requires very little x-ray power in comparison to large bore systems to obtain equivalent CT image quality. The gantry has retractable 100mm diameter rotating caster wheels so the system can be moved easily to different locations. #### (5) Intended Use: The NL3000 CereTom is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 25cm field of view, primarily head and neck. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "NeuroLogica" in a bold, sans-serif font. The "O" in Logica is stylized with a circle around it. The image has some noise and artifacts, possibly from scanning or compression. ## Comparison of Technological Characteristics with the predicate device: (6) NeuroLogica Corporation believes that the NL3000 Computed Tomography Noteriogrea Corporated use, is of comparable type in design, material, System, for tto meetidor and is substantially equivalent to the following cleared predicate devices: Philips Tomoscan M/EG (also named ANATOM 2009, ref: predicate dovices: 1 milling ref: K000300, and Siemens SOMATOM Plus4 with Translating Gantry option, ref: K991600 - Material: The CereTom uses similar material to the above listed o scanners such as solid state detectors, x-ray generator, slip ring, data acquisition ICs, rotational bearing, and motion control systems. It also uses batteries and wheels similar in material to the Tomoscan M/EG. - Design: The CereTom is similar in general design principle to all of o the above listed CT systems. Specifically it is similar to the 1) Lightspeed in multi-slice (8 Row) image quality, 2) Tomoscan M/EG and Somatom Plus 4 as to the translating gantry (patient stays still while the gantry translates), and 3) Tomoscan M/EG as to batteries and wheels. # 7) General Safety and Effectiveness Concerns: All components of the NL3000 CereTom system subject to Federal Diagnostic An component Performance Standard and applicable regulations of 21 CFR Part 1020.30 and 1020.33 are certified to meet those requirements. aller 1020.55 are certired to the Part 1002.10 with the Center for Device and Radiological Health (CDRH). and Radiological Heath (ODTC1). To minimize electrical, mechanical and radiation hazards, Neurologica adheres to recognized and established industry practices. The NL3000 CereTom system is designed to meet UL60601-1, IEC 60601-1 and EN 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety. {3}------------------------------------------------ NeuroLogica ## 8) Conclusion Based upon the above considerations, NeuroLogica Corporation believes that the NL3000 CereTom Computed Tomography System is of comparable type in design, material, functionality, technology and is, for its intended use, substantially equivalent to the following cleared predicate devices: Philips Tomoscan M/EG (also named ANATOM 2000, ref: K964890), GE LightSpeed Ultra, ref: K000300, and Siemens SOMATOM Plus4 with Translating Gantry option, ref: K991600. A product report, according to 21 CFR 1002.10, will be submitted to the FDA prior to first delivery of the NL3000 CereTom. Use of the NL3000 CereTom does not result in any new potential safety risks. The equipment performs as well in its intended use as devices currently on the market. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NeuroLogica Corporation % Mr. Neil E. Devine, Jr. Responsible Third Party Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719 Re: K051765 Trade/Device Name: NL3000 CereTom Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 29, 2005 Received: June 30, 2005 Dear Mr. Devine: 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 (Premarket Approval), it may be subject to such 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. JUL 1 4 2005 {5}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will anow you to ocgin hancellig your antial equivalence of your device to a legally premarket notification. The PDA Intentig of Sacolantial of Prour 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 If you desire spectic advice for your device of our laboring regional ( 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation childer, frinscrange your responsibilities under the Act from the 807.97). You may obtain other general missistance at its toll-free number (800) Division of 201) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, 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}------------------------------------------------ NeuroLogica Corporation NeuroEogica Corporation NL3000 CereTom Computed Tomography System 510(k) Submission Section C # Indications for Use | 510(k) Number (if known): | <span style="text-decoration: line-through;">Not known</span> K051765 | |---------------------------|-----------------------------------------------------------------------| |---------------------------|-----------------------------------------------------------------------| .............................................................................................................................................................................. NL3000 CereTom___ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: The NL3000 CereTom is intended to be used for x-ray computed tomography . In the comment in the counted in the 25em field of view, primar The NL3000 Cerel om is meended to be used for x Tay other in the may of the may be and and neck. X Prescription Use (Part 21 CFR 801 Subpart D AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ) THE CONTINUE BELOW TENFEDED IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy C Brogdon (Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number Page *1* of *1*