AUTOLITH TOUCH; URO TOUCH

{0}------------------------------------------------ : l . : ## 510(k) Summary | Submitter: | Northgate Technologies Inc.<br>1591 Scottsdale Court<br>Elgin, Illinois 60123<br>Telephone: 224-856-2222<br>Fax: 847-608-9405 | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Casey Kurek<br>Regulatory Manager<br>Telephone: 224-856-2222<br>Fax: 847-608-9405<br>Email: ckurek@northgate-tech.com | | Preparation Date: | April 25, 2013 | | Registration #: | 1450997 | | Trade Name: | AUTOLITH® TOUCH (9-202-00) /<br>AUTOLITH® URO-TOUCH (9-203-00)<br>Lithotripters<br>Note: The AUTOLITH® TOUCH and<br>AUTOLITH® URO-TOUCH are exactly the same<br>devices with just one exception, a software partition<br>that allows the unit to read resistor values in the<br>various bipolar disposable EHL probes offered.<br>This software difference allows Northgate<br>Technologies to isolate the devices to use specific<br>probes and thus market and sell the two separately<br>labeled devices for separate specialties (Biliary and<br>Urology). Historically, Northgate marketed a single<br>AUTOLITH® device (predicate device listed below)<br>that was used in both Biliary and Urologic<br>applications. Although the new AUTOLITH®<br>TOUCH and AUTOLITH® URO-TOUCH devices<br>are exactly the same, the ability to isolate Biliary<br>and Urologic EHL probes to the specifically labeled<br>units provides marketing flexibility for Northgate<br>Technologies (pricing, targeted marketing, etc.) The<br>NOV 15 2013 | Northgate Technologies Inc. . * : . 1591 Scottsdale Court, Elgin, IL 60123 1-800-348-0424 IL: 847-608-8900 FAX: 847-608-9405 {1}------------------------------------------------ 2 instructions for use and the Operator's Manual for both of the new devices are essentially the same, with the only differences being the product images, the indications for use (Biliary vs. Urology) and the accessory probes available (longer probes for Biliary applications and shorter probes for Urologic applications). | Common / Usual Name: | Lithotripter, Electro-Hydraulic | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification<br>Name: | Lithotripter, Electro-Hydraulic<br>21 C.F.R. 876.4480 | | Regulatory Class: | II | | Product Code(s): | 78FFK | | Predicate Devices: | Northgate Technologies Inc. AUTOLITH®<br>TOUCH and AUTOLITH® URO-TOUCH units<br>operate identically, with the only difference being<br>the intended probe lengths to be used with each<br>device (as described above in the Trade Name<br>section of this Summary). Both devices utilize the<br>legacy AUTOLITH® Lithotripter unit as a<br>predicate. The only significant differences between<br>the new devices and the predicate AUTOLITH®<br>relate to a revised user interface and more modern<br>internal electronic components allowing for a<br>smaller and lighter-weight design. The predicate<br>device is: | | | Autolith® For Renal and Biliary Procedures,<br>(K923822), approved, January 28, 1993. | | Device Description: | The AUTOLITH® TOUCH unit is designed to be<br>used with Northgate Technologies Inc. bipolar<br>disposable EHL probes for the fragmentation of<br>biliary calculi. The AUTOLITH® URO-TOUCH<br>unit is designed to be used with Northgate<br>Technologies Inc. bipolar disposable probes for the<br>fragmentation of renal calculi. | | | 4<br>2 | {2}------------------------------------------------ Both devices operate just like the legacy (predicate) AUTOLITH® device. The units are softwarecontrolled, electronic devices capable of cracking calculi of virtually any size and composition. The devices are table-top units that connect to a disposable probe that is used in the working channel of an endoscope. A surgeon places the tip of the probe near the surface of the calculus/stone under endoscopic visualization. The physician then steps on a pneumatic foot pedal to activate the device. The electronic circuitry of the device generates a single high-voltage pulse or a series of pulses across the tip of the disposable flexible bipolar lithotripter probe. The discharge (in 0.9% normal physiological saline) produces sharp, high-amplitude hydraulic shockwaves that help to fragment the calculus/stone so it can be passed or removed without major surgery. The AUTOLITH® TOUCH and AUTOLITH® URO-TOUCH systems include the following major components: - · Base unit - · Detachable Power Cord - · Pneumatic Footswitch - · Extender Cable to connect disposable probes to unit - · Four types of Disposable Bipolar EHL Probes: - o 250cm and 375cm 1.9Fr probes for AUTOLITH® TOUCH - o 120cm (1.9Fr) and 54cm (9.0Fr) probes for AUTOLITH® URO-TOUCH Note: All accessory items (Power Cord, Pneumatic Footswitch, Extender Cable and four Disposable Probes) are the same accessories that have historically been used with the predicate AUTOLITH® device. The only modifications to 3 {3}------------------------------------------------ accessories have been the elimination of the preattached ferrite core on the Extender Cable (although previously-sold Extender Cables with ferrite cores are also compatible with the new devices) and a minor modification to the Disposable Probes (change of the resistor value of the individual probe) so that the new devices can detect which type of probe is attached to the unit. These modifications have no impact on the application or efficacy of the accessories. The AUTOLITH® TOUCH and AUTOLITH® URO-TOUCH devices, just as the predicate AUTOLITH® device, will: - · Regulate the discharge voltage and repetition rate of a pulse delivered to a connected extender cable and probe. - · Display the relative power delivered to the probe. - · Display the number of pulses to be delivered to the probe as requested by the operator. - · Automatically sense the existence of a plugged-in probe. - · Automatically preset start-up values for power and pulses according to the probe type. - · Automatically scale power range according to the probe type. - · Prohibit discharge of high voltage when the footswitch is activated if an extender cable/probe is not properly connected. - · Automatically compare the pulses delivered at the selected power levels and display when to inspect or replace the probe. - · Display the number of pulses delivered. All accessories are cleared medical devices that may be used with this device. The 1.9fr 120cm Probe was cleared by K914514 on January 6, 1992, and the 9fr 54cm Probe was cleared by K914516 on January 7, 1992. The 1.9fr 250cm Probe was cleared by 4 - 4 র্বা {4}------------------------------------------------ 4 5 The new units have the same performance characteristics as the predicate device. The only significant modified technological characteristics of the new AUTOLITH® TOUCH and AUTOLITH® URO-TOUCH as compared to the predicate AUTOLITH® device include a revised user interface and more modern internal electronic components allowing for a smaller and lighterweight design. The "Intended Use" for the AUTOLITH® TOUCH Intended Use: and AUTOLITH® URO TOUCH as well as the legacy AUTOLITH® Electro-Hydraulic Lithotripters shall be "Fragmentation of Calculi." The AUTOLITH® TOUCH unit is designed to be Indications for Use: used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of biliary calculi. The AUTOLITH® URO-TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable probes for the fragmentation of renal calculi. All materials used to manufacture the Northgate Materials: Technologies Inc. AUTOLITH ® TOUCH, catalog number 9-202-00 (115 VAC /100 VAC/ 230 VAC), and AUTOLITH® URO-TOUCH, catalog number 9-203-00 (115 VAC / 100 VAC / 230 VAC) and probes are not toxic and have been previously used to manufacture other medical devices. Stainless Steel Probe Materials: Polymide Copper Kynar Nylon Polyolefin Epoxy K913955 on November 29, 1991. The Extender Cable was cleared by K914517 on June 30, 1992. {5}------------------------------------------------ These materials have been tested and have passed the requirements of the ISO 10993-1 Standard. Listed below are the specific tests. Cytotoxicity Sensitization (Kligman Maximization) Irritation or Intracutaneous Reactivity Acute Systemic Toxicity Test Pyrogenicity Latex DEHP Performance Data: Both Design Verification and Design Validation have been completed. The new units have the same performance Feature Comparison: characteristics as the predicate device. The only modified technological characteristics of the new AUTOLITH® TOUCH and AUTOLITH® URO-TOUCH as compared to the predicate AUTOLITH® device include the following: - New units include an easy-to-use color . touchscreen user interface, rather than the membrane switches and segmented digital displays from the predicate device. The new interface has also allowed for multi-language displays and selections. - New units utilize more modern electronic . components that have allowed for a smaller and lighter-weight platform. - Additionally, there are some very minor t t modifications that have been implemented to simplify use of the device: - 0 New units have a universal switching power supply; that of a type used on other cleared Northgate Technologies Inc. devices, that autoadjusts for various voltage requirements. The predicate device 6 4 6 {6}------------------------------------------------ had multiple part numbers for units that were intended for specific voltage requirements. - New units have simplified selection o of High/Medium/Low pulse power delivery, rather than power selection ranges from 10%-100% (in 10% increments) utilized by the predicate device - New units force the replacement of a o disposable probe when the 'Replace Probe' message appears, whereas the predicate device allowed continued usage of the probe. - New units have standardized the o frequency of the pulse firings to 30hz, whereas the predicate device allowed for some little used, user modification and customization of the frequency. - O New units allow for selectable (adjustable) and storable user preferences for start-up values of power and pulse settings. The different technological characteristics and information submitted to the FDA do not raise new questions of safety and efficacy and demonstrate that the device is at least as safe and effective as the legally marketed predicate device. Non-clinical bench tests have been performed to prove substantial equivalence in the overall performance characteristics of the device. Below is a summary of how this testing supports the claim of substantial equivalence: The main design requirement for the AUTOLITH® TOUCH / AUTOLITH® URO-TOUCH was to produce the same output as the current device. The design goal was to produce a modern, simpler, and more reliable version of the current device. To those Substantial Equivalence: 7 ಿ 7 {7}------------------------------------------------ 8 ﺘﺴ 4 8 ends, it was necessary to ensure the new device produces the same pressure wave output as the current AUTOLITH® device. The pressure wave output is completely dependent on the voltage waveform applied to the probe. By design, the 6kV output capacitor is the main contributor in determining the voltage waveform applied to the probe. The new device incorporates the same 6kV output capacitor as the current device and uses modern circuitry to produce the same voltage waveform for the probe. Comparison testing was performed to prove that the output of the Autolith Touch is, in fact, the same as the output of the current device. These tests compared both the voltage waveform output applied to the probe as well as the actual pressure wave output from the probe that will be applied to the target stone. ### Date Prepared: April 25, 2013 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, clutching a caduceus in its talons. The eagle is facing to the right. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002 November 15, 2013 Northgate Technologies, Inc. Casey Kurck Regulatory Manager 1591 Scottsdale Court Elgin, IL 60123 Re: K130368 > Trade/Device Name: AUTOLITH® TOUCH / AUTOLITH® URO-TOUCH Regulation Number: 21 CFR& 876.4480 Regulation Name: Electrohydraulic lithotriptor Regulatory Class: II Product Code: FFK Dated: September 20, 2013 Received: October 4, 2013 Dear Casey Kurek, · We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have decemined 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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); medical device reporting (reporting of {9}------------------------------------------------ Page 2 - Casey Kurek medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm | 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Herbert P. Lerner -S for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the FDA logo. The logo is in white and is set against a black background. The letters 'FDA' are stylized and connected. ## Food and Drug Administration CENTER FOR DEVICES AND RADIOLOGICAL HEALTH FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH ### Indications for Use 510(k) Number K130368: ## AUTOLITH ® TOUCH / AUTOLITH® URO-TOUCH Indications for Use: Device Name: The AUTOLITH® TOUCH unit is designed to be used with Northgate Technologies Inc. THE AUTOLITED TO Antiques of a freementation of biliery calculi. The AUTOLITE® The AUTOLITH® TOUCH unit is designer to tie used wiar realmigi. The AUTOLITED bipolar disposable EHL probes to the reagued with Northgate Technologies Inc. bipolar disposable URO-TOUCH unit is designed to the sales lealed colouli EHL probes for the fragmentation of renal calculi. Prescription Use X (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 OF AND THE BELOW THIS ATEDED) NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1_of _1 ## Herbert P. Lerner -S 2013.11.15 13:02:21 -05'00' (Posted November 13, 2003) CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaiment Page | CDRH | CDRH A-Z Index | Contact | Contect EDA | HHS Home Page CDRH Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page Center for Devices and Radlological Health / CDRH 17 -27