The AUTOLITH® TOUCH unit is designed to be 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. 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.

AI/ML Overview

The provided text describes a 510(k) summary for the AUTOLITH® TOUCH / AUTOLITH® URO-TOUCH lithotripters, stating their substantial equivalence to a predicate device. However, the document does not contain specific acceptance criteria, performance metrics, or details of a study proving the device meets acceptance criteria in the way typically expected for an AI/ML medical device submission.

This document is for a medical device (lithotripter) that is not an AI/ML device, but rather a hardware device with software controls and slight modifications from its predecessor. Therefore, the questions related to AI/ML specific studies (like sample size for test/training sets, ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this submission.

The "Performance Data" section briefly mentions "Both Design Verification and Design Validation have been completed" and that "Non-clinical bench tests have been performed to prove substantial equivalence in the overall performance characteristics of the device."

Here's an attempt to extract the relevant information based on the provided text, while acknowledging the limitations for AI/ML-specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific quantifiable performance acceptance criteria for a novel AI/ML algorithm. The core acceptance criterion for substantial equivalence in this context is that the new device produces the same pressure wave output as the current device.

Acceptance Criteria (Implied)	Reported Device Performance
Production of the same pressure wave output as the predicate device	"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." The design goal was to produce a modern, simpler, and more reliable version of the current device while ensuring it "produces the same pressure wave output as the current AUTOLITH® device." "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."
Biological Safety	Materials used are "not toxic and have been previously used to manufacture other medical devices." Tests include: Cytotoxicity, Sensitization (Kligman Maximization), Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity Test, Pyrogenicity, Latex, DEHP, all passing ISO 10993-1 requirements.
Electrical and Functional Safety	The device functions as intended with features such as regulating discharge voltage, displaying power and pulse count, automatically sensing probes, preset start-up values, prohibiting discharge without proper connection, and displaying when to replace probes. The "Modifications have no impact on the application or efficacy of the accessories."

Study Details:

The study referenced is the "Comparison testing" mentioned in the "Substantial Equivalence" section. This was a non-clinical bench test.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for the bench testing. The testing would likely involve multiple iterations or samples of the device and various probes to ensure consistent output.
Data Provenance: Not applicable as it's a non-clinical bench test of physical output characteristics, not human or clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a bench test comparing physical output characteristics (voltage waveform and pressure wave) to a predicate device. Ground truth is established by objective engineering measurements against the predicate device's known output, not expert human interpretation.

4. Adjudication method for the test set

Not Applicable. See point 3.

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. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an AI/ML device. While the device has software controls, its performance is measured by its physical output as a lithotripter, not an AI algorithm's diagnostic or predictive capabilities.

7. The type of ground truth used

Objective measurement against predicate device's output. The "ground truth" was the voltage waveform output and pressure wave output of the already cleared predicate AUTOLITH® device. The new system was designed to replicate this physical output.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning. The device was engineered to replicate the predicate's performance.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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510(k) Summary

Submitter:	Northgate Technologies Inc.1591 Scottsdale CourtElgin, Illinois 60123Telephone: 224-856-2222Fax: 847-608-9405
Contact Person:	Casey KurekRegulatory ManagerTelephone: 224-856-2222Fax: 847-608-9405Email: ckurek@northgate-tech.com
Preparation Date:	April 25, 2013
Registration #:	1450997
Trade Name:	AUTOLITH® TOUCH (9-202-00) /AUTOLITH® URO-TOUCH (9-203-00)LithotriptersNote: The AUTOLITH® TOUCH andAUTOLITH® URO-TOUCH are exactly the samedevices with just one exception, a software partitionthat allows the unit to read resistor values in thevarious bipolar disposable EHL probes offered.This software difference allows NorthgateTechnologies to isolate the devices to use specificprobes and thus market and sell the two separatelylabeled devices for separate specialties (Biliary andUrology). Historically, Northgate marketed a singleAUTOLITH® device (predicate device listed below)that was used in both Biliary and Urologicapplications. Although the new AUTOLITH®TOUCH and AUTOLITH® URO-TOUCH devicesare exactly the same, the ability to isolate Biliaryand Urologic EHL probes to the specifically labeledunits provides marketing flexibility for NorthgateTechnologies (pricing, targeted marketing, etc.) TheNOV 15 2013

Northgate Technologies Inc.

. *

1591 Scottsdale Court, Elgin, IL 60123 1-800-348-0424 IL: 847-608-8900

FAX: 847-608-9405

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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
ClassificationName:	Lithotripter, Electro-Hydraulic21 C.F.R. 876.4480
Regulatory Class:	II
Product Code(s):	78FFK
Predicate Devices:	Northgate Technologies Inc. AUTOLITH®TOUCH and AUTOLITH® URO-TOUCH unitsoperate identically, with the only difference beingthe intended probe lengths to be used with eachdevice (as described above in the Trade Namesection of this Summary). Both devices utilize thelegacy AUTOLITH® Lithotripter unit as apredicate. The only significant differences betweenthe new devices and the predicate AUTOLITH®relate to a revised user interface and more moderninternal electronic components allowing for asmaller and lighter-weight design. The predicatedevice is:
	Autolith® For Renal and Biliary Procedures,(K923822), approved, January 28, 1993.
Device Description:	The AUTOLITH® TOUCH unit is designed to beused with Northgate Technologies Inc. bipolardisposable EHL probes for the fragmentation ofbiliary calculi. The AUTOLITH® URO-TOUCHunit is designed to be used with NorthgateTechnologies Inc. bipolar disposable probes for thefragmentation of renal calculi.
	42

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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

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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

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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.

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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

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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:

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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

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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

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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

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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)

Center for Devices and Radlological Health / CDRH

17 -27

Regulation Number and Section

§ 876.4480 Electrohydraulic lithotriptor.

(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”