URO-TOUCH 9 French Probe
Device Facts
| Record ID | K202813 |
|---|---|
| Device Name | URO-TOUCH 9 French Probe |
| Applicant | Northgate Technologies, Inc. |
| Product Code | FFK · Gastroenterology, Urology |
| Decision Date | Jun 14, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4480 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The "Intended Use" for the AUTOLITH® URO-TOUCH 9 Fr Probe shall be "Fragmentation of calculi".
Device Story
The AUTOLITH® URO-TOUCH 9 Fr Probe is a bipolar disposable electro-hydraulic lithotripter (EHL) probe used with the AUTOLITH® URO-TOUCH generator. The system functions by delivering high-voltage pulses through the probe tip into 0.9% physiological saline, creating high-amplitude hydraulic shock waves that fragment renal calculi. The device is used by clinicians in a clinical setting to reduce stone size for non-surgical removal. The generator automatically senses the probe, presets power/pulse values, monitors pulse delivery, and prohibits discharge if the probe is improperly connected. The probe is 54 cm long and designed for use with a transurethral scope. The current design update focuses on material compliance with ISO 10993-1:2009 standards for biological safety, replacing previous materials with ISO-compliant alternatives including PEEK, to mitigate risks associated with material degradation during use. The device is contraindicated for use in the ureters due to potential risks of stricture or perforation.
Clinical Evidence
Bench testing only. Design verification and validation were completed to confirm performance and material safety. Materials were tested for cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, and hemocompatibility per ISO 10993-1.
Technological Characteristics
Bipolar disposable EHL probe, 9 French (3mm) diameter, 54 cm length. Materials include Brass, Copper, Kynar, Nylon, Polyimide, Acrylated Olefin, Epoxy, and PEEK. Compliant with ISO 10993-1:2009. Energy source: high-voltage electrical pulses from the AUTOLITH® URO-TOUCH generator. Connectivity: plug-in probe sensing.
Indications for Use
Indicated for the fragmentation of renal calculi located in the kidneys and urinary bladder using the Northgate Technologies Inc. AUTOLITH® URO-TOUCH unit/generator.
Regulatory Classification
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.
Special Controls
The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”
Predicate Devices
- AUTOLITH® URO-Touch 9 Fr Probe (K130368)
Reference Devices
Submission Summary (Full Text)
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June 7, 2021
Northgate Technologies, Inc. Todd Gatto Director of Quality Assurance and Regulatory Affairs 1591 Scottsdale Court Elgin, IL 60123
Re: K202813
> Trade/Device Name: AUTOLITH® URO-TOUCH 9 Fr Probe Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electro-Hydraulic Lithotriptor Regulatory Class: II Product Code: FFK Dated: May 11, 2021 Received: May 14, 2021
Dear Todd Gatto:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for https://www.fda.gov/combination-products/guidance-regulatorycombination products (see information/postmarketing-safety-reporting-combination-products); manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH and Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino -S
Mark J. Antonino, M.S. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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#### Indications for Use
510(k) Number (if known) K202813
Device Name AUTOLITH® URO-TOUCH 9 Fr Probe
Indications for Use (Describe)
The Northgate Technologies Inc. AUTOLITH®URO-TOUCH 9 Fr Probe, bipolar disposable EHL is designed to be used with the Northgate Technologies Inc. AUTOLITH®URO-TOUCH unit/generator for the fragmentation of renal calculi located in the kidneys and urinary bladder.
Type of Use (Select one or both, as applicable)
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> |
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| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> |
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Image /page/3/Picture/0 description: The image contains the logo for Northgate Technologies, Inc. The logo features the letters "NTI" in a bold, sans-serif font, with a curved line above the letters that ends in a teal circle. Below the letters, the full name of the company, "Northgate Technologies, Inc.," is written in a smaller, sans-serif font.
1591 Scottsdale Court Elgin, IL 60123 847.608.8900 Main 847.608.9405 Fax www.ntisurgical.com
> K202813 Page 1 of 6
### 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: | Todd Gatto<br>Director of Quality and Regulatory<br>Telephone: 224-856-2250<br>Fax: 847-608-9405<br>Email: tgatto@ntisurgical.com |
| Preparation Date: | June 7, 2021 |
| Registration #: | 1450997 |
| Trade Name: | AUTOLITH® URO-TOUCH 9 Fr Probe |
| Common / Usual Name: | Lithotripter, Electro-Hydraulic |
| Classification Name: | Lithotripter, Electro-Hydraulic<br>21 C.F.R. 876.4480 |
| Regulatory Class: | II |
| Product Code(s): | FFK |
| Rationale For Change: | Northgate is submitting this design change to the AUTOLITH®<br>URO-TOUCH 9 Fr Probe in order to update compliance<br>to the most current standards for biological safety. The<br>materials are being updated to comply with the ISO<br>10993-1:2009, "Biological Evaluation of Medical Devices<br>Part 1: Evaluation and Testing", and associated standards. The<br>Predicate devices were classified as USP Class IV, but did not<br>conform to the ISO 10993-1:2009 requirements. |
| Predicate Devices: | Northgate Technologies Inc. AUTOLITH® URO-TOUCH 9 Fr Probe is the same as the current 9 Fr Probe with the exception of materials used to manufacture the probe, which are ISO 10993 compliant. The “Predicate Devices” are listed below:<br>A) Product – Autolith Touch; Uro Touch, For Biliary and Renal Procedures, K130368; Clearance November 15, 2013 (Primary) |
| Device Description: | The Northgate Technologies Inc. AUTOLITH® URO-TOUCH 9 Fr Probe, bipolar disposable EHL is designed to be used with the Northgate Technologies Inc. AUTOLITH® URO-TOUCH unit/generator for the fragmentation of calculi located in the kidneys and urinary bladder.<br><br>The Northgate Technologies Inc. AUTOLITH® URO-TOUCH System consists of a software controlled, electronic unit (Generator) which generates a single high-voltage pulse or a series of pulses across the tip of a flexible bipolar lithotripter probe. When discharged in 0.9% normal physiological saline solution, these pulses produce sharp, high-amplitude hydraulic shock waves that crack calculi (stones) located inside the body. They are capable of cracking calculi of virtually any size and composition. The objective is to reduce the size of the calculi so that fragments can be removed without major surgery.<br><br>The AUTOLITH® URO-TOUCH System includes the following major components:<br>AUTOLITH® URO-TOUCH Unit/Generator (K130368)<br>Regulate the discharge voltage and repetition rate of a shot 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<br>according to the probe type. | |
| · Automatically scale power range according to the probe type. | |
| · Prohibit discharge of high voltage when the footswitch is<br>activated if an extender cable/probe is not properly connected. | |
| · Automatically compares the pulses delivered at the selected<br>power levels and displays when to INSPECT or REPLACE<br>PROBE. | |
| · Displays the number of pulses delivered. | |
| · Automatic AC Voltage Adjust. For use in all countries. | |
| The AUTOLITH® URO-TOUCH 9 Fr Probe is 54 cm long and<br>is used with a transurethral scope for fragmentation of calculi in<br>the kidneys and urinary bladder. | |
| The 9 Fr Probe, 54 cm long, was previously cleared by K914516<br>on January 7, 1992. The Extender Cable was cleared by K914517<br>on June 30, 1992. | |
| Intended Use: | The "Intended Use" for the AUTOLITH® URO-TOUCH 9 Fr<br>Probe shall be "Fragmentation of calculi". |
| Indications for Use: | The Northgate Technologies Inc. AUTOLITH® URO-<br>TOUCH 9 Fr Probe, bipolar disposable EHL is designed to be<br>used with the Northgate Technologies Inc. AUTOLITH®<br>URO-TOUCH unit/generator for the fragmentation of renal<br>calculi located in the kidneys and urinary bladder. |
| Materials: | All materials used to manufacture the Northgate Technologies<br>Inc. AUTOLITH® URO-TOUCH 9 Fr Probe, catalog number<br>9-203-0543, are not toxic and have been previously used to<br>manufacture other medical devices. |
| Probe Materials: | Brass<br>Copper |
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Kynar Nylon Polymide Acrylated Olefin Epoxy Polyetheretherketone (PEEK) These materials have been tested and have passed the requirements of the ISO 10993-1 Standard. Listed below are the specific tests. Cytotoxicity Sensitization Irritation or Intracutaneous Reactivity Acute Systemic Toxicity Test Hemocompatibility Latex-Free DEHP Free Both Design Verification and Design Validation have been Performance Data: completed. These documents can be found in Volumes 018 and 021.
Feature Comparison: A URO-TOUCH 9 French Probe Feature Comparison follows.
| Trade/proprietary<br>name and 510(k)<br>number | AUTOLITH® URO-<br>TOUCH 9 Fr Probe | Primary<br>Predicate<br>AUTOLITH®<br>URO-Touch 9 Fr<br>Probe (K130368) |
|------------------------------------------------|-------------------------------------|------------------------------------------------------------------------|
| Feature Compared | | |
| Common/usual<br>Name | Lithotripter, Electro-<br>Hydraulic | Lithotripter, Electro-<br>Hydraulic |
| Model Number | 9-203-0543 | 9-203-0543 (72-<br>00198-0) |
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| Trade/proprietary<br>name and 510(k)<br>number | AUTOLITH® URO-<br>TOUCH 9 Fr Probe | Primary<br>Predicate<br>AUTOLITH®<br>URO-Touch 9 Fr<br>Probe (K130368) |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature Compared | | |
| Intended Use | Fragmentation of<br>calculi | Fragmentation of<br>calculi |
| Indication for use | The Northgate<br>Technologies Inc.<br>AUTOLITH® URO-<br>TOUCH 9 Fr<br>Probe, bipolar<br>disposable EHL is<br>designed to be used<br>with the Northgate<br>Technologies Inc.<br>AUTOLITH URO-<br>TOUCH<br>unit/generator for the<br>fragmentation of<br>renal calculi located<br>in the kidneys and<br>urinary bladder. | The AUTOLITH®<br>URO-TOUCH unit<br>is designed to be<br>used with Northgate<br>Technologies Inc.<br>bipolar disposable<br>EHL probes for the<br>fragmentation of<br>renal calculi (located<br>in the kidneys,<br>ureters and urinary<br>bladder). |
| Diameter | 9 French (3mm) | 9 French (3mm) |
| Length | 54 cm | 54 cm |
| Materials – Tip | Brass | Brass |
| Materials - Outer<br>Sheath | INSULTAB 3/32"<br>714 HS WHITE | Alpha FIT-221-<br>3/32" |
Note: There are no feature differences with the exception of an updated Materials for ISO 10993 Compliance. Power output is discussed further in the Bench Testing section.
The minor differences in Indications for Use between the subject Differences: device and the predicate is (1) the re-structure of the Indications statement for the subject device to be specific to the 9 French Probe in its use with the AUTOLITH URO-TOUCH generator, whereas the Indications for the predicate include the use of the
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URO-TOUCH generator with AUTOLITH Northgate Technologies' bipolar disposable EHL probes more generally, and (2) the removal for use of the device in the ureters. The Northgate risk assessment suggests that the power output (4000 PSI) of the 9 French Probe poses a risk of injury (stricture or perforation) to the patient if used in the ureters and therefore it has been removed from the Indications. The Indications for Use for the subject device are therefore more restricted than the Indications of the predicate device.
The most significant difference and primary subject of this 510(k), was the change of the patient contacting material, the outer sheath material, 32-00324-0 Tubing, HS White 3/32" used on the predicate to the 32-00583-0 Tubing HS 3/32" White used in the subject device.
This type of heat shrink was also contained within the tip of the device (Part Number 32-00323-0, claimed as non-patient contacting for the predicates). Northgate changed this component to a material confirmed to be ISO 10993-compliant and updated the material to potential patient contacting due to the normal use degradation of the center conductor over the normal life of the probe. This part was replaced with the 32-00578-0 Tubing, PEEK .02" X .062" X 1".
The different technological characteristics and information Conclusion: 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.
