(263 days)
No
The description focuses on the electronic control of voltage pulses and automatic sensing/display functions, which are typical of software-controlled medical devices but do not indicate the use of AI or ML for tasks like image analysis, predictive modeling, or adaptive control based on complex data patterns. The "Automatically compares the pulses delivered" function is likely a simple comparison against predefined thresholds, not an AI/ML algorithm.
Yes
The device is designed to fragment renal calculi (kidney and bladder stones), which is a medical intervention intended to treat a condition.
No
Explanation: The device is described as an extracorporeal lithotripsy system used for the fragmentation of renal calculi, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines hardware components including a generator unit, probes, and cables, in addition to software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "fragmentation of renal calculi located in the kidneys and urinary bladder." This is a therapeutic procedure performed on the patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device description details a system that generates shock waves to break up stones inside the body. This is a physical intervention, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to physically break up stones within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FFK
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.
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.
The AUTOLITH® URO-TOUCH System includes the following major components:
AUTOLITH® URO-TOUCH Unit/Generator (K130368)
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
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 compares the pulses delivered at the selected
power levels and displays when to INSPECT or REPLACE
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
is used with a transurethral scope for fragmentation of calculi in
the kidneys and urinary bladder.
The 9 Fr Probe, 54 cm long, was previously cleared by K914516
on January 7, 1992. The Extender Cable was cleared by K914517
on June 30, 1992.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidneys and urinary bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Both Design Verification and Design Validation have been completed. These documents can be found in Volumes 018 and 021.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
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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.
1
Page 2
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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
1591 Scottsdale Court
Elgin, Illinois 60123
Telephone: 224-856-2222
Fax: 847-608-9405 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Todd Gatto
Director of Quality and Regulatory
Telephone: 224-856-2250
Fax: 847-608-9405
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
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®
URO-TOUCH 9 Fr Probe in order to update compliance
to the most current standards for biological safety. The
materials are being updated to comply with the ISO
10993-1:2009, "Biological Evaluation of Medical Devices
Part 1: Evaluation and Testing", and associated standards. The
Predicate devices were classified as USP Class IV, but did not
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:
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.
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.
The AUTOLITH® URO-TOUCH System includes the following major components:
AUTOLITH® URO-TOUCH Unit/Generator (K130368)
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
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 compares the pulses delivered at the selected
power levels and displays when to INSPECT or REPLACE
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
is used with a transurethral scope for fragmentation of calculi in
the kidneys and urinary bladder. | |
| The 9 Fr Probe, 54 cm long, was previously cleared by K914516
on January 7, 1992. The Extender Cable was cleared by K914517
on June 30, 1992. | |
| Intended Use: | The "Intended Use" for the AUTOLITH® URO-TOUCH 9 Fr
Probe shall be "Fragmentation of calculi". |
| Indications for Use: | 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. |
| Materials: | All materials used to manufacture the Northgate Technologies
Inc. AUTOLITH® URO-TOUCH 9 Fr Probe, catalog number
9-203-0543, are not toxic and have been previously used to
manufacture other medical devices. |
| Probe Materials: | Brass
Copper |
4
5
6
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
name and 510(k)
number | AUTOLITH® URO-
TOUCH 9 Fr Probe | Primary
Predicate
AUTOLITH®
URO-Touch 9 Fr
Probe (K130368) |
|------------------------------------------------|-------------------------------------|------------------------------------------------------------------------|
| Feature Compared | | |
| Common/usual
Name | Lithotripter, Electro-
Hydraulic | Lithotripter, Electro-
Hydraulic |
| Model Number | 9-203-0543 | 9-203-0543 (72-
00198-0) |
7
| Trade/proprietary
name and 510(k)
number | AUTOLITH® URO-
TOUCH 9 Fr Probe | Primary
Predicate
AUTOLITH®
URO-Touch 9 Fr
Probe (K130368) |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature Compared | | |
| Intended Use | Fragmentation of
calculi | Fragmentation of
calculi |
| Indication for use | 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. | The AUTOLITH®
URO-TOUCH unit
is designed to be
used with Northgate
Technologies Inc.
bipolar disposable
EHL probes for the
fragmentation of
renal calculi (located
in the kidneys,
ureters and urinary
bladder). |
| Diameter | 9 French (3mm) | 9 French (3mm) |
| Length | 54 cm | 54 cm |
| Materials – Tip | Brass | Brass |
| Materials - Outer
Sheath | INSULTAB 3/32"
714 HS WHITE | Alpha FIT-221-
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
8
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.