(263 days)
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 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.
The provided document is an FDA 510(k) clearance letter for the Northgate Technologies Inc. AUTOLITH® URO-TOUCH 9 Fr Probe. This type of document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing extensive details about the performance of the device or a clinical study proving its effectiveness through specific acceptance criteria.
The submission is for a design change to the device, specifically updating materials to comply with ISO 10993-1:2009 for biological safety. The document does not describe a study to prove the device meets acceptance criteria related to its clinical effectiveness or diagnostic performance (like an AI/ML device would). Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device clearance and the information provided in this document.
However, I can extract the information that is present and explain why other information is absent based on the nature of this submission.
Device: Northgate Technologies Inc. AUTOLITH® URO-TOUCH 9 Fr Probe
Type of Submission: 510(k) Premarket Notification for a design change (material update for biological safety compliance). This is not an AI/ML device.
Acceptance Criteria and Reported Device Performance (as inferred from the document for a materials update)
Since this document is primarily about a material update for a medical device (Electro-Hydraulic Lithotriptor Probe) to comply with biological safety standards, the "acceptance criteria" and "reported device performance" are centered around the biocompatibility and functional equivalence tests, not clinical efficacy or diagnostic accuracy.
| Acceptance Criteria Category | Specific Criteria (Inferred from Document) | Reported Device Performance (Proof in Document) |
|---|---|---|
| Material Biocompatibility | Compliance with ISO 10993-1:2009 for biological evaluation of medical devices. | "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." (Page 6) |
| Functional Equivalence | The updated probe must maintain the same intended use, indications for use, and physical characteristics (diameter, length, tip material) as the predicate device, and deliver comparable power output. | - Intended Use & Indications for Use: "Fragmentation of cacti" (Intended Use) and "fragmentation of renal calculi located in the kidneys and urinary bladder" (Indications for Use) are substantially equivalent to the predicate, with a restriction on use in ureters for safety (Page 7, 8). - Physical Characteristics: Diameter (9 French), Length (54 cm), Tip Material (Brass) are identical to the predicate (Page 7). - Power Output: "Power output is discussed further in the Bench Testing section." (Page 7) - While not detailed, the implication in a 510(k) is that it's shown to be functionally equivalent for its purpose. |
| Risk Assessment | New materials must not introduce new questions of safety or efficacy. | The risk assessment led to the removal of ureter indication due to risk of injury with the 9 Fr probe's power output (4000 PSI) (Page 8). This indicates a proactive risk mitigation. The conclusion states: "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." (Page 8) |
Information Not Applicable or Not Found in the Provided Document:
The following information would typically be found in a submission for an AI/ML device or a device requiring a clinical efficacy study, but is not present or relevant for this specific 510(k) submission concerning a material update for an electro-hydraulic lithotripter probe.
- Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to material testing for biocompatibility and bench testing for functional equivalence, not a clinical data set. There's no clinical "test set" described for performance evaluation in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. This relates to expert adjudication of clinical data, which is not part of this submission type. Ground truth for biocompatibility and functional tests is established by standardized laboratory methods.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons above.
- 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: Not applicable. This is for AI/ML diagnostic devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an algorithm/AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. For material tests, ground truth is established by the specifications of the ISO standards and the results of the laboratory tests.
- The sample size for the training set: Not applicable. There is no AI/ML model or "training set" for this device.
- How the ground truth for the training set was established: Not applicable for the reasons above.
In summary, this 510(k) pertains to a change in materials for an existing device to meet biological safety standards. The "study" referenced would be the battery of biocompatibility tests performed according to ISO 10993 standards and a comparison to the predicate device through bench testing, not a clinical trial or AI/ML performance evaluation.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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.1591 Scottsdale CourtElgin, Illinois 60123Telephone: 224-856-2222Fax: 847-608-9405 |
|---|---|
| Contact Person: | Todd GattoDirector of Quality and RegulatoryTelephone: 224-856-2250Fax: 847-608-9405Email: 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-Hydraulic21 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 complianceto the most current standards for biological safety. Thematerials are being updated to comply with the ISO10993-1:2009, "Biological Evaluation of Medical DevicesPart 1: Evaluation and Testing", and associated standards. ThePredicate devices were classified as USP Class IV, but did notconform 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 pulsesaccording to the probe type. | |
| · Automatically scale power range according to the probe type. | |
| · Prohibit discharge of high voltage when the footswitch isactivated if an extender cable/probe is not properly connected. | |
| · Automatically compares the pulses delivered at the selectedpower levels and displays when to INSPECT or REPLACEPROBE. | |
| · 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 andis used with a transurethral scope for fragmentation of calculi inthe kidneys and urinary bladder. | |
| The 9 Fr Probe, 54 cm long, was previously cleared by K914516on January 7, 1992. The Extender Cable was cleared by K914517on June 30, 1992. | |
| Intended Use: | The "Intended Use" for the AUTOLITH® URO-TOUCH 9 FrProbe shall be "Fragmentation of calculi". |
| Indications for Use: | The Northgate Technologies Inc. AUTOLITH® URO-TOUCH 9 Fr Probe, bipolar disposable EHL is designed to beused with the Northgate Technologies Inc. AUTOLITH®URO-TOUCH unit/generator for the fragmentation of renalcalculi located in the kidneys and urinary bladder. |
| Materials: | All materials used to manufacture the Northgate TechnologiesInc. AUTOLITH® URO-TOUCH 9 Fr Probe, catalog number9-203-0543, are not toxic and have been previously used tomanufacture other medical devices. |
| Probe Materials: | BrassCopper |
{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/proprietaryname and 510(k)number | AUTOLITH® URO-TOUCH 9 Fr Probe | PrimaryPredicateAUTOLITH®URO-Touch 9 FrProbe (K130368) |
|---|---|---|
| Feature Compared | ||
| Common/usualName | Lithotripter, Electro-Hydraulic | Lithotripter, Electro-Hydraulic |
| Model Number | 9-203-0543 | 9-203-0543 (72-00198-0) |
{7}------------------------------------------------
| Trade/proprietaryname and 510(k)number | AUTOLITH® URO-TOUCH 9 Fr Probe | PrimaryPredicateAUTOLITH®URO-Touch 9 FrProbe (K130368) |
|---|---|---|
| Feature Compared | ||
| Intended Use | Fragmentation ofcalculi | Fragmentation ofcalculi |
| Indication for use | The NorthgateTechnologies Inc.AUTOLITH® URO-TOUCH 9 FrProbe, bipolardisposable EHL isdesigned to be usedwith the NorthgateTechnologies Inc.AUTOLITH URO-TOUCHunit/generator for thefragmentation ofrenal calculi locatedin the kidneys andurinary bladder. | The AUTOLITH®URO-TOUCH unitis designed to beused with NorthgateTechnologies Inc.bipolar disposableEHL probes for thefragmentation ofrenal calculi (locatedin the kidneys,ureters and urinarybladder). |
| Diameter | 9 French (3mm) | 9 French (3mm) |
| Length | 54 cm | 54 cm |
| Materials – Tip | Brass | Brass |
| Materials - OuterSheath | 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.
§ 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.”