Search Results

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.

• 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.

2. 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.
3. 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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons above.
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: Not applicable. This is for AI/ML diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an algorithm/AI device.
7. 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.
8. The sample size for the training set: Not applicable. There is no AI/ML model or "training set" for this device.
9. 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.

Ask a specific question about this device

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.

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.

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.

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.

Ask a specific question about this device