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NORTHGATE TECHNOLOGIES INC.

Panel

Gastroenterology/Urology

Reference & Predicate Devices

K914514,K914516,K913955,K914517,K923822

Intended Use

Device Description

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.

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K Number

K120151

Device Name

NEBULAE I

Manufacturer

Date Cleared

2012-08-17

(212 days)

Product Code

HIF,FCX,OSV

Regulation Number

Type

Panel

Reference & Predicate Devices

K983326,K022052,K063367

Intended Use

The Nebulae™ I 50 LPM Insufflator provides CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic, Minimally Invasive Vessel Harvesting.

Device Description

The Nebulae™ I 50 LPM Insufflator is microprocessor controlled. This CO2 (Carbon Dioxide) High Flow Insufflator has touch screen control and multiple operating modes. The System can be used for General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic, and Minimally Invasive Vessel Harvesting procedures.

AI/ML Overview

The Nebulae™ I 50 LPM Insufflator is a medical device designed to provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Device Flow Rates	Bench testing in simulated use environment for all operating modes confirmed device performed within specified flow rates.
Fill Time (Abdomen Simulator)	Bench testing in simulated use environment proved the Nebulae™ I could fill an abdomen simulator within the specified time period.
Flow Accuracy	Bench testing proved the Nebulae™ I could maintain specified flow accuracy for the flow rates in all modes, performing within the specified flow accuracy range.
Overpressure Relief	Bench testing proved the Nebulae™ I relieves overpressure conditions of 5mmHg above the preset and returns to the preset within the specified time range. Tested with different size abdominal simulators (to address all modes and sizes of pediatric patients) and at all specified flow rates, the device relieved pressure within the specified time. This also includes the functional requirement of "Relieves over pressure conditions of 5mmHg above the preset and returns to the preset in three (3) seconds or less."
Comparative Flow Rate (vs. Predicate)	The Nebulae™ I was tested along with predicate devices using an 11mm trocar with a 10mm laparoscope. Highest flow rates measured were 32 LPM. (Implies satisfactory comparative performance).
Pediatric Mode Comparative Testing	Tested along with predicate device in pediatric mode (various weight modes, with Veress needle and trocar, appropriate simulated abdomen sizes). Response times to introduced/removed leaks and over/under pressure conditions were measured. Nebulae™ I performed as well as, or better than, the predicate device.
Tissue Desiccation Effect	Cross-comparison test with 40L Abdominal Insufflator at maximum flow rates (5mm trocar, 5mm laparoscopic instrument, moist bovine liver, 30 and 60-second exposures). Results showed negligible change to tissue surface and no perceivable depth of desiccation. Concluded that 50LPM and 40LPM insufflators were identical relative to tissue desiccation and drying.
Electrical Safety (IEC 60601-1:2005)	Device shown to conform to standard.
EMC (EN 60601-1-2:2007)	Device shown to conform to standard.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample sizes for each test (e.g., number of units tested, number of simulated abdomens, number of tissue samples). The testing appears to be solely bench testing in a simulated use environment; therefore, the data provenance is not from human subjects/patients, but rather from laboratory/bench testing, typically conducted in the country of manufacture (implied to be the USA, based on the applicant's address). The studies are prospective in nature, as they were conducted to evaluate the performance of the newly developed device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. The described studies are purely bench testing and do not involve human interpretation or subjective assessment of results by experts in a clinical context to establish ground truth. Performance was measured objectively against pre-defined specifications or through comparative measurements with predicate devices.

4. Adjudication Method for the Test Set

Not Applicable. As there are no human experts establishing ground truth or making subjective assessments requiring agreement, no adjudication method was used. The performance was determined by direct measurement and comparison with objective criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a hardware insufflator and does not involve human readers interpreting images or data where AI assistance would be relevant.

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

Yes. All reported performance testing was conducted as standalone bench testing, evaluating the algorithm's control of the device's mechanical and gas delivery functions without human intervention in the device's operational performance measurements. The "algorithm" in this context refers to the device's internal microprocessor control logic.

7. The Type of Ground Truth Used

The ground truth used for these studies consisted of:

Pre-defined engineering specifications/performance ranges: For criteria like flow rates, fill time, flow accuracy, and overpressure relief.
Objective measurements: Direct quantitative measurements obtained during bench testing.
Comparative performance against predicate devices: Performance of the Nebulae™ I was measured and directly compared to the performance of legally marketed predicate devices under similar conditions. This established an "equivalency ground truth" for certain aspects.
Standard conformity: Adherence to recognized electrical safety (IEC 60601-1:2005) and EMC (EN 60601-1-2:2007) standards.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware medical device, and the submission describes verification and validation testing for a solidified design, not the iterative training of a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML development. The design, however, would have undergone extensive internal development and testing during its engineering phase, which could be considered analogous to "training" in a broad sense, but specific data sets for algorithm training are not relevant here.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As explained above, there is no "training set" in the AI/ML context for this device. The underlying engineering principles and design parameters were established through conventional medical device design and development practices.

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K Number

K041560

Device Name

FLO-ASSISTANT

Manufacturer

Date Cleared

2004-09-28

(110 days)

Product Code

Regulation Number

Type

Panel

MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215

Reference & Predicate Devices

N/A

Intended Use

The Nortech Flo-Assistant™ Product is indicated to provide a squeezing mechanism to a tubing set, providing increased capacity fluid irrigation for arthroscopic procedures.

Device Description

The Flo-Assistant™ is designed to be used with the Nortech® 7-510-33 Flo-Assistant™ tubing set for increased fluid capacity. The device is comprised of a main unit, cable and foot pedal assembly.

AI/ML Overview

I am sorry, but the provided text does not contain any information regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for the Flo-Assistant™ device, primarily focusing on its description, intended use, and assertion of substantial equivalence to predicate devices. It does not include details about clinical trials, performance specifications, or study methodologies.

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K Number

K033614

Device Name

Manufacturer

Date Cleared

2004-07-29

(255 days)

Product Code

Regulation Number

Type

Panel

40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0

Reference & Predicate Devices

N/A

Intended Use

The NORTECH IntraMyst Humidification System is indicated for use as a means of supplying humidity within the intra-abdominal cavity during diagnostic and/or operative laparoscopic procedures.

Device Description

Nortech's IntraMyst Humidification System incorporates front panel controls that are similar to Northgate's current Insufflators. The system is designed to provide continuous or on demand humidification to the laparoscopic environment. This may reduce the incidence of postoperative pain, diminish the likelihood of adhesion formation and reduce laparoscope lens fogging. The controller will contain the appropriate pneumatics for supplying and controlling the gas to the catheter at 100 PSI and 5 LPM. In addition, the controller will have displays for indicating abdominal pressure, overpressure, gas supply low, mist active, active pressure sense and amount of fluid dispensed.

AI/ML Overview

The Nortech IntraMyst Humidification System is a Class II device designed to provide continuous or on-demand humidification to the laparoscopic environment. The provided SSS document acts as a 510(k) premarket notification, which is a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. Therefore, the "acceptance criteria" and "device performance" in this context refer to the demonstration of substantial equivalence, rather than specific performance metrics from a dedicated clinical study for this device.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (as demonstrated by similarity to predicate devices)
Intended Use: The device must have the same intended use as legally marketed predicate devices.	The Nortech IntraMyst Humidification System is indicated for use as a means of supplying humidity within the intra-abdominal cavity during diagnostic and/or operative laparoscopic procedures. (This is stated to be substantially equivalent to predicate devices.)
Technological Characteristics: The device must have technological characteristics (materials, design, operating principles) that are substantially equivalent to predicate devices.	- Materials: Non-toxic and previously utilized in other devices.

Front Panel Controls: Similar to Northgate's current insufflators.
Controller Functionality: Contains appropriate pneumatics for gas supply and control (100 PSI, 5 LPM), with displays for abdominal pressure, overpressure, gas supply low, mist active, active pressure sense, and fluid dispensed.
Standards Compliance: Will meet UL-2601-1, CAN/CSA-C22.2 No. 601.1, EN 60601-1, EN 60601-1-2. Microbiological testing to meet ISO 10993-X. |
| Safety and Effectiveness: When compared to predicate devices, the new device must not raise different questions of safety and effectiveness. | The document implicitly asserts this by claiming "substantial equivalence in materials, and intended use to numerous currently marketed devices." The compliance with recognized standards (UL, CAN/CSA, EN, ISO) suggests the device's safety and effectiveness will be comparable. |

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

The document does not describe a clinical "test set" in the traditional sense for evaluating device performance against pre-defined criteria. This is a 510(k) submission focused on substantial equivalence, which primarily relies on direct comparison to predicate devices, engineering testing (to meet standards), and possibly bench testing. Therefore:

Sample Size for Test Set: Not applicable in the context of a clinical performance study. The evaluation likely involved engineering tests and potentially bench tests, but no specific human clinical test set is described.
Data Provenance: Not applicable in the context of a clinical performance study. The information provided is about the device's design, materials, intended use, and its assertion of substantial equivalence to predicate devices, rather than clinical data from a new study.

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

Not applicable. As this is a 510(k) submission focusing on substantial equivalence, there is no mention of a human-in-the-loop clinical test set requiring expert consensus for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication is described.

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 device is a laparoscopic insufflator and humidification system, not an AI-based diagnostic or assistive technology for human readers.

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

Not applicable. This is a medical device, not an algorithm. Its performance would be evaluated through engineering specifications, bench testing, and compliance with standards, not as a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For a 510(k) submission of this type of device, "ground truth" isn't typically established in the sense of clinical outcomes or expert labels. Instead, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective, and the new device demonstrates equivalence to them through design, materials, and intended use. Performance is implicitly demonstrated by meeting recognized safety and performance standards.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product developed using a training set.

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

Not applicable. This device is not an AI/ML product developed using a training set.

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K Number

K022052

Device Name

Manufacturer

Date Cleared

2003-01-24

(214 days)

Product Code

Regulation Number

Type

Panel

HUMI-FLOW, MODEL 6-850-00/ 01/02

Reference & Predicate Devices

N/A

Intended Use

The NORTECH 40LPM ABDOMINAL INSUFFLATOR®, 72-00203-0 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.

Device Description

The Abdominal CO, Gas Insufflator (catalog # 72-00203-0) incorporates front panel controls similar to our current Omniflator® model #7640, although it utilizes membrane switches. The Abdominal Insufflator has an adjustable gas flow rate from 0-40 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO2 from a central supply or E-Cylinder tank.

AI/ML Overview

This document is a 510(k) premarket notification for a laparoscopic insufflator. It describes the device, its intended use, and states that it is substantially equivalent to legally marketed predicate devices.

The document does not contain acceptance criteria for device performance or a study demonstrating that these criteria are met. This type of information is typically found in design verification and validation reports, which are part of the technical documentation submitted to the FDA but are not usually included in the public-facing 510(k) summary or cover letters.

Therefore, I cannot provide the requested information based solely on the provided text. The prompt asks for information that is not available in these specific parts of the 510(k) submission.

To answer your questions, I would need access to the actual performance and testing data, which are not present in the provided excerpt. The document only states that the device is substantially equivalent, implying that its performance is comparable to existing predicate devices, but it does not quantify this performance or detail specific tests.

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K Number

K010053

Device Name

Manufacturer

Date Cleared

2001-10-23

(288 days)

Product Code

Regulation Number

Type

Panel

HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05

Reference & Predicate Devices

N/A

Intended Use

Device Description

AI/ML Overview

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K Number

K011928

Device Name

Manufacturer

FLO ASSISTANT, MODEL 4-250-00

Date Cleared

2001-08-10

(51 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

THE HYDROTOWER® ARTHROSCOPIC ADMINISTRATION TUBING SET IS USED TO MOVE FLUID FROM THE TOWER BAG TO THE PATIENT.

Device Description

The Hydrotower® Arthroscopic Administration Tubing Set is designed to be used with the Nortech® Hydrotower® System. The device is comprised of pvc tubing, check valve, a pressure relief valve, and numerous polymer fittings.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for the Hydrotower® Arthroscopic Administration Tubing Set, which primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table or answer the questions related to the study design, sample sizes, expert qualifications, or comparative effectiveness.

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K Number

K001325

Device Name

Manufacturer