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The SubQKath Catheter and Needle Kit is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for subcutaneous infiltration local anesthesia, peripheral plexus anesthesia and pain management during pre-operative, perioperative and post-operative periods associated with surgical procedures.

The HK SubOKath Subcutaneous Catheter is a device intended to provide a means of delivery of local analgesics into the human body via a fenestrated catheter. The device is a single lumen catheter available in a single gauge (16g) size. The distal end of the device allows for flow of analgesia into the surgical wound. The device is supplied sterile and is intended for single use.

This document describes the 510(k) premarket notification for the SubQKath Catheter and Needle Set (K193664). The acceptance criteria and study proving the device meets these criteria are primarily based on non-clinical performance data demonstrating substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithm performance.

Therefore, many of the typical questions for AI/ML-based medical devices (like sample size for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance) are not applicable to this submission. This device is a physical medical device, and its safety and effectiveness are established through engineering testing and comparison to existing devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list acceptance criteria in a quantitative table format for each test, but it states that "The subject device met the acceptance criteria of the above tests, and did not raise new questions of safety and effectiveness." The study design is focused on demonstrating physical and material properties, rather than diagnostic accuracy metrics.

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

• Sample Size: Not explicitly stated in terms of a "test set" as this is a physical device and testing involves material and functional evaluations, not typically patient data sets. The sample sizes for the various engineering and biocompatibility tests would be dependent on the specific test protocols (e.g., number of catheters tested for flow rate, number of samples for material strength). These details are not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data. The data provenance refers to the results of laboratory-based physical, chemical, and biological performance testing of the device itself. This would be generated from the manufacturer's testing facilities or contract labs.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. Ground truth for a physical device is established through validated testing methodologies and adherence to standards (e.g., ISO, ANSI/AAMI). There's no "ground truth" derived from expert consensus on medical images or clinical outcomes in this type of submission.
• Qualifications of Experts: Not applicable in the context of clinical readers. The "experts" would be engineers, material scientists, and toxicologists conducting the specified tests and interpreting the results according to relevant standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a study requiring reader adjudication of medical data.

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

• MRMC Study: No. This is not an AI/ML diagnostic device, nor is it a device that would typically undergo a human-reader comparative effectiveness study. It's a physical catheter.
• Effect Size of Human Readers' Improvement: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device is based on engineering specifications, material science standards (e.g., ISO 9626, ISO 11607, ISO 10993-1), and functional performance requirements of similar, legally marketed predicate devices. For biocompatibility, it's the biological response measured against established safety thresholds.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve AI/ML and therefore does not have a "training set."

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

• Ground Truth for Training Set Establishment: Not applicable.

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The KleinTouch Pump is an infiltration pump used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional. The KleinTouch pump is not intended to be used as an IV infusion pump.

Device Functionality: The KleinTouch Pump is an electrically or battery operated, manually controlled, peristaltic pump using three rollers to create pumping action in a section of sterile tubing.
Scientific Concept(s): The KTP is designed to specifically function with sterile single use only Klein Touch Tubing (KT20). Tubing must be primed before use. Please refer to the KT20 Instructions for Use for further details.
Physical And Performance Characteristics: Device Design Display: Color Graphic LCD Dual Foot Switches With Hose - Air Activated Dimensions: 11" x 10 ¾" x 5" Weight: 8.4 lbs.
Components Used: Motor Fluid Pathway Materials Silicone Inlet Hospital Power Cord Hospital Grade Plugs Barcode Reader Base, Plastic Battery Instrument Foam PCBA - Power Board PCBA, Main Circuit Board Pump, Peristaltic, 3-Roller, Fixed Clamp Switch, Rocker, Lighted
Physical Properties: The Pump is intended for use in combination with the KT20 tubing. The peristaltic pump using three rollers will create pumping action in KTP20 tubing set specifically designed for the KleinTouch Pump

The provided text describes the 510(k) Notification for the HK Surgical KleinTouch Pump and Tubing Set. However, it does not contain specific acceptance criteria tables or detailed study results that typically outline performance metrics for AI/ML-based medical devices. The document focuses on regulatory compliance, intended use, and general safety testing for an infusion pump, which is a physical device, not an AI/ML algorithm.

Therefore, it is not possible to extract the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML, as the document describes a traditional medical device (an infiltration pump).

Here's an analysis of what can be extracted and why other parts of your request cannot be fulfilled:

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

• Cannot be provided. The document lists general performance testing categories (UL Standards, EMC, Biocompatibility, Sterilization, Human Factors) but does not provide specific quantitative acceptance criteria or reported performance values for these tests. For example, it states "Performance testing demonstrates the KleinTouch Pump meets the specifications" but doesn't detail what those specifications are or the exact results obtained.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot be provided. This information is relevant for studies involving data-driven devices or algorithms. The KleinTouch Pump is a physical device, and its testing involves physical and electrical safety standards, biocompatibility, and human factors, not data samples in the context of AI/ML.

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):

• Cannot be provided. "Ground truth" in the context of expert consensus is typically for evaluating diagnostic or predictive AI/ML models. For a physical pump, testing involves adherence to engineering standards and safety protocols by qualified testing labs (MET LABS is mentioned), not expert consensus on medical image interpretation or similar. The "Human Factors evaluation" implies expert observation, but no specific numbers or qualifications are given for that.

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

• Cannot be provided. Adjudication methods are specific to scenarios where multiple experts might disagree on ground truth, which is not applicable to the testing described for this device.

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:

• Cannot be provided. MRMC studies are for evaluating diagnostic accuracy, particularly with AI assistance, which is not relevant to a physical infiltration pump.

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

• Cannot be provided. This device is a physical pump, not an algorithm. Therefore, "standalone" performance in the AI/ML sense is not applicable.

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

• Cannot be provided. The "ground truth" for this device's performance is adherence to established international and national safety and performance standards (e.g., UL 2601-1, IEC/EN 60601-1, ISO10993-1, ISO11135). The testing verifies that the device meets these engineering and safety requirements.

8. The sample size for the training set:

• Cannot be provided. The device is not an AI/ML model, so there is no "training set."

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

• Cannot be provided. As there is no training set, this question is not applicable.

In summary: The provided text is a 510(k) summary for a physical medical device (an infiltration pump) and details its design, intended use, and compliance with various established safety and performance standards. It does not describe an AI/ML device or studies involving data-driven performance metrics, ground truth establishment, or human-AI interaction.

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The HK Liposuction Aspiration Pump is for aesthetic body contouring.

The HK Liposuction Pump is a powered suction pump/ aspirator which uses an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/adipose(Suction Lipoplasty), soft tissue, and general surgical waste.

This FDA document is a 510(k) premarket notification for a medical device and, as such, does not contain the detailed study information typically found in a clinical trial report or a journal publication. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting and evaluating specific acceptance criteria and detailed study results from a de novo clinical study.

Therefore, the requested information components (Acceptance Criteria, Reported Device Performance, Sample Sizes, Expert Qualifications, Adjudication Methods, MRMC Studies, Standalone Performance, Ground Truth Type and Establishment for Training Set) cannot be extracted from the provided text.

The document confirms the following about the device and its regulatory clearance:

• Device Name: HK Liposuction Aspiration Pump (also referred to as HK Liposuction Aspirator, Model Ap-III & Ap230-iii)
• Intended Use: Aesthetic Body Contouring (Stated in the "Indications for Use Statement" and "510(k) Summary")
• Regulatory Class: Class II
• Regulation Number: 21 CFR 878.5040
• Regulation Name: Suction Lipoplasty System
• Product Code: MUU (later updated to QPB in 2021 as an administrative change)
• Clearance Type: 510(k) Substantial Equivalence
• Predicate Devices: Byron Medical K980392, Byron Medical K981215, Kolster Methods K895761, Wells Johnson K832274

The clearance is based on the claim that the device is "substantially equivalent ... in terms of intended use, design, operating principles, materials and performance" to the listed predicate devices. The document does not describe a clinical study with specific acceptance criteria that a new device must meet. Substantial equivalence typically relies on non-clinical performance testing and comparison to predicates, which are not detailed in this public 510(k) summary.

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This Infiltration Pump is used to cause a flow of fluid from an IV bag into patient in a manner controlled manually by a health care professional. The Klein Pump is not intended to be used as an IV infusion pump.

Not Found

The provided text is an FDA 510(k) clearance letter for the Klein Surgical Infiltration Pump, Model KIP-II. It does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, sample sizes, or expert qualifications as requested in the prompt.

This type of FDA letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not typically include the detailed study results that would be found in a comprehensive submission document or scientific publication. Answering the prompt would require information not present in the provided text.

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