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510(k) Data Aggregation
(188 days)
NELIS
The Endo Keeper is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
This device is single use and sterilized.
The Endo Keeper is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery. This device is single use and sterilized.
The Endo Keeper is laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen.
The Urethane Forming Sheet (components of the Endo Keeper) function is to cover the incision site of abdominal.
The provided text describes a 510(k) premarket notification for a medical device called "Endo Keeper." This document focuses on demonstrating that the Endo Keeper is substantially equivalent to a legally marketed predicate device, the "Glove Port" (K141715). The information primarily outlines the device's intended use, technological characteristics, and performance testing conducted to support this claim.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for performance metrics in a table. It states that "Bench testing is performed to demonstrate the functionality and mechanical safety as following items." The reported performance is summarized as demonstrating "functionality and mechanical safety" and being "same as functional and effective as the legally marketed predicate device."
| Performance Metric | Acceptance Criteria (Not explicitly stated as numerical targets) | Reported Device Performance |
|---|---|---|
| Leak rate | Functionality and Mechanical Safety Comparable to Predicate | Demonstrated functionality and mechanical safety; "same as functional and effective as the legally marketed predicate device." |
| Tensile strength | Functionality and Mechanical Safety Comparable to Predicate | Demonstrated functionality and mechanical safety; "same as functional and effective as the legally marketed predicate device." |
| Insufflation flow rate | Functionality and Mechanical Safety Comparable to Predicate | Demonstrated functionality and mechanical safety; "same as functional and effective as the legally marketed predicate device." |
| Insertion-withdrawal forces of instrument | Functionality and Mechanical Safety Comparable to Predicate | Demonstrated functionality and mechanical safety; "same as functional and effective as the legally marketed predicate device." |
| Minimum size of skin incision | Functionality and Mechanical Safety Comparable to Predicate | Demonstrated functionality and mechanical safety; "same as functional and effective as the legally marketed predicate device." |
| Biocompatibility (in-vivo) | No irritations and necrosis of the skin and fascia (ISO 10993-2 and ISO 10993-1 compliance implied) | "Verified of feasibility and functionality." "No irritations and necrosis of the skin and fascia." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench testing" and "Animal test" as performance data.
- Bench Testing: The sample sizes for each specific bench test (leak rate, tensile strength, etc.) are not specified in the provided text.
- Animal Test: The sample size (number of animals) for the in-vivo test is not specified.
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given that this is a 510(k) submission for a Korean company (NELIS), it's highly probable the testing was conducted in Korea or at an accredited facility. It is prospective testing, as it was performed to support device approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance data is based on bench tests and an animal study, not human interpretation requiring experts for ground truth establishment in the traditional sense of diagnostic AI.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are bench and animal tests, not studies involving human interpretation that would require an adjudication method.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed. The studies described are engineering bench tests and an animal biocompatibility/functionality study. The document explicitly states the comparison is between the "Endo Keeper" and the "Glove Port (K141715)" based on "materials, structure and component" and "function and effectiveness" through bench and animal testing, not human reader performance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This concept is not applicable to the "Endo Keeper" device, which is a physical surgical access port, not an algorithm or AI system. The performance studies are for the physical device itself.
7. Type of Ground Truth Used
- Bench Testing: The "ground truth" for the bench tests would be the established engineering and ISO standards for properties like leak rate, tensile strength, insertion/withdrawal forces, etc. The comparison is against the predicate device's performance.
- Animal Test: The "ground truth" for the in-vivo test regarding feasibility, functionality, irritations, and necrosis would be direct observation and pathological examination of the animal tissues, assessed against established biological response criteria (e.g., ISO 10993).
8. Sample Size for the Training Set
This information is not applicable as the "Endo Keeper" is a medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the "Endo Keeper" is a medical device, not an AI model that requires a training set.
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(273 days)
NELIS
The Glove Port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
The Glove Port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery. This device is single use and sterilized.
The GLOVE PORT is laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen.
The document describes a 510(k) premarket notification for the "Glove Port" device, which is an endoscopy surgery instrument. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the bench testing performed to demonstrate functionality and mechanical safety. The reported device performance is that these tests showed the device is "as safe, as effective and performs in a substantially equivalent manner to the predicate device."
| Acceptance Criteria (Implied from Bench Tests) | Reported Device Performance |
|---|---|
| Comparative leak rate (without instruments) | Substantially equivalent to predicate devices |
| Comparative leak rate (with instruments) | Substantially equivalent to predicate devices |
| Comparative leak rate (after vigorous manipulation of instruments) | Substantially equivalent to predicate devices |
| Insufflation flow rate | Substantially equivalent to predicate devices |
| Insertion-withdrawal forces of instruments | Substantially equivalent to predicate devices |
| Determination of minimum size of skin incision | Substantially equivalent to predicate devices |
| Evaluation of device fixation | Substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that "Bench testing is performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the bench tests. The tests appear to be physical or mechanical assessments rather than clinical evaluations requiring expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication for the bench tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described is bench testing, not a clinical study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The "Glove Port" is a physical medical device, not an algorithm or AI.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" would be the established functional and safety specifications for such devices, determined by engineering, regulatory, and mechanical principles. The comparison is made against the performance of predicate devices.
8. The Sample Size for the Training Set
Not applicable. The "Glove Port" is a physical medical device, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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