(188 days)
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.