(44 days)
The OCTO™ Port is intended to use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
The OCTO™ Port is a sterile, disposable laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen.
The provided text describes modifications to an existing device (OCTO™ Port) and asserts its substantial equivalence to a predicate device (OCTO™ K100045) rather than presenting detailed acceptance criteria and a study to prove they are met. The document focuses on demonstrating that the new modifications do not alter the fundamental safety or effectiveness of the device.
Here's an analysis based on the information provided and how it relates to your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide specific, quantifiable acceptance criteria with corresponding performance results in a tabular format. Instead, it lists general types of bench tests conducted to ensure the device performs as expected after modifications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Appearance inspection | Not specified (implied to pass) |
| Dimension test | Not specified (implied to pass) |
| Pressure leak test | Not specified (implied to pass) |
| Tensile strength test | Not specified (implied to pass) |
| Pressure injection test | Not specified (implied to pass) |
| Instrument insertion/removal test | Not specified (implied to pass) |
| Insertion test | Not specified (implied to pass) |
| Fixation test | Not specified (implied to pass) |
| Leak resistance | Not specified (implied to pass) |
| Cannula insertion and removal evaluation | Not specified (implied to pass) |
| Device compatibility | Not specified (implied to pass) |
| One-handed use | Not specified (implied to pass) |
| Retractor removal test | Not specified (implied to pass) |
| Insufflation tube fixation forces maintain pneumoperitoneum | Not specified (implied to pass) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any of the bench tests listed. It states "The testing scope for Bench Test was selected to include..." which indicates tests were performed, but no details on the number of samples or data provenance are given.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
This information is not applicable or provided in the context of this 510(k) submission. No clinical study involving experts establishing ground truth is described. The assessment is based on physical and functional changes to the device compared to a predicate.
4. Adjudication Method for the Test Set
This information is not applicable or provided. There's no mention of expert adjudication for the bench tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted or mentioned. The device is a surgical access port, not an imaging or diagnostic device that would typically involve MRMC studies for AI assistance.
6. Standalone (Algorithm Only) Performance
This is not applicable as the device is a physical surgical instrument, not an algorithm or AI.
7. Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For the bench tests, the "ground truth" would be established engineering specifications, performance standards, and comparisons to the known performance of the predicate device. For example, "pressure leak test" would likely have a pre-defined maximum allowable leak rate, and the test results would be compared against that.
8. Sample Size for the Training Set
This is not applicable as the device is not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is not an AI or machine learning model.
Summary Explanation:
This 510(k) submission (K112196) is for modifications to an already cleared medical device (OCTO™ Port, predicate K100045). The purpose of the submission is to demonstrate "substantial equivalence" of the modified device to the predicate. This means showing that the changes (e.g., color, thickness, gas valve addition/relocation) do not fundamentally alter the device's safety, effectiveness, indications for use, or technological characteristics.
Instead of presenting detailed acceptance criteria and performance data for a novel device, the submission asserts that:
- The modified system has the "same intended use and fundamental scientific technology" as the previously-cleared system.
- "Performance testing (Bench)" was conducted to include a list of various physical and mechanical tests (e.g., pressure leak, tensile strength, instrument insertion/removal). However, no specific acceptance criteria or quantitative performance results for these tests are provided in this summary. The implication is that the device passed these tests and met internal specifications consistent with its intended use and comparison to the predicate.
- "No additional animal testing was performed" because the mechanism and materials are "identical and consistent with the previously submitted models."
- "No additional biocompatibility testing was performed" for the same reason.
In essence, the "study" proving the device meets criteria is a battery of specified bench tests, but the specific quantifiable passing criteria and detailed results are not included in this high-level summary. The FDA's clearance (SEP 14 2011) indicates that they were satisfied with the provided information, which presumably included detailed test reports that are not part of this public summary.
§ 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.