(202 days)
The VersaOne™ optical trocar with fixation balloon cannula is indicated for use in general, gynecologic, thoracic and urologic minimally invasive surgical procedures.
The intended purpose of the device is to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
VersaOne™ optical trocar with fixation balloon cannula with a low-profile design is a 5mm diameter transparent fixation cannula in various lengths and is comprised of three components: obturator with optical tip, seal system, and cannula assembly. The obturator is bladeless and has a transparent 'dolphin nose' window at distal end. The obturator housing contains a scope retention mechanism. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, thermoplastic elastomer (not made with natural rubber latex) balloon, anti-migration disc and a stopcock. The seal system prevents the loss of pneumoperitoneum and can accommodate instruments 5mm in diameter. The cannula sleeve is beveled and a thermoplastic elastomer (not made with natural rubber latex) balloon is attached at the distal end. The stopcock valve is for insufflation and desufflation of the abdominal cavity. The thermoplastic elastomer (not made with natural rubber latex) balloon provides fixation (defined as force that resists the cannula from being inadvertently removed out of the patient). The anti-migration disc is on the proximal end of the cannula body and provides anchoring (defined as the force that resist the cannula from being inadvertently pushed into the patient). The devices are supplied sterile f o r single use. VersaOne™ optical trocar with fixation balloon cannula is packaged with a 5 mL syringe for inflation/deflation of the thermoplastic elastomer (not made with natural rubber latex) balloon. The thermoplastic elastomer (not made with natural rubber latex) balloon is packaged with a protective cap which is removed and discarded before device use.
The provided text describes a 510(k) premarket notification for a medical device, the VersaOne™ optical trocar with fixation balloon cannula. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove safety and effectiveness from scratch. Therefore, the information provided mainly focuses on non-clinical performance data (bench testing and animal testing) rather than a detailed human-in-the-loop study often seen with AI/software as a medical device.
Based on the provided document, here's a breakdown of the acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:
The "acceptance criteria" for a 510(k) device like this are primarily demonstrated by showing that its performance characteristics are comparable to a predicate device, and that any new features (like the balloon fixation) do not raise new questions of safety or effectiveness. The "studies" here are the non-clinical tests.
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of "acceptance criteria" with quantitative targets and reported performance values in the way one might see for an AI algorithm's diagnostic accuracy. Instead, the acceptance is implicitly based on the device meeting design specifications and performing comparably to predicates in various non-clinical tests.
However, we can infer some key performance aspects tested and the general conclusion:
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: | Tested and demonstrated according to: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity. |
| Mechanical Performance (Bench Testing): | |
| - Visual Inspection | Performed and presumably passed. |
| - Anchor Mechanism Force | Tested. (Implied to meet design specs.) |
| - Instrument Insertion/Removal Force | Tested. (Implied to meet design specs.) |
| - Cannula Leak Rate | Tested. (Implied to meet design specs.) |
| - Cannula Seal Anchoring | Tested. (Implied to meet design specs.) |
| - Fixation Mechanism Burst Force | Tested. (Implied to meet design specs.) |
| - Fixation Mechanism Inflation/Deflation Force | Tested. (Implied to meet design specs.) |
| - Anchor Mechanism Activation/Deactivation Force | Tested. (Implied to meet design specs.) |
| Functional Performance (Animal Testing): | |
| - Fixation Force | Tested. (Implied to meet design specs.) |
| - Removal Force | Tested. (Implied to meet design specs.) |
| - Cavity Access | Demonstrated in side-by-side animal testing with predicate/reference devices. |
| - Tissue Visualization | Demonstrated in side-by-side animal testing with predicate/reference devices. |
| - Establish/Maintain Pneumoperitoneum | Demonstrated in side-by-side animal testing with predicate/reference devices. |
| - Instrument Manipulation | Demonstrated in side-by-side animal testing with predicate/reference devices. |
| Overall Safety & Effectiveness: | Concluded to be as safe and effective as the legally marketed predicate (K112349) and does not raise different questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of devices tested for burst force, number of animals used). It simply states that "Testing... performed" or "Animal testing... performed." For a 510(k) of this nature, detailed sample sizes for specific engineering tests would be in the full submission, not typically summarized in the public 510(k) decision letter.
- Data Provenance: The document does not explicitly state the country of origin for the data or if the tests were retrospective or prospective. Given that this is non-clinical testing (bench and animal), the terms "retrospective" or "prospective" don't apply in the same way they would for human clinical data. The tests were presumably conducted as part of the device development and submission process.
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):
This question is not applicable in the context of this device's 510(k) submission. "Ground truth" established by experts is typically for diagnostic imaging devices where human expert interpretation is the standard against which an algorithm or new diagnostic method is compared. For a surgical trocar, ground truth is established by physical measurement (e.g., force testing), engineering analysis, and direct observation during performance testing (e.g., in animal models). The document mentions "side-by-side" animal testing, which implies comparative observation by individuals conducting the tests, but not "expert consensus" on diagnostic findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for human reader studies or clinical trials where discordant findings among human readers or clinical outcomes need to be resolved to establish a definitive "truth" for comparison. For bench and animal testing of a surgical instrument, results are typically objective measurements or direct observations without requiring such adjudication.
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. An MRMC study is a type of clinical comparative effectiveness study, usually for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images with or without AI assistance). This 510(k) is for a physical surgical instrument and explicitly states: "Clinical performance data - No clinical study has been performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/algorithm device. The performance tests ("bench testing" and "animal testing") are for the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established through:
- Engineered Specifications and Physical Measurements: For bench testing (e.g., anchor mechanism force, leak rate, burst force). The device performs to its design specifications.
- Direct Observation and Functional Assessment in Animal Models: For animal testing (e.g., cavity access, tissue visualization, ability to establish/maintain pneumoperitoneum, instrument manipulation). Performance is considered "successful" if it meets the functional needs for a surgical trocar.
- Comparison to Predicate Devices: The ultimate "ground truth" for a 510(k) is demonstrating "substantial equivalence" to a legally marketed predicate device, meaning it performs similarly and does not raise new safety or effectiveness concerns.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable. (See #8)
§ 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.