(109 days)
The Artemis Lap Cannula has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for minimally invasive instruments. Artemis Lap Cannula may be used for primary and secondary insertions.
Artemis Lap Cannula system is a radiolucent, reusable, bladeless laparoscopic trocar, consisting of a cannula, an obturator, a depth limiter, and a disposable standalone seal pack. The trocar is available in two diameters: Ø5mm and Ø12mm, each consists of 4 different length variants. Depth limiter component is available in two diameters and fits either the Ø5mm or Ø12mm cannula regardless of the length. Depth limiter can be used to prevent over penetration during surgical procedures. Artemis Lap Cannula may be used in abdominal, thoracic, or gynecological procedures.
This document describes a 510(k) premarket notification for the "Bladeless Trocar - Artemis Lap Cannula." The submission seeks to prove substantial equivalence to a legally marketed predicate device (K032676, the ENDOPATH III Trocar System).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria for performance metrics in a table format, nor does it provide detailed quantitative performance data for the Artemis Lap Cannula. Instead, the document focuses on demonstrating substantial equivalence through a comparison of technological characteristics and nonclinical testing.
Here's a summary of the stated performance and comparisons:
| Acceptance Criteria (Implied) | Reported Device Performance (Artemis Lap Cannula) | Comparison to Predicate (ENDOPATH III Trocar System) |
|---|---|---|
| Biocompatibility | Found biocompatible for intended use. | Implied equivalent to predicate. |
| Reprocessing Effectiveness | Validated reprocessing instructions are sufficient to clean and sterilize it in healthcare settings. | Implied equivalent to predicate. |
| Small-Bore Connectors (ISO 80369-7) | Completed testing; data demonstrates success and met the criteria of ISO 80369-7. | Implied equivalent/compliant to standard. |
| Leak Testing | Data demonstrates the proposed devices perform statistically equivalent to the predicate device. | Statistically equivalent to predicate device for leak performance. |
| Intended Use | Applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry. | Identical to the relevant part of the predicate device. |
| Basic Design | Radiolucent, reusable, bladeless laparoscopic trocar, consisting of cannula, obturator, depth limiter, and disposable standalone seal pack. Two diameters (5mm, 12mm), 4 length variants, depth limiter. | Same basic design, but with differences in sleeve/obturator material, packaging, sleeve design, and inclusion of a depth limiter. These differences do not raise new questions of safety or effectiveness. |
| Sterilization | Cobalt, irradiation. | Equivalent (Cobalt, irradiation). |
| Seal Design (Outer & Inner) | Multi-piece (Pacman), overlapping outer seal; Duckbill inner seal. | Equivalent to predicate. |
| Obturator Tip Design | Bladeless. | Equivalent to predicate. |
| Sleeve Design | Low-profile design; release button for removal and locking of seal pack. | Equivalent to predicate for low-profile design; Difference: release button for seal pack vs. predicate's outer seal only. |
| Obturator Design | Low-profile design. | Equivalent to predicate. |
| Cannula Design | Low-profile design. | Equivalent to predicate. |
| Outer Seal Material | Polycarbonate and Polyisoprene. | Equivalent to predicate. |
| Inner Seal Material | Polyisoprene. | Equivalent to predicate. |
| Dimensions (Diameter) | 5 mm & 12 mm. | Equivalent to predicate. |
| Dimensions (Length) | 75 mm, 100 mm, 150 mm. | Equivalent to predicate. |
| Sleeve Material | Radel. | Difference: Radel vs. predicate's Polycarbonate. |
| Obturator Material | Radel. | Difference: Radel vs. predicate's Polycarbonate. |
| Packaging | Flexible Film Composite, with lidding film top stock (FMP-521®). | Difference: Flexible Film Composite vs. predicate's Copolyester rigid blister. |
| Depth Limiter | 5 or 12 mm in diameter. | Difference: Included vs. predicate's "Not included with system." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for specific tests (e.g., biocompatibility testing might involve various samples for different analyses, and leak testing would have its own sample size).
- Test Set Sample Size: Not explicitly stated for each test.
- Data Provenance: Not explicitly stated whether retrospective or prospective. Given the nature of pre-market testing for medical devices (biocompatibility, reprocessing, performance testing), it is typically prospective testing conducted specifically for the submission. The country of origin of the data is not specified beyond the applicant's location (Israel).
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 tests described (biocompatibility, reprocessing, ISO standard testing, leak testing) are primarily objective engineering/scientific tests, not typically reliant on expert interpretation for "ground truth" in the same way clinical imaging or diagnostic studies might be.
4. Adjudication Method for the Test Set
Not applicable for the types of nonclinical tests described. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, which the "Bladeless Trocar - Artemis Lap Cannula" is not. It is a surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study (algorithm only) was not done. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for the nonclinical tests (biocompatibility, reprocessing, ISO standards, leak testing) typically refers to established scientific methodologies, validated test methods, and pre-defined acceptance criteria based on industry standards and regulatory requirements. For example:
- Biocompatibility: Established ISO standards (e.g., ISO 10993 series) define the ground truth for evaluating biological response.
- Reprocessing: Ground truth is established by validated protocols demonstrating the device can be consistently cleaned and sterilized to meet sterility assurance levels.
- ISO 80369-7: Ground truth is the successful meeting of the dimensional and performance requirements defined in the standard.
- Leak Testing: Ground truth is the quantitative measurement of leakage and its statistical equivalence to the predicate, demonstrating it meets performance expectations for sealing.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
§ 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.