(64 days)
Aesculap's Needlescopic Instrument System (N.I.S.) is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery.
The system consists of three primary components: a 2.5mm trocar, a 2.0mm endoscope, and 2.5mm modular instruments. The N.I.S. trocar is intended to establish ports through which endoscopes and endoscopic instruments pass into the abdominal cavity. The N.I.S. endoscope is used to examine body cavities, hollow organs and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures. The N.I.S. instruments are used to cut, manipulate, grasp and/or cauterize selected tissue.
This submission is for a 510(k) Premarket Notification for the Aesculap Needlescopic Instrument System (N.I.S.). The document does not describe a study with acceptance criteria to demonstrate device performance in the manner typically associated with clinical trials or AI/software validation. Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This submission does not define specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a study. The "performance data" section states that "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." The primary performance criterion mentioned is compliance with an electrical safety standard for electrosurgical instruments.
| Acceptance Criteria Category | Specific Criteria (as applicable from document) | Reported Device Performance |
|---|---|---|
| Technological Characteristics | No new technological characteristics (other than reduction in diameter) from currently marketed Aesculap endoscopic product line. | The N.I.S. does not impart any new technological characteristics from the current system other than the reduction in diameter size of the devices. |
| Electrical Safety | Meet requirements of IEC 601-2-18 for electrosurgical instruments. | The instruments in Aesculap's Needlescopic Instrument System that are intended for electrosurgery meet the requirements of IEC 601-2-18. |
| Design, Function, Intended Use | Substantially equivalent to listed predicate devices. | Aesculap believes the N.I.S. is substantially equivalent in design, function, and intended use to a list of predicate devices (K942053, K941239, K942730, K940936, K965055, K962799, K955479, K946164, K972415, K unknown). |
| Intended Use | Indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery. | The N.I.S. is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document describes a submission for substantial equivalence based on technological characteristics and predicate device comparison, not a study involving a "test set" of data or patient samples to measure performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth establishment with experts is not relevant to this type of 510(k) submission, which focuses on comparing a new device to existing ones rather than evaluating diagnostic accuracy against a true condition.
4. Adjudication Method
Not applicable for the same reasons as points 2 and 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic imaging devices or algorithms where human readers' performance is being assessed with and without AI assistance. This submission is for surgical instruments, where such a study design is not relevant.
6. Standalone Performance Study
No, a standalone (algorithm only without human-in-the-loop performance) study was not done. This concept is applicable to AI algorithms, not to physical surgical instruments.
7. Type of Ground Truth Used
Not applicable. The concept of "ground truth" as a reference standard for diagnostic accuracy is not relevant here. The "truth" for this submission is whether the device is functionally and technologically similar to predicate devices and meets safety standards (like IEC 601-2-18).
8. Sample Size for the Training Set
Not applicable. This submission does not involve an AI algorithm or machine learning that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned in the document.
In summary:
The Aesculap Needlescopic Instrument System 510(k) submission demonstrates "substantial equivalence" to predicate devices, focusing on the absence of new technological characteristics (other than reduced diameter) and compliance with relevant safety standards (IEC 601-2-18 for electrosurgical components). It is a regulatory submission for physical medical devices, not an AI/software performance study, and therefore the criteria for evaluating AI algorithm performance (like test sets, ground truth, expert adjudication, MRMC studies) do not apply.
§ 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.