FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Aesculap's Sovereign® mini system can be used in adult and pediatric laparoscopic general surgery. The system consists of modular forceps and scissors in lengths of 200 and 290 millimeters with interchangeable ratcheting and non-ratcheting handles. The system also includes reusable trocars and trocar pins. The trocars and trocar pins are available in 3.5 millimeter diameter and 60 and 110 millimeter lengths, and 5 millimeter and 60,110 and 150 millimeter lengths with or without a stopcock. The 3.5mm trocars are for use with the 3.5mm instruments, and the 5mm trocars accommodate 4 and 5mm endoscopes. The instruments and trocars are composed of stainless steel and PEEK materials.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria based on performance data.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

No Performance Data or Acceptance Criteria: The document explicitly states under the "PERFORMANCE DATA" section that "No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices." This indicates that there are no specific, quantitative performance criteria or studies for this device outlined in this submission.
Focus on Substantial Equivalence: The primary purpose of this 510(k) submission is to demonstrate "Substantial Equivalence" to a predicate device (Aesculap Needlescopic Instrument System K982623). The comparison focuses on "TECHNOLOGICAL CHARACTERISTICS" such as design, size, materials, and monopolar capabilities, rather than on new performance data against set acceptance criteria.

Therefore, the following information cannot be provided from the given text:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample size used for the test set and the data provenance: No test set or performance data is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth or expert review is discussed for performance.
Adjudication method for the test set: No test set is mentioned.
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: This device is a surgical instrument, not an AI-assisted diagnostic tool, so such a study would not be applicable and is not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a surgical instrument.
The type of ground truth used: Not applicable, as performance data against a ground truth is not provided.
The sample size for the training set: Not applicable, as this is not a learning algorithm.
How the ground truth for the training set was established: Not applicable.

Summary from the provided documents:

The submission focuses on the Sovereign® mini system being substantially equivalent to the Aesculap Needlescopic Instrument System (K982623).

The device is a Laparoscope, General and Plastic Surgery instrument (Endoscope and Accessories).
It is intended for adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery.
The modified instruments are stated to have the same technological characteristics as the predicate devices, being similar in design, size, manufacturing materials, and monopolar capabilities.
No specific performance standards or performance data are provided in this regulatory submission for the modified device.

Summary

Regulation Number and Section

§ 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.