(191 days)
S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium.
For Urology:
Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required.
Transurethral resection of the prostate (TURP) and bladder neck. Transurethral resection of the bladder tumors (TURBT). Transurethral incision of the prostate. Coagulation of bleeding in the lower urinary tract.
For Gynecology:
Tissue cutting, removal, and desiccation as required or encountered in gynecologic hystroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.
Excision of intrauterine myomas. Excision of intrauterine polyps. Lysis of intrauterine septa. Endometrial ablation.
The bipolar S-line Resectoscopes with electrodes have a design similar to the traditional monopolar resectoscopes, but with an additional pin for the neutral pole at the working element. The HF bipolar connection cables have a standard resectoscope connector and in addition a neutral connection to the neutral pin at the neutral pin at the S-line working element and on unit side plugs for connection to bipolar generators.
The provided 510(k) summary for the "S-line" Saline Bipolar Resectoscope does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way a diagnostic AI/ML device submission would. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and states that no performance standards are known and no clinical tests were performed for this specific submission.
However, based on the information provided, we can infer the overarching "acceptance criteria" through the lens of safety and effectiveness, and how the submitter "proved" this through substantial equivalence.
Here's an analysis based on your requested categories:
Acceptance Criteria and Device Performance
Since no specific quantitative performance metrics are provided (e.g., sensitivity, specificity, accuracy), the "acceptance criteria" are implied to be that the device functions safely and effectively for its intended use, comparable to its predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe operation for intended use | "Designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." |
| Effective for tissue ablation and hemostasis in urological and gynecological procedures | "The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness." (Substantial equivalence claim) |
| Minimization of adverse effects (e.g., TUR-Syndrome, muscle tremor) compared to monopolar resectoscopes | "The saline used in bipolar resectoscope applications can minimize adverse effects... intra-operative muscle tremor (stimulation of nerve obturatorius) is largely avoided..." |
| Comparable performance to predicate devices (monopolar and bipolar resectoscopes) | "The submitted devices are substantially equivalent to existing 510(k)-cleared devices sold by Richard Wolf, Gyrus, and ACMI." |
Study Details (or lack thereof, in an AI/ML context)
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Sample size used for the test set and the data provenance:
- Test set size: Not applicable. No dedicated "test set" in the context of an AI/ML performance study was used. The submission relies on technical characteristics and substantial equivalence, not data from a specific test set.
- Data provenance: Not applicable. No clinical data provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment in the customary sense for evaluating a diagnostic device's performance.
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Adjudication method for the test set:
- Not applicable. No test set or adjudication performed.
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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:
- No. This device is a surgical instrument, not an AI/ML diagnostic aid for human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a surgical resectoscope, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. Ground truth for performance metrics was not established as part of this submission. The "truth" is based on the design and intended function being safe and effective, similar to predicate devices.
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The sample size for the training set:
- Not applicable. This device is a hardware instrument, not a learned algorithm.
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How the ground truth for the training set was established:
- Not applicable.
Summary of the "Study" provided in Ko62720:
The submission for K062720 does not describe a "study" in the typical sense of a clinical trial or performance evaluation for an AI/ML device. Instead, it follows a 510(k) pathway for medical devices which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices.
The arguments made are:
- Technological Characteristics: The device has a similar design to traditional monopolar resectoscopes but includes an additional pin for the neutral pole, enabling bipolar functionality. It highlights the benefits of using saline over Purisole/Glycine solution (minimizing TUR-syndrome) and avoids intra-operative muscle tremor due to current localization.
- Safety and Effectiveness: The conclusion states that the devices are "designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." This suggests manufacturing controls and design verification/validation (which are typically part of a Quality System) rather than a specific clinical performance study for regulatory submission.
- Predicate Devices: Substantial equivalence is claimed to several predicate devices, including resectoscopes from Richard Wolf (K980302, K042523), Olympus, ACMI (K031001, K022480), and a Gyrus system. The device's safety and effectiveness are considered to be comparable to these established devices, with the new technological characteristics not diminishing safety or effectiveness.
- No specific performance standards or clinical tests were performed for this submission.
In essence, the "proof" the device meets acceptance criteria is derived from its design, its intended function, and its demonstrated similarity (substantial equivalence) to devices already on the market where safety and effectiveness have been previously established.
§ 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.