(128 days)
The Scuba is intended to be used for tissue cutting, vaporization and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for excision of intrauterine myomas and polyps, lysis of intrauterine adhesions, and excision of uterine septa.
The Scuba is a bipolar electrosurgical system designed for hysteroscopic surgical correction of myomas, polyps, intrauterine adhesions, and septate uteri. It consists of an electrosurgical generator, a footswitch, three types of electrodes, and a cable connecting the electrode to the generator. The generator is designed to operate from any voltage source between 95-125V and 190-250V a.c. at 50 or 60Hz. It provides six modes of operation (i.e., six waveforms): three vaporize modes, two blend modes (a combination of vaporization and coagulation) and a desiccate mode similar to the traditional coagulation waveform. The generator controls the power settings from 1 to 200 Watts. A green fluorescent display provides up to 16 characters of alphanumeric information, including the selected mode of operation, the power settings, and other messages related to the operation of the generator. Like other electrosurgical equipment, the generator is designed to be located outside the sterile field, with adjustment of operating settings performed by ancillary operating staff.
Three electrode configurations are available: the Spring, Ball and Twizzle. The electrodes are identical in construction except for the distal end and are designed for insertion down a 5 French or larger working channel of commercially available hysteroscopes. The electrodes are operated in a conductive (i.e., saline) fluid environment. When connected to the generator via the connector cable, the system detects the type of electrode attached and automatically adjusts the default power settings to the optimal level for each electrode type. The surgeon can change the default power settings as required. The electrodes are provided as sterile, single-use items. The connector cable is steam sterilizable, designed for twenty times reuse.
The provided text describes a medical device, the "Scuba System," which is a hysteroscopic electrosurgical device. It outlines its specifications, intended use, and provides a summary of non-clinical and clinical studies conducted to demonstrate its safety and effectiveness.
However, the text does not contain the specific information requested in the prompt regarding acceptance criteria, reported device performance metrics in a table, sample sizes for test sets, data provenance, expert details for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for training sets.
The document describes comparative studies where the Scuba system was compared to existing technologies (monopolar electrosurgery, laser surgery, and the Erbotom Generator with Karl Storz accessories). These comparisons are intended to demonstrate substantial equivalence, a common requirement for 510(k) submissions.
Here's a breakdown of what can be inferred and what is missing based on your request:
What can be inferred/extracted:
- Device: Scuba System (Hysteroscopic Electrosurgical Device)
- Intended Use: Tissue cutting, vaporization, and desiccation in gynecologic hysteroscopic electrosurgical procedures for excision of intrauterine myomas and polyps, lysis of intrauterine adhesions, and excision of uterine septa.
- Study Type: Comparative studies against predicate devices (monopolar electrosurgery, laser surgery, Erbotom Generator).
- Non-Clinical Studies:
- In vivo studies using porcine animal models (stomach test model and skin flap model in live swine) to demonstrate vaporization and coagulation of live tissue.
- Biocompatibility testing.
- Clinical Studies (Extirpated Uteri):
- One study compared the Scuba system to monopolar electrosurgery and laser surgery, finding it "as effective in cutting and coagulating uterine tissue."
- Another study used ten extirpated uteri, comparing the Scuba and Erbotom Generator side-by-side in each uterus. Both devices were "effective in excising and coagulating uterine tissue."
- Ground Truth Type for Clinical Studies (Extirpated Uteri): Histological evaluation of tissue effects was performed, indicating a form of "pathology" or "expert assessment of tissue damage." Serosal temperature measurements were also recorded.
What is explicitly MISSING from the provided text:
- A table of acceptance criteria and the reported device performance: The text states the device was "as effective" or "performed similarly" to predicate devices but does not provide specific quantitative performance metrics or a formal acceptance criteria table.
- Sample size used for the test set and the data provenance: Only "ten uteri" are mentioned for one clinical study. No information on data provenance (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is an electrosurgical device, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an electrosurgical device operated by a human.
- The type of ground truth used: For in vivo animal studies, it was observed tissue effects. For ex vivo human uterine studies, it involved histological evaluation and temperature measurements. This is broadly "pathology" or "direct observation/measurement of tissue effects."
- The sample size for the training set: Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable for the same reason.
Conclusion:
The provided document (K9624822, 510(k) Summary for the Scuba System) focuses on demonstrating substantial equivalence through comparative studies of its electrosurgical capabilities. It lacks the detailed information typically associated with the evaluation of AI/ML-based diagnostic devices, particularly regarding acceptance criteria, specific performance metrics, expert roles, and data set characteristics (training/test sets, provenance, adjudication methods) that would be relevant for such systems.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.