(45 days)
The Schoelly Cystoscopes Hysteroscopes and Accessories are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes and Accessories are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.
The proposed Schoelly Cystoscopes/Hysteroscopes and Accessories comprise several models of rigid endoscopes as well as endoscopic sheaths, obturators, instrument bridges and grasping forceps. The devices are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes/Hysteroscopes and Accessories are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.
Endoscopes (Cystoscopes/Hysteroscopes):
The endoscopes described in this submission are rigid reusable endoscopes for visualization of the operating site during cvstoscopic and hysteroscopic minimally invasive procedures in conjunction with a commercially available light source, video camera, monitor, and printer.
Light that is created by an external light source is transmitted from the endoscope's light guide connector through the endoscope itself to the tip via a fiber optic system. Images are transferred the other way back through a rigid lens system.
Technical parameters of the Schoelly Cystoscopes/Hysteroscopes that characterize the optical view are the Direction of View (0°-70°) and the Field of View (70°-85°). The image can be displayed by a camera/monitor system which can be connected to the endoscope eyepiece. Models of the Schoelly Cystoscopes/Hysteroscopes differ in diameter and length of the insertion tube (2.9mm; 4mm / 300mm - 365mm). None of the endoscope models have a working channel.
Like other currently marketed rigid cystoscopes and hysteroscopes, all endoscope models have outer surfaces mainly made from metal (Phynox cobalt-nickelchromium stainless steel alloy, 304 stainless steel) and incorporate fiber optics for light transmission and rigid lenses for image transmission.
Some Schoelly endoscope models have already been cleared for marketing by FDA (K060899) for the same general intended use but with a different material of the insertion tube and a different bonding material used for the fixation of the plan glass at the endoscope's distal end. Accessories do not have a prior 510(k) clearance.
Sheath:
The endoscopic sheaths included in this submission are rigid reusable instruments with an inner lumen and mainly made from stainless steel; the sheath serves as the most outer part of the whole device setup in cystoscopic or hysteroscopic procedures. The proximal end of the endoscopic sheath has two irrigation ports with integral stopcocks for the introduction and the egress of irrigation media. The distal end of the sheath is cut away in a fenestration to permit the use of working instruments and endoscopes with a Direction of View of more than 0°. Opposite to the fenestration, the sheath is bevelled to facilitate its introduction into natural body orifices (transurethral/transvaginal). The outer diameter of the sheaths in this submission ranges from 17Fr - 25Fr, which are standard sizes used in cystoscopic or hysteroscopic procedures in adults. The sheaths can be used with all endoscopes models, obturators and bridges that are included in this submission.
Obturator:
The obturators included in this submission are rigid reusable instruments with (visual obturators) or without (blind obturators) an inner lumen and mainly made from stainless steel. During application, the obturator can be attached to the endoscopic sheath; it fills the space inside the sheath to provide a smooth surface. The visual obturator has an inner channel that accommodates the endoscope and allows the sheath to be introduced under direct vision. The overall length of the obturator used in conjunction with the sheath complies with the working length of the endoscope.
Bridges:
This submission includes standard endoscope bridges, which are rigid reusable instruments with an inner lumen and mainly made from stainless steel. The evaluation bridges without any accessory port allow the connection of the endoscope to the endoscopic sheath; the single horn bridges include an accessory port with stopcock to allow the insertion of instruments through the inner lumen of the sheath. Both types of bridges are available in a range of lengths for use with the full range of endoscope working lengths.
Grasping forceps:
As with standard endoscopic grasping forceps, the one described in this submission is a flexible forceps solely made from stainless steel and designed for grasping tissue and/or retrieving foreign bodies under endoscopic visualization. It consists of a flexible shaft and a manual proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws. The outer diameter and the working length of the grasping forceps comprised in this submission are 7Fr and 400 mm, respectively. The grasping forceps can be introduced into the instrument bridge and moved forward through the inner lumen of the sheath towards the tip.
The Schoelly Cystoscopes/Hysteroscopes and Accessories are delivered in a nonsterile condition and will have CE mark.
The provided document describes Schoelly Cystoscopes/Hysteroscopes and Accessories, which are medical devices intended for endoscopic diagnostic and therapeutic surgical procedures. The document focuses on establishing substantial equivalence to legally marketed predicate devices through non-clinical performance testing.
Here's an analysis of the acceptance criteria and study information provided:
1. Acceptance Criteria and Reported Device Performance:
The document states that the "Performance data demonstrated that the Schoelly Cystoscopes/Hysteroscopes and Accessories have met pre-determined acceptance criteria and are substantially equivalent to predicate devices. The devices are as safe, as effective, and perform as well as or better than the predicate devices."
The specific acceptance criteria are not explicitly detailed in a pass/fail format within the provided text. Instead, the document lists various performance tests and implies that meeting the standards referenced is the acceptance criteria. The reported device performance is that it met these criteria.
| Test Category | Specific Test / Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009 | Met acceptance criteria (implicitly, as part of overall statement) |
| - Cytotoxicity (ISO 10993-5:2009) | Met acceptance criteria | |
| - Sensitization (ISO 10993-10:2002) | Met acceptance criteria | |
| - Irritation (ISO 10993-10:2002) | Met acceptance criteria | |
| - Systemic toxicity (ISO 10993-11:2006) | Met acceptance criteria | |
| Temperature | IEC 60601-2-18:2009 | Met acceptance criteria |
| General Performance | ISO 8600-1:2013 and FDA Guidance Hysteroscopes and Gynecologic Laparoscopes - Submission Guidance for a 510(k), March 7, 1996 | Met acceptance criteria |
| - Field of view | Met acceptance criteria | |
| - Direction of view | Met acceptance criteria | |
| - Diopters | Met acceptance criteria | |
| - Eccentricity | Met acceptance criteria | |
| - Size of view | Met acceptance criteria | |
| - Vignetting | Met acceptance criteria | |
| - Image resolution | Met acceptance criteria | |
| - Image distortion | Met acceptance criteria | |
| Packaging | ISO 2248:1985 | Met acceptance criteria |
| Reprocessing | - Manual and automated cleaning efficacy (AAMI TIR12:2010 and AAMI TIR30:2011) | Met acceptance criteria |
| - Steam sterilization efficacy (ISO 17664:2004 and ANSI/AAMI/ISO 17665-1:2006) | Met acceptance criteria | |
| - High level disinfection efficacy (ASTM E 1837:96 (2007)) (for cystoscopy) | Met acceptance criteria | |
| Risk Management | ISO 14971:2012 | Risks associated with use found acceptable |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in terms of patient data or images. The testing described is non-clinical performance testing on the device itself.
- Sample Size for Test Set: Not applicable in the context of patient data. The number of physical devices or components subjected to each non-clinical test is not specified, but it's implied that sufficient samples were used to meet the requirements of the listed standards.
- Data Provenance: Not applicable in the context of patient data. All testing is non-clinical, likely conducted in a laboratory setting. The manufacturer, Schoelly Fiberoptic GmbH, is based in Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the described testing is non-clinical performance and not an assessment of diagnostic performance against a ground truth established by medical experts for patient data.
4. Adjudication Method for the Test Set:
This information is not applicable as the described testing is non-clinical performance and not an assessment of diagnostic performance against a ground truth established by medical experts for patient data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing of the device's physical and optical characteristics, sterilization, and biocompatibility, not its effectiveness in a clinical diagnostic setting with human readers.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This information is not applicable. The device is a rigid endoscope and accessories, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used:
This information is not applicable as the described testing is non-clinical performance (e.g., optical properties, reprocessing efficacy, material biocompatibility), which uses established engineering and biological standards as the "ground truth" for performance.
8. The Sample Size for the Training Set:
This information is not applicable as the device is a physical medical instrument, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is a physical medical instrument, not a machine learning algorithm.
§ 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.