(81 days)
The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. The types of procedures where the LiNA OperaScope could offer visualization include:
- Assessment of abnormal bleeding, pelvic pain, amenorthea and abnormal findings from hysterosalpingogram
- Assessment of infertility and pregnancy wastage
- Confirmation of the presence of intrauterine foreign body
- Assist in locating submucosal fibroids and polyps targeted for removal
- Provide visual guidance during directed biopsy, submucosal myomectomy, transection of intrauterine adhesions and septa.
The LiNA OperaScope can also be used to permit viewing of the adult female urinary bladder through minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.
The LiNA OperaScope is a handheld, battery-operated portable hysteroscope which allows direct viewing of the cervical canal and uterine cavity via the on-board LCD display. If the user wants to capture images and/or record video sequences utilizing a USB stick, a Recording Module is available, which connects to the device via the HDMI cable. The LiNA OperaScope can also be connected to an external monitor via the HDMI cable. External monitors are not provided by LiNA Medical ApS and therefore, monitors are not the subject of this 510(k) submission.
The LiNA OperaScope is supplied as a sterile, single use device and the Recording Module is supplied as a non- sterile reusable unit. The LiNA OperaScope contains a miniature Complimentary Medical Oxide Semiconductor (CMOS) camera and a Light-Emitting Diode (LED) illumination at the tip, a channel for infusion of irrigating fluid and a channel for fluid outflow, a display), microelectronics, firmware and single use batteries for powering the device. The Recording Module contains microelectronics, software, controls for recording pictures and video sequences, USB port for storage of pic/video, HDMI port for connection of the LiNA OperaScope, HDMI port for connecting an external monitor and an input port for external 9V DC power supply.
The provided document is a 510(k) summary for the LiNA OperaScope, which is a medical device for visualizing the cervical canal, uterine cavity, and adult female urinary bladder. Notably, the document states "10. Clinical Performance Data: Not Applicable". This indicates that a clinical study, with human subjects, was not conducted to compare the device's performance against specific acceptance criteria.
Instead, substantial equivalence was demonstrated through non-clinical performance data, comparing the device to legally marketed predicate devices and against established standards. Therefore, I cannot provide a table of acceptance criteria with reported device performance from a clinical study, nor answer questions related to sample sizes for test/training sets, expert consensus, adjudication methods, or MRMC studies, as these types of studies were explicitly stated as "Not Applicable."
However, I can extract information regarding the non-clinical performance acceptance criteria and the methods used to prove the device met these criteria.
Summary of Acceptance Criteria and Device Performance (Non-Clinical):
Since no clinical performance data was deemed applicable, the device's performance was evaluated against non-clinical criteria. The acceptance criteria were met by passing various tests aligned with internal requirements, national standards, and international standards.
Table of Non-Clinical Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criterion (Standard/Test) | Reported Device Performance |
|---|---|---|
| Overall Design & Safety | Overall design, sterilization, biocompatibility, electrical safety. | Meets all requirements and confirms design output meets design inputs/specifications. |
| Optical Performance | Field of view and direction of view (ISO 8600-3) | Passed applicable testing. |
| Spatial Resolution (ISO 3334, test chart No. 2) | Passed applicable testing. | |
| Visualization and illumination study (in uterine cavity using hysteroscopy simulator) | Demonstrated adequacy of imaging. | |
| Distortion characteristics (FDA Guidance Hysteroscopes and Gynecologic Laparoscopes Submission Guidance for 510(K), section V(E)(6b)) | Passed applicable testing. | |
| Physical Dimensions | Maximum width of insertion portion (ISO 8600-4) | Passed applicable testing. |
| Biocompatibility | Biocompatibility testing (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12) | Passed applicable testing. |
| EO and ECH residual testing (ISO 10993-7) | Passed applicable testing. | |
| Electrical Safety & EMC | Electromagnetic Compatibility (EN/IEC 60601-1-2) | Passed applicable testing. |
| Electrical Safety (AAMI/ANSI ES60601-1 and EN 60601-2-18) | Passed applicable testing. | |
| Sterilization & Shelf Life | Sterilization Validation (ISO 11135 for EO, ISO 11137-1 and ISO 11137-2 for Radiation - OperaScope Batteries) | Passed applicable testing. |
| Maintenance of sterilization (ISO 11737-2) | Passed applicable testing. | |
| Shelf-Life and Simulated shipping conditions (ASTM D4169) | Passed applicable testing. | |
| Mechanical & Functionality | Mechanical testing (bending (displacement), tensile strength and torque) | Passed applicable testing. |
| In-flow and out-flow fluid delivery, including leak testing | Passed applicable testing. | |
| Functionality testing (compatibility of instruments and accessories with respect to dimensions) | Passed applicable testing. | |
| Battery lifetime | Passed applicable testing. | |
| Software Validation | Software Validation and Verification (IEC 62304) | Passed applicable testing. |
| FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Moderate Level of Concern) | Compliant with guidance. |
Regarding a "study that proves the device meets the acceptance criteria":
Based on the document, the "study" was a series of non-clinical performance tests that are detailed in section "9. Non-Clinical Performance Data". The device passed all these tests.
Based on the provided text, the following information cannot be extracted or is explicitly stated as "Not Applicable":
2. Sample sizes used for the test set and the data provenance:
- No human clinical test set was used for performance evaluation, as indicated by "Clinical Performance Data: Not Applicable". The "test set" in the context of non-clinical data would refer to the samples used for physical, electrical, and optical testing, but specific sample sizes for each non-clinical test are not provided. Data provenance would be from internal lab testing based on the referenced standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no human clinical test set was used requiring expert ground truth establishment for performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no human clinical test set was used.
5. 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:
- Not applicable. This device is a direct visualization tool, not an AI-assisted diagnostic tool, and no clinical study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm/AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" was established by the specifications and parameters defined within the relevant national and international standards (e.g., ISO, EN/IEC, ASTM) and the device's design inputs. For instance, for "Field of view," the ground truth is the specified range defined by ISO 8600-3.
8. The sample size for the training set:
- Not applicable, as this device does not involve a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for 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.