(473 days)
ShenDa® Sinuscope is intended to provide an endoscopic means to view the nasal cavity and nasopharynx.
ShenDa® Sinuscope is an unchanneled endoscope intended to provide an endoscopic means to view the nasal cavity and nasopharynx. The endoscope is available in the various combination of outer diameter (2.7mm, 3mm, 4mm) and vision direction angles (0, 12, 30, 45, 70 and 90 degree). It can be connected to OLYMPUS light source and OLYMPUS light cable. It is a reusable device subject to cleaning and steam sterilization.
The ShenDa® Sinuscope K161298 is a rigid endoscope intended to provide an endoscopic means to view the nasal cavity and nasopharynx. The device's performance was evaluated through non-clinical tests to verify its design specifications and substantial equivalence to a predicate device (SHARPSITE Ac K965233).
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Test Item | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1-2005 (Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance) | Complies with IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2007 (Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests) | Complies with IEC 60601-1-2 |
| Basic Safety & Essential Performance of Endoscopic Equipment | IEC 60601-2-18:2009 (Medical Electrical Equipment- Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment) | Complies with IEC 60601-2-18 |
| Biocompatibility (Cytotoxicity) | ISO 10993-5:2009 (Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity) | Complies with ISO 10993-5; No adverse reaction demonstrated in cytotoxicity tests. |
| Biocompatibility (Irritation & Skin Sensitization) | ISO 10993-10:2010 (Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization) | Complies with ISO 10993-10; No adverse reaction demonstrated in intracutaneous and skin sensitization tests. |
| General Requirements for Endoscopes | ISO 8600-1:2015 (Endoscopes--Medical endoscopes and Endotherapy Devices--part 1: General Requirements) | Complies with ISO 8600-1 |
| Optical Resolution | ISO 8600-5:2005 (Optics and photonics-Medical endoscopes and endotherapy devices part 5: Determination of optical resolution of rigid endoscopes with optics) | Complies with ISO 8600-5; Specific resolution values are not explicitly stated in the summary but were deemed compliant. |
| Insertion Width | Design Specifications (Expected to match the stated shaft body diameters) | Available in 2.7mm, 3.0mm, 4.0mm diameters. The test results demonstrated the proposed device met design specifications. |
| Field of View | Design Specifications (Expected to match the stated field of view angles) | Available in 60, 90, and 110 degrees. The test results demonstrated the proposed device met design specifications, offering a wider range than the predicate device. |
| Direction of View | Design Specifications (Expected to match the stated direction of view angles) | Available in 0, 12, 30, 45, 70, and 90 degrees. The test results demonstrated the proposed device met design specifications, offering a wider range than the predicate device. |
| Depth of Field | Design Specifications (Appropriate for clinical use) | 1-50mm. The design of the depth of field was considered appropriate for clinical use, even though the predicate device's depth of field was unknown. |
| Reprocessing | Effective cleaning and steam sterilization | The device is reusable and subject to cleaning and steam sterilization, indicating that the reprocessing methods were validated and found effective. |
2. Sample size used for the test set and the data provenance:
- The document describes non-clinical tests conducted to verify design specifications and substantial equivalence. These tests likely involved a sample of the manufactured devices for physical and performance measurements. Specific sample sizes for each test are not provided in the summary.
- The data provenance is from Shenyang, Liaoning, China, where the manufacturer (Shenyang Shenda Endoscope CO., LTD.) is located. The tests are non-clinical, so "retrospective or prospective" doesn't directly apply in the same way it would to human subject studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the evaluation involved non-clinical performance and safety testing against established engineering and biocompatibility standards, not expert-derived ground truth for diagnostic imaging or clinical outcomes.
4. Adjudication method for the test set:
- This information is not applicable as the evaluation involved non-clinical performance and safety testing, not adjudication by clinical experts.
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:
- No, an MRMC comparative effectiveness study was not done. This device is an endoscope, a viewing tool, not an AI-assisted diagnostic device.
- The submission explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a manual medical instrument (endoscope), not a software algorithm or an AI-enabled device.
7. The type of ground truth used:
- The "ground truth" for the non-clinical tests was established by international consensus standards (e.g., IEC 60601 series, ISO 10993 series, ISO 8600 series) and the design specifications of the device for parameters like physical dimensions, field of view, and direction of view.
8. The sample size for the training set:
- This information is not applicable. The device is an endoscope and does not involve AI or machine learning algorithms that require a training set.
9. How the ground truth for the training set was established:
- This information is not applicable for the reasons stated in point 8.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.