(107 days)
The Single-use Flexible Rhinolaryngoscope is designed to be used with the Digital Video Monitor, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.
The Digital Video Monitor is specially designed to be used with endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The Vathin® Video Rhinolaryngoscope System is for use in a hospital environment.
The Vathin® Video Rhinolaryngoscope System consists of Single-use flexible Rhinolaryngoscope (eight models shown in below) and Digital Video Monitor (model: DVM-A1, DVM-A2, DVM-B1, DVM-B2) for clinical image processing and display.
The Single-use Flexible Rhinolaryngoscope is designed for use with Vathin Display Units, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.
The Digital Video Monitor is specially designed to be used with compatible Vathin endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
There are eight subject nasopharyngoscope models: RL-S1800, RL-S1801, RL-E1800, RL-E1801, RL-S1E00, RL-S1E01, RL-E1E00, RL-E1E01. The main differences between product models are in the working channel inner diameter (whether channel is present or not), outer diameter, and rotate function.
Single-use flexible Rhinolaryngoscope is a sterile single Rhinolaryngoscope. Digital Video Monitor is a reusable monitor.
The light emitted by the LED cold light source of the Single-use flexible Rhinolaryngoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Digital Video Monitor via the encoding circuit. The Digital Video Monitor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal.
Single-use flexible Rhinolaryngoscope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user .
- Flexible insertion cord .
- Camera and LED light source at the distal tip .
- . Sterilized by Ethylene Oxide
- For single use
The differences between the Single-use flexible Rhinolaryngoscope models are as follow:
- . Have or haven't working channel
- . Working channel inner diameter
- . Insertion tube outer diameter
- . The length of insertion tube
Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your requested information:
Device: Vathin® Video Rhinolaryngoscope System (includes Single-use Flexible Rhinolaryngoscope and Digital Video Monitor)
1. A table of acceptance criteria and the reported device performance
The provided document describes the device's technical specifications and reports that all evaluation acceptance criteria were met for the non-clinical tests. However, it does not explicitly state numerical acceptance criteria for each performance parameter, nor does it provide a direct comparison table of "acceptance criteria vs. reported performance" in a quantitative manner. Instead, it lists the tests performed and implies compliance.
Below is a table summarizing the reported device performance characteristics where numerical values are given, and notes where general compliance is stated without specific numerical acceptance criteria.
| Feature | Reported Device Performance | Acceptance Criteria (Implied / Stated) |
|---|---|---|
| Rhinolaryngoscope | ||
| Field of View (degree) | 110° | Not explicitly stated, but "larger (than predicate) is beneficial" |
| Direction of View (degree) | 0° | Not explicitly stated |
| Bending Angle (degree) | Up: 210°, Down: 210° | Not explicitly stated, but "larger (than predicate) means more flexibility" |
| Max Insertion Portion Width (mm) | RL-S1800, etc.: 3.2; RL-S1E00, etc.: 5.0 | Not explicitly stated, but "smaller (than predicate) for easier patient entry" |
| Min Insertion Channel Width (mm) | RL-S1800, etc.: 0; RL-S1E00, etc.: 2.2 | Not explicitly stated, but "larger (than predicate) is more convenient for doctors" |
| Working Length (mm) | 300 | "Meets the needs of clinical use," considered substantially equivalent to predicate's 350mm |
| Illumination Source | LED | Same as predicate |
| Single-Use | Yes | Same as predicate |
| Biocompatibility | No Cytotoxicity, No Irritation to Skin, No significant evidence of sensitization, No pyrogen | All evaluation acceptance criteria were met (based on ISO 10993-1) |
| Sterilization | EO | Same as predicate |
| Digital Video Monitor | ||
| Max. Resolution | 1280 x 800 | Not explicitly stated, but higher than reference device's 800x480 |
| Display Type | 12.1" touch screen | Not explicitly stated, but different from reference device's 8.5" colour TFT LCD |
| USB Connection | A-type | Same as reference device |
| Video Output | HDMI/USB 2.0 | Different from reference device's RCA connection |
| Image/Video Capture | Yes | Same as reference device |
| Electrical Safety / EMC | System complies with standards | IEC 60601-1, IEC60601-2-18 for safety; IEC 60601-1-2 for EMC |
| Other Performance Tests | All "evaluation acceptance criteria were met" | (Tests listed in Section VII: Appearance, dimensions and weight, Functional performance) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document comprehensively lists various non-clinical tests conducted (Biocompatibility, Electrical Safety/EMC, Performance testing including Appearance, Dimensions, Weight, and Functional Performance). However, it does not specify the sample size used for any of these test sets, nor does it provide information on the country of origin of the data or whether the studies were retrospective or prospective. These were non-clinical, bench-top tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document describes non-clinical, bench-top testing. For such tests, the "ground truth" is typically established by industry standards, engineering specifications, and validated measurement methods, rather than by human expert consensus or qualifications in the medical sense for diagnostic performance. Therefore, no information on the number or qualifications of experts for establishing ground truth is provided or relevant in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since the study described involves non-clinical engineering and performance testing, rather than human interpretation of medical data, the concept of an "adjudication method" (like 2+1 or 3+1 for resolving discrepancies in expert interpretations) is not applicable and not mentioned.
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 MRMC comparative effectiveness study was mentioned or performed. This submission is for a medical device (endoscope system) and not an AI-powered diagnostic tool. The focus is on the substantial equivalence of the hardware's performance and safety.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned or performed. This device is a physical Rhinolaryngoscope and Digital Video Monitor, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests conducted:
- Biocompatibility: Ground truth was established by adherence to ISO 10993-1:2018 standards and validated laboratory tests (Cytotoxicity, Irritation, Sensitization, Pyrogenicity, Acute systemic toxicity).
- Electrical Safety and Electromagnetic Compatibility (EMC): Ground truth was established by compliance with international standards (IEC 60601-1, IEC60601-2-18, IEC 60601-1-2).
- Performance Testing (Appearance, Dimensions, Weight, Functional Performance): Ground truth was established by engineering specifications and validated measurement methods as defined in the test protocols (e.g., measuring angles, lengths, diameters, image quality parameters).
8. The sample size for the training set
Not applicable. This submission describes a hardware medical device, not a machine learning or AI model that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set was used.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 14, 2023
Hunan Vathin Medical Instrument Co., Ltd. Du Jing RA Manager 1/F, Building 12, Innovation and Entrepreneurship Service Center No 9 Chuanqi west road, Jiuhua Economic Development Xiangtan, Hunan 411100 China
Re: K230536
Trade/Device Name: Single-use Flexible Rhinolaryngoscope; Digital Video Monitor Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: May 15, 2023 Received: May 15, 2023
Dear Du Jing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control pro visions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230536
Device Name Vathin® Video Rhinolaryngoscope System
Indications for Use (Describe)
The Single-use Flexible Rhinolaryngoscope is designed to be used with the Digital Video Monitor, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.
The Digital Video Monitor is specially designed to be used with endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The Vathin® Video Rhinolaryngoscope System is for use in a hospital environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K230536 510(k) summary
l Submitter Device submitter: Hunan Vathin Medical Instrument Co., Ltd. Address: 1/F, Building 12, Innovation and Entrepreneurship Service Center, No 9 Chuanqi west road, Jiuhua Economic Development Zone, 411100 Xiangtan, Hunan, China Contact person: Du Jing Title: Requlatory Affairs Manager Phone: 4000789990 E-mail: charlene@vathin.com II Device Trade Name of Device: Vathin® Video Rhinolarvngoscope System Model: Single-Use Flexible Rhinolaryngoscope RL-S1800, RL-S1801, RL-E1800, RL-E1801, RL-S1E00, RL-S1E01, RL-E1E00, RL-E1E01 Digital Video Monitor DVM-A1, DVM-A2, DVM-B1, DVM-B2 21 CFR 874.4760 Regulation number: Nasopharyngoscope (flexible or rigid) and accessories Regulation name: Regulation Class: ll Product Code: EOB Review Panel: Ear Nose & Throat
III Predicate Device and reference device
| Predicate Device | Reference Device | |
|---|---|---|
| Trade name: | Ambu AScope 4RhinoLaryngo Intervention | Ambu® aView Monitor |
| Regulationnumber: | 21 CFR 874.4760 | 21 CFR 874.4680 |
| Regulation name: | Nasopharyngoscope,Flexible or rigid | Bronchoscope (Flexible or Rigid)and Accessories |
| Regulatory class: | Class II | Class II |
| Product code: | EOB | EOQ |
| Submitter: | Ambu A/S | Ambu A/S |
| 510(k) number: | K190972 | K173727 |
IV Device description
The Vathin® Video Rhinolaryngoscope System consists of Single-use flexible Rhinolaryngoscope (eight models shown in below) and Digital Video Monitor (model: DVM-A1, DVM-A2, DVM-B1, DVM-B2) for clinical image processing and display.
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The Single-use Flexible Rhinolaryngoscope is designed for use with Vathin Display Units, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.
The Digital Video Monitor is specially designed to be used with compatible Vathin endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
There are eight subject nasopharyngoscope models: RL-S1800, RL-S1801, RL-E1800, RL-E1801, RL-S1E00, RL-S1E01, RL-E1E00, RL-E1E01. The main differences between product models are in the working channel inner diameter (whether channel is present or not), outer diameter, and rotate function.
Single-use flexible Rhinolaryngoscope is a sterile single Rhinolaryngoscope. Digital Video Monitor is a reusable monitor.
The light emitted by the LED cold light source of the Single-use flexible Rhinolaryngoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Digital Video Monitor via the encoding circuit. The Digital Video Monitor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal.
Single-use flexible Rhinolaryngoscope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user .
- Flexible insertion cord .
- Camera and LED light source at the distal tip .
- . Sterilized by Ethylene Oxide
- For single use
The differences between the Single-use flexible Rhinolaryngoscope models are as follow:
- . Have or haven't working channel
- . Working channel inner diameter
- . Insertion tube outer diameter
- . The length of insertion tube
V Indications for use
The Single-use Flexible Rhinolaryngoscope is designed to be used with the Digital Video Monitor, for examination of nasal cavity and upper respiratory tract. For Rhinolaryngoscope models that include a working channel and permit the use of a compatible 3rd party
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accessory, treatment is also possible.
The Digital Video Monitor is specially designed to be used with compatible Vathin endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The Vathin® Video Rhinolaryngoscope System is for use in a hospital environment.
VI Comparison of technological characteristics with the predicate device and reference devices
The Single-Use Flexible Rhinolaryngoscope has the same intended use and principal operation, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. Any differences in various attributes as listed below between the Single-Use Flexible Rhinolaryngoscope and predicate device do not alter suitability of the proposed device for its intended use nor impact substantial equivalence with the predicate.
The Single-Use Flexible Rhinolaryngoscope are identical to the ones cleared in K221581, and so any differences in bending angle, etc. were previously compared.
| Device feature | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Trade Name | Single-Use FlexibleRhinolaryngoscope | Ambu AScope 4 RhinoLaryngoIntervention (K190972) | / |
| ClassificationName | Nasopharyngoscope, Flexible orrigid | Nasopharyngoscope, Flexible orrigid | Same |
| Product Code | EOB | EOB | Same |
| RegulationNumber | 21 CFR 874.4760 | 21 CFR 874.4760 | Same |
| Intended use | The Single-use FlexibleRhinolaryngoscope is designedfor use with Vathin Display Units,for examination of nasal cavityand upper respiratory tract. ForRhinolaryngoscope models thatinclude a working channel andpermit the use of a compatible 3rdparty accessory, treatment is alsopossible. | The endoscope is a sterile, single-use, flexible endoscope intendedforendoscopic procedures andexamination within the nasallumens and upper airway anatomy.The endoscope is intended toprovidevisualization via a monitor. | Same |
| Application field | The device is for use in a hospitalor qualified medical institution. | The endoscope is intended for usein a hospital environment. | Same |
| Device feature | Proposed Device | Predicate Device | Remark |
| Trade Name | Single-Use FlexibleRhinolaryngoscope | Ambu AScope 4 RhinoLaryngoIntervention (K190972) | / |
| Intended user | The device is only to be used byskilled medical staff trained inclinical endoscopic techniquesand procedures. | Before initial use of the aScope 4RhinoLaryngo Intervention it isessential for operators to havereceived sufficient training inclinical endoscopic techniques andto be familiar with the intendeduse, warnings and cautionsmentioned in these instructions. | Same |
| Patientpopulation | Adults | Adults | Same |
| Scope type | Flexible | Flexible | Same |
| Field ofview(degree) | 110° | 85° | *1 |
| Directionofview (degree) | 0° | 0° | *1 |
| Bending angle(degree) | Up: 210°Down: 210° | Up: 130°Down: 130° | *2 |
| Maximuminsertionportionwidth(mm) | RL-S1800、RL-S1801、RL-E1800、RL-E1801: 3.2RL-S1E00、RL-S1E01、RL-E1E00、RL-E1E01: 5.0 | 5.5 | *3 |
| Minimuminsertionchannelwidth(mm) | RL-S1800、RL-S1801、RL-E1800、RL-E1801: 0RL-S1E00、RL-S1E01、RL-E1E00、RL-E1E01: 2.2 | 2.0 | *4 |
| Working length(mm) | 300 | 350 | *5 |
| Illuminationsource | LED | LED | Same |
| Single-use | Yes | Yes | Same |
| Biocompatibility | No CytotoxicityNo Irritation to SkinNo significant evidence ofsensitization | No CytotoxicityNo Irritation to SkinNo significant evidence ofsensitization | Same |
| Device feature | Proposed Device | Predicate Device | Remark |
| Trade Name | Single-Use FlexibleRhinolaryngoscope | Ambu AScope 4 RhinoLaryngoIntervention (K190972) | / |
| No pyrogen | No pyrogen | Same | |
| Sterilization | EO | EO | Same |
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Compared with K221581, only the monitors are being updated in the present 510(k). Because the monitor is required to be connected during the use of the Ambu AScope 4 RhinoLaryngo Intervention, the Ambu aView used with Ambu AScope 4 is selected as the reference device for the Digital Video Monitor.
| Device feature | Proposed Device | Reference Device | Remark |
|---|---|---|---|
| Trade Name | Digital Video Monitor | Ambu® aView Monitor (K173727) | / |
| Classification Name | Nasopharyngoscope, Flexible or rigid | Bronchoscope (Flexible or Rigid) and Accessories | *6 |
| Product Code | EOB | EOQ | *6 |
| Regulation Number | 21 CFR 874.4760 | 21 CFR 874.4680 | *6 |
| Models | Digital Video Monitor:DVM-A1, DVM-A2,DVM-B1, DVM-B2 | Ambu® aView Monitor | / |
| Intended use | The Digital Video Monitor isspecially designed to be usedwith compatible Vathinendoscopes and other auxiliaryequipment for the purposes ofendoscopic diagnosis, treatmentand video observation. | The aViewTM monitor is a non-sterile, reusable digital monitor,intended to display live imagingdata from Ambu visualisationdevices. | / |
| Application field | The device is for use in a hospitalor qualified medical institution. | For in-hospital use. | Same |
| Intended user | For use by trainedclinicians/physicians only. | For use by trainedclinicians/physicians only. | Same |
| Max. resolution | 1280 x 800 | 800 * 480 | / |
| Display type | 12.1" touch screen | 8.5" colour TFT LCD | / |
| USB connection | A-type | Type A | Same |
| Video output | HDMI/USB 2.0 | RCA connection (use adapter | / |
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| Device feature | Proposed Device | Reference Device | Remark |
|---|---|---|---|
| cable included) | |||
| Image/Videocapture | Yes | Yes | Same |
Note: Explain the conclusion.
*1: Field of view: Because the Field of view is larger, it means more content can be seen, which is beneficial for the clinical use of the product.
*2: Bending angle: Because the Bending angle is larger, it means more flexibility in clinical use.
*3: Maximum insertion portion width: In a comprehensive comparison, the Proposed Device has a smaller outer diameter than the Predicate Device, which means that it can enter the patient's body more easily during clinical use.
*4: Minimum insertion channel width: In a comprehensive comparison, the Proposed Device has a larger inner diameter than the Predicate Device, which means that it is more convenient for doctors to operate in clinical use.
*5: Working length: The length of 300mm meets the needs of clinical use, and it is considered that the Working length is substantially equivalent.
*6: Classification name/product code/Regulation Number: The predicate device itself does not contain a monitor, it is intended to be used with the Aview Monitor which is included in the 510(k) number K173727.
VII Summary of Non-clinical tests:
Biocompatibility testing
Biocompatibility of the Single-Use Flexible Rhinolaryngoscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation, Sensitization, Pyrogenicity and Acute systemic toxicity. All evaluation acceptance criteria were met.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Vathin® Video Rhinolaryngoscope System. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.
Performance testing
The following performance testing was conducted on the Vathin® Video Rhinolaryngoscope System.
Appearance, dimensions and weight
- . Working length
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- Bending angle .
- Work channel ID .
- Insert tube outside diameter .
- Maximum outer diameter of insertion section .
- . Package reliability
- coaxiality deviation .
- direction of view
- LED temperature test .
- . Product length
- Product weight .
- . Product appearance
Functional performance
- . Attractive features
- Rotating sleeve function test .
- Handle shape ●
- Wire length ●
- Hot-swap function
- Image display .
- Edge uniformity .
- Illuminated mirror light effect .
- Field of view .
- Observe the depth of field ●
- Field of view central angle resolution .
- Field of view quality ●
- . Colour rendering index
- . Related colour temperatures
- Radiation flux ratio of red, green and blue light ●
- . Infrared cut-off performance
- . Brightness response characteristics
- Signal-to-noise ratio ●
- . Spatial frequency response
- Still Image Tolerance ●
- Water delivery .
- Volume of attraction .
VIII Conclusion
The Vathin® Video Rhinolaryngoscope System is substantially equivalent to its proposed devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed predicate device cleared under K190972.
§ 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.