(170 days)
No
The summary describes a standard flexible rhinolaryngoscope and its associated display units and accessories. There is no mention of AI, ML, image processing for analysis, or any data sets for training or testing AI/ML models. The performance studies focus on biocompatibility, electrical safety, EMC, and general performance testing, not AI/ML performance metrics.
Yes
The "Intended Use / Indications for Use" section states that for models with a working channel, "treatment is also possible," indicating a therapeutic function.
Yes
The intended use explicitly states "examination of nasal cavity and upper respiratory tract", which is a diagnostic purpose. While it also mentions "treatment is also possible" with certain models, the primary and general use described is for examination, making it a diagnostic device.
No
The device description clearly describes a physical, flexible rhinolaryngoscope with different models based on physical characteristics like working channel diameter and outer diameter. It also mentions connection to display units and accessories, and performance studies include biocompatibility and electrical safety testing, all indicative of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Single-use Flexible Rhinolaryngoscope is a device used for direct visual examination and potentially treatment of the nasal cavity and upper respiratory tract. It is an endoscopic device used in vivo (within the body), not in vitro (in a lab setting).
- Intended Use: The intended use clearly states "examination of nasal cavity and upper respiratory tract" and "treatment is also possible." This aligns with the function of an endoscope used for direct visualization and intervention.
- Device Description: The description focuses on the physical characteristics and connection to display units for visualization, not on analyzing biological samples.
- Performance Studies: The performance studies mentioned are related to biocompatibility, electrical safety, EMC, and general performance testing of the device itself, not on the accuracy of diagnostic tests performed on samples.
Therefore, this device falls under the category of a medical device used for examination and treatment, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
EOB
Device Description
The Single-use Flexible Rhinolaryngoscope can be connected to the compatible Vathin Display Units and other accessories for examination and treatment of nasal cavity and upper respiratory tract.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal cavity and upper respiratory tract
Indicated Patient Age Range
Adults
Intended User / Care Setting
The device is only to be used by skilled medical staff trained in clinical endoscopic techniques and procedures.
The device is for use in a hospital or qualified medical institution.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 21, 2023
Hunan Vathin Medical Instrument Co., Ltd. Du Jing RA Manager 1/F, Building 12, Innovation and Entrepreneurship Service Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone Xiangtan, Hunan 411100 China
Re: K221581
Trade/Device Name: Single-Use Flexible Rhinolaryngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB
Dear Du Jing:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 18, 2022. Specifically, FDA is updating this SE Letter to reflect the enclosed Indications for Use Statement page where the "Prescription Use" box is checked, as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shu-Chen Peng, Ph.D., Team Assistant Director, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, (301) 796-6481, shu-chen.peng(@fda.hhs.gov.
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 Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services - USA and the FDA U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and white.
November 18, 2022
Hunan Vathin Medical Instrument Co., Ltd. Du Jing RA Manager 1/F, Building 12, Innovation and Entrepreneurship Service Ctr. No. 9 Chuangi West Road Jiuhua Economic Dev. Zone Xiangtan, Hunan 411100 China
Re: K221581
Trade/Device Name: Single-Use Flexible Rhinolaryngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: October 19, 2022 Received: October 19, 2022
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/cfpmr/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
2
requirements, including, but not limited to: registration and listing (21 CFR Part 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 provisions (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 Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221581
Device Name
Single-use Flexible Rhinolaryngoscope
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) summary
l Submitter
| Device submitter:
Address: | Hunan Vathin Medical Instrument Co., Ltd.
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: RA Manager
Phone: +86-18915069265
E-mail: charlene@vathin.com |
II Device
Trade Name of Device: Single-Use Flexible Rhinolaryngoscope Common name: Nasopharyngoscope, Flexible or rigid Classification: Class II, 21 CFR 874.4760 Product Code: EOB Review Panel: Ear Nose & Throat
III Predicate Device
| Trade name: | Ambu AScope 4 RhinoLaryngo Intervention |
|---|---|
| Regulation number: | 21 CFR 874.4760 |
| Regulation name: | Nasopharyngoscope, Flexible or rigid |
| Regulatory class: | Class II |
| Product code: | EOB |
| Submitter: | Ambu A/S |
| 510(k) number: | K190972 |
IV Device description
The Single-use Flexible Rhinolaryngoscope can be connected to the compatible Vathin Display Units and other accessories for examination and treatment of nasal cavity and upper respiratory tract.
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.
V Indications for use
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
5
that include a working channel and permit the use of a compatible 3rd party accessory, treatment is also possible.
VI Comparison of technological characteristics with the predicate 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.
| Device
| feature | Proposed Device | Predicate Device |
|---|---|---|
| Trade Name | Single-Use Flexible | |
| Rhinolaryngoscope | Ambu AScope 4 RhinoLaryngo | |
| Intervention (K190972) | ||
| Classification | ||
| Name | Nasopharyngoscope, Flexible or rigid | Nasopharyngoscope, Flexible or rigid |
| Product Code | EOB | EOB |
| Regulation | ||
| Number | 21 CFR 874.4760 | 21 CFR 874.4760 |
| Intended use | 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 endoscope is a sterile, single-use, | |
| flexible endoscope intended for | ||
| endoscopic procedures and | ||
| examination within the nasal lumens | ||
| and upper airway anatomy. The | ||
| endoscope is intended to provide | ||
| visualization via a monitor. | ||
| Application | ||
| field | The device is for use in a hospital or | |
| qualified medical institution. | The endoscope is intended for use in | |
| a hospital environment. | ||
| Intended user | The device is only to be used by | |
| skilled medical staff trained in clinical | ||
| endoscopic techniques and | ||
| procedures. | Before initial use of the aScope 4 | |
| RhinoLaryngo Intervention it is | ||
| essential for operators to have | ||
| received sufficient training in clinical | ||
| endoscopic techniques and to be | ||
| familiar with the intended use, | ||
| warnings and cautions mentioned in | ||
| these instructions. | ||
| Patient | ||
| population | Adults | Adults |
| Device | ||
| feature | Proposed Device | Predicate Device |
| Trade Name | Single-Use Flexible | |
| Rhinolaryngoscope | Ambu AScope 4 RhinoLaryngo | |
| Intervention (K190972) | ||
| Scope type | Flexible | Flexible |
| Field of view | ||
| (degree) | 110° | 85° |
| Direction of | ||
| view (degree) | 0° | 0° |
| Bending | ||
| angle | ||
| (degree) | Up: 210° | |
| Down: 210° | Up: 130° | |
| Down: 130° | ||
| Maximum | ||
| insertion | ||
| portion | ||
| width(mm) | RL-S1800、RL-S1801、RL-E1800、 | |
| RL-E1801: 3.2 | ||
| RL-S1E00、RL-S1E01、RL-E1E00、 | ||
| RL-E1E01: 5.0 | 5.5 | |
| Minimum | ||
| insertion | ||
| channel | ||
| width(mm) | RL-S1800、RL-S1801、RL-E1800、 | |
| RL-E1801: 0 | ||
| RL-S1E00、RL-S1E01、RL-E1E00、 | ||
| RL-E1E01: 2.2 | 2.0 | |
| Working | ||
| length (mm) | 300 | 350 |
| Illumination | ||
| source | LED | LED |
| Single-use | Yes | Yes |
| Biocompatibility | No Cytotoxicity | |
| No Irritation to Skin | ||
| No significant evidence of sensitization | ||
| No pyrogen | No Cytotoxicity | |
| No Irritation to Skin | ||
| No significant evidence of sensitization | ||
| No pyrogen | ||
| Sterilization | EO | EO |
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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 (