Rhinolaryngoscope system

K232435 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · EOB · Apr 26, 2024 · Ear, Nose, Throat

Device Facts

• Record ID: K232435
• Device Name: Rhinolaryngoscope system
• Applicant: Shenzhen HugeMed Medical Technical Development Co., Ltd.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Apr 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

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 an Image Processor. The endoscope is intended for use in a hospital environment. It is designed for use in adults.

Device Story

System comprises single-use flexible rhinolaryngoscope (models RH-M58, RH-M52, RH-M50, RH-M40, RH-M32, RH-M22) and reusable VLM-02 image processor. Device captures visual data from nasal/upper airway anatomy via distal-tip LED illumination and sensor; transmits signal to image processor for display. Used by clinicians in hospital settings for diagnostic/procedural visualization. Output allows real-time anatomical inspection to assist clinical decision-making. Benefits include sterile, single-use design eliminating reprocessing requirements and cross-contamination risks.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench performance testing, including optical performance (ISO 8600), mechanical bending, photobiological safety (IEC 62471), thermal safety (IEC 60601-2-18), and biocompatibility (ISO 10993-1).

Technological Characteristics

Flexible, single-use rhinolaryngoscope with LED illumination at distal tip. System includes reusable image processor (VLM-02). Complies with IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2. Sterilization via EO (ISO 11135).

Indications for Use

Indicated for endoscopic procedures and examination within the nasal lumens and upper airway anatomy in adults in a hospital environment.

Regulatory Classification

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.

Predicate Devices

• Ambu aScope 4 RhinoLaryngo Slim (K191080)

Reference Devices

• Ambu AScope 4 RhinoLaryngo Intervention (K190972)
• Single-Use Flexible Rhinolaryngoscope (K221581)
• Image Processor VLM-02 (K222910)

Submission Summary (Full Text)

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April 26, 2024

Shenzhen HugeMed Medical Technical Development Co., Ltd. % Yang Jie Consultant Shenzhen Chonconn Medical Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China

### Re: K232435

Trade/Device Name: Rhinolaryngoscope system Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: March 27, 2024 Received: March 27, 2024

### Dear Yang Jie:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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/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 ([e-mail]) or phone [phone] 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

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### Indications for Use

510(k) Number (if known) K232435

Device Name Rhinolaryngoscope System

### Indications for Use (Describe)

The endoscope is a sterile, single endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via an Image Processor. The endoscope is intended for use in a hospital environment. It is designed for use in adults.

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|-----------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

The assigned 510(k) number is K232435.

Prepared Date: 2024/04/25

#### 1. Submission sponsor

Name: Shenzhen HugeMed Medical Technical Development Co., Ltd.

Address: 415, 416-1,516-1, Building 2, No. 1, Mawu Road, Baoan Community, Yuanshan Street, Longgang District, Shenzhen, Guangdong, 518115, China Contact person: Cathy Title: Regulatory engineer E-mail: [e-mail] Tel: [phone]

#### 2. Submission correspondent

Name: Shenzhen Chonconn Medical Device Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China Contact person: Yang Jie E-mail: [e-mail] Tel: [phone]

| Trade/Device Name | Rhinolaryngoscope System |
|-------------------|------------------------------------------------------------------------------------------------------------|
| Model | Single-use Rhinolaryngoscope: RH-M58, RH-M52, RH-M50,<br>RH-M40, RH-M32, RH-M22<br>Image Processor: VLM-02 |
| Common Name | Rhinolaryngoscope System |
| Regulatory Class | Class II |
| Classification | 21CFR 874.4760 / Nasopharyngoscope (flexible or rigid) and<br>accessories / EOB |
| Submission type | Traditional 510(K) |

#### 3. Subject Device Information

#### 4. Predicate Device

- 1) Predicate device 510(k) number: K191080 Product name: Ambu aScope 4 RhinoLaryngo Slim Submitter: Ambu Inc.
- Reference device 2) 510(k) number: K190972 Product name: Ambu AScope 4 RhinoLaryngo Intervention

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Submitter: Ambu A/S

Reference device 3)

510(k) number: K221581 Product name: Single-Use Flexible Rhinolaryngoscope Submitter: Hunan Vathin Medical Instrument Co., Ltd.

### ട. Device Description

The Rhinolaryngoscope System consists of Single-Use Rhinolaryngoscope (six models shown in below) to be introduced within the nasal lumens and upper airway anatomy and Image Processor (model: VLM-02) for clinical image processing. The Image Processor provides power and processes the images for medical electronic endoscope.

| System name | Component name | Model |
|-----------------------------|---------------------------------|----------------------------------------------------|
| Rhinolaryngoscope<br>System | Single-Use<br>Rhinolaryngoscope | RH-M58, RH-M52, RH-M50, RH-<br>M40, RH-M32, RH-M22 |
| | Image Processor | VLM-02 |

The Single-Use Rhinolaryngoscope is a sterile single used flexible Rhinolaryngoscope. The Image Processor is a reusable monitor.

The differences between the Single-use Rhinolaryngoscope models are as follow:

- Have or haven't working channel
- Working channel inner diameter
- Insertion tube outer diameter

### 6. Intended use & Indication for use

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 an Image Processor.

The endoscope is intended for use in a hospital environment. It is designed for use in adults.

### 7. Comparison to the Predicate Device

The Rhinolaryngoscope System consists of Single-Use Rhinolaryngoscope (six models shown in below) and Image Processor (model: VLM-02). However, the Image Processor (model: VLM-02) has been cleared by K222910. The following lists the comparison with the predicate device for the Single-Use Rhinolaryngoscope.

| Features | Subject Device | Predicate<br>Device | Comparison |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K232435 | K191080 | / |
| Manufacturer | Shenzhen HugeMed<br>Medical Technical | Ambu Inc. | / |
| Features | Subject Device | Predicate Device | Comparison |
| | | | |
| Model | Development Co.,<br>Ltd. | Ambu aScope 4<br>RhinoLaryngo Slim | / |
| | Single-use<br>Rhinolaryngoscope:<br>RH-M58, RH-M52,<br>RH-M50, RH-M40,<br>RH-M32, RH-M22 | | |
| Product code<br>&<br>Classification | 21 CFR 874.4760,<br>EOB Class II | 21 CFR<br>874.4760,<br>EOB Class II | Same |
| Intended use | The endoscope is a<br>sterile, single-use,<br>flexible endoscope<br>intended for<br>endoscopic<br>procedures and<br>examination within<br>the nasal lumens and<br>upper airway<br>anatomy. The<br>endoscope is<br>intended to provide<br>visualization via an<br>Image Processor.<br>The endoscope is<br>intended for use in a<br>hospital<br>environment. It is<br>designed for use in<br>adults. | The endoscope is<br>a sterile, single-<br>use, flexible<br>endoscope<br>intended for<br>endoscopic<br>procedures and<br>examination<br>within the nasal<br>lumens and<br>upper airway<br>anatomy. The<br>endoscope is<br>intended to<br>provide<br>visualization via<br>Ambu displaying<br>unit.<br>The endoscope is<br>intended for use<br>in a hospital<br>environment. It<br>is designed for<br>use in adults. | Same |
| Scope type | Flexible | Flexible | Same |
| Field of view<br>(degree) | 120° | 85° | Similar<br>Although the field of view<br>is slightly different from the<br>predicate device, the area |
| Features | Subject Device | Predicate Device | Comparison |
| | | | within the view can be<br>adjusted by the advance or<br>retreat of the endoscope.<br>Therefore, the difference in<br>FOV does not affect the<br>safety and effectiveness of<br>the subject device. |
| Direction of<br>view<br>(degree) | 0° | 0° | Same |
| Depth of<br>Field | 3-50mm | 6-50mm | Similar<br>The subject device has a<br>wider range of depth of view<br>than the predicate device to<br>give physicians more<br>options for diagnosis and<br>treatment based on the<br>patient's condition.<br>Therefore, this difference<br>will not raise new question<br>on safety and effectiveness<br>of the proposed device. |
| Bending<br>angle<br>(degree) | 210° (up and down) | 130° (up and<br>down) | Different, but the K221581<br>reference device has the<br>same 210° (up and down)<br>Bending angle.<br>Because the Bending angle<br>is larger, it means more<br>flexibility in clinical use.<br>Therefore, this difference<br>will not raise new question<br>on safety and effectiveness<br>of the proposed device. |
| Maximum<br>insertion<br>portion<br>width(mm) | RH-M22:<br>2.2±10%mm<br>RH-M32:<br>3.2±10%mm<br>RH-M40:<br>4.4±10%mm | 3.5 mm | Similar, and the K190972<br>reference device also has a<br>similar 5.5 mm Maximum<br>insertion portion width.<br>The difference in Maximum<br>insertion portion width for |
| Features | Subject Device | Predicate Device | Comparison |
| | RH-M50:<br>$5.0\pm10\%mm$ | | the subject device does not<br>alter or change the<br>indications for use or result<br>in a new intended use. |
| | RH-M52:<br>$5.2\pm10\%mm$ | | |
| | RH-M58:<br>$5.8\pm10\%mm$ | | |
| | | | |
| Minimum<br>insertion<br>channel<br>width(mm) | RH-M22: /<br>RH-M32: $1.2\pm10\%$<br>mm<br>RH-M40: Φ≥1.1 mm<br>RH-M50: $2.8\pm10\%$<br>mm<br>RH-M52: Φ≥2.1 mm<br>RH-M58: Φ≥2.50<br>mm | 3.0mm | Similar<br>The difference in Minimum<br>insertion channel width for<br>the subject device does not<br>alter or change the<br>indications for use or result<br>in a new intended use. |
| Working<br>length<br>(mm) | 350 mm | 300 mm | Similar, and the K190972<br>reference device has the<br>same 350 mm Working<br>length.<br>The length of 300mm meets<br>the needs of clinical use.<br>Therefore, this difference<br>will not raise new question<br>on safety and effectiveness<br>of the proposed device. |
| Illumination<br>Source | LED | LED | Same |
| LED Light<br>source | At distal tip | At distal tip | Same |
| Single-use | Yes | Yes | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Safety | IEC 60601-1<br>IEC 60601-2-18 | IEC 60601-1<br>IEC 60601-2-18 | Same |
| Bench test | ISO 8600-1<br>ISO 8600-3<br>ISO 8600-4 | ISO 8600-1<br>ISO 8600-3<br>ISO 8600-4 | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |

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#### 8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

### Biocompatibility testing

Biocompatibility of the Single-Use Rhinolaryngoscope was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The following tests were performed, as recommended:

- . Cytotoxicity
- . Sensitization
- Oral Mucosa Irritation

The Single-Use Rhinolaryngoscope is considered surface - mucosal membrane contacting for a duration of less than 24 hours.

### Sterilization and shelf life testing

The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Single-use Rhinolaryngoscope is validated.

### Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Rhinolaryngoscope System. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.

### Bench performance testing

The following bench tests were performed:

1. Optical performance testing according to ISO 8600 series.

2. Color performance (color reproduction), geometric distortion, optical performance (resolution, depth of field and image intensity), SNR and dynamic range, image frame frequency and system delay test compared with the predicate device.

- 3. Mechanical bending testing.
- 4. Photobiological safety test verified compliance to IEC 62471:2006

5. Thermal safety performance test verified compliance to Protection against excessive temperature and other safety hazards of IEC 60601-2-18:2009

## 9. Clinical study

No clinical study is included in this submission

## 10. Conclusion

Substantial equivalence comparisons, performance testing and compliance with voluntary

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standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.